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 


jspears on DSK121TN23PROD with NOTICES1
34692 Federal Register / Vol. 87, No. 109 / Tuesday, June 7, 2022 / Notices 

guidance-documents/fda-and-industry-actions-denovo-classification-requests-effect-fda-review-clockand-goals). 

180 days, consistent with preexisting 

guidance. 

When the COVID–19 public health 

emergency began, FDA understood that 

applicants may face challenges affecting 

their ability to meet their applicable 

response date for submissions placed on 

hold. FDA also recognized our potential 

difficulty in processing a high volume of 

individual extension requests on a 

timely basis. To alleviate these 

concerns, the guidance document 

articulated that FDA did not intend to 

consider an application or submission 

to be withdrawn for an additional 180 

days beyond the relevant response date, 

regardless of whether the applicant 

submitted an extension request. 

By weighing the current burdens on 

industry with FDA’s interest in patients 

receiving timely access to new devices, 

FDA has determined it is in the interest 

of the public health to return to prepandemic policies regarding hold times. 

Reverting to policies regarding hold 

times described in the preexisting 

guidance documents should facilitate 

more timely premarket review of 

innovative and potentially lifesaving 

devices. In addition, closing out files 

that have been abandoned in a timelier 

manner allows for better management of 

the device review program. The Agency 

acknowledges that the circumstances 

giving rise to the public health 

emergency declaration for the COVID– 

19 pandemic continue to exist. 

However, the conditions that created the 

need for these policies have evolved, 

such that these policies are no longer 

needed, and it is in the best interest of 

patients and providers to reinstitute the 

original hold times to ensure patients 

have timely access to advanced 

technologies, diagnostics, and 

therapeutics without unnecessary delay. 

The guidance document also 

discussed FDA’s ability to host advisory 

committee meetings virtually and FDA’s 

intention to work with relevant 

stakeholders to host all advisory 

committee meetings virtually. In 

returning to pre-pandemic policies, FDA 

will assess the appropriate venue for 

advisory committee meetings, keeping 

in mind FDA’s successful 

implementation of virtual advisory 

committee meetings. Consistent with 

existing policy, the venue will be 

announced via the Federal Register. 

Therefore, after careful review of 

current Agency processes, industry 

practices with regard to resolving 

submission deficiencies, and comments 

submitted to the public docket 

associated with the guidance, FDA is 

withdrawing the ‘‘Effects of the COVID– 

19 Public Health Emergency on Formal 

Meetings and User Fee Applications for 

Medical Devices—Questions and 

Answers (Revised)’’ guidance in its 

entirety. 

II. Withdrawal Date 

The withdrawal date for the guidance 

document discussed in this document is 

July 7, 2022. For submissions or 

applications that receive a major 

deficiency letter for PMA and HDE 

applications or additional information 

letters for 510(k) and De Novo requests 

prior to or on the guidance withdrawal 

date, FDA does not intend to consider 

the submission or application to be 

withdrawn for an additional 180 days 

beyond the relevant response date. For 

submissions or applications that receive 

a major deficiency letter or additional 

information letter after the guidance 

withdrawal date, FDA will generally 

consider the application or submission 

to be withdrawn if a complete response 

is not received by the relevant response 

date identified in that letter. 

Authority: 21 U.S.C. 371(h). 

Dated: June 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12176 Filed 6–3–22; 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; The Stem Cell 

Therapeutic Outcomes Database OMB 

No. 0915–0310—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this Notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than July 7, 2022. 

ADDRESSES: Written 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 Review—Open for 

Public Comments’’ or by using the 

search function. 

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: 

Information Collection Request Title: 

The Stem Cell Therapeutic Outcomes 

Database OMB No. 0915–0310— 

Revision. 

Abstract: The Stem Cell Therapeutic 

and Research Act of 2005, Public Law 

(Pub. L.) 109–129, as amended by the 

TRANSPLANT Act of 2021, Public Law 

117–15 (the Act), provides for the 

collection and maintenance of human 

blood stem cells for the treatment of 

patients and research. The Act requires 

the Secretary to contract for the 

establishment and maintenance of 

information related to patients who 

have received stem cell therapeutic 

products and to do so using an 

electronic format. HRSA has established 

the Stem Cell Therapeutic Outcomes 

Database (SCTOD), one component of 

the C.W. Bill Young Cell 

Transplantation Program (Program), 

which necessitates certain electronic 

record keeping and reporting 

requirements to perform the functions 

related to hematopoietic stem cell 

transplantation (HCT) under contract to 

HHS. Data is collected from transplant 

centers by the Center for International 

Blood and Marrow Transplant Research 

and is used for ongoing analysis of 

transplant outcomes to improve the 

treatment, survival, and quality of life 

for patients who may benefit from 

cellular therapies. Over time, there is an 

expected increase in the information 

reported as the number of transplants 

performed annually increases, and 

survivorship after transplantation 

improves. Similarly, because of ongoing 

rapid evolution in transplant 

indications, methods to establish 

diagnoses, disease prognostic factors, 

treatments provided before HCT, 

methods to determine donor matching, 

and transplantation techniques, the 

Program anticipates frequent 

incremental changes in information 


jspears on DSK121TN23PROD with NOTICES1