Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79189 

Prescription Drug Products,’’ which 

addresses prescription drug products. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 Agency’s current thinking 

on ‘‘Best Practices in Developing 

Proprietary Names for Human 

Nonprescription 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may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://

www.regulations.gov. 

Dated: December 4, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27057 Filed 12–8–20; 8:45 am] 

BILLING CODE 4164–01–P 

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: 

• 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– 

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. 

• 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 


jbell on DSKJLSW7X2PROD with NOTICES
79190 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

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 twoletter 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/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Fourth Amendment to the Declaration 

Under the Public Readiness and 

Emergency Preparedness Act for 

Medical Countermeasures Against 

COVID–19 and Republication of the 

Declaration 

ACTION: Notice of Amendment and 

Republished Declaration. 

SUMMARY: The Secretary issues this 

amendment pursuant to section 319F–3 

of the Public Health Service Act to 

amend his March 10, 2020 Declaration 

Under the Public Readiness and 

Emergency Preparedness Act for 

Medical Countermeasures Against 

COVID–19. 

DATES: The amendments to the 

Declaration are applicable as of 

February 4, 2020, except as otherwise 

specified in Section XII. 

FOR FURTHER INFORMATION CONTACT: 

Robert P. Kadlec, MD, MTM&H, MS, 

Assistant Secretary for Preparedness 

and Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue 


jbell on DSKJLSW7X2PROD with NOTICES