60686 Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Healthcare Response and Prevention 

Training Curriculum for Health 

Departments—New—National Center 

for Emerging and Zoonotic Infectious 

Diseases (NCEZID), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

CDC funds Healthcare-Associated 

Infection and Antibiotic Resistance 

(HAI/AR) programs in 64 state, local 

and territorial health departments. 

Funding is awarded through the 

Epidemiology and Laboratory 

cooperative agreements (ELC). Funds 

are intended to provide critical 

resources to recipients in support of a 

broad range of healthcare infection 

prevention and control and 

epidemiologic surveillance activities to 

detect, monitor, mitigate, and prevent 

the spread of HAI/AR in healthcare 

settings. Recently, HAI/AR programs 

have experienced an increase in 

program size and scope through 

COVID–19 supplemental funds. To 

better support the growing programs, 

CDC has developed high-priority 

trainings requested by the health 

department programs with the goal of 

strengthening public health workforce 

capacity to prevent and respond to HAI/ 

AR outbreaks in healthcare settings, 

including preventing the spread of 

SARS–CoV–2. 

The proposed training evaluation will 

be used to assess whether the CDCdeveloped trainings are reaching the 

intended audience and achieving the 

intended goal of strengthening public 

health workforce capacity to prevent 

and respond to HAI/AR outbreaks, 

including COVID–19 at the individual 

trainee and program level. CDC requests 

OMB approval for an estimated 316 

annual burden hours. There is no cost 

to respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents 

Form 

name 

Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Public Health Trainees ................................... Registration ................................................... 600 2 5/60 

Public Health Trainees ................................... Pre-Test ......................................................... 600 2 5/60 

Public Health Trainees ................................... Post-test ........................................................ 600 2 5/60 

HAI/AR Program Leads ................................. Public Health program impact of trainings .... 64 1 15/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–19066 Filed 9–1–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–3370] 

Post-Warning Letter Meetings Under 

the Generic Drug User Fee Act; 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 ‘‘PostWarning Letter Meetings Under 

GDUFA.’’ This draft guidance provides 

information on the implementation of 

the Post-Warning Letter Meeting process 

for certain drug manufacturing facilities, 

a program enhancement agreed upon by 

the Agency and industry as part of the 

negotiations relating to the 

reauthorization of the Generic Drug User 

Fee Amendments (GDUFA), as 

described in ‘‘GDUFA Reauthorization 

Performance Goals and Program 

Enhancements Fiscal Years 2023–2027’’ 

(GDUFA III commitment letter). 

Specifically, this draft guidance 

describes the process detailed in the 

GDUFA III commitment letter for how 

an eligible facility may request a PostWarning Letter Meeting with FDA 

regarding the facility’s ongoing 

remediation efforts to current good 

manufacturing practice (CGMP) 

deficiencies described in a warning 

letter, how to prepare and submit a 

complete meeting package, and how 

FDA intends to conduct the PostWarning Letter Meeting. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 5, 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: 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 60687 

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–3370 for ‘‘Post-Warning Letter 

Meeting Under GDUFA.’’ 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: 

Rebecca Frey-Cooper, Office of 

Manufacturing Quality, Center for Drug 

Evaluation and Research (HFD–003), 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002, 240–402–4127. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Post-Warning Letter Meetings under 

GDUFA.’’ This draft guidance provides 

information on the implementation of 

the Post-Warning Letter Meeting 

process, a program enhancement agreed 

upon by the Agency and industry as 

part of the negotiations relating to the 

reauthorization of GDUFA, as described 

in ‘‘GDUFA Reauthorization 

Performance Goals and Program 

Enhancements Fiscal Years 2023–2027’’ 

(GDUFA III Commitment Letter). 

Specifically, this draft guidance 

describes the process in the GDUFA III 

commitment letter for how an eligible 

facility may request a Post-Warning 

Letter Meeting with FDA regarding the 

facility’s ongoing remediation efforts to 

current good manufacturing practice 

(CGMP) deficiencies described in a 

warning letter, how to prepare and 

submit a complete meeting package, and 

how FDA intends to conduct the PostWarning Letter Meeting. 

The Generic Drug User Fee 

Amendments of 2012 (GDUFA I) 

amended the FD&C Act to authorize 

FDA to assess and collect user fees to 

provide FDA with additional resources 

to help ensure patients have access to 

quality, affordable, safe, and effective 

generic drugs. GDUFA fee resources 

bring greater predictability and 

timeliness to the review of generic drug 

applications. GDUFA has been 

reauthorized every 5 years to continue 

FDA’s ability to assess and collect 

GDUFA fees, and this user fee program 

has been reauthorized twice since 

GDUFA I, most recently in the Generic 

Drug User Fee Amendments of 2022. As 

described in the GDUFA III 

Commitment Letter applicable to this 

latest reauthorization, FDA has agreed 

to performance goals and program 

enhancements regarding aspects of the 

generic drug assessment program that 

build on previous authorizations of 

GDUFA. New enhancements to the 

program are designed to maximize the 

efficiency and utility of each assessment 

cycle, with the intent of reducing the 

number of assessment cycles for ANDAs 

and facilitating timely access to generic 

medicines for American patients. 

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 ‘‘Post-Warning Letter Meetings 

Under GDUFA.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
60688 Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 

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 314 have been approved 

under OMB control number 0910–0001. 

The collections of information in 21 

CFR parts 210 and 211 pertaining to 

current good manufacturing practice has 

been approved under OMB control 

number 0910–0139. The collections of 

information in 21 CFR part 11 for 

electronic records and electronic 

signatures have been approved under 

OMB control number 0910–0303. The 

collections of information pertaining to 

the submissions of GDUFA III 

commitment letter, meetings related to 

generic drug development, and the 

Generic Drug User Fee Program have 

been approved under OMB control 

number 0910–0727. 

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/ 

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

www.regulations.gov. 

Dated: August 30, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19081 Filed 9–1–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3575] 

Reauthorization of the Over-theCounter Monograph Drug User Fee 

Program; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing a public meeting to discuss 

proposed recommendations for the 

reauthorization of the Over-the-Counter 

(OTC) Monograph Drug User Fee 

Program (OMUFA) for fiscal years (FYs) 

2026 through 2030. OMUFA authorizes 

FDA to assess and collect user fees to 

support OTC monograph drug activities. 

The current legislative authority for 

OMUFA expires September 30, 2025. At 

that time, new legislation will be 

required to reauthorize the OMUFA 

program for future fiscal years. The 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) directs that FDA consult 

with the public as part of the OMUFA 

reauthorization process. FDA invites 

public comment as the Agency begins 

the process to reauthorize the program 

for FYs 2026 through 2030. 

DATES: The public meeting will be held 

on September 28, 2023, from 9 a.m. to 

5 p.m. Registration to attend the meeting 

should be received by September 27, 

2023. Either electronic or written 

comments on this public meeting must 

be submitted by October 27, 2023. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, Rm. 1503, Silver 

Spring, MD 20993. Entrance for the 

public meeting participants (non-FDA 

employees) is through Building 1 where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.fda.gov/about-fda/visitorinformation. Any changes to the public 

meeting location and remote 

information, as appropriate, will be 

posted to https://www.fda.gov/industry/ 

fda-user-fee-programs/over-countermonograph-drug-user-fee-programomufa in advance of the meeting. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of October 27, 2023. 

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– 

2023–N–3575 for ‘‘Reauthorization of 

the Over-the-Counter Monograph Drug 

User Fee Program; Public Meeting; 

Request for Comments.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1