79186 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

Estimated Total Annual Burden 

Hours: 2,240. 

Comments: The Department 

specifically requests comments on (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 42 U.S.C. 1397 through 1397e. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–27015 Filed 12–8–20; 8:45 am] 

BILLING CODE 4184–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1076] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection pertaining to Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 8, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before February 8, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 8, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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–N–1076 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Guidance 

for Industry on Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 


jbell on DSKJLSW7X2PROD with NOTICES
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 


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