Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; the Stem Cell Therapeutic Outcomes Database, OMB No. 0915-0310-Revision

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; 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.

DATES:

Comments on this ICR should be received no later than September 23, 2019.

ADDRESSES:

Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to

OIRA_submission@omb.eop.gov

or by fax to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT:

To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at

paperwork@hrsa.gov

or call (301) 443-1984.

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 Stem Cell Therapeutic and Research Reauthorization Act of 2015, Public Law 114-104 (the Act), provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. HRSA's Healthcare Systems Bureau has established the Stem Cell Therapeutic Outcomes Database. Operation of this database necessitates certain recordkeeping and reporting requirements to perform the functions related to hematopoietic stem cell transplantation under contract to HHS. 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 a standardized, electronic format. Data is collected from transplant centers, under contract, by the Medical College of Wisconsin's Center for International Blood and Marrow Transplant Research and is used for ongoing analysis of transplant outcomes. Over time, there is an expected increase in the number of recipients for whom data are reported as an increasing number of transplants are performed annually and survivorship after transplantation improves.

A 60-day notice was published in the

Federal Register

on March 7, 2019, vol. 84, No. 45; pp. 8334-8335. There were no public comments.

Need and Proposed Use of the Information:

HRSA uses the information to carry out its statutory responsibilities. Information is needed to monitor the clinical status of transplantation and provide the Secretary of HHS with an annual report of transplant center specific survival data. Modifications of these forms fall into several categories: Consolidating questions and removing duplicate questions across the forms, implementing `check all that apply' formatting to reduce data entry time, and removing items no longer clinically significant (

e.g.,

drugs). These modifications reduced the overall hours of burden inventory.

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.

Total Estimated Annualized Burden Hours

Form name

Number of

respondents

1

Number of

responses per

respondent

Total

responses

Average

burden

per response

(in hours)

Total burden

hours

Baseline Pre-Transplant Essential Data (TED)

200

48

9,600

2

0.68

6,560

Disease Classification

200

48

9,600

3

0.43

4,160

Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts)

200

45

9,000

1.00

9,000

100-day Post-TED

200

48

9,600

0.85

8,160

6 month Post-TED

200

43

8,600

0.85

7,310

1 year Post-TED

200

40

8,000

0.65

5,200

2 year Post-TED

200

34

6,800

0.65

4,420

3+ years Post-TED

200

172

34,400

4

0.52

17,773

Total

200

95,600

62,583

1

The total of 200 is the number of centers completing the form; the same group will complete all of the forms.

2

The decimal is rounded down, and the actual number is .683333333.

3

The decimal is rounded down, and the actual number is .433333333.

4

The decimal is rounded up, and the actual number is .516667.

Maria G. Button,

Director, Division of the Executive Secretariat.

[FR Doc. 2019-18088 Filed 8-21-19; 8:45 am]

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