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

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