Participating Organizations
Centers for Disease Control and Prevention,
at http://www.cdc.gov/
Components of Participating Organizations
National Center for HIV, STD and TB
Prevention (NCHSTP/CDC), at http://www.cdc.gov/nchstp/od/nchstp.html
Title: Opt-Out
HIV Testing in Emergency Department Settings
The CDC policies, guidelines, terms, and conditions
stated in this announcement may differ from those used by the NIH.
Authority:
Public Health Service Act, Section 301(a), 42 U.S.C. 241(a), as amended,
and Section 317(a), 42 U.S.C. 247b(a), as amended.
Announcement Type: New
Request For Applications (RFA) Number: RFA-PS-06-003
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(s):
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
1. Research Objectives
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 of identifying new HIV infections and is in alignment with NCHSTP performance goal(s) to strengthen the capacity nationwide to monitor the epidemic, develop and implement effective HIV prevention interventions, and evaluate prevention programs. In addition, this program addresses the following Division of HIV/AIDS Prevention priorities: develop new methods for diagnosing HIV infection, and institute integrated surveillance with emphasis on incidence, surveillance, and evaluation. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.
The purpose of the program is to assess the feasibility of offering HIV testing on a voluntary opt-out basis in the emergency department (ED) setting in high-prevalence communities; to evaluate models for providing opt-out testing; to compare opt-out testing to traditional and routinely offered HIV testing in EDs; and to increase access to quality medical care, treatment, and ongoing prevention services for those diagnosed with HIV. HIV counseling and testing programs should include promotion of abstinence, faithful monogamy and correct, consistent condom use (ABC).
Emergency departments (EDs) have been shown to be an important setting in the identification of undiagnosed human immunodeficiency virus (HIV) infection. The prevalence of HIV is frequently higher in emergency care settings than in other health care settings. Additionally, EDs often treat underserved and socially marginalized sections of the community that have minimal or no access to health services. Routinely offered HIV testing has increased testing rates and receipt of HIV test results in many EDs. However, there is still the potential to increase further testing rates with voluntary opt-out testing. With this approach, patients are told that HIV testing is a standard and routine part of services delivered to all ED patients, and that if they do not wish do be tested, they can decline. Additionally, opt-out testing can further reduce stigma as a barrier to HIV testing when compared to routinely-offered testing and simplify the testing process. While opt-out testing has been successfully implemented in the perinatal setting, it has not been implemented and evaluated in the ED setting. Additionally, there is some evidence that patients are accepting of routinely offered testing in the ED setting, yet patients perspectives on opt-out testing are largely unknown.
To achieve project objectives, the following activities are anticipated:
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section II. Award Information
This funding opportunity will use the U 18 award mechanism.
The CDC U 18 mechanism 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 $850,000 in direct and indirect costs in FY 2006 to fund 2-3 awards. The average award amount will be $280,000 - $425,000 in direct and indirect costs for the first 12-month budget period. An applicant may request a project period of 24 months. An applicant may request up to $425,000 for the first 12-month budget period. The approximate total project period funded amount is approximately $560,000 to $850,000 over two years. The anticipated start date for new awards is September 1, 2006.
All estimated funding amounts are subject to availability of funds.
CDC will accept and review applications with budgets greater than the ceiling amount.
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
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. The Principle Investigator should
have a thorough understanding of HIV prevention interventions including promotion
of abstinence, faithful monogamy, and correct, consistent condom use.
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
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
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 the deadline date. 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(s): 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 CIO 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
Mail stop 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 PS06-003
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
Mail stop 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
The following items should be included as appendices
with your application:
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.
The use and disclosure of data for this initiative may be subject to HIPAA. All sites must comply with Privacy Rule requirements for the use and disclosure of protected health information (PHI). Funded sites will coordinate with CDC to determine whether individual authorizations will be obtained, data sharing agreements put in place, or a waiver of HIPAA authorization will be requested from reviewing IRB(s).
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?
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? Are
the proposed methods feasible? To what extent will they accomplish the program
goals? Can the proposed methods for offering voluntary opt-out testing in
an emergency department setting be successfully achieved during the project
period? Does the applicant clearly describe a plan for establishing the project
within their agency, to include describing how they will successfully address:
staff training requirements; logistics of providing opt-out testing to patients
in a busy ED setting; tracking system for HIV test results; reasoned approach
for contacting clients when necessary to ensure receipt of confirmatory test
results for all positive; process for ensuring follow-up with patients; linkage
to care, treatment, and prevention services for those patients who test HIV
positive; and a system for reporting HIV-positive test results to the health
department, where required. Will the applicant be able to utilize an existing
electronic ED tracking system for this project? Has the applicant shown clear
evidence that project is supported by hospital leadership (to include required
letter of support, as listed above) and that project will meet any requirements
of local and state legislation or policy (again, must clearly document how
such local and state legislative or policy requirements will be met)? Is
a timeline with realistic and measurable milestones for major project activities
provided? Is the plan adequate to carry out the proposed objectives?
How complete and comprehensive is the plan for the entire project period?
Does the plan include quantitative process and outcome measures?
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?
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)?
Is the project director well qualified, by education
and experience, to lead the project team, hire and train appropriate staff,
and provide programmatic and scientific oversight?
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? Does the applicant show evidence that the emergency department
(or urgent care setting) serves a community facing a demonstrated estimated
HIV prevalence between 0.5% - 1.0%, ≥ 1.0% or an annual AIDS case rate
of 10 per 100,000 population? Has applicant demonstrated
support from: 1) hospital administration, 2) emergency department leadership,
3) hospital laboratory leadership, 4) nursing administration,
and 5) local health department through official letters of support? Has the applicant demonstrated
that hospital policy would allow for voluntary opt-out testing in the ED setting
under the auspices of an IRB-approved research study through official letter
of support from hospital administration in consultation with hospital legal
counsel? Has the applicant demonstrated that
local and state legislation will allow voluntary opt-out testing in the ED
setting, as described in this announcement under the auspices of an IRB-approved
research study (either by referencing local/state legislation or through a
letter to that effect from state’s attorney general’s office)?
Has the applicant demonstrated that the proposed ED setting currently utilizes
an electronic medical records tracking system which will allow for additional
data elements deemed critical to this project and whose database would be
accessible for evaluating this project? Does the applicant have appropriate
facilities and staff to conduct this program? Is adequate and objective information
provided to demonstrate sufficient prevalence of HIV seroprevalence in the
communities being served?
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:
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
Not Applicable
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 U 18 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:
Awardees will retain custody
of and have primary rights to the data and software developed under these
awards, subject to Government rights of access consistent with current HHS,
PHS, and CDC policies.
2.A.2. CDC Responsibilities
A CDC Project Scientist will have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards,
as described below.
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 Responsibilities
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
Mailstop 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
Mailstop 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:
Angie Tuttle, Grants Management Specialist
Procurement and Grants Office
Centers for Disease Control and Prevention
Mailstop E 15
2900 Brandywine Road
Atlanta, GA 30341
Telephone: (404) 639-8305
FAX: (404) 639-8095
Email: ATuttle@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:
Angie Tuttle, Grants Management Specialist
Procurement and Grants Office
Announcement Number RFA PS06-003
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.
Public Health System Reporting
Requirements
This program is subject to the Public Health System Reporting Requirements.
Under these requirements, all community-based non-governmental organizations
submitting health services applications must prepare and submit the items
identified below to the head of the appropriate State and/or local health
agency(s) in the program area(s) that may be impacted by the proposed project
no later than the application deadline date of the Federal application. The
appropriate State and/or local health agency is determined by the applicant.
The following information must be provided:
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 2010
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas.
This PA is related to one or more of the priority areas. Potential applicants
may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
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:
a. In a timely manner.
b. Completely, and as accurately as possible.
c. To facilitate the broader community.
d. Developed in accordance with CDC policy on Releasing and Sharing Data.
April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html.
Applications must include a copy of the applicant's Data Release Plan. Applicants should provide 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.
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