Federal Register / Vol. 61, No. 112 / Monday, June 10, 1996 / Notices 29383

1See ‘‘Background’’ section and ‘‘Program

Requirements’’ section of the Program

Announcement included in the Application Kit for

information about BDRFSP.

public regarding the exclusion and

detention of Japanese Americans during

World War II so that the causes and

circumstances of this and similar events

may be illuminated and understood.

(10) Applicants are encouraged to

develop a strategy and plan for reaching

a broad, multicultural population

through project activities.

(11) Applicants are encouraged to

develop local and regional consortia of

organizations and individuals engaged

in similar educational, research and

community development efforts.

(12) Applicants are encouraged to

coordinate and collaborate with

organizations and individuals engaging

in similar educational, research and

community development endeavors to

maximize the effect of grants with

respect to (a) Impact on geographic

regions; and/or (b) impact on

institutions, public policy, or culture;

and/or (c) impact on academic field or

discipline.

(13) Applicants are encouraged to

utilize creative and/or innovative

methods and approaches in the

development and implementation of

their projects.

(14) Applicants are encouraged to

seek matching funds, in-kind

contributions or other sources of

support to enhance their proposal.

Dated: May 29, 1996.

Betty T. Sedgwick,

Program Analyst.

[FR Doc. 96–14481 Filed 6–7–96; 8:45 am]

BILLING CODE 6820–34–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement 643]

Cooperative Agreement To Establish

Centers of Excellence To Provide

Surveillance, Research, Services and

Evaluation Aimed at Prevention of

Birth Defects

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for a cooperative agreement

program for Centers of Excellence to

provide surveillance, research, services

and evaluation aimed at the prevention

of birth defects. 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 areas of Alcohol and Other

Drugs, Environmental Health, Maternal

and Infant Health, and Surveillance and

Data Systems. (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 317C of the Public

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

247b–4], as amended.

Smoke-Free Workplace

The CDC strongly encourages all grant

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

Eligible applicants are State and local

health departments, or their bona fide

agents or instrumentalities. This

includes the District of Columbia,

American Samoa, the Commonwealth of

Puerto Rico, the Virgin Islands, the

Federated States of Micronesia, Guam,

the Northern Mariana Islands, the

Republic of the Marshall Islands, the

Republic of Palau, and federally

recognized Indian tribal governments.

Applicant institutions must have

ongoing access to data generated from a

state-based birth defects surveillance

(ascertainment) program based on a

population of not less than 30,000 live

births per year within a State. This

access will provide the source of birth

defect cases for participation in the

Birth Defects Risk Factor Surveillance

Program (BDRFSP).1 Applicants must

also have a suitable source for obtaining

controls from the same population from

which cases are derived. State health

departments or their bona fide agents

must also have an ongoing surveillance

program with a capability of

contributing not less than a total of 400

interviews (300 cases and 100 controls)

per year to the ongoing BDRFSP.

Availability of Funds

Approximately $2,400,000 will be

available in FY 1996 to fund three

cooperative agreements (includes both

direct and indirect costs). It is expected

that each award will be approximately

$800,000. 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

up to 5 years. The funding estimate may

vary and is 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 these awards is to

assist States to:

1. Bolster their ongoing surveillance

activities, including the integration of

prenatal diagnoses into their

surveillance registry.

2. Develop, implement, and evaluate

local studies chosen from among the

following categories of activities:

a. Evaluation of methods for primary

prevention of birth defects;

b. Evaluation of potential

teratogenicity of drugs;

c. Evaluation of potential

environmental causes of birth defects;

d. Evaluation of genetic

susceptibilities to environmental causes

of birth defects;

e. Evaluation of behavioral causes of

birth defects;

f. Evaluation of costs of birth defects.

3. Contribute not less than 400

interviews per year to the BDRFSP,

using the existing BDRFSP parental

interview instrument.

Program Requirements

In conducting activities to achieve the

purpose of this program, the applicant

shall be responsible for conducting the

following activities under A., below,

and CDC shall be responsible for

conducting activities under B., below:

A. Recipient Activities

1. Develop and implement methods

and approaches which will improve and

expand the capacity of the applicant’s

existing surveillance system to ascertain

cases and generate timely populationbased data of birth defects including the

integration of prenatal diagnoses into

their registry. This may include

provision of background surveillance

data generated through recipient’s

surveillance program for collaborative

efforts.

2. Develop a comprehensive plan for

implementing studies that are tailored

to the applicants activities, and is

chosen from one of the following

categories:

a. An evaluation of methods related to

the primary prevention of birth defects;

b. An evaluation of the potential

teratogenicity of drugs related to the

possible causes of birth defects;
29384 Federal Register / Vol. 61, No. 112 / Monday, June 10, 1996 / Notices

c. An evaluation of the potential

environmental causes of birth defects;

for example, endocrine disrupting

chemicals or drinking water

contaminents;

d. An evaluation of genetic factors

influencing the occurrence of birth

defects, e.g., gene—environment

interactions;

e. An evaluation of the behavioral

causes of birth defects;

f. An evaluation of the costs

associated with birth defects.

3. Develop and implement a plan that

will contribute not less than 400

interviews per year to the BDRFSP.

Initially, the plan should address the

development and the conduct of the

BDRFSP parental interview

questionnaire. This should include:

a. The development of a plan for the

selection of specific cases and controls

for interview;

b. The development of a plan for

conducting telephone interviews of

cases and controls;

c. The development of a mechanism

for reducing interview data to computer

readable form;

d. The conduct of parental interviews

in accordance with the plans developed

under activities a–c above;

e. The development of a plan to

implement a more refined clinical

approach to the classification of birth

defects for the purpose of improving

risk factor surveillance;

f. The applicant should develop a

plan to implement the laboratory phase

of their risk factor surveillance program,

including the use of biologic specimens

(to evaluate markers of exposure and

susceptibility) and environmental

sampling to explore the potential

relationship between environmental

exposures and birth defects. For

example, the program may include

sampling of water in the home to

determine the levels of exposure to

potentially harmful agents in the water.

B. CDC Activities

1. Epidemiologic Research Related

Activities

a. Provide consultation for the

development and implementation of

study protocol.

b. Assist with the review of the

conduct of the study, as outlined in the

protocol.

c. Provide consultation with regard to

data collection and management.

d. Provide technical consultation in

the review of data analysis.

e. Consult with the recipient before

releasing the recipient’s findings to a

third party while the project is in

progress.

f. Review reports of research findings

being submitted for publication.

g. Provide technical assistance to

project management through

evaluations of the quality of

performance by various program

activities and staff members.

2. BDRFSP Related Activities

a. Assist recipients in developing a

plan for the selection of specific cases

and controls for interview.

b. Assist recipients in developing a

plan for conducting telephone

interviews of cases and controls.

c. Assist recipients in developing a

mechanism for reducing interview data

to computer-readable form.

d. Assist recipients to develop a plan

to implement a more refined clinical

approach to the classification of birth

defects for the purpose of improving

risk factor surveillance.

e. Assist recipients in developing a

plan to implement the laboratory phase

of the risk factor surveillance program.

Evaluation Criteria

Applications will be reviewed and

evaluated according to the following

criteria as they relate to the applicant’s

response to the ‘‘PROGRAM

REQUIREMENTS.’’

1. Applicant’s Understanding of the

Problem (10%)

The extent to which the applicant has

a clear, concise understanding of the

requirements, objectives, and purpose of

the grant. The extent to which the

application reflects an understanding of

the complexities surrounding the

establishment of a Center of Excellence.

2. Organizational Experience (30%)

The extent to which the applicant has

the skills, experience, and access to data

generated from a birth defects

surveillance (ascertainment) program

based on a population of not less than

30,000 live births per year. This access

provides the source of birth defect cases

for participation as a Center of

Excellence.

3. Approach and Capability (40%)

The extent to which the applicant has

included a description of their approach

to implementing the activities as

described in the Program Requirements.

The applicant shall describe and

indicate the availability of facilities and

equipment necessary to carry out this

project.

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.

4. Program Personnel (20%)

The adequacy of the description of

present staff and capability to assemble

competent and trained staff to conduct

the Center for Excellence. The applicant

shall identify all current and potential

personnel who will be utilized to work

on this grant, including qualifications

and specific experience as it relates to

the requirements set forth in this

request.

5. Budget Justification and Adequacy of

Facilities (not scored)

The budget will be evaluated for the

extent to which it is reasonable, clearly

justified, and consistent with the

intended use of the cooperative

agreement funds. The applicant shall

describe and indicate the availability of

facilities and equipment necessary to

carry out this project.

6. Human Subjects Review (not scored)

Whether or not exempt from the

DHHS regulations, are procedures

adequate for the protection of human

subjects? Recommendations on the

adequacy of protections include: (1)

Protections appear adequate, and there

are no comments to make or concerns to

raise, (2) protections appear adequate,

but there are comments regarding the

protocol, (3) protections appear

inadequate and the Objective Review

Group has concerns related to human

subjects, or (4) 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.

Executive Order 12372

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
Federal Register / Vol. 61, No. 112 / Monday, June 10, 1996 / Notices 29385

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 Ron Van Duyne, 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–13, Atlanta, GA 30305, no

later than 45 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 Announcement

Number and Program Title should be

referenced on the document. The

granting agency does not guarantee to

‘‘accommodate or explain’’ the 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 CDC, they should forward

them to Ron Van Duyne, 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–13, Atlanta, GA 30305, no

later than 45 days after the application

deadline date. The Announcement

Number and Program Title should be

referenced on the document. 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 not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.283.

Other Requirements

Human Subjects

The proposed project involves

research on human subjects, therefore,

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 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 forms 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 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.

Paperwork Reduction Act

Projects that involve the collection of

information from ten or more

individuals and are funded by the

cooperative agreement will be subject to

review and approval by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act.

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 Ron Van Duyne, 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–13, 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

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 will 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,

information on application procedures,

an application package, and business

management technical assistance may

be obtained from David Elswick, 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–13, Atlanta, GA 30305,

telephone (404) 842–6521, Internet

address: DCE1@opspgo1.em.cdc.gov, or

facsimile (fax) (404) 842–6513.

Programmatic technical assistance may

be obtained from Larry Edmonds,

Associate Chief for State Services, or

Terry G. Fitch, Public Health Advisor,

Birth Defects and Genetic Diseases

Branch, Division of Birth Defects and

Developmental Disabilities, National

Center for Environmental Health,

Centers for Disease Control and

Prevention (CDC), 4770 Buford

Highway, NE., Mailstop F–45, Atlanta,

GA 30341–3724, telephone (770) 488–

7160, e-mail address:

lde@cehbddd.em.cdc.gov.

Please refer to Announcement 643 when

requesting information and submitting an

application.
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)