[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