federal_register: 04-27198
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 04-27198 | Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs-Designation, Development, and Application Review | 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 the proposed collection of information concerning requests for fast track designation by sponsors of investigational new drugs (INDs) and applicants for new drug approvals or biological licenses as provided in the guidance for industry on fast track drug development programs. | 2004-12-13 | 2004 | 12 | https://www.federalregister.gov/documents/2004/12/13/04-27198/agency-information-collection-activities-proposed-collection-comment-request-guidance-for-industry | https://www.govinfo.gov/content/pkg/FR-2004-12-13/pdf/04-27198.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... |