Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices 4255 

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 laws. 

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: 

Bryan Spells, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1117, Silver Spring, 

MD 20993–0002, Bryan.Spells@

fda.hhs.gov, 240–402–6511; or Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911, Stephen.Ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is committed to achieve the longterm goal of improving the 

predictability and consistency of the 

electronic submission process and 

enhancing transparency and 

accountability of FDA information 

technology-related activities. In the 

document containing the performance 

goals and procedures for the 

Prescription Drug User Fee Act 

(PDUFA) reauthorization for fiscal years 

2018 through 2022 (the PDUFA VI 

commitment letter), FDA agreed to hold 

annual public meetings to seek 

stakeholder input related to electronic 

submissions and data standards to 

inform the FDA Information Technology 

Strategic Plan and published targets. 

The PDUFA VI commitment letter 

outlines FDA’s performance goals and 

procedures under the PDUFA program 

for the years 2018 through 2022. The 

PDUFA VI commitment letter can be 

found at https://www.fda.gov/media/ 

99140/download. 

FDA will consider all comments made 

at this meeting or received through the 

docket (see ADDRESSES). 

II. Participating in the Public Meeting 

Registration: To register to attend 

‘‘Prescription Drug User Fee Act of 

2017; Electronic Submissions and Data 

Standards,’’ please visit the following 

website: https://www.eventbrite.com/e/ 

pdufa-vi-data-standards-publicmeeting-2022-tickets-215684276477?

ref=estw. Please provide complete 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone. A draft 

agenda will be posted approximately 1 

month prior to the meeting. 

Opportunity for Public Comment: 

Those who register online by March 22, 

2022, will receive a notification about 

an opportunity to participate in the 

public comment session of the meeting. 

If you wish to speak during the public 

comment session, follow the 

instructions in the notification and 

identify which topic(s) you wish to 

address. We will do our best to 

accommodate requests to make public 

comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

comments and request time jointly. All 

requests to make a public comment 

during the meeting must be received by 

March 22, 2022, 11:59 p.m. Eastern 

Time. We will determine the amount of 

time allotted to each commenter and the 

approximate time each comment is to 

begin, and we will select and notify 

participants by April 1, 2022. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will be 

held via Zoom (https://fda.zoom

gov.com/j/1606221249). 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/ 

forindustry/userfees/prescription

druguserfee/ucm446608.htm. 

Dated: January 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01570 Filed 1–26–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6854] 

Good Abbreviated New Drug 

Applications Submission Practices; 

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 ‘‘Good 

ANDA Submission Practices.’’ This 

guidance is intended to assist applicants 

preparing to submit to FDA abbreviated 

new drug applications (ANDAs). This 

guidance highlights common, recurring 

deficiencies that may lead to a delay in 

the approval of an ANDA. It also makes 

recommendations to applicants on how 

to avoid these deficiencies with the goal 

of minimizing the number of review 

cycles necessary for approval. This 

guidance finalizes the draft guidance 

entitled ‘‘Good ANDA Submission 

Practices’’ issued on January 4, 2018. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 27, 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 


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4256 Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices 

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– 

2017–D–6854 for ‘‘Good ANDA 

Submission Practices.’’ 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. 

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: 

Mindy Ehrenfried, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1673, 

Silver Spring, MD 20993–0002, 301– 

796–4515. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Good 

ANDA Submission Practices.’’ This 

guidance is intended to assist applicants 

preparing to submit ANDAs to FDA. It 

highlights common, recurring 

deficiencies that may lead to a delay in 

the approval of an ANDA. This 

guidance also makes recommendations 

to applicants on how to avoid these 

deficiencies so that applicants can 

submit ANDAs that may be approved in 

the first review cycle. This guidance has 

been developed as part of FDA’s ‘‘Drug 

Competition Action Plan’’ (https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/fdadrug-competition-action-plan), which, 

in coordination with the Generic Drug 

User Fee Amendments (GDUFA I and II) 

(Pub. L. 112–144 and Pub. L. 115–52, 

respectively) and other FDA activities, 

is expected to increase competition in 

the market for drugs, facilitate entry of 

high-quality and affordable generic 

drugs, and improve public health. 

This guidance finalizes the draft 

guidance of the same title issued on 

January 4, 2018 (83 FR 532). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized and made minor edits and 

other editorial changes to improve 

clarity. Revisions include clarification 

of the recommendations pertaining to 

patent and exclusivity deficiencies, as 

well as those pertaining to product 

quality deficiencies relating to the drug 

substance. We have also clarified the 

recommendations relating to ANDAs 

that propose to use bioequivalence 

methods that differ from 

recommendations in a relevant productspecific guidance. 

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 ‘‘Good ANDA 

Submission Practices.’’ 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. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

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: January 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01580 Filed 1–26–22; 8:45 am] 

BILLING CODE 4164–01–P 


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