30966 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 

RMPs depends on the stakeholder type 

(primary, secondary, or other 

stakeholder) and its operation. 

We anticipate that stakeholders will 

be able to leverage information across 

products, but we understand that the 

actual burden for a given stakeholder 

will depend on the portfolio of covered 

products and the complexity of their 

operations. Our estimate reflects what 

we believe is the average burden among 

all respondents. 

This draft guidance also refers to 

previously approved FDA collections of 

information found in FDA regulations. 

The collections of information found in 

21 CFR 310.306, 314.81(b)(3)(iii), and 

600.82 on notifying FDA of a permanent 

discontinuance or an interruption in 

manufacturing of certain drugs or 

biological products, and 21 CFR part 

314 new drug and abbreviated new drug 

applications, and 21 CFR part 600 

biologics license applications have been 

approved under OMB control numbers 

0910–0001 and 0910–0338, respectively; 

the collections of information in 21 CFR 

parts 210 and 211 on current good 

manufacturing practice have been 

approved under OMB control number 

0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

drugs/guidance-compliance-regulatoryinformation/guidances-drugs, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: May 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10698 Filed 5–19–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Medicare Rural 

Hospital Flexibility Program 

Performance, OMB No. 0915–0363— 

Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than June 21, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Samantha Miller, the acting HRSA 

Information Collection Clearance Officer 

at paperwork@hrsa.gov or call (301) 

443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information collection request title for 

reference. 

Information Collection Request Title: 

Medicare Rural Hospital Flexibility 

Program Performance OMB No. 0915– 

0363—Revision. 

Abstract: This information collection 

comment request is for continued 

approval of the Medicare Rural Hospital 

Flexibility Program Performance 

Measures. HRSA is proposing to 

continue this data collection with minor 

changes to the organization of the data. 

The current performance measures are 

collected electronically in the 

Performance Improvement and 

Measurement System which awardees 

access securely through the HRSA 

Electronic Handbooks. 

The Medicare Rural Hospital 

Flexibility Program (Flex Program) is 

authorized by Section 1820 of the Social 

Security Act (42 U.S.C. 1395i–4), as 

amended. The purpose of the Flex 

Program is to enable state designated 

entities to support critical access 

hospitals in quality improvement, 

quality reporting, performance 

improvement, and benchmarking; to 

assist facilities seeking designation as 

critical access hospitals; and to create a 

program to establish or expand the 

provision of rural emergency medical 

services. 

A 60-day notice published in the 

Federal Register, Vol. 87, No. 46, FR 

13300–13301 (March 9, 2022). There 

were no public comments. 

Need and Proposed Use of the 

Information: For this program, 

performance measures were developed 

to provide data useful to the Flex 

program and to enable HRSA to provide 

aggregate program data required by 

Congress under the Government 

Performance and Results Modernization 

Act of 2010. These measures cover 

principal topic areas of interest to the 

Federal Office of Rural Health Policy, 

including: (a) Quality reporting, (b) 

quality improvement interventions, (c) 

financial and operational improvement 

initiatives, (d) population health 

management, (e) rural emergency 

medical services integration and (f) 

innovative care models. In addition to 

informing the Office’s progress toward 

meeting the goals set in Government 

Performance and Results Modernization 

Act of 2010, the information is 

important in identifying and 

understanding programmatic 

improvement across program areas, as 

well as guiding future iterations of the 

Flex Program and prioritizing areas of 

need and support. 

This submission includes the addition 

of minor revisions in the organization of 

the measures to align with the changes 

to the organization of the program areas 

within the Flex Program. The revisions 

include changes to align with current 

language and a broadening of scope for 

some activities. The measures will 

remain unchanged. For example, 

population health improvement 

activities were previously combined 

with rural emergency medical services 

integration, and these measures will be 

separated into two distinct program 

areas. The burden remains unchanged 

with these changes. 

Likely Respondents: Respondents are 

the Flex Program coordinators for the 

states participating in the Flex Program. 

There are currently 45 states 

participating in the Flex Program. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 


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Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 30967 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Performance Improvement Measurement System (within 

the Electronic Handbooks system .................................... 45 1 45 70 3,150 

45 ........................ 45 ........................ 3,150 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2022–10808 Filed 5–19–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0275–60D] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the information 

collection request (ICR) must be 

received on or before July 19, 2022. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier OS–0990–0275– 

60D and project title for reference. 

Submit requests to Sherrette A. Funn, 

the Reports Clearance Officer, at 

Sherrette.Funn@hhs.gov or call (202) 

795–7714. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Information Collection Request Title: 

Performance Data System (PDS). 

Type of Collection: Renewal. 

OMB No.: 0990–0275. 

Abstract: This request for clearance is 

to extend data collection activities for a 

currently approved collection using the 

OMB approved Performance Data 

System (PDS) (OMB No. 0990–0275), 

the tool used by the Office of Minority 

Health (OMH) to collect program 

management and performance data for 

all OMH-funded projects. The revised 

data collection instrument keeps all the 

same data elements, but includes 

additional formatting to clarify data 

elements. Additionally, a few columns 

were reordered in order to make the 

form more intuitive. Grantee data 

collection via the UDS (original data 

collection system) was first approved by 

OMB on June 7, 2004 (OMB No. 0990– 

275). 

Need and Proposed Use of the 

Information: The clearance is needed to 

continue data collection using the PDS, 

a system that enables OMH to comply 

with Federal reporting requirements and 

monitor and evaluate performance by 

enabling the efficient collection of 

performance-oriented data tied to OMHwide performance reporting needs. The 

ability to monitor and evaluate 

performance in this manner, and to 

work towards continuous program 

improvement are basic functions that 

OMH must be able to accomplish to 

carry out its mandate with the most 

effective and appropriate use of 

resources. 

Likely Respondents: Respondents for 

this data collection include the project 

directors for OMH-funded projects and/ 

or the date entry persons for each OMHfunded project. Affected public includes 

non-profit institutions, State, Local, or 

Tribal Governments. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions, to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information, to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information, and to 

transmit or otherwise disclose the 

information. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Project Directors .............................................................................................. 100 4 45/60 300 


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