Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79187 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Formal Dispute Resolution: Scientific 

and Technical Issues Related to 

Pharmaceutical Current Good 

Manufacturing Practice OMB Control 

Number 0910–0563—Extension 

Section 562 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

360bbb–1) directs FDA to establish 

adequate dispute resolution (DR) 

procedures to ensure appropriate review 

of scientific controversies between FDA 

and members of regulated industry, 

including possible review by a scientific 

advisory committee. To implement this 

provision, we amended the general 

appeal regulation applicable across all 

FDA components (21 CFR 10.75), 

Internal agency review of decisions) to 

provide for advisory committee review 

(§ 10.75(b)(2)). At the same time and 

consistent with the mandates of section 

562 of the FD&C Act, we adopted an 

approach whereby specific 

implementation procedures regarding 

scientific controversy associated with 

review of certain FDA decisions are 

detailed in center-issued guidance. 

Accordingly, we developed the 

guidance for industry ‘‘Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice.’’ 

We intend that the guidance inform 

manufacturers of veterinary and human 

drugs, including human biological drug 

products, on how to resolve disputes 

about scientific and technical issues 

relating to current good manufacturing 

practice (CGMP). 

Disputes related to scientific and 

technical issues may arise during FDA 

inspections of pharmaceutical 

manufacturers to determine compliance 

with CGMP requirements or during 

FDA’s assessment of corrective actions 

undertaken as a result of such 

inspections. The guidance recommends 

procedures that we believe encourage 

open and prompt discussion of disputes 

and lead to their resolution. The 

guidance describes procedures for 

raising such disputes to the Office of 

Regulatory Affairs and Center levels and 

procedures for requesting review by the 

DR panel. The guidance is available on 

our website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, along with 

additional information regarding the 

resolution of scientific disputes at FDA. 

We estimate only a nominal burden 

for the information collection and 

assume that one manufacturer will 

submit one request annually for tier-one 

DR and that it will take manufacturers 

approximately 30 hours to prepare and 

submit each tier-one DR request. Since 

our last request for OMB approval of the 

information collection, we have 

received no tier-two DRs. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Requests for tier-one DR ..................................................... 1 1 1 30 30 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated burden for the 

information collection reflects a 

decrease of 38 hours and a decrease of 

1 request. This adjustment corresponds 

to a decrease in the number of 

submissions we have received over the 

last few years. 

Dated: December 2, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27060 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–2020–D–0770] 

Best Practices in Developing 

Proprietary Names for Human 

Nonprescription Drug Products; Draft 

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 draft 

guidance for industry entitled ‘‘Best 

Practices in Developing Proprietary 

Names for Human Nonprescription Drug 

Products.’’ FDA is issuing this draft 

guidance to help sponsors develop 

human nonprescription drug product 

proprietary names. This draft 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. The draft guidance also 

describes the framework FDA uses in 

evaluating proposed proprietary names 

for nonprescription drug products, 

which is available to sponsors to use 

before marketing a nonprescription drug 

product bearing a particular proprietary 

name. This draft guidance is issued in 


jbell on DSKJLSW7X2PROD with NOTICES
79188 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

response to industry stakeholders’ 

requests to specifically address the 

approaches for naming of human 

nonprescription drug products. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by February 8, 

2021. 

ADDRESSES: You may submit comments 

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– 

2020–D–0770 for ‘‘Best Practices in 

Developing Proprietary Names for 

Human Nonprescription 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 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

Submit written requests for single 

copies of the draft 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; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

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 draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Danielle Harris, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4461, 

Silver Spring, MD 20993–0002, 301– 

796–4590; 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 draft guidance for industry entitled 

‘‘Best Practices in Developing 

Proprietary Names for Human 

Nonprescription Drug Products.’’ 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. FDA issued the draft guidance 

for industry ‘‘Best Practices in 

Developing Proprietary Names for 

Drugs’’ published in the Federal 

Register of May 29, 2014 (79 FR 30852). 

The 2014 draft guidance focused on the 

safety aspects in the development and 

selection of proposed proprietary names 

for all prescription and nonprescription 

human drug products. In the comments 

we received in response to the 2014 

draft guidance on proprietary naming, 

industry stakeholders urged FDA to 

separate the content pertaining to 

nonprescription drug product 

proprietary names from that pertaining 

to prescription drug product proprietary 

names and issue a separate guidance to 

address the name development process 

for nonprescription drugs. Thus, to 

provide greater clarity on the 

considerations applicable to the 

products regulated as nonprescription, 

this draft guidance ‘‘Best Practices in 

Developing Proprietary Names for 

Human Nonprescription Drug Products’’ 

was developed as a separate draft 

guidance. 

FDA is separately announcing the 

availability of a final guidance entitled 

‘‘Best Practices in Developing 

Proprietary Names for Human 


jbell on DSKJLSW7X2PROD with NOTICES
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