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Office of AIDS Research

• Vision and Mission
• Progress Against HIV/AIDS Timeline
• OAR: 35th Anniversary
• Organization
• OAR Leadership
• OAR Advisory Council
• Frequently Asked Questions

Located within the NIH Office of the Director, the Office of AIDS Research (OAR) strives to create a collaborative working environment in which highly qualified professionals work toward ending the HIV pandemic.

This page lists the following current employment opportunities at OAR:

Communications Specialist

Health science policy analyst.

• Associate Director for AIDS Research

To learn more about careers at NIH or across the federal government, visit these pages:

• NIH Division of Program Coordination, Planning, and Strategic Initiatives Careers : OAR is one of the coordinating offices in DPCPSI in the NIH Office of the Director. This webpage lists careers available within these coordinating offices.
• Jobs at NIH : NIH supports health research – making important discoveries that prevent disease, improve health, and save lives. This webpage lists careers available across the agency.
• USAJOBS : USAJOBS connects jobseekers with federal employment opportunities across the United States and around the world. This portal is the federal government’s official employment site.

Open Positions

• Physician (Research) – GS 14/15

POSITION DESCRIPTION: The NIH Office of AIDS Research (OAR) coordinates the NIH HIV research program across 3,500 projects in nearly 100 countries. Its mission is to ensure that NIH HIV research funding is directed at the highest priority research areas. OAR seeks a GS-13 Communications Specialist to contribute to the efforts of a strong and dynamic team to help translate the research agenda and its impact to key partners and the public.

The successful applicant will be a strong communications strategist, writer, and project manager . They will support a broad portfolio of communications and engagement activities, including activities such as:

• Driving communications efforts—including digital content strategy—for one or more of OAR’s signature programs, which focus on the intersection of HIV research with women, technology, aging, and early career investigators.
• Writing and editing content for OAR channels, including our website, director’s blog, social media, email marketing platform, and event collateral.
• Managing planning, promotion, and execution of the annual NIH World AIDS Day observance.
• Representing OAR in select federal communicator working groups.
• Contributing to an active redesign of the OAR website.
• Serving as the lead point of contact for the OAR website—overseeing the implementation of a maintenance plan, identifying opportunities for improvement, and coordinating updates with a team of contractors.

Applications may be submitted via USAJOBS July 22-26:

• GS-1001-13, Communication Specialist, DE (open to public applicants): https://www.usajobs.gov/GetJob/ViewDetails/800504800
• GS-1001-13 Communication Specialist, MP https://www.usajobs.gov/GetJob/ViewDetails/800505100

If you have questions about the position, please contact [email protected] .

POSITION DESCRIPTION: The Policy, Legislative, Communications, and Engagement (PLCE) team in the Office of AIDS Research (OAR) seeks a Health Science Policy Analyst (GS 12/13) to support reporting, planning, and legislative activities.

OAR coordinates the scientific, budgetary, and policy components of a diverse HIV/AIDS research program across NIH. The PLCE team was created in May 2022 to fulfill the responsibilities of the OAR to collect, coordinate, and disseminate information among key partners.

The HSPA primarily will support policy and legislative activities, including:

• Developing content for mandated reports, including the OAR Congressional Justification and NIH HIV/AIDS Professional Judgment Budget
• Preparing talking points and briefing materials for OAR leadership
• Responding to ad hoc requests from NIH, HHS, or Congress (e.g., data calls, controlled correspondence)
• Participating in OAR planning activities (i.e., organizational and strategic planning)

As a coordinating office, OAR has a dynamic, highly collaborative culture to support a productive HIV research program that spans across NIH. Priorities can evolve quickly and require frequent collaboration across internal teams and with NIH partners. The successful applicant will demonstrate flexibility in responding to shifting priorities and the ability to communicate complex information clearly and concisely.

Applications may be submitted via USAJOBS July 22-31:

GS-601-12, FPL 12 Health Science Policy Analyst, HHS-wide https://www.usajobs.gov/GetJob/ViewDetails/800273800  

GS-601-13, FPL 13 Health Science Policy Analyst, HHS-wide https://www.usajobs.gov/GetJob/ViewDetails/800274400

If you have questions about the position, please contact [email protected] and [email protected] .

Associate Director for AIDS Research, NIH, and Director, Office of AIDS Research, Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI)

POSITION:  The National Institutes of Health (NIH) is seeking exceptional candidates for the leadership position of Associate Director for AIDS Research (ADAR), NIH . The ADAR also functions as the Director, Office of AIDS Research (OAR) within the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the Office of the Director. The ADAR is a national and international leader who serves as the NIH official for establishing agency-wide policies and goals in AIDS research and coordinating the activities undertaken in the performance of this research. The position is established in legislation as a Secretarial appointment, reports to the Director, NIH, and the Director, DPCPSI, and has NIH-wide responsibilities summarized below.

This Title 42 position oversees the world’s largest AIDS research program, that reflects a comprehensive and complex NIH, multi-disciplinary, global program of basic, clinical, and behavioral and social science research on prevention and treatment of HIV infection, its associated co-infections, opportunistic infections, malignancies, and other complications. OAR is the only NIH component that carries out legislatively mandated NIH-wide coordination through a strategic planning and budgeting process to identify cross-cutting initiatives, increase interdisciplinary efforts, and establish a balanced portfolio of basic, translational, and clinical research investments across nearly all of the NIH Institutes and Centers (IC). This process requires innovation and adaptation to meet current scientific challenges and budget constraints. The position leads efforts to plan, coordinate, fund, and evaluate all NIH AIDS activities through unique authorities, including management of all scientific, legislative, budgetary, public policy, economic, and other health matters relevant to NIH AIDS research across all NIH components. These processes allow the position to adjust and refocus program efforts to meet national and international needs in the evolving epidemic. The position provides authoritative leadership, consultation, and advice to IC Directors in defining the overall short- and long-range scope and direction of AIDS research to be supported by the NIH. The position establishes special initiatives to address emerging issues and new frontiers of AIDS research. The position identifies and sets the scientific priorities for AIDS research which shape and determine the overall NIH AIDS research agenda and budget. More information about the NIH Strategic Plan for HIV and HIV-Related Research can be found at:  https://www.oar.nih.gov/hiv-policy-and-research/strategic-plan .

The OAR Director designs, leads, and directs efforts to: develop and execute a comprehensive strategic plan establishing scientific priorities and objectives for all NIH AIDS research activities and an annual comprehensive NIH-wide research budget; allocates all appropriated funds for NIH AIDS research activities to the NIH ICs in accordance with the strategic plan; develops the Presidential Professional Judgment Budget for NIH-funded AIDS research; plans, coordinates, and integrates all AIDS research activities across and throughout the NIH ICs; assesses and evaluates all current scientific portfolios to enhance collaboration, minimize duplication, and ensure that research dollars are invested in the highest priority areas of scientific opportunity; develops NIH-wide policies related to AIDS research; supports and maintains the Office of AIDS Research Advisory Council (OARAC), its related task forces and guidelines working groups; convenes the NIH AIDS Executive Committee; facilitates innovative cooperation in AIDS research between government, industry, and universities; and fosters meaningful interaction and collaboration in international AIDS research activities including with scientific and community groups. The ADAR directs a unique OAR process to collect, track, monitor, and assess all funds allocated to AIDS grants, contracts, research management and support, and intramural projects through a database system coding all projects according to the objectives of the plan. OAR employs over 48 full-time Federal employees and oversees the NIH AIDS budget of approximately $3 billion. The OAR has a FY 2023 estimated operating budget of more than $67 million, the majority of which is used to support unanticipated scientific opportunities by the Institutes and Centers.

The Office of AIDS Research was established in 1988 to plan, coordinate, and evaluate AIDS research and other activities conducted or supported by the NIH. OAR has unique legislative authorities unlike any other NIH entity to plan, coordinate, evaluate, and budget the entire NIH AIDS research program. OAR serves as the principal liaison with the U.S. Department of Health and Human Services, other Federal agencies, and domestic and international governmental and nongovernmental organizations on behalf of NIH AIDS-related research. OAR serves as a model of NIH-wide planning and management vested with primary responsibility for overseeing all NIH AIDS-related research, and thus allowing the NIH to pursue a united research front against the global AIDS pandemic.

Information about OAR is located at its website:  https://www.oar.nih.gov/ . Information about the National Institutes of Health is located at its website.

ABOUT THE NIH:  As the world's largest medical research facility, NIH consists of 27 Institutes/Centers, including the Clinical Center (an on-site research hospital), the Fogarty International Center, and the National Library of Medicine. NIH's national program of health research and research training is currently funded at more than $40 billion annually. NIH has over 18,000 employees.

LOCATION:  Bethesda, MD

REQUIRED QUALIFICATIONS:  Applicants must possess a Ph.D., M.D., or comparable doctorate degree in the biomedical or behavioral sciences plus senior-level scientific experience and knowledge of research programs in one or more scientific areas related to behavioral and social sciences research. They should be known and respected within their profession as individuals of scientific prominence, with a distinguished record of research accomplishments and knowledge of HIV/AIDS policy issues. Candidates should have demonstrated leadership and broad vision in the HIV/AIDS research arena involving dealings with outside groups; serving as spokesperson; planning, program assessment, and analysis of program objectives; resolution of operational problems and issues; and the ability to manage financial and human resources including building, motivating, and maintaining a culturally diverse staff.

SALARY/BENEFITS:  The Director, OAR, will be appointed at a salary commensurate with their qualifications. Full Federal benefits will be provided including leave, health and life insurance, long-term care insurance, retirement, and savings plan (401k equivalent). A recruitment and/or relocation incentive may be available; and relocation expenses may be paid.

EQUAL OPPORTUNITY EMPLOYMENT:  Selection for this position will be based solely on merit, with no discrimination for non-merit reasons such as race, color, religion, gender, sexual orientation, national origin, political affiliation, marital status, disability, age, or membership or non-membership in an employee organization. The NIH encourages the application and nomination of qualified women, minorities, and individuals with disabilities.

STANDARDS OF CONDUCT/FINANCIAL DISCLOSURE:  The National Institutes of Health inspires public confidence in our science by maintaining high ethical principles. NIH employees are subject to Federal government-wide regulations and statutes, as well as agency-specific regulations described at the NIH Ethics website. We encourage applicants to review this information. The position is subject to a background investigation and requires the incumbent to complete a public financial disclosure report prior to the effective date of the appointment.

FOREIGN EDUCATION:  Applicants who have completed part or all of their education outside the U.S. must have their foreign education evaluated by an accredited organization to ensure that the foreign education is equivalent to education received in accredited educational institutions in the U.S.  We will only accept the completed foreign education evaluation.  For more information on Foreign Education verification, visit the National Association of Credential Evaluation Services (NACES) website. Verification must be received prior to the effective date of the appointment.

ADDITIONAL INFORMATION:  HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.

REASONABLE ACCOMMODATION:  NIH provides reasonable accommodations to applicants with disabilities. If you require reasonable accommodation during any part of the application and hiring process, please notify us. The decision on granting reasonable accommodation will be made on a case-by-case basis.

HOW TO APPLY:  Applicants must electronically submit a current curriculum vitae, bibliography (if not included in your curriculum vitae), a photocopy of your doctoral degree, and full contact details for three (3) references. In addition, applicants are asked to prepare three (3) statements: a vision statement; a statement that addresses the specific qualification requirements; and a statement indicating how you have promoted diversity, equity, inclusion, and accessibility, and describing your mentoring and outreach activities, especially those involving underrepresented groups in biomedical research (please limit all statements to two pages each).  Review of applications will begin on August 28, 2023, but applications will be accepted until the position is filled. Complete application packages must be submitted to  [email protected] .

Please contact Betina Orezzoli at  [email protected]  for questions about the application process or position. Additional information may be found on the NIH HR website.

Do not include your birth date or social security number (SSN) on application materials.

HHS and NIH are equal opportunity employers dedicated to diversity, equity, inclusion, and accessibility.

This page last reviewed on July 25, 2024

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Job Vacancy Announcement – Social and Behavioral Sciences Administrator/Health Scientist Administrator (Program Officer)

Department of Health and Human Services (HHS) National Institutes of Health (NIH) National Institute of Mental Health (NIMH) Division of Services and Intervention Research (DSIR) Services Research and Clinical Epidemiology Branch (SRCEB)

Program Overview

The NIMH Services Research and Clinical Epidemiology Branch (SRCEB) in the Division of Services and Intervention Research (DSIR) seeks motivated and experienced health services researchers to develop and manage portfolios of innovative grant-supported research. Competitive applicants will have expertise in at least two of the following areas:

• Health disparities research that aims to understand and eliminate mental health disparities in access, continuity, quality, and outcomes of care, in minority, marginalized, and vulnerable populations, across a range of settings where care is or could be delivered. This program also seeks to expand understanding of the social, structural, behavioral, cultural, and environmental health determinants.
• Services research for people with early psychosis, clinical high risk, and/or serious mental illness (e.g., bipolar disorder or schizophrenia) that includes services interventions to reduce morbidity and premature mortality associated with severe mental illness.
• Mental health policy and health economic research that seeks to generate evidence that has promise to directly influence policy/rulemaking at federal, state, and local levels, and that includes large commercial third-party payers. This program ultimately seeks to increase affordability and improve outcomes for people with or at risk for mental illness.
• Child and adolescent services research that aims to improve access, engagement, quality, equity, utilization, effectiveness, and delivery of mental health services for children and adolescents with mental illness, serious emotional disturbance, and/or autism spectrum disorder.
• Research to improve the organization, coordination, and collaboration within and across relevant service sectors and settings whose primary mission is not mental health care delivery. These sectors and settings include criminal justice/law enforcement, housing and employment programs, adult social services, educational settings, and rehabilitation programs.
• Services research to address access, service, and other policy barriers to evidence-based practices for the mental health of older adult and geriatric populations. Areas of interest include research to understand care transitions due to insurance coverage, workforce development, research in nursing homes and other settings serving older adults, and research on systems-level interventions to improve the quality of mental health care for aging populations.

The ideal candidates will have a strong background in research methods. Examples include but are not limited to the following: analyzing large data sets, quasi-experimental techniques that utilize “natural experiments,” testing systems-level (multi-level) services interventions, randomized and comparative effectiveness trials, mixed method approaches, community-engaged research, and/or hybrid effectiveness-implementation designs.

Position Duties

DSIR offers a stimulating and collegial work environment with opportunities to influence mental health research priorities, develop new research initiatives, and contribute to advancing a national program of health services research.

General responsibilities for Program Officers in SRCEB include administering and managing a portfolio of extramural research grants; collaborating with researchers and Program Officers from related scientific programs within NIMH, NIH, the Department of Health and Human Services, and other public and private funding agencies; and communicating SRCEB research priorities via outreach to the scientific community (e.g., conference presentations, workshops, and special journal issues).

The successful candidate will have primary responsibility for planning, supporting, and administering programs of research, research training, and research infrastructure development, on all mental health services research issues. These include service organization, delivery (process and receipt of care), and related health economics at the individual, clinical, program, community, and systems levels in specialty mental health, general health, and others (such as the workplace).

Additionally, the incumbent will also support SCREB research areas including interventions to improve the quality and outcomes of care, (diagnostic, treatment, preventive, and rehabilitation services), dissemination and implementation of evidence-based interventions into service settings, and clinical epidemiology of mental disorders across all clinical and service settings.

Qualifications

The ideal candidate will possess a Ph.D. or equivalent doctoral degree (e.g., MD, DSW, ScD) from an accredited college or university, with graduate and/or postdoctoral training in health services, policy, and/or health economic research. Experience in the conduct of research, research management/coordination, and a history of relevant data-based publications are required. Strong organizational, oral, writing, and communication skills are required. Experience with the grants process is preferable. The successful candidate is subject to a background investigation and public financial disclosure requirements.

Applicants must be U.S. citizens. The NIH encourages the application and nomination of qualified women, minorities, and individuals with disabilities. HHS and NIH are Equal Opportunity Employers. The work site is in Rockville, Maryland. A full package of federal Civil Service benefits is available, including retirement, health, and life insurance, leave, and a Thrift Savings Plan (401K equivalent). Salary is competitive and commensurate with experience.

How to Apply

A Global Social and Behavioral Scientist Administrator (Program Officer) announcement will be available opening on November 18, 2024.

A Global Health Scientist Administrator (Program Officer) announcement will be available opening January 13, 2025.

Candidates must apply through USAJOBS: USAJOBS - The Federal Government's official employment site  . Interested applicants are strongly encouraged to also send a letter of interest and curriculum vitae to [email protected] .

Please set up notifications via USAJOBS for future announcements that fit your criteria. Visit the NIH Federal Resume Tips website for guidance on creating a federal resume  .

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The Department of Health and Human Services and National Institutes of Health encourage the application and nomination of qualified women, minorities, and individuals with disabilities. HHS and NIH are equal-opportunity employers. Applications from women, persons from underrepresented groups, and persons with disabilities are strongly encouraged.

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The Office of Data Science Strategy is committed to helping develop the NIH workforce with motivated, top tier talent. The ODSS Data Science Job Board serves to connect Institutes, Centers, and Offices (ICOs) with highly qualified, passionate applicants. View opportunities here .

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NIH launched the  Data and Technology Advancement National Service Scholars (DATA Scholars) Program in 2020. These scholars will spend one to two years transforming NIH programs by applying cutting-edge methods to health-related datasets. Scholars will bring innovative expertise in data or computer science, engineering, or related fields and an interest in using their skills to advance biomedicine and improve human health and well-being. 

The first cohort of DATA Scholars started in the fall of 2020.

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Coding it Forward is a non-profit focused on developing the next generation of technology leaders through the summer Civic Digital Fellowship. NIH hosted its inaugural cohort of Civic Digital Fellows in 2019. These fellows spend 10 weeks at NIH channeling their computational expertise toward hands-on experience with biomedical data-related challenges. 

To learn more about the fellowship, visit the Coding it Forward website .

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To learn more about the GDSSP and to apply, visit the OITE website .

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NIH’s CARE for Health Primary Care Research Network: Connecting the Lab, the Clinic, and the Community

Posted on October 8th, 2024 by Dr. Monica M. Bertagnolli

Since I became NIH Director last year, one key principle has guided my vision and approach: Our work is not finished when we deliver scientific discoveries; our work is finished when all people are living long and healthy lives.

But unfortunately, we’re seeing some alarming trends in the health of the U.S. population. It’s a bit of a puzzle. On one hand, significant advances in biomedical research over the last several decades have led to lifesaving interventions for a range of diseases and conditions. At the same time, the overall health of the people in this country appears to be stalled and even getting worse.

Looking at one measure of health, U.S. life expectancy is no longer steadily increasing—in fact, we’ve had a decline in life expectancy over the last decade. And though this included a dramatic drop because of the COVID-19 pandemic, the rate was declining before that. Life expectancy in the U.S. is also low compared to peer nations , even though we spend much more money on our health system. Disparities in mortality also persist among certain racial and ethnic groups and geographic regions . Our health is determined not only by the genes we inherit from our parents, but by our environment and social and economic factors. We know that in the U.S. today, your zip code can significantly impact your health.

I believe that biomedical research can play a key role in reversing these trends. In my first blog post , I explained how one of my goals as NIH Director is to ensure that the biomedical research enterprise is more inclusive to people from all walks of life, and I noted we can engage more communities as our research partners by meeting people where they are. Despite having the knowledge and technology to do so, our research and advances are not reaching everyone they should. Many people are not adequately represented in clinical research, and research data is especially lacking for people who are older, uninsured, belong to minority groups, or live in rural locations. Many people also face barriers to participating in clinical research, such as arranging and paying for transportation, getting time off from work and coordinating childcare, or lack of trust in medical institutions. To address these concerning trends in health, we need to do a better job of connecting the lab, the clinic, and the community.

In September, we moved closer to this goal by announcing awards as part of a new NIH primary care clinical research network that aims to improve access to and involve communities in the clinical research that informs medical care. The Communities Advancing Research Equity for Health™ or  CARE for Health ™ program will actively engage communities historically underrepresented in clinical research. This effort is very close to my heart, as I was born and raised in a rural community, and I’d like to tell you more about how it will work.

In this program, NIH will connect with primary care providers and their patients, giving them access to research and the opportunity to participate in clinical trials. By engaging people on the front lines of health care—in the primary care clinician’s office—we will build an infrastructure that leads to sustained relationships with primary care providers and patients and earns people’s trust. Many of the areas of the country where we want to focus do not have medical specialists, and primary care providers are often the only practitioners available for every health challenge. Through CARE for Health, we want to integrate clinical care with research to support knowledge generation that meets the needs of people in all communities.

The awards we’ve announced, totaling over $5 million in funding for the first year, will support three Network Research Hubs to establish the program’s initial infrastructure. The first awardee institutions are Oregon Health and Science University, the University of Wisconsin-Madison, and West Virginia University. These institutions will participate in three ongoing NIH-funded clinical trials that cover a range of topics important to primary health care, including pain management, opioid and polysubstance use, and gout, with many more studies on areas important to diverse communities to come in the future. Overall, NIH is investing approximately $30 million in total over fiscal years 2024 and 2025 to pilot the program, which is supported through the NIH Common Fund. After the first year, we will aim to broaden the program so communities throughout the country can participate.

CARE for Health is a new paradigm for biomedical research. NIH has never had a network for the primary care medical environment that works across all 27 Institutes and Centers of NIH. We are starting it with a pilot program because we know that for a program of this scale, we first need to learn from our research teams and from the primary care clinicians who are going to help us bring this kind of research to their communities. We will also ask community members what their health priorities are and allow them to select the research studies that are most meaningful to them. In the future, CARE for Health partners will have a long menu of studies to pick from based on local interests and needs.

Ultimately, we believe that this program will have a meaningful impact on health outcomes, especially among those who have been previously underrepresented and underserved in medical research.

Bertagnolli MM. Connecting lab, clinic, and community . Science . DOI:10.1126/science.adq2140 (2024).

NIH Support: NIH Common Fund

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Posted In: Health , News , Science

Tags: biomedical research , CARE for Health , community health , health disparities , life expectancy , primary care , rural health care

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Part 1. Overview Information

National Institutes of Health ( NIH )

Centers for Disease Control and Prevention ( CDC )

CDC and CDC/NIOSH disclaimer:

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this notice of funding opportunity (NOFO) might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.

National Eye Institute ( NEI )

National Heart, Lung, and Blood Institute ( NHLBI )

National Human Genome Research Institute ( NHGRI )

National Institute on Aging ( NIA )

National Institute on Alcohol Abuse and Alcoholism ( NIAAA )

National Institute of Allergy and Infectious Diseases ( NIAID )

National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS )

Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD )

National Institute on Deafness and Other Communication Disorders ( NIDCD )

National Institute of Dental and Craniofacial Research ( NIDCR )

National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK )

National Institute on Drug Abuse ( NIDA )

National Institute of Environmental Health Sciences ( NIEHS )

National Institute of General Medical Sciences ( NIGMS )

National Institute of Mental Health ( NIMH )

National Institute of Neurological Disorders and Stroke ( NINDS )

National Institute on Minority Health and Health Disparities ( NIMHD )

National Center for Complementary and Integrative Health ( NCCIH )

National Center for Advancing Translational Sciences ( NCATS )

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs ( ORIP )

National Cancer Institute ( NCI )

CENTERS FOR DISEASE CONTROL AND PREVENTION ( CDC )

National Center for Emerging and Zoonotic Infectious Diseases (NCEZID/CDC)

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP/CDC)

National Center for Immunization and Respiratory Diseases (NCIRD/CDC) National Institute for Occupational Safety and Health (NIOSH/CDC)

R41 Small Business Technology Transfer (STTR) Grant - Phase I only, NIH only R41 / R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track, NIH only R43 Small Business Innovation Research (SBIR) Grant - Phase I only (NIH and CDC) R43 / R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track, NIH only U43 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase I U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II UT1 Small Business Technology Transfer (STTR) – Cooperative Agreements - Phase I UT2 Small Business Technology Transfer (STTR) – Cooperative Agreements - Phase II

See Section III. 3. Additional Information on Eligibility.

This Notice of Funding Opportunity (NOFO), issued by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), provides administrative supplement awards to active SBIR (NIH and CDC) and STTR Phase I (NIH only) recipients. The I-Corps at NIH program is designed to educate biomedical innovators on how to translate innovative technologies into products in the marketplace.

The program provides three-member project teams with access to instruction and mentoring to accelerate the translation of technologies currently being developed with NIH and CDC SBIR and STTR funding. The participants conduct market research to identify where the company's technology can have greatest impact on unmet clinical needs. It is anticipated that outcomes for the I-Corps teams participating in this program will include significantly refined commercialization plans and when necessary, well-informed pivots in their commercialization strategies. Prospective applicants are strongly encouraged to contact relevant Scientific/Research staff listed in Section VII for more information about the program before applying.

Not Applicable

November 22, 2024, January 31, 2025 by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

January 2025, March 2025

It is critical that applicants follow the instructions in the How to Apply - Application Guide , as appropriate except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
• Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section i. notice of funding opportunity description.

The NIH, and the CDC seek to accelerate the development and commercialization of innovations that arise from currently funded Phase I SBIR (NIH and CDC) and STTR (NIH only) projects. NIH and CDC investments in the I-Corps at NIH program strengthen these projects by addressing challenges inherent in the early stages of product development with a focus on the commercial feasibility of the end products.

The I-Corps at NIH program provides biomedical entrepreneurs with a proven methodology to develop an evidence based strategic business model through intensive customer discovery. During the practice of customer discovery, teams are expected to interview at least 100 individual stakeholders in the biomedical ecosystem to identify unmet clinical needs.  The I-Corps methodology provides teams with an understanding of concepts critical to start-up success, such as creating a business model canvas, customer segmentation, strategic partnerships, and revenue modeling. It also educates teams on aspects of commercialization specific to life science markets, with respect to pre-clinical development, regulatory strategy, and medical reimbursement.

I-Corps participants begin with a postulate of how their innovations will help impact clinical needs. Over the course of the 8-week program, insights gained from the 100 stakeholder interviews help the teams modify and fine-tune their null-hypothesis resulting in evidence-based business models and commercialization plans. Teams also build expansive networks, that enhance their downstream potential for securing follow-on investments or other relationships with strategic partners.

The National Institutes of Health (NIH) is the nation's medical research funding agency, spearheading important discoveries in basic research and translational medicine that advance clinical practice and improve public health. The NIH also supports many innovative training programs that foster scientific creativity and exploration, with the goals of strengthening our nation's research capacity, broadening our research base, and expanding the breadth and skill set of the scientific workforce. As the nation’s health protection agency, the Centers for Disease Control and Prevention (CDC) safeguards the health security of our nation. To accomplish its mission, CDC conducts and supports critical research and monitoring to provide life-saving information in response to dangerous health threats as they arise.

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are engines of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat human diseases. These are Congressionally mandated set-aside programs for domestic small business concerns (SBCs) to engage in research and development that has the potential for commercialization. Both programs seek to increase the participation of small businesses in Federal research & development (R&D) and to increase private sector commercialization of technologies developed through Federal R&D.

Program Description

The I-Corps Program accelerates the translation of biomedical research to the marketplace by providing entrepreneurship training to SBIR and STTR recipients. In most cases instructors have direct personal experience as biomedical entrepreneurs and/or investors. I-Corps enables the development of early-stage biomedical technologies by focusing on developing a clear understanding of the market value of an innovation, and ultimately on how to navigate the advancement of a technology from the research lab into the commercial sector. I-Corps at NIH is designed to complement activities within the scope of the parent SBIR / STTR Phase I grant or the Phase I portion of an SBIR/STTR Fast-Track grant, to help accelerate the commercialization of new products and services derived from NIH and CDC-funded technical feasibility studies. Insights gained during the I-Corps program inform and improve the commercialization strategies of follow-on Phase II SBIR/STTR applications.

I-Corps teams participate in an entrepreneurial immersion course using a hypothesis-driven methodology of customer discovery to better understand the issues associated with technology commercialization. Participants are required to conduct one hundred or more interviews with potential customers, strategic partners, and other third-party stakeholders. Collectively the I-Corps cohort share their findings with instructors and other teams, integrating those insights into the iterative refinement of their business thesis on a weekly basis. 

The I-Corps program will be supported through administrative supplement awards to active SBIR (NIH and CDC) and STTR (NIH only) Phase I recipients. Administrative supplement awards are intended only to support travel and other direct costs associated with the training program. A cohort (up to 24 teams per cohort) will be selected to participate in the I-Corps at NIH program, which lasts approximately eight weeks.

Scheduling details for the FY2025 cohorts are provided in the table below. All team members accepted to the I-Corps at NIH are required to participate in each of the scheduled program events.

I-Corps Teams

To apply under this program, eligible applicants must assemble three-member I-Corps teams that will work collaboratively to complete the activities and assignments required by the I-Corps training program. Applicants should designate teams consisting of the following members/roles:

• C-level Corporate Officer (CLO)
• Technical Lead/Expert (TL)
• Industry Expert (IE)

It is strongly recommended that the participating C-level Corporate Officer should be the chief executive officer (CEO) of the applicant small business concern (SBC); however, other C-level corporate officers may also serve in this role. In this context, C-level refers to "Chief" Technology Officer, "Chief" Operating Officer, or similar level officer. This person should have substantial decision-making authority within the company to implement changes in direction regarding the overall commercialization strategy. In the event that findings gained during the I-Corps program have a significant impact on the underlying business thesis, it is recommended that the C-level Corporate Officer should lead the three-member I-Corps team.

The PD/PI on the SBIR/STTR Phase I award should participate as a Technical Lead/Expert (TL) of the I-Corps team. The TL has primary responsibility for achieving the technical success of the project, while also complying with the financial and administrative policies and regulations associated with the SBIR/STTR award. In the scenario in which the PD/PI is also the CEO of the small business, applicants may designate the PD/PI as the CLO and recruit an additional scientific technical expert to serve as TL; or the PD/PI may serve as TL and another C-level Corporate Officer may lead the team. In the scenario where the PD/PI of the grant is not a member of the team, an alternative team member may be an individual with a strong understanding of the grant's underlying technology; in all cases, the Research Plan must include justification for the team's personnel structure.

The designated Industry Expert should be an experienced or emerging entrepreneur with proximity to the SBC and experience in translating technologies to the marketplace. The IE may be someone that has an established relationship with the company (e.g., Board Member), or this person may be selected as a third-party resource. Ideally, the IE should have prior experience in the development and commercialization of other products within the broader technology space related to the specific SBIR/STTR project under development.

NOTE: Additional guidance in determining how to structure an I-Corps team is provided in the I-Corps FAQs on the NIH SEED website at: I-Corps FAQ , Additional questions about the roles of each team member and how to consider individuals that can fulfill each of these roles may be directed as a general inquiry to [email protected] or to the appropriate NIH/CDC staff member at the Institute or Center that is funding the Phase I SBIR/STTR award (see the listing Scientific/Research staff under Section VII ). 

Entrepreneurial Immersion

The I-Corps curriculum provides real-world, hands-on, immersive learning about what it takes to successfully translate promising technologies into products or services that will benefit society. At the beginning of the training program, all I-Corps team members are required to attend an in-person kick-off reception followed by an intensive, 3-day workshop (exact locations to be announced). After the workshop, I-Corps teams are required to spend the next 6 weeks conducting customer discovery activities as well as participating in weekly web-based conference meetings with the instructors. In addition, it is expected that I-Corps teams will take advantage of instructor office hours for individualized consultations and mentoring. At the completion of the course, I-Corps teams must attend a 2-day finale Course Close-out/Lessons-Learned Workshop in Bethesda, MD. Customer discovery activities may take place in person or via video conferencing, as scheduling allows. Teams are also encouraged to take advantage of any scientific/industry conferences and  meetings that are scheduled concurrently with the program, to facilitate customer discovery. 

The approach to develop the "business thesis" will be a structured hypothesis/validation approach. Here, the term "business thesis" is defined as a short description of the company represented by the idea/technology/service explored during the I-Corps program. The C-level Corporate Officer (or designated team representative) will be responsible for leading the team along a content-guided path over the course of the I-Corps program to develop a final business thesis.

The I-Corps program will introduce the concept of a "Business Model Canvas," which provides the framework that guides the I-Corps learning. As part of this curriculum, each team must commit to pursuing a formal hypothesis-validation approach to identify and mitigate gaps in knowledge in the following nine areas:

• Value Proposition of the proposed product or service;
• Customer/User-case and pain points;
• Key Activities;
• Key Resources;
• Key Partners;
• Customer Relationships;
• Resource Streams; and
• Cost Structure.

To successfully complete the I-Corps at NIH program, the entire I-Corps team should be deeply committed and dedicated to the time-intensive curriculum. Each team member should plan to spend at least 25 hours per week on I-Corps activities and learning exercises for the full duration of the 8-week program. Unexcused absences may result in a team being withdrawn from the program.

Online Curriculum

During the I-Corps program, online content will be hosted by the designated content purveyor to establish process and progress tracking. The team's progress will be shared with the entire cohort of I-Corps teams to facilitate group learning.

Report-Out Session & Lessons Learned

The members of each team must attend a 2-day Course Close-out/Lessons-Learned Workshop at which final business theses are presented. I-Corps teams typically demonstrate an enhanced understanding and validation of the key components of the Business Model Canvas, significantly refined commercialization plans, and well-informed "pivots" in the overall commercialization strategy. In this context, the term "pivot" is used to mean a reorientation or repositioning relative to the original commercialization strategy.

Prospective applicants are strongly encouraged to contact Scientific/Research Contact(s) staff (as listed in Section VII) for more information about this program before submitting an application.

Outcomes Evaluation

Outcomes resulting from I-Corps at NIH program (e.g., refined commercialization plans) will be carefully evaluated as the NIH considers the continuation and further expansion of this program. As such, the NIH will seek to collect outcomes data from participating I-Corps teams immediately following the completion of the program. Evaluations by the NIH may include customer evaluation surveys, interviews, and/or other approaches to obtain feedback on the overall effectiveness of the training. Outcomes data may also be collected by the NIH at different intervals following the completion of this program. Short-term evaluation metrics may focus on such areas as the key pivots that occurred in the commercialization strategy during the training program. Mid-term metrics may focus on areas such as evaluating the relative success of participating teams in competing for future SBIR/STTR Phase II funding (as compared to SBIR/STTR Phase I recipients that did not participate in the I-Corps program). Longer-term metrics may focus on tracking the success of I-Corps teams in raising funds from third-party investors, as well as consummation of partnerships critical to the commercialization of the products/technologies under development.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

The funding instrument will be the same as the parent award.

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Non-competing Administrative Supplements.

Not Allowed: Accepting applications that do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

The number of awards is contingent upon NIH appropriations, reauthorization and extension of the SBIR and STTR programs, and the submission of a sufficient number of meritorious applications.

The NIH and CDC intend to commit $2,640,000 in direct costs in FY 2025 to fund up to 48 awards.

Application budgets are limited to no more than $55,000 in total costs and must reflect the actual needs of the proposed project. Note in Section IV.2 that proposed budgets should also include $25,000 per team to cover workshop registration fees ($25,000 out of the total budget allowed of $55,000).

The remaining budget should be allocated to cover travel costs to conduct on-site customer development interviews and personnel time for the I-Corps team members, as appropriate.

The travel costs associated with the in-person meetings may be requested when such meetings occur in person.

The Small Business Administration (SBA) has approved waivers to allow businesses to exceed the overall budget caps on their award for particular topic areas. The current list of approved topics can be found at https://seed.nih.gov/sites/default/files/HHS_Topics_for_Budget_Waivers.pdf . Applicants are strongly encouraged to contact NIH or CDC program officials prior to submitting any application.

The project and budget periods must be within the currently approved project period for the existing parent award. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this Notice of Funding Opportunity (NOFO).

Section III. Eligibility Information

1. eligible applicants eligible organizations only united states small business concerns (sbcs) are eligible to submit applications for this opportunity. a small business concern is one that, at the time of award of phase i and phase ii, meets all of the following criteria:  1. is organized for profit, with a place of business located in the united states, which operates primarily within the united states or which makes a significant contribution to the united states economy through payment of taxes or use of american products, materials or labor;  2. is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;  3.  i. sbir and sttr. be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the united states), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the united states), an indian tribe, anc or nho (or a wholly owned business entity of such tribe, anc or nho), or any combination of these; or  ii. sbir-only. be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. no single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the united states; or  iii. sbir and sttr. be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. a joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements.  4. has, including its affiliates, not more than 500 employees.  if the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see section iv. application and submission information for additional instructions regarding required application certification.  if an employee stock ownership plan owns all or part of the concern, each stock trustee and plan member is considered an owner.  if a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner. definitions:  1. hedge fund has the meaning given that term in section 13(h)(2) of the bank holding company act of 1956 (12 u.s.c. 1851(h)(2)). the hedge fund must have a place of business located in the united states and be created or organized in the united states, or under the law of the united states or of any state.  2. portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.  3. private equity firm has the meaning given the term private equity fund in section 13(h)(2) of the bank holding company act of 1956 (12 u.s.c. 1851(h)(2)). the private equity firm must have a place of business located in the united states and be created or organized in the united states, or under the law of the united states or of any state.  4. venture capital operating company means an entity described in 121.103(b)(5)(i), (v), or (vi). the venture capital operating company must have a place of business located in the united states and be created or organized in the united states, or under the law of the united states or of any state.  5. anc means alaska native corporation.  6. nho means native hawaiian organization.  sbcs must also meet the other regulatory requirements found in 13 c.f.r. part 121. business concerns, other than investment companies licensed, or state development companies qualifying under the small business investment act of 1958, 15 u.s.c. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. the sf424 (r&r) sbir/sttr application guide should be referenced for detailed eligibility information.  small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are not eligible to apply to the nih sttr program.  phase i to phase ii transition rate benchmark  in accordance with guidance from the sba, the hhs sbir/sttr program is implementing the phase i to phase ii transition rate benchmark required by the sbir/sttr reauthorization act of 2011. this transition rate requirement applies to sbir and sttr phase i applicants that have received more than 20 phase i awards over the past 5 fiscal years, excluding the most recently-completed fiscal year. for these companies, the benchmark establishes a minimum number of phase ii awards the company must have received for a given number of phase i awards received during the 5-year time period in order to be eligible to apply for a new phase i award fast-track, or direct phase ii (if available). this requirement does not apply to companies that have received 20 or fewer phase i awards over the 5 year period.  companies that do not meet or exceed the benchmark rate will not be eligible to apply for a phase i fast-track, or direct phase ii (if available) award for a period of one year from the date of the application submission. the transition rate is calculated as the total number of sbir and sttr phase ii awards a company received during the past 5 fiscal years divided by the total number of sbir and sttr phase i awards it received during the past 5 fiscal years excluding the most recently-completed year. this funding opportunity is for supplements to existing projects. to be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. the proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. all additional costs must be within the scope of the peer reviewed and approved project. important: the research proposed by the nih recipient in the supplement application must be within the original scope of the nih-supported grant project. foreign organizations non-domestic (non-u.s.) entities (foreign organizations) are not eligible to apply. non-domestic (non-u.s.) components of u.s. organizations are not eligible to apply. foreign components, as defined in the nih grants policy statement , are not allowed.  required registrations applicant organizations applicant organizations must complete and maintain the following registrations as described in the how to apply - application guide to be eligible to apply for or receive an award. all registrations must be completed prior to the application being submitted. registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. failure to complete registration in advance of a due date is not a valid reason for a late submission, please reference nih grants policy statement 2.3.9.2 electronically submitted applications for additional information. system for award management (sam) – applicants must complete and maintain an active registration, which requires renewal at least annually . the renewal process may require as much time as the initial registration. sam registration includes the assignment of a commercial and government entity (cage) code for domestic organizations which have not already been assigned a cage code. nato commercial and government entity (ncage) code – foreign organizations must obtain an ncage code (in lieu of a cage code) in order to register in sam. unique entity identifier (uei) - a uei is issued as part of the sam.gov registration process. the same uei must be used for all registrations, as well as on the grant application. era commons - once the unique organization identifier is established, organizations can register with era commons in tandem with completing their grants.gov registration; all registrations must be in place by time of submission. era commons requires organizations to identify at least one signing official (so) and at least one program director/principal investigator (pd/pi) account in order to submit an application. grants.gov – applicants must have an active sam registration in order to complete the grants.gov registration. sba company registry – see how to apply – application guide for instructions on how to register and how to attach proof of registration to your application package. applicants must have a uei to complete this registration. sba company registration is not required before sam, grants.gov or era commons registration. program directors/principal investigators (pd(s)/pi(s)) all pd(s)/pi(s) must have an era commons account.  pd(s)/pi(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in era commons. if the pd/pi is also the organizational signing official, they must have two distinct era commons accounts, one for each role. obtaining an era commons account can take up to 2 weeks. eligible individuals (program director/principal investigator) any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the program director(s)/principal investigator(s) (pd(s)/pi(s)) is invited to work with their organization to develop an application for support. individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for nih support. see, reminder: notice of nih's encouragement of applications supporting individuals from underrepresented ethnic and racial groups as well as individuals with disabilities, not-od-22-019 and notice of nih's interest in diversity, not-od-20-031 . for institutions/organizations proposing multiple pds/pis, visit the multiple program director/principal investigator policy and submission details in the senior/key person profile (expanded) component of the how to apply - application guide . individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. individuals are encouraged to work with their organizations to develop applications for support. for supplements to parent awards that include multiple pds/pis, the supplement may be requested by any or all of the pds/pis (in accordance with the existing leadership plan) and submitted by the recipient organization of the parent award. do not use this administrative supplement application to add, delete, or change the pds/pis listed on the parent award. visit the multiple program director/principal investigator policy in the how to apply - application guide for more information. 2. cost sharing.

This NOFO does not require cost sharing as defined in the  NIH Grants Policy Statement Section 1.2 Definition of Terms . 

3. Additional Information on Eligibility

Number of Applications

Since applications to this NOFO will only receive administrative review by the awarding Institute or Center, and will not receive a peer review, the NIH policy on resubmissions will not apply. However, applications not accepted by the Institute or Center for review, or not funded by the Institute or Center, should not be submitted again without either responding to any written concerns or contacting the awarding Institute or Center for instructions.

Only one supplement application per parent SBIR/STTR Phase I award is allowed under this NOFO. Applicant organizations with multiple, currently-active SBIR and/or STTR Phase I awards from the different participating Institutes and Centers listed on this NOFO may choose only ONE award to serve as the predicate for an administrative supplement to support the I-Corps at NIH program activity. The NIH and CDC will not fund multiple administrative supplement awards to the same applicant organization under this NOFO.

To apply for an administrative supplement award under this NOFO, applicants must have received a prior SBIR or STTR Phase I grant from one of the participating ICs. The predicate Phase I grant must extend (at least) through the Lessons Learned workshop of the cohort schedule, and the grant should have remaining budget and R&D activities that extend at least until that date. Grant awards currently under a no-cost extension are eligible, provided they meet the above criteria.

NIH- and CDC-funded SBIR Phase I contractors are not eligible to apply under this NOFO.

NIH- funded SBIR/STTR Fast-Track recipients are eligible to apply under this NOFO provided that the Phase I portion of the award extends (at least) through the end of the Lessons Learned workshop as described above.

The following participating organizations have additional eligibility guidance:

• The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will only support administrative supplements to Small Business Innovation Research (SBIR) Phase I grants or Fast-Track grants actively in the Phase I portion of award (R43).
• The Office of Research Infrastructure Programs (ORIP) will support applications from Women-Owned and Socially and Economically Disadvantaged Small Business Concerns.
• The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) will only support administrative supplements to SBIR/STTR Phase I grants or Fast-Track grants actively in the Phase I portion of the award during the originally approved project period. NIAMS will not support administrative supplements to grants in no-cost extension.
• The Centers for Disease Control and Prevention (CDC) will only support administrative supplements to SBIR Phase I grants in the Phase I portion of the award during the originally approved period of performance. CDC will not award administrative supplements to grants during a no cost extension period.
• The National Institute on Alcohol Abuse and Alcoholism (NIAAA) will only support administrative supplements to SBIR/STTR Phase I grants or Fast-Track grants actively in the Phase I portion of the award during the originally approved project period. Grants in no-cost extension are not eligible.

Contractual/Consortium Arrangements

In Phase I, normally, two-thirds or 67% of the research or analytical effort is carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort is generally not more than 33% of the total amount requested (direct, F&A/indirect, and fee).

In Phase II, normally, one-half or 50% of the research or analytical effort is carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort is generally not more than 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).

Deviations from these requirements may be considered on a case by case basis. Please contact a program officer for additional information. Deviations must be approved in writing by the Grants Management Officer (GMO) after consultation with the agency SBIR Program Manager/Coordinator.

In Phase I and Phase II, at least 40% of the research or analytical effort must be performed by the small business concern and at least 30% of the research or analytical effort must be performed by the single, “partnering” research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct, F&A/indirect costs, and fee attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS 398 Research Plan component of the SF424 (R&R) application forms.

A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. § 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS 398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide. 

Section IV. Application and Submission Information

1. requesting an application package.

Applicants must prepare applications using current forms in accordance with the How to Apply - Application Guide .

The application forms package specific to this opportunity must be accessed through ASSIST , Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions for their submission option and the  How to Apply - Application Guide , as appropriate. except where instructed in this NOFO to do otherwise. Conformance to documented requirements is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

All page limitations applicable to the parent award as described in the Application Guide and the  How to Apply - Application Guide  for the activity code of the parent award must be followed, with the following exceptions or additional requirements, except where instructed in a Notice of Special Interest (NOSI) to do otherwise.

Administrative supplement requests must be submitted through Grants.gov using electronic submission processes.

Use the “Apply” button(s) in Part I of this NOFO to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation. 

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow all instructions in the  How to Apply - Application Guide  to ensure you complete all appropriate required and optional forms, with the following additional guidance:

SF424 (R&R) Cover Form: Select “Revision” in the “Type of Application” field. The "Descriptive Title of the Applicant's Project" must match the title of the currently funded grant.

SF424 (R&R) Senior/Key Person Profile (Expanded) Form: List the PD/PI (of predicate Phase I grant) as the first person (regardless of their role on the supplement activities). Also include the C-level Corporate Officer and Industry Expert being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each. The I-Corps team will consist of only three roles (as described above under Funding Opportunity Description): (1) C-level Corporate Officer; (2) Technical Lead/Expert; and (3) Industry Expert. You should not submit more than the three individuals who make up the I-Corps team.

R&R Budget Form: Only costs associated with participation in the I-Corps Program may be requested under this NOFO. Proposed budgets may not exceed a total of $55,000 per team.

Proposed budgets must include $25,000 per team to cover workshop registration fees ($25,000 out of the total budget allowed of $55,000). In addition, budget funds must be set aside for the three team members (C-level Corporate Officer, Technical Lead, and Industry Expert) mandatory attendance at the evening reception and 3-day kick-off entrepreneurial immersion workshop (dates and locations as noted in Section I of this announcement), followed approximately six weeks later by the two-day course Close Out/Lessons Learned workshop at the end of the course in Bethesda, Maryland.

Any remaining budget should be allocated to cover travel costs to conduct on-site customer development interviews and personnel time for the I-Corps team members, as appropriate.

PHS 398 Research Plan Form: At a minimum, the Research Strategy or Program Plan section, as applicable, must be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.

Executive Summary of Predicate SBIR or STTR Phase I Grant and Team (one page only)

Applicants should provide a one-page executive summary of the predicate SBIR or STTR Phase I award that will serve as the basis for the I-Corps Program. This summary should include a brief description of the specific aims of the Phase I project, and it should describe any progress that has been made toward achieving the specific aims (current as of the time of the supplement request). Applicants should also include a description of any technical, administrative, or commercial challenges that have been encountered and how those challenges have been addressed. In addition, applicants should include a brief introduction of the three proposed team members, their I-Corps roles, why they are appropriate for those roles; and a statement indicating that each team member is committed to the time requirements of the program.

I-Corps Team and Project Plan (up to 5 pages)

This section should include the following information:

1. I-Corps Team

• Describe the I-Corps team and provide the rationale for its formation, focusing on the team members' entrepreneurial expertise, experience bringing previous products to the market, relevance of the team's background to the innovation effort, and their experience in collaborating on previous projects. The composition of the I-Corps team should reflect the requirements listed above under Section I (Program Description), to include a: (1) C-level Corporate Officer; (2) Technical Lead/Expert; and (3) Industry Expert.
• Provide clear statements to indicate that all team members are committed to meeting the time-intensive requirements of the training program (expected to be at least 25 hours per week per team member), including attending all scheduled program events and webinars.
• Briefly describe how the team will benefit from the I-Corps at NIH program.
• Discuss the team's willingness to modify/refine the overall commercialization strategy, based on knowledge gained during the course of the I-Corps Program.

2. Potential Commercial Impact

• Briefly describe how this research has led the team to believe that a commercial opportunity exists for the SBIR/STTR Phase I project moving forward.
• Provide a brief profile of a typical customer of the proposed innovation.
• Describe the customer need(s) that will be met by the proposed innovation.
• Describe how the customer currently meets those needs.
• What is the competitive advantage that is offered by the proposed product or service?
• How much would a customer pay for the solution (current best estimate)?

3. Project Plan

• Describe the stage of development for the SBIR or STTR Phase I project that is currently under development (proof-of-concept, prototype stage, etc.)
• Provide a brief description of the proof-of-concept or technology demonstration that will be provided by the end of the SBIR or STTR Phase I project.
• Describe the next steps that the company will take to advance the project closer toward commercialization, assuming the outcomes of the SBIR/STTR Phase I award are promising. 

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit electronic applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Applicants are responsible for viewing their electronic application before the due date in the eRA Commons to ensure accurate and successful submission.

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the  How to Apply - Application Guide . 

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .

Applications must be submitted using the instructions specified above.

Applicants must complete all required registrations prior to submission. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission contact the Application Submission Contacts in Section VII.

Important reminders:

For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the eRA Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide .

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35 .

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] . 

Section V. Application Review Information

1. criteria.

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

NIH staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Overall Impact

Applications received under this NOFO will be reviewed in a Two-Stage Process.

Stage I: In the first stage of review, NIH and CDC staff will evaluate the written application to consider the ability of the proposed supplement to increase the parent award's overall impact through the proposed team's participation in the I-Corps at NIH program. Specific criteria that will be considered will include the following:

• Has the applicant SBC assembled the appropriate I-Corps team members, including a C-level Corporate Officer, Technical Lead/Expert, and Industry Expert?
• To what extent have the proposed team members indicated a deep commitment to the time-intensive requirements of the I-Corps training program and a sincere desire to investigate the commercial landscape surrounding the innovation?
• To what extent do these team members have the appropriate backgrounds and expertise to utilize the insights gained during the I-Corps program to advance the commercial goals of the predicate SBIR or STTR Phase I project?
• As appropriate for the specific project, to what extent does the (6-page) Research Plan clearly articulate: market opportunity; potential impact of the project/technology on public health; stage of technology development; competitive advantage of the technology and value proposition; skills and experience of the management team; commercial strengths (including the intellectual property portfolio and other proprietary technologies or trade secrets); key strategic partnerships and collaborations; and fundraising potential?
• To what extent will the company be able to "pivot" and refine its commercialization strategy if the information gained during the customer discovery process reveals commercial opportunities that had not previously been considered or pursued?

Stage II: In the second stage of review, the best qualified candidates will be contacted by agency staff to provide clarification on the information contained in the written application AND to provide responses to additional questions in a scheduled phone interview. All Team members must participate in the phone interview. Typical follow-up questions may include, but are not necessarily limited to, the following:

• Introduce the team and provide a brief summary of the team members' background. What are the perceived strengths and weaknesses of the team and its members? 
• What is the Industry Expert's experience with this product/technology space? Does the Industry Expert have prior experience with start-up companies in this technology space what happened to those start-ups? 
• Why does the team believe that the product/technology is ready for translation to the marketplace? What customer "pain" will the proposed product/technology alleviate? Who are the first two customers?
• Does the team verbally commit to the I-Corps session/schedule as published under this NOFO? 
• What does the team envision getting out of the I-Corps curriculum?
• To what extent are the team members willing to "pivot" if the information gained during the customer discovery process reveals commercial opportunities that had not previously been considered or pursued? 

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement. 

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects .

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.  

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

NIH staff will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

2. Review and Selection Process

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

Section vi. award administration information, 1. award notices.

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions. 

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at  2 CFR Part 200 , Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the  NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the  NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and  Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities . 
• HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in  NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See  2 CFR Part 200.340 Termination and  NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support . 

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

3. Data Management and Sharing

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Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.   To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see  Post-Award Monitoring and Reporting . 

Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

Disclosure of Foreign Relationships Reporting Requirements 

Recipients are responsible for monitoring their relationships with foreign countries of concern post-award, for any changes that may impact previous disclosures. SBCs receiving an award under the SBIR/STTR program are required to submit an updated Disclosure Form to report any of the following changes to NIH, CDC, and FDA throughout the duration of the award: 

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If the recipient reports a covered foreign relationship that meets any of the risk criteria prohibiting funding described in this NOFO, NIH, CDC, and FDA may deem it necessary to terminate the award for material failure to comply with the federal statutes, regulations, or terms and conditions of the federal award. Refer to NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support for more information. Recipients are encouraged to monitor their covered foreign relationships post-award and avoid entering into relationships, both funded and unfunded, that may pose a security risk and jeopardize their ability to retain their award. 

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An SBC will be required to repay all amounts received from NIH, CDC, and FDA under the award if either of the following determinations are made upon assessment of a change to their disclosure: 

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there is a change in ownership, change in entity structure, or other substantial change in circumstances of the SBC that NIH, CDC, and FDA determine poses a risk to national security. The repayment requirements and procedures provided in Section 8.5.4 Recovery of Funds of the NIH GPS apply and may also be subject to additional noncompliance and enforcement actions as described in Section 8.5.2 of the GPS. Recipients are required to follow the repayment procedures provided in the Guidance for Repayment of Grant Funds to the NIH.

Section VII. Agency Contacts

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Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, P.L. 115-232, and P.L. 117-183. The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR and STTR Policy Directive.

The STTR Program is mandated by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorizing legislation, P.L. 107-50, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, P.L. 115-232, and P.L. 117-183. The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) SBIR and STTR Policy Directive.

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The effects of exercise on bone. Basic concepts and implications for the prevention of fractures

Cosimo roberto russo md.

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Address for correspondence: Centro Fitness Metagym Piazza Matteotti 8, 50018 Scandicci, Florence, Italy Ph. +39 055 255244 Fax +39 055 252358 E-mail: [email protected]

Osteogenic dynamic loads delivered to the skeleton during exercise prevent aging-associated bone fragility. Moreover, because of its pleiotropic favourable effects on health, exercise improves quality of life, and specific types of exercise increase muscle strength, a known predictor of bone strength, and coordination and balance, and so reduce the risk of fallrelated fractures. Exercise should definitely be the mainstay of the prevention and treatment of osteoporosis; often however, physicians don’t have enough know-how for evidencebased prescription of exercise. Moreover, the lack of facilities for safe implementation of the exercise programs compound the problem. Scientific societies and health authorities should invest in patient and physicians education about exercise and in promoting facilities (Gyms) devoted to training of persons with, or at risk of, metabolic diseases (osteoporosis, obesity, diabetes), like Metagym in Florence, Italy.

Keywords: exercise, muscle strength, bone strength, falls, osteoporosis, fractures, Gym, Metagym, nutrition adaptation to exercise.

Introduction

Osteoporosis is defined as a condition characterized by reduced bone strength and high propensity to fractures. This definition implies a cause-and-effect relationship between osteoporosis and fragility fractures. Hence, based on DXA measurements as a proxy for bone strength, operative diagnostic criteria for osteoporosis and the intermediate condition, osteopenia, have been established by a WHO study group and widely used in the clinical practice ( 1 ). Even if it is known that DXA measurements can be grossly inaccurate, and that this inaccuracy can go undetected, efforts of major research teams and pharmaceutical companies have been directed toward developing (and selling) drugs capable to treat DXA-detected osteoporosis (and osteopenia), with the purpose to prevent fractures ( 2 ). However, the cost and safety of drug treatment to prevent fractures should be carefully considered: if the diagnostic threshold to initiate the treatment is set at -2.5 SD, the cost of preventing one vertebral fracture has been estimated to be more than 30000 dollars, and the cost to prevent one hip fracture even more, and even with this expensive strategy most fractures would still occur ( 3 ). Moreover, even drugs like bisphosphonates that have been thoroughly investigated in thousands of patient/years, and have been used for many years in the clinical practice, are not necessarily safe or effective in any single patient ( 4 ).

In fact, osteoporotic fractures usually occur in connection with a fall, and anti-osteoporotic drugs have no effect on falls, with the notable exception of high dose vitamin D ( 5 ). Indeed, based on the above considerations, a shift in the focus from osteoporosis to falls in the prevention of fractures has been recently proposed ( 3 ). This shift is not likely to be easy, given that osteoporosis is diagnosed and treated by clinicians that usually don’t assess the risk of falling of their patients but, rather, limit their intervention to prescription of drugs.

However, falls can, and should be prevented using evidence-based assessment of risk and intervention ( 6 ). The assessment of the risk for falling is relatively simple and could be directly provided by the physician caring for the osteoporotic patient; in fact it includes careful history of past falls, review of medical risk factors including assumption of drugs, and assessment of mobility and physical performance ( 6 ).

The chore of the interventions aimed at reducing the risk for falling is, however, a structured exercise program which includes strength and balance training, and requires an adequate facility (i.e. a Gym) and skilled personnel. Although also such exercise programs are expensive they have the merit to positively influence both components of fracture risk: bone strength and falls and therefore deserve careful consideration in every patient with osteoporosis. Moreover, exercise has pleiotropic positive effects on health, including, among others, prevention of diabetes, cardio- and cerebro-vascular disease, improvement of urinary incontinence, reduction in cognitive decline, improvement of mood, self-esteem, and general well-being ( 7 , 8 ).

Because metabolic diseases, including diabetes and osteoporosis, are highly prevalent in the population and are often associated, and because diabetes leads to an increased fracture risk, exercise can reduce fracture occurrence well beyond its direct effects on bone.

According to the above considerations, the careful prescription of exercise should be part of the optimal management of every patient with osteoporosis. However, this is not usually the case: instead, patient are typically given by the caring physician only a generic advise to increase physical activity such as, for instance, walking, swimming or stretching or, at best, they are advised to attend a gym but rarely receive an individualized, clear and detailed prescription of the type and amount of the exercise likely to be effective in his/her particular case. Even more rarely, a follow-up schedule is provided such that exercise- related improvements are recorded and used in the global management of the patient. The reasons for downplaying the value of exercise in the osteoporosis management are both cultural and practical; on one hand physicians often ignore the principles of exercise for metabolic diseases and on the other hand there is a lack of facilities devoted to train these difficult patients: many gyms even exclude from their membership patients with a diagnosed osteoporosis. Moreover, cost-effectiveness and convenience considerations suggest that medical management of osteoporosis and exercise programs adequate to prevent falls through improvement in balance and muscle and bone strength be provided in the same setting. Therefore, I have recently developed in Scandicci (Florence, Italy) Metagym, a centre specifically designed to meet the demands of patients with metabolic problems including obesity, diabetes, and osteoporosis. Metagym (a Gym for the Metabolism), is equipped to provide strength, balance and vibration exercise; it has personnel qualified and trained to assess physical performance, posture, muscle power, cardiovascular fitness, and capable to devise and implement exercise programs for patients of any age, including nonagenarians, and with physical limitations. Metagym is linked to a medical facility, where medical management of osteoporosis and other metabolic diseases is possible, including endocrinology counselling, assessment of physical performance, anthropometry, bioimpedenziometry, bone densitometry, and medical nutrition therapy. Metagym is also a research centre: it participated in IDES (Italian Diabetes and Exercise Study), a multicenter trial aiming to prove the superiority of combined aerobic and resistance exercise over counselling of exercise in type 2 diabetic patients with metabolic syndrome ( 9 ).

This review is focused on the effects of exercise in the adult bone with the aim to prevent falls and bone loss, and to foster favourable geometric bone adaptations. However, it should be noted that exercise interventions in children and adolescents with the aim to optimize the attainment of peak bone mass and the development of a robust bone architecture are also feasible and they are probably an effective strategy to reduce the burden of osteoporotic fractures in the population.

Mechanical loading and bone properties

The main function of the skeleton is to support muscles to allow posture and movement in the space. Architectural properties of the skeleton, including size and shape, are adapted to this function: in any species and at any age, every single bone is rigid proportionally to its habitual loads, without being too massive. A well adapted bone allows movement with a low probability to break during conditions of habitual use.

Because exercise mainly acts through changes in the mechanical environment of the skeleton, it elicits physiologic responses in bone architecture whose knowledge is essential to understand the responsiveness of the osteoporotic patients to exercise, and to prescribe the right exercise program for every single patient.

Habitual loads to bone derive essentially from gravity and, more importantly, muscle contraction (during heavy exercise the latter delivers up to 10 times the gravity force).

In general, the resistance of a given structure is determined by property, amount, and spatial distribution of its constituent material ( 10 ). Moreover, in order to optimize resistance, the bone material can change its distribution thus modifying bone size and shape in response to specific challenges. Therefore, assessment of both material properties and architecture of bone are necessary to predict if a bone can resist to a given load. In old age for instance, a reduction in volumetric density of cortical bone (a proxy of material property) or a reduction in the amount of cortical bone (bone mass) is associated with a redistribution of bone material toward the periphery of bone, leading to increased bone size ( 11 - 13 ). This response is homeostatically sound since it maintains bone resistance in the face of a reduction in some bone properties (see later for details).

Bones can be subjected to compressive, tensile, bending and torsional loads. In short bones such as vertebrae and in the metaphyses of long bones compression and tension are the main loads, while bending and torsion are mainly beared by long bones diaphyses. Buckling is a bending secondary to compression; it occurs only in long bones diaphyses and is of uncertain significance in bone pathophysiology.

Resistance to compression and tension

Resistance to compression and tension is determined by the modulus of elasticity (E), whose best proxy is the volumetric density, and the cross-sectional area of the bone, A. Therefore, the formula E*A best describes the resistance to compression and tension. Accordingly, during growth bone metaphyses typically become wider than diaphyses in order to resist their habitual compressive loads ( 10 ).

Resistance to bending and torsion

While resistance to compression is proportional to the amount of bone material, the resistance to bending and torsion is critically dependent on the distribution of the material. Moments of inertia and section modulus (I) are geometric variables that strongly depend from the distance of every small particle of material from the bending and torsional axis and best predict the resistance to bending and torsion, according to the formula E*I ( 10 ). Please note that I is proportional to the fourth power of the radius. For this reason bone diaphyses, usually loaded in bending and torsion, have evolved ontogenetically into empty cilinders. Moreover, the age-related thinning of bone cortex, potentially leading to a dramatic reduction in mechanical resistance, is compensated for by modeling and consequent periosteal expansion, a strategy capable of increasing the moments of inertia and so maintaining the resistance to bending and torsion into old age. There is evidence that periosteal expansion is less efficient in old women, explaining, at least in part, the greater propensity of older women to fragility fractures ( 12 , 13 ). There is also evidence that exercise stimulates periosteal expansion leading to architectural adaptation, rather than accumulation of bone material (that is bone mass) ( 14 ).

For this reason measuring bone mass to verify the effects of exercise on bone may be futile and can underestimate the effects of exercise on bone ( 10 - 12 ).

Assessing the bone mechanical resistance in the laboratory

Mechanical resistance of bones is expressed by the load-deformation curve, obtained applying a progressive load and recording the consequent bone deformation until fracture. The area under the load-deformation curve describes the energy-absorbing capacity of bone. The stress-strain curve, which describes the bone material properties, is obtained dividing both loads and deformations by the cross-sectional area of the bone. The slope of the first, linear, portion of the stress-strain curve describes the stiffness of the bone material, while the area under the curve, also influenced by the second, non linear, portion of the deformation is called thoughness or capacity to absorb energy before breaking. The stiffness is a function of the degree of mineralization and porosity of bone, while thoughness is strongly influenced by the bone matrix and the collagen structure.

Estimation of bone strength and fracture risk in the clinical practice: beyond bone densitometry

As noted in the introduction, according to the WHO study group guidelines bone strength and fracture risk are usually estimated using DXA bone densitometry. This approach has proved ineffective for two main reasons.

1. DXA is not capable of detecting changes in bone architecture . DXA measures bone mass, and therefore it does estimate bone strength. However, as noted in the preceding section, a reduction in bone mass, or the amount of bone material, is absolutely not the only determinant of a reduced bone strength or of the presence of osteoporosis. Rather, an increase in bone size or a more peripheral distribution of bone material, which are putative adaptive processes to aging and bone loss, are disregarded by DXA or, worse, are erroneously detected as reduction in BMD and bone strength ( 11 - 13 ). This occurs because the low BMC value (because of the bone loss) is divided by a wider area (because of the periosteal expansion) yielding a disproportionately lower BMD value. A similar technical and interpretative problem occurs after exercise training; in this case BMD does not change because the moderate increase in bone mass resulting from exercise is obscured by the concomitant periosteal expansion, with the resultant reduction in the calculated BMD ( 14 , 15 ).

2. DXA measurements are confounded by differences in bone and body size . In individuals of low stature DXA, because of its planar nature, attributes erroneously low BMD values.( 16 ) This problem is compounded in subjects with low volumetric density, in which DXA has often difficulty in detecting bone edges and therefore tends to underestimate BMD. As a result of these inaccuracies old ladies of low stature often receive inappropriate diagnoses of osteoporosis and unnecessary treatment aimed at reducing fracture risk. Conversely, osteoporosis in tall people can go undetected ( 16 ).

As a result of the above the predictivity of DXA in diagnosing osteoporosis and predicting fracture risk is low.

Because of the limitations of DXA, efforts have been put in the search of alternative methods of estimating fracture risk. Simple clinical risk factors have proved effective in estimating absolute fracture risk and have evolved in the FRAXI algorithm that combines clinical risk factors with DXA derived BMD to yield a 10 years absolute risk of fractures. The development of FRAXI has been an advance for the clinicians, however it needs to be refined since it lacks, for instance, important risk factors for fracture such as assessment of the risk for falling ( 17 ).

Bone densitometry methods alternative to DXA have been developed with the objective to improve the prediction of fractures.

• Quantitative bone ultrasonography (QUS) of the heel has proven valuable in predicting the risk of fracture in several prospective studies and, in a head to head comparison, it has recently performed better than DXA ( 18 ). In particular QUS proved more accurate than DXA in detecting high risk for fracture among individuals with low BMD value ( 18 ). Because QUS is portable and it is less expensive than DXA, it probably deserves further consideration as an alternative or adjunctive method for predicting fracture risk. Recently, concomitant use of FRAXI-derived clinical risk factors and QUS has been successful for the improvement of risk prediction over QUS alone ( 19 ).

• Quantitative Computerized Tomography (QCT) of radius and tibia has considerable advantages over DXA and QUS. In fact, QCT accurately assesses volumetric density (a proxy of the material property stiffness) and Section Modulus (a geometric parameter of material distribution). The combination of volumetric density and section modulus yields a Bone Strength Index (BSI), a realistic predictor of true bone strength that needs to be validated against other bone strength predictors ( 20 ). The capability of QCT to assess bone geometry may give advantages in evaluating the effects of exercise on bone ( 12 ).

Bone and muscle mass and strength

Muscle force is a strong determinant of bone mass and strength. Therefore, assessing both muscle force and an indicator of bone strength (such as bone strength index) in osteoporotic patients may give useful information as to the cause of low bone mass. Based on this premise, several groups have evaluated the relationship between muscle CSA at forearm and calf by pQCT as a surrogate measure of muscle strength and cortical bone CSA or moment of inertia at the same site. As expected, a close relationship linked the muscle and bone parameter both in children and in adults (R2= 0.60-0.95) ( 21 ), and studies suggest that osteopenia may be further characterized by investigating the proportionality between muscle and bone mass. In fact, according to this view, bone loss following a hypomobility condition associated with sarcopenia would give origin to a “concordant” osteopenia, in which both muscle mass and bone mass are reduced and the ratio between them remains constant. On the other hand, a bone loss caused by an endocrino-metabolic disorder, such as a “true” osteoporosis or hyperparathyroidism, would lead to a “discordant” osteopenia, in which bone mass is reduced to a greater extent than muscle mass. In one study osteoporotic patients with fractures had a similar cortical bone mass at the tibia diaphysis as agematched healthy postmenopausal women, however, in the fracture patients the ratio between cortical CSA and muscle CSA was reduced compared with the controls ( 22 ). Other studies in children obtained similar results ( 23 ). These findings raise the possibility of distinguishing patients with osteoporosis and high fracture risk from osteopenic individuals whose low bone mass is merely a consequence of muscle hypotrophy. In the latter patients the mainstay of treatment is an appropriate “sarcogenic” and “osteogenic” form of physical exercise, not an antiresorptive drug. The aging process is characterized by progressive reduction in trabecular and cortical volumetric density and in cortical bone thinning. In the physically active people, these phenomena lead to greater deformation and greater strains of bones and, as a consequence, activation of adaptive periosteal expansion through modeling, with the purpose to maintain bone strength. In fact, periosteal expansion leads to wider bones that have a more peripheral distribution of bone material, and so greater cross-sectional area and moments of inertia. However, we may speculate that in the sedentary people, the insufficient mechanical stimulation does not produce enough architectural adaptation and bone fragility ensues ( 13 ).

If this hypothesis is correct, and considering that exercise also improves balance and reduces the risk for falling, promoting and implementing exercise can have the potential to considerably reduce the risk for fracture in the population.

Physical exercise and nutrition therapy to maintain and increase muscle mass and strength

It is well established that muscle strength depends on muscle mass and neuromotor function, and that both of them decrease with aging but can be improved at any age with appropriate exercise. A less known determinant of muscle force is the architecture of muscle fibers in pennated muscle, and this too improves with exercise ( 24 ).

Within minutes, and for several hours after each bout of exercise, both protein synthesis and protein breakdown are increased in the muscle fibers. However, only if post-exercise circulating levels of essential aminoacids are sufficient will synthesis prevail on degradation. Different temporal relationships for these processes have been described in old versus young subjects and in males versus females. In fact, compared with the young, in older people higher amount of aminoacids intake, in a closer temporal relationship with the exercise bout are necessary to maximize post-exercise protein synthesis. A thorough discussion of the details of the nutrition-exercise interactions is out of the scope of this article; therefore, the interested reader can refer to recent reviews ( 25 , 26 ).

Which type of exercise for the bone?

Since several types of exercise exist it is important to recognise which type of exercise is useful for muscle and bone strength and, in general, for reducing fracture risk.

The classical studies by Rubin and Lanyon ( 27 - 29 ) have established that bone responds to dynamic loads while it is insensitive to static loads, independent of their magnitude, and have defined the following principles of the maximal osteogenic mechanical stimulus:

– a few load cycles are necessary and sufficient (for instance: 4-5 jumps);

– loads must be of high magnitude;

– loads must be applied at high rate;

– loads should produce an unusual distribution of strain (strain is the unit of deformation)

Further studies from the same authors have established that bone responds to loads of a progressively lower magnitude, provided that the frequency of their application increases. In other words, the higher the frequency of load application, the lower the threshold of bone sensitivity to the load itself. This principle forms the basis for the use of vibration exercise to prevent and treat osteoporosis ( 30 - 32 ).

Both endurance and resistance exercise are dynamic and, therefore, both of them are potentially osteogenic. It is known that aerobic exercise stimulates preferentially mitocondrial biogenesis and the synthesis of proteins involved in the oxidative fosforilation, while resistance exercise stimulates preferentially the synthesis of the miofibrillar proteins involved in muscle contraction.

Therefore, only resistance exercise significantly increases the cross-sectional area of the trained muscles, and, as a consequence, their force and power ( 25 , 26 ).

Walking and jogging increase modestly the loads on the skeleton above gravity and do not lead to increase in muscle force and power. Not unexpectedly this type of exercise has proved to be relative ineffective in osteoporosis prevention. On the other hand, resistance exercise increases muscle force and has a greater potential to be useful in osteoporotic patients. Sports like soccer, volleyball and basketball are very effective osteogenic exercises but they are unlikely to be practised by frail osteoporotic individuals.

Vibration exercise is a special form of exercise that consists in standing over a vibrating platform; the high frequency oscillations of the platform elicit reflex muscle contractions of low magnitude that modestly increase O2 consumption. Vibration training has been tested in several trials involving individuals of different age and condition without provoking significant side effects ( 33 ). Vibration has been effective in increasing muscle power in young athletes and in sedentary postmenopausal women ( 34 ), and in improving physical performance in obese diabetic patients with metabolic syndrome ( 35 ) and in frail institutionalised old people ( 36 ).

With these premises, vibration exercise has increased femoral BMD in a few trials involving individuals at risk of osteoporosis ( 37 ), and, in a recent trial, it proved superior to walking in increasing femoral BMD and reducing fracture risk ( 38 ).

Observational studies and clinical trials on the effects of exercise, and lack thereof, on bone

Bone loss is considered a universal feature of aging and is associated with increased fracture risk, especially in older women. However, bone loss may not be an inevitable consequence of aging. Indeed, in the Utterite women, who engage in heavy daily manual work, no age-related decrease in BMD has been detected ( 39 ). Moreover, in the longitudinal SOF study, a subset of older women maintained their BMD up to 15 years, and experienced a lower risk of fractures, disability, and mortality. Among other features, these successful aging representatives did not smoke and had higher levels of physical activity and physical performance ( 40 ).

The most impressive demonstration of the effects of muscle force on bone is paraplegia. Prospective studies have established that in this condition muscle atrophy is followed by profound bone loss at both trabecular and cortical sites, and consequent high fracture risk ( 41 - 43 ). The causal role of muscle atrophy on microgravity bone loss has been confirmed by space flight and, recently, bed rest studies involving young volunteers ( 44 ).

Cross-sectional, retrospective, and prospective observational studies involving elite and amateur athletes have confirmed the major role of exercise, and especially resistance exercise, in the accrual of bone mass and in the development of an optimal bone architecture and high bone strength ( 14 , 15 ).

Several clinical trials have tested the hypothesis that exercise increases bone mass in children and adults, with mixed results.

In children, exercise has consistently shown improvement in mass and architectural parameters assessed by tibial QCT that persist for years after the completion of the intervention ( 45 , 46 ). On the other hand, results of exercise in adults have usually been modest, and they have often been considered trivial.

However, most of the adult trials have used DXA to examine the bone changes after exercise, and this is inadequate, considering that most of the beneficial effects of exercise in the adult bone are characterized by changes in geometry, to which DXA is virtually blind (see above), rather than mass, which is the parameter measured by DXA (47). This notwithstanding, 18 months high-impact exercise in premenopausal women aged 35-45 years was followed by a significant increase (+1.6%) in femoral neck BMD ( 48 ). In postmenopausal women aged 50-70 years, high-intensity strength training for one year prevented the significant bone loss that occurred in the control group at femoral neck (-2.5%) and lumbar spine (-2%) ( 49 ). Moreover, in the exercise group muscle mass and strength, dynamic balance, and overall physical activity also improved, potentially decreasing fall risk and future fracture risk ( 49 ). Furthermore, considering that exercise has established pleiotropic favourable effects on health, besides those on bone, even small improvements in bone characteristics in older individuals should be considered of clinical import. Accordingly, a recent meta-analysis evaluating randomized trials of high quality that involved a total of 256 osteopenic or osteoporotic participants revealed that interventions with combined exercise programs improved physical function, pain, and vitality (i.e. improved quality of life) more in the exercise groups than in the controls ( 50 ).

In summary, observational studies and clinical trials in children have consistently shown the beneficial effects of exercise, and the deleterious effects of the lack thereof, on bone characteristics and fracture risk. On the other hand, clinical trials in adults have usually been of limited quality, and therefore they don’t allow to draw firm conclusions. Moreover, because of the lack of financial interest, these trials were not powered to detect the effects of exercise on fracture incidence. Nonetheless, Rizzoli et al. in a recent review of the evidence-based strategy for the management of osteoporosis in the elderly listed exercise training in the first line, then vitamin D and calcium supplementation, and use of evidence-based anti-osteoporotic drugs ( 51 ).

Summary and conclusions

In summary, the effects of exercise on bone health are complex and fascinating. The following take-home messages are proposed:

1. The clinically meaningful objective of the management of osteopenia and osteoporosis is the prevention of fracture occurrence; therefore, both preservation of bone strength and reduction in fall risk should be explicitly set as the target of the interventions. Because of its favourable effects on both bone strength and fall risk, exercise should be the first choice intervention in the management of osteopenia and osteoporosis;

2. The ontogenetic adaptations of bones to mechanical forces, and the effects of exercise on bone geometry described in the above sections suggest that bone has a unique plasticity that can be therapeutically exploited in the osteoporosis prevention and management. The bone plasticity is present at any age, including old age, but it is more evident in children, suggesting that the prevention of osteoporosis is indeed primarily a pediatric, rather than geriatric, task.

3. Muscle and bone are strongly linked, both anatomically and functionally; unsurprisingly therefore, differences in muscle mass and force explain most of the differences in bone mass and strength in both children and adults of any age. As a consequence, interventions aimed at increasing bone strength should be primarily aimed at improving muscle force and power, not directly delivering mechanical loads on the skeleton.

4. The effects of different types of exercise on muscle and bone properties have been studied and characterized. Clinicians should refer to these studies to choose appropriate exercise interventions for their patients; it not acceptable any more that physicians prescribe walking or swimming or chalistenics to their osteoporotic patients as the only exercise intervention.

Instead, based on the scientific evidence available, resistance and vibration exercise should have the highest priority. Moreover, prescribing exercise for balance, coordination, endurance, and stretching may allow to exploit the whole range of beneficial effects of exercise on bone and general health.

5. Adequate nutrition intervention should complement the exercise prescription. Besides the well known recommendations on adequate intake of calcium and other macro and micronutrients, nutrition intervention should include the chronologic adaptation of meals to the training sessions. In particular, it is recommended that within 1-2 hours after each training session the patients consume a meal that contains abundant high quality proteins and adequate amounts of carbohydrates. If this is not possible, the prescription of additional essential aminoacids to the post-exercise meals should be considered.

6. Several difficulties often hinder the application of the principles of exercise to the practice. Particularly unusual is the availability of Gyms that accept the membership of osteoporotic patients, and offer adequate supervision of the exercise. Therefore, the example of Metagym in Scandicci (Florence, Italy), a Gym dedicated to the training of patients with metabolic problems, and connected to a medical facility where diagnosis and medical management of osteoporosis is ensured, should be followed. Such centres should be supported by the health authorities because of their strong potential for improvement in the care of the patients with osteoporosis and other metabolic diseases, and for reduction in health costs for the community.

In conclusion, exercise improves physical performance and quality of life, and reduces fracture risk, disability, and mortality. The rationale to use exercise as a therapeutic intervention in individuals at risk for fracture is strong and it should be the mainstay of the management of osteopenia and osteoporosis.

However, exercise is seldom prescribed with evidence-based criteria; moreover, the quantitative, qualitative, and chronologic adaptation of nutrition therapy to exercise is largely ignored by both physicians and dieticians, often precluding the unique opportunity to derive from exercise the maximal benefit. An effort is required by physicians and politicians to make rational, evidence- based choices for the patients and to make exercise interventions feasible and effective.

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