81 FR 31245 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 96 (May 18, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 96 (May 18, 2016)
| Page Range | 31245-31246 | |
| FR Document | 2016-11672 |
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)] [Notices] [Pages 31245-31246] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11672] ----------------------------------------------------------------------- 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 AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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 June 17, 2016. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to [[Page 31246]] 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 the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443- 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Rural Network Allied Health Training Program Performance Improvement Measurement System (PIMS) OMB No.: 0906-xxxx--NEW. Abstract: The Rural Network Allied Health Training Program will support the development of formal, mature rural health networks that focus on activities that achieve efficiencies, expand access to, coordinate and improve the quality of essential health care services, and strengthen the rural health care system as a whole. This purpose will be achieved through the recruitment, clinical training, and retention of allied health professionals. This program will further support integrated rural health networks that can partner with local community colleges and other accredited educational institutions (such as vocational and technical colleges) to develop formal clinical training programs. Need and Proposed Use of the Information: For this program, performance measures were drafted to provide data to the program and to enable HRSA to provide aggregate program data required by Congress under the Government Performance and Results Act of 1993. These measures cover the principal topic areas of interest to the Federal Office of Rural Health Policy (FORHP), including: (a) Access to care; (b) population demographics; (c) staffing; (d) consortium/network; (e) sustainability; and (f) project specific domains. Several measures will be used for this program. All measures will speak to FORHP's progress toward meeting the goals. Likely Respondents: The respondents are recipients of the Rural Network Allied Health Training Program grant funding. 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: ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total burden per Total burden Form name respondents responses per responses response (in hours respondent hours) ---------------------------------------------------------------------------------------------------------------- Rural Network Allied Health 10 1 10 6.55 65.5 Training Program Performance Measures....................... ------------------------------------------------------------------------------- Total....................... 10 .............. 10 .............. 65.5 ---------------------------------------------------------------------------------------------------------------- Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016-11672 Filed 5-17-16; 8:45 am] BILLING CODE 4165-15-P
![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
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![31246 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
OIRA_submission@omb.eop.gov or by This program will further support Likely Respondents: The respondents
fax to 202–395–5806. integrated rural health networks that are recipients of the Rural Network
FOR FURTHER INFORMATION CONTACT: To can partner with local community Allied Health Training Program grant
request a copy of the clearance requests colleges and other accredited funding.
submitted to OMB for review, email the educational institutions (such as Burden Statement: Burden in this
HRSA Information Collection Clearance vocational and technical colleges) to context means the time expended by
Officer at paperwork@hrsa.gov or call develop formal clinical training persons to generate, maintain, retain,
(301) 443–1984. programs. disclose or provide the information
SUPPLEMENTARY INFORMATION: Need and Proposed Use of the requested. This includes the time
Information Collection Request Title: Information: For this program, needed to review instructions; to
Rural Network Allied Health Training performance measures were drafted to develop, acquire, install and utilize
Program Performance Improvement provide data to the program and to technology and systems for the purpose
Measurement System (PIMS) enable HRSA to provide aggregate of collecting, validating and verifying
program data required by Congress information, processing and
OMB No.: 0906–xxxx—NEW.
Abstract: The Rural Network Allied under the Government Performance and maintaining information, and disclosing
Health Training Program will support Results Act of 1993. These measures and providing information; to train
the development of formal, mature rural cover the principal topic areas of personnel and to be able to respond to
health networks that focus on activities interest to the Federal Office of Rural a collection of information; to search
that achieve efficiencies, expand access Health Policy (FORHP), including: (a) data sources; to complete and review
to, coordinate and improve the quality Access to care; (b) population the collection of information; and to
of essential health care services, and demographics; (c) staffing; (d) transmit or otherwise disclose the
strengthen the rural health care system consortium/network; (e) sustainability; information. The total annual burden
as a whole. This purpose will be and (f) project specific domains. Several hours estimated for this ICR are
achieved through the recruitment, measures will be used for this program. summarized in the table below.
clinical training, and retention of allied All measures will speak to FORHP’s Total Estimated Annualized Burden
health professionals. progress toward meeting the goals. Hours:
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Rural Network Allied Health Training Program Perform-
ance Measures ................................................................. 10 1 10 6.55 65.5
Total .............................................................................. 10 ........................ 10 ........................ 65.5
Jason E. Bennett, Intellectual Property: U.S. Provisional E–136–2012/0–US–07]; and all
Director, Division of the Executive Secretariat. Patent Application 61/654,232 entitled continuing U.S. and foreign patents/
[FR Doc. 2016–11672 Filed 5–17–16; 8:45 am] ‘‘High-affinity Monoclonal Antibodies patent applications for the technology
BILLING CODE 4165–15–P To Glypican-3 And Use Thereof’’ [HHS family, to Lentigen Technology, Inc.
Ref. E–136–2012/0–US–01]; PCT Patent The patent rights to these inventions
Application PCT/US2013/043633 have been assigned to and/or
DEPARTMENT OF HEALTH AND entitled ‘‘High-affinity Monoclonal exclusively licensed to the Government
HUMAN SERVICES Antibodies To Glypican-3 And Use of the United States of America.
Thereof’’ [HHS Ref. E–136–2012/0– The prospective exclusive licensed
National Institutes of Health PCT–02]; Chinese Patent Application territory may be the United States,
201380039993.7 entitled ‘‘High-affinity Australia, Canada, the European Union,
Prospective Grant of an Exclusive Monoclonal Antibodies To Glypican-3 Russia, China, Hong Kong, Japan,
License: The Development of an Anti- And Use Thereof’’ [HHS Ref. E–136– Taiwan, South Korea and Singapore,
GPC3 Chimeric Antigen Receptor 2012/0–CN–03]; Japanese Patent and the field of use may be limited to:
(CAR) Based on HN3 for the Treatment Application 2015–515243 entitled ‘‘The development of a glypican-3
of Human Cancers ‘‘High-affinity Monoclonal Antibodies (GPC3) chimeric antigen receptor (CAR)-
To Glypican-3 And Use Thereof’’ [HHS based immunotherapy using autologous
AGENCY: National Institutes of Health,
Ref. E–136–2012/0–JP–04]; South Korea (meaning one individual is both the
Public Health Service, Department of
Patent Application 10–2014–7037046 donor and the recipient) primary human
Health and Human Services.
entitled ‘‘High-affinity Monoclonal lymphocytes (T cells or NK cells)
ACTION: Notice. Antibodies To Glypican-3 And Use transfected with a lentiviral or retroviral
Thereof’’ [HHS Ref. E–136–2012/0–KR– vector, wherein the vector expresses a
SUMMARY: This notice, in accordance 05]; Singapore Patent Application CAR having (1) a single antigen
sradovich on DSK3TPTVN1PROD with NOTICES
with 35 U.S.C. 209(c)(1) and 37 CFR 11201407972R entitled ‘‘High-affinity specificity and (2) comprising at least:
Part 404.7(a)(1)(i), that the National Monoclonal Antibodies To Glypican-3 (a) the complementary determining
Institutes of Health, Department of And Use Thereof’’ [HHS Ref. E–136– region (CDR) sequences of the anti-GPC3
Health and Human Services, is 2012/0–SG–06]; United States Patent antibody known as HN3; and (b) a T cell
contemplating the grant of an exclusive Application 14/403,896 entitled ‘‘High- signaling domain; for the prophylaxis
license to practice the inventions affinity Monoclonal Antibodies To and treatment of GPC3-expressing
embodied in: Glypican-3 And Use Thereof’’ [HHS Ref. cancers.’’
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Document Created: 2016-05-18 00:06:59
Document Modified: 2016-05-18 00:06:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than June 17, 2016. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 81 FR 31245 |
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