[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31244-31245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11674]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the requirement for opportunity for public

[[Page 31245]]

comment on proposed data collection projects (Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (HRSA) announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Prior to 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 Information Collection Request must be received 
no later than July 18, 2016.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N-39, 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 [email protected] or call 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 (P.L.) 109-129, as amended by the Stem Cell Therapeutic and 
Research Reauthorization Act of 2015, P.L. 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 record keeping and reporting 
requirements to perform the functions related to hematopoietic stem 
cell transplantation under contract to the U.S. Department of Health 
and Human Services (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 by the Center for International Blood and Marrow 
Transplant Research and is used for ongoing analysis of transplant 
outcomes. The increase in burden is due to an increase in the annual 
number of transplants and increasing survivorship after 
transplantation.
    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.
    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 Information Collection Request are summarized in the table below.
    Total Estimated Annualized Burden Hours:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
                                    respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
Baseline Pre-Transplant                      200              44           8,800            1.15          10,120
 Essential Data (TED)...........
Product Form (includes Infusion,             200              33           6,600               1           6,600
 HLA, and Infectious Disease
 Marker inserts)................
100-Day Post-TED................             200              44           8,800               1           8,800
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  ..............          59,800  ..............          66,460
----------------------------------------------------------------------------------------------------------------
* The Total of 200 is the number of centers completing the form. The same group of 200 centers completes each 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.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-11674 Filed 5-17-16; 8:45 am]
 BILLING CODE 4165-15-P