83 FR 18569 - The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 82 (April 27, 2018)

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).

[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)]
[Notices]
[Pages 18569-18570]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-08926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2462]


The Index of Legally Marketed Unapproved New Animal Drugs for 
Minor Species; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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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 anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-2462 for ``The Index of Legally Marketed Unapproved New 
Animal Drugs for Minor Species.'' Received comments will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dorothy Bailey, Center for Veterinary 
Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0565, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of September 15, 2017 (82 FR 43381), FDA 
published the notice of availability for a draft guidance entitled 
``The Index of Legally Marketed Unapproved New Animal Drugs for Minor 
Species'' giving interested persons until November 14, 2017, to comment 
on the draft guidance. FDA received several comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. Editorial changes were made to improve clarity. The guidance 
announced in this notice finalizes the draft guidance dated September 
2017. The Index consists of a list of legally marketed unapproved new 
animal drugs for minor species that meet the requirements of section 
572 of the FD&C Act.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance

[[Page 18570]]

practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on The Index of Legally Marketed Unapproved New 
Animal Drugs for Minor Species. It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 516.119 through 516.165 have been 
approved under OMB control number 0910-0620.

IV. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov.

    Dated: April 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08926 Filed 4-26-18; 8:45 am]
 BILLING CODE 4164-01-P