Part I Overview Information


Department of Health and Human Services

Issuing Organization
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)

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

Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)

Title: Obesity/Nutrition Research Centers

Announcement Type
New

Request For Applications (RFA) Number: RFA-DK-04-021

Catalog of Federal Domestic Assistance Number(s)
93.848

Key Dates
Release Date: January 25, 2005
Letters of Intent Receipt Date(s): June 10, 2005
Application Receipt Date(s): July 12, 2005
Peer Review Date(s): October-November 2005
Council Review Date(s): February 2006
Earliest Anticipated Start Date: April 2006
Expiration Date: July 13, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Obesity/Nutrition Research Center (ONRC) grants. The ONRCs are core centers (P30) that are part of an integrated program of nutrition and obesity-research support provided by NIDDK. A total of $2,000,000 in FY 2006 will be committed to fund a total of two new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $ 750,000 per year. Two existing ONRCs are expected to submit competing renewal applications.

Eligible organizations to apply to this RFA are for-profit or non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of state and local governments; eligible agencies of the Federal government; and domestic institution. Foreign institutions are not eligible to apply. For the purpose of this RFA, the NIDDK will not support more than one ONRC grant (P30) in an applicant institution.

An individual is eligible to become a principal investigator if they have the skills, knowledge, and resources necessary to carry out the proposed research and the administrative management of the Core Center. Individuals from underrepresented racial and ethnic groups, women, and individuals with disabilities are always encouraged to apply for NIH programs.

Application must be prepared using the PHS 398 research grant application. 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. The Obesity/Nutrition Research Center Guidelines provide more detailed information on the Centers and on preparing the application. The guidelines are accessible at http://www.niddk.nih.gov/fund/other/centers/onrc.doc or from the program director listed under INQUIRES. Telecommunications for the hearing impaired is available at TTY 301-451-5936.

An applicant can only submit one application to this RFA.

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
    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 objectives of the Obesity/Nutrition Research Centers are to encourage a multidisciplinary approach to research in the nutritional sciences and to bring together, on a cooperative basis, clinical and basic science investigators in a manner that will enhance and extend the effectiveness of research being conducted in the field of obesity, eating disorders, and energy regulation. A Core Center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. To accomplish the overall goal of these centers, there must be in existence at the applicant's institution an ongoing program of excellence in biomedical research related to the study of obesity. This research should be in the form of NIH-funded research projects (R01), program projects (P01), or other peer-reviewed research from Federal and non-federal sources that is already funded at the time of submission of a Center grant application.

The research base related to obesity can include a focus on behavior, physical activity, energy metabolism, body composition, cell biology, or nutrient metabolism. Other nutritional sciences research may be included if the investigators make use of the same core services as justified by the research base related to obesity. It would be highly desirable that the Principal Investigator, as well as the applicant institution, have a commitment to the treatment and prevention of obesity. The availability of a clinic population with adequate representation of women and minorities that can be readily utilized by investigators will play a major role in attracting investigators to the field of obesity research and to serve as a resource in the design of pilot and feasibility projects. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. Applicants should consult with NIDDK staff concerning plans for the development of the Center and the organization of the application.

The Obesity/Nutrition Research Centers are based on the core concept. Four to six cores are usually included in a Center. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in obesity and nutritional sciences research to accomplish the stated goals of the Center. Examples of such resources include biostatistics, imaging, biotechnology, and instrumentation facilities. It is appropriate and may be beneficial to have one or more central themes around which core center research investigations are focused.

Centers are encouraged to include a clinical component or core that deals with patients. This clinical component can exist as a stand alone core or part of another core such as the administrative core. Besides leading to a better understanding of disease etiology and natural history of disease, such cores might provide biostatistics support; enhance clinical study design; enhance collaboration among researchers and recruitment of subjects for clinical studies; provide for epidemiological studies; or provide modest funding for tissue, DNA, or serum storage. In addition, a clinical or epidemiology core may more effectively address NIH policies concerning issues of children, women, and ethnic minority participation in clinical studies.

Two other types of activities should also be supported with Center funding: a pilot and feasibility (P/F) program and an enrichment program. The P/F program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators; at investigators established in other research disciplines with expertise that may be applied to obesity and nutritional sciences research; and, occasionally, at investigators who wish to make a substantial change in the direction of their research. In addition, temporary salary support for one Named New Investigator in a specified area of research with a defined P/F study may be requested for up to 24 months, with subsequent individuals to be named by the Center Director and approved by the Center's External Advisory Board and the NIDDK. The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the Core Center (P30) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.


2. Funds Available

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to commit approximately 2,000,000 dollars in FY 2006 to fund two new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and budget for direct costs up to 750,000 dollars per year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIDDK provide support for this program, awards pursuant to this funding opportunity 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 if your organization has any of the following characteristics:

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.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement. The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

The ONRC Director, who is the Principal Investigator on the P30 application and Director of the Administrative Core, should be a scientist who can provide effective administrative and scientific leadership and can demonstrate proficiency in managing a large, multi-component project. The Director will be responsible for the organization and operation of the ONRC and for communication with the NIDDK on scientific and operational matters. Center Directors are required, and their administrators are strongly encouraged, to attend an annual meeting to be held at a location to be determined by the NIDDK. Funds for travel to this meeting should be included in the budget for the Administrative Core of the Center.

Successful ONRC applications require an existing program of excellence in biomedical research in the areas of basic and clinical research related to obesity, behavior, physical activity, energy metabolism, body composition, and the nutritional sciences. To justify Core Center support, the ONRC must serve a strong obesity-related research base that has a consistent and outstanding record in NIH and other peer-reviewed funding. The research base grants must be summarized in accordance with the Administrative Guidelines for NIDDK Obesity/Nutrition Research Centers (ONRC). (See Application Procedures.)

At least 50 percent of the obesity, energy metabolism, behavior, physical activity, body composition, and nutritional sciences-related research comprising the research base must be supported by Federal Agencies.

Scientific personnel and institutional resources capable of supporting the research base must be available. In addition, the institution and pertinent departments must show a strong commitment to the Center's support. Such commitment may be provided as dedicated space, staff recruitment, salary support for investigators, dedicated equipment, or other financial support for the proposed Center.

Each core unit proposed for funding under the ONRC must be utilized by a minimum of two federally funded research projects. A detailed description of each core unit proposed as part of the Center must be provided, with a detailed budget and budget justification. A Core director must be named for each core proposed. The description of each core unit proposed should include a rationale, indicating how it will support the research effort in a cost-effective manner. Facilities must be available for the primary needs of the ONRC Program because funds for new construction are not available.

Promoting interdisciplinary and multidisciplinary collaboration among scientists working within a Center is a major goal of the ONRC Program. Each Center application should describe how continuing and new interactions will be fostered and encouraged by the ONRC.

Another goal of the ONRC is to attract scientists to the fields of obesity, behavior, energy metabolism, physical activity, and nutritional sciences. Therefore, a Pilot and Feasibility (P/F) program as well as an Enrichment Program should be supported within the ONRC program. For the purpose of this RFA, the NIDDK will not support more than one ONRC grant (P30) in an applicant institution.

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.

The ONRC Guidelines provide more detailed information on the Centers and on preparing the application. The guidelines are accessible at http://www.niddk.nih.gov/fund/other/centers/onrc.doc or from the program director listed under INQUIRIES.

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: June 10, 2005
Application Receipt Date(s): July 12, 2005
Peer Review Date: October/November 2005
Council Review Date: February 2006
Earliest Anticipated Start Date: April 2006


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 O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@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:


Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@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/label-bk.pdf. Personal deliveries of applications are no longer permitted.


3.C. Application Processing

Applications must be received on or before the application receipt date 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 NIDDK . 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

Additional application instructions are available in the Obesity Nutrition Research Center Guidelines available on the internet at http://www.niddk.nih.gov/fund/other/centers/onrc.doc or from the Program Director listed under INQUIRES, below.

Section V. Application Review Information


1. Criteria

Only 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 NIDDK . 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 NIDDK 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.

All applications responding to this RFA will be evaluated according to the review criteria as outlined in the Obesity/Nutrition Research Centers Administrative Guidelines available on the Internet at http://www.niddk.nih.gov/fund/other/centers/onrc.doc or from the Program Director listed under Scientific/Research Contacts, below.

As part of the initial scientific review, which will result in one overall numerical priority score for the entire P30 application, reviewers will rate each individual research core and, if requested, the clinical component, as well as the P/F program. The scientific Cores will be evaluated individually and each core will receive an adjectival descriptor. The evaluation of the Enrichment program will be reflected in the adjectival score of the Administrative Core. The merit descriptors for each of these components will appear in the summary statement. The review group will assign a descriptor, rather than a score, for the research base, the P/F program, and the Center Director.

Review Criteria

The most important component of an ONRC is an ongoing, strong base related to obesity, behavior, physical activity, energy metabolism, body composition, cell biology, and nutritional sciences-related research.

Specific review criteria for ONRC Core Centers are:

The 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.

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).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.


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.

2.C. Sharing Research Data
N/A

Since these are P30 applications to set up core services to support other research projects, these cores will not maintain data that can be shared.

2.D. Sharing Research Resources
N/A

3. Anticipated Announcement and Award Dates

Applicant can expect to learn about the disposition of their applications, whether successful or unsuccessful by February of 2006

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 NGA will be sent by email to the Business Official with a copy to the Principal Investigator.


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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

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 Contact:

Carolyn W. Miles, Ph.D.
Division of Digestive Diseases and Nutrition
National Institutes of Diabetes and Digestive and Kidney Disease
6707 Democracy Blvd., Room 665
Bethesda, MD 20892-5450
Telephone: (301) 451-3759
FAX: (301) 480-8300
Email: cm294e@nih.gov


2. Peer Review Contact:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institutes of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Rm. 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

3. Financial or Grants Management Contact:

Sharon Bourque
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 719
Bethesda, MD 20892-5456
Telephone: (301) 594-8846
FAX: (301) 480-3504
Email: sb114m@nih.gov


Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
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, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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://grants.nih.gov/grants/policy/model_organism/index.htm). 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.

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.

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-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (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. Applications that do not provide this information will be returned without review.

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.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 and 405 of the Public Health Service Act as amended (42 USC 241 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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