29386 Federal Register / Vol. 61, No. 112 / Monday, June 10, 1996 / Notices

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.

Atlanta, Georgia, will be the host of

the 1996 Summer Olympics Games (July

19 through August 4, 1996). As a result

of this event, it is likely that the

Procurement and Grants Office (PGO)

may experience delays in the receipt of

both regular and overnight mail

deliveries. Contacting PGO employees

during this time frame may also be

hindered due to the possible telephone

disruptions.

To the extent authorized, please

consider the use of voice mail, e-mail,

and fax transmissions to the maximum

extent practicable. Please do not fax

lengthy documents, contract proposals

or grant applications.

Dated: June 4, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–14552 Filed 6–7–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement Number 638]

Development and Feasibility Testing of

Interventions to Increase HealthSeeking Behaviors in, and Health Care

for, Populations at High Risk for

Gonorrhea

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 research to: (a)

Identify factors (at the client, provider,

and systems levels) that influence the

health-seeking behaviors of, and health

services for, populations at high risk of

transmitting and acquiring gonorrhea;

(b) use the above information to develop

and test interventions to increase health

care seeking and improve health care;

and (c) develop interdisciplinary

approaches and augment a behavioral

research infrastructure related to

sexually transmitted diseases (STDs).

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

areas of STDs and HIV Infection. (For

ordering a copy of ‘‘Healthy People

2000,’’ see the section ‘‘WHERE TO

OBTAIN ADDITIONAL

INFORMATION.’’)

Authority

This program is authorized under

section 318 of the Public Health Act [42

U.S.C. 247c], as amended.

Smoke-Free Workplace

The CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

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 research organizations and their

agencies. Thus, universities, colleges,

hospitals, research institutions and

other public and private organizations

and small, minority and/or womenowned businesses are eligible to apply.

Also, 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.

Avaliability of Funds

Approximately $1 million is available

in FY 1996 to fund approximately 5

awards. The project will be conducted

in two stages. The project period for

Stage I is expected to be two years. For

Stage I, it is expected that the average

award will be $250,000, ranging from

$200,000 to $300,000. It is expected that

the awards will begin on or about

September 30, 1996, and will be made

for a 12-month budget period. Funding

estimates may vary and are subject to

change. Before completion of Stage I,

recipients will compete for continuation

awards for Stage II which is expected to

be an additional two years. Successful

completion of Stage I is required to

compete for Stage II.

Stage I—(Years 1 & 2)

Focuses on formative research to

identify client, provider, and system

level determinants of health care

seeking by, and health care for,

populations at high risk of transmitting

and acquiring gonorrhea.

Stage II—(Years 3 & 4)

Focuses on developing and testing the

client, provider, and system level

interventions to increase health care

seeking by, and to improve health care

for, populations at risk for gonorrhea.

Further detail on Stages I and II is

presented below under the ‘‘PURPOSE’’

section. Continuation awards within an

approved project period will be based

on satisfactory progress and the

availability of funds.

Purpose

The overall purpose of this program is

to assist the recipients in developing

and utilizing behavioral and social

science research methods to learn the

influences on health care seeking and

health care at the client, provider, and

system levels, and to use this

information to develop:

* Community-level behavioral

interventions to increase health care

seeking and;

* Provider and systems interventions

to improve health care for populations

at high risk of transmitting and

acquiring gonorrhea.

The research program has two stages

of activity and funding:

Stage I: Formative Research and

Intervention Development.

Stage II: Intervention Implementation

and Feasibility Testing.

The fundamental goal of this program

announcement is best understood in the

context of Stage II (years 3 and 4 of the

anticipated 4-year project), in which the

grantees will implement and evaluate

the feasibility of a science-based

community intervention to increase

health care seeking among those at high

risk for gonorrhea. In addition, the

recipients will implement and evaluate

the feasibility of science-based provider

and systems interventions to improve

health care for this same population.

Applications for such Stage II

intervention activities are not required

at this time because well-developed,

science-based, promising approaches to

changing health-seeking behavior or the

provision of health care will be based

upon the aggregate results of the

research conducted by grantees during

Stage I.

Program Requirements

The following are applicant

requirements:

(1) For research institutions, a

documented research partnership with a

public health agency of a State or local

government or their bona fide agents.

For health agencies, a documented

research partnership with a university

or other qualified research institution.

Applicants are also encouraged to

demonstrate ongoing collaboration with

community-based organizations (CBOs)
Federal Register / Vol. 61, No. 112 / Monday, June 10, 1996 / Notices 29387

that have histories of access to and

success with the target population;

(2) Proof that the catchment area has

(a) A calendar year (CY) 1995

gonorrhea incidence rate that is higher

than 225 per 100,000 or 750 per 100,000

for 15 to 19 year olds, and

(b) Access to at least 500 new cases of

gonorrhea per year;

(3) Include documentation of a multidisciplinary research team with

behavioral, clinical, epidemiologic, and

health economics or health services

research expertise, as well as in

statistics or data management;

(4) State a willingness to participate

in the development and implementation

of common protocols and methods for

formative research on client, provider,

and system determinants of health care

seeking by, and health care provision to,

populations at high risk of transmitting

and acquiring gonorrhea.

Applications that do not satisfy these

eligibility requirements will not be

considered and will be returned.

Cooperative Activities

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 under B. (CDC Activities), as

listed below:

A. Recipient Activities

1. Develop an overall framework that

would allow gonorrhea research to be

conducted that would validate, verify,

and expand upon the initial choice of a

catchment area and target population.

Specify the demographics of the target

population and any subgroups.

2. Develop an intervention and justify

the selection of a particular subgroup

toward which to direct future

interventions.

3. Verify access sites within the

catchment area (e.g., STD clinics,

school-based clinics, job training sites,

health centers, substance abuse

treatment facilities; shelters or drop-in

facilities for runaway and homeless

youth, mental health clinics, other

health care facilities such as community

health centers, facilities ‘‘without walls’’

that provide outreach to ‘‘hard-to-reach’’

populations; units within the criminal

justice system) where populations at

risk for gonorrhea will potentially be

accessible for interviewing and for the

intervention.

4. Conduct qualitative and

quantitative behavioral and

psychosocial research to identify client,

provider, and system factors influencing

health care seeking by, and health care

for, populations in the catchment areas

at risk of acquiring and transmitting

gonorrhea.

5. Develop common protocols to

conduct this formative research. In

particular, CDC and the recipient will

agree on appropriate sampling

approaches for the collection of

behavioral and psychosocial data.

Recipients may enhance the common

protocol or develop additional protocols

to address questions and issues specific

to their local conditions.

6. Develop assessment instruments

and participate in cross-site

implementation of those instruments.

Each recipient will analyze and report

results of this three-level assessment

and will produce a report synthesizing

knowledge about the community. This

report should reflect the community’s

health care system in the current era of

health care reform, with particular

attention to the type of health care

coverage extended to subgroups in the

community and the number of persons

enrolled in these plans.

7. Manage, analyze, and interpret

data. Data from the Stage I activities

must be collected, managed, and stored

securely and confidentially. Recipients

will use common computer and data

management systems and will have

submitted the data from their client,

provider, and system assessments in

appropriate format to CDC.

Any materials developed in whole or

in part with CDC funds shall be subject

to a nonexclusive, irrevocable, royaltyfree license to the government to

reproduce, translate, publish, or

otherwise use and authorize others to

use for government purposes.

8. Travel to Atlanta or another

location and participate with other

recipients and CDC representatives in

four meetings during Stage I. The first

meeting will be held within 60 days

after awards are made to develop

common approaches and instruments

for the Stage I formative research.

9. Assemble a local Internal Review

Board (IRB) for each catchment area to

review protocols developed under this

program and submit approvals to CDC.

10. Provide progress reports to

representatives of communities affected

by gonorrhea and other involved

organizations, agencies, and persons.

By the end of Stage I (24 months), it

is expected that each recipient will

have:

1. Completed formative research, data

reduction, and will have prepared

research summaries and a final report.

This report should, at a minimum,

identify client, provider, and system

determinants of health care seeking and

health care provision behaviors.

2. Established access to the target

population in sufficient numbers to

provide meaningful sample sizes for

feasibility studies of community

interventions as a condition of going on

to Stage II feasibility research.

3. Established access to providers or

health care systems in order to carry out

provider and system interventions as a

condition of going on to Stage II

research.

4. Demonstrated that their proposed

catchment areas are minimally affected

by confounding factors or have

identified appropriate methods for

controlling competing interventions and

research.

B. CDC Activities

1. Provide scientific and technical

oversight in the general operation of the

formative stage of the gonorrhea

prevention and health care behavior

project.

2. Host a meeting of the recipients to

plan common approaches and protocols

for the formative research stage (years 1

and 2) of this initiative. CDC will host

three other meetings of recipients

during Stage I to promote collaboration.

3. Monitor and evaluate scientific and

operational accomplishments of this

project through periodic site visits,

frequent telephone calls, and review of

technical reports and interim data

analyses.

4. Assist recipients in the aggregation

of data and analysis and distribution of

results of multisite analyses.

Evaluation Criteria

Applications that meet the eligibility

requirements will be reviewed and

evaluated according to the following

criteria:

1. Understanding of the objectives of

this research as reflected in the

statement of research background and

research questions. (15 points)

2. Documentation of the

epidemiologic, demographic, and health

care and prevention program

characteristics of geographical

catchment area in which the applicant

will have access to at least 500 cases of

new gonorrhea per year. (15 points)

3. Appropriateness of the

methodologies initially proposed for

formative research on client, provider,

and system determinants of health care

seeking by and health care for

populations at high risk of transmitting

and acquiring gonorrhea. (20 points)

4. Overall ability (that of the applicant

and proposed sites) to perform the

technical aspects of the project as

reflected in the availability of qualified

and experienced personnel for a multidisciplinary team; facilities and plans
29388 Federal Register / Vol. 61, No. 112 / Monday, June 10, 1996 / Notices

for the administration of the project,

including a detailed and realistic

schedule for the specified activities and

access to study populations, providers,

and health care institutions. (20 points)

5. The extent to which the research

approach is interdisciplinary and

culturally and programmatically

relevant. (5 points)

6. 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 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 will be documented. (5

points)

7. The extent to which collaborations

among health departments, research

institutions, and other participating

health care entities are likely to be

sustained for the duration of the project.

(5 points)

8. Documentation of experience with

behavioral interventions for bacterial

STDs. (5 points)

9. Consideration of the extent to

which the formative research activities

conducted in Stage I will result in Stage

II pilot intervention protocols for testing

the feasibility of client, provider, and

system interventions. (10 points)

10. In addition, consideration will be

given to the extent to which the budget

is reasonable, clearly justified, and

consistent with the intended use of the

funds. (Not scored)

Funding Preferences

Final determination may be

influenced by the geographic

distribution of project sites. In addition,

due to the changes in the health care

system, consideration will be given to

funding at least one applicant who has

contractual research agreements with a

managed care organization.

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 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. A current list of

SPOCs is included in the application

kit. 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., Mailstop E–15,

Atlanta, GA 30305, no later than 60 days

after the application deadline. The

Program Announcement Number and

Program Title should be referenced on

the document. The granting agency does

not guarantee to ‘‘accommodate or

explain’’ State process

recommendations it received after that

date.

Public Health System Reporting

Requirement

This program is subject to the Public

Health System Reporting Requirements.

Under these requirements, all

community-based nongovernment

applicants must prepare and submit the

items identified below to the head of the

appropriate State or local health agency

in the program areas(s) that may be

affected 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 (SF424); and

B. A summary of the project that

should be titled ‘‘Public Health System

Impact Statement’’ (PHSIS), not to

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 Sate and/or

local health agencies.

If the State and/or local health

officials 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 93.978.

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.

Confidentiality

Applicants must have in place

systems to ensure the confidentiality of

patient records.

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. 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 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. In

conducting review for scientific merit,

review groups will evaluate proposed

plans for inclusion of minorities and

both sexes as part of the scientific

assessment and scoring.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

the subjects. Further guidance to this
Federal Register / Vol. 61, No. 112 / Monday, June 10, 1996 / Notices 29389

policy is contained in the Federal

Register, Vol. 60, No. 179, pages 47947–

47951, dated Friday, September 15,

1995.

Application Submission and Deadline

A. Preapplication Letters of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. On or before July 5,

1996, the letter should be submitted to

Kimberly P. Boyd, 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, Atlanta GA 30305. The letter

should identify the announcement

number and the name of the

investigator. The letter does not

influence review or funding decisions,

but will enable CDC to plan the review

more efficiently, and will ensure that

each applicant receives timely and

relevant information prior to application

submission.

B. Applications

The original and two copies of the

application PHS 5161–1 (OMB Number

0937–0189) must be submitted on or

before August 5, 1996, to Mr. Van

Malone, Grants Management Officer,

Attention: Kimberly Boyd, 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 E15, Atlanta, GA 30305.

C. 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

receipt from a commercial carrier or the

U.S. Postal Service. Private metered

postmarks are not acceptable as proof of

timely mailing.)

(c) Late Applications: Applications

which do not meet the criteria in (a) or

(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 Kimberly Boyd, 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 E15, Atlanta GA 30305,

telephone (404) 842–6592, Facsimile

(404) 842–6513, or Internet at

<KPT0@OPSPGO1.em.cdc.gov>.

Programmatic technical assistance may

be obtained from Sevgi Aral, Ph.D.,

Division of STD Prevention, Behavioral

Interventions and Research Branch

(BIRB), National Center for STD, HIV,

and TB Prevention, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Mailstop E02,

Atlanta, GA 30333, telephone (404)

639–8259, Facsimile (404) 639–8608.

Please refer to Announcement

Number 638 ‘‘Development and

Feasibility Testing of Interventions to

Increase Health-Seeking Behaviors in,

and Health Care for, Populations at High

Risk for Gonorrhea’’ when requesting

information and submitting an

application.

You 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.

There may be delays in mail delivery

and difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics. Therefore, CDC suggest

applicants use Internet, follow all

instructions in this announcement and

leave messages on the contact person’s

voice mail for more timely responses to

any questions.

Dated: June 4, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–14554 Filed 6–7–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 627]

Replication of Effective HIV Behavioral

Interventions

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for a cooperative agreement

program for replicating HIV behavioral

interventions which have been found to

be effective in intervention research

studies. This announcement supports

the development and implementation of

plans, materials, and training to

accomplish the replication of the

intervention in one site.

The 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 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), of the Public

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

247b], 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 $900,000 is available

in FY 1996 to fund approximately 5

awards. It is expected that the average

award will be $200,000, ranging from

$175,000 to $225,000. It is expected that

the awards will begin on or about

September 30, 1996, and will be made

for a 12-month budget period within a

project period of 2 years. Funding

estimates may vary and are subject to

change based on availability of funds.