[Federal Register Volume 85, Number 237 (Wednesday, December 9, 2020)]
[Notices]
[Pages 79189-79190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27058]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0622]


Best Practices in Developing Proprietary Names for Human 
Prescription Drug Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Best 
Practices in Developing Proprietary Names for Human Prescription Drug 
Products.'' This document provides guidance to sponsors on the 
development and selection of proposed proprietary names. This guidance 
describes best practices to help minimize medication errors and 
otherwise avoid adoption of proprietary names that contribute to 
violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 
its implementing regulations and provides a voluntary framework for 
evaluating proposed proprietary names before submitting them for FDA 
review. This guidance finalizes the draft guidance issued in May 2014 
entitled ``Best Practices in Developing Proprietary Names for the 
Drugs.''

DATES: The announcement of the guidance is published in the Federal 
Register on December 9, 2020

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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2014-D-0622 for ``Best Practices in Developing Proprietary Names 
for Human Prescription Drug Products.'' 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, 240-402-7500.
    <bullet> 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.govinfo.gov/content/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

[[Page 79190]]

and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Lubna Merchant, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4418, Silver Spring, MD 20993-0002, 301-
796-5162, or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Best Practices in Developing Proprietary Names for Human 
Prescription Drug Products.'' This guidance describes best practices to 
help minimize proprietary name-related medication errors and otherwise 
avoid adoption of proprietary names that contribute to violations of 
the FD&C Act and its implementing regulations. This guidance also 
describes the framework FDA uses in evaluating proprietary names that 
sponsors could use before submitting names for FDA review if they wish.
    FDA has long recognized the importance of proprietary name 
confusion as a potential cause of medication errors and has addressed 
this issue repeatedly in recent decades. Our focus has been to develop 
and communicate to sponsors a systematic, standardized, and transparent 
approach to proprietary name evaluation within the product development, 
review, and approval process.
    In the Federal Register of May 29, 2014 (79 FR 30852), FDA 
announced the availability of a draft guidance entitled ``Best 
Practices in Developing Proprietary Names for Drugs.'' The guidance 
announced in this notice finalizes the draft guidance issued in May 
2014. The Agency has carefully reviewed and considered the comments it 
received in developing this final version of the guidance.
    FDA received several comments on the guidance and revised the 
guidance in response to these comments. The revisions include (a) 
adding a note in the section discussing the United States Adopted Name 
(USAN) stating that FDA will no longer object to the use of two-letter 
USAN stems in names for products that do not share any association with 
the stem in question; (b) streamlining the name simulation study 
section based on the feedback received; (c) providing clarifications to 
the section that discusses medical abbreviations, modifiers, and 
computational methods; (d) separating the content pertaining to 
nonprescription proprietary names and issuing separate guidance to 
address the name development process for nonprescription drugs; (e) 
revising the misbranding discussion for greater clarity and included 
information on one possible study methodology that sponsors may 
consider to test proposed names for misbranding concerns; and (f) 
adding certain definitions and specific criteria for prescreening 
proprietary name candidates and updating definitions in the glossary 
and clarified terminology where needed. FDA also revised the document 
throughout to ensure consistency in terminology, clarified section 
headings, and reordered information for clarity where applicable.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a draft guidance entitled ``Best Practices in 
Developing Proprietary Names for Human Nonprescription Drug Products.'' 
That draft guidance is issued in response to industry stakeholders' 
requests to specifically address the approaches for naming of human 
nonprescription drug products. The draft guidance is being issued to 
provide greater clarity on the considerations applicable to 
nonprescription drug products.
    The guidance announced in this notice is being issued consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). The 
guidance represents the current thinking of FDA on ``Best Practices in 
Developing Proprietary Names for Human Prescription Drug Products.'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 314 have been approved under OMB control 
number 0910-0001, and the collections of information in 21 CFR part 601 
have been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the document at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: December 4, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27058 Filed 12-8-20; 8:45 am]
BILLING CODE 4164-01-P