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: HIV/AIDS Risk Reduction Interventions for Heterosexually-Active African-American Men (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-07-002
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): June-July 2007
Earliest Anticipated Start Date(s): July 31, 2007
Additional Information to Be Available Date: Conference
call for potential applicants to be held February 12, 2007, 2:00pm ET, phone
number 1-877-951-9728, passcode 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/AIDS 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/.
The purpose of this funding opportunity is to support the development and pilot testing of novel interventions that reduce sexual risk for HIV among heterosexually-active African-American men who do not inject drugs, who are at-risk primarily due to unprotected sex with multiple or concurrent sex partners of the opposite sex, and for whom few evidence-based interventions are identified. The intervention must be developed based on formative research (e.g., focus groups and in-depth individual interviews) with the target population. The approach or method should include the application of existing or enhanced behavioral theories to the development of novel interventions that are feasible, sustainable, and likely to lead to positive behavioral change.
African Americans continue to be disproportionately affected by HIV/AIDS. Results from the National HIV Behavioral Surveillance Project published in the June 2006 Morbidity and Mortality Weekly Reports showed that during 2001-2004, although blacks accounted for approximately 13 percent of the population, they accounted for the majority (51 percent) of HIV/AIDS diagnoses in 33 states. When compared to other racial and ethnic groups, rates of heterosexually transmitted HIV are substantially higher among African Americans.
Presently, there is insufficient knowledge regarding heterosexually-active African-American men’s sexual risk behaviors and the context in which they occur. Although prior research has suggested that the high rates of heterosexual HIV transmission in African American communities is associated with a myriad of factors including individual-level factors and broader socio-cultural and structural-level factors, the emphasis of most intervention programs has been limited to changing individual-level risk behaviors. Thus, little attention has been paid to examining contextual factors that may confound prevention efforts and contribute to high risk behaviors.
Further, few HIV prevention interventions with demonstrated efficacy in reducing HIV related sexual risk behaviors have been developed and evaluated specifically for heterosexually-active African-American men who do not inject drugs, and who are at-risk primarily due to unprotected sex with multiple or concurrent sex partners of the opposite sex. Existing HIV risk reduction interventions that have included African American heterosexually active men have largely been limited in scope and focused almost exclusively on specific populations (e.g., STD clinic patients and injection drug or other substance users).
Thorough examinations of sexual risk behaviors and the context in which they occur is essential for developing effective HIV/AIDS prevention interventions for at-risk, heterosexually-active African-American men, and for informing policies and programs that will more effectively protect them and their partners from infection.
The objectives of this research program are to support three sites to work collaboratively with each other and federal investigators to accomplish both of the following:
(1) Conduct formative research (focus groups, in-depth individual interviews with a subset of focus group participants, and a brief risk assessment survey);
(2) Develop and conduct preliminary evaluations of three unique interventions intended to reduce sexual risk behaviors among heterosexually active African American men, ages 18-45, who do not inject drugs, and who are at-risk primarily due to unprotected sex with multiple or concurrent sex partners of the opposite sex.
The research sought for this announcement is intended to target African American men who have sex with women, who do not inject drugs, and primarily those who are of unknown or negative serostatus and at-risk for HIV. At-risk heterosexually-active African-American men may include persons who have multiple or concurrent sex partners of the opposite sex and who have unprotected sex.
This research program also seeks to reach a broad cross-section of African American men at-risk for HIV. Thus, study participants may be recruited from one or a combination of multiple traditional and nontraditional venues (e.g., barbershops, night clubs, historically Black colleges and universities, Black social organizations, sports events, and fitness/athletic clubs). Applicants are also being asked to increase the understanding of a broad array of factors as they relate to sexual risk behaviors of heterosexually-active African-American men who do not inject drugs.
These factors may include, but are not limited to:
All interventions must include promotion of abstinence, faithful monogamy and correct, consistent condom use (ABC).
Each site will be expected to develop a distinct, contextually and culturally appropriate intervention based on the formative research and behavioral and social science theory.
Each awardee is expected to enroll 50 to 80 participants in the intervention. The intervention evaluation should be a pre-post test design (i.e. pre-intervention assessment and 3-month follow-up assessment).
The proposed intervention should not have been previously evaluated in a rigorous manner. An intervention that replicates or makes limited changes to an existing intervention or merely applies an existing intervention to the targeted population would not fulfill the goals of this announcement.
Funds awarded under this announcement cannot supplant funds that are currently being used to implement an existing intervention being conducted by the applicant. Awardees are expected to collaborate with other funded sites and federal investigators in the development of a common subset of assessment items (e.g., using CDC’s Program Evaluation and Monitoring System (PEMS) data elements previously approved by the Office of Management and Budget [OMB]), in addition to site-specific assessment items that will be collected using audio computer self-administered interview (ACASI) software and common data management procedures as determined in post-award grantee meetings.
Applicants are also encouraged to propose two site investigators: a senior research investigator, who will be the Principal Investigator on the grant, and a junior research investigator, both with existing linkages to the target population, and who also have a documented history of success in reaching and working with the target population.
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 cooperative agreement assistance
instrument, the Recipient Organization retains the primary responsibility and
dominant role for planning, directing, and executing the proposed project, with
HHS/CDC staff being 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 $675,000 including both direct and indirect costs in FY2007 to fund 3 applications. The average award amount will be $225,000 for the first 12-month budget period. An applicant may request a project period of up to 3 years. An applicant may request up to $225,000 for the first 12-month budget period including both direct and indirect costs. The funding amount for the 2nd and 3rd year of the project may vary and is subject to the availability of funds. The approximate total project period funded amount is $675,000. 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.
Facilities and Administrative (F&A) costs requested by
consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your organization has any of the following characteristics:
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, previous
experience 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.
Applicants are encouraged to propose two site investigators: a senior research investigator as the Principal Investigator and a junior research investigator, both with existing linkages to the target population, and who also have a documented history of success in reaching and working with the target population. The junior and senior investigators may be at different institutions.
The following must be demonstrated in the applicant’s biographical sketches and in the appendices where appropriate.
Other eligibility requirements for investigators:
2. Cost
Sharing or Matching
Cost
sharing, matching, or cost participation is not required for this program.
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
Intervention must not be a direct replication or adaptation of an intervention, and should not have been previously evaluated in a rigorous manner.
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 an applicant institution/organization should complete before submitting an electronic application are 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 research plan should be limited to 25 single-spaced pages of 12-point font. The plan should address activities to be conducted over the entire project period. All tables, graphs, figures, diagrams, and charts must be included in the 25-page limit. There is no requirement to use all 25 pages; however, the additional pages in proposals exceeding 25 pages will not be read nor considered in the scoring.
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): June -
July 2007
Earliest Anticipated Start Date(s): 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
Scientific Program Administrator – RFA
PS07-002
Extramural Research Program Office
Coordinating Center for Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, 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. Applications submitted electronically through Grants.gov (http://www.grants.gov), will be electronically time/date stamped by Grants.gov. Applicants will receive an e-mail notice of receipt from Grants.gov when HHS/CDC receives the application.
All requested information must be submitted through Grants.gov by 5:00 p.m. Eastern Time on the deadline date.
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.
3. C.
Application Processing
Applications
must be submitted to Grants.gov 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 or 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.
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.
Applicants’ research 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 ten publications, manuscripts (accepted for publication), abstracts, 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.
In addition, preference may be given to:
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 as appropriate for each application.
Note that
an application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: 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 the field of
HIV prevention for African Americans and for at-risk, heterosexually-active
African-American men who
do not inject drugs and for whom few evidence-based interventions are identified?
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 provide documentation
from the research literature that supports the applicant’s approach to the
proposed study? Does the applicant clearly describe the recruitment strategies
for the formative research and propose an adequate plan for conducting qualitative interviews
including focus groups, in-depth
individual interviews and a brief risk assessment survey with heterosexually-active African-American
men who do not
inject drugs, and who have unprotected sex with multiple or concurrent
partners of the
opposite sex? Does
the applicant clearly describe a scientifically sound approach for developing
and evaluating an HIV sexual risk reduction intervention for heterosexually-active African-American
men who do not
inject drugs? Does
the applicant include an adequate plan to pilot test the intervention
built on the findings of the formative research? Does the applicant
clearly describe a sampling plan that will successfully recruit and retain the
required minimum number of eligible participants (50 to 80 participants who are at-risk for HIV)? Does the applicant propose an
adequate plan to retain at least 80 percent of the study sample across a follow-up period of three months? Does the applicant have a thorough
understanding of HIV prevention interventions including promotion of
abstinence, faithful monogamy, and correct, consistent condom use (ABC)? Does the
applicant adequately address the issues and challenges of engaging at-risk, heterosexually-active African-American men in the proposed research? Is the research plan for
developing and implementing an HIV sexual risk
reduction intervention culturally appropriate? Does the applicant provide a sound
approach for collecting high quality data? Does the applicant show that the
proposed intervention approach has not been previously evaluated in a rigorous manner and is not currently supported by other federal funds? Does the applicant propose to
involve the study population, advocates, or service providers in the
development of research activities, and to inform them of research results, if
feasible? Does the applicant demonstrate existing linkages (e.g., participation in civic/local/community organizations, advocacy groups,
community advisory boards serving the targeted population) to facilitate recruitment and referral
to programs serving the study population, as appropriate (including letters of support)? Is there evidence of a
plan to refer and link participants with prevention, medical, and/or any other
services as needed? Does the proposed research plan protect the rights and
confidentiality of all participants? Does the applicant present an adequate
plan for data management and analysis?
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 project address important
gaps in knowledge? Does the project specifically address contextual and
cultural factors influencing heterosexually-active
African-American men’s sexual risk for HIV? Does
the project employ an innovative approach not previously evaluated?
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)? Do the investigators have extensive knowledge of the issues and
challenges faced by the study population, and documented experience in working with the population? Do the investigators have adequate
experience recruiting the targeted study population and retaining this
population in a study? Do the investigators demonstrate strong linkages with organizations
that serve or work with at-risk, heterosexually-active African-American men who do not inject drugs? Do the investigators provide evidence of a history of success in serving the target population, including
length and type of services provided and a description of their relationship with the community? Does the applicant have experience recruiting participants from
non traditional settings? Have the investigators successfully implemented and evaluated
culturally appropriate HIV risk reduction interventions? Does the proposed
staff have an adequate amount of time devoted to this project to ensure
success? Do the investigators demonstrate a willingness to engage in a
collaborative effort with other funded sites to help guide the research and
intervention activities, and then engage in ongoing collaboration throughout
the project? Does the applicant have adequate training and experience and
demonstrated ability to collect, manage, and analyze data in a timely manner? Does the applicant demonstrate adequate
knowledge of the social and behavioral sciences to conduct the proposed
research? Does the applicant have adequate experience in conducting qualitative
research and data analyses? Are the described duties and responsibilities of
project personnel, including clear lines of authority and supervisory capacity,
clearly identified? Do staffing plans include, at a minimum, a senior principal investigator and
a junior investigator (both with direct links to the community –
e.g., participation in local/civic/community
organizations, advocacy groups or advisory boards serving the targeted population), a study coordinator, and interviewers/outreach workers? Does the applicant clearly delineate the roles and responsibilities of the senior and junior principal investigator and state how the project will benefit from their experience and expertise? Does the senior
principal investigator demonstrate
evidence of mentoring junior investigators in behavioral and/or social science investigations?
The following must be demonstrated on the applicant’s biographical sketches and in the appendices where appropriate.
Applicants are encouraged to propose two site investigators: a senior research investigator as the Principal Investigator and a junior research investigator, both with existing linkages to the target population, and who also have a documented history of success in reaching and working with the target population. The senior and junior investigators may be at different institutions.
Other eligibility requirements for investigators:
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? Is the planned location for the study a central location with
access to adequate numbers of the target population? Does the applicant demonstrate a
strong partnership with a community, as evidenced by the inclusion of letters
of support? Will the
study be conducted in an environment that has a high prevalence of HIV
infection among African American heterosexually active men? Does the scientific environment provide the resources - including
adequate facilities, equipment, and systems for managing data security and
confidentiality - needed to
successfully conduct the formative research and implement and
evaluate the proposed intervention?
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)] located at, 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, item 12 Vertebrate Animals of the Research Plan component of the SF424 (R&R). 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 effect 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 has 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 on 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 courtesy 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 below.
2.A.1.
Recipient Rights and Responsibilities
The Recipient will have the primary responsibility for the following:
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
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) 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.
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
Coordinating Center for Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, 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
U.S. Department of Health and Human
Services
Center for Disease Control and Prevention
Coordinating Center for Infectious Diseases
Extramural Research Program Office
1600 Clifton Road, NE MS E05
Bldg., 12, Rm., 5211
Atlanta, GA 30333
Telephone:
(404) 639-6101
FAX:
(404) 639-0801
Email:
FRogers@cdc.gov
3. Financial or
Grants Management Contacts:
Charles Elder
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:
(770) 488-5391
FAX:
(770) 488-2777
Email: CElder@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