federal_register: 04-28138
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 04-28138 | Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program | Notice | The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on revisions to Form FDA 3500 and Form FDA 3500A, (also known as MedWatch reporting forms). These forms are currently used to report to the agency about adverse events, product problems and medication/device use errors that occur with FDA regulated products, including drugs, biologicals, medical devices, special nutritional products, and cosmetics. | 2004-12-27 | 2004 | 12 | https://www.federalregister.gov/documents/2004/12/27/04-28138/agency-information-collection-activities-proposed-collection-comment-request-medwatch-food-and-drug | https://www.govinfo.gov/content/pkg/FR-2004-12-27/pdf/04-28138.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice... |