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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. Start Printed Page 67518
|Type of respondent||Form name||No. of respondents||No. of responses per respondent||Avg. burden per response (in hours)|
|All Respondents||Telephone script for permission to seek consent (C1a or C1b)||294||1||3/60|
|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 Questionnaire (D2)||200||1||30/60|
|Follow-up pregnancy questionnaire (D3)||200||1||20/60|
|Initial infant questionnaire (D4)||200||1||20/60|
|Follow-up infant questionnaire (D5)||200||1||15/60|
|Groups 2 and 3||Initial breastfeeding questionnaire (D6)||100||1||20/60|
|Follow-up breastfeeding questionnaire (D7)||100||1.5||15/60|
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