[Federal Register Volume 63, Number 125 (Tuesday, June 30, 1998)]
[Notices]
[Pages 35589-35592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17305]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 98035]


Epidemiologic Research Studies of Acquired Immunodeficiency 
Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) Infection Notice 
of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1998 funds for new and competitive 
continuation cooperative agreements for epidemiologic and behavioral 
research studies of AIDS and HIV infection. This program addresses the 
``Healthy People 2000'' priority area of HIV Infection. These awards 
will help support researchers in the conduct of HIV-related 
epidemiologic research studies that foster prevention of HIV infection 
or HIV-related disease in children. These include studies that address 
the follow-up of HIV-infected children and other HIV epidemiologic 
studies.

Research Issue: HIV Infection in Children--Follow Up of Perinatally-
Infected Children

    Applications are solicited for continued prospective follow-up of 
HIV-infected children enrolled in the Perinatal AIDS Collaborative 
Transmission Study (PACTS) between 1986 and 1998. This is a research 
issue of programmatic interest to the health care community and to CDC 
for FY 1998. This issue is considered significant to gaining a greater 
understanding of the epidemiology of AIDS and HIV infection. Follow-up 
should be done at least every 3 months, and include: (1) collecting 
information on HIV-related clinical conditions, HIV-related medication 
use, hospitalizations, and vital status; and (2) collecting blood 
specimens for viral load testing, lymphocyte immunophenotyping, and 
storage for other HIV-related testing. Applicants will use a common 
data collection instrument, protocol, and data management system 
designed and implemented in collaboration with CDC.
    Applications submitted by organizations that examine additional 
important HIV-related epidemiologic research issues will also be 
accepted and considered for funding.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit organizations, State and local governments or 
their bona fide agents, and federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations.

C. Availability of Funds

    Approximately $4.5 million is available in FY 1998 to fund 
approximately 6 awards. It is expected that awards will range from 
$250,000 to $1.5 million. It is expected that 4 projects addressing HIV 
infection in children and 2 other HIV epidemiologic studies will be 
funded. Awards will begin on or about September 29, 1998, and will be 
made for a 12-month budget period, within a project period of up to 3 
years. Funding estimates may change.

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.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities listed under 
``Recipient Activities,'' below, and CDC will be responsible for 
conducting activities listed under ``CDC Activities'', below:

Recipient Activities

    Applicants addressing the same research issue should be willing to 
participate in collaborative studies with other CDC-sponsored 
researchers, including using common data collection instruments, 
specimen collection protocols, and data management procedures, as 
determined in post-award grantee planning conferences. Applicants will 
be required to pool data for analysis and publication. Applicants are 
also required to:
    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.

[[Page 35590]]

    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.

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.

E. Application Content

Competing Applications (New Applications and Competing Continuation 
Applications)

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan.
    Applicants should identify their proposed research issue on line 
one of the face page of the application form. Applicants must 
demonstrate adequate capacity for continued follow-up of children, 
routine virologic and immunologic testing, data management, and 
specimen storage. Applicants also must demonstrate the capacity to 
analyze data and specimens collected in the PACTS project to address 
important issues related to preventing HIV infection and its 
manifestations in children, and provide proposed analyses to be 
completed during the project period.
    In future years, noncompeting continuation applications submitted 
within the approved project period should include:
    A. brief progress report describing the accomplishments of the 
preceding budget period;
    B. new or significantly revised items or information (objectives, 
scope of activities, operational methods, evaluation), that is, not in 
the initial application; and
    C. annual budget and justification (budget items that are unchanged 
from the preceding budget period do not need rejustification, simply 
list the items in the budget and note that they are continuation 
items).

F. Submission and Deadline

    On or before JULY 31, 1998, submit the original and five copies of 
PHS-398 (OMB Number 0925-0001) (adhere to the instructions on the 
Errata Instruction Sheet for PHS 398) to: Kevin Moore, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Announcement 98035, Centers for Disease Control and Prevention 
(CDC), 255 East Paces Ferry Road, N.E., Room 300, Mail Stop E-15, 
Atlanta, Georgia 30305-2209.
    Applications must be postmarked by the U.S. Postal Service or a 
commercial carrier by the deadline date. If your application does not 
arrive in time for submission to the independent review panel, it will 
not be considered in the current competition unless you can provide 
proof that you mailed it on or before the deadline (i.e., receipt from 
U.S. Postal Service or a commercial carrier; private metered postmarks 
are not acceptable).

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent reviewer group appointed by CDC. 
Applicants will be ranked on a scale of 100 maximum points according to 
the research area identified. All applicants must state which research 
category they are addressing. Applicants 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.

HIV Infection in Children

A. Recruitment, Retention, and Adherence to Study Protocol (20 Points)
    (1) Extent of applicant's experience in perinatal and pediatric HIV 
infection epidemiologic research.
    (2) Evidence of ability to successfully follow HIV-infected 
children in longitudinal research studies.
    (3) Evidence of ability to collect complete data from HIV-infected 
children.
B. Description and Justification of Research Plans (30 Points)
    (1) Extent of familiarity and quality of experience pertinent to 
proposed research activities.
    (2) Understanding of the research objectives as evidenced by high 
quality of the proposed plan for research and a study design that is 
appropriate to answer research questions.
    (3) Originality of research, extent to which it does not replicate 
past or present research efforts, and direct relevance of research to 
guiding current efforts to prevent perinatal HIV transmission and HIV 
disease progression in children.
    (4) Feasibility of plans to follow study participants, and adequacy 
of sample size to address research questions. This includes 
demonstration of the experience of the investigator in enrolling and 
following such persons, and the comprehensiveness of the plan to 
protect the rights and confidentiality of all participants.
    (5) Thoroughness of plans for data management, data analysis, and 
laboratory analysis; reasonableness of data collected; and statistical 
rigor.
    (6) Extent to which proposal demonstrates feasible plans for 
coordinating research activities of multiple clinical sites, where 
appropriate, and with CDC. Letters of support from cooperating 
organizations that demonstrate the nature and extent of such 
cooperation should be included.
    (7) 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; and (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.
C. Research Capability (30 Points)
    (1) Capacity to conduct study as evidenced by quality of experience 
with similar or related research as evidenced by previous related 
research, including demonstration of ability to collect, manage, and 
analyze accurate data in a timely manner.
    (2) Demonstration of working relationships with proposed 
collaborators.
    (3) Demonstration of epidemiologic, behavioral, administrative, 
clinical, laboratory, data management, and statistical expertise needed 
to conduct proposed research.

[[Page 35591]]

D. Staffing, Facilities, and Time-line (20 Points)
    (1) Availability of qualified personnel with realistic and 
sufficient percentage-time commitments, and the clarity of the 
descriptions of the duties and responsibilities of project personnel.
    (2) Adequacy of plans for project oversight to assure quality of 
data.
    (3) Adequacy of facilities, equipment, data processing and analysis 
capacity, and systems for management of data security and participant 
confidentiality.
    (4) Adequacy of time line for completion of project activities.
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: Does the application adequately address the 
institutional review board requirements for the protection of human 
subjects?

________ Yes    ________ No

Comments:--------------------------------------------------------------

Other HIV/AIDS Epidemiologic Research Studies

A. Familiarity With and Access to Study Population (25 Points)
    (3) Extent of applicant's knowledge of issues faced by study 
population and experience in working with this population.
    (4) Existence of linkages to facilitate recruitment from and 
referral to programs providing services for the study population and 
letters of support from these programs.
    (5) 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.
    (6) Evidence that plans for recruitment of 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) Feasibility of plans to sample, recruit, enroll, test, 
interview, and follow study participants and 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, including: (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, and (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; comprehensiveness of the plan to protect the rights 
and confidentiality of all participants; and proposed justification 
when representation is limited or absent.
    (5) Thoroughness of analysis plans, reasonableness for data 
collected, statistical rigor and complexity.
    (6) 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; and the clarity of the 
description of duties and responsibilities of project personnel with 
epidemiologic, behavioral, 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: Does the application adequately address the 
institutional review board requirements for the protection of human 
subjects?
________ Yes    ________ No

Comments:--------------------------------------------------------------

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of
    1. Annual progress report;
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial status report and performance report, no more 
than 90 days after the end of the project period send all reports to: 
Kevin Moore, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, N.E., Room 300, Mail Stop 
E-15, Atlanta, GA 30305-2209.
    For descriptions of the following Other Requirements, see 
Attachment 1:

AR98-1  Human Subjects
AR98-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR98-4  HIV/AIDS Confidentiality Provisions
AR98-5  HIV Program Review Panel Requirements
AR98-6  Patient Care
AR98-7  Executive Order 12372 Review
AR98-8  Public Health System Reporting Requirements
AR98-9  Paperwork Reduction Act
AR98-10  Smoke-Free Workplace Requirements

[[Page 35592]]

AR98-11  Healthy People 2000
AR98-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under the Public Health Service Act, 
Sections 301(a) and 317(k)(2) [42 U.S.C. 241(a) and 247b(k) (2)], as 
amended. The Catalog of Federal Domestic Assistance number is 93.943.

J. Where To Obtain Additional Information

    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and to identify the Announcement number, 
98035. If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Kevin Moore, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Announcement 98035, Centers for 
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, N.E., 
Room 300, Mail Stop E-15, Atlanta, GA 30305-2209, Telephone (404) 842-
6550, E-mail [email protected].
    See also the CDC Internet home page at: www.cdc.gov
    For program technical assistance, contact: Jeff Efird, Acting 
Chief, Epidemiology Branch, Division of HIV/AIDS Prevention 
Surveillance & Epidemiology, 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 [email protected].
    Eligible applicants are encouraged to call before developing and 
submitting their applications.

    Dated: June 23, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 98-17305 Filed 6-29-98; 8:45 am]
BILLING CODE 4163-18-P