Research on Malignancies in AIDS and Acquired Immune Suppression

PA Number: PA-04-157

Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organization:
National Cancer Institute (NCI/NIH) (http://www.nci.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov/

Announcement Type:
This Program Announcement (PA) replaces PA-01-094, PA-01-113, and PA-03-024, which were published in the NIH Guide on 5/16/2001, 6/28/2001 and 11/7/2002 respectively.

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

Catalog of Federal Domestic Assistance Number(s): 93.393-93.396 and 93.121

Key Dates

Release Date: September 17, 2004
Application Receipt Dates(s):
Standard AIDS receipt deadlines; January 2, May 1, September 1
Non-AIDS receipt deadlines: February 1, June 1, and October 1 for new grants and
March 1, July 1, and November 1 for competing continuation, supplemental, and revised grants
Peer Review Date(s): February-March, June-July, October-November
Council Review Date(s): May-June, September-October, January February
Earliest Anticipated Start Date: July, December, April
EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Executive Summary

The purpose of this initiative is to stimulate research that will improve our understanding of the biological basis of development and progression of cancer in the context of Human Immunodeficiency Virus (HIV) infection and Acquired Immune Deficiency Syndrome (AIDS) or acquired immune suppression not associated with HIV infection such as organ transplantation. The NCI and NIDCR seek to encourage novel approaches to discovery and preclinical development of novel therapeutic agents and biomarkers for early diagnosis and monitoring of disease progression. Molecular epidemiologic studies of the role of chronic latent viruses and their interaction with one another or with environmental factors in the context of acquired immune suppression or HIV infection leading to the development of tumors or lesions with oncogenic potential are also of interest. This PA will use the NIH exploratory/development (R21) award mechanism and the NIH investigator-initiated research project grants (R01) award mechanism. Please see the link at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-041.html for the NIH policy on submitting revised applications. It is anticipated that $ 2 million in total costs will be awarded in the first year to fund 8 12 applications. Application material and instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.

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

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.

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 and Instructions
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

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. Sharing Research Data
D. Sharing Research Resources

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 Responsibilites
4. Arbitration Process
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
Research into the pathogenesis of HIV-associated tumors has focused on interactions of cytokines, HIV, viral co-factors (Human Herpes Virus Type 8 [HHV-8], Human Papilloma Virus [HPV], Epstein-Barr Virus [EBV]), and oncogenes. Studies have identified the effects of specific viral genes on cellular pathways and oncogenes that contribute to tumor development and/or affect the tumor microenvironment and may promote tumor progression or maintenance of the tumorogenic phenotype. Additional characterization of virus-host gene interactions is necessary for novel and specific target identification. Although therapies developed for cancers in the non-immunocompromised setting are not necessarily effective in patients with AIDS, novel targets and therapies for AIDS malignancies might be effective in non-AIDS patients with viral-associated cancers. The goal of this Program Announcement (PA) is to encourage applications ranging in scope from basic science through molecular epidemiology to preclinical studies and including but not limited to: 1) developing and utilizing animal and cell culture models to study disease pathogenesis of the prevalent viral agents found in AIDS associated cancers (i.e. Kaposi’s Sarcoma Herpes Virus [KSHV], EBV, HPV); 2) discovering and characterizing new viral and microbiological agents that act as co-factors in tumor promotion or progression; 3) developing and utilizing predictive models for the preclinical evaluation of new therapies against AIDS-related malignancies; 4) developing preclinical applications to translate basic knowledge of AIDS related malignancies towards the development of new treatments for these diseases; 5) defining the molecular epidemiology of HIV-associated cancers and their pre-neoplastic conditions and; 6) discovering, developing and utilizing biomarkers of cancer risk, progression, or response to treatment including immunologic markers and markers that change during the course of disease (such as cytokines or viral load). Projects may identify, characterize, and validate targets for ongoing or future drug discovery, prognostic marker utility, or molecular epidemiology efforts for established disease or disease prevention. Novel agents could include, but are not restricted to, small molecules, antivirals, gene therapy, immunotherapy, vaccines, natural products, or drug delivery systems. Applications directly linking pathogenesis to molecular target identification and interdisciplinary approaches among virologists, microbiologists, molecular biologists, chemists, tumor biologists, immunologists, biochemists, pharmacologists or other disciplines appropriate to the proposed research are encouraged.

NCI and NIDCR are also interested in receiving applications proposing studies of HIV-associated malignancies in international settings of high HIV incidence and prevalence, including India, South East Asia, Eastern Europe, Central/South America, and Africa, that offer unique research opportunities.

Areas of study may include but are not limited to the following examples.
Biomarkers, Diagnostics and Therapeutics: Etiology, pathogenesis and immunology: Molecular epidemiology:

In addition the NIDCR is interested in the following topics; however the examples listed are by no means inclusive:

This PA does not encourage applications for clinical trials of treatment for AIDS-related malignancies. Such studies should be submitted in response to PA-03-005 Quick-Trials for Novel Cancer Therapies. However, analysis of samples and data collected from clinical trials and identified costs for patient visits, specimen shipping and handling specific to the applicants proposed research is appropriate. Descriptive research and recruitment or retention of cohorts is not encouraged under this PA. However, proposed analysis of samples and data acquired from existing cohorts and tissue banks is encouraged. Examples of such cohorts and repositories include the Women’s Inter-Institute HIV Study (WIHS) (https://statepiaps.jhsph.edu/wihs/), the Multicenter AIDS Cohort Study (MACS) (http://statepi.jhsph.edu/macs/macs.html), and the AIDS and Cancer Specimen Resource (http://acsr.ucsf.edu). Investigators are encouraged to utilize infrastructure support of the Centers for AIDS Research (http://www.niaid.nih.gov/research/cfar/) or the NCI designated Cancer Centers if located at those institutions. For drug development purposes, investigators are encouraged to utilize the resources of the NCI supported contract facilities though the Inter-Institute Program for Development of AIDS Related Therapeutics (http://www.cancer.gov/about_nci/doc.aspx?viewid=8B8991BA-C27E-488C-BE9E-2831512A322B)

Section II. Award Information


1. Mechanisms of Support

This funding opportunity will use the NIH exploratory/development (R21) award mechanism and the NIH investigator-initiated research project grants (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. For the R21 mechanism, applicants may request a project period of up to 2 years with a combined budget for direct costs of up to $275,000 for the 2-year period (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html ). For example, an applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year.

This funding opportunity uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications.

2. Funds Available

It is anticipated that $ 2 million in total costs will be awarded to fund approximately 8 12 applications with costs per award ranging from $150,000 - $300,000 in the first year dependent upon grant mechanism requested with the first award date in August of 2005.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your institution 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. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at Http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part2.htm

3. Other Special Eligibility Criteria

Not Applicable

Section IV. Application Submission Instructions

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) 710-0267, 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 instructions and forms (rev. 5/2001). 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.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Subsection VI.2. Administrative and National Policy Requirements for additional information.

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.

3. Submission Dates
Applications must be mailed on or before the receipt dates listed below.

3.A. Receipt, Review and Anticipated Start Dates

Application Receipt Dates(s):
Standard AIDS receipt deadlines; January 2, May 1, September 1
Non-AIDS receipt deadlines: February 1, June 1, and October 1 for new grants and
March 1, July 1, and November 1 for competing continuation, supplemental, and revised grants
Peer Review Date: February-March, June-July, October-November,
Council Review Date: May-June, September-October, January-February,
Earliest Anticipated Start Date: July, December, April,

3.A.1. Letter of Intent

Not applicable

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 five 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)

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm .

The NIH will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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 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. Award Criteria)

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

All R21 applications and R01 applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting $500,000 or more in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html . Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and the related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section V. Application Review Information

1. Criteria
This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

3. Merit Review Criteria

Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

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. 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.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

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

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigator: Is the investigator 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 (if any)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

3.A. Additional Review Criteria:
In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: 3.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.C. Sharing Research Data

1. Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

3.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgpsand http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

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/grants/policy/nihgps_2003/NIHGPS_part4.htm

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award 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 (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The NGA will be sent via email to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398.

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/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.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.

2.A. Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Award Criteria

The following will be considered in making funding decisions:

4. 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 two areas: scientific/research and financial or grants management issues:

1. Scientific/Research Contacts:
Direct your questions about basic science issues to:

Elizabeth Read-Connole, Ph.D.
Division of Cancer Biology
National Cancer Institute, NIH
6130 Executive Blvd., EPN Room 5016
Bethesda, MD 20892-7398
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-6085
Fax: (301) 496-2025
E-mail: bconnole@mail.nih.gov

Direct your questions about molecular epidemiology studies to:

Sandra L. Melnick, Dr. P.H.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN Room 5103, MSC 7395
Bethesda, MD 20892-7395
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-4914
Fax: (301) 402-4279
Email: melnicks@mail.nih.gov

Vaurice Starks, B.S.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN Room 5103, MSC 7395
Bethesda, MD 20892-7395
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-9375
Fax: (301) 402-4279
Email: vs38j@nih.gov

Direct your questions about pre-clinical diagnostics and therapeutics studies to:

Roy S. Wu, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Blvd., EPN Room7009
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8866
Fax: (301) 480-4663
E-mail: wur@ctep.nci.nih.gov

Jodi B. Black, Ph.D.
Division of Cancer Treatment and Diagnosis
Building 31, Room 3A44
National Cancer Institute
Bethesda, MD 20892
Telephone: (301) 402-6293
Fax: (301) 496-0826
E-mail: blackj@mail.nih.gov

Direct your questions about oral malignant complications of HIV/AIDS to:

Mostafa Nokta, M.D., Ph.D.
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research,
Building 45, Room 4AN-18H
Bethesda MD, 20892-6402
Telephone: (301) 594-7985
Fax: (301) 480-8319
Email: Mostafa.Nokta@nih.gov

2. Peer Review Contacts:

Not Applicable.

3. Financial or Grants Management Contacts:

Ms. Judy Sint
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd., EPS Room 243
Bethesda, MD 20892
Telephone: (301) 496-7240
Fax number: (301) 496-8601
Email: judy.sint@nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
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. See 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. (See the NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998 at 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 (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible

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 priority score.

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/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 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-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 (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. 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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