Expired RFA-HD-08-002: Short Term Courses in Developmental Epigenetics (T15)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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: Short Term Courses in Developmental Epigenetics (T15)

Announcement Type
New

Request For Applications (RFA) Number: RFA-HD-08-002

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: December 13, 2007
Letters of Intent Receipt Date: February 18, 2008
Application Receipt Date: March 18, 2008
Peer Review Date: June 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: December 2008
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: March 19, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The National Institute of Child Health and Human Development (NICHD) invites applications for grants to develop and conduct short-term continuing education programs in cutting edge techniques and applications of epigenetics. The program should include both didactic and hands-on laboratory experiences. The goal of this short course training program is to develop skills and knowledge in epigenetics among investigators that will enable their application in basic research studies, and to disseminate course materials and instructional experience to the larger scientific community.

The NICHD plans to commit $300,000 in total costs in this program in FY2009, to fund 3-6 awards. New awards will be up to 5 years in duration.
The NIH Continuing Education Training Grant (T15) mechanism will be used.
Eligible organizations include: Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Small Business; For-Profit Organization (Other than Small Business); State Government; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Regional Organization; Eligible agencies of the Federal government; Faith-based or community based organization
Eligible principal investigators include individuals with the skills, knowledge and institutional resources necessary to carry out the proposed short-term continuing education program.
Renewals and Resubmissions. Neither renewals or resubmissions will be accepted for this RFA.
Applicants may submit more than one application, provided they are scientifically distinct. See Section IV.1 for application materials.
Telecommunications for the hearing impaired is available at: TTY 301-451-5936.
Special Receipt Date: March 18, 2008

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Epigenetics refers to heritable changes in gene activity and expression (in the progeny of cells or of individuals), as well as stable, long-term alterations in the transcriptional potential of a cell that are not necessarily heritable. Epigenetic marks such as DNA methylation or histone acetylation or methylation, and other marks regulate gene expression. These types of modifications are as physiologically significant as changes in actual DNA sequence. Recent studies indicate that these marks can be profoundly altered by the cellular or organismal environment from gametogenesis and embryogenesis through all stages of life, that they can be heritably stable over several generations, and that they can alter important traits such as birth weight, basic metabolism, blood pressure, fertility and behavior, to name a few. We are just beginning to understand the nature and types of epigenetic marks, how they are established and maintained, and how they affect gene expression. It is generally accepted that epigenetic processes are involved in additional phenotypes for complex, common diseases as well as more subtle conditions, developmental trajectories, and variations between individuals.

There is a vast amount of research to be done in this burgeoning field and a dearth of qualified researchers. This initiative will establish short-term training courses for scientists interested in learning cutting-edge techniques and state-of-the-science didactics in the field of Developmental Epigenetics.

The objective of this grant program is to support the development and implementation of short-term continuing education programs on skills and techniques in Developmental Epigenetics, and the dissemination of course materials and instructional experience to the larger scientific community. Educational programs should improve the participants understanding of the role of epigenetic processes throughout development, and should enhance research skills to answer looming questions in Developmental Epigenetics. Both didactic and hands-on training experiences should be included. The long-term objective is to increase the number of researchers who have the knowledge and skills to propose and perform important research in Developmental Epigenetics.

There is a broad array of techniques, applications and didactic material that could be incorporated into short-term courses in Developmental Epigenetics. The following are broad examples of potential program content areas and are not meant to be restrictive or exhaustive, and applicants may propose other topic areas.

Assessing chromatin structure and its relation to gene activity
Identification of imprinted regions of the genome; the establishment, maintenance and erasure of imprinting marks
Global assessment of multiple epigenetic marks across the genome
Comparison of epigenetic states in different cell types, development stages, or disease states
Assessing impact of environmental variables on epigenetic marks and associated alterations in gene expression
Quantification, statistical analysis and presentation methods for epigenetic data
Techniques for differentiating genetic and epigenetic effects, and estimating their relative contributions to phenotypes
Techniques to acquire, preserve and manipulate specimens for epigenetic analyses
Introduction to existing databases and resources of epigenetic information
Cellular pathways that regulate the acquisition, maintenance, stability, heritability and removal of epigenetic marks
Techniques to manipulate epigenetic marks or machinery in vivo and in vitro

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the T15 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 plans to commit $300,000 in total costs to this program in FY 2009.
It is anticipated that 3-6 grants will be awarded in this program in FY 2009.
The earliest anticipated start date is December 1, 2008 and the period of performance for new awards is for up to 5 years.

Because the nature and scope of the proposed program 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 IC(s) 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 (F&A) costs are limited to 8%. This applies to the applicant organization and any approved sub-contracts.

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:

Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
U.S. Territory or Possession
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organization
Hispanic-serving Institution
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Regional Organization
Eligible agencies of the Federal government
Faith-based or community based organization

Foreign institutions are not eligible for this funding opportunity announcement.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed Program 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 support.

2. Cost Sharing or Matching

Not applicable

3. Other-Special Eligibility Criteria

Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

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 the face page of the PHS 398 form.

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

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

Letters of Intent Receipt Date: February 18, 2008
Application Receipt Date: March 18, 2008
Peer Review Date: June 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: December 2008

3.A.1. Letter of Intent

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

Descriptive title of proposed research
Name, address, and telephone number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

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:

Susan Taymans, Ph.D.
Reproductive Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 8B01, MSC 7510
Bethesda, MD 20892-7510 (Rockville, MD 20852 for express mail)
Telephone: (301) 496-6517
FAX: (301) 496-0962
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications 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)

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

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
Room 5B01, MSC 7510
Bethesda, MD 20892-7510 (Rockville, MD 20852 for express mail)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]

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 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.

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.

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

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Allowable Costs: Allowable costs must be consistent with NIH policy, well documented and justified for the continuing education program. Grant funds may not be used to supplant funds otherwise available at the applicant institution. The following items apply to this T15 program:

Personnel Costs Individuals participating in the design and implementation of the continuing education program may request salary and fringe benefits appropriate for the percent of time devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the Congressionally mandated cap. Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. The level of effort for the principal investigator will depend on the training program s design and implementation.
Consultant costs; purchase of laboratory supplies required for experiments; travel and per diem for faculty; and other costs such as printing, telephone, audio-visuals, postage, recruitment materials, and computer software are allowed.
Off-site rental space and rental of laboratory equipment will be considered if shown to be necessary for the implementation and execution of the continuing education program. Matching funds from the applicant institution or other organizations for such rental costs are strongly encouraged.
Participant support for travel and per diem while attending the continuing education program are appropriate when necessary. However, it is expected that the program will be partially funded through registration fees paid for by the participants and their home institutions.
Facilities and Administrative (F&A) Costs are limited to 8%. This applies to the applicant organization and any approved subcontracts.

Unallowable Costs:

Equipment costs and renovation costs are not allowable.

Specific Application Instructions for this RFA: Applicants must use the forms for regular research grants and follow the specific instructions in the PHS 398 application kit http://grants.nih.gov/grants/funding/phs398/phs398.html with the exceptions listed below. Note that the page limitations given in the instructions apply to these applications. A complete detailed budget (Form Pages 4 & 5) with narrative justifications is required.

Description, Performance Sites, and Key personnel (Form Page 2): Under Performance Sites include when applicable any Consortium/Contractual Arrangements, with a description of plans for collaborating with other institutions for purposes of exchange and sharing of resources including faculty, equipment, and facilities. If multiple sites are to be used, a strong justification must be included.
Resources (Resources Format Page): Describe the educational environment; include a description of the facilities, laboratories, participating departments, computer services, and any other resources to be used in the conduct of the proposed continuing education program. Include letters of institutional support from collaborating institutions that are providing resources (e.g., reagents, laboratory facilities, etc.) in support of the program.
Research Plan: Parts a and b should follow the instructions in the PHS 398 kit to describe the Specific Aims and Background and Significance of the proposed continuing education program, respectively.
Research Plan: Part c of this section should be re-titled Preliminary Activities and included if applicable. This section should contain information on steps that have led to the proposed continuing education program.
Research Plan: Part d of this section should be re-titled Continuing Education Program Plan and should contain the material organized under the following subheadings, as appropriate to the specific program:
Program Direction Describe arrangements for administration of the program; provide evidence that the Program Director is actively engaged in research and/or teaching in epigenetic techniques, can organize and administer the continuing education program, and can effectively promote collaboration among scientific and educational experts to develop and implement the program; provide evidence that the necessary resources, reagents and laboratory facilities will be available to conduct the laboratory portion of the program; provide evidence of institutional commitment and support for the proposed program. It is anticipated that the Program Director will promote collaboration among scientific and educational experts to develop a sound continuing education program.
Program Faculty/Staff Describe the qualifications and responsibility of the faculty and staff involved in the continuing education program and any follow-up activities after participants return to their home institution; provide evidence that the participating faculty have the knowledge, skills, and expertise necessary for teaching didactic, hands-on laboratory courses and for providing follow-up consultation; when using consulting faculty from other institutions, provide letters of agreement to serve as faculty/staff in appendices.
Proposed Continuing Education Program Describe the curricula for the program; include the objectives for each didactic and hands-on laboratory course in terms of scientific skills and knowledge; describe educational materials to be developed and those that are currently available; indicate what methods will be used for instruction ( e.g., live versus media-based instruction), and include examples of currently available materials as appendices; describe a plan for continuing exchange of information after participants return to their home institutions; describe the expected length of the program, how frequently the program will be offered each year, and the number of participants anticipated for each program session.
Recruitment and Program Participants Describe plans for announcing the program, application and selection procedures, and criteria for selection of participants that range from junior through senior biomedical researchers; include plans to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.
Continuing Education Evaluation Plan Include evaluation plans for determining success of the program in achieving its goals and objectives. The inclusion of evaluation instruments is encouraged.
Dissemination Plans Include plans for disseminating the program materials and any programmatic instructional experience to the larger scientific community.
Research Plan: Part e of this section should include the information requested in PHS 398 for Human Subjects and Vertebrate Animals if the proposed educational program will include experimentation using either human subjects or vertebrate animals.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources

NIH policy expects that grant 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/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). 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 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). See Section VI.3., Reporting.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

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:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council.

Specific T15 Review Criteria: The goal of this short course training program is to develop skills and knowledge among investigators that will enable their application in basic research studies, and to disseminate course materials and instructional experience to the larger scientific community. The review criteria will include:

Impact of the course: Will the course be effective in imparting knowledge of the field of Developmental Epigenetics, and training in research techniques, across a broad range of scientists? Is the dissemination plan for the course content and materials to the broader scientific community adequate? Will the course content and materials be useful to the broader community?
Course content: Are the course content and syllabus appropriate? Is there an adequate balance between didactic and hands-on training? Is the time allotted sufficient to cover the planned material? Is the level of individual attention for participants sufficient?
Faculty: Is the caliber of the faculty, in terms of their research interests and expertise, and experience in teaching/training in the field of Developmental Epigenetics, appropriate for their roles? Are the commitment and availability of the faculty well-suited for the program? Is there sufficient interaction planned between faculty and participants?
Environment and Resources: Are the necessary institutional facilities (for example, laboratory space, equipment and reagents) adequate for the training program? Is there evidence of institutional support?
Selection criteria: Are the recruiting/advertising procedures for the course and selection criteria for participants adequate and well-defined? Are the plans to recruit women, minorities and individuals with disabilities adequate? Are there plans for awarding scholarships, and if so, are the criteria appropriate and well-defined?
Course evaluation: Is the course evaluation plan adequate and sufficiently detailed to rate participants satisfaction with the course and determine the success of the course? Does it include a system to track longer-term outcomes, such as participants future publications, grant proposals, or career trajectory? Is a plan to evaluate the extent and impact of course materials disseminated to the broader scientific community well-defined?
Dissemination of course materials and instructional experience: Is the plan to disseminate course material and instructional experience adequate? Will the course material be disseminated to a broad audience? Is the disseminated material comprehensive and user-friendly?

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review
Availability of funds
Relevance of program priorities

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

Not applicable

2.D. Sharing Research Resources

NIH policy expects that grant 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/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/grants/policy/nihgps_2003/NIHGPS_part4.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/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).

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. The progress report should include information of evaluation and dissemination efforts conducted during the previous grant period.

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:

Susan Taymans, Ph.D.
Reproductive Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 8B01, MSC 7510
Bethesda, MD 20892-7510 (Rockville, MD 20852 for express mail)
Telephone: (301) 496-6517
FAX: (301) 496-0962
Email: [email protected]

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 (Rockville, MD 20852 for express mail)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]

3. Financial or Grants Management Contacts:

Cecilia Bruce
Grants Management
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 8A17L, MSC 7510
Bethesda, MD 20892-7510 (Rockville, MD 20852 for express mail)
Telephone: (301) 496-1304
Email: [email protected]

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).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing 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/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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 RFA 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 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR part 63a. 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.