82 FR 43381 - The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 178 (September 15, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GIF) #210 entitled ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' This draft guidance describes the process for adding a new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index).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).

[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43381-43383]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19609]


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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Minor Species; Draft Guidance for Industry; Availability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 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the availability of draft guidance for industry (GIF) #210 entitled 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 This draft guidance describes the process for adding a new 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DATES: Submit either electronic or written comments on the draft 
guidance by November 14, 2017 to ensure that the Agency considers your 
comments on this draft guidance before it begins work on the final 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:

[[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 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, 7519 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

    The Minor Use and Minor Species Animal Health Act of 2004 (MUMS 
Act) (Pub. L. 108-282) amended the FD&C Act to provide animal drug 
companies with incentives to develop new animal drugs for minor species 
and minor uses in major species, while still ensuring appropriate 
safeguards for animal and human health.
    One of the incentives established by the MUMS Act is the Index of 
Legally Marketed Unapproved New Animal Drugs for Minor Species, also 
referred to as ``the Index.'' The Index is available for new animal 
drugs intended for use in minor species; the Index is not available for 
drugs intended for minor use in major species (horses, cattle, pigs, 
turkeys, chickens, dogs, and cats).
    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 (21 U.S.C. 360ccc-1). We refer to the process of 
adding a new animal drug to the Index as ``indexing.'' Indexing 
represents a pathway for legally marketing unapproved new animal drugs 
for minor species.
    In the Federal Register of December 6, 2007, FDA published final 
regulations establishing administrative procedures and criteria for 
listing a new animal drug for use in a minor species in the Index (72 
FR 69108). These regulations, which are codified at 21 CFR part 516, 
subpart C, are administered by the Office of Minor Use and Minor 
Species Animal Drug Development (OMUMS) within FDA's Center for 
Veterinary Medicine (CVM). That office also maintains the Index, which 
is available to the public through FDA's Web site at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm125452.htm.
    FDA is announcing the availability of a draft 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.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent 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

[[Page 43383]]

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 draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov.

    Dated: September 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19609 Filed 9-14-17; 8:45 am]
 BILLING CODE 4164-01-P