Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The Stem Cell Therapeutic Outcomes Database OMB No. 0915-0310-Revision
| Published date | 07 March 2019 |
| Record Number | 2019-04117 |
| Section | Notices |
| Court | Health And Human Services Department,Health Resources And Services Administration |
Federal Register, Volume 84 Issue 45 (Thursday, March 7, 2019)
[Federal Register Volume 84, Number 45 (Thursday, March 7, 2019)]
[Notices]
[Pages 8334-8335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04117]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: 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 6,
2019.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 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
[[Page 8335]]
instruments, email paperwork@hrsa.gov or call Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at (301) 443-1984.
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 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. 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. HRSA's
Healthcare Systems Bureau has established the Stem Cell Therapeutic
Outcomes Database, which necessitates certain electronic record keeping
and reporting requirements to perform the functions related to
hematopoietic stem cell transplantation 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. Over time, there is an expected increase in the
number of recipients for whom data are reported as the increasing
number of transplants are performed annually and survivorship after
transplantation improves.
Need and Proposed Use of the Information: Per statutory
responsibilities, information collected on the forms outlined in the
``Total Estimated Annualized Burden Hours'' section below is needed to
monitor the clinical status of transplantation and provide the
Secretary with an annual report of transplant center-specific survival
data. The proposed revisions of these data collection 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 proposed revisions are not
anticipated to affect total burden hours.
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
----------------------------------------------------------------------------------------------------------------
Number of Number of Average burden
Form name respondents responses per Total per response Total burden
\1\ respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Baseline Pre-Transplant 200 44 8,800 1.00 8,800
Essential Data (TED)...........
Disease Classification.......... 200 44 8,800 0.15 1,320
Product Form (includes Infusion, 200 33 6,600 1.00 6,600
HLA, and Infectious Disease
Marker inserts)................
100-Day Post-TED................ 200 44 8,800 1.25 11,000
6-Month Post-TED................ 200 36 7,200 1.15 8,280
12-Month Post-TED............... 200 32 6,400 1.15 7,360
Annual Post-TED................. 200 110 22,000 1.15 25,300
-------------------------------------------------------------------------------
Total....................... 200 .............. 68,600 .............. 68,660
----------------------------------------------------------------------------------------------------------------
\1\ The total of 200 is the number of centers completing the form; the same group will complete all of the
forms.
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.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-04117 Filed 3-6-19; 8:45 am]
BILLING CODE 4165-15-P
