federal_register: 2019-04429
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-04429 | Agency Information Collection Activities; Proposed Collection; Comment Request; Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act | Notice | 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, 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 the information collection involving interviews of pharmaceutical manufacturers who submit 351(k) biologics license applications (BLAs) to FDA under the Program for Enhanced Review Transparency and Communication (the Program) during FYs 2018 through 2021. | 2019-03-12 | 2019 | 3 | https://www.federalregister.gov/documents/2019/03/12/2019-04429/agency-information-collection-activities-proposed-collection-comment-request-review-transparency-and | https://www.govinfo.gov/content/pkg/FR-2019-03-12/pdf/2019-04429.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | 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... |