71876 Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Improving the Quality and 

Representativeness of the Treatment 

Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format To Minimize 

Misclassification 

OMB Control Number 0910–NEW 

FDA has a need for valid, high-quality 

surveillance data on misuse of 

pharmaceutical products and use of 

other substances in the United States. 

FDA is funding the evaluation and 

improvement of the data validity and 

reliability of the Researched Abuse, 

Diversion and Addiction-Related 

Surveillance (RADARS®) Substance 

Abuse Treatment Center Programs 

Combined (TCPC) survey. The RADARS 

TCPC is comprised of two unique 

programs, the Opioid Treatment 

Program and the Survey of Key 

Informants’ Patients Program. These two 

programs use the same core paper data 

collection form and complement each 

other by providing information from 

patients entering both private and 

public opioid addiction treatment 

programs. Patients enrolling in the 

study complete a self-administered 

anonymous questionnaire, within the 

first week of admission. The objective of 

these programs is to provide timely 

prevalence estimates of abuse of legal 

and illegal opioids and other 

substances, within the past month, 

among patients enrolling in treatment 

primarily for opioid use disorders. 

Surveillance data collected by these 

programs are used by FDA as well as 

researchers, industry, and other public 

health stakeholders to inform policy and 

regulatory decisions. FDA will be 

providing public health expertise on the 

survey validity and reliability questions 

before implementation to ensure that 

they generate quality data. FDA will 

also be providing its expert input on the 

results, analysis, and interpretation, as 

well as how the survey may be 

improved in light of the results. 

This FDA-funded information 

collection will include three survey 

arms, two arms focused on survey 

validity (is the survey measuring what 

it is intended to measure) and the third 

arm focused on survey reliability (do the 

questions consistently produce the same 

results when asked at different time 

points and in a different format). For 

both survey validity arms—a digital 

survey only and digital survey plus 

interview arm—volunteer participants 

will be asked to pause after answering 

each survey question to answer a series 

of content validation questions 

concerning comprehension and quality 

of survey items. Items assessed will 

include survey instructions, active 

pharmaceutical ingredient and product 

content, reason for use, and route of 

administration. For the survey 

reliability arm, TCPC paper survey 

participants at selected sites will be 

invited to voluntarily participate in a 

second, digital survey, and the results of 

the two survey formats will be 

compared. The data collected through 

the three arms of this information 

collection will be analyzed to validate 

the content of a modified TCPC survey 

and to then determine the reliability 

among a proxy population for the target 

population. Results from the three arms 

will inform the format, structure, and 

wording of the modified digital TCPC 

survey, prior to its launch. 

The annual participant burden hours 

requested are based on the number of 

collections FDA expects the contractor 

to conduct over the requested time 

frame for this clearance. FDA estimates 

the burden of this collection of 

information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of respondent/interview Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Content Validity—Digital Survey Arm .................. 175 1 175 0.25 (15 minutes) .......... 44 

Content Validity—Digital Survey and Cognitive 

Interview Arm.

25 1 25 1.5 (90 minutes) ............ 38 

Reliability Survey Arm—Digital Survey ................ 250 1 250 0.33 (20 minutes) .......... 83 

Total .............................................................. 450 ........................ 450 ....................................... 165 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: October 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22966 Filed 10–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0465; FDA–2023– 

N–1529; FDA–2010–N–0583; FDA–2020–N– 

0145; FDA–2023–N–0918; FDA–2014–N– 

1721] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 71877 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection 

OMB 

control 

No. 

Date 

approval 

expires 

Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response 

Act of 2002 ........................................................................................................................................................... 0910–0520 9/30/2026 

Voluntary Qualified Importer Program ..................................................................................................................... 0910–0840 9/30/2026 

Radioactive Drug Research Committees ................................................................................................................ 0910–0053 9/30/2026 

Animal Drug and Animal Generic Drug User Fee Submissions ............................................................................. 0910–0540 9/30/2026 

Food Labeling Requirements .................................................................................................................................. 0910–0381 9/30/2026 

Investigational New Drug Application Requirements .............................................................................................. 0910–0014 9/30/2026 

Dated: October 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23002 Filed 10–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Strategic 

Preparedness and Response 

Request for Information (RFI): HHS 

Initiative To Enhance National All 

Hazards Hospital Situational 

Awareness 

AGENCY: Administration for Strategic 

Preparedness and Response (ASPR), 

HHS. 

ACTION: Notice of request for 

information. 

SUMMARY: The Administration for 

Strategic Preparedness and Response 

(ASPR), Centers for Disease Control and 

Prevention (CDC), Centers for Medicare 

& Medicaid Services (CMS), and the 

Office of the National Coordinator for 

Health Information Technology (ONC) 

are seeking broad public input from 

entities across the health care readiness 

community on a national, all-hazards 

standardized set of essential elements of 

information (EEIs) and vendor-neutral 

data collection mechanisms for hospital 

data that drive action for emergency 

preparedness and response. This input 

will inform efforts to provide 

recommendations for a standardized 

lens into the readiness of, stress on, and 

resources available in hospitals before, 

during, and after emergencies 

DATES: To be assured consideration, 

comments on the RFI must be received 

on or before December 18, 2023. HHS 

will not reply individually to 

responders but will consider all 

comments submitted by the deadline. 

ADDRESSES: Please submit all responses 

via email to AllHazards@hhs.gov within 

60 days of publication of this notice as 

a Word document attachment or in the 

body of an email. Include ‘‘All Hazards 

Hospital Situational Awareness RFI’’ in 

the subject line of the email. 

FOR FURTHER INFORMATION CONTACT: For 

additional information, direct questions 

to Sayeedha Uddin at (202) 699–1874 or 

Sayeedha.Uddin@hhs.gov. 

When submitting comments or 

requesting information, please include 

‘‘All Hazards Hospital Situational 

Awareness RFI’’ in the subject line of 

the email. 

When submitting comments or 

requesting information, please include 

‘‘All Hazards Hospital Situational 

Awareness RFI’’ in the subject line of 

the email. 

SUPPLEMENTARY INFORMATION: 

Respondents may provide information 

for one or more of the questions or topic 

areas listed below, as desired. 

Outside of the federal COVID–19 

hospital data collection, what essential 

elements of information does your 

entity report or collect (or plan to 

report/collect in the future) related to 

health care capacity, facility status, 

stress, supplies, staffing, infrastructure, 

and/or other information that is needed 

to inform hospital emergency 

preparedness and response? 

What information do you collect 

internally, including key areas your 

leadership monitors for preparedness 

and response purposes? 

What information do you report to 

other entities, and to whom? 

Specifically, consider regular reporting 

that is required by regulatory agencies, 

notifiable disease reporting, payors, as 

well as time-limited or voluntary 

reporting efforts to trade groups and 

professional associations. 

On what cadence does your entity 

collect and report these essential 

elements of information? 

How is information used for driving 

action in areas such as patient 

placement, patient movement, load 

balancing, equipment/supply 

procurement, or other preparedness and 

response areas? If you are a reporting 

entity (ex. hospital), do you know how 

your data is being used to create value 

for your community? 

What electronic systems are used to 

collect the essential elements of 

information (e.g., electronic health 

record systems (EHRs), hospital 

operations systems, etc.)? Who are the 

primary vendors/developers? 

What is your expectation for federal 

government situational awareness of 

hospital status, capacity, stress, etc. 

before, during, and after a crisis? 

Please share any potentially relevant 

clinical and/or situational awareness 

measures, efforts, and/or definitions that 

might be helpful to inform this effort 

(ex. National Emergency Department 

Overcrowding Scale (NEDOCS) scores, 

International Organization for Standards 

(ISO) Health informatics— 

Interoperability of public health 

emergency preparedness and response 

information systems, the Situational 

Awareness Network for Emergencies 

(SANER) Project, etc.). 

We are interested in promising 

practices in specific areas: 

Decreasing burden is a core goal of 

this initiative. Please share any 

promising practices related to data 

automation and/or other ways to reduce 

burden of data collection and reporting. 


ddrumheller on DSK120RN23PROD with NOTICES1