[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: 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.
[[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
