[Federal Register Volume 61, Number 118 (Tuesday, June 18, 1996)]
[Notices]
[Pages 30899-30902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15379]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 625]


FY 1996 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) 1996 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 
disease progression of HIV infection in women, mother-to-child HIV 
transmission, sexual and needleborne transmission of HIV among drug 
users, and the spread of HIV infection in rural and small cities in the 
United States. The study of these research areas as they pertain to 
racial and ethnic minority populations (defined as Black, Hispanic, 
Asian and Pacific Islander, and American Indian) is encouraged because 
minorities constitute over 50% of all reported cases of AIDS and 
approximately 76% 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. This is consistent with 
the PHS mission to protect and advance the physical and mental health 
of American people.

Eligible Applicants

    Eligible applicants include all public and private, nonprofit and 
for-profit organizations and governments and their agencies. Thus, 
universities, colleges, research institutions, hospitals, and other 
public and private organizations, 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 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.

Availability of Funds

    Approximately $6,900,000 will be available in FY 1996 to fund 
approximately 16 awards. It is expected that the average new award will 
be approximately $300,000 and that the average continuation award will 
be $500,000, ranging from $100,000 to $1,000,000. It is expected that 
approximately 3 new and 13 competing renewal awards will be made and 
that awards will begin on or about September 30, 1996. Awards will be 
funded for a 12-month budget period within a project period of up to 5 
years. Funding estimates may vary and are subject to change. 
Continuation awards within the project period will be made on the basis 
of satisfactory programmatic progress and the availability of funds.

Purpose

    The purpose of these awards is to help support researchers in the 
conduct of HIV-related epidemiologic and behavioral research studies. 
These include studies to examine factors related to disease progression 
of HIV infection in women, mother-to-child HIV transmission, sexual and 
needleborne transmission of HIV among drug users, and the spread of HIV 
infection in small cities and rural areas in the United States. The 
study of these research areas as they pertain to minority populations 
are of special interest.

Research Issues

    Four research issues of programmatic interest to the health care 
community and to CDC for FY 1996 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. 
Applicants are required to identify their proposed research issue on 
line 1 of the face page of the application if the PHS-398 is used, or 
Block 11 of the face page if the PHS-5161-1 is used (for more 
information on the forms to use, see the section APPLICATION SUBMISSION 
AND DEADLINE).

1. Studies of HIV Disease Progression in Women

    Studies should be designed to identify, enroll, and prospectively 
follow women who are HIV-infected and demographically similar women who 
are not HIV-infected but who have demonstrable risk for HIV infection 
so that the biologic, behavioral, and psychosocial determinants and 
correlates of HIV disease progression

[[Page 30900]]

and other health outcomes can be assessed. Preference will be given to 
sites (1) where at least 200 HIV-infected and 100 HIV-uninfected women 
are already being systematically followed, (2) at which behavioral 
scientists are part of the research team, and (3) at which the 
applicant or its documented collaborative partners have the ability to 
perform virologic and immunologic assays. Applicants must demonstrate 
that they can provide adequate rates of follow-up, including collection 
of laboratory specimens, tracking and abstraction of medical records, 
and determination of causes of deaths. Applicants must be willing to 
participate in collaborative studies with other CDC-sponsored women's 
HIV disease progression projects, including the use of common data 
collection instruments, specimen collection protocols, and data 
management procedures. Applicants must demonstrate cost-efficient local 
data management and statistical capability.

2. Mother-to-Child HIV Transmission Studies

    Studies should be designed to identify HIV-infected women during 
pregnancy or at delivery and enroll the women and their infants in a 
prospective follow-up study to examine factors related to mother-to-
child HIV transmission, early diagnosis of infant infection, and 
disease progression in children. Studies designed to examine the effect 
of interventions such as zidovudine use to prevent mother-to-child HIV 
transmission are of particular interest. Preference will be given to 
applicants with studies in which mother-infant pairs are already being 
systematically identified and followed, and which have the ability to 
perform virologic and immunologic assays. Applicants must demonstrate 
that they can provide adequate rates of follow-up of both mothers and 
infants, including collection of laboratory specimens at periodic 
intervals (particularly within the first 48 hours of birth and during 
the first 6 months of life), and long-term follow-up of infants, 
including those placed in foster care. Applicants must be willing to 
participate in collaborative studies with other CDC-sponsored mother-
to-child HIV transmission projects, including use of common data 
collection instruments and study design where warranted. Applicants 
must demonstrate cost-efficient data management, laboratory testing, 
and statistical capability or provide explicit plans for data 
management by CDC or an outside group. Applicants must demonstrate the 
ability to enroll and follow at least 30 HIV-positive mother-infant 
pairs per year.

3. Sexual and Needleborne Transmission of HIV Among Drug Users

    Study proposals are solicited that address HIV infection in young 
drug-abusing populations that are recruited on the street and not 
routinely seen in clinics, hospitals, or similar institutional 
settings. The purpose of such studies will be to address issues 
important to the sexual, needleborne, and injection paraphernalia 
related transmission of HIV and settings that may contribute to HIV 
infection among drug users who are not seen in the usual medical and 
drug-treatment facilities. Preference will be given to projects that 
involve community outreach to enroll recently initiated drug users for 
interview and examination and that focus on inner-city or rural areas 
where drug use among young adults is prevalent.
    Examples of worthwhile proposals are HIV seroincidence cohorts that 
describe initiating practices of injection and risks for young adults; 
current sources, acquisition, and cleaning and disposal of needles and 
syringes; issues of violence as they relate to drug use and the impact 
on individual, family and community; social networks including contacts 
and community dynamics that affect HIV incidence. Other related aspects 
of incidence and management of infectious complications of drug use, 
including skin and respiratory infections that could be altered by HIV 
immune suppression, and their possible impact on the progression of HIV 
infection. Applicants should demonstrate their ability to access young 
injection drug-using populations not currently in drug treatment, 
interview and examine them in a confidential manner, and provide or 
link study participants to appropriate medical, drug-treatment and 
other services. Applicants for studies of these difficult-to-reach 
populations should demonstrate their ability to provide new insights 
into the epidemiology of HIV infection in injecting drug users and not 
duplicate other projects; possess cost-effective data management and 
statistical capabilities, or provide specific plans for management of 
data; and participate collaboratively in a multisite study with other 
researchers in the development, implementation, and analysis of data 
from the proposed study.

4. HIV Infection in Small Cities and Rural Areas

    Studies should be designed to identify, interview, and learn more 
about HIV-infected persons who live in rural and small cities (small 
cities and rural areas outside metropolitan statistical areas of more 
than 500,000) such as their (1) modes of exposure to HIV, (2) substance 
abuse, (3) travel/migration patterns, (4) health care seeking 
behaviors, (5) barriers to care, and (6) sexually transmitted diseases. 
Preference will be given to studies that address the following 
questions. What specific behaviors (e.g., sexual and substance abuse) 
are related to infection of persons residing in these areas? Did 
persons from these areas become infected in their current areas of 
residence or during travel or residences in large metropolitan areas? 
What are the barriers to care specific to HIV-infected persons living 
in small cities and rural areas? What health care sites (e.g., STD and 
family planning clinics) did the patient visit during and before the 
estimated time period of infection, and what HIV prevention messages 
and services were offered and received?
    Applicants must demonstrate the ability to enroll and follow at 
least 50 HIV-infected patients residing in small cities and rural 
areas. Applicants must be willing to participate collaboratively in a 
multi-site study with other researchers in the development, 
implementation, and analysis of data from the proposed study. 
Applicants are expected to determine proper distribution of 
participants by sex, race, and ethnicity for their topic of study and 
to state clearly in the application the composition of the proposed 
study population. If women, racial, or ethnic minorities are not 
included in the proposed study, applicants must justify their 
exclusion.

Program Requirements

    Under this cooperative agreement program, CDC will assist the 
researcher in conducting the epidemiologic research of AIDS and HIV 
infection described in the PURPOSE section of this announcement.
    In conducting activities to achieve the purpose of this program, 
the recipient shall be responsible for the activities listed under 
subparagraph 1., below, and CDC shall be responsible for the activities 
listed under subparagraph 2., below:

1. Recipient Activities

    Applicants addressing the same research issue must 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.

[[Page 30901]]

    a. Meet with other funded grantees and develop the research study 
protocol and the interview instrument.
    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 
research findings subject to the provisions of the following section, 
CDC Activities.

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 questionnaires.
    c. Assist in designing a data management system.
    d. Perform selected laboratory tests.
    e. Coordinate research activities among the different sites.
    f. Participate in the analysis of research information and the 
presentation of research findings.

Evaluation Criteria

    All applications will be reviewed according to the same criteria; 
however, applicants will be ranked on a scale of 200 maximum points 
according to the four research issues listed above and a fifth 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 CDC. Applications will be reviewed and 
evaluated based on the evidence submitted, which specifically describes 
the applicant's abilities to meet the following criteria:
    1. The inclusion of a detailed review of the scientific literature 
pertinent to the study being proposed and specific research questions 
or hypotheses that will guide the research; (25 points)
    2. The originality and need for the proposed research, the extent 
to which it does not replicate past or present research efforts, and 
how findings will be used to guide prevention and control efforts; (25 
points)
    3. The quality of the plans to develop and implement the study 
describing how study participants (including racial and ethnic minority 
populations) will be identified, enrolled, tested and followed; (25 
points)
    4. The ability to enroll and follow an adequate number of eligible 
study participants to ensure proper conduct of the study. This includes 
demonstration of the availability of HIV-infected potential study 
participants 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. This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation;
    b. The proposed justification when representation is limited or 
absent;
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted;
    d. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with community(ies) and recognition of mutual benefits will be 
documented; (25 points)
    5. The applicant's understanding of the research objectives and the 
ability, willingness, and need to collaborate with CDC and researchers 
from other study sites in study design and analysis, including use of 
common forms, and sharing of specimens (when appropriate) and data; (25 
points)
    6. The applicant's current experience in AIDS and HIV epidemiologic 
or behavioral research and how it will be applied to achieving the 
objectives of the study (letters of support from cooperating 
organizations that demonstrate the nature and extent of such 
cooperation should be included); (20 points)
    7. The comprehensiveness of the plan to protect the rights and 
confidentiality of all participants; (20 points)
    8. Availability of qualified and experienced personnel with 
realistic and sufficient percentage-time commitments; clarity of the 
described duties and responsibilities of project personnel; adequacy of 
the facilities, equipment, and plans for the administration of the 
project, including project oversight and data management; (20 points)
    9. A comprehensive schedule for accomplishing the activities of the 
research and an evaluation plan that identifies methods and instruments 
for evaluating progress in designing and implementing the research 
objectives. (15 points)
    10. Other (Not Scored).
(1) Budget
    The 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: (a) protections appear adequate and 
there are no comments to make or concerns to raise, or (b) protections 
appear adequate, but there are comments regarding the protocol, or (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.

Funding Preferences

    Priority 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 not subject to review under Executive Order 12372, 
Intergovernmental Review of Federal Programs.

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

[[Page 30902]]

Other Requirements

1. 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.

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/AIDS Requirements

    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 should 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 and/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 completed application packet 
PHS 398 (Revised 5/95, OMB No. 0925-0001) must be submitted to Van 
Malone, Grants Management Officer (ATTN: Kevin Moore), Grants 
Management Branch, Procurement and Grants Office (625), Centers for 
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., 
Room 320, Mail Stop E-15, Atlanta, Georgia 30305, on or before August 
2, 1996. States and local governments may use Form PHS-5161-1 (Revised 
7/92, OMB No. 0937-0189); however, Form PHS-398 is preferred. If using 
Form PHS-5161-1, submit an original and two copies to the address 
stated above.

1. Deadline

    Applications shall 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 shall not be accepted as proof of timely mailing.)

2. Late Applications

    Applications that do not meet the criteria in 1.a. or 1.b. above 
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. Eligible applicants are encouraged to call before 
developing and submitting their application. Please refer to 
Announcement Number 625 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: June 11, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-15379 Filed 6-17-96; 8:45 am]
BILLING CODE 4163-18-P