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to be withdrawn for an additional 180 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
Federal Register / Vol. 87, No. 109 / Tuesday, June 7, 2022 / Notices 34693 

1This burden estimate table refers to data 

collections at different time periods consistent with 

approved practice. The SCTOD contractor is 

working with respondents to reduce burden by 

submitting data using interoperability standards. 

These data collections may include OMB-approved 

forms. 

2The total number of transplant centers that 

submit data to the SCTOD is 177. 

3The Number of Responses per Respondent was 

calculated by dividing the Total Responses by the 

Number of Respondents and rounding to the nearest 

tenth. 

4The total number of responses is less than 

previous calculations because of improvements in 

estimation. Previous estimates assumed all years 

had the same number of transplants. This improved 

estimate includes accurate transplant counts from 

prior years, which are often less than the current 

year leading to less follow-up activity. 

5Total responses for Pre-Transplant Information 

Collection equals estimated number of new 

transplant patients in 2021. 

6Pre-transplant Data includes baseline recipient 

data including patient demographics, pertinent 

medical history, disease characteristics and status, 

and co-morbidities, transplant data procedure 

characteristics, including preparative regimen, and 

donor data. This number is rounded to nearest 

tenth. The actual burden estimate for these data is 

1.4175. 

7Transplant Procedure and Product Information 

equals estimated number of new transplant patients 

in 2021. 

8Transplant Procedure and Product Information 

includes Graft-vs-Host Disease (GVHD) prophylaxis, 

graft source, donor type and degree of HLA 

matching and graft manipulation; graft 

characteristic data for cord blood units, including 

infused cell dose; and product information. This 

number is rounded to nearest tenth. The actual 

burden estimate for these data is 1.0616. 

9The number of responses for Post-Transplant 

Periodic Information Collection is based on a 

predetermined schedule: 100 days after transplant, 

6 months after transplant, 1 year after transplant, 

annually for 6 years after transplant and then 

biennially thereafter. In any given year the number 

of responses is a function of the number of 

transplants in that year, the number of transplants 

in previous years, and expected patient survival 

between the time of transplant and any follow-up 

activity. 

10Post-Transplant Data Collection includes 

hematopoietic recovery and engraftment, serious 

complications including GVHD and second cancers, 

disease status, survival status, and cause of death; 

and subsequent procedures. This number is 

rounded to nearest tenth. The actual burden 

estimate is 0.5247. 

collected by the SCTOD to reflect 

current clinical care and facilitate 

statistical modeling throughout the 

approval period to fulfill the 

requirements of the Program. Such 

small incremental changes will not 

significantly affect the burden. Changes 

from the prior data collection 

spreadsheet include addition of a 

response option for pre-transplant 

information collection and three 

questions to collect donor lymphocyte 

infusion for post-transplant information 

collection. The burden has decreased 

due to better estimates of the number of 

responses and use of burden testing 

results to estimate the time required. 

A 60-day Notice published in the 

Federal Register, Volume 87, Number 

53, FR 15439–15440 (March 18, 2022). 

There were no public comments. 

Need and Proposed Use of the 

Information: Per statutory 

responsibilities, the collection of 

information outlined in the ‘‘Total 

Estimated Annualized Burden Hours’’ 

section below is needed to collect, 

analyze, and publish stem cell 

transplantation related data including 

patient outcomes data and provide the 

Secretary of HHS with an annual report 

of transplant center-specific survival 

data. The proposed revisions of this 

information collection reflect the most 

up-to-date medical evidence while 

simultaneously reducing HCT facility 

burden. Revisions fall into several 

categories: consolidating questions, 

implementing interactive requests 

(electronic check boxes, check all that 

apply and pull-down menus) to reduce 

data entry time, adding necessary 

information fields, adding clarity to 

information requests and removing 

items no longer clinically significant 

(e.g., drugs). These revisions also 

incorporate COVID–19 vaccine 

questions currently under emergency 

approval. From time to time, there may 

be refinements in the information 

collection to keep pace with changes in 

the field or to enhance the ability to 

collect information in an automated 

fashion from respondent source 

systems, such as electronic health 

records. The contractor requests OMB 

approval by June 30, 2022. 

Likely Respondents: Transplant 

Centers. 

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 revised total annual 

burden hours estimated for this ICR are 

summarized in the table below. The 

total hours decreased from 56,786 to 

51,526 due to minor changes in the ICR. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name 1 Number of 

respondents 2

Number of 

responses per 

respondent 3

Total 

responses 4

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Pre-Transplant Information Collection ............................... 177 52.6 5 9,315 6 1.4 13,041 

Transplant Procedure and Product Information ................ 177 52.6 7 9,315 8 1.1 10,247 

Post-Transplant Periodic Information Collection based on 

Predetermined Schedule ................................................ 177 319.1 9 56,476 10 0.5 28,238 

Total ............................................................................ 177 .......................... 75,106 ........................ 51,526 

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. 2022–12225 Filed 6–6–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


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