Federal Register #FDA-2026-N-8361

FDA Seeks Survey Services to Improve Pregnancy Exposure Registry Enrollment

This opportunity involves the Food and Drug Administration (FDA), part of the Department of Health and Human Services, seeking public comment on a proposed survey project to improve pregnancy exposure registry enrollment. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - FDA is the only organization mentioned; no commercial OEMs or vendors are specified - Products/Services Requested: - Internet-based survey administration and data collection service - Targeting primary healthcare providers (obstetrician/gynecologists, family practice physicians, certified nurse-midwives, physician assistants), consulting healthcare providers (neurologists, infectious disease specialists, psychiatrists, rheumatologists, cardiologists, pulmonologists, dermatologists), and pharmacists - Goal: 400 completed surveys, screening up to 2,000 providers - Unique or Notable Requirements: - Use of automated technology for data collection - Ensuring a nationally representative sample of healthcare providers - Focus on identifying barriers to registry enrollment and gathering improvement ideas - No specific products or part numbers requested; this is a service-focused opportunity

Description

The Food and Drug Administration (FDA) is soliciting public comments on a proposed study titled "Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications." The study aims to gather information from healthcare providers about barriers to patient enrollment in pregnancy exposure registries to improve pregnancy safety data collection and health communication strategies. The survey will target primary healthcare providers, consulting healthcare providers, and pharmacists who routinely care for or counsel pregnant patients. The study will be conducted via an internet survey with a target sample size of 400 completed surveys.

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