Cooperative Agreement To Establish Centers of Excellence To Provide Surveillance, Research, Services and Evaluation Aimed at Prevention of Birth Defects

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.

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\1\ See ``Background'' section and ``Program Requirements''

section of the Program Announcement included in the Application Kit

for information about BDRFSP.

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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 population-based 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;

[[Page 29384]]

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

[[Page 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: DCE[email protected], 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:

[email protected].

Please refer to Announcement 643 when requesting information and

submitting an application.

[[Page 29386]]

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