federal_register: 2011-13821
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-13821 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Revised Guidance for Industry on “Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish a Microbiological ADI” (VICH GL-36(R)); Request for Comments; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (<greek-i>159) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI" (VICH GL36(R)). This draft revised guidance, which updates a final guidance on the same topic for which a notice of availability was published in the Federal Register of February 11, 2005, has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft revised VICH guidance was revised to include Appendix D--Supplement to Section 2 Regarding the Determination of the Fraction of Oral Dose Available to Microorganisms. This draft VICH guidance document is intended to provide guidance for assessing the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora. | 2011-06-03 | 2011 | 6 | https://www.federalregister.gov/documents/2011/06/03/2011-13821/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary | https://www.govinfo.gov/content/pkg/FR-2011-06-03/pdf/2011-13821.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (<greek-i>159) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to... |