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 Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)

Title: Population Research Infrastructure Program

Announcement Type
This is a reissue of RFA-HD-04-022 which was previously released August 11, 2004.

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

Request For Applications (RFA) Number: RFA-HD-05-028

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: April 20, 2005
Letters of Intent Receipt Date(s): October 19, 2005
Application Receipt Dates(s): November 16, 2005
Peer Review Date(s): March/April, 2006
Council Review Date(s): June 2006
Earliest Anticipated Start Date: July 1, 2006
Additional Information To Be Available Date (Url Activation Date): April 12, 2005
Expiration Date: November 17, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, 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. Award Criteria

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

This RFA invites applications for infrastructure grants in support of population research relevant to the mission of the Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research (CPR), NICHD. Applicants may request funds to support infrastructure development and/or research designed to: (1) enhance the quality and quantity of population research conducted at an institution; and (2) develop new research capabilities to advance population research through innovative approaches. A central goal of this program is to facilitate interdisciplinary collaboration and innovation in population research while providing essential and cost-effective core services in support of the development, conduct, and translation of population research based in centers or comparable administrative units. This announcement invites applications for Research Infrastructure Awards. A separate announcement (available at: http://grants.nih.gov/grants/guide/pa-files/PAR-04-138.html) invites applications for Developmental Infrastructure Awards, which are intended to support the development and demonstrate the feasibility of programs that have high potential for advancing population research, but have not yet fully developed the necessary resources and mechanisms to be competitive for a Research Infrastructure Award. A table summarizing the differences between the Infrastructure Award (R24) and Developmental Infrastructure Award (R21) is available at http://www.nichd.nih.gov/RFA/HD-05-028/HD-05-028.htm. See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Purpose The primary purposes of the Population Research Infrastructure Program are to provide resources to support and advance research that will improve understanding of the antecedents and consequences of population structure and change, facilitate interdisciplinary collaboration among investigators conducting population-related research and in allied fields, and promote innovative approaches to population research questions. An additional goal is to facilitate interaction among scientists in locations throughout the United States that contributes to the integration and coordination of population research.

The Infrastructure Grant funds infrastructure to support a portfolio of population research housed in or coordinated by a center or other research unit (hereafter, "research unit" or "unit") at an institution. Through this support, the Infrastructure Grant is intended to:

Applicants must identify the signature population-related themes of the unit and these must be relevant to the DBSB mission. Signature themes are defined as research topics that exemplify the applicant program's most significant current and/or anticipated contributions to population research. The themes should reflect major strengths of the program and need not encompass all research topics covered by program researchers. Applicants must also articulate a vision for the potential future contributions of the program.

Scope

The Population Research Infrastructure Program seeks to advance scientific knowledge in areas related to the mission of the Demographic and Behavioral Sciences Branch (DBSB). DBSB is one of three programs in the Center for Population Research of the NICHD. Its mission is to foster research on the processes that determine population size, growth, composition, and distribution, and on the determinants and consequences of those processes. This mission translates into a research portfolio that looks intensively at the demographic processes of fertility, mortality, and migration and at their broad interrelationships with larger social, economic, and cultural processes. Areas of supported research include fertility and family planning, sexually transmitted disease, family and household demography, mortality and health, population movement, population and environment, and population composition and change. Research supported by the Branch uses a broad spectrum of scientific approaches in the clinical, behavioral, and social sciences.

A description of the DBSB mission is available at http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm. Illustrative examples of population research topics that fall within the DBSB mission include, but are not limited to, the list that follows. Applicants may consult with program staff listed under WHERE TO SEND INQUIRIES to discuss the relevance of other topics to the DBSB mission.

1. Research on the antecedents and consequences of changes in population size, structure, and composition, including the documentation, analysis, and/or projection of population composition with respect to demographic, economic, social, and geographic characteristics; economic and social mobility; the relationship of economic, social, and cultural factors to population change; and the interrelationship between population and the physical environment.

2. Research on families and households, including studies of the determinants of trends in marriage, divorce, and cohabitation; the formation of and changes in household structures, fatherhood, patterns of child support and visitation with absent parents; the use of child care services; the relationship between changing fertility and family patterns and the well-being of children; intergenerational demography; and the implications of welfare and health policies on families.

3. Fertility research, including research on individual, social, economic, and cultural determinants and consequences of fertility and fertility trends, on the interrelationship between fertility patterns and education, work, union formation and dissolution, family structure, and health; and on contraceptive use, abortion, and sexual behavior.

4. Research on population movement and distribution, including studies of the determinants and consequences of international and internal migration and residential mobility, assimilation and adaptation of migrants; migrant selectivity; residential segregation; and spatial demography.

5. Demographic aspects of health, morbidity, disability, and mortality, including research on infant mortality and low birth weight; health disparities; research that relates demographic and social processes to mortality and health across the life course; and the health and well being of children (see http://www.nichd.nih.gov/cpr/dbs/dbsb_mission.htm for more information).

6. Behavioral research on the sexual transmission of HIV, including demographic studies of sexual behaviors related to HIV transmission; studies of the interrelationships between social, institutional, economic, and cultural contexts and sexual behavior; studies of the interrelationships among pregnancy, pregnancy prevention, and HIV prevention; theoretically grounded intervention studies within these areas; and related methodological studies (see http://grants.nih.gov/grants/guide/pa-files/PAS-00-136.html).

Infrastructure Support

Applicants may request support in the following categories: (1) Research Support Cores; (2) Developmental Infrastructure; and (3) Public Infrastructure. Applicants need not request support in all of the categories; rather, they should request types and levels of support that best suit their needs and objectives. The NICHD expects that the amount and allocation of infrastructure support that applicant's request will vary substantially.

The first two categories of infrastructure support are intended to advance the scientific program of the applicant research unit. For these categories, applicants must justify the types and amounts of support requested in terms of: (1) the scope, objectives, and current and potential impact of the applicant's research program; (2) the potential contribution of requested infrastructure to advancing the research program; and (3) the cost-effectiveness of the requested support. Applicants are expected to define guidelines for determining the eligibility of researchers and research projects to access resources provided under this program, and guidelines and procedures for allocating such resources. No restrictions on access (e.g., by students, investigators lacking research support, investigators in fields other than population research) are imposed under this announcement. However, applicants must demonstrate that their proposed guidelines and procedures for controlling access to core resources are consistent with the goal of effectively advancing the scientific program of the unit and the goals of this RFA. Similarly, the announcement imposes no restrictions on how applicants define membership in their unit. Applicants are encouraged to develop flexible guidelines for membership that permit the involvement of researchers from other relevant fields. Membership may be extended to individuals who do not meet the criteria used to define applicant eligibility and budget guidelines (see Sections II.2 Funds Available and Section III.3, Other- Special Eligibility Requirements).

Definitions of Infrastructure Support Categories

1. Research Support Cores provide shared resources that support the applicant's research program. Examples include:

Research Support cores should be designed to advance the applicant's research program while providing essential, cost-effective services to support on-going research activities. Cores should be designed to facilitate and promote innovation in the science conducted by program researchers in addition to responding to researcher needs. Equipment and support services that are specific to individual research projects or researchers are not allowable.

2. Developmental Infrastructure refers to activities that promote the development of new research capabilities. Such activities may lead to outcomes such as innovative projects and approaches, new interdisciplinary collaborations, the scientific development of junior researchers, or the integration of experienced researchers from other fields into population research. Examples of potential developmental infrastructure activities include:

3. Public Infrastructure activities differ from the first two categories of infrastructure support in that they are not solely intended to advance the research program at the applicant institution, but are primarily directed instead at significant external audiences. These audiences may include (but are not limited to) the broad community of population researchers or communities concerned with public policy or health or social programs.

Illustrative examples of activities benefiting the broader scientific community include: supporting and disseminating databases of high relevance to population research; developing and disseminating multidisciplinary bibliographic databases; and providing infrastructure for data sharing.

Illustrative examples of activities benefiting policy or program audiences include the development of tools for effectively communicating population research findings to relevant audiences and innovative strategies for translating research findings for application to programs designed to improve health and well-being.

Applicants are encouraged to request funds for public infrastructure activities only when they can justify: (1) that these activities will significantly advance the field of population research and/or benefit policy or practice communities; (2) that the proposed activity does not duplicate existing resources or services at that or at other institutions; and (3) that the proposed activity is cost-effective. They should also address the time frame during which the resource(s) or service(s) will be needed, and the short- and long-term plans for supporting them. This plan should address, as applicable, expectations for NICHD support, support from the institution and other sources of support, and plans for charging users and managing program income.

Applicants may propose to cooperate with other institutions in undertaking any of the above-mentioned infrastructure activities. Cooperative activities may include the development of research partnerships involving scientists in the applicant's program and colleagues in other institutions, and/or joint ventures with other institutions to provide research, developmental, or public infrastructure services. Proposed partnerships must be justified in terms of the advances to be gained through collaboration across institutions relative to those likely to emerge from within-institution partnerships. Partners in a cooperative venture need not be another funded applicant or Center. Applicants must clearly describe the rights and responsibilities of each proposed partner in the funding, administration, and use of shared resources.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the Resource-Related Research Project (R24) award mechanism(s). 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 NICHD intends to commit approximately $2.9 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2006 to support five - seven new and/or competing continuation grants in response to this RFA. Applicants should request a project period of five years and should request support appropriate to the size and impact of their scientific portfolio and to the goals of their infrastructure program. As a general rule, NICHD expects direct cost budget requests for R24 applications to average approximately $17,000 for each researcher who can provide evidence of research activity directly relevant to the DBSB mission in two or more of the following categories: (1) externally funded research grants or contracts in the past three years; (2) publications in peer-reviewed journals during the past three years; and (3) papers in preparation and future plans for research. See Section III.3, Other Special Eligibility Requirements, below, for further information on these categories of research activity. Count only researchers holding permanent (tenured or non-tenured) appointments; do not count trainees, post-doctoral fellows, or visiting professors. Requests may vary from the guideline provided above as justified by evidence of exceptionally high impact or productivity or special features of the proposed infrastructure program. Applicants may request additional funds beyond those suggested by the guideline for Public Infrastructure activities (see Section I.1, Research Objectives, above). Applicants may discuss budget requests with program staff listed under Section VII. Agency Contacts, below, prior to submission.

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 NICHD 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:

Although foreign institutions are not eligible to submit applications in response to this RFA, consortium arrangements between foreign and domestic institutions are permitted. New, revised, and competing continuation applications may be submitted in response to this RFA.

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. The Principal Investigator should be a scientist or science administrator who can provide effective administrative and scientific leadership.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm. However, because the Infrastructure Program is expected to enhance the unit's competitiveness for NIH funding, the institution and pertinent departments are expected to show a strong commitment to the unit by providing additional infrastructure support at a level appropriate to the resources of the institution and the scope of the proposed program activities. Such commitment may be demonstrated by the provision of dedicated space, faculty appointments in subject areas relevant to the goals of the unit's research program, salary support for investigators or core staff, dedicated equipment, or other financial support for the proposed program. Applicants may consult with program staff listed under WHERE TO SEND INQUIRIES to discuss this expectation.

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

Additional eligibility criteria for this RFA include:

Applications not meeting the above eligibility criteria will be returned without review. One application per institution is permitted.

Note that the criterion used for unit eligibility above (at least three researchers with evidence of research activity in all three categories) differs from the criteria used to define guidelines for requested budgets under Section II.2 Funds Available and to define page limitations under the Application Guidelines at http://www.nichd.nih.gov/RFA/HD-05-028/HD-05-028.htm.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. 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.

Applications for Research Infrastructure Awards (R24) should be prepared according to the Application Guidelines available at http://www.nichd.nih.gov/RFA/HD-05-028/HD-05-028.htm and from program staff listed under Section VII. Agency Contacts. All instructions and guidelines accompanying the PHS 398 are to be followed, with the exception of the sections modified by these guidelines.

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: October 19, 2005
Application Receipt Date(s): November 16, 2005
Peer Review Date: March/April 2006
Council Review Date: June 2006
Earliest Anticipated Start Date: July 1, 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 NICHD 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:

Christine Bachrach, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-9485
Email: bachracc@mail.nih.gov

3.B. Sending an Application to the NIH

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

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

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

Robert Stretch, Ph.D. Director,
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)

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

3.C. Application Processing

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

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).

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

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). 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 any 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, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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 NICHD. 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 NICHD in accordance with the review criteria stated below.

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

Peer reviewers will evaluate each application for overall scientific merit according to the criteria provided below. Reviewers will also evaluate the merit of proposed Infrastructure Support Components. The size and scope of applicant programs are not a review criterion. NICHD believes that investments of infrastructure resources in small centers of excellence with focused scientific programs may be highly cost-efficient for the field. Reviewers are encouraged to take the number of researchers involved in a program into account in applying the review criteria below, particularly when evaluating current and potential program impact. While both larger and smaller programs are expected to demonstrate research activity of high quality, programs with fewer researchers would not be expected to demonstrate the same quantity of research productivity and program impact as programs with a greater number of researchers.

Overall Program

Three primary criteria will be used to evaluate the overall scientific merit of an application for a Research Infrastructure Award:

Applicants proposing only Public Infrastructure activities will be judged on the basis of the secondary criteria below and the detailed review criteria listed below under "Public Infrastructure."

Three secondary criteria will also be used to assess the overall scientific merit of applications:

Infrastructure Support Components

Each individual element of the proposed infrastructure program will be evaluated separately based on the criteria below.

Research Support Cores:

Developmental Infrastructure:

Public Infrastructure:

Public infrastructure components will be evaluated according to the following criteria:

Collaborations

Applications proposing to undertake any infrastructure activity in cooperation with another institution will be evaluated for the value added by the involvement of other institutions and the appropriateness and adequacy of plans for the sharing of rights and responsibilities among proposed partners with respect to the funding, administration, and use of shared resources.

2.A. Additional Review Criteria:
Not applicable

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
Not applicable

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. 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 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.

Once all administrative and programmatic issues have been resolved, the NGA will be generated via email notification from the awarding component, NICHD, to the grantee business official (designated in Item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NGA 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 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.

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 Contacts:

Christine Bachrach, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-9485
Email: bachracc@mail.nih.gov

2. Peer Review Contacts:

Robert Stretch, Ph.D. Director,
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Rashawn Farrior
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-7010
FAX: (301) 451-5510
Email: farriorl@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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.

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

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

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

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

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

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

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


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