Part I Overview Information


United States Department of Health and Human Services (HHS)

Participating Organizations
Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov

Components of Participating Organizations
National Center for HIV, STD and TB Prevention (NCHSTP), at http://www.cdc.gov/nchstp/od/nchstp.html

Title: Adopting and Demonstrating the Adaptation of Prevention Techniques for Persons at Highest Risk of Acquiring or Transmitting Human Immunodeficiency Virus (ADAPT 2) - (UR6)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may differ from those used by the HHS National Institutes of Health (NIH).  If a CDC policy does not exist to cover an applicable topic, or is in the process of being drafted, then for purposes of this announcement, the NIH policy is hereby adopted by CDC and will be applicable to that particular topic.  In addition, if written guidance for completing this application is not available on the CDC website, then applicants will be directed elsewhere for that information.

Authority: Sections 301 and 318 of the Public Health Service Act (42 U.S.C. Sections 241 and 247c), as amended

Announcement Type:
New

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply).

A registration process is necessary before submission, and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Time on the application submission receipt date (see “Key Dates” below.)

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number: RFA-PS-07-004

Catalog of Federal Domestic Assistance Number(s):
93.941

Key Dates
Release/Posted Date: February 6, 2007
Letter of Intent Receipt Date: February 28, 2007
Application Submission Receipt Date(s): March 30, 2007
Peer Review Date(s): May-June, 2007
Council Review Date(s): May-June, 2007
Earliest Anticipated Start Date(s): July 31, 2007
Additional Information To Be Available Date: Conference call with potential applicants to be held February 13, 2007, 2:00pm, E.T., phone number 1-877-951-9728, pass code 362242
Expiration Date: March 31, 2007

Due Date for E.O. 12372

Due no later than 60 days after the application receipt date.

Additional Overview Content

Executive Summary

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

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
    2.Cost Sharing or Matching
    3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
    1. 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. Submitting an Application to CDC
        C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

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

Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements  
        A. Cooperative Agreement
            1. Recipient Rights and Responsibilities
            2. HHS/CDC Responsibilities
            3. Collaborative Responsibilities
    3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The NCHSTP of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority area(s) of HIV and is in alignment with NCHSTP performance goal(s) to develop and implement effective HIV prevention interventions. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

This funding opportunity will support three to four awards to conduct research in the United States to determine the efficacy of adapted Effective Behavioral Interventions (EBIs).  The interventions will be adapted (or have previously been adapted) through a systematic process for new populations (i.e., populations different than those used in the original research) at high risk for acquiring or transmitting HIV.  The adapted interventions will be rigorously evaluated to determine whether they reduce HIV-related risk behaviors (e.g., sex or drug behaviors) or new HIV or STD diagnoses.  The primary intent of this program is to help grantees obtain data they need to successfully adapt, implement, and assess efficacious EBIs in their local areas.  In addition, this program can increase the number of EBIs for populations at high risk for acquiring or transmitting HIV.

This funding announcement will use two funding options, Option A and Option B, to support the adaptation and randomized controlled trial of an existing EBI (Option A) or to support the randomized controlled trial of a previously adapted EBI (Option B).   Each submitted proposal must be limited to either Option A or Option B.  The number of awards made for this funding opportunity will be based on application scores and proposed target populations. There is no funding preference for Option A or Option B.

EBIs that effectively reduce HIV risk behaviors remain one of the most powerful tools in curbing the HIV epidemic. The CDC has developed a three-phase process where EBIs are identified, packaged in a user-friendly format, and disseminated nationally to HIV prevention providers. However, there are gaps in the CDC’s current portfolio of EBIs. According to recent surveillance reports, HIV disproportionately impacts minority populations in the United States, including African American and Hispanic men who have sex with men (MSM) and heterosexual women (CDC, 2005). Although CDC has identified EBIs for some of these populations, there remains an urgent need to develop additional culturally appropriate evidence-based prevention interventions for populations at the highest risk for HIV transmission or acquisition.

The development and rigorous testing of new interventions is a time- and resource-intensive process. One strategy that has been used to accelerate the development of new interventions involves the adaptation of existing EBIs for new target populations and settings. Adaptation is defined as “the process of modifying an intervention without competing with or contradicting its core elements or internal logic.” Core elements are components that are critical features of an intervention’s intent and design, and are thought to be responsible for successful behavior change.

Interventions can be adapted to fit the cultural context and determinants of risk behaviors of the target population, as well as the characteristics of the implementing agency. The CDC has developed the Map of the Adaptation Process (MAP): A Systematic Approach for Adapting Evidence-Based Behavioral Interventions to guide implementing agencies through the adaptation process (McKleroy V, Galbraith J, Cummings B, Jones P, Gelaude D, and Carey J.  Adapting evidence-based behavioral interventions for new settings and target populations. AIDS Educ Prev. 2006;18 (Suppl. A):59-73).

For the purpose of this funding opportunity announcement, grantees must adapt and test one of the following EBIs:

1.       Baker, et al., 2003, Choices Project.  (Baker SA, Beadnell B, Stoner S, et al. Skills training versus health education to prevent STDs/HIV in heterosexual women: a randomized controlled trial utilizing biological outcomes.  AIDS Educ Prev. 2003;15:1-14).

2.       Carey, et al., 2004, Health Improvement Project (HIP). (Carey MP, Carey KB, Maisto SA, et al. Reducing HIV-risk behavior among adults receiving outpatient psychiatric treatment: Results from a randomized controlled trial. J Consult Clin Psychol. 2004;72:252-268).

3.       DiClemente, et al., 2004, Sistas Informing, Healing, Living and Empowering (SiHLE).* (DiClemente RJ, Wingood GM, Harrington KF, et al. Efficacy of an HIV prevention intervention for African American adolescent girls: a randomized controlled trial. JAMA. 2004;292:171-179).

4.       Dilley, et al., 2002, Personalized Cognitive Risk-Reduction Counseling. (Dilley JW, Woods WJ, Sabatino J, et al. Changing sexual behavior among gay male repeat testers for HIV: a randomized, controlled trial of a single-session intervention. J Acquir Immune Defic Syndr. 2002;30:177-186).

5.       Ehrhardt, et al., 2004, The Future is Ours (FIO).  (Ehrhardt AA, Exner TM, Hoffman S, et al. A gender specific HIV/STD risk reduction intervention for women in a health care setting: short and long term results of a randomized clinical trial. AIDS Care. 2002;14:147-161).

6.       El-Bassel, et al., 2004, Project CONNECT (Couples or Women Alone). (El-Bassel N, Witte SS, Gilbert L, et al. The efficacy of a relationship-based HIV/STD prevention program for heterosexual couples. Am J Public Health. 2003;93:963-969).

7.       Hobfall, et al., 2002, Communal Effectance—AIDS Prevention. (Hobfoll SE, Jackson AP, Lavin J, et al. Effects and generalizability of communally oriented HIV-AIDS prevention versus general health promotion groups for single, inner-city women in urban clinics. J Consult Clin Psychol. 2002;70:950-960).

8.       Jemmott et al., 2005, Sister Saving Sister. (Jemmott JB, Jemmott LS, Braverman PK, Fong GT. HIV/STD risk reduction intervention for African American and Latino adolescent girls at an adolescent medicine clinic: A randomized controlled trial. Arch Pediatr Adolesc Med. 2005;159:440-449).

9.       Jemmott et al., 2007 in press, Sister to Sister.  (Jemmott LS, Jemmott JB, O’Leary A. A randomized controlled trial of brief HIV/STD prevention interventions for African American women in primary care settings: Effects on sexual risk behaviors and STD incidence.  Am J Public Health. 2007 in press).

10.     Kalichman, et al., 1999, NIA: A Program of Purpose for African-American Men. (Kalichman S, Cherry C, and Brown-Sperling F. Effectiveness of a Video-Based Motivational Skills-Building HIV Risk-Reduction for Inner-City African American Men.  J Consult Clin Psychol. 1999;67:959-966).

11.     Kalichman, et al., 2001, Healthy Relationships.* (Kalichman SC, Rompa D, Cage M, et al. Effectiveness of an intervention to reduce HIV transmission of risks in HIV-positive people. Am J Prev Med. 2001;21:84-92).

12.     Latkin, et al., 2003, Self-Help in Eliminating Life-Threatening Diseases (SHIELD). (Latkin CA, Sherman S, Knowlton A. HIV prevention among drug users: outcome of a network-oriented peer outreach intervention. Health Psychol. 2003;22:332-339).

13.     Metcalf et al., 2005, RESPECT-2.* (Metcalf CA, Malotte K, Douglass JM, et al.  Efficacy of a booster counseling session 6 months after HIV testing and counseling: A randomized, controlled trial (RESPECT-2). Sex Transm Diseases. 2005;32:123-129).

14.     Robles, et al., 2004, Modelo de Intervención Psicomédica (MIP). (Robles RR, Reyes JC, Colon HM, et al. Effects of combined counseling and case management to reduce HIV risk behaviors among Hispanic drug injectors in Puerto Rico: a randomized controlled study. J Subst Abuse Treat. 2004;27:145-152).

15.     Rotheram-Borus, et al., 2004, Choosing Life: Empowering, Actions, Results (CLEAR).* (Rotheram-Borus MJ, Swendeman D, Comulada WS, et al. Prevention for substance-using HIV-positive young people: telephone and in-person delivery. J Acquir Immune Defic Syndr. 2004;37(suppl 2):S68-S77).

16.     Shain, et al., 2004, Project SAFE (Standard Version).* (Shain RN, Piper JM, Holden AE, et al. Prevention of gonorrhea and Chlamydia through behavioral intervention: results of a two-year controlled randomized trial in minority women. Sex Transm Dis. 2004;31:401-408).

17.     Sterk, et al., 2003, Female and Culturally Specific Negotiation Intervention. (Sterk CE, Theall KP, Elifson KW. HIV risk reduction among African American women who inject drugs: A randomized controlled trial. AIDS Beh. 2003;7:73-86).

18.     Villarruel et al., 2006, ¡Cuídate! (Villarruel A, Jemmott JB, Jemmott LS. A randomized controlled trial testing an HIV prevention intervention for Latino youth.  Arch Pediatr Adolesc Med. 2006;160:722-777).

19.     Wechsberg, et al., 2004, The Women’s Co-Op. (Wechsberg WM, Lam WK, Zule WA, Bobashev G. Efficacy of a woman-focused intervention to reduce HIV risk and increase self-sufficiency among African American crack abusers. Am J Public Health. 2004;94:1165-1173).

20.     Wingood, et al., 2004, Women Involved in Life Learning from Other Women (WiLLOW).* (Wingood GM, DiClemente RJ, Mikhail I, et al. A randomized controlled trial to reduce HIV transmission risk behaviors and sexually transmitted diseases among women living with HIV: the WiLLOW Program. J Acquir Immune Defic Syndr. 2004;37(suppl 2):S58-S67).

21.     Wolitski and the Project START Study Group, 2006, START. (Wolitski, R., Project START Study Group. Relative efficacy of a multi-session sexual risk reduction intervention for young men released from prisons in 4 US states.  Am J Pub Health. 2006;96:1854-1861).

22.     Wu, et al., 2003, Focus on Kids* + Informed Parents and Children Together (ImPACT). (Wu Y, Stanton BF, Galbraith J, et al. Sustaining and broadening intervention impact: a longitudinal randomized trial of 3 adolescent risk reduction approaches. Pediatrics. 2003;111:e32-e38).

*Interventions currently packaged and available to the public.

This funding opportunity will support grantees to work collaboratively with CDC and a community-based organization, AIDS service organization, faith-based organization, or government agency having experience providing HIV prevention interventions. Funding will support the adaptation of an EBI listed above for use with a target population at high risk for acquiring or transmitting HIV. The proposed new target population should differ from the population used in original intervention in such a way as to require significant adaptation. Potential new target populations include, but are not limited to: African Americans, including men who have sex with men (MSM), women, and heterosexual men; Hispanics, including MSM, women, and heterosexual men; persons with HIV infection; HIV serodiscordant couples; persons with a history of incarceration; transgender persons; substance using MSM; or persons who live in rural areas and whose behaviors put them at high risk for HIV acquisition or transmission. Interventions delivered to students as part of a school-based curriculum will not be considered for funding.

Diversity of geographic location (i.e., city, county, or metropolitan area), target population (i.e., race/ethnicity and risk behavior; see list above), and intervention (i.e., 22 evidence-based interventions, see list above) is preferable. If two or more of the highest-scoring applications contain the exact same geographic location, target population, AND intervention, then only the highest scoring application will be funded.

It is expected that during year one, grantees under both Options A and B will develop, submit, and receive approval for a comprehensive protocol from the CDC Institutional Review Board (IRB) and local IRBs as applicable prior to the start of any data collection.

Option A grantees will use the MAP or other adaptation guidance to systematically adapt and rigorously test the intervention, including the following:

Option B grantees will rigorously test the adapted intervention, including the following:

For both Options A and B, the applicant must submit a plan for randomized controlled trial of the adapted intervention that meets published standards for interventions with “best-evidence” of efficacy in reducing HIV risk behaviors. These standards from the scientific literature have been summarized and are discussed in greater detail online at http://www.cdc.gov/hiv/topics/research/prs/efficacy_best-evidence.htm. The research design and analytic plan must address the following criteria:

The applicant must submit a plan for analysis that includes the following:

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the UR6 activity code.

The HHS/CDC UR6 is a cooperative agreement assistance instrument. Under the UR6 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

The participating Centers, Institute, and Offices (CIO) (s) NCHSTP intends to commit approximately $1,000,000 including both direct and indirect costs dollars in FY2007 to fund 3-4 applications. The average award amount will be $250,000 to $334,000 including both direct and indirect costs for the first 12-month budget period.  Average award amounts for subsequent years will vary based on eligibility for Option A or B, proposed intervention to be adapted, and proposed time-phased activities and staffing needs. The total amount funded for the entire project period will not exceed $1,800,000 per grantee. An applicant may request a project period of up to five years. An applicant may request up to $334,000 in total costs for the first 12-month budget period. The approximate total funded amount for the entire project period is $1,350,000 to $1,800,000 per award. The anticipated start date for new awards is July 31, 2007.

All estimated funding amounts are subject to availability of funds.

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

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:

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status.  Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.

1. B. Eligible Investigators

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support.   Additional requirements listed below are qualifications that must be documented in the Principal Investigator’s or Co-Investigator’s biographical sketch, curriculum vitae, or résumé:

2. Cost Sharing or Matching

Cost sharing, matching, or cost participation are not required.

The most current HHS Grants Policy Statement is available at: http://www.cdc.gov/od/pgo/funding/HHS_GPS_Oct_2006.doc

3. Other-Special Eligibility Criteria

To be qualified to apply for this program, applicants must include each of the following in an appendix labeled Appendix A: Eligibility Criteria:

Under Option A, applicants must not propose to replicate the adaptation of an EBI in the same target population or setting for which it has already been adapted and rigorously evaluated in a controlled trial.

Under Option B, applicants must not propose a previously adapted EBI that has already been rigorously tested in a randomized controlled trial.

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at the following:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA); although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact PGO TIMS: Telephone 770-488-2700, Email:  PGOTIM@cdc.gov

HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Sub award Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC UR6 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

3. Submission Dates and Times

See Section IV.3.A for details

3. A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date: February 28, 2007
Application Submission Receipt Date(s): March 30, 2007
Peer Review Date (s): May-June, 2007
Council Review Date (s): May-June, 2007
Earliest Anticipated Start Date: July 31, 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 CDC Program staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A

The letter of intent should be sent to:

Trudy Messmer, PhD
Extramural Research Program Office – PS07-004
Coordinating Center for Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Rd, Mailstop C-19
Atlanta, GA  30333
Telephone: (404) 639-2176
FAX: (404) 639-2469
Email: TMessmer@cdc.gov

3. B. Submitting an Application to CDC

If the instructions in this announcement differ in any way from the SF424 R&R instructions, follow the instructions in this announcement.

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov.  Applicants will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application. 

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.

All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date.

3. C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Time on the application submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness and responsiveness by NCHSTP and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.

There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons.  

4. Intergovernmental Review

Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Restrictions, which applicants must take into account while writing their budgets, are as follows:

6. Other Submission Requirements

Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. “Award Administration Information.”

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement.  If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.  If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately. 

Applicantsresearch plan(s) should address activities they will conduct over the entire project period.

The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a. PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments.  Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.

The following materials may be included in the Appendix:

Up to 10 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

Do not to use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.

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 should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, 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 the awardee will place any conditions 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). 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 HHS/CDC data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. 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.

Section V. Application Review Information


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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCHSTP in accordance with the review criteria stated below.

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

The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness.  In the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals.  Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them and weighted, as appropriate for each applications. 

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance:

Does this study address an important problem? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventative interventions that drive this field? Are the proposed study activities likely to have a positive impact on HIV prevention? How is the proposed target population at high risk for acquiring or transmitting HIV, including current behavioral determinants, cultural and social norms, and risk behaviors for acquisition or transmission of HIV? 

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the applicant justify how the proposed target population differs from the target population of the original EBI in such a way as to require adaptation? 

Does the applicant propose to adapt an EBI that is listed in Section I above and demonstrates that the selected EBI is an appropriate intervention to adapt for the proposed target population?  Does an intervention package exist for the proposed EBI?  If an intervention package for the EBI does not exist, does the applicant: (1) demonstrate a partnership with the original researcher (e.g., letter of support or memorandum of understanding), and (2) demonstrate that intervention materials will be available for the proposed project?Does the applicant demonstrate that it has obtained all relevant permissions to adapt, implement, and rigorously evaluate the original EBI? Does the applicant include a plan for process monitoring and evaluation of the adapted intervention to facilitate rapid packaging and dissemination if warranted?  Does the applicant describe an outcome evaluation design that meets the criteria established for distinguishing “Best Evidence” interventions listed in Section I above (also see http://www.cdc.gov/hiv/topics/research/prs/index.htm), including a plan to retain at least 70 percent of participants for each study group at follow-up assessment(s), and proposes to use outcome measures that may include, but are not limited to, behavioral outcomes such as abstinence, mutual monogamy, number of sex partners, negotiating safer sex, condom use, injection drug use, HIV testing behaviors, or a biologic measure such as sexually transmitted disease (STD) incidence? Does the applicant include a power analysis that demonstrates the proposed sample size, after anticipated attrition, is sufficient to detect moderate effects, and includes a minimum of 100 participants per study group? Does the applicant provide plans for recruitment and outreach of study participants from the proposed target population?  How feasible are the study plans to involve the proposed target population in the development of research activities and to inform them of the research results?

Additional review criteria specific for applicants applying for funding under Option A, adapting and rigorously evaluating an existing EBI:

Additional review criteria specific for applicants applying for funding under Option B, rigorously evaluating a previously adapted EBI:

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does the applicant propose a novel approach to HIV prevention for the target population that is culturally appropriate? Did the applicant verify that the proposed adaptation has not yet been rigorously evaluated and is not currently supported by other federal funds?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the applicant demonstrate an understanding of the research objectives of this announcement as evidenced by the quality of the proposed research plan and specific study design?

Does the applicant have a thorough understanding of HIV prevention approaches including but not limited to promotion of abstinence, faithful monogamy, and correct and consistent condom use? Does the applicant have experience conducting research with the proposed target population? Does the applicant have experience conducting behavioral intervention trials? Does the applicant have the ability to collect, manage, and analyze accurate data in a timely manner? Does the applicant have the appropriate training and skills to implement culturally-relevant HIV prevention interventions with the proposed target population? Does the applicant provide a Memorandum of Agreement with an appropriate local community-based organization, AIDS service organization, faith-based organization, governmental agency, or other organization which supports the proposed implementation and randomized controlled trial of the adapted intervention?

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

Does the planned location for the study have access to adequate numbers of the proposed target population? Does the applicant identify areas where implementing agencies will need to build capacity to adapt and implement the proposed EBI? 

How adequate is the timeline for conducting the research? Does the applicant have access to qualified personnel with realistic and sufficient percentage-time commitments relative to each phase of the study timeline? Does the applicant provide a description of duties, percentage time commitments, and responsibilities of project personnel including clear lines of authority and supervisory capacity over the behavioral, administrative, data management, and statistical aspects of the research? How adequate are the plans for facilities, equipment, assessment programming, data processing, and analysis capacity, and systems for management of data security and participant confidentiality in achieving the research objectives? Does the applicant provide a detailed budget for the total project period that includes a staffing plan and list of activities for each project year?    

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. [see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available  on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Inclusion of Women and Minorities in Research:

Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research:  If applicants plan to use vertebrate animals in the project, HHS/CDC will assess the five items described under Section 2, Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm. 

Biohazards:  If applicants propose materials or procedures that are potentially hazardous to research personnel and/or the environment, HHS/CDC will determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed?  Is each budget category realistic and justified in terms of the aims and methods?  The evaluation of the budget should not affect the priority score.

2.C. Sharing Research Data
 
Data Sharing Plan: HHS/CDC will assess the reasonableness of the data sharing plan. 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

Not applicable

3. Anticipated Announcement and Award Dates

Earliest anticipated award date is July 31, 2007

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the applicant organization will receive a written critique called a “Summary Statement.”  The applicant organization and the PD/PI will be able to access the Summary Statement via the eRA Commons.

HHS/CDC will contact those applicants under consideration for funding for additional information.

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 (GMO) is the authorizing document.  HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application. 

Selection of the application for award is not an authorization to begin performance.  Any cost incurred before receipt of the NoA is 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

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about  requirements.  For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements are available Section VIII. Other Information of this document or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.
 

The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courteous copy to the PD/PI at the time of award.

2.A. Cooperative Agreement

The following terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS/CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement UR6 an "assistance" instrument (rather than an "acquisition" instrument), in which substantial HHS/CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the HHS/CDC may share specific tasks and activities, as defined above.

2.A.1. Recipient Rights and Responsibilities

The Recipient will have the primary responsibility for the following:

When feasible, shared measures will be used and Recipient Organizations' site-specific information, data, and software developed under this award will be combined and made available for analyses by all Recipient Organizations and CDC, subject to U.S. Government rights of access consistent with current HHS and applicable HHS/CDC policies.

Recipient Organization will retain custody of and have primary rights to the information, data and software developed under this award, subject to U.S. Government rights of access consistent with current HHS, HHS/PHS, and applicable HHS/CDC policies.

2.A.2. HHS/CDC Responsibilities

An HHS/CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Additionally, an HHS/CDC agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA.

2. A.3. Collaborative Responsibilities

3. Reporting

Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:

1.     Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHSCDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.

2.     Financial status report, no more than 90 days after the end of the budget period.

3.     Final financial and performance reports, no more than 90 days after the end of the project period.

Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this NoA.

Although the financial plans of the HHS/CDC CIO(s) is to provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

Section VII. Agency Contacts


HHS/CDC encourages your inquiries concerning this FOA and welcomes the opportunity to answer questions from potential applicants. Inquiries can fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Trudy Messmer, PhD
Extramural Research Program Office
Coordinating Center for Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Rd, Mailstop C-19
Atlanta, GA  30333
Telephone: (404) 639-2176
FAX: (404) 639-2469
Email: TMessmer@cdc.gov

2. Peer Review Contacts:

J. Felix Rogers, PhD, MPH, Scientific Review Administrator
National Immunization Program
Centers for Disease Control and Prevention

U.S. Department of Health and Human Services
1600 Clifton Road
Mailstop E05
Atlanta, GA  30303
Telephone: (404) 639-6101
FAX:  (404) 639-0801
Email: FRogers@cdc.gov

3. Financial or Grants Management Contacts:

Deborah Mercy-Rogers
Procurement and Grants Office
Center for Disease Control and Prevention
U.S. Department of Health and Human Services
Colgate Building

2920 Brandywine Road
Atlanta, GA 30341
Telephone: (404) 639-8265
FAX: (404) 639-2200
Email: dem2@cdc.gov

4. General Questions Contacts:

Technical Information Management Section
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA  30341
Telephone:  (770) 488-2700
Email: PGOTIM@cdc.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection
Federal regulations (45 CFR Part 46) 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).   Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.

The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

HIV/AIDS Confidentiality Provisions

Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.

Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.

Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.

HIV Program Review Panel Requirements

Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.

To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.

If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.

Before funds are used to develop educational materials, determine whether suitable materials already exist in the CDC National Prevention Information Network (NPIN).  The website can be found at; http://www.cdcnpin.org/scripts/index.asp.

Patient Care

Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (E.O.) 12372. The order sets up a system for State and local governmental review of proposed Federal assistance applications. Applicants should contact their State single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC for each State affected.

Click on the following link to get the current SPOC list http://www.whitehouse.gov/omb/grants/spoc.html

Indian tribes must request tribal government review of their applications.

Specs or tribal governments that have recommendations about an application submitted to HHS/CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:

Deborah Mercy-Rogers, Grants Management Specialist
Procurement and Grants Office
Announcement Number RFA-CDC-PS07-004
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146

HHS/CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.

Paperwork Reduction Act Requirements

Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).

Smoke-Free Workplace Requirements

HHS/CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

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 FOA 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.

Lobbying Restrictions

Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Accounting System Requirements

The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

Capability Assessment

It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.

Proof of Non-profit Status

Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.

Small, Minority, And Women-owned Business

It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:

  1. Place small, minority, women-owned business firms on bidders mailing lists.
  2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
  3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
  4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

Research Integrity

The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).

For example:

Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

Compliance with Executive Order 13279

Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations.  All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS.  If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance.  A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above.  A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols.  In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities.  For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site:http://www.whitehouse.gov/government/fbci/

Health Insurance Portability and Accountability Act Requirements

Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data

The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:

  1. In a timely manner.
  2. Completely, and as accurately as possible.
  3. To facilitate the broader community.
  4. Developed in accordance with CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide HHS/CDC with appropriate documentation on the reliability of the data.  Applications submitted without the required Plan may be ineligible for award.  Award will be made when reviewing officials have approved an acceptable Plan.  The successful applicant and the Program Manager will determine the documentation format.  HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 

National Historic Preservation Act of 1966

(Public Law 89-665, 80 Stat. 915)

The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:

a.     Section 106 of the National Historic Preservation Act (NHPA) states:

The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking,  shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register.  The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.

b.     Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”

Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.

Conference Disclaimer and Use of Logos

{Mandatory for all grants and cooperative agreements.}

Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:

“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) .  The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003).  Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer.  It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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