34690 Federal Register / Vol. 87, No. 109 / Tuesday, June 7, 2022 / Notices 

update data more frequently on LTC 

providers and service users for which 

nationally representative administrative 

data do not exist; and (4) enable 

comparisons across LTC sectors and 

timely monitoring of supply and use of 

these sectors over time. 

Data will be collected from national 

samples of two types of LTC providers 

in the 50 states and the District of 

Columbia: 2,090 RCCs and 1,750 

ADSCs. The RCC sampling frame will 

contain all of the state-licensed RCCs 

that are licensed for four or more beds. 

Participants in the ADSC component 

will be sampled from a comprehensive 

listing of ADSCs maintained by the 

National Adult Day Services 

Association (NADSA). 

Data were collected in 2012, 2014, 

2016, 2018, and 2020. The data to be 

collected in 2022 include the basic 

characteristics, services, staffing, and 

practices of RCCs and ADSCs, and the 

demographics, selected health 

conditions and health care utilization, 

physical functioning, and cognitive 

functioning of RCC residents and ADSC 

participants. The 2022 NPALS also 

includes interviews with subject matter 

experts about electronic health records 

(EHRs) use among ADSCs and RCCs and 

available EHRs data for them. 

Expected users of data from this 

collection effort include, but are not 

limited to, CDC; other DHHS agencies, 

such as the Office of the Assistant 

Secretary for Planning and Evaluation, 

The Administration for Community 

Living, and the Agency for Healthcare 

Research and Quality; associations, such 

as LeadingAge, National Center for 

Assisted Living, American Seniors 

Housing Association, Argentum, 

Advancing States, and National Adult 

Day Services Association; universities; 

foundations; and other private sector 

organizations such as the Alzheimer’s 

Association, the AARP Public Policy 

Institute, and the National Academies of 

Sciences, Engineering, and Medicine. 

Expected average burden for data 

collection is 60 minutes per respondent: 

30 minutes for a provider questionnaire 

and 30 minutes for a services user 

questionnaire. In addition, 20 

individuals with subject matter 

expertise in the use of electronic health 

records (HER) will be recruited to 

participate in a one-hour interview. 

Changes to be implemented in 2022 

include; reducing the number of 

sampled RCCs and ADCSs; use of a 

provider questionnaire and a services 

user questionnaire (instead of a multipurpose form); and minor changes to 

questions and response options to 

improve usability and data quality. 

OMB approval is requested for two 

years. The annualized estimates for 

number of respondents and burden 

hours are summarized below, assuming 

a 100% response rate. The total 

estimated annualized burden hours are 

1,932. Participation is voluntary and 

there is no cost to respondents other 

than their time to participate. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

RCC Director/Designated Staff Member ........ RCC Provider Questionnaire ......................... 1,045 1 30/60 

ADSC Director/Designated Staff Member ...... ADSC Provider Questionnaire ....................... 875 1 30/60 

RCC Director/Designated Staff Member ........ RCC Services User Questionnaire ................ 1,045 1 30/60 

ADSC Director/Designated Staff Member ...... ADSC Services User Questionnaire .............. 875 1 30/60 

RCC/ADSC Subject Matter Experts ............... EHRs Subject Matter Expert Interview .......... 10 1 1 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–12146 Filed 6–6–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Announcing the Intent To Award a 

Single-Source Supplement for the 

Amputee Coalition of America, Inc. for 

the National Limb Loss Resource 

Center Cooperative Agreement 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living (ACL) announces the 

intent to award a single-source 

supplement to the current cooperative 

agreement held by the Amputee 

Coalition of America, Inc. for the 

National Limb Loss Resource Center 

(NLLRC). The purpose of this project is 

to expand on current grant activities 

occurring across communities. These 

activities include programs that promote 

independence, community living, and 

the adoption of healthy behaviors that 

promote wellness and prevent and/or 

reduce chronic conditions associated 

with limb loss and increase partnerships 

and collaborations with ACL programs 

that will benefit all people living with 

limb loss or limb differences. The 

administrative supplement for FY 2022 

will be for $490,698 bringing the total 

award for FY 2022 to $3,883,259. 

FOR MORE INFORMATION CONTACT: For 

further information or comments 

regarding this program supplement, 

contact Elizabeth Leef, U.S. Department 

of Health and Human Services, 

Administration for Community Living, 

Administration on Disabilities, Office of 

Disability Services Innovation: 

telephone (202) 475–2486 email: 

Elizabeth.leef@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

additional funding will not be used to 

begin new projects. The funding will be 

used to enhance and expand existing 

programs that can serve an increased 

number of veterans and people living 

with limb loss and limb differences by 

providing increased technical assistance 

activities; promoting health and 

wellness programs; addressing 

healthcare access issues, including 

maternity care; promoting the adoption 

of healthy behaviors with the objective 

of preventing and/or reducing chronic 

conditions associated with limb loss; 

increasing partnerships and 

collaborations with ACL programs that 

will benefit all people living with limb 

loss or limb differences; enhancing and 

expanding the evaluation activities 

currently under way; and enhancing 

website capacities for improved 

information dissemination. 

Program Name: National Limb Loss 

Resource Center. 

Recipient: The Amputee Coalition of 

America, Inc. 

Period of Performance: The 

supplement award will be issued for the 

fourth year of the five-year project 

period of April 1, 2019, through March 

29, 2024. 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 109 / Tuesday, June 7, 2022 / Notices 34691 

1The virus has been named ‘‘SARS–CoV–2’’ and 

the disease it causes has been named ‘‘Coronavirus 

Disease 2019’’ (COVID–19). 

2The term ‘‘device(s)’’ in this document refers to 

devices regulated by the Center for Devices and 

Radiological Health (CDRH) as well as devices 

regulated by the Center for Biologics Evaluation and 

Research (CBER), including devices regulated as 

biological products under section 351 of the Public 

Health Service (PHS) Act. 

3For more information, please see the FDA 

guidance document entitled ‘‘FDA and Industry 

Actions on Premarket Approval Applications 

(PMAs): Effect on FDA Review Clock and Goals’’ 

(https://www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/fda-and-industryactions-premarket-approval-applications-pmaseffect-fda-review-clock-and-goals). 

4For more information, please see the FDA 

guidance document entitled ‘‘Humanitarian Device 

Exemption (HDE) Program’’ (https://www.fda.gov/ 

regulatory-information/search-fda-guidancedocuments/humanitarian-device-exemption-hdeprogram). 

5For more information, please see the FDA 

guidance document entitled ‘‘FDA and Industry 

Actions on Premarket Notification (510(k)) 

Submissions: Effect on FDA Review Clock and 

Goals’’ (https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/fdaand-industry-actions-premarket-notification-510ksubmissions-effect-fda-review-clock-and-goals). 

6For more information, please see the FDA 

guidance document entitled ‘‘FDA and Industry 

Actions on De Novo Classification Requests: Effect 

on FDA Review Clock and Goals’’ (https://

www.fda.gov/regulatory-information/search-fdaContinued 

Total Supplement Award Amount: 

$490,698 in FY 2022. 

Award Type: Cooperative Agreement 

Supplement. 

Statutory Authority: This program is 

authorized under Section 317 of the 

Public Health Service Act (42 U.S.C. 

247(b–4)); Consolidated and Further 

Continuing Appropriations Act, 2015, 

Public Law 113–235 (Dec. 16, 2014). 

Basis for Award: The Amputee 

Coalition of America, Inc. is currently 

funded to carry out the objectives of this 

program, entitled The National Limb 

Loss Resource Center for the period of 

April 1, 2019, through March 29, 2024. 

Almost 2 million Americans have 

experienced amputations or were born 

with limb difference and another 28 

million people in our country are at risk 

for amputation. The supplement will 

enable the grantee to carry their work 

even further, serving more people living 

with limb loss and/or limb differences 

and providing even more 

comprehensive training and technical 

assistance in the development of longterm supportive services. The additional 

funding will not be used to begin new 

projects or activities. The NLLRC will 

enhance and expand currently funded 

activities such as conducting national 

outreach for the development and 

dissemination of patient education 

materials, programs, and services; 

providing technical support and 

assistance to community based limb loss 

support groups; and raising awareness 

about the limb loss and limb differences 

communities. 

Establishing an entirely new grant 

project at this time would be potentially 

disruptive to the current work already 

well under way. More importantly, the 

people living with limb loss and limb 

differences currently being served by 

this program could be negatively 

impacted by a service disruption, thus 

posing the risk of not being able to find 

the right resources that could negatively 

impact on health and wellbeing. If this 

supplement were not provided, the 

project would be less able to address the 

significant unmet needs of additional 

limb loss survivors. Similarly, the 

project would be unable to expand its 

current technical assistance and training 

efforts in NLLRC concepts and 

approaches, let alone reach beyond 

traditional providers of services to this 

population to train more ‘‘mainstream’’ 

providers of disability services. 

Date: May 27, 2022. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2022–12205 Filed 6–6–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1138] 

Effects of the COVID–19 Public Health 

Emergency on Formal Meetings and 

User Fee Applications for Medical 

Devices—Questions and Answers 

(Revised); Withdrawal of Guidance 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the withdrawal of the 

guidance document entitled ‘‘Effects of 

the COVID–19 Public Health Emergency 

on Formal Meetings and User Fee 

Applications for Medical Devices— 

Questions and Answers (Revised),’’ 

which was issued in June 2020 (and 

updated December 2020). FDA is 

withdrawing this guidance document in 

recognition that the conditions that 

created the need for these policies have 

evolved, such that these policies are no 

longer needed. 

DATES: The withdrawal date is July 7, 

2022. 

FOR FURTHER INFORMATION CONTACT: 

Joshua Nipper, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2438, Silver Spring, 

MD 20993–0002, 301–796–5640, 

Joshua.Nipper@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

As part of FDA’s commitment to 

providing timely guidance to support 

continuity and response efforts to the 

Coronavirus Disease 2019 (COVID–19) 1

pandemic, in June 2020, the Agency 

published this guidance document (June 

23, 2020 at 85 FR 34638) and updated 

it in December 2020, to recognize that 

the COVID–19 public health emergency 

was affecting the public health in 

numerous direct and indirect ways, 

including device development 

programs.2 This guidance document 

answered frequently asked questions 

and implemented temporary policies to 

reduce industry burden. 

FDA has continually assessed the 

needs and circumstances related to 

these temporary policies, and as 

relevant needs and circumstances 

evolved, the Agency made updates and 

modifications to these temporary 

policies. FDA has determined that the 

needs and circumstances related to the 

temporary policies described in the 

guidance document have evolved, such 

that they are no longer needed, and the 

guidance document should be 

withdrawn. In weighing the current 

burden to industry and the Agency 

relating to the COVID–19 response 

efforts with the need to ensure patients 

have timely access to new devices, FDA 

is withdrawing this guidance document. 

Below is a brief description of the 

guidance document and temporary 

policies that will be withdrawn: 

The guidance articulated FDA’s 

policy that for marketing submissions 

and applications on hold, FDA did not 

intend to consider a submission or 

application to be withdrawn for an 

additional 180 days beyond the relevant 

response date. Returning to prepandemic policies for marketing 

submissions and applications placed on 

hold after the withdrawal of this 

guidance means FDA will generally 

consider the submission or application 

to be withdrawn if the submitter or 

applicant does not provide a complete 

response to major deficiency letters for 

Premarket Approval Applications 

(PMAs) (original and supplements) 3

and Humanitarian Device Exemption 

(HDE) applications (original and 

supplements) 4 within 360 days or to 

additional information letters for 

510(k) 5 and De Novo requests 6 within 


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