[Federal Register Volume 64, Number 75 (Tuesday, April 20, 1999)]
[Notices]
[Pages 19364-19367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99070]


Pregnancy Risk Assessment Monitoring System; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
program for a Pregnancy Risk Assessment Monitoring System (PRAMS) 
program. This program addresses the ``Healthy People 2000 Objectives'' 
priority area of Maternal and Infant Health. The purpose of the program 
is to assist State public health agencies to: (1) Establish and 
maintain State-specific, population-based surveillance of selected 
maternal behaviors and experiences that occur around the time of 
pregnancy and early infancy, and (2) to generate State-specific data 
for informing perinatal health programs and policies.

B. Eligible Applicants

    Assistance will be provided only to the official State and 
territorial public health agencies designated as registration areas for 
vital statistics, the Commonwealth of Puerto Rico, the Virgin Islands, 
the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, 
the Federated States of Micronesia, the Republic of the Marshall 
Islands, and the Republic of Palau.
    The following are excluded:
    1. States funded in September 1996, under Program Announcement 659, 
entitled `` Pregnancy Risk Assessment Monitoring System'': Alabama, 
Alaska, Arkansas, Colorado, Florida, Georgia, Illinois, Maine, New 
Mexico, New York, North Carolina, Oklahoma, South Carolina, Washington, 
and West Virginia.
    2. District and States which have previously received funds from 
CDC for PRAMS: District of Columbia, Indiana, and Michigan.
    In addition, all applicants must provide the following evidence of 
support:
    1. Written assurance, signed by the head of the State's Vital 
Statistics unit, that the recipient PRAMS program will have timely 
(i.e., able to draw a sample from birth certificates within 2 to 4 
months after delivery) access to edited birth certificate information 
needed for sampling and data collection. In addition, written assurance 
that a final birth tape will be available to CDC by December 1 of the 
following data year for the purpose of weighting the annual dataset.
    2. A letter of commitment from the Directors of the Maternal and 
Child Health (MCH), the Vital Statistics, the Data Processing units, 
that they will work collaboratively to support the PRAMS program.
    Applicants who do not provide these assurances and letters of 
commitment will not be eligible for funding, and their applications 
will be returned.

C. Availability of Funds

    Approximately $600,000 is available in FY 1999 to fund 
approximately 5 awards. It is expected that the average award will be 
$100,000 ranging from $60,000 to $120,000. It is expected that

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the awards will begin on or about September 30, 1999, and will be made 
for a 12-month budget period within a project period of up to 2 years. 
Funding estimates may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and on the availability of funds.

Use of Funds

    Supplantation of existing program efforts funded through other 
Federal or non-Federal sources is not allowable.

Recipient Financial Participation

    CDC funding usually is sufficient to cover some operational costs 
for PRAMS, but it is not intended to fully support all aspects of the 
program. States currently receiving cooperative agreement funds 
contribute their own resources to PRAMS--mostly in the form of 
operational resources and in-kind staff support. Recipients of awards 
under this announcement are expected to commit a minimum of two full-
time staff to the project.

Funding Preferences

    Funding preferences will be given to states which have not 
implemented PRAMS through a Memorandum of Understanding with CDC.

D. Program Requirements

    Recipients must identify and obtain review and approval from a NIH-
approved Institutional Review Board (IRB). No data collection may begin 
until the provisions of 45 CFR 46, Protection of Human Subjects, have 
been met (See ``Other Requirements'' section below).
    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. 
(Recipient Activities), and CDC will be responsible for conducting 
activities under 2. (CDC Activities).

1. Recipient Activities

    a. Adopt the standard PRAMS written protocol.
    b. Identify, at a minimum, a program coordinator and a data manager 
dedicated to overall coordination and operations of PRAMS.
    c. Form a Steering Committee consisting of representatives from the 
organizational units housing and collaborating on PRAMS, as well as 
other public and private health community representatives. The 
committee should provide oversight and set directions for the program 
and, at a minimum, meet at least once per year.
    d. Assure active cooperation and collaboration among the 
participating organizational units such as MCH, Vital Records, and Data 
Processing units.
    e. Design a State-wide PRAMS program that assures access to needed 
vital record information. Timely (i.e., able to draw a sample from 
birth certificates within 2 to 4 months after delivery) access to birth 
certificates is essential.
    f. Prepare State-specific questions and their rationale and 
pretest, if needed, the questionnaire. With other participating States, 
revise the common questions at agreed upon intervals.
    g. Define the study population and design and maintain a 
representative PRAMS sample.
    h. Develop a cycle of sampling and data collection in accordance 
with the protocol and CDC developed PRAMS software.
    i. Individual interviewers used by the State to conduct telephone 
interviewing must follow the standard PRAMS protocol and should be 
trained in accordance with PRAMS standards for phone interviewing.
    j. Develop, maintain, and make available to CDC, using the 
standardized PRAMS protocol, electronic files on birth certificate 
information of the sampling frame, and of sampled women, data 
collection activities, and questionnaire data on a timely basis for 
data management (i.e., sampling, cleaning, and weighting).
    k. Monitor, at least, monthly the quality of data collected and its 
management (i.e., through verification and validation efforts).
    l. Develop and implement an analysis plan.
    m. Collaborate with CDC on multi-State analyses combining or 
comparing data across PRAMS States.
    n. Disseminate PRAMS findings through presentations and 
publications to health departments, professional societies, voluntary 
agencies, universities, other PRAMS States, and other interested 
individuals and organizations.
    o. Participate with other States in training, workshops, and 
meetings at least once per year.
    p. Assure that CDC has a final birth tape by December 1 of the 
following data year. The birth tape is needed by CDC for the weighting 
of the annual dataset which is returned to the State for analyses.

2. CDC Activities

    a. Provide model protocol and assist with development of State-
specific written protocols.
    b. Assist the recipient agencies with development and revisions of 
State-specific questions and core questions for new States.
    c. Provide program software, training, and ongoing technical 
support for operations management, questionnaire data entry, and 
development of the PRAMS analysis database.
    d. Assist with the specification of variable descriptions and 
format layouts of all data files.
    e. Provide technical assistance for data editing.
    f. Assist with the development of computer programs for sampling.
    g. Provide technical assistance to resolve problems regarding data 
collection procedures, response rates, sampling procedures (unbiased 
sampling and estimate omissions), and database files (completeness).
    h. Assist in the development of annual weighted analysis datasets 
for recipient agencies, including developing statistical weights.
    i Assist recipient agency staff in obtaining training in sample 
survey analysis software.
    j. Provide recipients with epidemiological and statistical 
technical assistance.
    k. Conduct multi-State and single-State analyses, in collaboration 
with the State, and facilitate dissemination and translation of 
findings.
    l. Participate with recipient agencies in workshops, training, and 
meetings to exchange information among States.
    m. Conduct site visits to monitor the program operations and to 
provide technical assistance as needed.
    n. Assist in the development of a research protocol for IRB review 
by all cooperating institutions participating in the research project.
    o. The CDC IRB will review and approve the protocol initially and 
on at least an annual basis until the research project is completed.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than 30 double-spaced pages, 
printed on one side, with one inch margins, and unreduced font.
    The applicant must submit the following:

1. Background and Need

    a. Describe the rates of low birth weight and infant mortality on a 
Statewide basis and for high-risk sub-populations and geographical 
areas of

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special interest and describe their relationship to relevant national 
rates for the ``Healthy People 2000 Objectives''.
    b. Identify gaps in needed information concerning adverse pregnancy 
and infant outcomes, pregnancy and infant risk factors, and provide a 
description of how PRAMS data may be used to fill these gaps.
    c. Describe pregnancy-related information that State programs need 
to develop and direct intervention policies and activities; and 
identify priorities for information on risk factors.
    d. Describe how analyses of linked birth and infant death 
certificates have been used to identify infant health problems. The 
applicant should describe how data from PRAMS will complement the 
analyses of vital records by increasing understanding of previously 
identified infant health problems and identifying new problems.

2. Profile of State Birth Registration Process

    a. Describe, in detail, State process for registering births, to 
include each step from collection of information at the birth site, 
having an initial computerized file (the sampling frame from which the 
PRAMS sample will be drawn), and having a clean, edited file from which 
other information can be drawn. Documentation should be provided that 
the sample could be drawn from birth certificate information within 2 
to 4 months after the date of birth. The description should indicate 
whether development of the file requires linkage of medical and legal 
portions of the birth certificate. If so, this process should be 
described, along with the length of time needed to complete the 
linkage.
    b. Describe the schedule on which vital records information (frame 
files and end-of-year birth files, such as NCHS standard birth files) 
will be available to CDC. CDC uses these files for assisting the state 
with evaluation of the sample and weighting the data.
    c. Describe the current methods of processing birth certificates in 
the State: whether electronic birth certificate (EBC) registration is 
in place, and if so, for how long; if not, how long the current system 
has been in place; and any anticipated changes to the process.
    d. Describe the extent to which applicant can link birth 
certificate data to other data sources (e.g., infant deaths, 
Supplemental Nutrition Program for Women, Infants, and Children (WIC), 
Medicaid).

3. Plan of Operation

    a. Describe how and when the major project components (such as 
sampling, mail and telephone operations, data analysis, staffing plan, 
protocol development, steering committee) will be developed and 
implemented.
    b. Provide any available data that describe the extent to which the 
data collection approach is likely to produce adequate response rates 
among the sampled population, including high-risk sub-populations. 
Applicant should provide examples of previous surveys, including past 
experiences with PRAMS and other data collection activities, and their 
response rates in the proposed populations. Describe and provide for 
the inclusion of women, racial and ethnic minority populations in the 
proposed research to include:
    i. The proposed plan for the inclusion of women, racial and ethnic 
minority populations for appropriate representations.
    ii. The proposed justification when representation is limited or 
absent.
    iii. A statement whether the design of the study is adequate to 
measure differences when warranted.
    iv. A statement whether the plans for recruitment and outreach for 
study participants include the process of establishing partnerships 
with community(ies) and recognition of mutual benefits.
    c. Describe the roles, responsibilities, and supervision of key 
personnel who will be contributing to the PRAMS program during the next 
budget period.
    d. Document the relevant expertise and experience of proposed 
personnel involved in PRAMS program direction, operational management, 
and data analysis and dissemination, and their placement within the 
organization. It is strongly recommended that a minimum of two full-
time equivalents at the State level be committed to working on daily 
operations and coordination of PRAMS.
    e. Thoroughly describe the specific roles and responsibilities of 
participating organizational units, such as MCH, vital records, and 
data processing units.
    f. Describe a plan for data analysis and dissemination of findings 
through various channels, including steering committee members, health 
policy makers, and health providers. Applicant should provide a 
description of existing partnerships and how findings from previous 
studies have been disseminated.
    g. Provide an organizational chart that shows the proposed location 
of units that participate in PRAMS.

4. Timetable

    Provide a general time-line of major milestones for the project 
period and a schedule of activities for the first 12 months of the 
project period.

5. Budget

    Provide a detailed budget and line-item justification of all 
operating expenses that is consistent with the planned activities of 
the project. The budget should also address funds requested, as well as 
the applicant's in-kind or direct support. The budget should indicate 
if funds are already committed to PRAMS and the amount requested under 
this announcement should be adjusted accordingly.

F. Submission and Deadline

Application

    Submit the original and two copies of CDC Form 0.1246(E). Forms are 
in the application kit. On or before June 18, 1999, submit the 
application to: Mildred S. Garner, Grants Management Officer, Grants 
Management Branch, Procurement and Grants Office, Announcement 99070, 
Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, 
Room 3000, Atlanta, Georgia 30341.
    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 prior to 
submission to the review panel. (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 shall not be acceptable as proof of timely mailing.)
    Late Applications: Applications which do not meet the criteria in 
(a) or (b) above are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.

1. Background and Need (30 Points)

    a. The extent to which problems of poor pregnancy outcome exist, 
their severity, and whether they exist on a Statewide basis, within 
high-risk sub-populations, or defined geographical areas, and may be 
assessed in relationship to relevant national rates, the ``Healthy 
People 2000 Objectives'', and the Maternal and Child Health Bureau MCH 
indicators (5 points).

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    b. The programmatic relevance of the maternal and infant health 
program priorities (5 points).
    c. The extent to which the applicant describes the surveillance 
information needed and how it may be used for health program planning 
and resource allocation (10 points).
    d. The extent to which the applicant has used vital records data or 
other data sources, (e.g., infant deaths, WIC, Medicaid, or PRAMS) to 
identify and analyze infant health problems (10 points).

2. Profile of State Birth Registration Process (25 Points)

    a. The extent to which the process is thorough; birth certificate 
information is computerized, edited, and available for sampling within 
2 to 4 months after date of birth; and vital records information 
schedule provides timely access to CDC for sample evaluation and 
weighting (10 points).
    b. The extent to which electronic birth certificate registration 
(EBC) or other methods for processing birth certificates are used, and 
whether any changes in the current process are anticipated along with a 
time frame for these changes (10 points).
    c. The extent to which the applicant can link to other data sources 
(e.g., infant deaths, WIC, Medicaid) (5 points).

3. Plan of Operation (40 Points)

    a. The extent to which the sampling method appears appropriate and 
likely to produce adequate response rates among the sampled 
populations. Applicants should provide evidence of previous 
experiences, including PRAMS, with the sampled populations (10 points).
    b. The adequacy of the plan and timeline to carry out major project 
components (i.e., sampling, mail and telephone operations, data 
analysis)(5 points).
    c. The extent to which the roles and responsibilities for 
organizational units, such as MCH, vital records, and data processing 
units; and key personnel and their expertise and experience, are 
documented and appear reasonable and appropriate; and whether two full-
time equivalents are committed to working on PRAMS (10 points).
    d. The extent to which the plan for data analysis assures 
dissemination of findings through multiple channels, to include 
steering committee members, health policy makers, and health providers 
and the extent to which previous study findings have been disseminated 
(10 points).
    e. 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 (5 points). This includes:
    i. The proposed plan for the inclusion of women racial and ethnic 
minority populations for appropriate representation.
    ii. The proposed justification when representation is limited or 
absent.
    iii. A statement as to whether the design of the study is adequate 
to measure differences when warranted.
    iv. 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.

4. Timetable (5 Points)

    The extent to which the timetable incorporates major PRAMS 
activities and milestones and is specific, measurable, and realistic.

5. Budget (Not Scored)

    The extent to which the budget is detailed, clear, justified, 
provides in-kind or direct project support, and is consistent with the 
proposed program activities.

6. Human Subjects: (Not Scored)

    Does the application include a plan to adequately address the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects (see AR-1 below)? ____Yes____No

Comments:--------------------------------------------------------------

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. progress report, no more that 90 days after the end of the 
budget period;
    2. financial status report, no more than 90 days after the end of 
the budget period; and
    3. final financial status and performance reports, no more than 90 
days after the end of the project period.
    Send all reports to: Mildred S. Garner, Grants Management Officer, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, 
Atlanta, GA 30341.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I in the 
application kit.

AR98-1  Human Subjects Requirements
AR98-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR98-5  HIV Program Review Panel Requirements
AR98-7  Executive Order 12372 Review
AR98-9  Paperwork Reduction Act Requirements
AR98-10  Smoke-Free Workplace Requirements
AR98-11  Healthy People 2000
AR98-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a) and 317(k)of the 
Public Health Service Act, [42 U.S.C. sections 241(a) and 247b(k) 
respectively], as amended. The Catalog of Federal Domestic Assistance 
number is 93.283.

J. Where To Obtain Additional Information

    To obtain additional information, contact: Robert Hancock, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Announcement 99070, Centers for Disease Control and Prevention 
(CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146 
telephone (770) 488-2746, E-mail: [email protected].
    See also the CDC home page on the Internet to obtain a copy of this 
announcement: http://www.cdc.gov
    For program technical assistance, contact: Mary M. Rogers, Dr.P.H., 
Project Officer, PRAMS, Program Services and Development Branch, 
Division of Reproductive Health, NCCDPHP 4770 Buford Highway, N.E., MS 
K-22, Atlanta, Georgia 31341, Phone: (770) 488-5220, E-Mail: 
[email protected].

    Dated: April 14, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-9824 Filed 4-19-99; 8:45 am]
BILLING CODE 4163-18-P