[Federal Register Volume 60, Number 92 (Friday, May 12, 1995)]
[Notices]
[Pages 25727-25729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11765]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 536]
State-Based Evaluation of Trends and Risk Factors in Morbidity
and Mortality From Sickle Cell Disease After Newborn Screening;
Availability of Funds for Fiscal Year 1995
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1995 funds for a cooperative agreement
program for the State- based evaluation of trends and risk factors in
morbidity and mortality from sickle cell disease (SCD) after newborn
screening.
The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of ``Healthy People
2000,'' a PHS-led national activity to reduce morbidity and mortality
and improve the quality of life. This announcement is related to the
priority area of Maternal and Infant Health. (For ordering a copy of
``Healthy People 2000,'' see the section entitled Where To Obtain
Additional Information.)
Authority
This program is authorized under sections 301 and 317 of the Public
Health Service Act (42 U.S.C. 241 and 247b), as amended.
Smoke-Free Workplace
PHS 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 the official public health agencies of
States or their bona fide agents or instrumentalities. This includes
the District of Columbia, American Samoa, the Commonwealth of
[[Page 25728]] Puerto Rico, the Virgin Islands, the Federated States of
Micronesia, Guam, the Northern Mariana Islands, the Republic of Palau,
and federally recognized Indian tribal governments. Each applicant must
have a minimum of 50 newborns identified each year, for at least the
past five years, with presumed Hemoglobin SS, SC, or S/-
thalassemia. Each applicant must also have an existing mechanism for
ascertaining health outcomes for these children.
Note: Eligible applicants may enter into contracts, including
consortia agreements, as necessary to meet the essential
requirements of this program and to strengthen the overall
application, provided that the lead organization is a State.
Availability of Funds
Approximately $100,000 is available in FY 1995 to fund one to three
awards. It is expected that the average award will be $50,000. It is
expected that the awards will begin on or about September 30, 1995, and
will be made for a 12-month budget period within a project period of up
to three years. Funding estimates may vary and are subject to change.
Continuation awards within the project period will be made on the
basis of satisfactory progress, the need to continue the program, and
the availability of funds.
Purpose
These awards will support State programs that are already involved
with the follow-up of children with SCD ascertained through their
newborn screening programs. Data from this program will be used to
determine the proportion of affected newborns who receive appropriate
health care, which will measure progress toward the applicable
``Healthy People 2000'' objectives.
Program Requirements
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).
A. Recipient Activities
1. Refine existing efforts to ascertain follow-up information about
cohorts of children with SCD, including vital status and other relevant
data, such as major illnesses and hospitalizations. The database of
outcomes will contain a core common to all collaborating States.
Individual States may, at their option, develop a non-core section to
account for local conditions.
2. Determine risk factors for mortality and morbidity from SCD
including (but not limited to) extent of medical care follow-up,
location of treatment, use of penicillin prophylaxis, immunization
patterns, and other relevant factors. The risk factor database will
contain a core common to all collaborating States. Individual States
may, at their option, develop a non-core section to account for local
conditions.
3. Conduct a collaborative case-control study of risk factors for
mortality and morbidity.
4. Design and implement a mechanism for reducing all data to
computer readable form.
5. Engage, and collaborate with, other States and CDC in the timely
sharing, joint analysis and publication of pooled data.
B. CDC Activities
1. Assist recipients in standardizing and implementing collection
of outcome data for the SCD cohorts.
2. Assist recipients in developing a common data-collection
instrument and database of risk factors for mortality and morbidity.
3. Assist recipients in designing and implementing a case-control
study of risk factors for mortality and morbidity.
4. Assist recipients in designing and implementing a mechanism for
reducing data to computer readable form.
5. Assist with statistical analyses, interpretation, and
dissemination of applicable results.
6. Provide technical assistance.
Evaluation Criteria
Applications will be reviewed and evaluated according to the
following criteria:
1. Need and Purpose (10%)
Responsiveness to the objectives of the cooperative agreement
program, including the applicant's recognition of the public health
significance of the problem and the relevance of the proposed project
to the purpose of the agreement.
2. Project Description and Methods (45%)
a. Strength of the project design in describing the objectives of
the proposed project.
b. Strength of the project design in describing the attributes of
the State SCD newborn screening database as related to the purposes of
the project.
c. Quality, extent, and history of the State newborn screening
program, including the population base and percent of State residents
screened, the cumulative number of infants identified with SCD since
the inception of screening, the existence of an established database of
identified infants, and efforts to ascertain mortality and morbidity
over time.
d. Quality of the project design in describing the technical
approach, including identification of available State resources for
follow-up; description of proposed and existing follow-up methods; and
description of methods for ascertaining risk factors for mortality and
morbidity.
e. Ability to protect the confidentiality of data.
f. Strength of the project design in describing the steps to be
taken in planning and implementing the project.
3. Capability and Experience (25%)
a. Demonstration of capability to conduct a project of this nature,
including reputation in the field, ability to access all necessary
data, and ability to demonstrate a pre-eminent position as an
appropriate agency to carry out the project.
b. Demonstration of ability to identify, organize, and determine
appropriate responsibilities among the applicant, CDC, and other
participants.
c. Demonstration of applicant's successful experience and
performance in conducting and evaluating similar projects, including
the strength and value to the project of any collaborating
organizations.
4. Staffing and Management Resources (20%)
a. Demonstration that proposed Project Director is knowledgeable
regarding newborn screening and prevention of SCD complications, and
has management capabilities, scientific skills, and experience with
prevention activities, as evidenced by publications, program summaries,
or other materials that document prior work. Demonstration of a minimum
of five percent time commitment to the project by the proposed Project
Director.
b. Demonstration that proposed professional staff are the
appropriate mix of professional disciplines based on their training,
experience, and expertise in their disciplines, as evidenced by
publications, program summaries, or other materials that document prior
work. Demonstration of a mimimum of twenty percent time commitment by
the proposed professional staff that is sufficient to accomplish the
project.
c. Demonstration of ability to provide facilities and other
necessary management or administrative resources. [[Page 25729]]
5. Budget (Not Scored)
Extent to which the project budget is reasonable, clearly
justified, and consistent with the intended use of funds.
6. Human Subjects (Not Scored)
The applicant must clearly state whether or not human subjects will
be used in their research.
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 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 of 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 Henry S. Cassell, III, 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 E13, Atlanta, Georgia 30305, no later
than 60 days after the application deadline. The Program Announcement
Number and Program Title should be referenced on the documents. The
granting agency does not guarantee to ``accommodate or explain'' for
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 send them to Henry S. Cassell, III, 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 E13, Atlanta, Georgia 30305, no later than 60 days
after the application deadline. The Program Announcement Number and
Program Title should be referenced on the documents. The granting
agency does not guarantee to ``accommodate or explain'' for State
process recommendations it receives after that date.
Public Health System Reporting Requirement
This program is not subject to the Public Health Reporting
Requirements.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.283.
Other Requirements
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 the appropriate
institutional review committees. 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. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
form provided in the application kit.
Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and are funded by the cooperative agreement will be subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act.
Application Submission and Deadline
The original and two copies of the application PHS Form 5161-1 (OMB
Number 0937-0189) must be submitted to Henry S. Cassell, III, 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 E13, Atlanta, Georgia 30305,
on or before July 14, 1995.
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 for 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 Adrienne Brown, 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 E13, Atlanta, Georgia 30305, telephone
(404) 842-6634. Programmatic technical assistance may be obtained from
Richard S. Olney, M.D., M.P.H., Division of Birth Defects and
Developmental Disabilities, National Center for Environmental Health,
Centers for Disease Control and Prevention (CDC), 4770 Buford Highway,
NE., Mailstop F45, Atlanta, Georgia 30341, telephone (404) 488-7176,
electronic mail [email protected].
Please refer to Announcement 536 when requesting information or
submitting an application.
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.
Dated: May 8, 1995.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 95-11765 Filed 5-11-95; 8:45 am]
BILLING CODE 4163-18-P