Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GIF) #210 entitled "The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species." This draft guidance describes the process for adding a new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
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-2017-D-2462] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GIF) #210 entitled “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” This draft guidance describes the process for adding a new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). DATES: Submit either electronic or written comments on the draft guidance by November 14, 2017 to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance.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: ( printed page 43382) 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 made public, you are solely responsible for ensuring that your comment does not inclu…
Other Federal Register documents from the same docket.
Citation: 82 FR 43381
