federal_register: 2016-17016
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-17016 | Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards | 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 collection of information related to certain regulations that provide protection for human subjects of clinical investigations conducted in support of applications or submissions to FDA for FDA-regulated products. The regulations provide protection of the rights, safety, and welfare of human subjects involved in research activities within FDA's jurisdiction. | 2016-07-19 | 2016 | 7 | https://www.federalregister.gov/documents/2016/07/19/2016-17016/agency-information-collection-activities-proposed-collection-comment-request-protection-of-human | https://www.govinfo.gov/content/pkg/FR-2016-07-19/pdf/2016-17016.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... |