[Federal Register Volume 61, Number 112 (Monday, June 10, 1996)]
[Notices]
[Pages 29383-29386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14552]



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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