Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices 65395 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6530] 

Formal Meetings Between the Food 

and Drug Administration and Sponsors 

or Applicants of Prescription Drug 

User Fee Act Products; Draft Guidance 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 ‘‘Formal 

Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products.’’ This draft guidance outlines 

the recommendations to industry on 

formal meetings between the FDA and 

sponsors or applicants relating to the 

development and review of new drug or 

biological drug products. This draft 

guidance replaces the guidance ‘‘Formal 

Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’ issued on December 29, 2017. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 21, 2023 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2017–D–6530 for ‘‘Formal Meetings 

Between the FDA and Sponsors or 

Applicants of PDUFA 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

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 (CBER), 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: 

Jennifer Mercier, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5390, 

Silver Spring, MD 20993–0002, 301– 

796–0957; or Anne Taylor, 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 

‘‘Formal Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products.’’ This draft guidance outlines 

the recommendations to industry on 

formal meetings between FDA and 

sponsors or applicants relating to the 

development and review of drug or 

biological drug products as agreed upon 

during the Prescription Drug User Fee 

Act (PDUFA) VII negotiations. The draft 

guidance describes the different meeting 

types, formats, and timelines associated 

with those requests. It also provides 

industry with the information necessary 

to have a complete meeting request and 

background package to help facilitate 

the meeting to gain useful feedback for 

product development. The draft 


lotter on DSK11XQN23PROD with NOTICES1
65396 Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices 

guidance provides examples to help 

guide stakeholders on selecting and 

requesting the proper meeting type for 

a given scenario. 

This draft guidance replaces the draft 

guidance entitled ‘‘Formal Meetings 

Between the FDA and Sponsors or 

Applicants of PDUFA Products’’ issued 

on December 29, 2017 (82 FR 61763). 

FDA considered comments received on 

the draft guidance as the guidance was 

revised. Changes made include the 

addition of Type D and Initial Targeted 

Engagement for Regulatory Advice on 

CDER and CBER ProducTs (INTERACT) 

meetings, request for clarification/ 

followup opportunity correspondence, 

and virtual meetings as a face-to-face 

meeting. 

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 current thinking of FDA 

on ‘‘Formal Meetings Between the FDA 

and Sponsors or Applicants of PDUFA 

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. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 312 pertaining to meetings, 

including ‘‘End-of-phase 2’’ and ‘‘preNDA’’, have been approved under OMB 

control number 0910–0014. The 

collections of information in 21 CFR 

part 314 pertaining to formal meetings 

between sponsors or applicants and 

FDA have been approved under OMB 

control number 0910–0001. The 

collections of information pertaining to 

formal meetings between the FDA and 

sponsors or applicants for biological 

products have been approved under 

OMB control number 0910–0718. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: September 19, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20592 Filed 9–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–3031] 

Alternative Tools: Assessing Drug 

Manufacturing Facilities Identified in 

Pending Applications; 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 

‘‘Alternative Tools: Assessing Drug 

Manufacturing Facilities Identified in 

Pending Applications.’’ This draft 

guidance provides information to 

applicants on how FDA intends to use 

alternative tools to assess manufacturing 

facilities identified in a marketing 

application (i.e., a new drug application 

(NDA), an abbreviated new drug 

application (ANDA), a biologics license 

application (BLA), or a supplement to 

any of these types of applications). As 

part of the negotiations relating to the 

reauthorization of the Prescription Drug 

User Fee Act (PDUFA) and the 

Biosimilar User Fee Act (BsUFA), as 

described in ‘‘PDUFA Reauthorization 

Performance Goals and Procedures 

Fiscal Years 2023 Through 2027’’ 

(PDUFA VII commitment letter) and 

‘‘Biosimilar Biological Product 

Reauthorization Performance Goals and 

Procedures for Fiscal Years 2023 

Through 2027’’ (BsUFA III commitment 

letter), FDA agreed to issue guidance on 

the use of alternative tools to assess 

manufacturing facilities named in 

pending applications and to incorporate 

best practices from the use of such tools 

during the Coronavirus Disease 2019 

(COVID–19) pandemic. This draft 

guidance, within the context of approval 

and licensure decisions by FDA, 

describes the use of alternative tools to 

assess manufacturing facilities 

identified in an NDA, an ANDA, or a 

BLA to establish that these facilities 

meet the applicable requirements, 

including under the Federal Food, Drug, 

and Cosmetic (FD&C Act) or the Public 

Health Service Act (PHS Act). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 21, 2023 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2023–D–3031 for ‘‘Alternative Tools: 

Assessing Drug Manufacturing Facilities 

Identified in Pending Applications.’’ 

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. 


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