Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices 15439 

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. 

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 

SHIP COVID–19 Testing and 

Mitigation Data Reporting.

1,540 .......................................

Number of unique organizations funded through the 

program.

6 ..............................................

Reported on a quarterly basis 

during the 18 month program or until the end of the 

public health emergency 

(whichever is first).

9,240 .25 2,310 

Total hours spent on responses for all funded organization over a 2-year period. 

Total .................................. 1,540 ....................................... .................................................. 9,240 ........................ 2,310 

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. 2022–05717 Filed 3–17–22; 8:45 am] 

BILLING CODE 4165–15–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 the 

requirement for an 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). Before 

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 May 17, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Samantha Miller, the acting 

HRSA Information Collection Clearance 

Officer at (301) 443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

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 for 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’s Health 

Systems Bureau 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 incremental 

changes in information 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. 

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 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 


jspears on DSK121TN23PROD with NOTICES1
15440 Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices 

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. 

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 total annual burden 

hours estimated for this ICR are 

summarized in the table below. The 

estimated total annual burden hours for 

this submission are 56,768 compared to 

62,583 estimated in the 30-day Federal 

Register notice posted on August 22, 

2019. 

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 5 ............................... 177 46.4 6 8,207 7 1.1 9,028 

Transplant Procedure and Product Information 8 ................ 177 46.4 9 8,207 1.0 8,207 

Post-Transplant Periodic Information Collection based on 

Predetermined Schedule 10 .............................................. 177 319.1 11 56,476 12 0.7 39,533 

Total .............................................................................. 177 ........................ 72,890 ........................ 56,768 

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 Number of Responses the total number of transplant centers that submit data to the SCTOD is equal to 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 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. 5Pre-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. 6Total Responses for Pre-Transplant Information Collection equals number of new transplant patients in 2020. 

7This number is rounded to nearest tenth. The actual burden estimate for these data is 1.11666666. 

8Transplant Procedure and Product Information includes Graft-vs-Host Disease (GVHD) prophylaxis, graft source, donor type and degree of 

human leukocyte antigen matching and graft manipulation; graft characteristic data for cord blood units, including infused cell dose; and product 

information. 9Total Responses for Transplant Procedure and Product Information equals number of new transplant patients in 2020. 

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. 11Total 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. 12This number is rounded to nearest tenth. The actual burden estimate is 0.74. 

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. 2022–05718 Filed 3–17–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Rural Health Clinic COVID–19 

Reporting Portal, OMB No. 0906– 

0056—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

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 April 18, 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 


jspears on DSK121TN23PROD with NOTICES1