Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is announcing the availability of guidance for industry #210 entitled "The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species." This final 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 a certain section of the Federal Food, Drug, and Cosmetic Act (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) is announcing the availability of guidance for industry #210 entitled “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” This final 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 a certain section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: The announcement of the guidance is published in the Federal Register on April 27, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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 made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyo…
Other Federal Register documents from the same docket.
Citation: 83 FR 18569
