Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 31245-31246 [2016-11672]

Download as PDF 31245 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 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. Comments on this Information Collection Request must be received no later than July 18, 2016. DATES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N–39, 5600 Fishers Lane, Rockville, MD 20857. ADDRESSES: 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. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the information request collection title for reference. 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 (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 Number of respondents Responses per respondent 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 centerspecific 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: Total responses Hours per response Total burden hours Baseline Pre-Transplant Essential Data (TED) ................... Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................ 100-Day Post-TED ............................................................... 6-Month Post-TED ............................................................... 12-Month Post-TED ............................................................. Annual Post-TED ................................................................. 200 44 8,800 1.15 10,120 200 200 200 200 200 33 44 36 32 110 6,600 8,800 7,200 6,400 22,000 1 1 1.15 1.15 1.15 6,600 8,800 8,280 7,360 25,300 * Total ............................................................................ 200 ........................ 59,800 ........................ 66,460 sradovich on DSK3TPTVN1PROD with NOTICES * 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 VerDate Sep<11>2014 17:10 May 17, 2016 Jkt 238001 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 Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health SUMMARY: PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 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. Comments on this ICR should be received no later than June 17, 2016. DATES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to ADDRESSES: E:\FR\FM\18MYN1.SGM 18MYN1 31246 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 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. Number of respondents Form name Number of responses per respondent 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 burden per response (in hours) Total responses Total burden hours Rural Network Allied Health Training Program Performance Measures ................................................................. 10 1 10 6.55 65.5 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive License: The Development of an AntiGPC3 Chimeric Antigen Receptor (CAR) Based on HN3 for the Treatment of Human Cancers National Institutes of Health, Public Health Service, Department of Health and Human Services. AGENCY: sradovich on DSK3TPTVN1PROD with NOTICES ACTION: Notice. This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: SUMMARY: VerDate Sep<11>2014 17:10 May 17, 2016 Jkt 238001 Intellectual Property: U.S. Provisional Patent Application 61/654,232 entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136–2012/0–US–01]; PCT Patent Application PCT/US2013/043633 entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136–2012/0– PCT–02]; Chinese Patent Application 201380039993.7 entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136– 2012/0–CN–03]; Japanese Patent Application 2015–515243 entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136–2012/0–JP–04]; South Korea Patent Application 10–2014–7037046 entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136–2012/0–KR– 05]; Singapore Patent Application 11201407972R entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136– 2012/0–SG–06]; United States Patent Application 14/403,896 entitled ‘‘Highaffinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E–136–2012/0–US–07]; and all continuing U.S. and foreign patents/ patent applications for the technology family, to Lentigen Technology, Inc. The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: ‘‘The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) the complementary determining region (CDR) sequences of the anti-GPC3 antibody known as HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.’’ E:\FR\FM\18MYN1.SGM 18MYN1

Agencies

[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31245-31246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11672]


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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.

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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