[Federal Register Volume 63, Number 22 (Tuesday, February 3, 1998)]
[Notices]
[Pages 5555-5562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 813]


Research Studies Evaluating Demonstration Projects on Feasibility 
of STD Treatment for HIV Prevention in the United States

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1998 funds for a cooperative agreement 
program for demonstration projects on the feasibility of STD treatment 
for HIV prevention.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2000,'' a national activity 
to reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of HIV Infection. (To 
order a copy of ``Healthy People 2000,'' see the section WHERE TO 
OBTAIN ADDITIONAL INFORMATION.

Authority

    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.
    Applicable program regulations are set forth in 42 CFR Part 52, 
entitled ``Grants for Research Projects.''

Smoke-Free Workplace

    CDC strongly encourages all cooperative agreement recipients to 
provide a smoke-free workplace and promote the non-use of all tobacco 
products, and Public Law 103-227, the Pro-Children Act of 1994, 
prohibits smoking in certain facilities that receive

[[Page 5556]]

Federal funds in which education, library, day care, health care, and 
early childhood development services are provided to children.

Eligible Applicants

    Eligible applicants are the direct recipients of Federal Sexually 
Transmitted Disease/Accelerated Prevention Campaign (STD/APC) project 
grants or HIV Prevention cooperative agreements. Eligibility is further 
limited to areas with a gonorrhea case rate of more than 200 per 
100,000 or a syphilis case rate of more than 9 per 100,000 (based on 
National Surveillance Data) for calendar year 1996. The HIV prevention 
program and STD prevention program within the same locale must 
collaborate with each other and submit one application. These areas 
are: Alabama, Arkansas, Baltimore, Chicago, Delaware, Georgia, 
Louisiana, Maryland, Mississippi, North Carolina, Philadelphia, San 
Francisco, South Carolina, Tennessee, Virgin Islands, and Washington, 
D.C. These applicants have access to STD clinic and other clinic 
populations at risk for HIV and other STDs and have continuing high 
incidence of syphilis or gonorrhea.

Availability of Funds

    Approximately $400,000 is available in FY 1998 to fund up to two 
awards for demonstration projects on the feasibility of STD treatment 
for HIV prevention. It is expected that the average new award will be 
approximately $200,000 and will begin on or about April 1, 1998. Awards 
will be funded for a 12-month budget period within a project period of 
up to 2 years. Funding estimates are subject to change. Continuation 
awards within the project period will be made on the basis of 
satisfactory progress and the availability of funds.

Use of Funds

    Funds are awarded for a specifically defined purpose and may not be 
used for any other purpose or program. Funds may be used to support 
personnel and to purchase equipment, supplies, and services directly 
related to project activities. Funds may not be used to supplant State 
or local health department funds or for inpatient care, medications, or 
construction.

Restrictions on Lobbying

    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 (which has been in effect since 
December 23, 1989), 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, the FY 1998 Department of Labor, Health and Human 
Services, and Education, and Related Agencies Appropriations Act (Pub. 
L. 105-78) states in Section 503(a) and (b) that no part of any 
appropriation contained in this Act 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 legislature, except in presentation to 
the Congress itself or any State legislature. No part of any 
appropriation contained in this Act 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 legislature.

Background

    The AIDS epidemic continues in the United States with over 548,102 
cases of AIDS, including 78,654 cases in females and 7,296 cases in 
children reported to the CDC as of June 30, 1996. More than 275,000 
persons are reported to be living with HIV infection. Both HIV cases 
and HIV-associated deaths are expected to continue to increase over the 
next decade. Surveillance data indicate that heterosexual transmission 
accounts for an increasing number of new infections in the U.S. Among 
women, heterosexual transmission was the most common exposure category 
for new cases of AIDS reported in 1995-96, accounting for 41 percent of 
cases. In addition, African Americans, Hispanics, women, adolescents, 
and persons living in the Southeastern U.S. are increasingly 
represented in both AIDS cases and new HIV infections.
    Current evidence suggests that the growth in the heterosexual HIV 
epidemic, particularly among the most vulnerable populations is, in 
part, fueled by other STDs that increase transmission efficiency. STDs 
in the HIV-uninfected increase their susceptibility to HIV; STDs in the 
HIV-infected increase their likelihood of transmitting HIV to others. 
Studies have demonstrated the increased risk of HIV seroconversion to 
be associated with both genital ulcer disease (GUD) and non-ulcerative 
STDs. HIV transmission has been associated with concurrent infection 
with syphilis, herpes, chancroid, gonorrhea, chlamydia, or 
trichomoniasis. STDs increase both the prevalence of HIV shedding and 
the magnitude of HIV RNA in semen and cervico-vaginal secretions. 
Treatment of the STD reduces the prevalence and magnitude of viral 
shedding. For example, gonococcal infection increases quantitative 
shedding of HIV RNA among men by about 10-fold, and treatment restores 
HIV shedding to near baseline levels. Similar effects have been 
demonstrated in HIV infected women with gonorrhea, chlamydia and 
cervico-vaginal ulcers. The Mwanza trial, which randomized communities 
in rural Tanzania to either their existing standard of care or an 
intervention that established an infrastructure to diagnose and treat 
STDs, found a 42 percent reduction in HIV incidence over 2 years in the 
intervention communities. Sexual behavior and condom use remained 
unchanged in the communities. Thus, there is compelling individual and 
community-level evidence that treating STDs can decrease HIV 
transmission.
    Despite sound scientific evidence for treating STDs to prevent HIV, 
the question remains how best to structure such an intervention in the 
U.S. To effectively target STD treatment for HIV prevention in the 
U.S., an intervention must target populations with a high incidence of 
STDs and HIV. Because STDs increase both infectivity and 
susceptibility, detection and treatment should target both HIV-infected 
and HIV-uninfected persons. These projects will focus on both persons 
infected with STDs who are reached by the health care system but not 
diagnosed and treated (e.g., patients in clinical situations who do not 
receive STD screening, diagnosis and treatment), and on persons not 
reached by the health care system (e.g., because of asymptomatic 
infection or problems of accessing health services). In this program we 
are particularly interested in structural or other interventions aimed 
at changing the environment. An intervention might include such program 
elements as referral of HIV-infected and HIV-uninfected-at-risk persons 
for STD care (e.g., screening, diagnosis and treatment for STDs), 
increasing access to STD care, promoting risk assessment and screening 
of persons asymptomatically

[[Page 5557]]

infected with STDs, diagnosing symptomatic STDs, ensuring effective 
treatment and follow-up for STDs, including STD risk-reduction 
counseling, and partner management for persons with STDs. Because 
populations-at-risk may access health care settings that are not 
providing the full array of services, study sites might include health 
care settings that serve those at high risk. Additionally, since 
populations-at-risk may not access health care, study sites might also 
include non-health care venues where high-risk persons may be found.
    The National Center for HIV, STD, and TB Prevention (NCHSTP) goals 
are to:
    1. Increase public understanding of, involvement in, and support 
for, HIV, STD, and TB prevention.
    2. Ensure completion of therapy for persons identified with active 
TB or TB infection.
    3. Prevent or reduce behaviors or practices that place persons at 
risk for HIV and STD infection or, if individual is already infected, 
place others at risk.
    4. Increase individual knowledge of HIV serostatus and improve 
referral systems to appropriate prevention and treatment services.
    5. Assist in building and maintaining the necessary State, local, 
and community support infrastructure and technical capacity to carry 
out the necessary prevention programs.
    6. Strengthen current systems and develop new systems to accurately 
monitor the HIV epidemic, STDs, and TB, as a basis for assessing and 
directing prevention programs.

Purpose

    The purpose of this program is to evaluate the feasibility of 
establishing an HIV prevention program in the U.S. that incorporates 
effective STD screening, diagnosis and treatment, in addition to 
existing HIV prevention services. Following the identification of 
existing problems in HIV and STD services, those problems will be 
prioritized, a protocol will be designed and implemented in a pilot 
fashion to establish the feasibility of a health service intervention 
package (focusing on STD treatment), and a set of evaluation tools will 
be developed to measure the intervention's effectiveness. The 
demonstration projects will likely form the basis for an expanded 
future multi-site initiative, and provide important information on such 
operational and evaluation issues as implementation, longitudinal 
follow-up, data collection, and assessment of outcomes.
    This project is conceived as a pilot effort to assess the 
feasibility and likely prevention effectiveness of improving access to, 
and the quality of, STD services for heterosexuals at risk of 
transmitting HIV and of becoming infected with HIV. This project will 
describe the feasibilities and barriers to improving and better linking 
STD diagnostic and treatment services and HIV counseling, testing and 
treatment services within a variety of settings (e.g., drug treatment 
sites, STD clinics, HIV counseling and testing sites, prenatal and 
family planning clinics, correctional facilities including juvenile 
detention facilities, emergency medical and urgent care facilities, 
adolescent clinics, school clinics, primary care settings in the 
private sector, community health centers, existing outreach settings, 
and potential new outreach settings).
    In a defined population where high levels of HIV and STD coexist, 
this project will have three phases consisting of: (I) An assessment 
and prioritization phase; (II) an intervention and protocol development 
phase; and (III) an implementation and evaluation phase.
    In Phase I (to be accomplished in the first year of the project), a 
community-based assessment will be conducted to determine who is at 
highest risk within the community (i.e., who has HIV and STD, and who 
has STD and is at risk for acquiring HIV), and how best to reach them. 
This phase would focus on a review of the epidemiology of HIV and STD 
trends in the community, on identifying where high-risk persons are 
currently accessing health care and other social services, what types 
of services are available (e.g., screening, diagnosis and treatment, 
and counseling), and what are the gaps in available services. This 
assessment could draw on existing data (e.g., through HIV community 
planning data collection) or on newly collected data, and may include 
data derived from public and private sources of care. Arising from this 
assessment, a local prioritization process would be used to develop 
Phase II activities. If most high-risk persons are utilizing health 
care services but are not being screened, diagnosed, or treated, then 
interventions will focus on improving the quality of STD care 
(increasing screening and treatment in existing sites and developing 
referral networks). If high-risk persons are not accessing health care 
(for reasons including: asymptomatic infections, lack of knowledge 
about STD status and need for care, perceived or actual barriers to 
health care, etc.), then interventions will focus these specific 
problems and include establishing new opportunities for provision of 
services to expand access and utilization (e.g., increasing screening 
and health services at correctional facilities, drug treatment centers, 
or outreach settings).
    In Phase II (to be accomplished by the end of the first year of the 
project, with the exception of developing and testing the evaluation 
criteria which is expected to extend into the second year of the 
project), the intervention and protocol development phase, 
interventions will be developed to address the specific priority needs. 
Following development of the intervention, a study protocol will be 
designed to test the feasibility, acceptability, operational 
requirements of the interventions, and to develop an evaluation plan 
including appropriate process and outcome measures for the 
interventions. The protocol will include choice of sites, 
implementation methods, use of comparison groups, and details of the 
evaluation plan.
    In Phase III (to be accomplished by the end of the second year of 
the project), the implementation and evaluation phase, the model 
intervention(s) will be implemented and evaluated in a pilot 
feasibility study.

Program Requirements

    In conducting activities to achieve this program, the recipient 
shall be responsible for the activities listed under A. (Recipient 
Activities), and CDC shall be responsible for conducting activities 
listed under B. (CDC Activities).

A. Recipient Activities

    1. Collaborate on Study Design for the Three Phases: Recipients 
will meet together with CDC to discuss potential study designs and 
formative research required to develop the study protocol, process, and 
operations procedures.
    2. Collaborate with Other Recipient and CDC During the Three Study 
Phases: Collaboration will begin with approaches to study design aimed 
at content, operations, and process of ultimately conducting the three 
study phases. Collaboration will include (a) communication with CDC 
staff and the other recipient, and (b) development of common study 
protocols, common data collection instruments, common specimen 
collection protocols, and common data management procedures. Recipients 
will collaborate with each other in all quality control procedures, and 
in regularly scheduled meetings and conference calls.
    3. Conduct Productive and Scientifically Sound Studies: Recipients 
will identify, recruit, obtain informed

[[Page 5558]]

consent forms, and enroll and follow to completion, a minimum of 500 
participants as determined by the study protocol and the program 
requirements. Recipients will perform laboratory tests as determined by 
the study protocol, and will follow study participants over time as 
determined by the protocol.
    4. Share Data and Specimens: Recipients will share data and 
specimens (when appropriate) with CDC to answer specific research 
questions.
    5. Collaborate on Publication of Results: Recipient researchers 
will work closely with CDC staff to develop at least one publication 
recording results from both sites for a peer-reviewed journal on the 
study findings. Recipients will also, as appropriate and relevant, 
develop secondary study hypotheses or site-specific hypotheses and for 
these, analyze data gathered over the course of the study and in 
collaboration with CDC staff, present and publish data.
    Recipient Activities Specific to the Study Phases Will Include:
    During Phase I (assessment and prioritization):
    6. Identify Those with STDs (among HIV-infected and HIV-uninfected 
persons): Within a defined population or geographic area, existing data 
will be reviewed and new information may be obtained through surveys to 
determine the extent of STDs and HIV in a study area, the demographic 
characteristics of these populations of infected persons, and trends in 
the epidemiology of STD and HIV. The focus should be on persons at risk 
for acquiring STDs heterosexually.
    7. Assess How Good the Current Health Care System Is at Reaching 
and Providing Care for HIV and STD Infected Populations: This activity 
will include determining where the STD infected population are getting 
care, and what care they are getting (e.g., type and quality of care), 
what services are actually available at the site to which they are 
referred, where they are getting other services (e.g., social services, 
drug treatment), and where else they might be found (e.g., correctional 
facilities). Determine what can be done to increase the numbers of 
infected (asymptomatic or symptomatic) persons who are diagnosed and 
treated for STDs within the existing organizational infrastructure. 
(This work could be done through individual and community level 
analysis, including site surveys, and interviews with at-risk persons 
(HIV/STD infected or uninfected) and service providers.)
    8. Identify and Prioritize Needed Services and the Venues for These 
Services: Evaluate the opportunity for improving the quality of 
existing services. If additional services are needed, should they be 
through direct on-site provision or via referral? If referral, how can 
linkages be developed between sites to better coordinate service 
delivery? (This work could be done through site observations, in-depth 
interviews with community members and service providers, literature 
review on direct service vs. referral models vs. other approaches to 
coordinated service delivery.)
    9. Identify Important Barriers, Including Patients' and Potential 
Patients' Perceptions of the Barriers, for Those with STDs (HIV-
infected and HIV-uninfected) to Access Needed Services: Determine what 
can be done to increase the numbers of symptomatic infected persons 
diagnosed and treated, and to decrease the time it takes to receive 
diagnostic and treatment services within the existing organizational 
infrastructure. Determine what can be done to increase the numbers of 
asymptomatic infected persons screened, diagnosed and treated. (This 
work could be done through individual interviews and focus groups with 
at-risk (HIV/STD infected or uninfected) persons, and with health and 
social service providers and community planners and community-based 
organizations.)
    During Phase II (intervention and protocol development):
    10. In Collaboration with Other Recipient, Design Model 
Intervention(s) Based on the Specific Needs, as Identified and 
Prioritized in Phase I.
    11. In Collaboration with Other Recipient, Develop a Protocol to 
Implement and Evaluate the Intervention(s) that Will Include Specific 
Outcome Measures.
    Phase III (implementation and evaluation):
    12. Implement and Assess the Feasibility of the Intervention(s) to 
Improve Delivery of and Access to High Quality HIV/STD Services.
    13. Develop, Implement, and Test Evaluation Techniques for 
Assessing Outcomes of a Future, Full Scale Demonstration Project: 
Explore the use of behavioral outcomes, biological disease-related 
outcomes (incidence of STD/HIV), and health services measures (such as 
cost, utilization, access).

B. CDC Activities

    1. Provide Technical Assistance and Coordination: CDC staff may 
assist in the design and conduct of the research and provide 
coordination of the project. The final design will be determined by a 
collaborative process.
    2. Provide Scientific Expertise: CDC staff will provide current 
scientific and programmatic information relevant to the project, and 
may provide technical assistance in the design and conduct of the 
research (including plan, operations, and evaluation) throughout the 
project. CDC staff will assist in designing a data management system 
and may coordinate research activities among the different study sites. 
CDC staff may also provide technical guidance in the development and 
dissemination of study protocols, consent forms, and questionnaires.
    3. Analyze Study Data and Coordinate Publication: CDC staff may 
assist in the analysis of data gathered over the course of the study in 
each site and in cross-site comparisons and may assist the recipients 
to develop at least one overall publication describing the project 
results.
    4. Share Data and Specimens: CDC staff may assist in the 
dissemination of study results and distribution of specimens.
    5. Monitor and Evaluate Scientific and Operational Accomplishments 
of the Project: This will be accomplished through periodic site visits, 
telephone calls, and review of technical reports and interim data 
analysis.

Technical Reporting Requirements

    An original and two copies of semi annual progress reports must be 
submitted no later than 30 days after the end of each 6-month budget 
period. An original and two copies of a financial status report (FSR) 
are required no later than 90 days after the end of each budget period. 
A final progress report and FSR are due no later than 90 days after the 
end of the project period. All reports are submitted to the Grants 
Management Branch, Procurement and Grants Office, CDC.

Application Content

    Applications must be developed in accordance with PHS Form 5161-1 
(OMB Number 0927-0189), information contained in the program 
announcement, and the instructions and format provided below.
    Applicants are required to submit an original and two copies of the 
application. Number each page clearly and sequentially, and provide a 
complete index to the application and its appendices. The original and 
each copy of the application set must be submitted UNSTAPLED and 
UNBOUND. All material must be typewritten, double spaced, with 
unreduced type on 8\1/2\''  x  11'' paper, with at least 1'' margins, 
headings and footers, and printed on one side only. Materials which 
should be part of the

[[Page 5559]]

basic application will not be accepted if placed in the appendices. The 
application should not exceed 25 pages (exclusive of official PHS 
application pages and relevant attachments).
    Applicants for demonstration projects on the feasibility of STD 
treatment for HIV prevention must demonstrate in the application an 
ability to access persons infected with STDs or HIV, and persons at 
high risk for acquiring STDs or HIV. Applicants must also demonstrate 
an ability to provide appropriate HIV and STD prevention counseling and 
HIV and STD testing for persons with STDs or at risk of acquiring STDs. 
In addition, applicants must demonstrate an ability to enroll at least 
500 participants per year, of whom at least 35 percent are women. 
Applicants must demonstrate high prevalence of STDs (>15 percent) and 
high prevalence of HIV (>2 percent) in STD clinic settings, an ability 
to complete high rates of participant follow-up, collection and 
handling of laboratory specimens, and collection of other relevant 
data. Applicants must demonstrate cost-efficient local availability of 
staff to complete data entry and data management. Applicants must be 
willing to participate collaboratively with each other and with CDC in 
conducting this research study.
    The application must address the following:
1. Background
    a. Describe the STD clinical and preventive health services 
available in the community through both public and private sources of 
care, including current collaboration between STD and HIV prevention 
programs. Describe availability of STD services in HIV counseling and 
testing (C & T) sites.
    b. Describe the epidemiology of HIV, gonorrhea, chlamydia, and 
primary and secondary (P&S) syphilis in calendar year 1996 for the 
proposed project area.
    c. Describe those at risk for heterosexually acquired STDs and HIV, 
and their access to health care. Information on the percentage 
uninsured, unemployed, under the poverty level, and those receiving 
public assistance is desirable.
    d. Include additional background on any health care policies and 
additional environmental and socio-demographic factors that may be 
relevant to the study of STD services. Examples include privatization 
of categorical STD clinics, existing or pending Federal Medicaid 
waivers, existing contracts, memoranda of understanding, agreements or 
arrangements between health plans and health departments.
2. Objectives
    Provide a focused research agenda with long-term and short-term 
objectives that are realistic, specific, measurable, time-phased, and 
consistent with the objectives of the announcement.
3. Site Selection
    Applicants must document access to populations with high syphilis 
or gonorrhea rates and high HIV prevalence rates. High HIV prevalence 
rates can be documented by surveys such as job corps, other 
seroprevalence surveys (e.g., among patients attending STD clinics, 
adolescent clinics, drug treatment centers, and among incarcerated 
populations), or survey of child bearing women data.
    Define a research site based on specific information included in 
the background. Provide information on participating clinics and 
community programs in the project area. Include available information 
on monthly and annual numbers of clinic patients and their STD and HIV 
prevalence rates, and STD and HIV prevalence rates in persons 
participating in community programs in the project area.
    Emphasis will be placed on applicant's demonstration of access to 
relevant clinic populations and community program populations such as 
adolescents, women, minorities, and Medicaid populations.
4. Methods
    Describe the methods and activities that will be undertaken to 
accomplish the objectives, including, when possible, outcomes to be 
evaluated (i.e., health services-related outcomes, program-related 
outcomes, or STD and HIV specific health-related outcomes), the use of 
appropriate comparison groups, the sampling scheme and sample size 
calculations, qualitative and quantitative methods, and how data will 
be accessed, collected, and used. The methods should address the 
different phases (Phase I, II & III) of the project. Provide a detailed 
time line with beginning and end dates for each phase, with the 
anticipation of completing Phase I and part of Phase II in the first 
year of the project and all of Phases II & III in the second year of 
the Project.
5. Evaluation Plan
    Provide an evaluation plan to monitor the effectiveness of the 
project activities and the progress made toward meeting the objectives.
6. Research Capacity
    Provide evidence of research capability. Describe past and current 
research experience, including the experience of the proposed staff who 
will participate in this project (include details of experience and 
competence in research design, data collection, analysis and 
dissemination). Attach the curriculum vitae of key staff. Describe your 
plan for project administration including details of the proposed 
collaboration between STD clinic and program staff and HIV program 
staff. The research team should include qualified and experienced 
personnel in epidemiology, health services research, and behavioral 
science, and the team should have a demonstrable balance of experience 
in STD management and HIV prevention. The eligible applicants are 
encouraged to collaborate with other organizations such as colleges, 
universities, research institutions, hospitals and other public and 
private organizations to carry out project activities. Minimum 
requirements for the research team are a principle investigator, 
project supervisor, and staff capable of providing data collection, 
data management, laboratory support, and clerical services.
7. Letters of Support
    Because each eligible locale can submit only one application, a 
Letter of Support is required by each Project Director, if the HIV 
prevention program and STD prevention program are administered 
separately.
8. Budget
    Provide a detailed, line-item annualized budget for the first year 
of the Project which should cover Phase I in its entirety (as defined 
above) and part of Phase II and a budget narrative that justifies each 
line-item. Provide a summary budget for the second year of the Project 
covering the remaining part of Phase II and all of Phase III.
    The budget should anticipate the need for appropriate staff (noted 
above in ``6. Research Capacity''), travel for principal investigator 
and project supervisor to meet with CDC two times per year, travel for 
outreach, supplemental needs related to STD and HIV clients and their 
longitudinal participation, and other needs. The budget should allocate 
at least 50 percent of resources to the STD prevention program 
activities (e.g., screening, diagnosis, treatment, and counseling for 
STDs).

Evaluation Criteria

    Applications for demonstration projects on the feasibility of STD 
treatment for HIV prevention will be reviewed and evaluated according 
to the following criteria:

[[Page 5560]]

1. Background and Objectives (5 Points)
    Understanding of purpose and objectives of this research and its 
relation to national program goals as reflected in the statement of 
research background and research questions.
2. Site Selection (25 Points)
    The extent to which the choice of the project area and specific 
clinic and community sites to conduct this research will be 
generalizable to other settings or populations, and is appropriate to 
the local and national objectives, STD and HIV epidemiology, social 
demography, and health care system. Emphasis will be placed on 
demonstrated access to populations at high risk for heterosexual 
transmission of STDs and HIV in the project area, particularly persons 
who currently may not be reached by the health care system. Evidence of 
high gonorrhea, syphilis, and HIV prevalence should be demonstrated. 
Prevalence of other STDs might also be demonstrated. Highest points 
will be given to applications demonstrating the capacity to enroll a 
substantial number of participants at risk for STDs and HIV (>500 
persons annually) and undertake longitudinal follow-up of these 
persons.
    Consideration will also be given to the extent to which the 
proposed site includes appropriate participation of women and racial 
and ethnic minority populations.
3. Methods (25 Points)
    The appropriateness and adequacy of the research design and 
methodology proposed to answer the research questions. This includes: 
(a) The selection of appropriate outcomes related to health services, 
STD and HIV programs, and STD morbidity; (b) the use of appropriate 
comparison groups; (c) the inclusion of appropriate sampling schemes, 
sample size calculation, handling of sampling biases; (d) access to the 
relevant data sources and the plan for data collection; and (e) the 
description of the specific quantitative and qualitative analytic 
technique to be used to answer the research questions.
4. Evaluation (20 Points)
    The extent to which the applications present a sound evaluation 
plan that includes aspects such as: Research progress measurements and 
communications, baseline data collection; intervention(s) testing, 
ability to measure specific intervention outcomes (including but not 
exclusively STD and HIV outcomes); and economic evaluation.
5. Research Capacity (25 Points)
    Overall ability to perform the technical aspects of the project 
including: (a) The availability of qualified and experienced personnel 
for a multi-disciplinary team in health services research including 
level of education and training, and relevant research experience of 
the principle investigator and key research personnel; (b) the 
availability of adequate facilities, general environment, and resources 
for the conduct of the proposed research; (c) assurance that staff can 
be hired within 4 months of award of monies; (d) plans for the 
administration of the project(s), including a detailed and realistic 
time line for the specified activities; (e) details of the proposed 
project-level collaboration between STD clinic and program staff and 
HIV program staff; and, (f) demonstration of the applicant's ability, 
willingness, and need to collaborate with CDC and researchers from 
other study site in study design and analysis, including use of common 
study protocols and data collection instruments, and (when appropriate) 
sharing of data and specimens.
6. Budget (not Scored)
    The appropriateness of budget estimates in relation to the proposed 
research. The extent to which budget is reasonable, clearly justified, 
and consistent with the intended use of funds. The budget should 
allocate at least 50 percent of resources to the STD prevention program 
activities. (e.g., screening, diagnosis, treatment, and counseling for 
STDs).
7. Human Subjects (not Scored)
    The extent to which the applicant complies with the Department of 
Health and Human Services Regulations (45 CFR Part 46) regarding the 
protection of human subjects.

Funding Preferences

    CDC reserves the right to make final funding selections based on 
geographic diversity and applicants with higher documented prevalence 
of STDs and HIV in proposed clinic study sites.

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 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 them to the 
prospective applications and receive any necessary instructions on the 
State process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC for each affected State. A 
current list of SPOCs is included in the application kit. If SPOCs have 
any State process recommendations on application submitted to CDC, they 
should send them to Adrienne S. Brown, Acting Grants Management 
Officer, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE, Atlanta, Georgia 30305, no later than 60 days after the 
application deadline date. The Program Announcement Number and Program 
Title should be referenced on the document. The granting agency does 
not guarantee to ``accommodate or explain'' State process 
recommendations it receives after that date.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance Numbers are: 93.941, HIV 
Demonstration, Research, Public and Professional Education Projects; 
and 93.978, Preventive Health Services Sexually Transmitted Diseases 
Research, Demonstration, and Public Information and Education Grants.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

Human Subjects

    This program involves research on human subjects. Therefore, all 
applicants must comply with the Department of Health and Human Services 
Regulations, 45 CFR Part 46, regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing assurance in accordance with the appropriate guidelines and 
form provided in the application kit.

[[Page 5561]]

HIV Program Review Panel

    Recipients must comply with the document entitled Content of AIDS-
Related Written Materials, Pictorials, Audiovisuals, Questionnaires, 
Survey Instruments, and Educational Sessions (June 1992) (a copy is in 
the application kit). To meet the requirements for a program review 
panel, recipients 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 the recipient forms its own program review 
panel, at least one member must be an employee (or a designated 
representative) of a State or local health department. The names of the 
review panel members must be listed on the Assurance of Compliance form 
CDC 0.1113, which is also included in the application kit. The 
recipient must submit the program review panel's report that indicates 
all materials have been reviewed and approved.

Patient Care

    Applicants should provide assurance that all STD or HIV-infected 
patients enrolled in the proposed studies will be linked to an 
appropriate local care system that can address their specific needs 
such as medical care, counseling, social services, and therapy.

Women, Racial and Ethnic Minorities

    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 Alaskan Native, Asian, Black or African American, 
Native Hawaiian or Other Pacific Islander, and Hispanic or Latino. 
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 or sex of subjects. Further guidance to this policy is 
contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, 
dated Friday, September 15, 1995.

Confidentiality

    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.
    Recipients must describe any 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 of the public health department and measures 
the health department has taken to ensure that the confidentiality of 
individuals reported to the surveillance system is protected from 
further or unlawful disclosure.

Application Submission and Deadlines

1. Preapplication Letter of Intent (LOI)

    A non-binding letter of intent-to-apply is requested from potential 
applicants. An original and two copies of a two-page, typewritten LOI 
should be submitted to the Grants Management Branch, CDC (see 
``Applications'' for address). It should be postmarked no later than 
February 13, 1998. The letter should identify the announcement number, 
title of the specific research activity for which application is being 
submitted, the name and institutional affiliation of the principal 
investigator, and the identity of other key participants and 
participating institutions. No attachments, booklets, or other 
documents accompanying the LOI will be considered. The letter should 
also include the estimated total cost of the research activity and the 
percentage of the total cost being requested from CDC. The LOI does not 
influence review or funding decisions, but it will enable CDC to plan 
more efficiently, and will ensure that each applicant receives timely 
and relevant information prior to application submission.

2. Applications

    An original and two copies of the application Form PHS 5161-1 
(Revised 7/92, OMB No. 0937-0189) must be submitted on or before March 
13, 1998 to Adrienne S. Brown, Acting Grants Management Officer, 
Attention: Kathy Raible, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, 
Mail Stop E-15, Atlanta, GA 30305.

3. Deadlines

    A. Applications will meet the deadline if they are either:
    1. Received on or before the deadline date; or
    2. Sent on or before the deadline date and received in time for 
submission to the objective review committee. (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 accepted as proof of timely mailing.)
    B. Applications that do not meet the criteria in 2.A.1. or 2.A.2. 
above are considered late applications. Late applications will not be 
considered in current competition and will be returned to the 
applicant.

Where To Obtain Additional Information

    A complete program description and information on application 
procedures, are contained in the application package. Business 
management technical assistance may be obtained from Kathy Raible, 
Grants Management Specialist, Grants Management Branch, Procurement and 
Grants Office, Centers for Disease Control and Prevention (CDC), 255 
East Paces Ferry Road, NE., Room 300, Mail Stop E-15, Atlanta, Georgia 
30305, telephone (404) 842-6649, or via email at: <[email protected]>.
    Programmatic technical assistance may be obtained from Mary Kamb, 
Division of HIV/AIDS Prevention, National Center for HIV/STD/TB 
Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC), 
1600 Clifton Road; Mailstop E-46, Atlanta, Georgia 30333, telephone 
(404) 639-2080, or via email at: <[email protected]>, or Kathleen Irwin, 
Division of STD Prevention, NCHSTP, CDC, 1600 Clifton Road; Mailstop E-
07, Atlanta, Georgia 30333, telephone (404) 639-8276, or via email at: 
<[email protected]>.
    Please refer to announcement number 813 when requesting information 
and submitting an application.
    The announcement will be available on one of two Internet sites on 
the publication date: CDC's home page at <http://www.cdc.gov>, or at 
the Government Printing Office home page (including free access to the 
Federal Register) at <http://www.access.gpo.gov>.
    Potential applicants may obtain a copy of ``Healthy People 2000'' 
(Full

[[Page 5562]]

Report, Stock No. 017-001-00474-0) or ``Healthy People 2000'' (Summary 
Report, Stock No. 017-001-00473-1) referenced in the ``INTRODUCTION'' 
through the Superintendent of Documents, Government Printing Office, 
Washington, DC 20402-9325, telephone (202) 512-1800.

    Dated: January 27, 1998.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 98-2571 Filed 2-2-98; 8:45 am]
BILLING CODE 4163-18-P