Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Extension of Comment Period

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2018-D-4533] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; extension of comment period. SUMMARY: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that published in the Federal Register on November 20, 2019. In that notice, FDA requested comments on the draft guidance for industry (GFI) #256 entitled “Compounding Animal Drugs from Bulk Drug Substances.” FDA is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is further extending the comment period on the document published November 20, 2019 ( 84 FR 64085 ), which was reopened in a document published February 20, 2020 ( 85 FR 9783 ). Submit either electronic or written comments on the draft guidance by October 15, 2020, to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be…