federal_register: 2014-07548
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-07548 | Guidance for Industry on What You Need To Know About Establishment, Maintenance, and Availability of Records-Small Entity Compliance Guide; Availability | Proposed Rule | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "What You Need To Know About Establishment, Maintenance, and Availability of Records-- Small Entity Compliance Guide" (SECG), which updates an earlier guidance of the same title. Previously, this guidance restated the legal requirements of FDA's maintenance and establishment of records regulation and served as that regulation's SECG. Because the FDA Food Safety Modernization Act (FSMA) amended FDA's maintenance and establishment of records regulation, FDA issued an interim final rule (IFR) amending certain regulations to be consistent with the changes. Accordingly, FDA is revising this guidance to help any entity comply with FDA's maintenance and establishment of records requirements, including the amendments to these requirements made by the IFR as finalized. This guidance continues to serve as FDA's SECG. | 2014-04-04 | 2014 | 4 | https://www.federalregister.gov/documents/2014/04/04/2014-07548/guidance-for-industry-on-what-you-need-to-know-about-establishment-maintenance-and-availability-of | https://www.govinfo.gov/content/pkg/FR-2014-04-04/pdf/2014-07548.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "What You Need To Know About Establishment, Maintenance, and Availability of Records-- Small Entity Compliance Guide" (SECG), which updates an... |