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
71878 Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 

We recognize data often are sourced 

from multiple systems. Please share any 

promising practices in aggregating and 

assessing data from multiple source 

systems in a cohesive and standard way. 

During response incidents, immediate 

patient care needs, power outages, and 

competing priorities can be significant 

challenges in maintaining shared 

situational awareness. Please share any 

promising practices for continued 

reporting during incidents. 

We recognize that some healthcare 

partners have more advanced data and 

situational awareness programs while 

others may have minimal resources. 

Please share any promising practices for 

effectively leveraging minimal 

resources. 

Please share any ongoing or 

anticipated challenges with reporting or 

collecting data related to hospital 

capacity, facility status, hospital stress, 

supply inventory, or other information 

that is needed to inform hospital 

emergency preparedness and response. 

Please share any non-financial 

resources that would be useful to 

improve your reporting capability. 

Title: Request for Information on AllHazards Hospital Data. 

Abstract: 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 co-leading an effort to define the 

vendor-agnostic technical and policy 

infrastructure, standards, and 

capabilities necessary to support allhazard data reporting by all hospitals 

nationally including rehabilitation, 

psychiatric, and long-term care acute 

care hospitals as well as those providing 

acute medical care. This effort will 

gather information to provide 

recommendations for a standardized 

lens into the readiness of, stress on, and 

resources available in hospitals before, 

during, and after emergencies (including 

all-hazard incidents such as public 

health emergencies, hurricanes, mass 

casualty incidents, infectious disease 

outbreaks, etc.) for needs across the 

country. While this effort is led by 

federal partners, it is intended to also 

support local response efforts. For 

example, standardized essential 

elements of information (EEIs) may help 

to facilitate coordination across 

jurisdictions when load balancing or 

medical operations coordination centers 

are needed. The effort will leverage past 

efforts and collaborate with ongoing 

initiatives across the healthcare 

situational awareness sphere, such as 

the National Biodefense Strategy. 

Importantly, this is a nationwide 

effort for which partner input across the 

healthcare readiness community is 

essential. The healthcare community 

rose to increased demands during the 

COVID–19 public health emergency, 

reinforcing their commitment to always 

providing the highest quality level of 

safe care to patients. ASPR, CDC, CMS, 

and ONC are committed to working 

together with partners to help shape the 

path forward towards efficient 

information sharing, minimizing burden 

and increasing transparency on how 

information is used to drive action. 

Partners such as jurisdictions, hospital 

associations, hospitals, healthcare 

coalitions, medical operations 

coordination centers, transfer centers, 

nurses, emergency medical services, 

health information technology, and 

more will help to inform the project. 

ASPR, CDC, CMS, and ONC will be cohosting a series of listening sessions in 

addition to seeking comments through 

this RFI. 

To date there has been a limited 

unified, all-hazards understanding of 

national level hospital-facility status, 

capacity, resources, and capabilities. An 

all-hazards approach addresses 

capabilities-based preparedness to 

prevent, protect against, respond to, and 

recover from terrorist attacks, major 

disasters, and other emergencies. 

Existing efforts have included the 

COVID–19 hospital data collection, adhoc surveys performed after incidents 

such as hurricanes, targeted surveillance 

systems for specific communicable 

diseases and/or specific types of care 

(ex. Emergency Department (ED) visits), 

and individual efforts within 

jurisdictions. While each existing effort 

has been important, data collection 

efforts are patchwork, crisis-driven, and 

not standardized with respect to how 

EEIs are defined and operationalized. As 

a result, the nation continues to lack a 

comprehensive, standardized view of 

the state of the healthcare system that 

can be shared across partners at all 

levels to inform coordinated action. 

In addition to informing nationwide 

EEIs, input provided will also be used 

for related initiatives such as the 

National Healthcare Safety Network 

(NHSN) hospital bed capacity data pilot 

project, the Health Level 7 (HL7) Helios 

Fast Healthcare Interoperability 

Resources (FHIR) Accelerator, the 

Medical Countermeasures and Data 

Information Technology Ecosystem, and 

CDC data modernization efforts. 

Nationwide EEIs identified through this 

effort will directly inform updates to the 

USCDI+ for Public Health, Situational 

Awareness, and Emergency Response 

dataset, where additional input will be 

solicited on how to represent concepts 

for data exchange purposes. The effort 

also aligns with programs across the 

ASPR Health Care Readiness Portfolio 

and the CDC Public Health Emergency 

Program. 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2023–22931 Filed 10–17–23; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer at (240) 276–0361. 

Project: SAMHSA Generic Clearance 

for the Collection of Qualitative 

Research and Assessment 

SAMHSA is requesting approval from 

the Office of Management and Budget 

(OMB) for their Generic clearance for 

purposes of conducting qualitative 

research. SAMHSA conducts qualitative 

research to gain a better understanding 

of emerging substance use and mental 

health policy issues, improve the 

development and quality of 

instruments, and to ensure SAMHSA 

leadership, centers and offices have 

recent data and information to inform 

program and policy decision-making. 

SAMHSA is requesting approval for at 

least four types of qualitative research: 

(a) interviews, (b) focus groups, (c) 

questionnaires, and (d) other qualitative 

methods. 

SAMHSA is the agency within the 

U.S. Department of Health and Human 

Services (HHS) that leads public health 

efforts to advance the behavioral health 

of the nation and to improve the lives 

of individuals living with mental and 

substance use disorders, and their 

families. It’s mission is to lead public 

health and service delivery efforts that 

promote mental health, prevent 

substance misuse, and provide 

treatments and supports to foster 

recovery while ensuring equitable 

access and better outcomes. SAMHSA 

pursues this mission by providing grant 


ddrumheller on DSK120RN23PROD with NOTICES1