Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD) (

Title:  Child Health Research Career Development Award (K12)

Announcement Type
This is a reissue of RFA-HD-06-011, which was previously released on February 16, 2006.

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

Request For Applications (RFA) Number: RFA-HD-07-010

Catalog of Federal Domestic Assistance Number(s)

Key Dates
Release Date: January 12, 2007
Letters of Intent Receipt Date(s): February 13, 2007
Application Receipt Date(s): March 13, 2007
Peer Review Date(s): June 2007
Council Review Date(s): October 2007
Earliest Anticipated Start Date(s): December 1, 2007
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: March 14, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary  

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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

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


The National Institute of Child Health and Human Development (NICHD) supports a program of Child Health Research Career Development Awards (CHRCDA) intended to develop resources to speed the transfer of knowledge gained through studies in basic science to clinical applications that will benefit the health of children. The CHRCDA will support research career development of pediatricians who have recently completed subspecialty training and who are commencing basic research training relevant to child health. The goal of this initiative is to advance research in child health and to support educational institutions in their ability to stimulate novel research initiatives and career development experiences for junior investigators. This will be accomplished by increasing the number and effectiveness of established pediatric investigators who have a grounding in basic science and research skills that can be applied to the health problems of children, as well as by increasing the number of pediatric medical centers that can stimulate and facilitate the application of research findings to pressing pediatric problems.

Research Objectives

A CHRCDA grant provides pediatric research institutions with an opportunity to build a greater capacity for nurturing junior investigators. Established investigators, with research funded by NIH or other sources through competitively awarded grants or contracts, combine to establish a center of research excellence in their institution. Individuals with a wide range of biomedical backgrounds, especially those with a basic science orientation, are expected to mentor newly trained pediatricians just embarking on their research careers. The established investigators, as mentors, will make available their expertise, guidance, and laboratory facilities to be utilized by junior investigators for research projects that will enhance their basic science knowledge and skills. Although mentors from collaborating departments may provide expertise and resources, the emphasis remains on research that is relevant to clinical pediatrics and its various subspecialty areas.

Components of a CHRCDA

1. Principal Investigator

The Principal Investigator of the CHRCDA must be the chairperson of the Department of Pediatrics or the chief of the pediatric service. He or she should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary program of this scope. The Principal Investigator is responsible for appointing the Program Director and members of the Advisory Committee (see below). He or she makes the decisions regarding appropriate recipients of the program funds for research and career development, taking into consideration recommendations from the CHRCDA Advisory Committee. The Principal Investigator does not receive salary or fringe benefit support from the CHRCDA for this activity. The Principal Investigator is expected to attend the annual scientific meeting of the CHRCDA centers.

2. Administrative Staff

The day-to-day administration of the CHRCDA may be made the responsibility of a senior faculty member, called the Program Director, supported for up to 10 percent time and effort for this activity. Alternatively, the Principal Investigator may serve as Program Director, with appropriate support. The Program Director must be knowledgeable about pediatric research, with a record of success in laboratory or clinical investigation and demonstrated skill in research career development. Administrative staff funds also may be used for a recruitment officer, supported up to 20 percent time and effort, to enhance participation in the program by women, individuals with disabilities, individuals from disadvantaged backgrounds, and individuals from racial and ethnic groups that are underrepresented in pediatric research (see below). The Program Director may also serve as the recruitment officer, but combined time and effort for these two roles may not exceed 20 percent.

3. Advisory Committee

The Principal Investigator must establish the Advisory Committee which will consist of a group of scientists, selected from the Pediatrics Department and other departments or institutions, as appropriate, who have interests and expertise relevant to pediatric research. The Advisory Committee is chaired by the Principal Investigator and must include the Program Director and some or all of the participating mentors. The Advisory Committee may also include the recruitment officer and any other persons considered essential by the Principal Investigator. The Committee's responsibilities should include selecting physician candidates, assigning preceptors, approving the scholars' research development plan, monitoring the progress of the scholars and evaluating the overall effectiveness of the program. The committee may utilize institutional or outside consultants for these functions. The Advisory Committee provides expert counsel essential to the Principal Investigator for his or her administration of the program. It should meet regularly and its evaluation activities should be formalized. A detailed report of the actions of the Committee must be provided in the annual progress report.

4. Mentors

At least six established investigators, with active support from NIH or other competitively awarded grants, are required as mentors for a CHRCDA. They should be expert in the application of new advances in basic science methodology to problems of human development and pediatric disease that are relevant to the mission of the NICHD. Their research interests must contribute to areas that justify their collective designation as a Child Health Research Career Development Award center, making the CHRCDA attractive to recently trained pediatricians as a place to develop their investigative careers. The mentors need not be pediatrics department members. Linkage to other departments is encouraged and can enhance the effectiveness of the CHRCDA and is expected to be a key feature of each center. When a junior investigator is to be supported by the CHRCDA through new project development funds, at least one of the established investigators must agree to provide his or her expertise as a mentor and collaborator, and allow the junior investigator access to his or her laboratories. Annual progress reports for a CHRCDA grant must describe ongoing research projects, current publications, and funding (see Section V.1). The mentors do not receive support for their salaries or fringe benefits from the career development awards. Mentors may be added as appropriate to the roster of an ongoing funded CHRCDA center without prior NICHD approval.

5. Career Development Program

Support for junior investigators (CHRCDA Scholars) is designed to enhance their research skills, thereby providing a bridge between formal research training and the receipt of independent research grants. The novel feature of these grants is the flexibility in the use of the funds awarded for career development; decisions about new projects and which junior investigators are to be supported are made by the grantee institution. Both competing and non-competing continuations of a CHRCDA grant are contingent on demonstration of good judgment in these decisions, as indicated by scientific progress, success of the junior investigators in competing for new research grants and contracts, and the development of new pediatric investigators.

The Principal Investigator, after considering recommendations from the Advisory Committee, will make CHRCDA Scholar appointments to junior investigators for the pursuit of research projects under the guidance and supervision of an established investigator. The institution will support CHRCDA Scholars for periods of one to four years consisting of consecutive 12-month appointments. In addition to research activity, the program should include an initial didactic phase that may include training in areas such as biostatistics, scientific writing and oral presentation, and biotechnology. The program must include appropriate training in biomedical ethics and the responsible conduct of research.

CHRCDA Scholars, as well as the Principal Investigator and Program Director, are expected to attend an annual CHRCDA program meeting. One purpose of this meeting is to allow Scholars to present their career development award-supported research to their peers. Principal Investigators and Program Directors are expected to attend these meetings to demonstrate their support of the program and the junior investigators. In addition, they will have an opportunity at these meetings to exchange ideas about common problems and make suggestions to NICHD staff about possible modifications in the program. Career development award-supported research reported in peer review journals or at scientific meetings must acknowledge the support received through this program.

6. CHRCDA Scholars

The scholar position is a junior faculty position offered to a pediatrician who has successfully completed a pediatric residency, who is no more than four years beyond attaining subspecialty board eligibility, and who has not previously been the Principal Investigator of an NIH research grant or contract (including R, P, and U awards). Scholars can be eligible for up to four years following the last clinical training to attain board eligibility that led to a nationally recognized subspecialty board certification. Scholars must have an M.D. degree and have completed a pediatric residency and subspecialty training. The scholar position is not a fellowship or an extension of a fellowship position. Similarly, these positions are not to be offered to more senior faculty members who are in need of funding. This junior faculty appointment should be extended to candidates who are willing to spend a minimum of 75 percent of full-time professional effort in research and research career development activities. During the award period, the scholars are encouraged and expected to seek independent grant support.

For an established scholar, current NIH policy allows for salary as PI on an NIH Research Project Grant (R01, R03, or R21) or as a subproject director on a multi-project grant if the scholar is in the last two years of appointment on a K award. [See NOT-OD-04-007, Mentored Career Development Awards: Change in NIH Policy Concerning Concurrent Support for Career Development Awards and Research Grants (]. For a two-year K-12 appointment, the scholar may derive salary on another research grant beginning the first day of the K12 appointment period. The level of effort for the career grant may be reduced to no less than 50 percent to allow for a level of effort on the research project. The total combined effort for the career and research grant must be at least 75 percent and not greater than 100 percent effort. CHRCDA scholars are eligible to receive K support if all such support totals no more than six years. Therefore, a scholar receiving two years of funding on the CHRCDA can only receive up to four years of support from any individual mentored career development award program, i.e., K08, K01, K23).

The K12 grant application should indicate the number of CHRCDA Scholar appointments proposed for each year and provide evidence that this number of worthwhile projects is likely to be forthcoming. The number of new scholars to be supported must be commensurate with the institution's capacity to develop and recruit appropriate candidates. CHRCDA projects must relate to the goals of the CHRCDA program.

Support of scholars is renewable at the discretion of the Principal Investigator, contingent upon presentation of evidence of satisfactory progress to the Advisory Committee and to the NICHD in the required annual progress report. The pool of potential scholars and criteria for selecting CHRCDA Scholars must be described in the grant application. Institutions are encouraged to develop novel mechanisms for recruiting qualified pediatricians to become grant-supported investigators. Such mechanisms could include special efforts to recruit individuals from underrepresented racial and ethnic groups, individuals from disadvantaged backgrounds, and individuals with disabilities.   

7. Environment/Institutional Support

The sponsoring institution should have a well-established record of success in developing independent pediatric investigators, and assure protected time necessary for the scholars to complete the approved career development program.  The sponsoring institution must also allow appropriate faculty to be mentors and provide the necessary facilities to carry out the program.

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 National Institutes of Health (NIH) Mentored Clinical Scientist Development Program (K12) award mechanism(s).

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 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

NICHD intends to commit approximately $3.46 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2008 to fund up to eight new and/or competing continuation grants in response to this RFA. Applicants may request a project period of up to five years and a budget of up to $400,000 for direct costs per year. It is not required that applications request the allowable budgetary maximum. Small size is not a disadvantage for CHRCDA funding. Because the nature and scope of the new projects may vary, it is anticipated that the size of awards also will vary. F&A costs on K12 awards are limited to eight percent of modified total direct costs. Although the financial plans of NICHD anticipate support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Eligible organizations must be children's hospitals or departments of pediatrics of approved medical schools in the U.S. that have as a primary teaching site either a general children's hospital or a children's program with an identifiable organizational structure that is part of a larger medical institution.

Foreign institutions are not eligible for this institutional career development award. Applications from institutions not previously funded for Child Health Research Career Development Awards are encouraged.

1.B. Eligible Individuals

Principal Investigators must be the chairperson of the Department of Pediatrics or the chief of the pediatric service.  Any eligible individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.

2. Cost Sharing or Matching

Not applicable.

The most current Grants Policy Statement can be found at:

3. Other-Special Eligibility Criteria

CHRCDA may be awarded to a children's hospital or to a department of pediatrics of an approved medical school in the U.S. that has as a primary teaching site either a general children's hospital or a children's program with an identifiable organizational structure that is part of a larger medical institution. Grantee institutions must have the clinical pediatric specialties and subspecialties, and the discrete clinical and research facilities, sufficient to meet the purposes of the CHRCDA program, namely, to bridge clinical pediatric training with a career in basic and/or clinical research relevant to child health.

CHRCDA mentors should be established investigators supported by NIH or other competitively award grants, and acknowledged experts in the application of new advances in basic science methodology to problems of human development and pediatric disease.  Their research interests must contribute to areas that justify their collective designation as a CHRCDA center, however they need not be pediatrics department members.

CHRCDA Scholars must have an M.D. degree, or equivalent, must have completed a pediatric residency and subspecialty training, and must be within four years of attaining their subspecialty board eligibility when starting the program. For foreign nationals, board eligibility criteria from their country of origin apply. Scholars may begin receiving funding when they are board eligible. Once they have attained this level of training, their academic appointments within their departments are not relevant to entry into the program. Scholar positions can not be awarded to individuals who are still in the process of completing a fellowship or research training program, or receiving any other Federal support that duplicates the provisions of this award at the time of entry into the K12 program.

Scholars must be willing to devote 75 percent of full-time professional effort conducting research and research career development activities. Scholars must be U.S. citizens or non-citizen nationals, or must be able to provide legal proof of lawful admission for permanent residence. Individuals on temporary or student visas are not eligible. At the time support begins, Scholars may not have served as the Principal Investigator or equivalent on an NIH research project grant (R01, R03, R21, U01, U10), a subproject of a program project (P01) or center grant (P50, U54), or equivalent PHS research grant awards.

The NICHD does not limit the number of applications for a CHRCDA program from one institution. However, each application from the institution must have a different Principal Investigator.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at 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:

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 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.

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(s): February 13, 2007
Application Receipt Date(s): March 13, 2007
Peer Review Date(s): June 2007
Council Review Date(s): October 2007
Earliest Anticipated Start Date(s): December 1, 2007

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Karen K. Winer, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS service)
Telephone: (301) 435-6877
FAX: (301) 480-9791

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

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/courier or non-USPS service)

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at:

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:

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

The CHRCDA grant may provide funds for two purposes:

(1) Administration of the CHRCDA Career Development Program

•Salaries and support for a Program Director (maximum 10 percent time and effort) and a recruiting officer (maximum 20 percent time and effort). If the Program Director and the recruiting officer are the same person, effort cannot exceed 20 percent for the combined roles.

•Administrative support services, including supplies, duplicating equipment, telephone, or maintenance contracts for equipment which are directly associated with and necessary for CHRCDA program and are not covered by institutional overhead charges.

•Travel of Scholars, Principal Investigator and Program Director to an annual CHRCDA scientific meeting.

(2) Career Development Support

Awards to CHRCDA Scholars need not all be equal in size. Up to $100,000 annually may be used per CHRCDA Scholar toward salary, fringe benefits and research costs. Individual Scholars are eligible for up to $75,000 salary plus fringe benefits per year. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the program. Within each CHRCDA Scholar's total award, grant funds may be used toward the following expenses:  1) salary as stated above, 2) research expenses, such as supplies, equipment (not to exceed $10,000 annually), and technical personnel, 3) travel to the annual CHRCDA meeting (not to exceed $3,500 annually), 4) CHRCDA research expenses generated by these projects in the laboratories of the established investigators who serve as mentors of the awardees.

Items that may not be supported with CHRCDA grant funds include:

•Salary and fringe benefits for the Principal Investigator

•Direct support of the laboratories, salaries, fringe benefits, travel, and research projects of the established investigators serving as mentors.

•Salary and support for central institutional administrative personnel.

•Salary and support for administrative activities such as public relations or health and educational services.

•Travel of the Principal Investigator, the Program Director, or other established investigators to scientific meetings except as previously noted in Section 1.5 for expected attendance at the annual CHRCDA program meeting.    

•Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the research.

•Alterations and renovations.   

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

6. Other Submission Requirements

Application Instructions

Refer to the Research Career Award section of the PHS 398 for guidance in preparing applications, noting modifications below. Page limitations on research project grant applications, as stated in the guidelines and instructions for PHS Form 398, do not apply to these K12 applications, although applicants are encouraged to be concise.

The application must include a table of contents and should include all information requested under Section I: Basic Administrative Data

Section II: Specialized Information should be modified as follows:

This section should begin with an overview of the proposed CHRCDA program.

•Describe, in general, the pool of potential candidates including information about the types of prior research training. Describe criteria used for candidate selection and subsequently evaluating their progress. For those currently or previously funded by the CHRCDA, provide aggregate information regarding the number of women, individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds interviewed and accepted for scholar positions.

•Competing renewal applications and applicants who have received CHRCDA funds in the past, are required to name all scholars who have ever received funding from this award, their current academic status, gender and minority information, and all funding awarded to the candidate since CHRC funding was initiated. This information may be provided in a table with specific dates each scholar was funded by CHRCDA, name of mentor, all funding history (provide grant numbers). Provide only grant information where scholar was the awarded PI. Additionally, a list of peer-reviewed articles published since the initiation of CHRCDA support with the scholar's name in bold is also required.

•Describe the previous success of the CHRCDA and programmatic changes planned for the future.

•For new applications: provide proof of adequate mentoring capabilities by detailing current and past career development programs with details of new junior faculty recruits from the past five years.

•Statement by Mentor: Summarize the long-term objectives of the program. Describe the career development plans for prospective candidates. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates.

•Environment and Institutional Commitment: Provide information and documentation establishing the commitment of the applicant institution. Describe the institution's research environment and the pool of mentors. Provide publication and grant history for mentors.

•Research Plan: For each potential mentor, include a paragraph on his or her research, relevant to the goals of this RFA that may be the foundation of the CHRCDA scholar's research experience.

•Describe the plans for the career development program on a year-by-year basis, i.e., expectations of yearly activities throughout the duration of the program.

•Recruitment, Selection, and Retention Plan

•Diversity Recruitment and Retention Plan to include individuals from disadvantaged backgrounds or persons with disabilities.

•Plans for Training in the Responsible Conduct of Research

•Plans for Evaluation and Tracking of Scholars selected for the program

Biographical Sketch

Biographical Sketches for the Principal Investigator, Program Director, and potential mentors should be provided, using the appropriate Format Page.

Budget Instructions

Each application submitted in response to this RFA should include the following information, using PHS 398 (rev. 9/2004) Form Pages 4 and 5, including appropriate budget justification, as indicated:

Using Form Page 4, detailed budget for the initial budget period, provide the following individual budgets, using separate pages for each:

•A budget for the administrative program related expenses that includes the Program Director and recruitment officer, supplies, travel expenses for the Principal Investigator and the Program Director to the annual CHRCDA scientific meeting and other expenses for the first year.   Include under Other Expenses, the total direct costs requested for the new project development funds for the Scholars.  The budget justification should indicate the minimum number of scholar positions these funds will support and the extent that these funds will be used for Scholars' salaries.  The new project development funds budget need not be allocated into categories in the initial application, since these will vary with the projects supported.

Using Form Page 5, budget for the entire proposed period of support, provide the following:

•Complete budget for each year of the proposed period of support. Provide budget justification in narrative form.  

Plan for Sharing Research Data

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

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 (NIH Grants Policy Statement and Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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

The following will be considered in making funding decisions:

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:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced?

Approach: Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation:  Is the proposed training program innovative?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Special 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 institutional research career development program. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research:  Applications must include a description of programs designed to provide formal and informal instruction in scientific integrity or the responsible conduct of research relevant to the K12 program. Applications without plans will be considered incomplete and may be returned to the applicant without review.

Although the NIH does not establish specific curricula or formal requirements, programs are encouraged to consider instruction in the following areas:  conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects.

Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by those selected for the K12 program and faculty participation , must be include in progress reports and future competing continuation (renewal) applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all undergraduate students, graduate students, postdoctorates and research staff regardless of their source of support.

Peer reviewers will assess the applicant’s plan 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 on instruction.

2.C. Sharing Research Data

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

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 and 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 (

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 ( and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (

The following related administrative policies apply to NIH Career Award (K12) programs:

A. Other Income

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.  Such fees must be assigned to the grantee institution for disposition by any of the following methods:

•The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation.  Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.

•The funds may be used for health-related research purposes.

•The funds may be paid to miscellaneous receipts of the U.S. Treasury.  Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892.  Checks must identify the relevant award account and reason for the payment.

Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted.  The awarding component will give consideration to approval for the use of released funds only under unusual circumstances.  Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

B. Special Leave

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months.  For longer periods, prior written approval of the NIH awarding institute or center is required.  Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at 

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made.  Support from the K12 award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support.  Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75%.  Such requests will be considered on a case-by-case basis during the award period.  In no case will it be permissible to work at less than 50% effort.  The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training.  In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee.  In addition, the awardee must submit assurance of his/her intention to return to at least 75% as soon as possible.  During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

C. Changes in Research or Career Development Program

Individual awards are made for career development at a specific institution in a specific research program.  A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH institute.  A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan.  The new research plan will be evaluated by staff of the awarding NIH component institute to ensure that the plan remains within the scope of the original peer-reviewed research program.  If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

D. Change of Institution

The K12 program may not be transferred to another institution.

E. Termination

Consultation with NICHD program staff is strongly encouraged when termination of the K12 program is being considered.

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled.  In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision period.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually ( and financial statements as required in the NIH Grants Policy Statement.

These reports should include the following:

(1) Budget

(2) Completed updated other support information for the PI and PD.

(3) Biographical sketches/other support information for any new Key Personnel added since the last application.

Progress Report

Annual progress reports must include a Biographical Sketch and other pertinent information on the new scholar recruits for the year reported. An overview of each scholar's research accomplishments and goals for the coming year should be clearly stated. This report should include a list of scholars' abstracts, publications, and grants, preferably in a table. These reports must state the number of scholar candidates applying, interviewed, and accepted. A biosketch and other pertinent information on all new scholars and their mentors should be provided. Describe both research (minimum 75 percent effort) and non-research activities (up to 25 percent effort) for each scholar. List private and government grants for which the scholar is the Principal Investigator. These reports will be reviewed by NICHD staff and outside consultants to confirm that the institution is continuing to meet its goal of recruiting promising new pediatric investigators and facilitating their career development. See Section V.1 for more details on annual progress reports.

(1) Recruitment: What outreach was performed? Number of candidates applying, interviewed, and accepted, by sex, race/ethnicity, and disability.

(2) Training in responsible conduct of research. All Scholars must participate in this activity during their period of K12 support.

(3) Summary of Advisory Committee activities.

(4) Individual Progress Report for each Scholar:

Final Reports:  A final progress report, invention statement, and Financial Status Report are required upon termination or relinquishment of an award.

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

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:

Karen K. Winer, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS service)
Telephone: (301) 435-6877
FAX: (301) 480-9791

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 service)
Telephone: (301) 496-1485
FAX: (301) 402-4104

3. Financial or Grants Management Contacts:

Fran Petti
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS service)
Telephone: (301) 402-7191
FAX: (301) 451-5510

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 ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( 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 (

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,

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 (

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 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 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 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 (; a complete copy of the updated Guidelines is available at 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 (

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( 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 ( 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 and view the Policy or other Resources and Tools including the Authors' Manual (

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 ( 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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at

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:

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