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 Institute of Allergy and Infectious Diseases (NIAID), (http://www3.niaid.nih.gov/)

Title: HIV Vaccine Research and Design (HIVRAD) Program (P01)

Announcement Type
This is a reissuance of PAR-03-094 which was released April 3, 2003.

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

Program Announcement (PA) Number: PAR-06-285

Catalog of Federal Domestic Assistance Number(s)
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research


Key Dates
Release/Posted Date: March 29, 2006  
Letters of Intent Receipt Date(s): June 23, 2006; May 21, 2007
Application Receipt Date(s):  August 17, 2006; June 21, 2007 (Additional date June 23, 2008 per NOT-AI-07-041)
Peer Review Date(s): November 2006; October 2007
Council Review Date(s): January 2007; January 2008
Earliest Anticipated Start Date: January 2007; January 2008
Additional Information To Be Available Date (Url Activation Date): Not Applicable.
Expiration Date: June 24, 2008

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
2. Special Requirements

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

Background

Every year approximately five million people worldwide are infected with the human immunodeficiency virus (HIV), the virus that causes the Acquired Immunodeficiency Disease Syndrome (AIDS).  Almost 14,000 people become infected each day and 45 million additional infections are projected to occur by 2010 unless more effective measures are taken to prevent new infections.  The human and economic toll of HIV/AIDS requires an accelerated effort to develop a preventive HIV vaccine.  The development of a safe and effective prophylactic vaccine against HIV/AIDS is one of the highest priorities of the National Institutes of Health (NIH).  Within NIH, the NIAID has a lead role in this endeavor and supports a number of research programs using multiple grant and contract funding mechanisms.  NIAID supports HIV/AIDS prophylactic vaccine research and development via three solicited grant programs ranging from early stage high risk/high impact research supported through the Phased Innovation Awards (PIA), to advanced research and vaccine design supported through the HIV Vaccine Research and Design (HIVRAD) Program, to vaccine development, optimization and production leading to human clinical trial testing supported by the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Program. 

Objective

The HIVRAD program is designed to fund projects for research that have advanced past the exploratory stage and that address topics crucial to the design of an efficacious HIV/AIDS vaccine.  To that end applicants may target any area of HIV/AIDS prophylactic vaccine research.  These areas may include, but need not be limited to, correlates of immunity to HIV/AIDS or appropriate model systems, approaches to increase immunogenicity of HIV antigens, approaches to stimulate pertinent arms of the immune system as they relate to HIV/AIDS vaccine efficacy, development or improvement of vaccine vectors, HIV structural studies as they relate to designing HIV immunogens, and development of improved animal model systems to address vaccine efficacy.  Extensive modeling of vaccine concepts in non-human primates may be included.  Clinical studies involving human subjects and/or vaccine research focused solely on therapeutic applications are not considered responsive to this PA.  For information on programs that support therapeutic vaccine development, please contact program staff. 

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

2. Special Requirements

Milestones

Applicants are required to delineate in their application discrete goals with measurable milestones, and include criteria that can be used to decide when to proceed to the next phase of vaccine research or development.  Based on comments from the peer reviewers, the Program Officer may negotiate milestones included in the application with the applicant.  The agreed upon milestones will be included in the Terms of Award.  The achievement of milestones will be the focus of discussion at the annual site visit review (as described below).

Scientific Advisory Group

It is strongly recommended that a 3-4 member Scientific Advisory Group (SAG), consisting of independent experts in the areas of research that the program project addresses, be identified soon after award of the program project.  SAG members will be requested to attend annual meetings sponsored by the grantee to assist the grantee with interpretation of results and planning of future studies, and to assist Program Staff with assessing progress during the course of the project.  Applicants are urged not to include names of proposed SAG members in their applications.

Annual Meetings

Awardees shall host an annual site visit review  for the Program Officer, NIAID Program Staff and Scientific Advisory Group. The PI and all co-investigators shall attend this meeting.  An update and summary of results generated from each project shall be presented by the PI, co-investigators and/or all pertinent staff.  These presentations shall include summaries of all goals and milestones achieved during the review period and a description of all problems encountered that may have an impact on the achievement of future goals and/or milestones.  It is suggested that investigators include the cost of travel and any proposed honorarium for attendance of the “to-be-named” members of the Scientific Advisory Group to these annual meetings in their proposed budgets.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Program Project (P01) award mechanism. Applications must include at least two (2) research projects and one (1) core.  Program project grants support broadly based, multidisciplinary research programs that have a well-defined, central research focus or objective.  An important feature is that the interrelationships of the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually.  The program project grant consists of a minimum number of interrelated individual research projects that contribute to the program objective.  This type of award also can provide support for certain common resources termed cores.  Such resources are required to be utilized by two or more projects within the application.  The total project period for HIVRAD P01 grants may not exceed five years.

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

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 NIAID 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 NOT-OD-05-004.

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:

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

Not applicable.

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

There is no limit to the number of applications an applicant may submit under the announcement.

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.

Applicants for P01 grants must follow the special instructions entitled “How to Prepare a Multi-Project Grant Application” located at: http://www.niaid.nih.gov/ncn/grants/multi/multi_pf.htm.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates  

Letters of Intent Receipt Date(s): June 23, 2006; May 21, 2007
Application Receipt Date(s):  July 24, 2006; June 21, 2007
Peer Review Date(s): November 2006; October 2007
Council Review Date(s): January 2007; January 2008
Earliest Anticipated Start Date: January 2007; January 2008

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:

Eugene R. Baizman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3125, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-1824 (for Express Couriers)
Telephone:  (301) 402-1464
Fax:  (301) 480-2408
Email:   eb237e@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. 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 photocopies of the grant application must be sent to:

Eugene R. Baizman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3125, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-1824 (for Express Couriers)
Telephone:  (301) 402-1464
Fax:  (301) 480-2408
Email:   eb237e@nih.gov

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

Applications must be received on or before the application receipt/submission 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 CSR. Incomplete 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 merit 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 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.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.


6. Other Submission Requirements

Plan for Sharing Research Data

Investigators submitting an application in response to this announcement are required to include a plan for data sharing or to state why data sharing is not possible. (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).  Applicants are encouraged to discuss their data sharing plan with the program contact prior to submission of their applicationProgram staff will be responsible for overseeing the data sharing policy and for assessing the appropriateness and adequacy of the proposed data-sharing plan.

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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131).

Unique research resources produced with funds awarded in response to this solicitation shall be made readily available for research purposes to qualified individuals with the scientific community no later than publication of the associated research funding.  (http://www.aidsreagent.org/)

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

Relevance and feasibility of proposed goals, measurable milestones, and criteria that can be used to decide when to proceed to the next phase of vaccine research or development

2. Review and Selection Process

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

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

Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review.  Incomplete applications will be returned to the applicant without further consideration.  Applications that are will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID. 

The review criteria listed below and presented in “How to Prepare a Multi-Project Grant Application” located at: http://www.niaid.nih.gov/ncn/grants/multi/multi_pf.htm will be used to assess  P01 applications.

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.

Research Projects.

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 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, 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, e.g., does it challenge existing paradigms or clinical practice or address an innovative hypothesis or critical barrier to progress in the field? Does it develop or use novel concepts?

4.      Investigator. Are the investigators appropriately trained and well suited to carry out this work? Is the work appropriate to the experience level of the PI 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 studies benefit from unique features of the scientific environment or subject populations or include useful collaborative arrangements? Is there evidence of institutional support?

Cores. Each core unit must provide essential facilities or services for two or more funded research projects. Review criteria for cores are:

 Review Criteria for Evaluating an Overall Multi-Project Application

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.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

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

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.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 (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and 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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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 awardee 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. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable.  

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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 Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA 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.


2. Administrative and National Policy Requirements

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

3. Reporting

Awardees will be required to host, for the Program Officer, NIAID Program Staff and Scientific Advisory Group, an annual site visit.  The PI and all co-investigators shall attend this meeting.  An update and summary of results generated from each project shall be presented by the PI, co-investigators and/or all pertinent staff.  These presentations shall include summaries of all goals or milestones achieved during the review period and a description of all problems encountered that may have an impact on the achievement of future goals and/or milestones.

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:

Dr. James Bradac
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5116, MSC-7620
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 435-3754
FAX: (301) 480-3684
Email: jbradac@niaid.nih.gov

2. Peer Review Contacts:

Eugene R. Baizman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3125, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-1824 (for Express Couriers)
Telephone:  (301) 402-1464
Fax:  (301) 480-2408
Email:   eb237e@nih.gov

3. Financial or Grants Management Contacts:

Chanee Williams
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2248, MSC-7614
6700-B Rockledge Drive
Bethesda, Maryland 20892-7614 (20817 express)
Telephone: (301) 496-7075 
FAX: (301) 480-3780
Email: cw174r@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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and 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.


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

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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

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/ in the following citations: No. 93.855, Allergy, Immunology and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research, 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.

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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