Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
Office of Research on Womens Health (ORWH), (http://orwh.od.nih.gov/)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Eye Institute (NEI), (http://www.nei.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
National Human Genome Research Institute (NHGRI), (http://www.nhgri.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
National Library of Medicine (NLM), (http://www.nlm.nih.gov/)
John E. Fogarty International Center (FIC), (http://www.fic.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)
Office of Dietary Supplements (ODS), (http://ods.od.nih.gov)

Title: Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers

Announcement Type
This is a reissue of PA-04-126 which was previously released July 9, 2004. This FOA also updates and replaces NOT-OD-07-068.

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PA-08-191

Catalog of Federal Domestic Assistance Number(s)
93.866, 93.273, 93.856, 93.846, 93.847, 93.848, 93.396, 93.213, 93.173, 93.121, 93.279, 93.113, 93.867, 93.839, 93.172, 93.242, 93.853, 93.361, 93.989, 93.879, 93.865, 93.286, 93.233, 93.837, 93.838, 93.389

Key Dates
Release Date: July 1, 2008
Letters Of Intent Receipt Date(s): Not Required
Application Receipt Date(s): Applications can be received at any time
Peer Review Date(s): Applications can be reviewed at any time
Council Review Date(s) : Not applicable
Earliest Anticipated Start Date: Within six months of the receipt of the application
Additional Information To Be Available Date: Notification approximately 10 weeks after receipt
Expiration Date: (Now Expired April 7, 2012 per issuance of PA-12-150), (New Date September 30, 2012 per NOT-OD-11-112), Original Date: September 30, 2011

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

The Office of Research on Womens Health (ORWH), participating Institutes and Centers (ICs) of the National Institutes of Health (NIH), and the Office of Dietary Supplements (ODS) announce a continuing program for administrative supplements to research grants to support individuals with high potential to re-enter an active research career after a qualifying interruption for family or other responsibilities. For a comprehensive listing of qualifying interruptions, see Section III.1.B.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)

Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
3. Award Criteria
4. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The Office of Research on Womens Health (ORWH), participating Institutes and Centers (ICs) of the National Institutes of Health (NIH), and the Office of Dietary Supplements (ODS) announce a continuing program for administrative supplements to research grants to support individuals with high potential to re-enter an active research career after taking time off to care for children or attend to other family responsibilities. The aim of these supplements is to encourage such individuals to re-enter research careers within the missions of all the program areas of NIH. This program will provide administrative supplements to existing NIH research grants for the purpose of supporting full-time or part-time research by these individuals in a program geared to bring their existing research skills and knowledge up to date. It is anticipated that at the completion of the supplement, the re-entry scientist will be in a position to apply for a career development (K) award, a research award (R), or some other form of independent research support.

The NIH recognizes the need to increase the number of underrepresented racial and ethnic groups, women, individuals with disabilities, and people from disadvantaged backgrounds in biomedical, behavioral, clinical and social science research careers. Among the reasons for the low representation of women may be the fact that women bear a majority of the responsibilities surrounding child and family care. To address this issue, this program is designed to offer opportunities to women and men who have interrupted their research careers to care for children or parents or to attend to other family responsibilities. A second objective of the program is to mentor and guide those who receive support to reestablish careers in biomedical, behavioral, clinical or social science research. Participating NIH ICs are listed in a separate table associated with this FOA (http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm).

Section II. Award Information


1. Mechanism(s) of Support

Eligible Awards:

Principal Investigators at domestic institutions who hold an active R01 (RL1), R10, R18, R22, R24, R35, R37, R41, R42, R43, R44, DP1, DP2, P01 (PL1), P20, P30, P40, P41, P50, P51, P60, U01 (Ul1), U10, U19, U41, U42, U54 grant may be eligible to submit a request for an administrative supplement to the awarding component of the parent grant. The P20, P30, and P60 award mechanisms are eligible for supplements only if they contain research components. In all cases, the mechanism of support under this program is the supplemental award.

A minimum of one year and a maximum of three years of supplemental support can be awarded under this program (but see also Funding Restrictions). Usually, a research grant or a subproject of a multi-project grant would support only one administrative supplement. Grants most likely to support more than a single administrative supplement are multi-project awards.

2. Funds Available

There is no set-aside amount for this program. Requests for administrative supplements can be submitted to the NIH Program Official listed in the contacts section at any time (http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm). Administrative supplements end with the competitive cycle of the parent grant.

The requested salary and fringe benefits for a re-entry candidate must be in accordance with the salary structure of the grantee institution, consistent with the level of effort. An additional amount up to $10,000 may be requested for supplies, domestic travel, and publication costs relevant to the proposed research. Equipment may not be purchased as a part of this supplement without justification and specific prior approval of the NIH awarding component.

The decision to fund a supplement will take approximately ten weeks from the time all of the necessary information is received by the awarding IC in an acceptable format. During the first budget period, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on funding of the parent grant and the re-entry candidates progress and cannot extend beyond the current competitive segment of the parent grant.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Only institutions currently receiving eligible NIH grant awards may submit an application for Re-Entry supplements.

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Principal Investigators on eligible NIH awards are invited to submit a request for an administrative supplement to the awarding component of the parent grant to support an eligible candidate interested in reestablishing a research career.

Candidates: Candidates must have a doctoral degree, such as M.D., D.D.S., Ph.D., O.D., D.V.M., or equivalent; and must have been in a postdoctoral or faculty position at the time they left active research. All candidates must be planning a career in biomedical or behavioral research. Candidates who have begun the re-entry process through a fellowship, traineeship, or similar mechanism are not eligible for this program. Awards will be limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application.

The following guidelines will generally be applied with discretion by the individual NIH ICs. In general, the duration of the career interruption should be for at least one year and no more than eight years. Examples of qualifying interruptions would include a complete or partial hiatus from research activities for child rearing; an incapacitating illness or injury of the candidate, spouse, partner, or a member of the immediate family; relocation to accommodate a spouse, partner, or other close family member; pursuit of non-research endeavors that would permit earlier retirement of debt incurred in obtaining a doctoral degree; and military service. The program is not intended to support additional graduate training and is not intended to support career changes from non-research to research careers for individuals without prior research training. Generally, the candidate should be in complete or partial hiatus from research activities at the time of application, and should not be engaged in full-time paid research activities. Preference will be given to candidates with a complete hiatus from research activities. Because NIH ICs may have varying degrees of flexibility in interpreting and implementing the Re-entry program, potential applicants should consult with the contact at the NIH awarding component at the earliest possible stage to discuss his or her unique situation (http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm).

2. Cost Sharing

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

In all cases, the proposed research must be directly related to the funded approved ongoing research of the parent grant or cooperative agreement. The individual supported under this supplemental award, hereafter called the re-entry candidate, must be afforded the opportunity to act as a full participant in the research project and must be given an opportunity to update and enhance her or his research capabilities. This will allow the candidate to begin the process of establishing or re-establishing a career as a productive, competitive research investigator. Supplemental awards will be consistent with the goals of strengthening the existing research program and with the overall programmatic balance and priorities of the funding program of the NIH. Administrative supplements provided under this program may be for either part-time or full-time (equivalent to 12 person-months) support for the candidate, and all supported time is to be spent updating and enhancing research skills. Proposed part-time appointments may not be less than 50% effort (equivalent to 6 person-months).

Applicants are strongly encouraged to contact the NIH institute staff prior to submission to obtain specific information about eligibility and preparing and submitting an application (http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm).

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application forms. Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com. The D&B number should be entered on the face page of the PHS 398 form.

See Section VI.2 for additional information.

The Principal Investigator must submit one original and two copies of the application to the address listed under the appropriate awarding component under Agency Contacts in Section VII.1 (http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm).

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

A request for a supplement may be made at any time during the funding year, providing there will be at least two full years of funding remaining for the parent grant at the time of the expected beginning date of the supplemental funding. In making requests, the grantee institution, on behalf of the Principal Investigator, should submit the request for supplemental funds directly to the awarding component that supports the parent grant. The request is NOT to be submitted to the NIH Center for Scientific Review (CSR) or the Office of Research on Womens Health (ORWH). Principal Investigators are encouraged to obtain the address for submission from the NIH program official on the parent grant (http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm).

The request for a re-entry supplemental award must include the following:

1. A completed face page (with appropriate signatures) from grant application form PHS 398 including the title and grant number of the parent grant and the type of supplement being requested.

2. A brief, six-page description, prepared by the Principal Investigator of the parent grant that includes:

3. A brief personal statement prepared by the candidate, to be included in the biosketch, which includes:

4. A biographical sketch of the candidate, not to exceed four pages, that includes:

5. A proposed budget entered on budget pages from the grant application form PHS 398 related to the percent effort for the research proposed for the re-entry candidate during the first and future budget period(s). (The amount requested for the supplement must coincide with the current period of support. Thus, if the initial budget period requested is less than 12 months, the budget must be prorated accordingly.)

6. Documentation if applicable, that the proposed research is approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) of the grantee institution.

7. Under unusual circumstances where the applicant and mentor would be at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must also be submitted.

The request must be signed by the Principal Investigator, the re-entry candidate, and the appropriate institution business official.

3. Submission Dates

Applications must be mailed directly to the awarding component and may be mailed at any time. However, some ICs have specific application submission dates. See http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: Not required
Application Receipt Date(s): May be submitted at any time
Peer Review Date(s): Applications can be reviewed at any time
Council Review Date(s): Not applicable
Earliest Anticipated Start Date: Notification approximately 10 weeks after receipt

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

In making requests, the grantee institution, on behalf of the Principal Investigator of the parent grant and in cooperation with the candidate must submit the request for supplemental funds directly to the awarding component that supports the parent grant. The request should NOT be submitted to the NIH Center for Scientific Review. The Principal Investigator must submit one original and two copies of the application to the address listed under the appropriate awarding component in the Inquiries section of this document.

3.C. Application Processing

Applications are received and evaluated for completeness by NIH staff within the awarding component that supports the parent grant.

Although there may be no immediate acknowledgement of the receipt of an application, applicants are generally notified of the decision to fund within approximately ten weeks after receipt.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3).

Awards are based on the current programmatic needs of the NIH awarding component, therefore investigators must contact their program officials at the NIH before applying (http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm). The decision to fund a supplement will take approximately ten weeks from receipt of a complete application.

In all cases, the proposed research must be directly related to the funded approved ongoing research of the parent grant or cooperative agreement. The individual supported under this supplemental award must be afforded the opportunity to act as a full participant in the research project and must be given an opportunity to update and enhance her or his research capabilities. This will allow the candidate to begin the process of establishing or reestablishing a career as a productive, competitive research investigator. Supplemental awards will be consistent with the goals of strengthening the existing research program and with the overall programmatic balance and priorities of the funding program of the NIH. Administrative supplements provided under this program may be for either part-time or full-time support for the candidate, and all supported time is to be spent updating and enhancing research skills. Proposed part-time appointments may not be less than 50% effort.

A minimum of one year and a maximum of three years of supplemental support can be awarded under this program. In most cases, during the first budget period, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on continued funding of the parent grant and cannot extend beyond the current competitive segment of the parent grant and the availability of funds.

6. Other Submission Requirements and Information

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025)

Only the review criteria described below will be considered in the review process.

The program staff of the individual ICs will review requests for re-entry supplements using the following general criteria:

In non-competing continuation applications, the progress report for the re-entry supplement should be clearly delineated from the progress report for the parent grant. The progress report should include information about the research activities supported by the supplement, even if support for future years is not requested. Since these applications will undergo administrative review, summary statements will not be produced. This is consistent with NIH practice for other similar programs, such as those referenced in the Eligibility Requirements section of this program announcement.

2. Review and Selection Process

Applications submitted for this FOA will be assigned to the awarding component for the parent grant and will be reviewed using the criteria shown above.

3. Merit Review Criteria

Applications submitted in response to this FOA will compete for available funds with all other recommended applications using the criteria shown in Section V.1.

3.A. Additional Review Criteria

In addition to the above criteria, the following items will be applied only when it has not been previously reviewed as part of the parent grant:

3.B. Additional Review Considerations

Not Applicable.

3.C. Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Section VI. Award Administration Information


1. Award Notices

Approximately ten weeks after receipt of the application, applicants will be notified of the intent to award. Staff at the awarding component will describe the award process at that time.

2. Administrative Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA.

3. Award Criteria

Awards are based on the current programmatic needs of the NIH awarding component, therefore investigators must contact their program officials at the NIH before applying (http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm). The decision to fund a supplement will take approximately ten weeks from receipt of a complete application.

4. Reporting

In non-competing continuation applications, the progress report and budget for the supplement must be clearly delineated from the progress report and budget for the parent grant. The progress report must include information about the research and career development activities supported by the supplement even if support for future years is not requested. Continuation of support for the candidate 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 grant 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 PHS Non-Competing Grant Progress Report, Form 2590, which can be found at http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement. In the future, identifying information on candidates supported by supplements will be collected at the beginning of the supplement period and at the beginning of each award year in order to evaluate the impact of this program on the candidates career development.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

For general information about the re-entry supplements, candidates and Principal Investigators should contact the program official of the parent grant at the appropriate awarding IC. Candidates who have not yet made contact with a Principal Investigator are encouraged to contact the program official whose IC is specific to the research interest (http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm).

2. Peer Review Contacts:

Not Applicable.

3. Financial or Grants Management Contacts:

Applicants should refer to the NIH Web site (http://grants.nih.gov/grants/guide/contacts/PA-08-191_Contact.htm) for information regarding each IC's grants management contact for this program.

Section VIII. Other Information


Required Federal Citations

Choose all citations that are appropriate to the funding opportunity announcement.

Vertebrate Animals:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity, and dose-finding studies (phase I); efficacy studies (Phase II) efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible, http://grants.nih.gov/grants/policy/data_sharing.

Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women, Minorities, and Children:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm.

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov/) It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigators NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR web site (http://www.hhs.gov/ocr) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of sections 301, 510, 515, and 504 of the Public Health Service Act. Federal regulations at 42 CFR Part 52, "Grants for Research Projects" and 45 CFR part 74, "Administration of Grants," are applicable to these awards. Grants must be administered in accordance with the NIH Grants Policy Statement (10/98).. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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NIH Funding Opportunities and Notices


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