FDA Wants Docs' Input on Pregnancy Drug Surveys: Zzz
Published Date: 9/9/2026
Notice
Summary
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled "Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications."
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Survey Intended to Improve Pregnancy Safety Data
FDA says results from this survey will advance pregnancy exposure registry enrollment and 'ultimately improve health communications' by informing pregnancy safety data collection and inclusion of human safety data in pregnancy labeling. The project targets a 400-survey sample and FDA intends to disseminate results after final analyses.
Health Care Providers: Survey Participation Burden
FDA will recruit and screen about 2,000 licensed U.S. health care providers to obtain 400 completed surveys. Eligible primary providers must counsel five or more pregnant patients per month, consulting providers and pharmacists must counsel three or more per month; the screener takes about 2 minutes and the main survey about 17 minutes, for a total estimated annual burden of 167 hours.
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