15438 Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity FDA Form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

ANADA .............................................................................................. 356v 20 1 20 159 3,180 

Phased review with administrative ANADA ...................................... 356v 6 5 30 31.8 954 

Biowaiver request for soluble powder oral dosage form product, 

using same formulation/manufacturing process approach ........... N/A 1 1 1 5 5 

Biowaiver request for soluble powder oral dosage form product, 

using same API/solubility approach .............................................. N/A 5 1 5 10 50 

Biowaiver request for Type A medicated article, using same formulation/manufacturing process approach ........................................ N/A 2 1 2 5 10 

Biowaiver request for Type A medicated article, using same API/ 

solubility approach ......................................................................... N/A 5 1 5 20 100 

Total ........................................................................................... ........................ ........................ ........................ 63 ........................ 4,299 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We base our estimates on our records 

of generic animal drug applications. We 

estimate that we will receive 26 ANADA 

submissions per year over the next 3 

years and that 6 of those submissions 

will request phased review. We estimate 

that each applicant that uses the phased 

review process will have approximately 

five phased reviews per application. We 

estimate that an applicant will take 

approximately 159 hours to prepare 

either an ANADA or the estimated five 

ANADA phased review submissions 

and the administrative ANADA. Our 

estimates of the burden of biowaiver 

requests for generic soluble powder oral 

dosage form products and Type A 

medicated articles differ based on the 

type of product and the basis for the 

request, as shown in table 1. We 

estimate that an applicant will take 

between 5 and 20 hours to prepare a 

biowaiver request. 

Our estimated burden for the 

information collection reflects an 

overall increase of 695 hours and a 

corresponding increase of 12 responses. 

Based on a review of the information 

collection since our last request for 

OMB renewal, the increase in the 

burden hours estimate is attributable to 

an increase in the number of 

respondents submitting generic drug 

applications. 

Dated: March 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05782 Filed 3–17–22; 8:45 am] 

BILLING CODE 4164–01–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; SHIP COVID–19 Testing and 

Mitigation Program Data Collection, 

OMB No. 0906–0066—Extension 

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 

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: 

SHIP COVID–19 Testing and Mitigation 

Program Data Collection OMB No. 

0906–0066—Extension. 

Abstract: The American Rescue Plan 

Act of 2021 (Pub. L. 117–2) provided 

one-time funding for awards that will be 

carried out under section 711 of the 

Social Security Act (42 U.S.C. 

912(b)(5)). The Small Rural Hospital 

Improvement Program (SHIP) is 

requesting an extension of an 

information collection request. State 

grantees will improve health care in 

rural areas by using the funding to 

provide support to eligible rural 

hospitals to increase COVID–19 testing 

efforts, expand access to testing in rural 

communities, and expand the range of 

mitigation activities. 

A 60-day Notice published in the 

Federal Register, 86 FR 74095 

(December 29, 2021). There were no 

public comments. 

Need and Proposed Use of the 

Information: The terms and conditions 

for this program specify that, ‘‘hospitals 

will be required to report on the number 

of tests provided and categories in 

which the funding is spent.’’ The data 

will allow HRSA to ensure SHIP 

COVID–19 recipients are meeting the 

terms and conditions of their funding, 

while providing HRSA with information 

on the effectiveness of funds distributed 

through this program. 

Likely Respondents: The respondents 

will be hospital staff and designated 

Representatives, and State Office of 

Rural Health Staff. 

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 


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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 


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