31128 Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Notices

Attendance at this workshop is not

mandatory. Applicants who are

currently funded by CDC may not use

project funds to attend this workshop.

Each potential applicant may send no

more than two representatives to this

meeting. Please provide the names of

the persons that are planning to attend

this meeting to Elizabeth Majestic,

Chief, Special Populations Section,

Division of Adolescent and School

Health; telephone (404) 488–5356; no

later than July 2, 1996.

Dated: June 11, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–15556 Filed 6–18–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 628]

Outcome Evaluations of HIV/AIDS

Prevention Interventions

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for a cooperative agreement

program to conduct outcome

evaluations of existing innovative

interventions designed to reduce the

transmission of the human

immunodeficiency virus (HIV).

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.

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- and/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 $500,000 is available

in FY 1996 to fund approximately three

awards each evaluating a different

intervention strategy in a different highrisk population. It is expected that the

average award will be $150,000, ranging

from $125,000 to $175,000. 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 three 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.

Definitions

For the purposes of this program, an

Innovative HIV Prevention Intervention

is an HIV prevention strategy that has

not been extensively researched in the

context in which it is being applied or

one that represents a new approach to

the integration of known prevention

strategies. The terms Outcome

Evaluation and Effectiveness Study are

used somewhat interchangeably and

refer to the design and methods used to

assess the short- or long-term effects that

can be reasonably attributed to the

intervention.

The term HIV Community Planning

Priorities are priorities based upon the

epidemiologic profile of HIV in a

community as determined by the

Community Planning Group (CPG). For

example, if a CPG determined that there

is a significant problem of HIV

intravenous drug (ID) use in the

community then the funding of HIV

prevention strategy for ID use would be

a priority for HIV community planning.

Purpose

The purpose of this program is to

support intervention effectiveness

studies that assess social, behavioral,

programmatic, and policy outcomes of

specific innovative HIV prevention

interventions. These outcome

evaluations should assess prevention

interventions that are innovative, have

new components or involve the

innovative application of interventions

that are commonly employed (e.g. HIV

counseling and testing) and have

potentially broad relevance to the field

of HIV prevention. These evaluation

studies will use methods common to

rigorous outcome evaluation research

(e.g. comparison groups, individual

baseline data, cohorts, cross-sectional

surveys) within the limits of the funding

available and appropriately matched to

the nature and size of the intervention.

This program is designed to provide

evaluation resources to organizations

that might not otherwise have the

resources to determine the effectiveness

of their programs. Funds are intended

solely to implement the evaluation and

not to support the intervention itself.

Interventions being evaluated should

target high-risk populations (e.g. men

who have sex with men, injection drug

users and their partners, youth in high

risk situations).

Lastly, this program is to devise

practical, yet reasonably rigorous,

outcome evaluation methods and

designs that integrate both qualitative

and quantitative data, possibly from

multiple sources, in the analysis and

interpretation of the findings.

Program Requirements

The application should demonstrate

the applicant’s ability to design and

implement the evaluation, analyze the

data, and disseminate the findings. 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

Recipients will be asked to attend

meetings in Atlanta approximately

twice a year to brief CDC staff on the

project and discuss key decisions.

Additionally the recipient should

expect to host periodic (up to 4 per year)

site visits by the CDC project officer.

1. Prepare a detailed evaluation

protocol, including a description of the

intervention and how it is innovative,

the study research questions, proposed

methods, including sampling,

assessment, and analysis plans, draft

measurement instruments, and project

timelines.
Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Notices 31129

2. Develop measures to evaluate the

intervention. New instruments should

be field-tested.

3. Develop procedures to ensure

confidentiality and informed consent

when appropriate and obtain IRB

clearances as needed.

4. Recruit study subjects and

comparison groups according to the

evaluation design.

5. Conduct individual baseline and

repeat assessments according to the

evaluation design.

6. Establish data management

systems, analyze and interpret the data.

7. Prepare a final report for CDC,

including submission of a cleaned data

set.

8. Prepare a paper that summarizes

the results and recommends future

research and describes programmatic

implications.

9. Present the findings locally.

Collaborate with other recipients in

presenting the findings at national

meetings.

B. CDC Activities

1. Assist the recipient in planning and

implementing the evaluation, including

providing technical guidance in the

development of the study design, data

collection instruments, selection of

comparison groups, outcome measures,

data collection protocols, and pretesting

of methods and instruments.

2. Provide project oversight and

technical assistance.

3. Assist in analyzing the data and

interpreting the results.

4. Assist in presenting the findings.

Evaluation Criteria

Before submitting an application,

applicants will need to identify an

innovative behavioral or social HIV

prevention intervention that is designed

to reduce risk behaviors by high-risk

persons or within high-risk

communities. Communities may be

defined by geopolitical boundaries or by

relational affiliations (e.g., men who

have sex with men, African American

community, youth in high risk

situations).

Evaluation criteria are based upon the

responsiveness to, and the quality of,

specific information requested in the

‘‘Application Content’’ section of the

program announcement included in the

application kit.

1. Justification and Significance of the

Intervention (30 Points)

The degree to which the intervention

is innovative, i.e., new or represents a

new approach to the integration of

known prevention strategies and has not

yet been extensively evaluated in the

context in which it is being applied. The

extent to which the intervention has

broader significance or relevance for

HIV prevention. In determining

significance, consideration will be given

to the degree to which the selected

intervention is based on behavioral or

social science theory, public health

practice or program experience and the

relevant research literature, including a

description of the social and contextual

issues if relevant. Degree to which clear

intervention goals and objectives are

articulated. Degree to which the

behavioral or social interventions

complement other biomedical or

socioenvironmental interventions. The

degree to which the proposed activity is

significant to HIV prevention. The

degree to which the intervention is

generalizable.

2. Evidence That Target Population

Reflects HIV Community Planning

Priorities (10 Points)

Degree to which the local, regional or

State HIV prevention community plan,

especially the epidemiologic profile and

behavioral data, were used in the

selection of the intervention. The degree

to which the target population is

described clearly and concisely.

Evidence that the intervention has

access to sufficient numbers of the target

population to show intervention effects

is also important.

3. Soundness of the Evaluation Plan (30

Points)

The extent to which the evaluation

plan, including the stated research or

evaluation question, study design and

methods, comparison groups, data

collection instruments and plans for

analysis, are scientifically sound and

capable of producing the intended

results. The degree to which the plan is

clear, complete, and includes timerelated milestones that CDC and

recipients can use to gauge progress.

The degree to which plans for data

management, analysis, and

interpretation are appropriate and

reflect the intention to collaborate with

CDC. Reasonableness of plans for

collecting and integrating qualitative

and quantitative data from multiple

sources.

4. Adequacy of the Dissemination Plan

(10 Points)

Degree to which a dissemination plan

is articulated. Evidence that the

applicant is committed to disseminating

findings locally and collaborating with

CDC in disseminating findings

nationally. The degree to which the

applicant is committed to collaborating

with CDC in coauthoring papers.

5. Evidence of Collaboration and

Capacity To Undertake the Evaluation

(20 Points)

Quality of supporting evidence

(letters and memorandums of

agreement) that the applicant has the

full support of all specified

collaborators. The degree to which the

applicant has the scientific and

programmatic capacity and proven track

record in successfully designing,

implementing and completing similar

evaluations, either alone or in

partnership with the proposed

collaborator. The degree to which the

affected population seems to be

involved in planning the evaluation. (To

obtain specific information on the

community plan for your location,

please contact your local health

department.)

In addition, 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 appropriateness of the

proposed justification when

representation is limited or absent.

c. Whether the design of the study is

adequate to measure differences when

warranted.

d. Whether the plans for recruitment

and outreach for study participants

include the process of establishing

partnerships with community(ies) and

recognition of mutual benefits.

6. Budget (Not Scored)

The extent to which the budget is

reasonable, itemized, clearly justified,

and consistent with intended use of

funds.

Funding Preferences

All applicants are encouraged to

provide evidence of support from their

local health departments. Preference

will be given to applicants who

collaborate with representatives of target

populations at highest risk for HIV

infection and who are served by the

program being evaluated. Special

consideration will be given to

applications to evaluate innovative

interventions to integrate or link

multiple intervention components, for

example, provision of HIV counseling

and testing services by

nongovernmental organizations (NGOs)

that serve high-risk communities and

also provide innovative behavior-change

services.
31130 Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Notices

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

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

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 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

committee. 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

guidelines and form provided in the

application kit.

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 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 Van Malone, Grants Management

Officer, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention, 255

East Paces Ferry Road, NE., Room 300,

Mailstop E–15, Atlanta, GA 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;

or

b. Sent on or before the deadline date

and received in time for submission to

the objective review committee.

(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 will

not be acceptable 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

To receive additional written

information call (404) 332–4561. You
Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Notices 31131

will be asked to leave your name,

address, and telephone number and will

need to refer to Announcement 628.

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 be

obtained from Deborah L. Rugg, Ph.D.,

Program Evaluation Branch, Division of

HIV/AIDS Prevention, National Center

for HIV, STD, and TB Prevention,

Centers for Disease Control and

Prevention, 1600 Clifton Road, NE.,

Mailstop E–59, Atlanta, GA 30333,

telephone (404) 639–0952, FAX (404)

639–0923, e-mail:

<dlr1@oddhiv1.em.cdc.gov>.

Please refer to Announcement 628

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. 96–15560 Filed 6–18–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement Number 639]

Resident Postdoctoral Research

Associates Program in Microbiology

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds to provide assistance for

developing and conducting a Resident

Postdoctoral Research Associates

Program in Microbiology.

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

Immunization and Infectious Diseases.

(For ordering a copy of Healthy People

2000, see the section Where To Obtain

Additional Information.)

Authority

This program is authorized under

sections 301 [42 U.S.C. 241] and 317(k)

[42 U.S.C. 247b(k)] of the Public Health

Service Act, as amended.

Smoke-Free Workplace

CDC encourages all grant recipients to

provide a smoke-free workplace and to

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.

Eligible Applicants

Assistance will be provided only to

public or nonprofit, private scientific

organizations. Eligible applicants must

be national in scope, devoted to

scientific pursuits in all areas of

microbiology that relate to infectious

diseases, including general, clinical,

medical, environmental, animal

virology, molecular microbiology,

immunology and medical technology,

and have experience in administering

postdoctoral training programs in

medical microbiology and public health

microbiology which are designed to

assist associates conducting

microbiologic research to solve medical

and public health problems.

Availability of Funds

Approximately $800,000 is available

in FY1996 to fund one award. It is

expected that the award will begin on or

about September 30, 1996, and is made

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 an

approved project period will be made

on the basis of satisfactory progress and

availability of funds.

Purpose

The purpose of this cooperative

agreement is to assist the recipient in

developing and conducting a Resident

Postdoctoral Research Associates

Program in Microbiology. The program

emphasizes microbiology related to

infectious disease prevention and

control. Particular emphasis is given to

studies at the molecular level. Areas of

investigation may include: viral and

rickettsial infections, nosocomial

infections, acquired immunodeficiency

syndrome, vector-borne infectious

diseases, respiratory and food-borne

bacterial diseases, sexually transmitted

diseases, parasitic diseases, and other

diseases or conditions relevant to the

disciplines of bacteriology, virology,

parasitology, medical entomology,

mycology, immunology, and pathology.

The recipient must be able to provide

support for postdoctoral scientists of

unusual ability and promise or proven

achievement by giving them an

opportunity to conduct applied and

operational research on significant

public health problems identified with

these research interests. Associateships

should be for a two year period.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for the activities

under A., below, and CDC shall be

responsible for conducting activities

under B., below:

A. Recipient Activities

1. Develop and conduct a Resident

Postdoctoral Research Associates

Program in Microbiology to support

development of new approaches,

methodologies, and knowledge in

infectious disease prevention and

control.

2. Identify specific research

opportunities from descriptions

provided by CDC.

3. Establish program policies/

procedures for application and selection

(e.g., establish applicant eligibility

criteria).

4. Develop announcements/

advertisements and an application

package describing the program, listing

research opportunities, and providing

application instructions. Widely

distribute the announcements and

application package with the objective

of soliciting applications from qualified

individuals throughout the United