81_FR_31340 81 FR 31244 - Agency Information Collection Activities: Proposed Collection: Public Comment Request

81 FR 31244 - Agency Information Collection Activities: Proposed Collection: Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 96 (May 18, 2016)

Page Range31244-31245
FR Document2016-11674

In compliance with the requirement for opportunity for public 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.

Federal Register, Volume 81 Issue 96 (Wednesday, May 18, 2016) 
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31244-31245]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11674]


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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.

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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 paperwork@hrsa.gov 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 paperwork@hrsa.gov 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
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* 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

31244 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices plans to submit an Information THCGME Program. The THCGME revisions, the content of the information Collection Request (ICR), described Program awards payment for both direct collected has not changed; however, the below, to the Office of Management and and indirect expenses to support order in which the information is Budget (OMB). Prior to submitting the training for primary care residents in presented on the chart has been ICR to OMB, HRSA seeks comments community-based ambulatory patient modified to provide clearer projections from the public regarding the burden care settings. The THCGME Program over a longer period of time. This estimate, below, or any other aspect of Eligible Resident/Fellow FTE Chart, extended time frame would allow the ICR. published in the THCGME Funding programs the flexibility to project the DATES: Comments on this ICR should be Opportunity Announcements (FOAs), is variations that occur during the natural received no later than July 18, 2016. a means for determining the number of expansion and scaling up of residency ADDRESSES: Submit your comments to eligible resident/fellow full-time programs. This would better equip paperwork@hrsa.gov or mail the HRSA equivalents (FTEs) in an applicant’s HRSA to make more accurate future Information Collection Clearance primary care residency program. The funding projections. Officer, Room 14A39, 5600 Fishers current THCGME Program Eligible Likely Respondents: Teaching Health Lane, Rockville, MD 20857. Resident/Fellow FTE Chart received Centers applying for THCGME funding FOR FURTHER INFORMATION CONTACT: To OMB clearance on September 16, 2013. through a THCGME FOA, which may request more information on the HRSA is revising the chart to provide include new applicants and existing proposed project or to obtain a copy of clearer projections over a longer period awardees. the data collection plans and draft of time. Need and Proposed Use of the Burden Statement: Burden in this instruments, email paperwork@hrsa.gov Information: The THCGME Program context means the time expended by or call the HRSA Information Collection Eligible Resident/Fellow FTE Chart persons to generate, maintain, retain, Clearance Officer at (301) 443–1984. requires applicants to provide data disclose or provide the information SUPPLEMENTARY INFORMATION: When related to the size and/or growth of the requested. This includes the time submitting comments or requesting needed to review instructions; to information, please include the residency program over previous academic years, the number of residents develop, acquire, install and utilize information request collection title for technology and systems for the purpose reference. enrolled in the program during the baseline academic year, and a projection of collecting, validating and verifying Information Collection Request Title: of the program’s proposed expansion information, processing and The Teaching Health Center Graduate over the next 5 academic years. It is maintaining information, and disclosing Medical Education (THCGME) Program imperative that applicants complete this and providing information; to train Eligible Resident/Fellow FTE Chart chart and provide evidence of a planned personnel and to be able to respond to OMB 0915–0367—REVISION expansion, as per the statute, THCGME a collection of information; to search Abstract: The Teaching Health Center funding may only be used to support an data sources; to complete and review Graduate Medical Education (THCGME) expanded number of residents in a the collection of information; and, to Program, Section 340H of the Public residency program or to establish a new transmit or otherwise disclose the Health Service (PHS) Act, was residency training program. Utilization information. The total annual burden established by Section 5508 of Public of a chart to gather this important hours estimated for this Information Law 111–148. Public Law 114–10, the information has decreased the number Collection Request are summarized in Medicare Access and CHIP of errors in the eligibility review process the table below. Reauthorization Act of 2015 (MACRA) resulting in a more accurate review and Total Estimated Annualized Burden provided continued funding for the funding process. In the proposed Hours: Average Number of Number of Total burden per Total burden Form name responses per respondents responses response hours respondent (in hours) Teaching Health Center GME Program Eligible Resident/ Fellow FTE Chart ............................................................. 90 1 90 0.5 45 Total .............................................................................. 90 ........................ 90 ........................ 45 HRSA specifically requests comments technology to minimize the information DEPARTMENT OF HEALTH AND on (1) the necessity and utility of the collection burden. HUMAN SERVICES proposed information collection for the Jason E. Bennett, Health Resources and Services proper performance of the agency’s functions, (2) the accuracy of the Director, Division of the Executive Secretariat. Administration estimated burden, (3) ways to enhance [FR Doc. 2016–11657 Filed 5–17–16; 8:45 am] Agency Information Collection the quality, utility, and clarity of the BILLING CODE 4165–15–P Activities: Proposed Collection: Public information to be collected, and (4) the sradovich on DSK3TPTVN1PROD with NOTICES Comment Request use of automated collection techniques or other forms of information AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: In compliance with the requirement for opportunity for public VerDate Sep<11>2014 17:10 May 17, 2016 Jkt 238001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1

Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31245 comment on proposed data collection Information Collection Request Title: transplants and increasing survivorship projects (Section 3506(c)(2)(A) of the The Stem Cell Therapeutic Outcomes after transplantation. Paperwork Reduction Act of 1995), the Database OMB No. 0915–0310— Need and Proposed Use of the Health Resources and Services Revision. Information: HRSA uses the information Administration (HRSA) announces Abstract: The Stem Cell Therapeutic to carry out its statutory responsibilities. plans to submit an Information and Research Act of 2005, Public Law Information is needed to monitor the Collection Request (ICR), described clinical status of transplantation and (P.L.) 109–129, as amended by the Stem below, to the Office of Management and provide the Secretary of HHS with an Cell Therapeutic and Research Budget (OMB). Prior to submitting the annual report of transplant center- Reauthorization Act of 2015, P.L. 114– ICR to OMB, HRSA seeks comments specific survival data. 104 (the Act), provides for the collection from the public regarding the burden Likely Respondents: Transplant and maintenance of human blood stem estimate, below, or any other aspect of Centers. the ICR. cells for the treatment of patients and Burden Statement: Burden in this research. HRSA’s Healthcare Systems context means the time expended by DATES: Comments on this Information Bureau has established the Stem Cell persons to generate, maintain, retain, Collection Request must be received no Therapeutic Outcomes Database. disclose or provide the information later than July 18, 2016. Operation of this database necessitates requested. This includes the time ADDRESSES: Submit your comments to certain record keeping and reporting needed to review instructions, to paperwork@hrsa.gov or mail the HRSA requirements to perform the functions develop, acquire, install and utilize Information Collection Clearance related to hematopoietic stem cell technology and systems for the purpose Officer, Room 14N–39, 5600 Fishers transplantation under contract to the of collecting, validating and verifying Lane, Rockville, MD 20857. U.S. Department of Health and Human information, processing and Services (HHS). The Act requires the maintaining information, and disclosing FOR FURTHER INFORMATION CONTACT: To Secretary to contract for the and providing information, to train request more information on the establishment and maintenance of personnel and to be able to respond to proposed project or to obtain a copy of information related to patients who a collection of information, to search the data collection plans and draft have received stem cell therapeutic data sources, to complete and review instruments, email paperwork@hrsa.gov products and to do so using a the collection of information, and to or call the HRSA Information Collection standardized, electronic format. Data is transmit or otherwise disclose the Clearance Officer at (301) 443–1984. collected from transplant centers by the information. The total annual burden SUPPLEMENTARY INFORMATION: When Center for International Blood and hours estimated for this Information submitting comments or requesting Marrow Transplant Research and is Collection Request are summarized in information, please include the used for ongoing analysis of transplant the table below. information request collection title for outcomes. The increase in burden is due Total Estimated Annualized Burden reference. to an increase in the annual number of Hours: Responses Number of Total Hours per Total burden per respondents responses response hours respondent Baseline Pre-Transplant Essential Data (TED) ................... 200 44 8,800 1.15 10,120 Product Form (includes Infusion, HLA, and Infectious Dis- ease Marker inserts) ........................................................ 200 33 6,600 1 6,600 100-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 DEPARTMENT OF HEALTH AND Resources and Services Administration on (1) the necessity and utility of the HUMAN SERVICES (HRSA) has submitted an Information proposed information collection for the Collection Request (ICR) to the Office of proper performance of the agency’s Health Resources and Services Management and Budget (OMB) for functions, (2) the accuracy of the Administration review and approval. Comments estimated burden, (3) ways to enhance submitted during the first public review Agency Information Collection the quality, utility, and clarity of the of this ICR will be provided to OMB. Activities: Submission to OMB for information to be collected, and (4) the Review and Approval; Public Comment OMB will accept further comments from use of automated collection techniques Request the public during the review and or other forms of information approval period. sradovich on DSK3TPTVN1PROD with NOTICES technology to minimize the information AGENCY: Health Resources and Services DATES: Comments on this ICR should be collection burden. Administration, HHS. received no later than June 17, 2016. Jason E. Bennett, ACTION: Notice. ADDRESSES: Submit your comments, Director, Division of the Executive Secretariat. including the Information Collection SUMMARY: In compliance with Section [FR Doc. 2016–11674 Filed 5–17–16; 8:45 am] 3507(a)(1)(D) of the Paperwork Request Title, to the desk officer for BILLING CODE 4165–15–P Reduction Act of 1995, the Health HRSA, either by email to VerDate Sep<11>2014 17:10 May 17, 2016 Jkt 238001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1


Document Created: 2016-05-18 00:05:52
Document Modified: 2016-05-18 00:05:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this Information Collection Request must be received no later than July 18, 2016.
ContactTo 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.
FR Citation81 FR 31244 
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