[Federal Register Volume 73, Number 221 (Friday, November 14, 2008)]
[Notices]
[Pages 67517-67518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27084]


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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 [email protected]. 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