Department of Health and Human Services
Participating OrganizationsTitle: Identifying “Ground-Breaking” Behavioral Interventions to Prevent Human Immunodeficiency Virus (HIV) Transmission in High Risk Groups
The CDC policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.
Authority: This program is authorized under Section 301 (42 U.S.C. Section 241), and Section 318 of the Public Health Service Act (42 U.S.C. Section 247c), as amended.
Announcement Type: New
Request For Applications (RFA) Number: RFA-PS-06-005
Catalog of Federal Domestic Assistance Number(s):
93.941
HIV Demonstration, Research, Public and Professional Education Projects
Key Dates
Release Date: February 27, 2006
Letter of Intent Receipt Date: March 23, 2006
Application Receipt Date: April 20, 2006
Peer Review Date: 06/2006
Council Review Date: 07/2006
Earliest Anticipated Start Date: September 1, 2006
Expiration Date: April 21, 2006
Due Date for E.O. 12372
Due no later than 60 days after the application receipt date.
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1.
Research Objectives
Section
II. Award Information
1.
Mechanism(s) of Support
2.
Funds Available
Section
III. Eligibility Information
1.
Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost
Sharing or Matching
3.Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1.
Address to Request Application Information
2.
Content and Form of Application Submission
3.
Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application
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 Terms and Conditions of Award
1. Principal Investigator Rights and
Responsibilities
2. 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
The CDC and NCHSTP are 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/.
The purpose of this funding opportunity announcement is to support the development and pilot testing of “ground-breaking” behavioral interventions that reduce the risk for HIV transmission among high-risk populations for whom few or no evidence-based interventions are identified. Eligible interventions include those that are currently being developed or already exist, but have never been evaluated. The intent of this announcement is to identify the most promising “ground-breaking” interventions that merit further rigorous testing to determine whether they are efficacious. The primary outcome of this research program will be to develop and pilot test “ground-breaking” behavioral interventions and to provide preliminary evidence that these interventions lead to change in HIV risk behaviors.
For the purpose of this funding opportunity announcement, a “ground-breaking” HIV behavioral intervention is an intervention to reduce HIV risk behavior(s) that uses an approach or method that is different from interventions used by other organizations that serve the target populations addressed by this announcement. The intervention must be or have been developed based on formative research with the target population and close collaboration with agencies with an established track record of working 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. Interventions that involve the provision of HIV prevention information should provide all participants with scientifically accurate information about the benefits of abstinence, mutual monogamy, and (for persons who are sexually active outside of a mutually monogamous relationship) condom use. All interventions must include promotion of abstinence, faithful monogamy, and correct, consistent condom use (ABC).
The proposed intervention must not have been previously evaluated using a pre-post design. If the proposed intervention is based upon an intervention that has been previously evaluated, the proposed intervention must be significantly and substantially different from the original intervention. An intervention that either replicates or makes limited changes to an existing intervention, or merely applies an existing intervention to a new target population would not fulfill the goals of this announcement.
The target populations for whom interventions may be developed as part of this announcement are populations that are at high risk for HIV infection and for whom there are currently only a few, if any, efficacious interventions. These include, but are not limited to, African American heterosexual men, Native Americans/American Indians, HIV-positive men and women, incarcerated populations, transgender populations, and sex partners of injection drug users (IDUs).
The research program will support up to four sites to work collaboratively with each other and with federal investigators to conduct preliminary evaluations of interventions intended to reduce HIV risk behaviors among populations at high risk for HIV infection for whom limited evidence-based interventions are identified. It is expected that during year one, each site will develop its own distinct intervention based on prior research and theory and on formative work (e.g., focus groups, pilot testing) conducted as part of this project. It is expected that during year two, each awardee will enroll 50 to 80 participants in the intervention. A repeated measure, pre-post test design with brief follow-up (one to three months) should be used to assess the interventions. Although a single common intervention is not expected across sites, a similar core subset of assessment items is anticipated if appropriate and depending upon the target population. Awardees are expected to collaborate with other funded sites and federal investigators, including in the development of similar data collection instruments and data management procedures as determined in post-award grantee meetings.
The interventions to be tested should be based on behavioral and social science theory and should be appropriate for the specific target population. Proposed interventions should be significantly and substantially different from existing interventions and should not have been evaluated previously. Funds awarded under this announcement cannot supplant funds that are currently being used to implement an existing intervention being conducted by the applicant. Intervention strategies should be sufficiently brief and of a technical level that would facilitate rapid dissemination to community-based organizations.
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 UR 6 award mechanism.
This
funding opportunity uses the just-in-time budget concepts. It also uses the
non-modular budget format described in the PHS 398 application instructions
(see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
The
CDC UR 6 is a cooperative agreement award
mechanism. In the cooperative agreement mechanism, the Principal Investigator
retains the primary responsibility and dominant role for planning, directing,
and executing the proposed project, with CDC staff being substantially involved
as a partner with the Principal Investigator, as described under the Section
VI. 2. Administrative Requirements, "Cooperative Agreement Terms and
Conditions of Award".
2. Funds Available
The participating CIO, NCHSTP, intends to commit approximately $800,000 including both direct and indirect costs in FY 2006 to fund four awards. The average award amount will be approximately $200,000 including both direct and indirect costs for the first 12-month budget period. An applicant may request a project period of up to 24 months. An applicant may request up to $260,000 for the first 12-month budget period. The approximate total project period funded amount is $450,000 per award. The anticipated start date for new awards is September 1, 2006.
All estimated funding amounts are subject to availability of funds.
If you request a funding amount higher than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.
Facilities and administrative costs requested by
consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.
Section III.
Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
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. Place this documentation behind the first page of your application form.
1.B.
Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for CDC programs.
Additional Principal Investigator qualifications are as follows:
2. Cost Sharing or Matching
Cost
sharing, matching, or cost participation is not required for this program.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/gps/
3. Other-Special Eligibility Criteria
Applications will be considered non-responsive under the following conditions:
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered 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
1. Address to Request Application
Information
The PHS 398
application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
CDC Telecommunications for the hearing
impaired: TTY 770-488-2783.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS
398 research grant application instructions and forms. Applications must have a
Dun & Bradstreet (D&B) Data Universal Numbering System number as the
universal identifier when applying for Federal grants or cooperative
agreements. The D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must be typed on line 2 of the
face page of the application form and the YES box must be checked.
3. Submission Dates and Times
All requested information must be received in the CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on April 10, 2006. If you submit your application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If CDC receives your submission after closing due to: (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, CDC will consider the submission as having been received by the deadline.
This announcement is the definitive guide on 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 will be discarded. You will be notified that you did not meet the submission requirements.
Otherwise, CDC will not notify you upon receipt of your
submission. If you have a question about the receipt of your application,
first contact your courier. If you still have a question, contact the PGO-TIMS
staff at: 770-488-2700. Before calling, please wait two to three days after
the submission deadline. This will allow time for submissions to be processed
and logged.
3.A. Receipt, Review and Anticipated Start Dates
Letter
of Intent Receipt Date: March 23, 2006
Application Receipt Date: April 20, 2006
Peer Review Date: 06/2006
Council Review Date: 07/2006
Earliest Anticipated Start Date: September 1, 2006
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 NCHSTP 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:
Amy L. Sandul, Scientific Program Administrator
Extramural Research Program Office
National
Center for HIV, STD and TB Prevention
Centers for Disease Control and Prevention
Mailstop E - 07
1600 Clifton Road, NE
Atlanta,
GA 30333
Telephone:
(404) 639-6485
FAX:
(404) 639-8600
Email: ASandul@cdc.gov
3.B. Sending an Application
Applications
follow the PHS 398 application instructions for content and formatting of your
applications. If the instructions in this announcement differ in any way from
the PHS 398 instructions, follow the instructions in this announcement.
Applications must be prepared using
the research grant applications found in the PHS 398 instructions for preparing
a research grant application. Submit a signed, typewritten original of the
application and all appendices, including the checklist, and one signed photocopy
in one package to:
Technical
Information Management Section – RFA PS06-005
CDC, Procurements and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
At the time of submission, three additional
copies of the application, including the appendix material, must be sent to:
Michael
Vance, Grants Technical Assistant
Extramural Research Program Office
National Center for HIV, STD and TB Prevention
Centers for Disease Control and Prevention
Mailstop E - 07
1600 Clifton Road, NE
Atlanta, GA 30333
Telephone:
(404) 639 - 8006
FAX:
(404) 639 - 8600
Email:
MVance@cdc.gov
3.C. Application
Processing
Applications
must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is received after that date, it will
be returned to the applicant without review. Upon receipt, applications will be
evaluated for completeness and responsiveness by NCHSTP and PGO. Incomplete
and non-responsive applications will not be reviewed.
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
CDC awards are subject to the terms and conditions, cost principles, and other
considerations described in the PHS Grants Policy Statement.
Restrictions, which must be taken into account while writing your budget, are as follows:
6. Other Submission Requirements
Awardees 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.
Your research plan should address activities to be conducted over the entire project period.
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 may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.
All
applicants must include a plan for sharing research data in their application.
The data sharing policy is available at http://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.
Sharing Research Resources
Not Applicable.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
2. Review and Selection Process
Applications
that are complete and responsive to the RFA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by OPHR in
accordance with the review criteria stated below.
As
part of the initial merit review, all applications will:
The goals of CDC-supported research are to advance the understanding of health promotion and prevention of disease, injury, and disability, and enhance preparedness. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.
Significance: Does this
study address an important problem? If the aims of the application are
achieved, how will scientific knowledge or clinical practice be advanced? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, services, 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 populations at high risk for acquiring or
transmitting HIV infection and for whom few evidence-based interventions are
identified?
Approach: Does the
application propose an adequate plan of formative research to develop and pilot
test an intervention? 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 propose intervention activities that are likely to have an impact on
the risk behavior of the target population? Does the
applicant present research that supports the applicant’s approach to
the proposed intervention? Does the applicant show that the
proposed approach has not yet been rigorously evaluated and is not currently
supported by other federal funds? Does the applicant propose an
adequate plan to recruit the required minimum number of eligible participants (50 to 80 participants)? Does the
applicant propose an adequate plan to retain at least 80% of the study sample
across the follow-up period (one to three months)? 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 employ a novel intervention approach or an approach that has not
previously been adapted for the target
population?
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 investigator have adequate
experience working with, and an
adequate appreciation of, the issues
relating to the specific target population? Does the
investigator have adequate experience recruiting the targeted study population
and retaining this population in a study? Does
the investigator have adequate experience developing and testing behavioral
interventions? Do the key staff have an appropriate
amount of time devoted to this project to ensure success? Does the
investigator demonstrate a willingness to engage in a collaborative effort to
conduct literature reviews and analyses of existing data sets to help guide the
research and intervention activities, and then engage in ongoing
collaboration throughout the project? Does the investigator have
adequate experience working with computer-assisted, self-interview
software? Does the investigator have experience in conducting interventions
that include promotion of abstinence, faithful monogamy and correct, consistent
condom use (ABC)?
Environment: Does the
scientific environment in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support? Is the planned location for the
study a location with access to adequate numbers of the target population? Does
the applicant demonstrate a strong partnership with a community-based
organization as evidenced by the inclusion of letters of support?
2.A. Additional
Review Criteria:
In
addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the priority score:
Is the proposed timeline sufficiently detailed, complete, and realistic?
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.
Inclusion of Women and Minorities in Research:
Does the application adequately address the 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.
2.B. Additional
Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing
Research Data
Data Sharing Plan: The reasonableness of the data
sharing plan or the rationale for not sharing research data will be assessed by
the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The
presence of a data sharing plan will be part of the terms and conditions of the
award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D.
Sharing Research Resources
Program
staff will be responsible for the administrative review of the plan for sharing
research resources.
The
adequacy of the resources sharing plan will be considered by Program staff of
the funding organization when making recommendations about funding
applications. Program staff may negotiate modifications of the data and
resource sharing plans with the awardee before recommending funding of an
application. The final version of the data and resource sharing plans
negotiated by both will become a condition of the award of the grant. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590 http://www.cdc.gov/od/pgo/forminfo.htm).
See Section VI.3. Reporting .
3. Anticipated Announcement and Award Dates
It is anticipated that awards will be announced by September 1, 2006.
Section VI. Award
Administration Information
1. Award Notices
After
the peer review of the application is completed, the Principal Investigator
will also receive a written critique called a Summary Statement.
Those applicants
under consideration for funding will be contacted by CDC 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. This document will be mailed and/or emailed 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
policy 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 can be found in Section VIII. Other Information of this
document or on the 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.
2.A. Cooperative
Agreement Terms and Conditions of Award
The
following special terms of award are in addition to, and not in lieu of,
otherwise applicable 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, PHS, and CDC grant
administration policies.
The administrative
and funding instrument used for this program will be the cooperative agreement UR 6, an "assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial CDC programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the 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 CDC as defined above.
2.A.1. Principal Investigator Rights and
Responsibilities
The Principal Investigator will have the primary
responsibility for development and preliminary testing of an intervention,
including:
Implementing stringent safeguards for protecting the confidentiality of participants.
Preparing an Institutional Review Board (IRB) protocol(s) for approval by the IRB at the awardees’ institutions and at the CDC.
Additionally, an 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 award notice.
2.A.3. Collaborative ResponsibilitiesA
Steering committee will be established consisting of Principal Investigators
and CDC Project Scientists. Each full member will have one vote. Awardee
members of the Steering Committee will be required to accept and implement
policies approved by the Steering Committee.
3. Reporting
You must provide CDC with an original, plus two hard copies of the following reports:
These reports must be forward by U.S. Postal Service or Express Delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.
Although the financial plans of the 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.
We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:
1. Scientific/Research Contacts:
Amy L. Sandul, Scientific Program Administrator
Extramural Research Program Office
National Center for HIV, STD
and TB Prevention
Centers for Disease Control and Prevention
Mail stop E - 07
1600 Clifton Road, NE
Atlanta, GA 30333
Telephone:
(404) 639-6485
FAX:
(404) 639 - 8600
Email:
ASandul@cdc.gov
2. Peer Review Contacts:
M.
Chris Langub, PhD
Office of Public Health Research
Centers for Disease Control and Prevention
Mail stop D - 72
1600 Clifton Road, NE
Atlanta, GA 30333
Telephone:
(404) 639-4640
FAX:
(404) 639-4903
Email: MLangub@cdc.gov
3. Financial or Grants Management
Contacts:
Merlin
Williams, Grants Management Specialist
Procurement
and Grants Office
Centers for Disease Control and Prevention
Mailstop
E – 15
2900 Brandywine Road
Atlanta, GA 30341
Telephone:
(404) 639-8052
FAX:
(404) 639-8095
Email: MWilliams@cdc.gov
4. General Questions Contacts:
Technical
Information Management Section
CDC Procurement and Grants Office
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 (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the research
to the subjects and others, and the importance of the knowledge gained or to be
gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Additional CDC Requirements under AR-1 Human Subjects Requirements can be found
on 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.
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 AIDS Clearinghouse.
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.
SPOCs or tribal governments that have recommendations about an application submitted to CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:
Merlin Williams, Grants Management Specialist
Procurement and Grants Office
Announcement Number RFA PS06-005
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146
CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.
Smoke-Free Workplace Requirements
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 2010The Public Health Service (PHS) is
committed to achieving the health promotion and disease prevention objectives
of "Healthy People 2010," a PHS-led national activity for setting
priority areas. This PA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
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 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, 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 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 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 CDC funds should give close attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that 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.
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:
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 (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. CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and 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 CDC data sharing agreement will be released as follows:
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 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. CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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