[Federal Register Volume 62, Number 130 (Tuesday, July 8, 1997)]
[Notices]
[Pages 36514-36522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17702]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 735]


FY 1997 Epidemiologic Research Studies of Acquired 
Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) 
Infection

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1997 funds for a cooperative agreement 
program for epidemiologic and behavioral research studies of AIDS and 
HIV infection. These include studies to examine factors related to: (I) 
manifestations and medical management of HIV infection in children and 
(II) acceptability of new prevention methods currently being tested 
that offer alternatives to male condoms for HIV/STD protection. The 
study of these research areas as they pertain to racial and ethnic 
minority populations (defined as Alaskan Native, African-American, 
Hispanic, Asian/Pacific Islander, and American Indian) is encouraged 
because minorities constitute more than 53 percent of all reported 
cases of AIDS and approximately 77 percent of all women and children 
with AIDS.
    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. Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities that receive Federal funds in which 
education, library, day care, health care, and early childhood 
development services are provided to children.

Eligible Applicants

    Eligible applicants include all public and private nonprofit 
organizations and governments and their agencies. Thus, universities; 
colleges; research institutions; hospitals and other public and private 
organizations; territories, District of Columbia, and State and local 
governments or their bona fide agents; federally recognized Indian 
tribal governments; Indian tribes or Indian tribal organizations; and 
small minority-or women-owned nonprofit businesses are eligible to 
apply.

    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.

[[Page 36515]]

Availability of Funds

    Approximately $1 million is available in FY 1997 to fund 
approximately two new awards and approximately $2 million is available 
to fund six competing continuation projects. It is expected that the 
average new awards will be range from $300,000 to $700,000 and 
continuation awards will be approximately $300,000. It is expected that 
awards will begin on or about September 30, 1997. Successful grantees 
will be funded for a 12-month budget period within a project period of 
up to three years. Continuation awards within the project period will 
be made on the basis of satisfactory programmatic progress and the 
availability of funds. Funding estimates may vary and are subject to 
change.

Use of Funds

Restrictions on Lobbying

    Applicants should be aware of restrictions on the use of Department 
of Health and Human Services (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 subtier 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 1997 Departments of Labor, HHS, and Education, 
and Related Agencies Appropriations Act, which became effective October 
1, 1996, expressly prohibits the use of 1997 appropriated funds for 
indirect or ``grass roots'' lobbying efforts that are designed to 
support or defeat legislation pending before State legislatures. 
Section 503 of this new law, as enacted by the Omnibus Consolidated 
Appropriations Act, 1997, Division A, Title I, Section 101(e), Pub. L. 
No. 104-208 (September 30, 1996), provides as follows:
    Sec. 503(a) 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, * * * except 
in presentation to the Congress or any State legislative body itself.
    (b) 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 581,429 cases 
of AIDS, including 7,629 cases in children, 85,500 cases in women and 
324,728 cases in men who have sex with men reported to the CDC as of 
December 1996. Approximately 62 percent of persons with AIDS have died.
    Current estimates reflect that approximately 700,000 Americans have 
been infected with HIV, the etiologic agent of AIDS. More difficult to 
estimate is the number of incident HIV infections occurring yearly. 
Heterosexual transmission is now the leading cause of AIDS cases among 
U.S. women and is the fastest growing mode of transmission in newly 
infected persons. However, male-to-male exposure continues as the 
single greatest risk category among men. Fifty percent of cumulative 
AIDS cases and 40 percent of annual AIDS cases in 1996 were attributed 
exclusively to male-to-male sexual exposure. African-Americans, 
Hispanics, women, and adolescents are increasingly represented in both 
AIDS cases and new HIV infections.
    Although it now may be possible to prevent most HIV transmission to 
children, there are approximately 15,000 children living with HIV 
infection in the U.S. and infected children will continue to be born 
despite prevention efforts. Timely prophylaxis and treatment are 
improving survival of these children but advances in diagnostics, 
prophylactic and treatment options, as well as ongoing changes in 
health care delivery (e.g., managed care) may add complexity to their 
medical management. Information is needed to monitor trends in medical 
management and progression of disease to evaluate implementation of 
treatment recommendations and their impact. Information is also needed 
to characterize HIV disease and social impact in children with long-
term survival (into adolescence).
    Additional studies of the epidemic of HIV are needed to guide 
prevention and control efforts. In particular, information that will 
guide development of new prevention technologies, including 
microbicides to prevent sexual transmission in women and men, is 
needed.

Purpose

    The purpose of these awards is to help support researchers in the 
conduct of HIV-related epidemiologic and behavioral research studies 
that foster prevention of HIV infection or HIV-related disease. These 
include studies to monitor medical care, social circumstances, and 
clinical course of HIV-infected children and adolescents infected in 
childhood; and studies to examine behavioral and biomedical factors 
related to the acceptability of new products to prevent sexual 
transmission of HIV infection such as vaginal and rectal microbicides. 
The study of these research areas as they pertain to minority 
populations are of special interest.

Research Issues

    Three research issues of programmatic interest to the health care 
community and to CDC for FY 1997 are listed below and are considered of 
significant importance in gaining a greater understanding of the 
epidemiology of AIDS and HIV infection. However, applications submitted 
by organizations that examine additional important HIV-related 
epidemiologic research issues will also be accepted and considered for 
funding.
    Applicants addressing the same research issue should be willing to 
participate in collaborative studies with other CDC-sponsored 
researchers, including the use of common data collection instruments, 
specimen collection protocols, and data management procedures, as 
determined in post-award grantee planning conferences. Applicants are 
required to identify their proposed research issue on line one of the 
face page of the application form. (For more information on which form 
to use, see the section Application Submission and Deadline)

1. Pediatric HIV Infection: Spectrum of Disease, Medical Management, 
Secondary Prevention, and Social Impact

    Applications are solicited for participation in an ongoing multi-
site longitudinal medical record review study, the Pediatric Spectrum 
of HIV Disease (PSD) Project. Applications must address both Parts A 
and B below.
A. Prospective Studies Monitoring HIV-Infected Children
    Applications are solicited for continued prospective monitoring, 
through repeated medical record review,

[[Page 36516]]

of: (i) trends in medical management of pediatric HIV infection 
(including treatment, prophylaxis for opportunistic infections, 
diagnostic testing and immunologic and virologic monitoring); (ii) 
clinical course of HIV infection,(e.g., occurrence of AIDS-defining 
conditions, other manifestations, and death); (iii) long-term outcomes, 
(i.e. clinical course in perinatally infected children who survive to 
adolescence); and (iv) social circumstances, (i.e. changes in 
caretakers and living arrangements, school attendance and knowledge/
disclosure of HIV status).
    Preference will be given to currently funded applicants with 
studies in which HIV-infected children have already been identified and 
are being systematically monitored, and with the capacity to begin 
monitoring newly identified HIV-infected children. Applicants must 
demonstrate adequate rates of follow-up of HIV-infected children, the 
capacity for timely completion of biannual medical record review, and 
must be willing to collaborate with other CDC PSD grantees in the study 
of HIV-infected children, including use of common data collection 
instruments and protocols and data management.
B. Monitoring HIV-Exposed Infants in the First Year of Life
    Applicants must be able to identify infants born to HIV-infected 
mothers after December 1995, and to monitor their HIV-specific medical 
management in the first year of life through retrospective medical 
record review initiated after a child's first birthday, including (i) 
antiretroviral prophylaxis and treatment, (ii) prophylaxis to prevent 
opportunistic infections, (iii) diagnostic testing, and (iv) 
immunologic and virologic monitoring.
    Applicants must have a plan for reporting (where required by law) 
HIV exposure, HIV infection status, or AIDS in children, including 
completion of CDC HIV/AIDS report forms, and entry and complete and 
timely transfer of case reports/updates to the State or local health 
department.

Acceptability of HIV/STD Prevention Methods Among Women and Men Who 
Have Sex With Men

    Studies are underway to determine the safety and efficacy of 
prevention methods that may offer options for HIV/STD protection other 
than the male condom (e.g., female condom, vaginal and rectal products 
that might be used as microbicides). As new methods for HIV/STD 
prevention become available, information is needed on the acceptability 
of the methods to different populations and effective communication 
strategies for informing persons of multiple options for protection 
from HIV and other STDs. Applications are solicited that address: (1) 
acceptability of various HIV/STD prevention methods, characteristics of 
persons choosing different methods, and the conditions under which 
different methods are preferred; (2) comprehension and interpretation 
of prevention messages offering multiple HIV/STD prevention options and 
the impact of these messages on sexual behaviors and intentions; and 
(3) strategies for integrating multiple-option HIV/STD prevention 
messages into more conventional interventions that exclusively promote 
male condom use.

2. Acceptability of Prevention Methods Among Women at Risk for HIV/STD

    Applications are sought that: (1) implement an HIV/STD prevention 
intervention that has previously been shown to be effective at 
increasing male condom use; (2) examine barriers to consistent condom 
use among women who have participated in the intervention; (3) describe 
characteristics of women who are unable to negotiate consistent condom 
use with male partners; and (4) determine if new HIV/STD prevention 
methods under development (e.g., female condom, products that might be 
used as vaginal microbicides) would be acceptable to these women. 
Applicants are sought who can enroll at least 750 women at risk for HIV 
or other STDs in a short-term longitudinal study to: (1) examine 
barriers to male condom use among women participating in a short-term 
intervention promoting male condom use; (2) determine acceptability of 
new HIV/STD prevention methods to women whose male partners are not 
using condoms after the intervention; (3) determine the conditions 
under which new methods would be acceptable and the characteristics of 
women and their partners who prefer the different methods; and (4) 
develop and test methods for presenting multiple HIV/STD options to 
women and for integrating these complex prevention messages into 
interventions promoting only male condom use.

3. Acceptability of HIV/STD Prevention Methods Among Men Who Have Sex 
With Men

    To better understand the acceptability of alternative methods to 
condoms currently being tested for HIV/STD prevention among men who 
have sex with men, applications are solicited that propose examination 
of (1) features that are important in a prevention method for men who 
have sex with men, (2) the extent to which alternative prevention 
methods being tested would be used and the conditions under which these 
methods would be preferred over condom use, (3) the characteristics of 
men and their partners who are likely to use alternative methods, (4) 
effective messages for presenting risks and benefits of various 
prevention methods and (5) effect of message content and format on 
behavioral intentions.
    Applicants are sought who can enroll at least 400 men who have sex 
with men in a cross-sectional study. Proposal should include study 
designs to collect: (1) survey data on current HIV/STD prevention 
practices among men who have sex with men, features that are desired in 
a prevention method, extent to which prevention methods being tested 
(e.g., products that could be used as rectal microbicide) are 
desirable, and the conditions under which these methods would be 
chosen; and (2) data on the influence of HIV/STD prevention message 
content, structure, and complexity on comprehension of the message, 
interpretation of effectiveness and potential risks associated with 
each HIV/STD prevention method contained in the message, and 
acceptability of the different methods.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities listed under 
subparagraph 1., below, and CDC will be responsible for conducting 
activities listed under subparagraph 2., below:

1. Recipient Activities

    A. Develop the research study protocol and data collection forms.
    B. Identify, recruit, obtain informed consent from, and enroll an 
adequate number of study participants as determined by the study 
protocol and the program requirements.
    C. Continue to follow study participants as determined by the study 
protocol.
    D. Establish procedures to maintain the rights and confidentiality 
of all study participants.
    E. Perform laboratory tests (when appropriate) and data analysis as 
determined in the study protocol.
    F. Collaborate and share data and specimens (when appropriate) with 
other collaborators to answer specific research questions.
    G. Conduct data analysis with all collaborators as well as present 
and publish research findings.

[[Page 36517]]

2. CDC Activities

    A. Provide technical assistance in the design and conduct of the 
research.
    B. Provide technical guidance in the development of study 
protocols, consent forms, and data collection forms.
    C. Assist in designing a data management system.
    D. Assist in performance of selected laboratory tests.
    E. Coordinate research activities among the different sites.
    F. Assist in the analysis of research information and the 
presentation and publication of research findings.

Technical Reporting Requirements

    An original and two copies of the following reports are required to 
be submitted to the Grants Management Branch (GMB), CDC in accordance 
with the following guidelines. See the section Where to Obtain 
Additional Information for the address of the GMB.

1. Annual Progress Report

    An annual progress report is required to be included in 
continuation applications for each year of the project. Continuation 
applications will be solicited each year by the Grants Management 
Branch, CDC. The progress reports must include the following for each 
program, function, or activity involved: (1) a comparison of actual 
accomplishments to the goals established for the period, including 
estimated performance for any time remaining in the budget period after 
submission of the application; (2) reasons for slippage if established 
goals are not likely to be met by the end of the budget period; and (3) 
other pertinent information including, when appropriate, analysis and 
explanation of any actual costs that significantly exceed budgeted 
levels.

2. Financial Status Reports (Standard Forms 269)

    Financial Status Reports (FSRs) are required to be submitted 
annually within 90 days after the end of each budget period. The 
purpose of the FSR is to report actual costs incurred as opposed to 
budgeted and to establish any unobligated balances of prior-year funds. 
A final progress report summarizing the progress for the entire project 
is required within 90 days after the end of the project period.

Application Content

    Applications must be developed in accordance with PHS Form 398, 
information contained in the program announcement and the instructions 
and format provided below.
    Applicants are required to submit an original and five copies of 
the application. The application may not exceed 25 double-spaced pages 
in length, excluding appendices. Applicants should provide a one-page 
abstract of the proposal. Number all pages clearly and sequentially and 
include a complete index to the application and its appendices. The 
original and each copy of the application must be submitted UNSTAPLED 
and UNBOUND. Print all material, double spaced, in a 12-point or larger 
font on 8\1/2\'' by 11'' paper, with at least 1'' margins and printed 
on one side only.
    The application should include a general introduction, followed by 
one narrative subsection per application content element in the order 
in which the elements appear below. Each narrative subsection should be 
labeled with the element title and contain all of the information 
needed to evaluate that element of the application (except for 
curriculum vita, references, and letters of support, which are 
appropriate for the appendices). The application content elements are 
outlined below for all research issues:

1. Pediatric HIV Infection: Spectrum of Disease, Medical Management, 
Secondary Prevention, and Social Impact

A. Familiarity With and Access to Study Population
    (1) Describe the population to be prospectively monitored, 
including number, age distribution, and other relevant demographic 
characteristics for Part A; note procedures for identifying HIV-
infected children (including, for example, death certificate review).
    (2) Describe procedures for identifying children born to HIV-
exposed mothers for Part B.
    (3) Describe prior research with or service provision to the study 
populations for Part A and Part B.
    (4) Demonstrate familiarity with issues regarding medical care for 
HIV exposure and infection in children, and progression of disease 
among and social circumstances of HIV-infected children.
    (5) Describe linkages and collaboration with organizations 
providing medical and psychosocial services to the study population 
including plans to improve PSD's case finding and follow up of exposed 
and infected children.
    (6) Document ability to monitor the study population prospectively 
for Part A and for the first year of life for Part B. As appropriate, 
include memoranda of agreement to document collaboration with 
organizations providing services to the study population; document 
ability to complete biannual review of medical records, and describe 
ability to track children who change care providers.
    (7) Describe procedures for involving the service providers in the 
design and implementation of research activities under Part B and for 
reporting results of the research to collaborating service providers 
(Parts A and B).
B. Description and Justification of a Research Plan
    (1) Based on review of the scientific literature, describe 
understanding of the overall research issues to be addressed by PSD and 
any specific research focus of interest to the applicant (Parts A and 
B). Research issues/topics may include participant characteristics 
(e.g., ethnicity, year of birth, clinical, immunologic, or social 
status), disease progression, survival, medical management, and 
developing and evaluating recommendations for medical care, including 
recommendations for preventing opportunistic infections.
    (2) Specify the number of HIV-infected enrollees to be 
prospectively monitored, and expected attrition from deaths and losses 
to follow-up over the study period based on prior experience (Part A).
    (3) Describe methods and procedures for data abstraction and 
assuring adequate follow-up and timely completion of data forms (Parts 
A and B).
    (4) Describe proposed quality assurance measures including methods; 
protocols; supervision of data abstraction, entry, and cleaning; 
maintaining consistency of data abstraction; accuracy and completeness 
of record keeping; monitoring of study progress; and forming and 
maintaining collaborative relationships (Parts A and B).
    (5) Describe plans to analyze local data using quantitative methods 
and statistical techniques and submit results and all data to CDC 
(Parts A and B).
    (6) Describe procedures for tracking follow-up of HIV-infected 
children.
    (7) Describe previous experience conducting data collection and 
management for PSD and PSD supplemental research projects.
    (8) Describe procedures for obtaining Institutional Review Board 
(IRB) approval and maintaining participant confidentiality (Parts A and 
B).
    (9) Identify and discuss any potential ethical issues associated 
with the proposed research and describe how these issues will be 
resolved (Parts A and B).

[[Page 36518]]

    (10) Describe plans to disseminate research findings (Parts A and 
B).
C. Provision of HIV/AIDS Report Data to and Collaboration With Local 
Pediatric HIV/AIDS Surveillance Activities
    (1) Describe procedures for collaborating with local health 
department pediatric HIV/AIDS surveillance staff to report children 
with HIV exposure, infection, and AIDS (depending on State law), 
including specific responsibilities and schedules for completion and 
computer entry of HIV/AIDS report forms, schedule for transfer of HIV/
AIDS report data to State/local health department surveillance unit, 
and measures to protect confidentiality of HIV/AIDS report data. (For 
applicants in States without HIV reporting laws, describe intentions 
for use of HIV infection data.) Include a signed memorandum of 
agreement detailing the outlined division of responsibilities, joint 
activities to evaluate completeness, timeliness, validity of the HIV/
AIDS report data, methods to ensure security and confidentiality of 
HIV/AIDS report data, and use of data.
    (2) Describe measures to assure completeness of HIV/AIDS report 
forms, and quality and timeliness of data.
D. Demonstration of Staff's Capability to Conduct Research
    (1) Summarize briefly the professional training and relevant 
research experience of the staff as it relates to their main 
responsibilities.
    (2) Provide brief descriptions and major findings of HIV-related 
research studies conducted by members of the research staff.
    (3) Include a table of current and previous relevant research 
projects, their status, sources and levels of funding, and principal 
investigators.
    (4) Include in the appendix the curriculum vitae for key staff 
members as well as memoranda of agreement that clearly and specifically 
document activities to be performed by any external experts, 
consultants, or collaborating agencies under the cooperative agreement.
    (5) Include copies of any publications on related research by study 
staff.
E. Staffing, Facilities, and Time Line
    (1) Explain the proposed staffing, percentage of time each staff 
member commits to this and other projects, and division of duties and 
responsibilities for the project; include brief position descriptions 
for existing and proposed personnel.
    (2) Identify and describe key roles of all study staff.
    (3) Provide justification that base staffing is adequate to keep 
pace with biannual medical record review for the number of children to 
be monitored prospectively for Part A, and to complete abstraction of 
records for all children studied in Part B by 15 months of age.
    (4) Describe support activities such as project oversight or data 
management that will contribute to the completion of all research 
activities.
    (5) Provide a statement of willingness of project staff to work 
collaboratively with other study sites to develop final research 
protocols and to disseminate findings.
    (6) Describe existing facilities, equipment, computer software, and 
data processing capacity.
    (7) Describe the procedures to ensure the security of research 
data.
    (8) Describe equipment and facilities to be used for data 
abstraction and follow-up tracking, data entry and analysis, and 
project management.
    (9) Justify the need for any proposed consultants.
    (10) Describe plans to communicate, ensure quality control and 
consistency, identify and resolve problems, and analyze data in 
collaboration with other sites.
    (11) Provide a time line showing plan for completion of research 
activities and goals.
F. Budget
    Provide a detailed, line-item budget for the project; justify each 
line-item with a budget narrative. Plan for at least one trip per year 
to Atlanta to meet with CDC representatives.

2. Acceptability of Prevention Methods Among Women At Risk for HIV/STD; 
3. Acceptability of HIV/STD Prevention Methods Among Men Who Have Sex 
With Men; and 4. Other HIV/AIDS Epidemiology Research Studies

A. Familiarity With and Access to Study Population
    (1) Describe prior research with or service provision to this 
population.
    (2) Demonstrate familiarity with issues faced by the study 
population regarding prevention of sexually transmitted infections, 
sexual behaviors, and reproductive decisions and contraception through 
experience or review of the scientific literature.
    (3) Describe how study participants will be referred to medical and 
psychosocial services that are requested by participants during study 
participation.
    (4) Document ability to recruit the study population for the 
proposed research study. As appropriate, include memoranda of agreement 
to document collaboration with organizations providing services to the 
study population.
    (5) Describe the characteristics of the study population and define 
the specific subgroup(s) that will be the primary focus of the proposed 
research. Using available data, provide a rationale for focusing on the 
proposed subgroup(s).
    (6) Describe procedures for involving the target population, their 
advocates, or service providers in the design and implementation of 
research activities.
    (7) 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 
will be documented.
    (8) The proposed plan for the inclusion of racial and ethnic 
minority populations for appropriate representation.
    (9) The proposed justification when representation is limited or 
absent.

B. Description and Justification of Research Plans

    (1) Based on review of the scientific literature, if relevant, 
describe the theoretical framework or previous research on which your 
plan is based and how this framework has been applied to the study 
design.
    (2) Describe factors to be examined, including specific research 
questions and hypotheses to be tested.
    (3) Define and describe type of study design.
    (4) Describe methods for collecting qualitative and quantitative 
data, including outcome measures, types and content of data collection 
instruments, and data collection schedules.
    (5) Specify the number research participants required, the 
recruitment and sampling plan, sample size estimates and power 
calculations based on justifiable assumptions about distributions of 
participant characteristics, and randomizations procedures, if 
appropriate.
    (6) Describe proposed quality assurance measures including methods, 
protocols, supervision, quality assurance, consistency, confidentiality 
of participant information, accuracy and completeness of record 
keeping, documentation of study visits, monitoring of study progress, 
field safety, and forming and maintaining collaborative relationships.
    (7) Describe procedures for obtaining informed consent and 
maintaining participant confidentiality.
    (8) Identify and discuss potential ethical issues associated with 
the

[[Page 36519]]

proposed research and describe how these issues will be resolved.
    (9) Discuss if design of the study is adequate to measure racial 
and ethnic differences, when warranted.
    (10) Describe plans to analyze data using qualitative or 
quantitative methods and statistical techniques.
    (11) Describe a plan to disseminate research findings.
C. Demonstrate Staff's Capability to Conduct Research
    (1) Describe the professional training and relevant research 
experience of the staff.
    (2) Provide descriptions and major findings of HIV-related 
research, behavioral and epidemiologic research studies conducted by 
members of the research staff.
    (3) Include a table of current and previous relevant research 
projects, their status, sources and levels of funding, and principal 
investigators.
    (4) Include in the appendix, the curriculum vitae for key staff 
members as well as memoranda of agreement that clearly and specifically 
document activities to be performed by any external experts, 
consultants, or collaborating agencies under the cooperative agreement.
    (5) Include copies of any publications on related research by study 
staff.
D. Staffing, Facilities, and Time Line
    (1) Explain the proposed staffing, percentage of time each staff 
member commits to this and other projects, and division of duties and 
responsibilities for the project; include brief position descriptions 
for existing and proposed personnel.
    (2) Identify and describe key roles of all study staff.
    (3) Describe support activities such as project oversight or data 
management that will contribute to the completion of all research 
activities.
    (4) Provide a statement of willingness of project staff to work 
collaboratively with other study sites.
    (5) Describe facilities, equipment, computer software, and data 
processing capacity.
    (6) Describe the procedures to ensure the security of research 
data.
    (7) Provide a time line for developing, implementing, and 
completing the research study, including data analysis and 
dissemination.
    (8) Describe equipment and facilities to be used for participant 
recruitment and interviews, clinical and laboratory assessment, data 
entry and analysis, and project management.
    (9) Justify the need for any proposed consultants.
    (10) If project is multisite, describe experience with multisite 
research projects. Describe plans to communicate, ensure quality 
control and consistency, identify and resolve problems, and analyze 
data in collaboration with other sites.
E. Budget
    Provide a detailed, line-item budget for the project; justify each 
line-item with a budget narrative. Plan for at least one trip to 
Atlanta to meet with CDC representatives.

Evaluation Criteria

    All applications will be reviewed according to the criteria listed 
below for each research issue. Applicants will be ranked on a scale of 
100 maximum points according to the three research issues listed above 
and a fourth category for all other HIV-related epidemiologic studies. 
All applicants must state which research category they are addressing. 
Applications should demonstrate the applicant's ability to address the 
research problem in a collaborative manner with other collaborators. 
Applications will be reviewed and evaluated based on the evidence 
submitted, which specifically describes the applicant's abilities to 
meet the following criteria:

1. Pediatric HIV Infection: Spectrum of Disease, Medical Management, 
Secondary Prevention, and Social Impact

A. Familiarity With and Access to Study Population (25 points)
    (1) Extent of applicant's knowledge of issues faced by study 
population and experience in working with medical records of this 
population (Parts A and B).
    (2) Existence of linkages to facilitate monitoring the study 
population (Parts A and B), including memoranda of agreement from the 
clinical facilities to permit record review.
    (3) Ability to identify and follow for one year all HIV-exposed 
children in the catchment area.
    (4) Feasibility of plans to improve linkages for PSD's follow-up of 
HIV-infected children (Part B).
    (5) Feasibility of plans to involve service providers in the 
development and implementation of research activities and to inform 
them of research results (Parts A and B).
    (6) Ability to monitor newly identified HIV-exposed children.
    (7) Demonstrated collaboration with local health departments and 
pediatric HIV/AIDS surveillance staff.
B. Description and Justification of Research Plans (15 Points)
    (1) Quality of the review of the scientific literature pertinent to 
the proposed activities, including justification for and relevance of 
research questions (Parts A and B).
    (2) The applicant's understanding of the research objectives as 
evidenced by high quality of the proposed research plan (Parts A and 
B).
    (3) Feasibility of plans to monitor study participants as evidenced 
by the experience of the investigator in enrolling and monitoring such 
children, and the comprehensiveness of the plan to protect the 
confidentiality of all participants (Parts A and B).
    (4) Creativity and thoroughness of analysis plans and 
reasonableness for data collected (Parts A and B).
    (5) Extent to which the study proposal demonstrates assurance of 
compliance with multisite research requirements (common protocol, data 
collection, and computer and data management systems) (Parts A and B).
    (6) The degree to which the applicant has met the requirements 
regarding plans for the inclusion of ethnic and racial groups in the 
proposed research, and comprehensiveness of the plan to protect the 
rights and confidentiality of all participants.
C. Provision of HIV/AIDS Report Data To and Collaboration With Local 
Pediatric HIV/AIDS Surveillance Activities (20 Points)
    (1) Feasibility of plans for completion and computer entry of HIV/
AIDS report forms and complete and timely transfer of HIV/AIDS case 
reports to local HIV/AIDS surveillance unit.
    (2) Adequacy of measures to assure completeness of HIV/AIDS report 
forms, data quality and timeliness, and protection of confidentiality.
D. Demonstration of Staff's Capability to Conduct Research (20 Points)
    (1) Capacity to conduct the proposed activities as evidenced by 
previous experience with PSD and PSD supplemental studies (Parts A and 
B).
    (2) Adequacy of base staff to keep pace with anticipated workload 
(Part A).
E. Staffing, Facilities, and Time Line (20 points)
    (1) Availability of qualified personnel with realistic and 
sufficient percentage-time commitments; clarity of the described duties 
and responsibilities of project personnel with epidemiologic, 
administrative, clinical, laboratory, data management (including HIV/
AIDS case reporting to local surveillance unit), and statistical 
responsibilities; adequacy of

[[Page 36520]]

clinical oversight of the project, especially supervision of data 
abstraction and entry.
    (2) Adequacy of the facilities, equipment, data processing and 
analysis capacity, and systems for management of data security and 
participant confidentiality.
    (3) Ability, willingness, and need to collaborate with researchers 
from other study sites in study design and analysis, including use of 
common forms, and sharing of data (Parts A and B).
F. Other (Not Scored)
    (1) Budget: Will be reviewed to determine the extent to which it is 
reasonable, clearly justified, consistent with the intended use of 
funds, and allowable. All budget categories should be itemized.
    (2) Human Subjects: Whether or not exempt from the DHHS 
regulations, are procedures adequate for the protection of human 
subjects? Recommendations on the adequacy of protections include the 
following: (a) protections appear adequate and there are no comments to 
make or concerns to raise, (b) protections appear adequate, but there 
are comments regarding the protocol, (c) protections appear inadequate 
and the Objective Review Group (ORG) has concerns related to human 
subjects; or (d) disapproval of the application is recommended because 
the research risks are sufficiently serious and protection against the 
risks are inadequate as to make the entire application unacceptable.

2. Acceptability of Prevention Methods Among Women at Risk for HIV/STD; 
3. Acceptability of HIV/STD Prevention Methods Among Men Who Have Sex 
With Men; and 4. Other HIV/AIDS Epidemiology Research Studies 
Evaluation Criteria Include

A. Familiarity With and Access to Study Population (25 Points)
    (1) Extent of applicant's knowledge of issues faced by study 
population and experience in working with this population.
    (2) Existence of linkages to facilitate recruitment from and 
referral to programs providing services for the study population and 
letters of support.
    (3) Feasibility of plans to involve the study population, their 
advocates, or service providers in the development of research and 
intervention activities and to inform them of research results.
    (4) Evidence that plans for recruitment and outreach for study 
participants will include establishing partnerships with communities.
B. Description and Justification of a Research Plan (40 points)
    (1) Quality of the review of the scientific literature pertinent to 
the proposed study, including theoretical basis for research, and 
relevance of research questions.
    (2) The originality of research, the extent to which it does not 
replicate past or present research efforts (including ongoing efforts 
not yet described in publications), and relevance to guiding current 
HIV prevention efforts.
    (3) Applicant's understanding of the research objectives as 
evidence by high quality of the proposed research plan with a study 
design that is appropriate to answer research questions.
    (4) Quality of the study design, including appropriateness for 
answering the proposed research questions.
    (5) Feasibility of plans to sample, recruit, enroll, test, 
interview and follow study participants, adequacy of sample size to 
address research questions. This includes demonstration of the 
availability of HIV-infected potential study participants and persons 
at risk for HIV infection and the experience of the investigator in 
enrolling and following such persons in a culturally and linguistically 
appropriate manner; 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, and comprehensiveness of the 
plan to protect the rights and confidentiality of all participants; and 
proposed justification when representation is limited or absent.
    (6) Thoroughness of analysis plans, reasonableness for data 
collected, statistical rigor and complexity.
    (7) Extent to which study proposal demonstrates assurance of 
compliance with multisite research requirements (e.g., common protocol, 
data collection, and computer and data management systems), if 
appropriate.
C. Demonstrate Staff's Capability To Conduct Research (20 points)
    (1) Capacity to conduct study as evidenced by experience with 
similar or related research as evidenced by their previous related 
research.
    (2) Extent of the team's productive working relations with proposed 
collaborators.
    (3) Ability, willingness, and need to collaborate with researchers 
from other study sites in study design and analysis, including use of 
common forms, and sharing of specimens (when appropriate) and data.
D. Staffing, Facilities, and Time Line (15 points)
    (1) Availability of qualified personnel with realistic and 
sufficient percentage-time commitments; clarity of the described duties 
and responsibilities of project personnel, with behavioral, 
epidemiologic, administrative, clinical, laboratory, data management, 
and statistical responsibilities.
    (2) Adequacy of the facilities, equipment, data processing and 
analysis capacity, and systems for management of data security and 
participant confidentiality.
    (3) Adequacy of time line.
E. Other (not scored)
    (1) Budget: Will be reviewed to determine the extent to which it is 
reasonable, clearly justified, consistent with the intended use of 
funds, and allowable. All budget categories should be itemized.
    (2) Human Subjects: Whether or not exempt from the DHHS 
regulations, are procedures adequate for the protection of human 
subjects? Recommendations on the adequacy of protections include the 
following: (a) protections appear adequate and there are no comments to 
make or concerns to raise, (b) protections appear adequate, but there 
are comments regarding the protocol, (c) protections appear inadequate 
and the Objective Review (OR) Group has concerns related to human 
subjects; or (d) disapproval of the application is recommended because 
the research risks are sufficiently serious and protection against the 
risks are inadequate as to make the entire application unacceptable.

Funding Preferences

    Preference will be given to competing continuation applications 
from satisfactorily performing projects over applications for projects 
not already receiving support under the program. Projects will be 
awarded so that the composite of projects represents the geographic and 
demographic characteristics of the HIV-infected population.

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 government review of proposed Federal 
assistance applications. Applicants (other than Federally recognized 
Indian tribal governments) should contact their State Single Point of 
Contact (SPOC) as early as possible to alert them to the prospective 
applications and receive

[[Page 36521]]

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 
applications submitted to CDC, they should send them to Mr. Van Malone, 
Grants Management Officer, Grants Management Branch, Procurement and 
Grants Office, Centers for Disease Control and Prevention (CDC), Room 
300, Mail Stop E-15, 255 East Paces Ferry Road, NE, Atlanta, GA 30305. 
Correspondence should arrive at CDC no later than 45 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.
    Indian tribes are strongly encouraged to request tribal government 
review of the proposed application. If tribal governments have any 
tribal process recommendations on applications submitted to the CDC, 
they should forward them to Van Malone, Grants Management Officer, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., 
Room 300, Mailstop E15, Atlanta, GA 30305. This should be done no later 
than 30 days after the application deadline date. The granting agency 
does not guarantee to accommodate or explain for tribal process 
recommendations it receives after that date.

Public Health System Reporting Requirements

    This program is subject to the Public Health System Reporting 
Requirements. Under these requirements, all community-based 
nongovernmental applicants must prepare and submit the items identified 
below to the head of the appropriate State and/or local health 
agency(ies) in the program area(s) that may be impacted by the proposed 
project no later than the receipt date of the Federal application. The 
appropriate State and/or local health agency is determined by the 
applicant. The following in information must be provided:
    1. A copy of the face page of the application.
    2. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not to exceed one page, and include 
the following:
    A. A description of the population to be served;
    B. A summary of the services to be provided; and
    C. A description of the coordination plans with the appropriate 
State and/or local health agencies.
    If the State and/or local health official should desire a copy of 
the entire application, it may be obtained from the State Single Point 
of Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance Number is 93.943, 
Epidemiologic Research Studies of Acquired Immunodeficiency Syndrome 
(AIDS) and Human Immunodeficiency Virus (HIV) Infection in Selected 
Population Groups.

Other Requirements

1. Paperwork Reduction Act

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

2. 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 or 
activity 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.
    In addition to other applicable committees, Indian Health Service 
(IHS) institutional review committees also must review the project if 
any component of IHS will be involved with or support the research. If 
any American Indian community is involved, its tribal government must 
also approve that portion of the project applicable to it.

3. 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.

4. Patient Care

    Applicants must provide assurance that all HIV-infected patients 
enrolled in their studies will be linked to an appropriate local HIV 
care system that can address their specific needs such as medical care, 
counseling, social services, and therapy. Details of the HIV care 
system should be provided, describing how patients will be linked to 
the system. Funds will not be made available to support the provision 
of direct care for study participants.

5. Women, Racial and Ethnic Minorities

    It is the policy of the CDC to ensure that individuals of both 
sexes and the various racial and ethnic groups will be included in CDC-
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, Alaskan Native, Asian/ 
Pacific Islander, Black and Hispanic. 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, Friday, September 15, 1995, pages 47947-47951 (a copy 
is included in the application kit).

Application Submission and Deadline

    The original and five copies of the application packet PHS-398 
(Revised 5/95, OMB No. 0925-0001) must be submitted to Van Malone, 
Grants Management Officer (ATTN: Kevin Moore, PA #735), Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry

[[Page 36522]]

Road, NE., Room 320, Mail Stop E-15, Atlanta, Georgia 30305, on or 
before August 8, 1997.
    1. Deadline: Applications will be considered as meeting the 
deadline if they are either:
    A. Received on or before the stated deadline date; or
    B. Sent on or before the deadline date and received in time for 
submission to the independent review group. (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 will not be accepted as proof of timely mailing.
    2. Late Applications: Applications that do not meet the criteria in 
1.A. or 1.B. are considered late applications. Late applications will 
not be considered in the current competition and will be returned to 
the applicant.

Where to Obtain Additional Information

    A complete program description, information on application 
procedures, an application package, and business management technical 
assistance may be obtained from Kevin Moore, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 320, Mail Stop E-15, Atlanta, Georgia 30305, telephone 
(404) 842-6550, E-mail address [email protected]. 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.
    Programmatic technical assistance may be obtained from Jeff Efird, 
Division of HIV/AIDS Prevention, National Center for HIV, STD, TB 
Prevention, Centers for Disease Control and Prevention (CDC), 1600 
Clifton Road, NE., Mail Stop E-45, Atlanta, Georgia 30333, telephone 
(404) 639-6130, E-mail address [email protected]. Eligible applicants are 
encouraged to call before developing and submitting their application. 
Please refer to Announcement Number 735 when requesting information.
    Potential applicants may obtain a copy of ``Healthy People 2000'' 
(Full Report: Stock No. 017-001-00474-0) or ``Healthy People 2000'' 
(Summary Report: Stock No. 017-001-00473-1) referenced in the 
Introduction from the Superintendent of Documents, Government Printing 
Office, Washington, DC 20402-9325, telephone (202) 512-1800.

    Dated: July 1, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-17702 Filed 7-7-97; 8:45 am]
BILLING CODE 4163-18-P