30906 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices

program may be disclosed: (1) In

summary, statistical, or other form, or

(2) for clinical or research proposed, but

only if the identity of the individuals

under such program is not disclosed.

HIV/AIDS Requirements

Recipients must comply with the

document entitled ‘‘Content of AIDSRelated Written Materials, Pictorials,

Audiovisuals, Questionnaires, Survey

Instruments, and Educational Sessions’’

(June 15, 1992), a copy of which is

included in the application kit. In

complying with 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

government health department

consistent with the content guidelines.

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, this includes conference

agendas.

Women, Racial and Ethnic Minorities

It is the policy of the Centers for

Disease Control and Prevention (CDC)

and the Agency for Toxic Substances

and Disease Registry (ATSDR) to ensure

that individuals of both sexes and the

various racial and ethnic groups will be

included in CDC/ATSDR-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, pages 47947–47951,

dated Friday, September 15, 1995.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (OMB

number 0937–0189) must be submitted

to Sharron Orum, Grants Management

Officer, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E–18, Atlanta,

Georgia 30305, on or before August 5,

1996.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective 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 acceptable as

proof of timely mailing.)

2. Late Applications: Applications

which 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 and

information on application procedures

are contained in the application

package.

Business management technical

assistance may be obtained from Locke

Thompson, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E–18, Atlanta,

Georgia 30305, (404) 842–6595; or by

Internet or CDC WONDER electronic

mail at: lxt1@opspgo1.em.cdc.gov.

Programmatic technical assistance may

be obtained from Sarah Wiley, MPH,

Hematologic Diseases Branch, Division

of AIDS, STD, and TB Laboratory

Research, National Center for Infectious

Diseases, Centers for Disease Control

and Prevention (CDC), 1600 Clifton

Road, NE., Mailstop E–64, Atlanta,

Georgia 30333, telephone (404) 639–

4026; or by Internet or CDC WONDER

electronic mail at:

sed5@ciddas1.em.cdc.gov.

Please refer to Announcement

Number 620 when requesting

information and submitting an

application.

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 through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

There may be delays in mail delivery

and difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics. Therefore, CDC suggests

using Internet, following all instructions

in this announcement and leaving

messages on the contact person’s voice

mail for more timely responses to any

questions.

Dated: June 11, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–15381 Filed 6–17–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 630]

Formative Behavioral Intervention

Research on the Prevention of Sexual

Transmission of HIV by HIVSeropositive Men

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for a cooperative agreement

program for the prevention of the sexual

transmission of HIV by men who have

tested positive for HIV infection.

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 Human Immunodeficiency Virus

(HIV) Infection. (For ordering a copy of

‘‘Healthy People 2000,’’ see the section

‘‘Where to Obtain Additional

Information.’’)

Authority

This program is authorized under

Sections 301 and 317(k)(2), of the Public

Health Service Act (42 U.S.C. 241 and

247b(k)(2)) as amended.

Smoke-Free Workplace

CDC strongly encourages all

recipients to provide a smoke-free

workplace and to promote the nonuse of

all tobacco products, and 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.
Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices 30907

Eligible Applicants

Applications may be submitted by

public and private, nonprofit and forprofit organizations and governments

and their agencies. Thus, universities,

colleges, research institutes, hospitals,

other public and private organizations,

State and local health departments or

their bona fide agents or

instrumentalities, federally recognized

Indian tribal governments, Indian tribes

or Indian tribal organizations, and

small, minority or women-owned

businesses are eligible to apply.

Availability of Funds

Approximately $750,000 is available

in FY 1996 to fund approximately three

awards. It is expected that the average

award will be $250,000, ranging from

$225,000 to $275,000. Awards are

expected to begin on or about

September 30, 1996, and will be made

for a 12-month budget period within a

project period of up to two years.

Funding estimates may vary and are

subject to change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Purpose

The purpose of this announcement is

to stimulate formative research on

behavioral intervention strategies to

further reduce HIV transmission by men

who know that they are HIVseropositive. Funding under this

cooperative agreement will support the

collection of qualitative and quantitative

data in the development and evaluation

of pilot behavioral intervention

programs for HIV-seropositive men.

These intervention activities should be

designed to motivate and support HIVseropositive men in sustaining sexual

practices that reduce the risk and

prevent HIV transmission to

seronegative partners.

It is expected that cooperative

agreement recipients will conduct the

formative research according to a

common protocol that will be developed

collaboratively with other cooperative

agreement recipients including CDC.

The intervention, or its core elements,

will be piloted and evaluated on a

limited basis during the award period.

The ultimate goal of this formative

research is the identification of potential

intervention strategies for HIVseropositive men that are appropriate

for implementation in community

settings (e.g., local health departments,

community-based organizations, health

maintenance organizations) and that

merit further evaluation to determine

their effectiveness in sustaining

reduced-risk sexual practices.

Program Requirements

In conducting activities to achieve the

purpose of this program the recipient

will be responsible for the activities

under A. (Recipient Activities), and

CDC will be responsible for the

activities listed under B. (CDC

Activities).

A. Recipient Activities

1. Collaborate with other recipients to

refine research and intervention

protocols and data collection

instruments.

2. Establish procedures to maintain

the rights and confidentiality of all

study participants, including review of

research activities by applicant’s and

CDC’s Internal Review Board (IRB).

3. Identify, recruit, obtain informed

consent, and enroll an adequate number

of research participants according to

procedures specified in the study

protocol.

4. Conduct interviews and other

assessments according to the research

protocol.

5. Summarize data and conduct

analyses for the recipient’s own site.

6. Establish a standardized format for

data entry to facilitate cross-site

analyses.

7. Collaborate with other recipients in

the preparation and dissemination of

research findings in peer-reviewed

journals and at professional meetings.

B. CDC Activities

1. Host a meeting(s) of the award

recipients to plan key aspects of the

research program. CDC will convene

additional meetings as needed.

2. Act as mediator on the recipients’

collaborative design of this research,

including data collection protocols and

instruments, and intervention protocols.

3. Monitor, coordinate, and evaluate

scientific and operational conduct and

accomplishments of this research

project in order to keep all recipients on

track with the common protocols and

their timelines.

4. Coordinate cross-site data

aggregation and the analysis of aggregate

data.

5. Participate in the preparation of

study findings for publication and

presentation.

6. Conduct site visits to assess

program progress and mutually solve

problems, as needed.

Evaluation Criteria

Applications that meet the eligibility

requirements will be reviewed and

evaluated according to the following

criteria:

1. Familiarity with and access to HIVseropositive men (20 points).

a. Extent of applicant’s knowledge of

issues faced by HIV-seropositive men

and experience in working with this

population;

b. Existence of linkages to facilitate

recruitment from and referral to

programs providing services for HIVseropositive men and;

c. Feasibility of plans to involve HIV

positive men, their advocates, or service

providers in the development of

research and intervention activities.

(1) 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.

(2) The proposed plan for the

inclusion of racial and ethnic minority

populations for appropriate

representation.

(3) The proposed justification when

representation is limited or absent.

2. Formative research plan (25

points).

a. Quality of the proposed formative

research plan, including research

questions, methodology, sampling

strategies, data summary methods, and

procedures for obtaining subjects’

consent and protecting their

confidentiality and;

b. Thoroughness of description of

proposed study group(s).

3. Intervention research plan (20

points).

a. Quality, feasibility, and theoretical

bases of the suggested behavioral

intervention;

b. Appropriateness of the suggested

research design, including recruitment

and randomization of subjects, process

and outcome measures, schedule for

data collection;

c. Adequacy of methods for obtaining

informed consent, maintaining

participant confidentiality, and

addressing any potential ethical issues

associated with the suggested research

strategy and;

d. A statement as to whether the

design of the study is adequate to

measure racial and ethnic differences

when warranted.

4. Research and intervention

capability (25 points).

a. Ability of the applicant to perform

the technical aspects of the project as

reflected in the training, research, and

behavioral intervention experience of

the applicant’s staff;

b. Applicant’s expertise in the

application of qualitative and

quantitative data collection methods

used in behavioral science and;
30908 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices

c. Quality and outcomes of applicant’s

previous HIV intervention and research

efforts.

5. Staffing, facilities, and time line (10

points).

a. Availability of qualified and

experienced personnel with sufficient

time dedicated to the proposed project.

Presence of behavioral scientists in key

leadership positions on the project;

b. Clarity of the described duties and

responsibilities of project personnel;

c. Stated agreement to work

collaboratively with CDC and other

cooperative agreement recipients in

developing common research,

intervention, and evaluation protocols

and to disseminate study findings;

d. Adequacy of the facilities,

equipment, data management resources,

and systems for ensuring data security

and;

e. Specificity and reasonableness of

time line.

6. Budget (not scored).

Extent to which the budget is

reasonable, itemized, clearly justified,

and consistent with the intended use of

the funds.

Funding Priorities

This announcement is for formative

research proposals that lead to the

development of innovative pilot

programs for reducing HIV transmission

by men who know they are HIV

positive. Priority will be given to

projects that focus on reducing the

sexual risk of HIV transmission by HIVseropositive men who are (1) men who

have sex with men (regardless of sexual

identity) or (2) male injecting drug

users. Involvement of HIV-seropositive

men, their advocates, or service

providers in the design of research and

intervention activities is required. Based

upon available funding, applications

will be accepted for behavioral

intervention studies targeting other

high-risk populations that have not been

adequately addressed.

Interested persons are invited to

comment on the proposed funding

priorities. All comments received on or

before July 24, 1996, will be considered

before the final funding priority is

established. If the funding priorities

should change as a result of any

comments received, a revised

Announcement will be published in the

Federal Register prior to the final

selection of awards.

Written comments should be

addressed to: Van Malone, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E15, Atlanta, GA 30305.

Executive Order 12372 Review

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372. E.O. 12372 sets up

a system for State and local government

review of proposed Federal assistance

applications. Applicants (other than

federally recognized Indian tribal

governments) should contact their State

Single Point of Contact (SPOC) as early

as possible to alert them to the

prospective applications and receive

any necessary instructions on the State

process. For proposed projects serving

more than one State, the applicant is

advised to contact the SPOC for each

affected State. A current list of SPOCs

is included in the application kit. If

SPOCs have any State process

recommendations on applications

submitted to CDC, they should send

them to Van Malone, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E15, Atlanta, GA 30305, no

later than 30 days after the application

deadline (the appropriation for this

financial assistance program was

received late in the fiscal year and

would not allow for an application

receipt date which would accommodate

the 60-day State recommendation

process period). The granting agency

does not guarantee to ‘‘accommodate or

explain’’ for State process

recommendations it receives after that

date.

Indian tribes are strongly encouraged

to request tribal government review of

the proposed application. If tribal

governments have any tribal process

recommendations on applications

submitted to the CDC, they should

forward them to Van Malone, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E15, Atlanta, GA 30305. This

should be done no later than 30 days

after the application deadline date. The

granting agency does not guarantee to

‘‘accommodate or explain’’ for tribal

process recommendations it receives

after that date.

Public Health System Reporting

Requirements

This program is subject to the Public

Health System Reporting Requirements.

Under these requirements, all

community-based nongovernmental

applicants must prepare and submit the

items identified below to the head of the

appropriate State and/or local health

department agency(s) in the program

area(s) that may be impacted by the

proposed project no later than the

receipt date of the Federal Application.

The appropriate State and/or local

health agency is determined by the

applicant. The following information

must be provided:

A. A copy of the face page of the

application (SF 424).

B. A summary of the project that

should be titled ‘‘Public Health System

Impact Statement’’ (PHSIS), not exceed

one page, and include the following:

1. A description of the population to

be served;

2. A summary of the services to be

provided and;

3. A description of the coordination

plans with the appropriate State and/or

local health agencies.

If the State and/or local health official

should desire a copy of the entire

application, it may be obtained from the

State Single Point of Contact (SPOC) or

directly from the applicant.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.941.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by the cooperative

agreement will be subject to review by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act.

Human Subjects

If the proposed project involves

research on human subjects, the

applicant 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 will be

subject to initial and continuing review

by an appropriate institutional review

committees. 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 or will support the research. If

any American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it. The applicant will be

responsible for providing assurance in

accordance with the appropriate
Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices 30909

guidelines and form provided in the

application kit.

Racial and Ethnic Minorities

It is the policy of the Centers for

Disease Control and Prevention (CDC)

and the Agency for Toxic Substances

and Disease Registry (ATSDR) to ensure

that individuals of the various racial

and ethnic groups will be included in

CDC/ATSDR-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 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, pages 47947–47951,

dated Friday, September 15, 1995.

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 of which is included

in the application kit. At least one

member of the program review panel

must be an employee (or designated

representative) of the health department

consistent with the Content guidelines.

The names of the review panel members

must be listed on the Assurance of

Compliance for CDC 0.1113, which is

also included in the application kit. The

recipient must submit, as an attachment

to the quarterly summaries, the program

review panel’s report that all material

have been reviewed and approved.

Application Submission and Deadlines

1. Preapplication Letter of Intent

A non-binding letter of intent-toapply is required from potential

applicants. An original and two copies

of the letter should be submitted to the

Grants Management Branch, CDC (see

‘‘Applications’’ for the address). It

should be postmarked no later than July

24, 1996. The letter should identify the

announcement number, name of

principal investigator, and specify the

activity(ies) to be addressed by the

proposed project. The letter of intent

does not influence review or funding

decisions, but it will enable CDC to plan

the review more efficiently, and will

ensure that each applicant receives

timely and relevant information prior to

application submission.

2. Applications

An original and two copies of the

application PHS Form 5161–1 (OMB

Number 0937–0189) must be submitted

to Van Malone, Grants Management

Officer, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E- 15, Atlanta, GA

30305, on or before August 19, 1996.

3. Deadlines

A. Applications shall be considered as

meeting the deadline if they are either:

1. Received on or before the deadline

date; or

2. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or the U.S. Postal Service. Private

metered postmarks shall not be

acceptable as proof of timely mailing.)

B. Applications that do not meet the

criteria in 3.A.1. or 3.A.2. 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

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and telephone number and will

need to refer to Announcment 630. You

will receive a complete program

description, information on application

procedures and application forms. If

you have questions after reviewing the

contents of all the documents, business

management technical assistance may

be obtained from Adrienne Brown,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–15, Atlanta, GA 30305,

telephone (404) 842–6634, email:

<asm1@opspgo1.em.cdc.gov>.

Programmatic technical assistance may

be obtained from Robert Kohmescher,

Division of HIV/AIDS Prevention,

National Center for HIV/STD/TB

Prevention, Centers for Disease Control

and Prevention (CDC), 1600 Clifton

Road, NE., Mailstop E–44, Atlanta, GA

30333, telephone (404) 639–8302, email:

<rnk1@cidhiv2.em.cdc.gov>.

Please refer to Announcement 630

when requesting information and

submitting an application.

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, through

the Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Internet Home Page

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.>.

There may be delays in mail delivery

and difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics. Therefore, CDC suggests

using Internet, following all instructions

in this announcement and leaving

messages on the contact person’s voice

mail for more timely responses to any

questions.

Dated: June 11, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–15382 Filed 6–17–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 637]

Grant for Injury Control Training and

Demonstration Center

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of funds in fiscal year (FY)

1996 for a Grant for an Injury Control

Training and Demonstration Center.

CDC is committed to achieving the

health promotion and disease

prevention objectives described in

‘‘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 Unintentional Injuries.

(For ordering a copy of ‘‘Healthy People

2000,’’ see the Section WHERE TO OBTAIN

ADDITIONAL INFORMATION.)