[Federal Register Volume 63, Number 141 (Thursday, July 23, 1998)]
[Notices]
[Pages 39572-39575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19618]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 98101]
Expanded Use of Rapid HIV Testing, and Barriers to HIV Testing;
Notice of Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal Year (FY) 1998
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funds for a cooperative agreement program on the Expanded Use of Rapid
HIV Testing, and Barriers to HIV Testing. This program addresses the
``Healthy People 2000'' priority area of HIV Infection.
The purpose of these studies is to evaluate barriers to HIV testing
among persons at high risk for HIV, and to evaluate the expanded use of
rapid HIV testing in a variety of public and private settings.
Applications in BOTH or EITHER of the following research areas may
be submitted:
1. Studies evaluating the barriers to HIV testing among persons at
high risk for HIV.
The purpose of these studies is to learn more about the use of HIV
testing in personal prevention plans by interviewing persons at high
risk for HIV infection who have not been tested for HIV, or persons who
have not been tested recently despite ongoing risk. Of special interest
are persons who may not access the health care system. These should
include persons of various racial/ethnic backgrounds found by outreach
to high-risk settings, or persons on the streets in areas with known
high prevalence of HIV infection. The sample should be representative
of all persons who are not getting tested even though they are at high
risk. The study should be designed to address the following research
questions:
a. What are the determinants of and barriers to getting tested for
the high risk population? How can this population be segmented? What
can be done to increase their likelihood of getting tested?
b. What will the preferences for different testing options be when
the high risk population is offered: clinic-based counseling and
testing; home collection kits with counseling and testing; and home
test kits? What are the profiles of the segments which prefer each
alternative?
2. Studies evaluating the expanded use of rapid HIV testing,
including investigational tests, in a variety of public or private
settings.
The purpose of these studies is to learn more about how individuals
might use rapid HIV testing to prevent HIV infection and how programs
might use rapid HIV testing to identify infected persons and refer them
for care. This study should demonstrate that rapid HIV testing is
reaching high-risk persons who might not otherwise be reached by
existing testing services and that it is increasing the number of
persons who learn their HIV serostatus.*
*For more information on the availability of licensed or
candidate investigational rapid HIV tests, contact CDC at (404) 639-
2090.
B. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies; that is,
universities, colleges, research institutions, hospitals, other public
and private nonprofit organizations, State and local governments or
their bona fide agents, and federally recognized Indian tribal
governments, Indian tribes, or Indian tribal organizations.
Note: Organizations described in section 501(c)(4) of the
Internal Revenue Code of 1986 that engage in lobbying are not
eligible to receive Federal grant/cooperative agreement funds.
Applicants are encouraged to collaborate with other organizations,
such as State health departments, colleges, universities, research
institutions, hospitals, correctional facilities, community
organizations, and other public and private organizations (e.g.,
managed care organizations), to carry out project activities.
C. Availability of Funds
Approximately $1.1 million is available in FY 98 to fund
approximately 4-6 awards. It is expected that the average award will be
$200,000, ranging from $100,000 to $300,000. It is expected that the
awards will begin on or about September 30, 1998 and will be made for a
12-month budget period within a project period of up to two years.
Funding estimates may change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required reports
and the availability of funds.
Funding Preference
Preference will be given to areas with high HIV prevalence and
incidence. Geographic and population risk group diversity will also be
considered.
D. Program Requirements
In conducting activities to achieve the purposes of the cooperative
agreement, the recipient shall be responsible for the activities listed
under 1. (Recipient Activities), and CDC shall be responsible for
conducting activities listed under 2. (CDC Activities).
1. Recipient Activities
a. Develop the research study protocol and data collection forms.
b. Plan and conduct project activities and where appropriate, with
the participation of state and local professional associations and
health care providers and institutions serving, diagnosing, or
providing treatment and care for persons with HIV/AIDS.
c. Promote the use of rapid HIV testing for HIV prevention and for
linkage to care for infected persons by: (1) providing data and ongoing
assistance to community planning groups; (2) disseminating data through
publications and presentations.
d. Participate in project planning and implementation meetings with
CDC and other collaborators, when appropriate.
e. Establish procedures to maintain the rights and confidentiality
of all study participants.
f. Identify, recruit, obtain informed consent from participants
(when appropriate), and enroll an adequate number of study participants
as determined by study protocol and the program requirements.
g. Perform laboratory tests (when appropriate) and data analysis as
determined in the study protocol.
h. Share data and specimens (when appropriate) with other
collaborators to answer specific research questions.
i. Participate in multi-site data analysis and presentation and
publication of research findings with collaborators, when appropriate.
j. Provide HIV counseling, appropriate to the risk of the
population being studied, including referrals to needed services.
2. CDC Activities
a. Provide technical assistance in the design and conduct of the
research. Provide technical assistance in the development of study
protocols, consent forms, and data collection forms.
b. Assist in designing a data management system.
c. Assist in performance of selected laboratory tests.
d. Coordinate research activities among the different sites, when
appropriate.
e. Assist in the analysis of research information and the
presentation and publication of research findings.
E. Application Content
Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. For those applying for more than one research area
described in the ``Purpose'' section above, applicants should submit a
separate application for each research area proposed. Each application
will be evaluated based on the evaluation criteria listed below, so it
is important to follow them in laying out your
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program plan. The narrative should be no more than 10 double-spaced
pages, printed on one side, and with one inch margins. Applicants
should include an annualized, justified budget for the current (FY98)
project period.
F. Submission and Deadline
Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for
PHS 398). Forms are in the application kit.
On or before August 23, 1998 submit the application to: Juanita
Crowder, Grants Management Specialist, Grants Management Branch,
Procurement and Grants Office, Announcement Number 98101, Centers for
Disease Control and Prevention (CDC), Room 300, 255 East Paces Ferry
Road, NE., Mailstop E-15, Atlanta, Georgia 30305-2209.
If your application does not arrive in time for submission to the
independent review group, it will not be considered in the current
competition unless you can provide proof that you mailed it on or
before the deadline (i.e., receipt from U.S. Postal Service or a
commercial carrier; private metered postmarks are not acceptable).
G. Evaluation Criteria
Each application will be evaluated individually against the
following criteria by an independent reviewer group appointed by CDC.
1. Scientific Significance (15 Points)
Demonstrated scientific significance of the proposed study in that
it provides data not otherwise available, and if appropriate, provides
unique opportunities for evaluating the use of rapid HIV testing in
various settings. Application should include a detailed review of the
scientific literature pertinent to the study being proposed and
specific research questions that will guide the research, goals and
objectives for the project, and how findings can be used to guide
prevention and control efforts.
2. Research Design (10 Points)
Appropriateness of the research design for addressing the specified
research questions.
3. Capacity to Access (25 Points)
The extent to which the applicant demonstrates the capacity to
access the relevant study population; ability to enroll appropriate
number of study participants who are at high risk for HIV infection;
ability to enroll a study population outside of the health care
systems; extent to which size and characteristics of the study
population proposed for enrollment are appropriate; investigator's
experience in enrolling such persons in a culturally and linguistically
appropriate manner; and letters of support from cooperating
organizations that detail the nature and extent of such cooperation.
4. Experience (15 Points)
Experience in similar HIV prevention research, availability of
qualified and experienced personnel, percentage-time commitments,
duties, responsibilities of project personnel, and evidence of adequate
facilities, equipment and plans for administration of the project.
5. Ability to Operationalize Proposed Study Methodology (Maximum of 30
Points for a and b, Below)
a. Application should include appropriate outcome measures;
appropriate sampling schemes, sample size calculations, and handling of
sampling biases; and plan for data collection; specific quantitative
and qualitative analytic techniques to be used to answer the research
questions. Where applicable, application should demonstrate capacity to
obtain specimens and conduct testing, using appropriate quality
assurance mechanisms. (15 points)
b. Comprehensive schedule for accomplishing the activities of the
research and an evaluation plan that identifies methods and instruments
for evaluating progress in designing and implementing the research
objectives. Application should include time-phased and measurable
objectives. (15 points)
6. Inclusion of Women, Ethnic, and Racial Groups (5 Points)
The quality of the plans to develop and implement the study,
including the degree to which the applicant has met the CDC Policy
requirements regarding the inclusion of women, ethnic, and racial
groups in the proposed research. This includes:
a. The proposed plan for inclusion of both sexes and racial and
ethnic minority populations for appropriate representation.
b. The proposed justification when representation is limited or
absent.
c. A statement as to whether the design of the study is adequate to
measure differences when warranted.
d. 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.
7. Human Subjects (not Scored)
Does the application adequately address the requirements of 45 CFR
Part 46 for the protection of human subjects? (not scored)
____ YES ____ NO
Comments:--------------------------------------------------------------
8. Budget (not Scored)
Budgets will be reviewed to determine the extent to which they are
reasonable, clearly justified, consistent with the intended use of the
funds, and allowable. All budget categories should be itemized.
H. Other Requirements
Technical Reporting Requirements Provide CDC with original plus two
copies of
1. quarterly progress reports;
2. financial status report, no more than 90 days after the end of
the budget period; and
3. final financial status report and performance report, no more
than 90 days after the end of the project period.
Send all reports to: Juanita Crowder, Grants Management Specialist,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention (CDC), Room 300, 255 East Paces Ferry
Road, NE., Mailstop E-15, Atlanta, GA 30305-2209.
The following additional requirements are applicable to this
program. A complete description of each is included in the application
kit.
AR98-1 Human Subjects Requirements
AR98-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR98-4 HIV/AIDS Confidentiality Provisions
AR98-5 HIV Program Review Panel Requirements
AR98-7 Executive Order 12372 Review
AR98-9 Paperwork Reduction Act Requirements
AR98-10 Smoke-Free Workplace Requirements
AR98-11 Healthy People 2000
AR98-12 Lobbying Restrictions
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under Sections 301(a) and 317(k)(2) of
the Public Health Service Act [42 U.S.C. 241(a) and 247b(k)(2)],as
amended. The Catalog of Federal Domestic Assistance Number is 93.941.
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J. Where To Obtain Additional Information
To receive additional written information and to request an
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked
to leave your name and address and will be instructed to identify the
Announcement Number 98101.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Juanita Crowder, Grants Management Specialist, Grants Management
Branch, Centers for Disease Control and Prevention (CDC), Procurement
and Grants Office, 255 East Paces Ferry Road, NE., Room 300, Mailstop,
E-15, Atlanta, GA 30305-2209, telephone (404), 842-6577, or E-mail
address: jdd2@cdc.gov.
See also the CDC home page on the Internet: http://www.cdc.gov
For program technical assistance, contact Kay Lawton, Deputy Chief,
Prevention Services Research Branch, National Center for HIV, STD, and
TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton
Rd., Mailstop E-46, Atlanta, GA 30333, telephone (404) 639-2090, E-mail
address: kel1@cdc.gov.
Dated: July 17, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 98-19618 Filed 7-22-98; 8:45 am]
BILLING CODE 4163-18-P
