Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 30229 

published. Furthermore, editorial 

changes were made to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Safety 

Considerations for Container Labels and 

Carton Labeling Design to Minimize 

Medication Errors.’’ 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. The collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. The collections of 

information in 21 CFR part 203 

described in the final rule entitled 

‘‘Prescription Drug Marketing Act of 

1987; Prescription Drug Amendments of 

1992; Policies, Requirements, and 

Administrative Policies’’ have been 

approved under OMB control number 

0910–0435. The collections of 

information in part 201 (21 CFR part 

201) described in the final rule entitled 

‘‘Bar Code Label Requirement for 

Human Drug Products and Biological 

Products’’ have been approved under 

OMB control number 0910–0537. The 

collections of information for 

prescription drug product labeling in 

§ 201.56 and 201.57 (21 CFR 201.56 and 

201.57) have been approved under OMB 

control number 0910–0572. The 

collections of information described in 

the FDA guidance for industry entitled 

‘‘Drug Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification’’ have 

been approved under OMB control 

number 0910–0806. 

In addition, the inclusion of warning 

statements on labels for certain drug 

products would be exempt from review 

by OMB under the PRA because the 

public disclosure of information 

originally supplied by the Federal 

government to the recipient for the 

purpose of disclosure to the public is 

not included within the definition of 

‘‘collection of information’’ (see 5 CFR 

1320.3(c)(2)). 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: May 12, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10699 Filed 5–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0880] 

Assessing User Fees Under the 

Generic Drug User Fee Amendments of 

2017; 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 

‘‘Assessing User Fees Under the Generic 

Drug User Fee Amendments of 2017.’’ 

This guidance provides stakeholders 

information regarding the 

implementation of the Generic Drug 

User Fee Amendments of 2017 (GDUFA 

II) and policies and procedures 

surrounding its application. This 

guidance is finalizing FDA’s draft 

guidance for industry ‘‘Assessing User 

Fees Under the Generic Drug User Fee 

Amendments of 2017,’’ published in 

November 2019. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on May 18, 2022. 

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– 

2012–D–0880 for ‘‘Assessing User Fees 

Under the Generic Drug User Fee 

Amendments of 2017.’’ 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 


lotter on DSK11XQN23PROD with NOTICES1
30230 Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 

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. 

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: 

Keith F. Verrett Jr., Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Rm. 2179, Silver 

Spring, MD 20993–0002, 301–796–7900, 

CDERCollections@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Assessing User Fees Under the Generic 

Drug User Fee Amendments of 2017.’’ 

GDUFA II (Pub. L. 115–52, Title III), was 

signed into law on August 18, 2017. 

GDUFA II extends FDA’s authority to 

assess and collect generic drug user fees 

from fiscal year (FY) 2018 through FY 

2022. The extension of this user fee 

authority under GDUFA II continues 

FDA’s and industry’s ability to meet the 

goals of improving public access to safe 

and effective generic drugs and 

enhancing the predictability of the 

review process. 

The guidance announced in this 

notice replaces the draft guidance for 

industry on ‘‘Assessing User Fees Under 

the Generic Drug User Fee Amendments 

of 2017,’’ dated October 2019 and 

published in November 2019. This 

guidance addresses changes in user fee 

assessments from GDUFA I, user fees 

incurred by industry under GDUFA II, 

payment procedures, reconsideration 

and appeals, and other additional 

information to assist industry in 

complying with GDUFA II. This 

guidance also describes how FDA 

determines affiliation for purposes of 

assessing generic drug user fees. 

FDA has reviewed the comments 

submitted to the docket and determined 

that the comments do not require 

substantive changes from the draft 

guidance. Clarifying language was, 

however, added to this final guidance 

largely based on the public comments 

and to update the Agency’s treatment of 

sponsor requests for ‘‘transfer’’ of 

certain user fee payments eligible for 

refund toward applicable user fee 

liabilities. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Assessing User 

Fees Under the Generic Drug User Fee 

Amendments of 2017.’’ 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 Form FDA 3913 (User 

Fee Payment Refund Request) have been 

approved under OMB control number 

0910–0805 and the collections of 

information in Form FDA 3914 (User 

Fee Payment Transfer Request) have 

been approved under OMB control 

number 0910–0805. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: May 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10702 Filed 5–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier OS–0990–xxxx] 

Agency Father Generic Information 

Collection Request. 60-Day Public 

Comment Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before July 18, 2022. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–New– 

60D, and project title for reference, to 

Sherrette Funn, the Reports Clearance 

Officer, Sherrette.funn@hhs.gov, or call 

202–795–7714. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: National 

Strategy for a Resilient Public Health 

Supply Chain Paper Reduction Act 

Clearance. 

Type of Collection: Father Generic 

ICR. 

OMB No. 0990–XXXX—Assistant 

Secretary for Preparedness and 


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