[Federal Register Volume 71, Number 242 (Monday, December 18, 2006)]
[Notices]
[Pages 75759-75760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21527]


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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 [email protected].
    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)....................................
                                                 ---------------------------------------------------------------
    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