Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
Fogarty International Center (FIC), (http://www.fic.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)

Title: Centers for AIDS Research: D-CFAR, CFAR (P30)

Announcement Type
This is a reissuance with modifications of PAR-03-089 published in the NIH Guide, March 27, 2003.

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

Program Announcement (PA) Number: PAR-06-291

Catalog of Federal Domestic Assistance Number(s)
No. 93.213, Research and Training in Complementary and Alternative Medicine
No. 93.242, Mental Health Research Grants
No. 93.279, Drug Abuse Research Programs
No. 93.393, Cancer Cause and Prevention Research
No. 93.394, Cancer Detection and Diagnosis Research
No. 93.396, Cancer Biology Research
No. 93.839, Blood Diseases and Resources Research
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
No. 93.865, Child Health and Human Development Extramural Research

Key Dates
Release Date: March 29, 2006
Letters of Intent Receipt Date(s): May 22, 2006, May 22, 2007 and May 23, 2008
Application Receipt Date(s): June 22, 2006, June 22, 2007 and June 23, 2008
Peer Review Date(s): September 2006, September 2007 and September 2008
Council Review Date(s): October 2007, October 2008 and October 2009
Earliest Anticipated Start Date: November 2006, November 2007 and November 2008
Additional Information To Be Available Date (URL Activation Date): Not Applicable.
Expiration Date:  June 24, 2008

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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  

Participating Institutes of the National Institutes of Health (NIH) invite applications for center core grants (P30) to support Centers for AIDS Research as either standard CFARs (CFAR) or Developmental CFARs (D-CFAR).  CFAR cores provide infrastructure and promote basic, clinical, behavioral and translational AIDS research activities at institutions that receive significant AIDS funding from  NIH Institutes or Centers.  CFARs can foster synergy and improve coordination of research, support emerging research opportunities, and promote efficiencies through resources shared by multiple independent laboratories.  CFARs and D-CFARs are intended to promote all AIDS research efforts at CFAR institutions.  D-CFARs provide support to assist investigators in the development of a competitive CFAR.  This announcement also defines a process for CFAR competitive supplements.  Before preparing an application to support a CFAR, investigators are urged to consult with the program staff listed under "Agency Contacts" in Section VII.

Definitions

Throughout this program announcement, P30 applications to support CFARs are abbreviated as "CFAR applications" and the corresponding P30 awards to support CFARs are abbreviated as "CFAR awards."  "Core" or "core facilities" are defined as entities providing services or expertise to be shared by multiple independent laboratories.  NIH CFAR awards support administrative, developmental, basic science, and clinical science cores for AIDS research. AIDS research includes AIDS and AIDS-related research.

Background

The CFAR program was established in 1988 and renewed in 1993, 1997, and 2000. In May 1999, an ad hoc external review committee convened by the Office of AIDS Research reviewed the CFAR program.  Suggestions made by the review committee at that time remain incorporated within this current program announcement.  The mission of the CFAR program and mechanisms for achieving this mission were developed by the CFAR directors in 1995 and revised in 1996, 1998, and in the 2002 Position Statement of the NIH CFAR Directors.

The CFAR mission is to support multi-disciplinary environments that promote basic, clinical, epidemiological, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and AIDS. The CFAR program accomplishes this mission by:

Additional information about CFAR goals and objectives and how they are to be addressed in the application may be found under Section IV.2. Content and Form of Application Submission.  Information concerning research objectives that are specific to the D-CFAR follows that for CFAR.

Section II. Award Information

1. Mechanism(s) of Support
 
This funding opportunity will use the NIH center core grant (P30) award mechanism.  The applicant will be solely responsible for planning, directing, and executing the proposed project.

The NIH (P30) is a Center Core grant that provides support for shared resources and facilities for a multidisciplinary research team or a group of investigators focusing on a common research topic. Funded independently of a center's component or program projects, the core grant provides accessible resources.

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 (or current NIH grant application) (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.

While this Program Announcement is being issued by FIC, NCI, NCCAM, NHLBI, NIAID, NICHD, NIDA, and NIMH, the National Center for Research Resources (NCRR) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) also have an interest in and support research on the topics covered.  Applicants may wish to contact each of these NIH components listed in “Agency Contacts” to find out about other funding opportunities.  Institutes and Centers at NIH use different grant mechanisms to support their portfolios of research; the components listed here may not use all of the mechanisms specified for this Program Announcement.

Applications submitted in response to this funding opportunity will be assigned to the National Institute of Allergy and Infectious Diseases.

This Program Announcement describes two types of CFAR awards.  The first is for a Developmental CFAR (D-CFAR) for AIDS investigators at an institution that is eligible, but does not yet have a CFAR.  The D-CFAR will provide the support necessary to develop a collaborative network that may permit the institution to be more competitive for a standard CFAR award.  The second type of award is for a standard CFAR (CFAR).  Both the D-CFAR and the CFAR are funded through the P30 mechanism for infrastructure development.  This PA describes requirements for both types of CFARs.  Sections for the D-CFAR describe characteristics unique to this award. 

The total project period for CFAR grants may not exceed five years, and applicants are encouraged to apply for five years.  For D-CFARs, the total requested project period may not exceed five years.  

2. Funds Available

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds. The number of awards will vary from year to year depending on the quality of the application and programmatic priorities.

The size, duration, and maximum funding level of each award will depend on the type of CFAR award as described below.  The maximum funding level is determined by the NIH AIDS-funded research base (FRB) which is described in Section III.  A CFAR cannot use the FRB of an institution that is already part of another CFAR.

D-CFAR: Maximum funding level, or base funding of a D-CFAR is limited to requests for 10% of the FRB as reported by the Office of AIDS Research (OAR) spreadsheet for the NIH fiscal year preceding receipt of the application, up to $750,000 total cost each year..

CFAR: For institutions with a FRB of $6M to $40M, a CFAR award (total cost) will be limited to 10% of the FRB, up to $1.5M, total cost.  For institutions with a FRB of $40M to $80M, a CFAR award will be a base of $2.25M, total cost.  For institutions with a FRB that is greater than $80M, a CFAR award will be a base of $3M total cost.

Below is a comparison of the D-CFAR and CFAR awards.

D-CFAR

CFAR

CFARs will be awarded and administered by NIAID.  However, a CFAR award will consist of funds from multiple NIH Institutes.  Management oversight of the CFAR grants will be provided through an NIH CFAR Steering Committee composed of representatives from the co-funding NIH Institutes and Centers, and from the OAR.  It is therefore suggested that the applicant contact the program representatives listed under 'Agency Contacts' in Section VII to discuss general CFAR issues, and how CFARs can enhance the AIDS research mission of the co-funding NIH Institutes.

The earliest anticipated start dates are as follows: March 2007 and March 2008.

Competitive supplements (described in Section IV.2. Content and Form of Application Submission) are announced at the beginning of the calendar year, depending upon funding availability.

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:

Foreign institutions are not eligible to apply but may be components of U.S. applications.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Women and individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. 

2. Cost Sharing or Matching

Not Applicable.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

CFAR-specific Eligibility Requirements:

1) NIH AIDS Funded Research Base

To be eligible for a CFAR award an institution must have a significant NIH AIDS-funded research base (FRB).  The FRB is defined as the amount of Total Cost funding from NIH for one fiscal year (October 1 to September 30) preceding the year of application submission.  The research base includes peer-reviewed AIDS grants, cooperative agreements, and research contracts utilizing the following mechanisms only:  P01, R01, R03, R18, R21, R24, R33, R34, R35, R37, U01, U10, U19, U24, U54, and K series awards, and N01 (excluding contracts that primarily fund the production of materials or services for support of research).  Excluded from the NIH AIDS FRB are all funds from any source other than NIH.  For the D-CFAR and CFAR awards, an FRB in excess of $6M is required.  A CFAR cannot use the FRB of an institution that is already part of another CFAR.

2) One CFAR award per institution

No institution will receive more than one CFAR award. Institutions that have significant overlap in faculty, resources or administration should submit only one application. Independent campuses that are part of a large multiple city university are considered to be separate institutions, and each may submit one application.  Applicants are encouraged to contact program staff listed under "Agency Contacts" for additional guidance. 

3) Guidelines for multi-institutional CFARs 

In some cases two or more institutions that can demonstrate a credible plan for collaborative research networks using CFAR cores may wish to submit an application for a single CFAR award.  Reviewers will look critically at the request for multi-institutional applications for the following indicators: a demonstration of exceptional need to establish collaboration between multiple investigators at each of the applicant institutions; evidence of unique plans, such as the development of organized communications systems, to overcome the scientific and management challenges that are naturally a part of multi-institutional collaborations; specific plans to address anticipated budgetary problems in the transfer of funds and resources from one institution to another; and evidence for centralized authority of the CFAR Director for the purpose of management of the CFAR facilities at other sites. 

Multi-institutional CFAR applications may combine the NIH AIDS-funded research of all the investigators at the institutions participating in the proposed CFAR to meet the NIH AIDS-Funded Research Base requirement.  A multi-institutional CFAR application must designate a lead institution that will receive the award and provide details of agreements regarding coordination and support of cores and activities at other participating institutions.

CFARs that use a distant institution for a core facility may not use the Funded Research Base of any single investigator at that institution if they are not including all of the NIH AIDS investigators at that institution as part of the CFAR.

4) Cores outside of the CFAR institution

With appropriate justification, CFAR awards may support a core at an institution that is not part of the CFAR, including a foreign institution that provides a unique resource such as a clinical site, or a primate facility.  NIH AIDS funding of the investigators at this core facility is not included as part of the FRB of the CFAR (see Funded Research Base).

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application (or current NIH grant 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 (or most current NIH grant application). 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 (or most current NIH grant application) form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.


Applicants for P30 grants must follow special application guidelines in the CFAR document  entitled ADVICE ON PREPARATION OF A CFAR APPLICATION; this document is available via the WWW at: http://www.niaid.nih.gov/research/cfar/cfarpa.htm. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 9/04) Application Kit (as modified in, ADVICE ON PREPARATION OF A CFAR APPLICATION) will be judged non-responsive and will be returned to the applicant.

For applications in response to this Program Announcement, the page limitation is 350 pages for the research plan of the CFAR or D-CFAR application, excluding appendices, required tables (http://www.niaid.nih.gov/research/cfar/cfarpa.htm), Bio-sketches,  Other Support, literature cited sections, and other sections that normally fall outside of sections A-D of the research plan.  Please note that appendices are provided only to the reviewers assigned to the application, and not to all reviewers.  Appendices should not contain information required for review by other committee members, and are limited to 10 documents or 100 pages.  The 350-page limit is a maximum, and applicants are encouraged to be concise.  Applicants submitting a revised application may include an additional 30 pages to discuss the response to the reviewers' comments.  It is helpful to the review committee if these are placed at the beginning of the CFAR Overview section with reference to locations in the application where changes can be found.  Other support should not be provided in the initial application submission.

SPREADSHEETS AND TABLES

NIH will provide applicants with a spreadsheet (Excel) electronically via email indicating all investigators receiving NIH AIDS funding at an applicant's institution (or institutions if a multi-institution application), arranged by NIH Institute.  These spreadsheets are prepared by the Office of AIDS Research (OAR) and are usually available in March or April.  In the first column of the spreadsheet, applicants should indicate those investigators who have formally agreed to participate in the CFAR, and the primary type of participation expected.  Applicants should develop their own key table to abbreviate the type of participation(s) for each CFAR Member (i.e., core director = CD, core user = CU, attends seminars = S. etc.) and indicate this in the first column.  This spreadsheet should be included in the administrative section of the application.  See section E, Administrative Core, for more detail on CFAR support of all investigators.

It is important that the CFAR be inclusive of the full range of AIDS science funded at a given institution.  Therefore, review committees will be interested in why some investigators listed in the spreadsheet chose not to be part of the CFAR.  Applicants may also indicate investigators at their institution(s) who will become part of the CFAR but who were not included in the spreadsheet.  The reason for inclusion, or exclusion, of a given investigator should be addressed.  A brief explanation should be included at the bottom of the table as to why investigators may not be participating as a CFAR member.

The NIH will provide five tables for additional information required of both new and recompeting applications.  These may be found at the CFAR program announcement website: http://www.niaid.nih.gov/research/cfar/cfarpa.htm

APPLICATION FORMAT

The following information and instructions should be considered when preparing an application for the CFAR or D-CFAR award.  Included here is the rationale, based on CFAR goals and objectives, for the information is being requested in the application and how it is to be addressed.

I.  CFAR added value

CFARs are expected to provide added value to the applicant institution's AIDS research efforts through support of activities that cannot easily be provided through standard research grants/awards.  CFARs should promote and encourage activities that enhance collaboration and coordination of AIDS research.  CFARs promote translational research activities, i.e., studies bringing findings of the laboratory to the clinic, and vice versa.

Measures of added value include, but are not limited to:

II.  CFARs should serve the research needs of NIH-funded AIDS investigators at the applicant institutions.

Cores aims and services should address the needs of AIDS investigators at the applicant institution(s) and be inclusive of the full range of AIDS science funded at the applicant institution(s).  Applicants should describe in detail the operation of each proposed core, i.e., its quality control, procedures, safety, training, etc., and how the proposed policies and procedures protect and incorporate the divergent needs of CFAR investigators (see additional details concerning policies and procedures under "Administrative Core").  Applicants are encouraged to contact program staff listed under "Agency Contacts" in Section VII. Agency Contacts to discuss strategies being planned for how the CFAR will foster collaboration among AIDS investigators from divergent disciplines.  Applicants for recompeting CFARs should describe how different NIH-funded AIDS programs, if funded at the institution, will participate in the CFAR.  Specific programs funded by the co-funding institutes are listed under "Administrative Core”.

III.  CFARs have scientific and fiscal flexibility.

CFARs have the responsibility to use their resources to meet the needs of their investigators.  A CFAR has the authority to change allocation of resources according to the guidelines of CFAR operating policies and procedures.  A CFAR has considerable flexibility and authority to alter funding of a Basic or Clinical Core, to delete a core, or to initiate a new core.  Applicants should state what policies and procedures will be used as the basis for reallocation of initial core funding to permit the establishment of new cores, as needed, without additional funding.  Applicants should describe how proposed policies and procedures provide structure for decision-making on several levels, and how each of the following individuals or groups would participate in the decision process: core director, CFAR director, internal advisory board, CFAR investigators, and external advisory board.  Applicants should also state the process for informing NIH of major changes in the CFAR.

The extent to which CFAR funding may leverage other resources in support of AIDS research is an important measure of a CFAR's value to AIDS investigators.  Basic and Clinical Cores may be supported totally, or in part by CFAR funds. Applicants are encouraged to develop creative collaborations to improve utilization of existing resources.  Convincing justification will be necessary for duplication of any basic or Clinical Core that exists in a similar form elsewhere in the applicant institution(s). Applicants should describe how cores with partial CFAR funding will be used to enhance the research of CFAR investigators. For example, a CFAR core supported by other funding (e.g., a NIAID AIDS Clinical Trial Unit or an NCI Cancer Center core facility) may become more accessible to AIDS investigators through CFAR association and coordination.  Commitments for continued funding in the non-competitive continuation years of all NIH grants are dependent upon the availability of funds. Applicants should describe decision-making policies and procedures for “down-sizing” the CFAR if funding is decreased in continuation years.

Responsible management includes annual reporting of progress.  NIH has developed guidelines that specify the kind of information required in progress reports in order to answer questions from various constituencies, including Congress.  NIH staff will assess the previous progress reports submitted by recompeting applicants, as well as responses to requests for additional information.  Results of this assessment will be made available to the applicant and if necessary, may also be made available to reviewers of the competitive renewal application.  Assessments will reflect general trends during the funding period, rather than any single outstanding or insufficient response.

IV.  Additional CFAR-supported activities

CFARs traditionally use a variety of strategies to achieve the objectives of the award.  Examples include industry collaborations, community outreach, development of minority scientists in AIDS research, AIDS research communications to non-scientists, approach to problems in enrollment and retention of women and minority groups in AIDS clinical trials, international collaborations, additional support of ongoing NIH programs not planned in the initial award, and other activities that meet the AIDS research needs of applicant institutions.

Applicants are encouraged to explore collaborative, multi-institutional linkages with international and domestic sites and Historically Black Colleges and Universities (HBCUs) and international institutions.  Such linkages foster international training and collaborative studies and are able to meet needs that cannot be easily addressed by other funding mechanisms.  Coordination with international programs funded by the Fogarty Center is strongly encouraged.  Contact information for Fogarty programs is provided under "Agency Contacts”.

Some examples of ways in which current CFARs are able to assist in the development of new investigators (including junior faculty and minority investigators at the CFAR institution(s), HBCUs, and both domestic and international institutions) are described below.  These examples are not meant to be all-inclusive.

V.  CFAR awards support four different types of cores: Administrative, Developmental, Basic Science, and Clinical Studies. 

Each CFAR must have a single Administrative and a single Developmental Core, and a minimum of one Basic and one Clinical Science Core to optimally support the AIDS research at the applicant institution(s).  The smallest CFAR would have a minimum of four cores that would consist of one of each type of core (Administrative, Developmental, Basic, and Clinical).  The terms Basic and Clinical Cores are generic, and the definition of what constitutes a Basic or Clinical Core is sufficiently broad to meet the needs of the applicant institution(s), and may vary among CFAR applicants.  For example, epidemiology, biostatistics, ethnography, and behavioral cores could be classified as either Basic or Clinical Cores, depending on their focus.  Clinical Cores will have more direct interaction with patients.

An applicant's initial choice of Basic and Clinical Cores is an important measure of the science management process.  Applicants should describe the Basic and Clinical Cores to be supported at the time that the CFAR is awarded, how the choice of cores was made, other potential cores that were evaluated but not selected, mechanisms for evaluating the utilization of proposed cores, and criteria for increasing or decreasing funding of these cores during the course of the award.

1. CFAR (D-CFAR) Overview and Administrative Core

A. Strategic plan – Successful applicants will be required to carry out and report on an ANNUAL basis the strategic planning process being used to assess current and expected scientific and fiscal needs and planned adjustments, according to the stated policies and procedures.

The purpose of the strategic plan is to identify the most significant scientific opportunities and gaps at the applicant institution targeted for the CFAR in the short and long term, and to identify objective milestones that can measure success or failure.  The following process and organization is suggested for the strategic plan:

  1. Strengths - Describe the strengths of the CFAR including a summary of research of CFAR participants and the current facilities and resources available.  Use Table 4, "Existing Core Facilities at the Institution Applying for a CFAR Award (all applicants) to list all core facilities and those that will be used by the CFAR.  This table can be found on the CFAR program announcement web page: (http://www.niaid.nih.gov/research/cfar/cfarpa.htm).   Use the column labeled "Member" in the Excel table showing the NIH AIDS Funded Research Base of the institution(s) to indicate how investigators will be participating in the CFAR.  Provide a brief explanatory sentence at the bottom of the table for any investigators who will not be participating.  Recompeting applicants should describe how any major AIDS programs at the CFAR institution that are supported by co-funding NIH Institutes are assisted by CFAR.
  2. Examples of programs are:

    FIC: AITRP, ICHORTA-AIDS/TB, GRIP. IRSDA, BIOETHICS TRAINING, FRAMEWORKS, ICOHRTA, INFORMATICS, BRAIN DISORDERS, STIGMA, ELLISON, GID
    NCI: AMC, ACSR
    NHLBI: CBR
    NICHD: WHIN, Ad health, REACH, ATN
    NIDA: NCCTN
    NIAID: NIAID Clinical Trials Networks, CIPRA, IPCP, MACS, WIHS
    NIMH: Brain Bank, NIMH Centers Program

  3. Opportunities - Identify and evaluate potential opportunities for use of CFAR funds. This analysis will probably require input  for suggestions from all potential CFAR participants.

  4. Action Plan - Choose the highest priority opportunities and develop a detailed plan for the first year of funding.  Examples of an action plan include determining which cores will be established; determining how existing cohorts will be utilized; identifying the categories of support for developmental projects, communication and outreach; and identifying the lectures and meetings the CFAR will sponsor.  Some CFARs may find that specific thematic areas emerge from this strategic planning process.  Development of an action plan that capitalizes on such programmatic themes is encouraged, but not required.

  5. Outcome Measurements - Determine how progress on action plans will be measured.  Include anecdotal and objective measurements of how the CFAR infrastructure award provides "added value" or the unique contributions of CFARs that cannot be provided by research awards.  Select long-term goals for the funding period and annual milestones for the first year.

The ability to manage the CFAR award will be judged in part, by the clarity and thoughtfulness of the scientific management strategies proposed for the Administrative and Developmental Core sections of the proposal. The annual strategic planning process for the selection and organization of additional cores through such methods such as acquisition of information, outside support of cores, and participation of the AIDS investigators at the applicant institution(s) in core development and usage should be described in detail.

B.  Policies and Procedures 

Policies should be considered to be "a set of guiding principles of operation."  There are no "correct" policies and different CFARs may adopt different polices.  Below are several examples of justifiable but not necessarily compatible policies that might be used to address funding issues. Funding issues are an example of an area that a CFAR considers in the development of policies and procedures. 

C.  Administrative issues

All information on the protection of human subjects, and the inclusion of women, children, and minorities should be included in the section entitled “Human Subjects” directly following the Administrative Core.  If there are specific details that pertain only to a specific Core, that additional information should also be included in this section.  Each Core should reference the Administrative Core section as appropriate .  Human subjects protection issues on studies funded through other research grants should be addressed in those individual grant applications.

All clinical studies supported by the CFAR and that use CFAR infrastructure must follow the Office for Human Research Protections (OHRP) and NIH guidelines for the protection of human subjects.  Thus, even though most clinical studies conducted under the CFAR will be funded directly through other research grants, human subjects’ protection issues must be addressed not only on those grant applications, but also in this new CFAR application.  For studies or clinical research involving assay development using human samples, or data/sample collection and storage that are funded only by the CFAR, applicants must provide all required documentation demonstrating protection of human subjects.  For Developmental Cores that are expected to fund future awards for clinical research it is sufficient to state the policies and procedures that are in place to address the requirements at that time.

Applicants should ensure that the face page of the application is marked “yes” for human subjects.   Failure to adequately address issues concerning human subjects could result in delayed funding should an application be recommended for funding.  Applicants must also address the policies and procedures for the CFAR’s data management by including the data sharing plan in the Administrative Core.

2.  Developmental Core

The intent of a CFAR Developmental Core is to support scientific studies for short periods of time to develop preliminary data for peer-reviewed research applications. Four general areas are eligible for support through the Developmental Core: (1)  investigators new to AIDS research who have not previously received R01-type awards in AIDS research; (2)  feasibility studies; (3) emerging research opportunities; and, (4) AIDS research activities of newly recruited faculty.  The Developmental Core may be used to fund a collaborative study that encompasses two scientific disciplines that may not have collaborated previously (e.g., basic scientists and scientists studying complementary and alternative medicine, such as chiropractic or acupuncture; or behavioral scientists and population geneticists; or studies that examine HIV in women or examine sex/gender differences in biological or behavioral responses to HIV infection or disease progression).  Examples provided are not meant to be all-inclusive.  Applicants may wish to consult with program staff listed under "Agency Contacts" to discuss how Developmental Cores are used at current CFARs. 

While the CFAR Administrative Core should focus on the mechanisms for allocation of developmental funds and for annual evaluation of supported activities, the CFAR Developmental Core should describe the mechanism to be used for identification, peer-review selection, and outcome evaluation of projects to be supported within this Core.  The Developmental Core director is responsible for ensuring that all developmental studies involving human or animal subjects have the appropriate approvals (i.e., IRB, FWA, IACUC, human subjects’ research training, etc. in domestic and foreign institutions).  Applicants must inform the NIH of any awards made for developmental studies involving foreign sites prior to initiation. Developmental studies involving foreign sites cannot be initiated without first obtaining NIH clearance and approvals for protection of human subjects and animals, including specimens.  Applicants who have current CFARs should describe outcome evaluation of previously funded developmental projects. The time period should include all years for which the CFAR was funded.  The applicant should use the table provided for this purpose on the CFAR program announcement web site (http://www.niaid.nih.gov/research/cfar/cfarpa.htm) and include with the application (Table 3).

The Developmental Core section should include a plan for the use of the first year developmental funds.

3.  Basic Science Cores

Basic Science Cores provide equipment, training, services, quality control, and expertise/advice for research activities that cannot easily be funded through standard research granting mechanisms.  Basic Science Cores should provide economy of scale through use by multiple laboratories and should foster collaboration between basic and clinical investigators.  Basic science cores do not substitute for resources that are obtainable commercially, or replace existing resources normally supported by individual research grants.  Cores should have a clear focus, and contribute to translational research. Applicants must emphasize well managed and efficient core functions above the overall number and breadth of cores in a given application.  Please use Table 4 to indicate all core facilities at your institution and whether or not CFAR members will be utilizing them.

CFAR applications should describe the Basic Science Cores to be supported at the time of the award and any changes anticipated during the course of the award. A basic science core should be designed to support multiple AIDS investigators and applicants should indicate the number of anticipated users and the percent time of use by each.  Mechanisms should be described to prioritize core usage, evaluate use annually, and justify level of continued CFAR support in the context of evolving scientific priorities at the applicant institution(s).

4.  Clinical Cores

Clinical Cores should focus clearly on providing resources for AIDS translational research between collaborating clinical and basic scientists.  The primary distinction between a Basic and Clinical Core is that a Clinical Core has direct interaction with human subjects.  This may involve developing a database for clinical specimens, an intervention for a behavioral study, or development of investigational new drugs (INDs).  Activities that will not be supported by a CFAR Clinical Core are normal patient care, including screening of clinical specimens, diagnosis, treatment, or rehabilitation.

Applicants are reminded of the Form PHS398 (or current NIH form) requirement to address the involvement of human subjects and vertebrate animals in the work proposed.  Any new work involving human subjects proposed in the Clinical Core sections of this application that are not covered by existing IRB approvals will require such approvals prior to funding.  CFAR Cores proposing direct work with human subjects or vertebrate animals must provide full Human Subjects Research and Vertebrate Animals Research sections as per Form PHS398 instructions.

Mechanisms should be described for prioritizing core usage, evaluating use annually, and justifying the level of continued CFAR support in the context of evolving scientific priorities at the applicant institution(s).

VI.  Institutional Commitment

Commitment of the CFAR institution is particularly important for the coordination of resources across the broad areas and potential boundaries of research supported by the co-funding Institutes.  Examples of the types of institutional commitment that are demonstrated at current CFARs are: level of institutional funding, space allocation, co-funding, endowments, and designation of center program status in the institutional bylaws..  These are examples, and are not exclusive of other possible ways in which an institution may demonstrate support for the CFAR.  The applicant must provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) defining:

  1. Position, authority, and reporting responsibility (on institution's organizational chart) for the CFAR director
  2. Financial and other resource support for the CFAR that will be provided by the applicant institution(s)
  3. Authority or influence that the CFAR director has and or will have over other AIDS projects, facilities and space, as well as decision-making authority for hiring and/or approving new faculty and support personnel

VII.  Scientific Programs

To take full advantage of the ability of CFARs to organize AIDS research at an institution, to encourage collaboration among scientific disciplines and diverse areas of expertise, and to explore significant questions and problems in AIDS that are not being addressed, the CFAR is encouraged, but not required, to identify from one to three Scientific Programs.  A Scientific Program is defined as a specific area of scientific focus for a group of investigators who share common research interests and goals and participate in competitively funded research.  Scientific Programs should capitalize on areas of excellence at that particular CFAR and should encourage interdisciplinary collaboration among investigators who have not previously collaborated with each other, or within that area of scientific focus.  Examples of possible Scientific Programs include, but are not limited to: HIV/TB Co-infection, HIV/AIDS and STIs, New Treatment Approaches for HIV/AIDS, Molecular Modeling Approaches to Vaccine Development, or HIV in Women and Sex/Gender Differences in HIV Infection or Disease Progression, AIDS-related Malignancies, etc.  The examples provided are meant to be broad enough to include diverse biomedical disciplines, e.g., behavioral science, epidemiology, pathogenesis, clinical research, etc., but are focused clearly in a specific research area.  Scientific Programs serve to unite a subgroup of CFAR scientists, whereas essential Cores are used by all or most CFAR members.  Applicants must address clearly the interaction between the Scientific Program(s) and the CFAR Cores. 

The Scientific Program Director is expected to encourage new collaborations, identification of high risk/high impact studies, submission of new proposals for peer-reviewed funding, and address knowledge gaps that cannot be addressed by standard funding mechanisms.  Such studies may be conducted both within a given Scientific Program, and between Scientific Programs within the CFAR.  The success of Programs will ultimately be measured by expansion of NIH-supported funding for the Program, and the establishment of successful collaborations within and between Programs.  Programs should be of adequate size and scientific quality, should exhibit a high degree of interaction, are encouraged to be multi-disciplinary, and should be capably led. To ensure adequate size and quality, a proposed Program must have the equivalent of at least three entire peer-reviewed and funded research projects, each led by a separate, independent principal investigator. Peer-reviewed, funded research sub-projects of larger program grants (e.g., P01s) may be counted as separate projects.  Peer reviewed awards that may be used to comprise a Program will come from the Funded Research Base of the CFAR.  Methods to develop collaborations will vary at each CFAR, but may include formal or informal planning meetings, seminars and retreats, new, shared resources, or key recruitments. 

It is possible that a program may achieve its stated goals, such as new funding, and the CFAR then may decide to refocus resources on a new Scientific Program.  Specific policies and procedures for determining when and how new Scientific Programs will be started, terminated, or extended should be explained clearly by the applicant.  Clear outcome measures of established Programs are strongly encouraged.  Decisions on development of new Programs made solely by the CFAR Director and Core Directors are strongly discouraged.

There are three possible ways for Scientific Programs to fund new collaborative projects: (1) through new R01 or P01 applications; (2) with CFAR base funding through the Developmental Core as described in Section I under the Developmental Core; (3) through competitive supplements to the CFAR grant as explained below.

The Scientific Program Director and colleagues within a CFAR program are strongly encouraged to identify innovative, high-risk/high impact projects as a strategy to increase collaboration among CFAR investigators.  Proposed projects are encouraged to be multi-disciplinary.  Projects may be submitted to the NIH as R01 or P01 applications, or may be funded through the Developmental Core of the CFAR.  The following are examples of scientific projects that suggest, but are not intended to limit, a variety of collaborations that could be considered:

Funding for the Scientific Program Director position(s) can be requested in the budget for development of a Scientific Program(s) through the Administrative Core.  CFAR funding for collaborative projects will be through the Developmental Core, either from base CFAR funds, or through a competitive supplement to the CFAR grant.  At the time of submission of a competitive renewal application, applicants should identify a Scientific Director(s),, the Scientific Program(s), and specific plans that will be used to develop collaborative activities.  In addition, procedures for identifying projects, reviewing project applications, and choosing projects to be supported, should be clearly identified.  Policies for continuing, terminating/revising, or rebudgeting funds for a project should be clearly identified in the event that the project director leaves the institution, the study achieves an earlier endpoint than expected, or other unexpected data or results becomes available that suggests a change in focus.  These policies will be evaluated by the reviewers to determine the ability of the applicant to manage funds responsibly for these projects during the CFAR funding period, and will be incorporated into the terms and conditions of award if the CFAR application is successful. 

The CFAR strategic planning process should be used to develop policies and procedures for identifying and prioritizing projects, and to develop funding plans for projects to be funded through the Developmental Core using base CFAR funding.  Funding for these projects is expected to be greater than for standard developmental awards, and must be fully justified.  At the Annual CFAR Directors' Meeting, investigators will be required to present a status report and to describe future plans for ongoing collaborative projects.

Before developing this part of the application investigators are strongly encouraged to discuss plans with appropriate NIH representatives identified under "Agency Contacts."

Competitive Supplements.  To provide additional encouragement for new collaborative studies, NIH institutes participating in the co-funding of CFARS may solicit on an annual basis for competitive supplements to the CFAR grant for scientific projects.  In addition, the NIH CFAR Program, and the Office of AIDS Research may solicit competitive supplements for collaborative projects in areas identified by NIH, and NIH Advisory groups, together with suggestions from CFAR investigators.  Both of these funding mechanisms are subject to funding availability each year; and funding opportunities, if available, will be announced in early January on the NIH CFAR web site, or by email communication to eligible investigators.

VIII.  CFAR Budget Items

A.  Core Budgets

Core budgets may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds. 

B.  Other Administrative Costs

This category includes the costs necessary for the central administration and fiscal management of the CFAR, including relevant and reasonable costs for reprints, graphics, and publications for Developmental Core users.

C.  Travel

CFAR Directors' Meeting(s) — Attendance to the Annual CFAR Directors’ Meeting is required by the CFAR Director and the CFAR Administrator.  Under extenuating circumstances a Core Director may attend in lieu of the CFAR Director.  The CFAR Director is required, as  the nature of the meeting is to discuss policy issues, new information related to the CFAR program and the potential for CFAR to CFAR scientific collaboration.  One senior scientist per center may also receive financial support for the Annual CFAR Directors’ Meeting.  Funds may also be requested for an additional CFAR meeting during the year at the NIH, at a CFAR site, or at the site of a scientific conference that most of the Directors plan to attend.  Applicants should include travel funds specifically for these meetings in the CFAR Administrative Core budget request. 

Other Travel — Applicants may request and justify travel funds in addition to the funds required for the two Directors' meetings.  These funds should not be used for travel to scientific meetings, nor should they be used for advertising and promotion.  They may be used for travel to meet with collaborators at foreign sites.  For example, this travel could be used to promote collaboration among CFAR investigators and AIDS investigators not in a CFAR Program, or at distant cores, for meetings of Core Directors of similar cores to share operational and scientific expertise, and for participation of junior or developing world investigators at CFAR-collaborative meetings and workshops.  These additional travel funds should not exceed $30,000 annual direct costs.  The procedures that the CFAR will follow on determining the use of these funds should be described clearly in the “Policies and Procedures” section of the Administrative Core.

D.  Definition of Effort for CFAR Directors and Core Directors

The effort requested should be limited to time devoted specifically to managing CFAR activities and not to research.  The effort devoted to CFAR activities should not be that which would normally be supported by research grants. Information documenting the level of effort on CFAR activities must be included in the application. All requested personnel costs should be carefully justified.

The effort of the CFAR Director should be justified in the context of the Director's other responsibilities.  Administrative support (a secretary or an administrative assistant) should be requested for the CFAR office only for matters directly pertaining to the CFAR.

Core Directors are CFAR members who are responsible for the overall technical excellence of a core facility.  The CFAR-supported percent effort of Core Directors involved in research activities should only include core management time.  The CFAR may support technical staff to provide CFAR services in core facilities. 

The use of Developmental Core funds for junior faculty salary support is allowed.  Established investigators with R01-type grants are expected to have salary support from other sources.

DEVELOPMENTAL CFARs (D-CFAR)

The purpose of the D-CFAR is to provide support for pre-CFAR applicants to develop collaborations, experiment with core facilities that may be important to support AIDS investigators at the institution, and to correct any deficiencies that might adversely affect an application for a standard CFAR award.  The emphasis for D-CFAR is on the identification of gaps or deficiencies that would hinder development of a competitive CFAR application, and core facilities that will reduce or eliminate these gaps.  For example, applicants may wish to initiate AIDS studies with investigators in the developing world, or expand collaborations between behavioral science and basic science investigators at an institution that has traditionally had a more narrow scientific focus in AIDS and AIDS-related research.  Other examples include expansion of communications technology among investigators who have begun, or are planning, collaborative studies, using the Developmental Core to fund a collaborative study that encompasses two scientific disciplines, especially two that may not have previously collaborated (behavioral scientists developing AIDS prevention interventions, and clinicians conducting clinical trials of AIDS therapeutics), or developing an outreach program that could not be started through institutional or research grant funding.  The D-CFAR mechanism may not be used to obtain a supplement to an existing CFAR award.

All eligibility requirements and specific descriptions provided in this PA for the CFAR awards are also required for and relevant to, the D-CFAR awards.  The minimum number and type of cores for a D-CFAR is the same as for a standard CFAR: one Administrative, one Developmental, one Basic and one Clinical.  There are several differences between a D-CFAR and a standard CFAR. The maximum funding level for the D-CFAR award is $750,000 and it is a one-time award for 5 years.  We encourage independent AIDS investigators interested in expanding collaborative efforts at their institution to consider applying for this award.

Applicants who have never received a CFAR award are eligible to apply, as are previous CFAR applicants who have not been successful in competing for the CFAR award and previous recipients who were not successful in renewing their CFAR award.  Applicants who have not received a CFAR award may choose to apply for either a standard or developmental CFAR award.  Because the D-CFAR is designed to assist the applicant in the organization and development of a competitive CFAR application, reviewers will look very carefully at previous CFAR applications from the same applicant regarding the feasibility of overcoming obstacles identified by previous reviewers. Note that a resubmitted application also must address prior reviewer critiques in the introductory section.  Applicants should clearly indicate in the title of the application and in the abstract that this is for the D-CFAR award.  If no indication is provided it will be assumed that the application is for a standard CFAR.

Applicants applying for a D-CFAR award should plan on providing as much detail for the Administrative and Developmental Cores as is required for the standard CFAR application.  Please see the instructions for the Administrative and Developmental Core for CFARs, above.  The strategic plan should provide sufficient detail about procedures that will be used to identify challenges at the institution and proposed solutions that would lead to development of a competitive CFAR application within the five-year funding period.  Proposed outcome measurements for strategies, and core facilities selected for year 1 should be clearly explained, as well as procedures for adjusting the plan for years 2 through 5, should changes be needed.

Like the standard CFAR award, the D-CFAR provides funding to foster synergy and improve coordination of research, support emerging research opportunities, and promote economy of scale through resources shared by multiple independent laboratories.  D-CFARs also encourage other activities that serve the requirements of AIDS research.  See IV. 'Additional CFAR supported activities' under Section IV. 2. Content and Form of Application Submission.  Any of these activities may be fostered through a D-CFAR award.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): May 22, 2006 and May 22, 2007
Application Receipt Date(s):
June 22, 2006 and June 22, 2007
Peer Review Date(s):
September 2006 and September 2007
Council Review Date(s): October 2007 and October 2008
Earliest Anticipated Start Date:
November 2006 and November 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:

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

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 (or most current NIH grant application) instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

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

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

At the time of submission, two additional single-sided copies of the application (text) and all copies of appendices must be sent to:

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

3.C. Application Processing

Applications must be received on or before the application receipt/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

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

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must include an Introduction addressing the previous critique.
 
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.


6. Other Submission Requirements

SPECIFIC INSTRUCTIONS FOR PREPARING THE CFAR APPLICATION CAN BE FOUND AT THE CFAR WEBSITE: http://www.niaid.nih.gov/research/cfar/cfarpa.htm.

The application must also include the five tables that are available on the CFAR website (http://www.niaid.nih.gov/research/cfar/cfarpa.htm).

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.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.


Section V. Application Review Information


1. Criteria

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

Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review and for responsiveness to the goals of this PA by NIAID staff in consultation with other co-funding Institutes and Centers.  Incomplete or non-responsive applications will be returned to the applicant without further consideration.

P30 applications that are complete and responsive to this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID.

2. Review and Selection Process

Applications submitted in response to this funding opportunity will be assigned to the NIAID.  

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

The following will be considered in making funding decisions:

In addition, the following review criteria specific to this PA will be used in evaluation of applications.  Review criteria are based on the mission of the CFAR Program and mechanisms for achieving this mission.  The initial review group (IRG) will evaluate D-CFAR, and CFAR applications for significance, approach, innovation, investigator, and environment.  In these evaluations, the IRG will also look for evidence of successful performance from applicants that have had CFAR awards or similar programs at their institutions.

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:

The NIH review criteria have been adapted to ensure that the major components of a CFAR application are evaluated appropriately.  The score should reflect the overall impact that the CFAR could have on the field based on consideration of the five criteria, with the emphasis on each criterion varying from one application to another, depending on the nature of the application and its relative strengths.  Note that an application need not be strong in all categories to be judged likely to have major scientific impact and thus deserve an outstanding 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.  Review criteria are listed separately for the standard CFAR (CFAR), the developmental CFAR (D-CFAR), awards.

REVIEW CRITERIA FOR Standard CFARS

Significance – The effect that a CFAR award would have on CFAR investigators'

AIDS research efforts

1.      The ability of Cores to support the research base, foster synergy, enhance AIDS research collaborations and produce an economy of scale

2.      Evidence that CFAR will enhance proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry

3.      Developmental Core procedures for selection of projects and outcomes evaluation

Approach – The quality of the CFAR scientific planning and management process

1.      Annual strategic planning process

2.      Policy and procedures to judge value of cores and reassign funding priorities; outcome measurements

3.      Methods for selection of Basic and Clinical Core users and for prioritization of use

Innovation – The utilization of CFAR resources in unique ways to achieve the scientific goals of all AIDS investigators at the participating institution(s)

1.      The degree of variety in AIDS research projects and disciplines that commit to participation in and coordination through the CFAR structure

2.      The incorporation into the CFAR of resources (Cores, projects, cohorts, trials, etc.) that are supported in part or not at all by CFAR funds

Investigator – The identification of appropriate leaders to carry out the CFAR mission

1.      Selection of CFAR Director with appropriate managerial experience, commitment, leadership in AIDS research and at the applicant institution

2.      Selection of Core directors and key personnel with appropriate qualifications, competence and commitment

3.      Proposed advisory groups: their responsibilities, methods for determining membership, and contribution to the overall CFAR goals

Environment – The likelihood that a CFAR will achieve its objectives 

1.      Evidence for a CFAR providing value added to AIDS research conducted at the institution

2.      Institutional commitment including space, institution financial support and other  resources and oversight provided for CFAR activities

3.      Previous history of CFAR support for developmental projects and outcomes

4.      Previous history of translational research efforts

5.      Appropriateness of the budget for the CFAR overall and individual Cores

In addition to the above review criteria, the following criteria for significance should be used for an application for a standard CFAR award with budget requests of $2.25M or $3M.

1.      Evidence that the CFAR provides significant, capacity building support for: junior faculty, minority investigators, developing world investigators, and new collaborations in AIDS that could not be possible without the CFAR.

2.      The need at the institution for coordination of AIDS science, and the ability of the CFAR to serve as the primary coordinating unit of AIDS science at the institution(s).

3.      Unique policies and procedures to obtain input from all AIDS investigators at the CFAR institution(s) concerning CFAR success at meeting their AIDS research needs.

REVIEW CRITERIA FOR D-CFARS

Significance – The effect that a D-CFAR award would have on an applicant's AIDS research efforts 

1.      Evidence that the proposed D-CFAR will lead to development of a competitive standard CFAR application

2.      The ability of Cores to support the research base, foster synergy, enhance AIDS research collaborations and produce an economy of scale

3.      The ability of proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry to assist AIDS investigators and lead to development of a competitive CFAR application

4.      Developmental Core procedures for selection of projects and outcomes evaluation

Approach – The quality of the CFAR scientific planning and management process

1.      Annual strategic planning process

2.      Policy and procedures to judge value of Cores and reassign funding priorities; outcome measurements

3.      Methods for selection of Basic and Clinical Core users and for prioritization of use

4.      Policies and procedures to identify gaps and mechanisms for filling them

Innovation – The utilization of D-CFAR resources in unique ways to achieve the scientific goals of all AIDS investigators at the participating institution(s)

1.      The degree of variety in AIDS research projects and disciplines that commit to participation in and coordination through the D-CFAR structure

2.      The incorporation into the D-CFAR of resources (Cores, projects, cohorts, trials, etc.) that are supported in part or not at all by D-CFAR funds

3.      Evidence that proposed D-CFAR goals are well-matched to the available resources and will foster future collaborative interactions

4.      Proposed strategy for expanding the D-CFAR focus

Investigator – The identification of appropriate leaders to carry out the D-CFAR missio

1.      Selection of a D-CFAR director with appropriate managerial experience, commitment, leadership in AIDS research and located at the applicant institution

2.      Selection of core directors and key personnel with appropriate qualifications, competence and commitment

3.      Proposed advisory groups: their responsibilities, methods for determining membership, and contribution to the overall D-CFAR goals

Environment – The likelihood that a D-CFAR will achieve its objectives

1.      Evidence for a D-CFAR providing value added to AIDS research conducted at the institution

2.      Institutional commitment including space, institution financial support and other  resources and oversight provided for D-CFAR activities

3.      Appropriateness of the budget for the D-CFAR overall and individual cores

REVIEW CRITERIA FOR SCIENTIFIC PROGRAMS AND PROPOSED PROJECTS

Significance – The effect that a collaborative project would have on the overall AIDS effort at the institution

1.      Evidence for innovative, high-risk/high-impact program(s) and project(s) that will address significant problems or gaps in the AIDS field that cannot be addressed easily through other funding mechanisms

2.      Evidence that the proposed program(s) and project(s) will enhance new multidisciplinary collaborations, that may include international collaboration, collaboration with industry, or collaboration with junior or minority investigators

3.      Evidence that the process for selection of program(s) and project(s) to be funded will lead to independent funding of high-risk/high-impact studies

Approach - The quality of the CFAR scientific program(s) and project(s), including planning and management proces

1.      Project design and appropriate Core selection

2.      Policy and procedures to identify and select scientific program(s) and project(s), reassign funding priorities, and to measure outcome of program(s) and project(s)

Innovation – The identification of a unique program and project or approach to solve a significant question or gap in AIDS research

1.      The degree of variety in AIDS scientific disciplines that is included in proposed program(s) and scientific project(s)

2.      The degree of innovation in program and project selection and experimental design

Investigator – Identification of appropriate scientists to lead the recognition and development of collaborative program(s) and project(s)

1.      Selection of a Program Director for scientific program proposed with leadership in the field of AIDS

2.      Selection of a project leader for individual collaborative projects proposed with scientific qualifications, commitment

Environment

1.      Availability of appropriate scientific expertise

2.      Previous history of support for developmental projects and outcomes

3.      Appropriateness of the budget for the Program Director and scientific project(s) and individual Cores involved

4.      Evidence that scientific collaborative areas and program(s) and project(s) arise from the scientific environment at the CFAR institution(s)

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: Total cost limitations and total award among for CFAR and D-CFAR grantees is based on the grantee’s FRB.  However, it is expected that reviewers will use the CFAR budget selection as one measure of the ability of the CFARs to manage their program during the funding period.  Reviewers may make suggestions or recommendations for reallocation of resources within total cost limitations, but because of the emphasis on fiscal and scientific flexibility within the CFAR program, will not reduce the total award.   These suggestions will be discussed between NIAID and the grantee prior to award to ensure that budget priorities are consistent with the goals of the CFAR Program..

2.C. Sharing Research Data

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

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

No funds may be provided for projects involving foreign sites unless specifically indicated on a revised NoA. This includes developmental awards that have foreign involvement.  If developmental awards involve international studies, prior approval must be received by NIAID Program and Grants Management Staff.

The Conditions of Award will incorporate the following items proposed by the applicant with potential modifications based on recommendations made by the Special Emphasis Panel (SEP).”      

Any changes in these items from the Notice of Award will require concurrence of NIH.

3. Reporting

Annual Progress Report:  The NIH has developed guidelines for information it needs in progress reports to respond to constituencies, including Congress.  Awardees can request a copy of this guidance document from the CFAR program officer.  The awardees’ annual progress reports must include a description of ongoing, completed, and planned activities as well as accomplishments during the previous funding/reporting period.  This also includes progress on competitive supplements awarded previously through the CFAR program.  The progress report should also include the five tables that are available on the CFAR website (http://www.niaid.nih.gov/research/cfar/cfarpa.htm). 

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Please check the following website for any changes in contact information: 

http://www.niaid.nih.gov/research/cfar/cfarpa.htm

For questions regarding D-CFAR, or CFAR management issues, scientific issues, or program interests of NIAID please contact:

Janet M. Young, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4152, MSC-7626
6700-B Rockledge Drive
Bethesda, MD 20892-7626
Telephone: (301) 496-6714
FAX: (301) 402-3211
Email: jy6r@nih.gov  

For questions regarding D-CFAR, or CFAR scientific issues or program interests of other Institutes or Centers please contact:

FIC
Jeanne McDermott, Ph.D.
Division of International Training and Research
Fogarty International Center
Room B2C39, MSC 2220
31 Center Drive
Bethesda, MD  20892-2220
Telephone: (301)-496-1492
FAX: (301) 402-0779
Email: jm548f@nih.gov

NCI
Kishor Bhatia, Ph.D., MRCPath.
Office of AIDS Malignancy Program
National Cancer Institute
Room 6034, MSC-7339
6130 Executive Plaza
Rockville, MD  20892-7339Telephone:  (301) 496-7147
FAX:  (301) 402-7819
Email:  bhatiak@mail.nih.gov

NCCAM
Morgan N. Jackson, M.D., M.P.H.
Division of Extramural Research and Training
National Center for Complementary and Alternative Medicine
Suite 401, MSC-5475
6707 Democracy Boulevard
Bethesda, MD 20892-5475
Bethesda, MD 20817 (use for express/courier service)
Telephone: (301) 402-1278
FAX: (301) 480-3621
Email: mj145m@nih.gov

NHLBI
Liana Harvarth, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung and Blood Institute
Suite 10042, MSC-7950
6701 Rockledge Drive
Bethesda, MD  20892-7950
Telephone:  (301) 435-0065
FAX:  (301) 480-0868
E-mail: lh8p@nih.gov  

NICHD

Pat Reichelderfer, Ph.D.
Center for Population Research
National Institute of Child Health and Development
Room 8B13, MSC-7510
6100 Executive Boulevard
Rockville, MD  20852-7510
Telephone: (301) 496-6991
FAX: (301) 480-1972
E-mail: pr20f@nih.gov  

NIDA

Jag Khalsa, Ph.D.
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
National Institute on Drug Abuse
Room 4137, MSC 9551
6001 Executive Boulevard
Bethesda, MD 20892-9551
Telephone: (301) 443-2159
FAX: (301) 594-2599
Email:  jk98p@nih.gov

NIMH

Christopher, Gordon, Ph.D.
Division of Mental Disorders, Behavioral Research & AIDS
National Institute of Mental Health
Room 6204, MSC-9621
6001 Executive Boulevard
Bethesda, MD  20892-9621
Telephone: (301) 443-1613
FAX: (301) 443-9719
E-mail: cg206o@nih.gov  

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Lori Zimand, M.P.H. M.B.A.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2246, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 451-4580
FAX: (301) 493-0597
Email: lz36k@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.


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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations:  No. 93.213, Research and Training in Complementary and Alternative Medicine; No. 93.242, Mental Health Research Grants; No. 93.279, Drug Abuse Research Programs; No. 93.393, Cancer Cause and Prevention Research; No. 93.396, Cancer Biology Research; No. 93.839, Blood Diseases and Resources Research; No. 93.855, Immunology, Allergy, and Transplantation Research; No. 93.856, Microbiology and Infectious Diseases Research; No. 93.864, Population Research; No. 93.865, Center for Research for Mothers and Children; and No. 93.989, Senior International Fellowships, 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 administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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