# Pregnancy Risk Assessment Monitoring System; Notice of Availability of Funds

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URL: https://www.frixlaw.com/law-library/documents/fr%3A99-9824

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** April 20, 1999
- **Citation:** 64 FR 19364

## Text

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

[[Page 19365]]

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

[[Page 19366]]

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).

[[Page 19367]]

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A99-9824. Public record. Not legal advice.