{"abstract":"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.\"","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/09/09/2026-18299.html","cfr_references":[],"citation":"91 FR 57352","comment_url":"http://www.regulations.gov/commenton/FDA-2026-N-8361-0001","comments_close_on":"2026-11-09","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the collection of information must be submitted by November 9, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-8361"],"dockets":[{"supporting_documents":[{"title":"Reference 9 - Sinclair S., M. Cunnington, J. Messenheimer, et al., ‘‘Advantages and Problems With Pregnancy Registries: Observations and Surprises Throughout the Life of the International Lamotrigine Pregnancy Registry,’’ Pharmacoepidemiology and Drug Safety, 2014 Aug;23(8):779–786. doi: 10.1002/\npds.3659. Epub 2014 Jun 27. PMID:24974947; PMCID: PMC4406353.","document_id":"FDA-2026-N-8361-0007"},{"title":"Reference 8 - Sarker A., P. Chandrashekar, A. Magge, et al., ‘‘Discovering Cohorts of Pregnant Women From Social Media for Safety Surveillance and Analysis,’’ Journal of Medical internet Research, 2017 Oct 30;19(10):e361. doi: 10.2196/jmir.8164. PMID: 29084707; PMCID: PMC5684515.","document_id":"FDA-2026-N-8361-0006"},{"title":"Reference 7 - Krueger, W.S., M.S. Anthony, C.W. Saltus, et al., ‘‘Evaluating the Safety of Medication Exposures During Pregnancy: A Case Study of Study Designs and Data Sources in Multiple Sclerosis,’’ Drugs Real World Outcomes, 2017 Sep;4(3):139–149. doi: 10.1007/s40801–017–0114–9. PMID: 28756575; PMCID: PMC5567459.","document_id":"FDA-2026-N-8361-0005"},{"title":"Reference 6 - Hartman, R.I. and A.B. Kimball, ‘‘Performing Research in Pregnancy: Challenges and Perspectives,’’ Clinics in Dermatology, 2016 May–Jun;34(3):410–415. doi: 10.1016/j.clindermatol.2016.02.014. Epub 2016 Feb 11. PMID: 27265080.","document_id":"FDA-2026-N-8361-0004"},{"title":"Reference 5 - Daniels, J.L., D.A. Savitz, C. Bradley, et al., ‘‘Attitudes Toward Participation in a Pregnancy and Child Cohort Study,’’ Paediatric and Perinatal Epidemiology, 2006 May;20(3):260–266. doi: 10.1111/j.1365–3016.2006.00720.x. PMID: 16629701.","document_id":"FDA-2026-N-8361-0003"},{"title":"Reference 1 - Gelperin, K., H. Hammad, K. Leishear, et al., ‘‘A Systematic Review of Pregnancy Exposure Registries: Examination of Protocol-Specified Pregnancy Outcomes, Target Sample Size, and Comparator Selection,’’ Pharmacoepidemiology and Drug Safety, 2017 Feb;26(2):208–214. doi: 10.1002/pds.4150. Epub 2016 Dec 27. PMID: 28028914.","document_id":"FDA-2026-N-8361-0002"}],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2026-09-09","updated_at":"2026-10-22T01:56:33.469-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-8361-0001","allow_late_comments":false,"id":"FDA-2026-N-8361-0001","comment_end_date":"2026-11-10","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":6,"id":"FDA-2026-N-8361","title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications"}],"document_number":"2026-18299","effective_on":null,"end_page":57355,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/09/09/2026-18299.xml","html_url":"https://www.federalregister.gov/documents/2026/09/09/2026-18299/agency-information-collection-activities-proposed-collection-comment-request-pregnancy-exposure","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-18299?publication_date=2026-09-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-09-09/2026-18299/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":377,"last_updated":"2026-10-23 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18299.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18299.pdf?1788871513","publication_date":"2026-09-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/09/09/2026-18299.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 9 - Sinclair S., M. Cunnington, J. Messenheimer, et al., ‘‘Advantages and Problems With Pregnancy Registries: Observations and Surprises Throughout the Life of the International Lamotrigine Pregnancy Registry,’’ Pharmacoepidemiology and Drug Safety, 2014 Aug;23(8):779–786. doi: 10.1002/\npds.3659. Epub 2014 Jun 27. PMID:24974947; PMCID: PMC4406353.","document_id":"FDA-2026-N-8361-0007"},{"title":"Reference 8 - Sarker A., P. Chandrashekar, A. Magge, et al., ‘‘Discovering Cohorts of Pregnant Women From Social Media for Safety Surveillance and Analysis,’’ Journal of Medical internet Research, 2017 Oct 30;19(10):e361. doi: 10.2196/jmir.8164. PMID: 29084707; PMCID: PMC5684515.","document_id":"FDA-2026-N-8361-0006"},{"title":"Reference 7 - Krueger, W.S., M.S. Anthony, C.W. Saltus, et al., ‘‘Evaluating the Safety of Medication Exposures During Pregnancy: A Case Study of Study Designs and Data Sources in Multiple Sclerosis,’’ Drugs Real World Outcomes, 2017 Sep;4(3):139–149. doi: 10.1007/s40801–017–0114–9. PMID: 28756575; PMCID: PMC5567459.","document_id":"FDA-2026-N-8361-0005"},{"title":"Reference 6 - Hartman, R.I. and A.B. Kimball, ‘‘Performing Research in Pregnancy: Challenges and Perspectives,’’ Clinics in Dermatology, 2016 May–Jun;34(3):410–415. doi: 10.1016/j.clindermatol.2016.02.014. Epub 2016 Feb 11. PMID: 27265080.","document_id":"FDA-2026-N-8361-0004"},{"title":"Reference 5 - Daniels, J.L., D.A. Savitz, C. Bradley, et al., ‘‘Attitudes Toward Participation in a Pregnancy and Child Cohort Study,’’ Paediatric and Perinatal Epidemiology, 2006 May;20(3):260–266. doi: 10.1111/j.1365–3016.2006.00720.x. PMID: 16629701.","document_id":"FDA-2026-N-8361-0003"},{"title":"Reference 1 - Gelperin, K., H. Hammad, K. Leishear, et al., ‘‘A Systematic Review of Pregnancy Exposure Registries: Examination of Protocol-Specified Pregnancy Outcomes, Target Sample Size, and Comparator Selection,’’ Pharmacoepidemiology and Drug Safety, 2017 Feb;26(2):208–214. doi: 10.1002/pds.4150. Epub 2016 Dec 27. PMID: 28028914.","document_id":"FDA-2026-N-8361-0002"}],"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-8361","supporting_documents_count":6,"docket_id":"FDA-2026-N-8361","document_id":"FDA-2026-N-8361-0001","regulation_id_number":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications","checked_regulationsdotgov_at":"2026-10-23T07:55:03Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2026-N-8361-0001","significant":null,"signing_date":null,"start_page":57352,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications","toc_doc":"Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals","topics":[],"type":"Notice","volume":91}