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: NICHD Institutional Predoctoral Training Program in Reproductive, Perinatal and Pediatric Epidemiology

Announcement Type
New

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

Program Announcement (PA) Number: PAR-05-130

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: June 24, 2005
Application Submission Dates(s): May 10, 2006, May 10, 2007, May 10, 2008
Peer Review Date(s): October/November, 2006, October/November, 2007, October/November, 2008
Council Review Date(s): January/February, 2007, January/February, 2008, January/February 2009
Earliest Anticipated Start Date: May 1, 2007, May 1, 2008, May 1, 2009
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: May 11, 2008

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

 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. Submission, 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. Review and Selection Process
   2. Review Criteria
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

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

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

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

Background

There is currently a dearth of National Institutes of Health (NIH)-sponsored graduate level training opportunities in reproductive, perinatal, and pediatric epidemiologic research despite the increasing demands for investigators with these skills. Needs assessments conducted by professional organizations demonstrate that demand exists for targeted training grants in reproductive, perinatal, and pediatric epidemiology. Among institutions responding to one study, 43 percent offered graduate courses in reproductive epidemiology, 40 percent in perinatal epidemiology, and 12 percent in pediatric epidemiology, with only 23 percent offering graduate courses in these disciplines combined. Frequent barriers that are cited to recruiting and training students include unavailability or lack of stipends, external funding, dedicated faculty, protected research time, and administrative support. Meanwhile, over 90% of respondents report they would apply for training grants if they were available.

Growing recognition that exposures before, during, and shortly after conception impact pregnancy outcomes and eventual child health status, along with hypotheses on the fetal origins of disease, underscore the need for investigators with substantive training in human reproduction and development and epidemiologic research expertise. R egulatory and legislative demands in the past few years have required the testing of chemicals for reproductive and developmental toxicity in addition to carcinogenicity. In addition, the etiology of most adverse reproductive and developmental outcomes remains unknown. To date, few training grants have supported graduate study in reproductive, perinatal, and pediatric epidemiology and serve as the impetus of study. There is an expanding need for qualified investigators, and there exist numerous opportunities for research and the resulting benefits.

The purpose of the NRSA program is to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the Nation's biomedical and behavioral research agenda.

The NRSA program has been used by the NIH as the primary means of supporting graduate and postdoctoral research training since enactment of the NRSA Legislation in 1974. More information about NRSA programs is available at http://grants.nih.gov/training/nrsa.htm. Information on the career outcomes of predoctoral NRSA recipients is available at http://grants.nih.gov/training/career_progress/index.htm.

The NIH will award National Research Service Award (NRSA) Institutional Training Grants (T32) to eligible institutions to develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers in reproductive, perinatal, and pediatric epidemiologic research.

Goals

The aims of this program are: 1) to encourage and support broad, early stage (pre-dissertation) training in reproductive, perinatal, and pediatric epidemiology; and 2) to produce a well-qualified cadre of academic and research investigators who are capable of research excellence. It is expected that such investigators will: 1) investigate the most pressing reproductive, perinatal, and pediatric outcomes, including those for which racial/ethnic disparities are observed, utilizing state-of-the-art and evolving study designs and methods (e.g., matched exposure cohort or case only designs) where optimal; 2) identify existing and new at-risk subgroups of the population; 3) identify emerging threats to human reproduction and development; and 4) design public health and/or clinical primary and secondary interventions to enhance health.

Scope

Trainees are expected to be participants in a formal predoctoral curriculum offering broad and fundamental training in epidemiology, as well as opportunities to acquire substantive knowledge of reproductive, perinatal, and pediatric health issues. The anticipated curriculum should cover epidemiologic skills and principles, and apply epidemiologic methods to research regarding reproductive, perinatal, and pediatric health, with the goals of producing competent and productive practitioners in these disciplines and sustainable training programs of excellence.

Training programs should include courses in epidemiologic methods and biostatistics, reproductive, perinatal and/or pediatric epidemiology, research ethics, and related areas. The training program will provide each trainee with a minimum of three years of full-time predoctoral research support.

Specific skills and research areas to be developed include, but are not limited to: fertility, measurement of peri-conceptual and pre-natal exposures (including occupational and pharmacologic), determinants of pregnancy outcomes, neonatal treatment issues regarding conduct of clinical trials in pregnant women and children, as well as concentrations on specific health care questions such as pediatric asthma, pediatric obesity, injury prevention, and management of pediatric psychiatric conditions.

The institutional research training grants described in this announcement provide support to training programs at institutions of higher education. Institutional NRSA training grants are designed to allow the director of the program to select the trainees and to develop a curriculum of study and research experiences necessary to provide high quality research training. The grant offsets the cost of stipends and tuition support for the appointed trainees. This program will support Predoctoral Training.

Predoctoral research training must lead to the Ph.D. degree or a comparable research doctoral degree. Students enrolled in health-professional training programs who wish to postpone their professional studies in order to engage in full-time research training may also be appointed to an Institutional Research Training Grant. Predoctoral research training must emphasize fundamental training in areas of biomedical and behavioral sciences.

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 Ruth L. Kirschstein National Research Service Award (T32) mechanism . As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

Institutional NRSA research training grants (T32) may be made for periods up to five years and are renewable. Awards within an approved competitive segment are normally made in 12-month increments with support for additional years based on satisfactory progress and the continued availability of funds. Trainee appointments are normally made in 12-month increments. No trainee may be appointed for less than nine months during the initial period of appointment, except with the prior approval of the NIH awarding unit or when health-professional students are appointed to approved, short-term research training positions. No individual trainee may receive more than five years of aggregate NRSA support at the predoctoral level including any combination of support from institutional training grants and individual fellowship awards. Any extension of the total duration of trainee support requires approval by the director of the NIH Institute or Center that supports the award. Requests for extension must be made in writing by the trainee, endorsed by the director of the training program and the appropriate institutional official, and addressed to the director of the awarding component. The request must include a compelling justification for an extension of the statutory limits on the period of support.

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

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the 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.

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:

Only domestic, non-profit, private or public institutions may apply for grants to support research training programs. Foreign institutions are not eligible to apply. An eligible institution (e.g., university) may submit only a single application in response to this PA. The applicant institution must have a strong research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed predoctoral research training 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 programs.

The training Program Director should be an established researcher with acknowledged accomplishments in reproductive, perinatal and/or pediatric epidemiology research and training, and should be capable of providing both administrative and scientific leadership to the proposed training program . The training Program Director will be responsible for planning, directing and executing the proposed training program.

Trainees appointed to the training program must have the opportunity to carry out supervised research in reproductive, perinatal or pediatric epidemiology, with the primary objective of developing their research skills and knowledge in preparation for a career in reproductive, perinatal or pediatric epidemiology.

2. Cost Sharing or Matching
Not applicable

3. Other-Special Eligibility Criteria

Eligible Trainees

At the time of appointment to the training program, individuals selected to participate in these training programs must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission for permanent residence. Non-citizen nationals are persons born in lands that are not States but are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible for NRSA support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.

Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at a post-baccalaureate level and enrolled in a program leading to a Ph.D. in epidemiology, an equivalent research doctoral degree program, or a combined clinical degree and Ph.D., such as M.D./Ph.D. Students enrolled in health-professional programs that are not part of a formal, combined program and who wish to postpone their professional studies to gain research experience, may also be appointed to a Kirschstein-NRSA institutional research training grant.

Individuals currently supported by other Federal funds are not eligible for trainee support from these programs at the same time. Further, NRSA traineeships are not given for study leading to a M.D., D.O., D.D.S., or other similar professional clinical degree, or master's clinical degree.

Additional information may be obtained in the NRSA Guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600187.

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.

Special Program Requirements

Trainee Appointments:

Trainees are customarily appointed for full-time, 12-month continuous periods. No trainee may be appointed for less than nine months during the initial period of appointment except with prior approval of the NIH program staff. All trainees are required to pursue their research training on a full-time basis, at a minimum of 40 hours per week. The amount of the stipend and tuition (defined for the purposes of NRSA as the cumulative amount of tuition, all fees, and health insurance) for each full appointment period must be obligated from funds available at the time the individual begins training. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-032.html for additional details on allowable stipends and training-related expenses.

By law, an individual trainee may receive no more than five years of NRSA support in the aggregate at the predoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.

The primary objective of the NRSA program is to prepare qualified individuals for careers that have a significant impact on the Nation's research agenda. Within the framework of this program's longstanding commitment to excellence and projected need for investigators in particular areas of research, attention must be given to recruiting individuals from racial or ethnic groups underrepresented in the biomedical and behavioral sciences. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups.

Applicant Pool:

Applicants should clearly articulate which groups are targeted for each specific program, and provide corresponding recruitment and selection strategies for each part of the Program.

Research Training Program:

The aim of this NIH Predoctoral Training Program is to support broad, early-stage training in reproductive, perinatal, and pediatric epidemiology by offering institutions a single comprehensive training grant. The training programs must ensure that there are ongoing research programs available to trainees in reproductive, perinatal, and pediatric epidemiology. Trainees are expected to participate in a formal predoctoral curriculum offering broad and fundamental training in epidemiology, as well as specialized courses in reproductive, perinatal or pediatric epidemiology, and coursework in basic sciences, medicine, policy, and statistics relevant to their concentration. We encourage a curriculum that spans the breadth of epidemiology, ensuring a thorough grounding in epidemiologic methods and principles, statistical methods and principles, special issues related to reproductive, perinatal, and pediatric epidemiology, collaboration with appropriate programs in fields such as demography, statistics, occupational health, pharmacoepidemiology, health services research, injury prevention, and molecular epidemiology, and integration with appropriate biomedical sciences such as genetics, developmental biology, obstetrics, gynecology, neonatology, pediatrics, psychiatry, and adolescent medicine. The training program should expose trainees to the clinical concepts relevant to reproductive, perinatal or pediatric epidemiology. This exposure, for example, may include seminars, coursework, laboratory rotations or field placements. Programmatic activities unique to this training program are formalized interactions of participating departments and programs that may include, but are not restricted to, journal clubs, seminar series, and an annual retreat.

Program Director:

The Program Director must possess the scientific background, leadership, and administrative capabilities required to coordinate and supervise a multi-disciplinary research training program of this scope. For example, the Program Director may be a senior faculty member, Associate Dean for Research, Director of a research center or institute, or research Program Director. The application may include a Co-Director who is an experienced investigator with administrative skills and background that complement those of the Program Director.

Mentors:

Trainees conducting research projects must be supervised by capable mentors. Each application should demonstrate a representative sample of mentors sufficient to support the proposed number of trainees. Formal co-mentoring with complementary expertise is strongly encouraged for the intensive training component. It is desirable that mentorship be available in the clinical, scientific, and methodological areas. The primary mentor should be recognized as an independent investigator actively involved in relevant research, and demonstrate a successful track record of mentoring. The mentors must be committed to continued involvement with the trainee for the duration of his/her appointment in the program.

The applicant must describe a plan for establishing a faculty core to provide mentor support and training. The application should include a list of the proposed faculty core, their primary appointment, and their role in the proposed program. For a representative sample of faculty, the application must also describe the faculty core member's research that is relevant to the program, and indicate how the trainees will participate in this research. The extent to which the faculty core cooperated, interacted, and collaborated with one another in the past should be described. The application should also list past and current students for whom each faculty member has served or is serving as their advisor, titles of the students' research project, and, for past students, their current positions and sources of funding.

Institutional Commitment:

The administration of the applicant institution as well as all participating units and departments should indicate, in the application, their support for the goals of the training program. Describe support (financial or otherwise) that the institution will provide for the proposed training program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the Program Director or participating faculty, support for additional trainees in the program, or any other creative mechanisms to improve the climate for the establishment and growth of the training program.

Evaluation and Tracking Component:

The application should describe a strong evaluation and tracking component that will review the effectiveness of all aspects of the program (including curriculum, training faculty, training program director). Program Directors must develop methods for ongoing evaluation of the quality of the training program. Although the T32 application process requires extensive career tracking information, it is often useful to obtain more proximal feedback from trainees. For example, Program Directors are encouraged to develop plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvements.

NIH scientific review groups will assess the applicant's plan based on the adequacy of plans for monitoring trainee progress, process and outcome measures, and overall program evaluation. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note of the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised acceptable plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

Minority Recruitment and Retention Plan:

The NIH remains committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research. As first announced in 1989, all competing applications for institutional NRSA research training grants must include a specific plan to recruit and retain underrepresented minorities in the training program. In addition, all competing continuation applications must include a report on the recruitment and retention of underrepresented minorities during the previous award period. If an application is received without a plan or without a report on the previous award period, the application will be considered incomplete and will be returned to the applicant without review. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993 (see http://grants.nih.gov/grants/guide/notice-files/not93-188.html ).

Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies. The report should provide information on the racial/ethnic distribution of:

For those trainees who were enrolled in the academic program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.

The success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool and thus will be included within the priority score. In addition, peer reviewers will separately evaluate the minority recruitment plan and report (for competing renewals) after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of minorities and whether the experience in recruitment during the previous award period has been incorporated into the formulation of the plan for the next award period. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan or the record of minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Training in the Responsible Conduct of Research:

Every NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research (see http://grants.nih.gov/grants/guide/notice-files/not92-236.html ). Applications must describe a program to provide formal and informal instruction on scientific integrity and ethical principles in research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review.

Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review

Budget and Related Issues:

The Training Program budget should be constructed using the following general guidelines:

1. Stipend. The NIH will provide the legislatively mandated stipend level for each predoctoral trainee position and for each intensive training core trainee position according to pre-doctoral NRSA guidelines. Only pre-doctoral NRSA stipends may be requested. A stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. Stipend levels are adjusted periodically and current stipend levels are available on the NIH website at: http://grants.nih.gov/training/nrsa.htm. The total stipend must be based on a 12-month appointment. The institution may supplement the NIH stipend up to a level that is consistent with the institution's scale from non-Federal sources only. It is expected that total stipends must be consistent with the level of effort, with the established stipend structure at the institution, and with stipends actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

2. Tuition, Fees, and Health Insurance. The NIH will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the current rates as published at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc5460018.

3. Trainee Travel. Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's research training, is an allowable trainee expense. In addition, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent institution must be justified considering the type of opportunities for training available, the manner in which these opportunities differ from and compliment those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and goals. This type of research training requires prior approval from the NIH. Letters requesting such training may be submitted to the NIH awarding component at any time during the award period.. U nder exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request institutional costs above the standard rate. Requests for additional trainee costs must be explained in detail and carefully justified in the application. Consultation with NICHD program staff in advance of such requests is strongly advised.

4. Training-Related Expenses. Institutional costs of $2,200 a year per predoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty. Training related expenses may be adjusted in future fiscal years.

5. Facilities and administrative costs. A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. See NRSA Policy Guidelines on the NIH Website at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

Program Directors Meeting:

Program Directors are expected to attend a one-day meeting with other Program Directors and NIH staff in the Washington, DC area every year. At this workshop, Program Directors will be asked to report on successes or problems in their training programs, and NIH staff will provide briefings on new training and career development opportunities through the participating NIH Institutes. Funds to cover the costs of travel to this meeting should be included in the budget under Training-Related Expenses, as described in 4. above.

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Application Submission Dates(s): May 10, 2006, May 10, 2007, May 10, 2008
Peer Review Date(s): October/November, 2006, October/November, 2007, October/November, 2008
Council Review Date(s): January/February, 2007, January/February, 2008, January/February 2009
Earliest Anticipated Start Date: May 1, 2007, May 1, 2008, May 1, 2009

3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. T he instructions for preparing an NRSA Application should be followed. 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
Rockville, MD 20852 (for express/courier or non-USPS delivery service)

3.C. Application Processing

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

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

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

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm). The section in the NIH Grants Policy Statement regarding Ruth L. Kirschstein National Research Service Awards may be found at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600187.

Concurrent Awards

An NRSA may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Taxability of Stipends:

Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS.

Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

Special Administrative Requirements

1. Carryover of unobligated balances: The carryover of funds from one budget period to the next requires prior written approval by NICHD.

2. Termination of Award: When a grantee institution plans to terminate an award, NICHD must be notified in writing by the Program Director and countersigned by the appropriate institutional business official at the earliest possible time.

3. Change of Institution: The Program may not be transferred from one institution to another. Trainees seeking to change institutions must terminate their current appointment at the earliest possible time using termination notice form PHS 416-7 located at http://grants.nih.gov/grants/forms.htm#training and apply directly to the desired program.

4. Change of Program Director: If change of a Program Director is necessary, support of the award is not automatic, but may be continued with NIH funding component prior approval, provided:

5. Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular Program Director. Changes in any of these parameters require prior approval by NICHD Program Staff. A rationale must be provided for any proposed changes in the aims of the original peer-reviewed program. Programmatic changes will be evaluated by NICHD Program Staff to ensure that the program remains within the scope of the original peer-reviewed application. If the new program does not satisfy this requirement, the award will be terminated.

6. Stipend supplementation, compensation, and other income: No departure from the established stipend schedule may be negotiated by the institution with the trainee. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the NICHD. Such additional amounts may be either in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the following conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program.

7. Leave: Trainees supported by academic institutions should refer to the NIH NRSA guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html for guidance regarding vacations and requested leave. In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research training experience longer than specified here must seek approval from the NICHD for an unpaid leave of absence. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271).

6. Other Submission Requirements

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

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

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

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

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

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

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 will be evaluated for scientific and technical merit by an appropriate review group convened by the NICHD in accordance with the review criteria stated below.

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

The following will be considered in making funding decisions:

2. Review Criteria

Because the goals of this NIH-supported research training and career development programs are to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs, applications are evaluated on/using the following criteria, and in the written comments, reviewers will be asked to discuss these aspects of the application, in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. Reviewers will first determine the quality of the training program and then consider whether the requested number of trainee positions is appropriate for the number of high-quality, eligible first/second-year trainees likely to be accepted in the program.

Training Program: This criterion assesses the objectives, design and direction of the research training program. Does the proposed training program provide broad-based, fundamental training in reproductive, perinatal or pediatric epidemiology? Are appropriate courses available to provide a curriculum that spans the breadth of reproductive, perinatal or pediatric epidemiology? Are appropriate programmatic activities incorporated into the training program?

Training Program Director: Does the Program Director have the scientific background, expertise, and experience or potential to coordinate and supervise a broad-based training program reproductive, perinatal or pediatric epidemiology? Has the Program Director committed adequate time to program administration?

Mentors: This criterion assesses the caliber of mentors as researchers, including successful competition for research support in areas directly related to the proposed research training program. Is there appropriate expertise available in the epidemiologic community at the institution? What is the overall quality of mentors' research, their publication record, and their successful competition for research support in areas directly related to the proposed training program? How strong is their record as mentors, especially as mentors of predoctoral students?

Institutional Training Environment: This criterion assesses the quality of the institutional training environment for NRSA supported trainees and the relationship of the NRSA program to the broader training program (if appropriate). What is the level of institutional commitment, quality of the facilities, availability of appropriate courses, and the availability of research and research training support? Does the environment in which the training program will be conducted, i.e. the quality of the participating departments and the extent of their participation, contribute to the probability of success? Is there evidence of adequate institutional commitment? Is there evidence of ongoing research in reproductive, perinatal or pediatric epidemiology? Is there evidence of adequate research support, equipment, and facilities?

Training Record: This criterion evaluates the past research training record of both the program and the designated mentors. How successful are former trainees in seeking further career development and in establishing productive scientific careers? Evidence of further career development can include successful completion of the Ph.D., receipt of fellowships, career development awards, additional training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. What is the track record of the mentors in directing predoctoral training or the potential of those mentors lacking a track record?

Applicant Recruitment, Selection and Retention: This criterion evaluates the quality of the applicant pool and the plan for selection of individuals for appointment to the training program. This assessment will include a consideration of the racial and ethnic diversity of the trainee pool, but will take into account the described recruitment and retention efforts as well as the availability of individuals from underrepresented groups within the relevant pool of applicants. Specifically, what is the quality and size of the applicant pool? Are the recruiting procedures, trainee selection criteria, and retention strategies appropriate and well defined? Is the racial and ethnic diversity of the trainee pool in keeping with the availability of individuals from underrepresented groups within the relevant pool of applicants? For competing renewal applications, how successful has the program been in their efforts to recruit and retain minority trainees?

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 training program. The priority score should not be affected by the evaluation of the budget. Is the requested number of trainee positions appropriate for the number of high-quality, eligible first/second-year trainees likely to be accepted into the training program? Given the availability of preceptors, their funding, and the number of trainees already in the program, can the program accommodate the number of positions proposed?

Evaluation and Tracking Plan: The application must describe a prospective evaluation and tracking plan. Is this plan adequate to help ensure the effectiveness of the training program?

Minority Recruitment and Retention Plan: The success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool and thus will be included within the priority score. In addition, peer reviewers will separately evaluate the minority recruitment plan and report (for competing renewals) after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of minorities and whether the experience in recruitment during the previous award period has been incorporated into the formulation of the plan for the next award period. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan or the record of minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable

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 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 Notice of Award will be generated via email notification from the awarding component 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 Notice of Award 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 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).

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 NRSA instructions for the Non-Competing Grant Progress Report (Form 2590) should be followed. The non-competing budget page should list the names and levels of those trainees who are continuing in the research-training program. Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions. This NRSA program is not subject to SNAP.

Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter. No funds may be provided until this document is submitted and accepted by the funding Institute. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS 416-7) to the NIH. Failure to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Service Payback Provisions: As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation only during the first 12 months of postdoctoral support. There is no service payback obligation for current predoctoral trainees.

Final Reports: A final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award.

Evaluation: In carrying out its stewardship of human resource-related programs, the trans-NIH Jointly Sponsored T32 Training Committee may request information essential to an assessment of the effectiveness of this Program. Accordingly, award recipients are hereby notified that they may be contacted during and after completion of this award for periodic updates on the trainees supported by this Program including various aspects of their employment history, publications, support from research grants or contracts, honors or awards, professional activities, and other information helpful in evaluating the impact of the Program.

Publication and Sharing of Research Results: Trainees are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from a trainee's research, NIH support should be acknowledged by a footnote in language similar to the following: "This project was supported by NIH grant number ________ which is part of the Jointly Sponsored NIH Predoctoral Training Program in Reproductive, Perinatal and Pediatric Epidemiology." Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Inventions and Patents: Traineeships made primarily for educational purposes are exempt from the PHS invention reporting requirements nor does NIH have any rights to inventions under these grants.

Copyright: Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

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:

A. Russell Gerber
Obstetric and Pediatric Pharmacology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 4A01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS delivery service)
Telephone: (301) 451-1673
Email: Gerberru@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
Rockville, MD 20852 (for express/courier or non-USPS delivery service)
Email: Stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Victoria Bishton
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 8A01B, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS delivery service)
Telephone: (301) 451-5857
FAX: 301-451-5510
Email: Bishtonv@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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

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.

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.

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 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.

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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

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

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

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

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

Authority and Regulations: (NOTE: incorrect legislative authority) dt
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 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


H H S Department of Health
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  N I H National Institutes of Health (NIH)
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