[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Notices]
[Page 67517-67518]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no08-89]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-08-07AA]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
Maryam I. Daneshvar, the CDC Reports Clearance Officer, at (404) 639-
5960 or send an e-mail to omb@cdc.gov. Send written comments to CDC
Desk Officer, Office of Management and Budget, Washington, DC or by fax
to (202) 395-6974. Written comments should be received within 30 days
of this notice.
Proposed Project
Pilot Project for a National Monitoring System for Major Adverse
Effects of Medication Use During Pregnancy and Lactation--New--National
Center on Birth Defects and Developmental Disabilities (NCBDDD),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
This data collection is based on the following components of the
Public Health Service Act: (1) Act 42 U.S.C. 241, section 301, which
authorizes ``research, investigations, experiments, demonstrations, and
studies relating to the causes, diagnosis, treatment, control, and
prevention of physical and mental diseases and impairments of man.''
(2) 42 U.S.C. 247b-4, section 317 C, which authorizes the activities of
the National Center on Birth Defects and Developmental Disabilities.
This section was created by Public Law 106-310, also known as ``the
Children's Health Act of 2000.'' This portion of the code has also been
amended by Public Law 108-154, which is also known as the ``Birth
Defects and Developmental Disabilities Prevention Act of 2003''.
The use of a number of medications during pregnancy is known to be
associated with serious adverse effects in children. However, because
pregnant and lactating women are traditionally excluded from clinical
trials, and because premarketing animal studies do not necessarily
predict the experience of humans, little information is available about
the safety of most prescription medications during pregnancy and
lactation at the time they are marketed. Nevertheless, many women
inadvertently use medications early in gestation before realizing they
are pregnant, and many maternal conditions require treatment during
pregnancy and breastfeeding to safeguard the health of both mother and
infant. Currently, the United States does not have a comprehensive
early warning system for major adverse pregnancy or infant outcomes
related to medication exposures.
Teratology Information Services (TIS) utilize trained specialists
to provide free phone consultation, risk assessment, and counseling
about exposures during pregnancy and breastfeeding--including
medications--to women and healthcare providers. Altogether, they
respond to approximately 70,000-100,000 inquiries each year in the
United States and Canada. Because they have direct contact with
pregnant and breastfeeding women, TIS are in a unique position to
monitor the adverse effects of medication exposures during pregnancy
and lactation. The objective of this project is to conduct a pilot
study to assess whether TIS in the United States can serve as an
effective monitoring and early warning system for major adverse effects
on (1) pregnancy outcomes (e.g., live birth, stillbirth, premature
birth, low birth weight, etc.) and (2) maternal and infant health. The
project will assess the willingness of pregnant and breastfeeding women
who contact a TIS about medication exposure to participate in and
complete a follow-up study; whether these women are similar in
demographic characteristics to the U.S. population of child-bearing age
women; the specificity and completeness of the information obtained
from such a study about adverse pregnancy outcomes, and maternal and
infant health; and the amount of time required to conduct the follow-
up.
Within a continuous six-month period, three individual TIS will
recruit all women who contact their service (up to a maximum of 250
enrollees per TIS) who have used any prescription or over-the-counter
medication, vitamin, herbal, or other dietary supplement during
pregnancy or while breastfeeding to participate in a follow-up study.
Informed consent to participate will be obtained from each woman by
telephone. For each pregnant woman who agrees to participate, the TIS
will then conduct 4 telephone interviews: (1) At enrollment; (2) during
the third trimester of pregnancy; (3) approximately one month after
delivery; and (4) when the infant is about 3 months old. For each
breastfeeding woman who agrees to participate, the TIS will then
conduct 3 telephone interviews: (1) At enrollment; (2) approximately
one month after enrollment; and (3) 3 months after enrollment, if the
woman is still taking medication and still breastfeeding. The
interviews will assess maternal and fetal health throughout pregnancy,
and maternal and infant health at delivery, during the newborn and
early infancy period, and while breastfeeding, and correlate these
outcomes with medication exposure during pregnancy and while
breastfeeding. There is no cost to respondents other than their time.
The total estimated annualized burden is 516 hours.
[[Page 67518]]
Estimate of Annualized Burden Hours
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Avg. burden per
Type of respondent Form name No. of No. of responses response (in
respondents per respondent hours)
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All Respondents................. Telephone script for 294 1 3/60
permission to seek
consent (C1a or C1b).
Screened Eligible Respondents--. Tracking Form (C1c)..... 250 1 5/60
Pregnancy Exposure (group 1).... Consent (C2a or C2b).... 250 1 20/60
Lactation Exposure (group 2).... ........................ ................ ................ ................
Pregnancy and Lactation Exposure ........................ ................ ................ ................
(group 3).
Groups 1, 2 and 3............... Enrollment (D1)......... 250 1 10/60
Group 1 and 3................... Initial pregnancy 200 1 30/60
Questionnaire (D2).
Follow-up pregnancy 200 1 20/60
questionnaire (D3).
Initial infant 200 1 20/60
questionnaire (D4).
Follow-up infant 200 1 15/60
questionnaire (D5).
Groups 2 and 3.................. Initial breastfeeding 100 1 20/60
questionnaire (D6).
Follow-up breastfeeding 100 1.5 15/60
questionnaire (D7).
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Dated: November 6, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-27084 Filed 11-13-08; 8:45 am]
BILLING CODE 4163-18-P