Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 60685 

(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 

Public Health/Public Safety Strategies 

to Reduce Drug Overdose Data 

Collection—New—National Center for 

Injury Prevention and Control (NCIPC), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

The drug overdose epidemic 

continues to pose a serious threat to 

communities across the country. In 

March 2023, the declaration of the 

opioid crisis as a national public health 

emergency was renewed yet again. 

Further, provisional data from the 

National Center for Health Statistics 

confirmed that the number of overdose 

deaths in 2022 was 109,680, which is a 

0.5% increase from 2020. Adding to this 

challenge, drug availability and 

overdose trends are rapidly changing, 

shaped by the westward expansion of 

fentanyl, the eastward expansion of 

methamphetamine, the inclusion of 

adulterants in the drug supply (e.g., 

fentanyl, xylazine), and increasing 

polysubstance-involved overdose. 

Multisector collaboration is critical to 

saving lives and reducing the overdose 

epidemic. Two key sectors in this 

response are public health and public 

safety (PH/PS), as they are both on the 

front lines and both tasked with 

improving community safety and wellbeing. CDC demonstrates strong 

commitment to PH/PS partnerships 

through implementation of several 

national programs. Beginning in 

September 2019, CDC’s Overdose Data 

to Action (OD2A) funds enhanced 

surveillance and prevention of fatal and 

nonfatal opioid overdoses in 47 States 

and 19 localities. In most of these 

jurisdictions, prevention activities are 

carried out in partnership with public 

safety. Since 2017, CDC has supported 

the Overdose Response Strategy (ORS), 

a unique collaboration between public 

health and public safety partners 

created to help local communities 

reduce drug overdose and save lives. 

CDC recently launched the Opioid 

Rapid Response Program, an 

interagency, coordinated Federal effort 

with the HHS Office of Inspector 

General to help mitigate overdose risks 

among patients who lose access to a 

prescriber of opioids due to law 

enforcement actions. As a relatively new 

and increasingly leveraged tool for 

overdose prevention, a greater 

understanding of PH/PS strategies are 

needed to inform these national 

programs. 

The goal of this Generic Clearance 

mechanism (Generic ICR, GenIC) is to 

collect data to improve overdose 

prevention efforts that involve PH/PS 

sectors or address justice-involved 

populations at increased risk of 

overdose. This requires practical 

information and experiential knowledge 

on current implementation of overdose 

prevention efforts by PH/PS. Based on 

previous experience, NCIPC anticipates 

that information will need to be 

collected to: (a) understand the design, 

implementation, and uptake of 

strategies that involve public health and 

safety, or individuals involved in the 

criminal legal system who are at 

increased risk of overdose; (b) identify 

barriers, facilitators, and best practices 

associated with strategy 

implementation; and, (c) identify 

disparities in access to strategies among 

diverse populations or the effectiveness 

of these strategies in reducing overdose. 

This Generic Clearance will allow for 

the gathering of information about PH/ 

PS strategies to identify actions to 

improve responses to the overdose 

crisis. No mechanism currently exists 

that would allow for exploration of 

programs, practices, and capacity among 

PH/PS partnerships to address overdose. 

The assessments conducted and 

information gathered through this 

Generic Clearance will be used to 

rapidly improve the implementation of 

programs enacted through these 

partnerships throughout the lifespan of 

CDC’s national programs. The estimated 

annual burden hours for this collection 

are 2,500. There are no costs to 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondent 

Form 

name 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Public Health/Public Safety Strategies Data 

Collection Participants.

Public Health/Public Safety Strategies Data 

Collection Instruments.

5,000 1 30/60 

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. 2023–19065 Filed 9–1–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day-23–23FZ] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘Healthcare 

Response and Prevention Training 

Curriculum for Health Departments’’ to 

the Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on June 16, 2023 to obtain 

comments from the public and affected 

agencies. CDC received one comment 

related to the previous notice. This 


ddrumheller on DSK120RN23PROD with NOTICES1
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