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
National Center on Minority Health and Health Disparities (NCMHD), (http://www.ncmhd.nih.gov/)

Title: NCMHD Community Participation in Health Disparities Intervention Research

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-MD-05-002

Catalog of Federal Domestic Assistance Number(s)
93.307

Key Dates
Release Date: February 9, 2005
Letters of Intent Receipt Date(s): March 14, 2005
Application Receipt Dates(s): April 14, 2005
Peer Review Date(s): July-August 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: September 2005
Expiration Date: April 15, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

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 or Matching
    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 and Times
      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

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources
    3. Anticipated Announcement and Award Dates

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
      A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. 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 goal of this RFA is to support community-based participatory research in planning, implementing, evaluating and disseminating effective interventions for a disease or condition to reduce and eventually eliminate health disparities through partnerships between minority health populations, subpopulations, and other heath disparity populations and researchers. This RFA invites applications using the NIH research-related research projects (R24) award mechanism.

Community-based participatory research (CBPR) is defined as scientific inquiry conducted in communities and in partnership with researchers. The process of scientific inquiry is such that community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community's health have the opportunity to be full participants in each phase of the work (from conception - design - conduct - analysis - interpretation - conclusions - communication of results). CBPR is characterized by substantial community input in the development of the grant application (http://www.niehs.nih.gov/translat/cbpr/cbpr.htm).

For the purpose of this RFA, community refers to populations that may be defined by: geography, race, ethnicity, gender, illness, or other health condition, or to groups that have a common interest or cause, such as health or service agencies and organizations, health care or public health practitioners or providers, policy makers, or lay public groups with public health concerns. Community-based organizations refer to organizations that may be involved in the research process as members or representatives of the community. While not an exhaustive list, organizations as varied as Tribal governments and colleges, state or local governments, independent living centers, other educational institutions such as junior colleges, advocacy organizations, health delivery organizations (e.g., hospitals), health professional associations, non-governmental organizations, and federally qualified health centers are possible community partners.

In the NIH Health Disparities Strategic Plan, Fiscal Years 2004-2008, the health disparity populations are the racial and ethnic minority groups delineated within Section 1707(g), Public Law 106-25, as well as populations with low socioeconomic status and those living in rural areas. The racial and ethnic minority group refers to American Indians (including Alaska Natives, Eskimos, and Aleuts), Asian Americans, Native Hawaiians and other Pacific Islanders, Blacks and Hispanics. Hispanics are individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or any other Spanish-speaking country. The other health disparity populations are population groups who suffer health disparities when compared to the general population. (http://www.ncmhd.nih.gov)

NCMHD is interested in supporting intervention research studies using community-based participatory research (CBPR) principles to reduce and eventually eliminate health disparities in any disease or condition of major concern to the community (e.g. cancer, cardiovascular diseases, diabetes, HIV/AIDS, infant mortality, immunization) with emphasis on racial and ethnic minorities.

This initiative will start with a three-year planning grant, followed by a competitive five- year intervention grant, and conclude with a competitive three-year dissemination grant. Receipt of a planning grant does not guarantee obtaining the subsequent intervention or dissemination grant. Subsequent grant awards will be based on scientific merit, progress, quality of the research proposal, and availability of funds.

This RFA is inviting applications for a three-year planning grant proposal. The first year of the grant is devoted to partnership development, community needs assessment, identifying the disease/condition for intervention research, and planning the intervention methodology with substantial input from the community. During the second and third year, a pilot intervention research study will be conducted with community participation.

Successful partnership development with a defined community and developing a plan for intervention research including a pilot intervention research study using CBPR principles are required for participating in the competition for the next stage of funding for the intervention research grant.

For more information about CBPR, review the following major references:

Viswanathan M, Ammerman A, Eng E, et al. Community-Based Participatory Research: Assessing the Evidence. Evidence Report/Technology Assessment No. 99 (Prepared by RTI  ---University of North Carolina Evidence-based Practice Center under Contract No. 290-02-0016). AHRQ Publication 04-E022-2. Rockville, MD: Agency for Healthcare Research and Quality. July 2004. Available at: http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1a.chapter.44133. Accessed February 3, 2005. A summary of this report is available at: http://www.ahrq.gov/clinic/epcsums/cbprsum.htm.

CBPR guidelines for reviewers and applicants are available as Exhibits 1-3 under Evidence-Based Practice at http://www.rti.org

Additional Resources:

Community-Based Participatory Research for Health. Meredith Minkler & Nina Wallerstein, Editors. Jossey Bass, San Francisco, 2003.

Successful Models of Community-Based Participatory Research (2000). O'Fallon, L., Tyson, F., and Dearry, A. (Editors), National Institute of Environmental Health Sciences: Research Triangle Park, NC. Available at: http://www.niehs.nih.gov/translat/cbr-final.pdf. Accessed February 3, 2005.

Institute of Medicine (2000). Promoting Health Intervention Strategies from Social and Behavioral Research. Smedley, B.D. & Syme, L., Editors. National Academy Press: Washington DC.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH research-related research projects (R24) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

By using the R24 mechanism, the NIH seeks to support research projects that will enhance the capability of resources to serve biomedical research. It also seeks to foster the introduction of novel scientific ideas, techniques, models, tools, agents, targets, methodologies, technologies, and applications that have the potential to substantially advance biomedical, behavioral and clinical research on health-related topics.

This funding opportunity uses just-in-time concepts. It also uses the non-modular budget format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Please follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

R24 applications must request a project period of up to three years with a budget for direct costs of up $375,000 per year for the three-year period. The request should be tailored to the needs of your project.

2. Funds Available

The National Center on Minority Health and Health Disparities intends to commit approximately $4.5 million dollars in FY 2005, to fund 5-10 new grants in response to this RFA. An applicant must request a project period of up to three years and a budget for direct costs up to $375,000 dollars per year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NCMHD provides support for this program, awards are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

To be responsive to this RFA, eligible institutions must demonstrate history and/ or evidence of partnerships between community-based organizations and academic research institutions. Evidence of partnerships may include current or previous research collaborations. A Memorandum of Agreement (MOA) or Memorandum of Understanding (MOU) should clearly delineate the roles and responsibilities of the collaborating organizations/institutions. The lead organization must demonstrate history and ability of managing grant awards.

Current NCMHD Excellence in Partnerships for Community Outreach, Research on Health Disparities and Training or Project EXPORT grantees are eligible to apply. A list of Project EXPORT grantees is located at: http://www.ncmhd.nih.gov.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Eligible individuals must have experience working with health disparity populations. These individuals must demonstrate history and/or evidence of partnerships between community-based organizations and academic research institutions. Evidence of partnerships may include current or previous research collaborations. A Memorandum of Agreement (MOA) or Memorandum of Understanding (MOU) should clearly delineate the roles and responsibilities of the collaborating individuals and organizations/institutions.

Non-responsive applications will not be reviewed.

2. Cost Sharing or Matching
Not applicable

3. Other-Special Eligibility Criteria

3.A. Special Eligibility Criteria
Not applicable

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. Applicants must use the currently approved version of the PHS 398. 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 most current PHS 398 research grant application instructions and forms. Applications must have a 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/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

In preparing and responding to this RFA:

The following element should also be considered in the 25-page limit for applications submitted in response to this announcement.

Required Personnel: Although a single institution or organization must be the applicant, one or more partners or multi-institutional arrangement (consortium) is required. Such an arrangement, entailing active participation by more than one organization, is required and there must be clear evidence of close interaction and equal responsibility among the participants.

It is important to note that, because of the wide range of health problems to be addressed and the diversity of affected communities, applications must include all of the following:

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: March14, 2005
Application Receipt Date(s): April 14, 2005
Peer Review Date: July-August 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: September 2005

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Francisco S. Sy, MD, DrPH
Chief, Office of Community-Based Participatory Research and Outreach
National Center on Minority Health and Health Disparities, National Institutes of Health
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: SyF@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Merlyn Rodrigues, M.D., Ph.D.
Director, Office of Extramural Activities
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800
MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
FAX: (301) 402-4070
Email: rodrigm1@mail.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Center on Minority Health and Health Disparities. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH 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. Reporting).

6. Other Submission Requirements
Not applicable

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCMHD. Incomplete and/or non-responsive applications will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCMHD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Special guidelines for the review of CBPR applications includes the applicant's ability to incorporate the following elements:

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

6. Translation (when relevant).

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3. Anticipated Announcement and Award Dates
September 2005

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

The Notice of Grant Award (NGA) will be e-mailed to the e-mail address established by the grantees. All the other NGAs will be mailed using postal service to the official business address indicated on the face page of the application.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Francisco S. Sy, MD, DrPH
Chief, Office of Community-Based Participatory Research and Outreach
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: SyF@mail.nih.gov

2. Peer Review Contacts:

Merlyn Rodrigues, M.D., Ph.D.
Director, Office of Extramural Activities
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800
MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
FAX: (301) 402-4070
Email: rodrigm1@mail.nih.gov

3. Financial or Grants Management Contacts:

Bryan S. Clark, M.B.A.
Chief Grants Management Officer
Grants Management Branch, Office of Extramural Activities
National Center on Minority Health and Health Disparities
National Institute of Health
6707 Democracy Boulevard, Suite 800, MSC 5465
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4089
Email: ClarkB@ncmhd.nih.gov

Section VIII. Other Information

Required Federal Citations

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, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Inclusion of Women And Minorities in Clinical Research:
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 (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.

Public 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 public 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 PA 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.

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 website (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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

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 and 405 of the Public Health Service Act as amended (42 USC 211 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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.


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  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892