Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices 30899

Wyoming

Sheryl Jeffries, State Single Point of Contact,

Herschler Building 4th Floor, East Wing,

Cheyenne, Wyoming 82002, Telephone:

(307) 777–7574, FAX: (307) 638–8967.

Territories

Guam

Mr. Giovanni T. Sgambelluri, Director,

Bureau of Budget and Management

Research, Office of the Governor, P.O. Box

2950, Agana, Guam 96910, Telephone:

011–671–472–2285, FAX: 011–671–472–

2825.

Puerto Rico

Norma Burgos/Jose E. Caro, Chairwoman/

Director, Puerto Rico Planning Board,

Federal Proposals Review Office, Minillas

Government Center, P.O. Box 41119, San

Juan, Puerto Rico 00940–1119, Telephone:

(809) 727–4444; (809) 723–6190, FAX:

(809) 724–3270; (809) 724–3103.

North Mariana Islands

State Single Point of Contact, Planning and

Budget Office, Office of the Governor,

Saipan, CM, North Mariana Islands 96950.

Virgin Islands

Jose George, Director, Office of Management

and Budget, #41 Norregade Emancipation

Garden Station, Second Floor, Saint

Thomas, Virgin Islands 00802.

Please direct all questions and

correspondence about intergovernmental

review to: Linda Clarke, Telephone: (809)

774–0750, FAX: (809) 776–0069.

[FR Doc. 96–15321 Filed 6–17–96; 8:45 am]

BILLING CODE 4184–01–P

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 ProChildren 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 HIVrelated 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
30900 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices

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 motherinfant pairs per year.

3. Sexual and Needleborne

Transmission of HIV Among Drug Users

Study proposals are solicited that

address HIV infection in young drugabusing 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 costeffective 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 HIVinfected 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.
Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices 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.
30902 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices

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 AIDSRelated 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 kgm1@opspgo1.em.cdc.gov. 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