[Federal Register: December 18, 2006 (Volume 71, Number 242)]
[Notices]
[Page 75759-75760]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de06-48]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-07-07AA]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 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
[[Page 75760]]
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 (approximately 250
enrollees per TIS) who have used any prescription or over-the-counter
medication 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 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 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.
Estimate of Annualized Burden Hours
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Number of Avg. burden
Respondent Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Prenatal exposure group alone................... 338 4 20/60 451
Lactation exposure group alone.................. 74 3 20/60 74
Prenatal exposure group and lactation exposure 338 4 30/60 676
group (pregnant women who subsequently
breastfeed)....................................
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Total....................................... 750 .............. .............. 1,201
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Dated: December 12, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E6-21527 Filed 12-15-06; 8:45 am]
BILLING CODE 4163-18-P