[Federal Register Volume 64, Number 95 (Tuesday, May 18, 1999)]
[Notices]
[Pages 26981-26984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12438]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 99115]
Cooperative Agreements for Strategies To Prevent Genital Herpes
Infections: Building A National Prevention Program, Notice of
Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1999 funds for a cooperative agreement
program for prevention research on genital herpes simplex virus (HSV)
infections. This program addresses the ``Healthy People 2000'' priority
area Sexually Transmitted Diseases. The purpose of the program is to
stimulate and support projects that will address existing gaps in our
knowledge about the psycho social and economic burden of HSV and
strategies to prevent transmission of genital herpes simplex infections
in the United States in the context of new diagnostic technologies and
new therapeutic strategies.
This program has four general objectives: (1) to assess behavioral
and psycho social impact and indirect and
[[Page 26982]]
intangible costs of genital herpes infections; (2) to assess
acceptability of screening for genital HSV using type-specific tests
likely to soon become commercially available for clinical use; (3) to
determine correlates of infectivity among asymptomatic and symptomatic
infected persons; and (4) to assess relative risks of HSV transmission
from asymptomatic and symptomatic infected persons to sex partners.
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: Public Law 104-65 states that an organization described in
section 501(c)(4) of the Internal Revenue Code of 1986 that engages
in lobbying activities is not eligible to receive Federal funds
constituting an award, grant, cooperative agreement, contract, loan,
or any other form.
C. Availability of Funds
Approximately $790,000 is available in FY 1999 to fund two to three
projects. It is expected that the average award will be $350,000,
ranging from $250,000 to $500,000. It is expected that the awards will
begin on or about September 30, 1999 and will be made for a 12-month
budget period within a project period of up to three 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 applicants with access to subjects
attending a wide variety of clinical service delivery settings in
addition to traditional public STD clinics such as managed care
organizations, family planning clinics, and community-based clinics.
Preference will also be given to proposals that address all four study
questions.
D. Study Questions
Applicants must address at least three of the following:
1. What is the behavioral and psycho social burden of diagnoses of
genital HSV infection on asymptomatic and symptomatic infected persons
and their sex partners? What are the indirect and intangible costs of a
diagnosis of genital HSV infection on asymptomatic and symptomatic
infected persons and their sex partners?
There is programmatic interest in determining the impact of a
genital HSV diagnosis on the ability to recognize genital lesions and
symptoms, frequency of sex when lesions/symptoms are present,
notification of sex partners, consistent and correct condom use, health
care seeking behaviors, adherence to counseling messages, willingness
to take medication and compliance with treatment regimens, work status,
general psycho social status, interpersonal relationships, perceived
stigma, partners' willingness to be tested, partners' willingness to
change sexual behaviors, and partners' willingness to take postexposure
prophylaxis. Preference will be given to proposals that (1) compare
outcomes for asymptomatic persons with those of symptomatic persons and
(2) compare these outcomes to those of persons with symptomatic and
asymptomatic curable STDs such as gonorrhea and chlamydia. Comparisons
with other sexually active persons not known to be infected with HSV
are also encouraged. A prospective design may be used for newly
diagnosed persons, and a cross-sectional design used for other infected
persons.
There is programmatic interest in developing, implementing, and
evaluating methods to assign costs to psycho social burden, pain, and
suffering (``intangible costs'') and economic costs related to lost
work or productivity or job choice (``indirect costs'') and to changes
in personal relationships associated with a diagnosis of genital HSV
infection in asymptomatic and symptomatic persons with newly diagnosed
infection, persons with infections diagnosed more than one year prior
to interview, and their sex partners. Preference will be given to
proposals that (1) use more than one method to assign costs to psycho
social burden, such as willingness-to-pay, quality of life, or other
methods; (2) compare outcomes for asymptomatic persons with those of
symptomatic persons; (3) compare outcomes to those of persons with
symptomatic and asymptomatic curable STDs such as gonorrhea.
2. What is the acceptability of screening tests to identify persons
infected with genital HSV?
There is programmatic interest in assessing acceptability of one or
more new type-specific serologic tests for genital HSV infection in
asymptomatic and symptomatic infected persons, including reasons why
tests are accepted or refused, predictors of sero positivity, and
predictors of receiving test results. Assessment of acceptability of
rapid ``point-of-service'' tests (whereby results are available to the
client during a visit to a health care provider) with other tests is
strongly encouraged. Applicants are encouraged to involve State Public
Health Department Laboratories in the performance of serologic tests
that are not point-of-service.
3. What are the correlates of infectivity among asymptomatic men
and women?
There is programmatic interest in determining correlates of
infectivity in asymptomatic persons who test positive on new type-
specific serologic tests for HSV infection, using viral culture, PCR
for HSV DNA, or other appropriate methods to determine viral shedding
including quantitative methods, in conjunction with assessment of sero
status of current sex partners. Determining relative frequency of viral
shedding from various anatomic sites in men (including penis, foreskin,
and scrotum) in a small sample of infected men is strongly encouraged.
Viral cultures and PCR should be performed by a reference laboratory
with a record of high performance.
4. What are the relative and absolute risks of transmission to sex
partners from asymptomatic infected persons, persons with symptoms not
recognized as HSV, and symptomatic persons?
There is programmatic interest in comparison of risk factors for
transmission of HSV from asymptomatic and symptomatic infected persons,
with respect to sexual practices, frequency of intercourse when
symptoms are present, duration of diagnosed genital herpes, consistent
and correct condom use, number of partners with genital herpes, length
of relationships with infected partners, age at diagnosis of genital
herpes, severity of symptomatic first episodes, frequency of
recurrences, and HSV-1 infection. A prospective or cross-sectional
design may be used. Identification of likely source contacts of newly
diagnosed persons is desirable. Consideration will be give to analyses
of existing databases.
E. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under 1. Recipient
Activities and CDC will be responsible of conducting activities under
2. CDC Activities:
1. Recipient Activities
a. Design and conduct a study to address the chosen study
questions listed in
[[Page 26983]]
Programmatic Interests. Recipients must address at least 3 of the
four study questions.
b. Evaluate and analyze data.
c. Disseminate study findings through presentations at
scientific meetings and publication in peer-reviewed journals.
2. CDC Activities
a. Provide up-to-date scientific information and technical
assistance and advice in the design and conduct of the research
b. Assist in the development of a research protocol for IRB
review by all cooperating institutions participating in the research
project. The CDC IRB will review and approve the protocol initially
and on at least an annual basis until the research project is
completed.
c. Monitor and evaluate scientific and operational
accomplishments of the project through periodic site visits,
telephone calls, and interim data analyses.
d. Assist, as needed, in the analysis and interpretation of
data.
e. Assist in the dissemination of finding to the public health
community for use in prevention programs.
F. Application Content
Follow the PHS-398 (Rev. 5/95) application and Errata sheet, and
include the following information. Applicants must document access to
men, persons of color, and young adults (e.g., age 18-24) to address
existing gaps in knowledge about HSV transmission.
1. Summarize current knowledge of transmission and burden of
genital herpes infections among asymptomatic and symptomatic infected
persons and their sex partners in the United States and the potential
role of new type-specific serologic tests for HSV likely to become
commercially available. Describe how activities evaluated in this
project can be implemented into public health practice.
2. Specific, measurable, and time-framed objectives.
3. A detailed plan describing the methods by which the objectives
will be achieved and evaluated, including their sequence. Describe the
extent to which the selected study sites and study populations will
enable the results from this research to be generalizable to other
settings or populations likely to be screened or at risk for genital
HSV infection, including clinical service delivery settings in addition
to traditional public STD clinics such as managed care organizations,
family planning clinics, and community-based clinics.
4. Describe procedures to disseminate the study findings through
presentation and publication.
5. Describe the principal investigator's role and responsibilities.
6. Describe qualifications of proposed staff and their previous
experience and achievements in genital herpes research, health services
research, health economics, behavioral and social sciences,
epidemiology and biostatistics, and laboratory sciences as appropriate
for the proposed project. For each member of the research team, include
their title, qualifications, experience, percentage of time each will
devote to the project, as well as that portion of their salary to be
paid by the cooperative agreement, and identify specific assigned
responsibilities.
7. Describe the nature and extent of collaboration with State and
local health departments or research institutions and CDC during
various phases of the project. Provide in an appendix, letters of
support from all key participating organizations which clearly indicate
their commitment to participate as described in the operational plan.
Collaboration with experts and organizations that have expertise in
genital herpes education, counseling, and advocacy is encouraged.
8. Describe proposed procedures for adequate protection of human
subjects. Describe how women and racial and ethnic minorities are
appropriately represented in the proposed research.
9. Provide a line-item budget and an accompanying detailed line-by-
line justification that demonstrates the request is consistent with the
purpose and goals of this program. Include a detailed first year's
budget for the cooperative agreement with future annual projections, if
relevant.
G. Submission and Deadline
Letter of Intent (LOI)
A letter of intent to apply is requested but not required from
potential applicants. Your letter of intent should include the
following information: announcement number 99115; name and address of
institution; name, address, and telephone number of contact person; and
specific objectives to be addressed by the proposed project. The letter
of intent must be postmarked on or before June 25, 1999, to: Sharron
Orum, Grants Management Specialist, Grants Management Branch,
Procurement and Grants Office, Announcement 99115, Centers for Disease
Control and Prevention (CDC), 2920 Brandywine Rd., Room 3000, Atlanta,
GA 30341.
Application
Applicants should follow the PHS-398 (Rev. 4/97) and Errata sheet.
Forms are in the application kit. On or before July 25, 1999, submit
the application to: Sharron Orum, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Announcement 99115,
Centers for Disease Control and Prevention (CDC), 2920 Brandywine Rd.,
Room 3000, Atlanta, GA 30341.
Deadline: Applications shall be considered as meeting the deadline
if they are either received on or before the deadline date or sent on
or before the deadline date and received in time for orderly
processing. (Applicants must request a legibly dated U.S. Postal
Service postmark or obtain a legibly dated receipt from a commercial
carrier or U.S. Postal Service. Private metered postmarks shall not be
acceptable as proof of timely mailing.) Applications that do not meet
these criteria are considered late applications, will not be
considered, and will be returned to the applicant.
H. Evaluation Criteria
Applications that are complete and responsive may be subjected to a
preliminary evaluation (triage)to determine if the application is of
sufficient technical and scientific merit to warrant further review;
CDC will withdraw from further consideration applications judged to be
noncompetitive and promptly notify the principal investigator or
program director and the official signing for the applicant
organization. Those applications judged to be competitive will be
further evaluated by a dual review process. Awards will be made based
on priority score by Peer Review, programmatic priorities and needs as
determined by a secondary review panel, and the availability of funds.
1. The first review will be a peer review of all applications.
Evaluation factors will be:
a. The background of the proposal, e.g., the basis for the
present proposal, a critical evaluation of existing knowledge, and
the specific knowledge gaps that the applicant intends to fill.
b. The specific aims of the research project, i.e., the
objectives and the hypothesis to be tested.
c. The originality of the proposed research from a scientific or
technical standpoint, including the adequacy of the theoretical and
conceptual framework.
d. The adequacy of the proposed research design, approaches, and
methodology to carry out the research, including quality assurance
procedures and plans for data management and statistical analyses,
and evaluation.
e. The extent to which the study population included men, racial
and ethnic minorities, and young adults, i.e., age 18-24.
f. The extent to which the research findings are likely to lead
to new policies and recommendations by advisory groups or feasible,
cost-effective interventions.
g. Qualifications, adequacy, and appropriateness of the
interdisciplinary
[[Page 26984]]
research team to accomplish proposed activities. The extent to which
the research team includes expertise in genital herpes research,
behavioral and social sciences, health services research, health
economics, epidemiology, biostatistics, and laboratory sciences as
appropriate for the proposed project.
h. The degree of commitment and cooperation of proposed
collaborators and participating organizations, as evidenced by
letters detailing the nature and extent of the involvement.
i. Capacity to carry out the project, including adequacy of
existing and proposed facilities and resources.
j. Inclusion of Women and Racial and Ethnic Minorities in
Research: 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:
(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.
(4) A statement as to whether the plans for recruitment and
outreach for study participants include the process of establishing
partnerships with communities and recognition of mutual benefits.
k. Human subjects: The extent to which the application
adequately addresses the requirements of Title 45 CFR Part 46 for
the protection of human subjects.
l. The reasonableness of the proposed budget to the proposed
research.
2. The second review will be conducted by a secondary review
committee of Senior Federal officials. The factors to be considered
will include:
a. The results of the peer review.
b. Geographic distribution.
c. The overall match between the proposal and the program
interests.
d. Overall balance among the four major areas of interest: (1)
the behavioral and psycho social impact and indirect and intangible
costs of genital herpes infections; (2) acceptability of screening
for genital HSV; (3) correlates of infectivity among asymptomatic
and symptomatic infected persons; and (4) relative risk of HSV
transmission from asymptomatic and symptomatic infected persons to
sex partners.
e. Budgetary considerations.
I. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of
1. Progress reports semiannually;
2. Financial status report, no more than 90 days after the end of
the budget period; and
3. Final financial status and performance reports, no more than 90
days after the end of the project period.
Send all reports to the Grants Management Specialists identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment I in the
application kit.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-7--Executive Order 12372 Review
AR-9--Paperwork Reduction Act
AR-10--Smoke-Free Workplace Requirements
AR-11--Healthy People 2000
AR-12--Lobbying Restrictions
J. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under section 318 of the Public Health
Service Act, [42 U.S.C. 247c], as amended. The Catalog of Federal
Domestic Assistance number is 93.978.
K. Where To Obtain Additional Information
This and other CDC announcements may be downloaded from the CDC
Internet home page--http://www.cdc.gov. Click on ``funding.''
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 of interest.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from: Sharron Orum, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Announcement 99115, Centers for
Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000,
Atlanta, Georgia 30341, Telephone (770)488-2716, E-mail address:
[email protected]
For program technical assistance, contact: Katherine Stone,
Division of STD Prevention, Centers for Disease Control and Prevention
(CDC), Mail Stop E-02, 1600 Clifton Road, Atlanta, Georgia 30333,
Telephone (404) 639-8183; FAX (404) 639-8610, E-mail address:
[email protected]
Dated: May 12, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 99-12438 Filed 5-17-99; 8:45 am]
BILLING CODE 4163-18-P