[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

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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

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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: 
spo2@cdc.gov
    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: 
kms1@cdc.gov

    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