83 FR 10732 - Proprietary Names for New Animal Drugs; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 48 (March 12, 2018)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #240 entitled ``Proprietary Names for New Animal Drugs.'' This draft guidance provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand the drug. This draft guidance proposes a framework for evaluating proposed proprietary names before submitting them for review by the Center for Veterinary Medicine (CVM or we). It also explains how new animal drug sponsors can request that CVM evaluate a proposed proprietary name.

[Federal Register Volume 83, Number 48 (Monday, March 12, 2018)]
[Notices]
[Pages 10732-10733]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04885]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0626]


Proprietary Names for New Animal Drugs; Draft Guidance for 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the availability of a draft guidance for industry #240 entitled 
``Proprietary Names for New Animal Drugs.'' This draft guidance 
provides recommendations to help new animal drug sponsors develop 
proprietary names for new animal drugs that do not contribute to 
medication errors, negatively impact safe use of the drug, or misbrand 
the drug. This draft guidance proposes a framework for evaluating 
proposed proprietary names before submitting them for review by the 
Center for Veterinary Medicine (CVM or we). It also explains how new 
animal drug sponsors can request that CVM evaluate a proposed 
proprietary name.

DATES: Submit either electronic or written comments on the draft 
guidance by May 11, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 
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

[[Page 10733]]

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-2018-D-0626 for ``Proprietary Names for New Animal Drugs.'' 
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: Tom Modric, Center for Veterinary 
Medicine (HFV-216), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5853, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
#240 entitled ``Proprietary Names for New Animal Drugs.'' CVM evaluates 
proprietary names as a part of the new animal drug approval process. 
Selecting a proprietary name is a critical element in the design and 
development of drug product labeling because end users may rely, in 
part, on the proprietary name to identify which product, among 
thousands of available products, is intended for a given animal.

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 
``Proprietary Names for New Animal Drugs.'' 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 is not a significant 
regulatory action 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 part 514 have been approved under 
OMB control numbers 0910-0032 and 0910-0699; 21 CFR part 511 have been 
approved under OMB control number 0910-0117.

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: March 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04885 Filed 3-9-18; 8:45 am]
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