Submission for OMB Review; 30-Day Comment Request: Cancer Trials Support Unit (CTSU) (NCI), 69428-69429 [2013-27554]

Download as PDF 69428 Federal Register / Vol. 78, No. 223 / Tuesday, November 19, 2013 / Notices ESTIMATES OF ANNUAL BURDEN HOURS—Continued Number of respondents Frequency of responses per respondent Average burden per response (in hours) Total annual burden hours Form name Type of respondents Ped Expedited Study Closure .................................. Adult Expedited Study Chair Response to Required Mod. Ped Expedited Study Chair Response to Required Mod. Reviewer Worksheet of Translated Documents ...... Reviewer Advertisement Checklist .......................... Board Members ......... Board Members ......... 20 350 1 1 20/60 15/60 7 88 Board Members ......... 150 1 15/60 38 Board Members ......... Board Members ......... 15 10 1 1 15/60 20/60 4 3 Dated: November 7, 2013. Vivian Horovitch-Kelley, Program Analyst, National Institutes of Health. [FR Doc. 2013–27556 Filed 11–18–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: Cancer Trials Support Unit (CTSU) (NCI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 30, 2013, Vol. 78, p. 53763 and allowed 60days for public comment. There have been no public comments. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. SUMMARY: Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Michael Montello, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number 240–276–6080 or Email your request, including your address to: montellom@ mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Cancer Trials Support Unit (CTSU) (NCI), 0925–0624, Expiration Date 12/31/2013, REVISION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Cancer Therapy Evaluation Program (CTEP) establishes and supports programs to facilitate the participation of qualified investigators on CTEP-supported studies, and to institute programs that minimize redundancy among grant and contract holders, thereby reducing overall cost of maintaining a robust treatment trials program. Currently guided by the efforts of the Clinical Trials Working Group (CTWG) and the Institute of Medicine (IOM) recommendations to revitalize the Cooperative Group program, CTEP has funded the Cancer Trials Support Unit (CTSU). The CTSU collects standardized forms to process site regulatory information, changes to membership, patient enrollment data, and routing information for case report forms. In addition, CTSU collects annual surveys of customer satisfaction for clinical site staff using the CTSU Help Desk, the CTSU Web site, and the Protocol and Information Office (PIO). An ongoing user satisfaction survey is in place for the Oncology Patient Enrollment Network (OPEN). User satisfaction surveys are compiled as part of the project quality assurance activities and are used to direct improvements to processes and technology. Additionally, there are three surveys that collect information about health professional’s interests in clinical trial, potential issues with opening and accruing to a clinical trial and reasons for low accrual. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 25,205. ESTIMATED ANNUALIZED BURDEN HOURS TKELLEY on DSK3SPTVN1PROD with NOTICES Form name CTSU IRB/Regulatory Approval Transmittal Form CTSU IRB Certification Form ............................... CTSU Acknowledgement ...................................... Withdrawal from Protocol Participation Form ....... Site Addition .......................................................... CTSU Roster Update Form .................................. CTSU Radiation Therapy Facilities Inventory Form. VerDate Mar<15>2010 17:21 Nov 18, 2013 Number of respondents Type of respondent Jkt 232001 Health Health Health Health Health Health Health PO 00000 Care Care Care Care Care Care Care Frm 00067 Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Fmt 4703 Sfmt 4703 Number of responses per respondent 9,000 8,500 500 50 25 50 20 E:\FR\FM\19NON1.SGM 12 12 12 12 12 12 12 19NON1 Average burden per response (in hours) 2/60 10/60 5/60 5/60 5/60 4/60 30/60 Total annual burden hour 3,600 17,000 500 50 25 40 120 69429 Federal Register / Vol. 78, No. 223 / Tuesday, November 19, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Form name Type of respondent CTSU IBCSG Drug Accountability Form .............. CTSU IBCSG Transfer of Investigational Agent Form. Site Initiated Data Update Form ........................... Data Clarification Form ......................................... RTOG 0834 CTSU Data Transmittal Form .......... MC0845(8233) CTSU Data Transmittal ............... CTSU Generic Data Transmittal Form ................. CTSU Patient Enrollment Transmittal Form ......... CTSU P2C Enrollment Transmittal Form ............. CTSU Transfer Form ............................................ CTSU System Account Request Form ................. CTSU Request for Clinical Brochure .................... CTSU Supply Request Form ................................ CTSU Web Site Customer Satisfaction Survey ... CTSU Helpdesk Customer Satisfaction Survey ... CTSU OPEN Survey ............................................ PIO Customer Satisfaction Survey ....................... Concept Clinical Trial Survey ............................... Prospective Clinical Trial Survey .......................... Low Accrual Clinical Trial Survey ......................... Health Care Practitioner Health Care Practitioner Dated: November 7, 2013. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: The Development of Modified T-cells for the Treatment of Multiple Myeloma National Institutes of Health, HHS. Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Thirsty Brook Bioscience, Inc., of an exclusive evaluation option license to practice the inventions embodied in the following US Patent Applications (and all continuing applications and foreign counterparts): Serial No. 61/622,6008 entitled, ‘‘Chimeric Antigen Receptors Targeting B-cell Maturation Antigen’’ [HHS Ref. E–040–2012/0–US–01]. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:21 Nov 18, 2013 Jkt 232001 Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner 10/60 20/60 22 12 10 341 60 50 500 200 15 20 20 75 75 275 325 60 100 500 1,000 1,000 12 12 12 12 12 12 12 12 12 12 12 1 1 1 1 1 1 1 10/60 20/60 10/60 10/60 10/60 10/60 10/60 10/60 20/60 10/60 10/60 15/60 15/60 15/60 5/60 5/60 5/60 5/60 20 1,364 120 100 1,000 400 30 40 80 150 150 69 81 15 8 42 83 83 Upon the expiration or termination of the exclusive evaluation option license, Thirsty Brook Bioscience, Inc. will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the exclusive evaluation option license. DATES: Only written comments or applications for a license (or both) which are received by the NIH Office of Technology Transfer on or before December 4, 2013 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive evaluation option license should be directed to: Patrick McCue, Ph.D., Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–5560; Facsimile: (301) 402–0220; Email: mccuepat@ mail.nih.gov. SUPPLEMENTARY INFORMATION: The invention concerns a series of CARs that specifically target BCMA (a.k.a. CD269), a protein that is highly expressed on the surface of multiple myeloma cells. The PO 00000 Frm 00068 Fmt 4703 Sfmt 9990 Total annual burden hour 12 12 ‘‘The research, development, and manufacture of chimeric antigen receptor (CAR)-expressing human T-cells directed against B-cell Maturation Antigen (BCMA) for the treatment of multiple myeloma.’’ BILLING CODE 4140–01–P ACTION: Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Average burden per response (in hours) 11 3 worldwide, and the field of use may be limited to: [FR Doc. 2013–27554 Filed 11–18–13; 8:45 am] AGENCY: Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Number of responses per respondent patent rights include claims to vectors incorporating the CARs, as well as methods of destroying multiple myeloma cells using T-cells engineered to express a CAR. The prospective exclusive evaluation option license is being considered under the small business initiative launched on 1 October 2011, and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive evaluation option license, and a subsequent exclusive commercialization license, may be granted unless the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404 within fifteen (15) days from the date of this published notice. Complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive evaluation option license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: November 13, 2013. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–27601 Filed 11–18–13; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\19NON1.SGM 19NON1

Agencies

[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Pages 69428-69429]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27554]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; 30-Day Comment Request: Cancer Trials
Support Unit (CTSU) (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH), has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on August 30, 2013, Vol. 78, p. 53763 and allowed 60-days for
public comment. There have been no public comments. The purpose of this
notice is to allow an additional 30 days for public comment. The
National Cancer Institute (NCI), National Institutes of Health, may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: Michael Montello, Cancer Therapy Evaluation
Program, Division of Cancer Treatment and Diagnosis, 9609 Medical
Center Drive, Rockville, MD 20850 or call non-toll-free number 240-276-
6080 or Email your request, including your address to:
montellom@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Proposed Collection: Cancer Trials Support Unit (CTSU) (NCI), 0925-
0624, Expiration Date 12/31/2013, REVISION, National Cancer Institute
(NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Cancer Therapy
Evaluation Program (CTEP) establishes and supports programs to
facilitate the participation of qualified investigators on CTEP-
supported studies, and to institute programs that minimize redundancy
among grant and contract holders, thereby reducing overall cost of
maintaining a robust treatment trials program. Currently guided by the
efforts of the Clinical Trials Working Group (CTWG) and the Institute
of Medicine (IOM) recommendations to revitalize the Cooperative Group
program, CTEP has funded the Cancer Trials Support Unit (CTSU). The
CTSU collects standardized forms to process site regulatory
information, changes to membership, patient enrollment data, and
routing information for case report forms. In addition, CTSU collects
annual surveys of customer satisfaction for clinical site staff using
the CTSU Help Desk, the CTSU Web site, and the Protocol and Information
Office (PIO). An ongoing user satisfaction survey is in place for the
Oncology Patient Enrollment Network (OPEN). User satisfaction surveys
are compiled as part of the project quality assurance activities and
are used to direct improvements to processes and technology.
Additionally, there are three surveys that collect information about
health professional's interests in clinical trial, potential issues
with opening and accruing to a clinical trial and reasons for low
accrual.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 25,205.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondent respondents responses per response (in burden hour
respondent hours)
----------------------------------------------------------------------------------------------------------------
CTSU IRB/Regulatory Approval Health Care 9,000 12 2/60 3,600
Transmittal Form. Practitioner.
CTSU IRB Certification Form... Health Care 8,500 12 10/60 17,000
Practitioner.
CTSU Acknowledgement.......... Health Care 500 12 5/60 500
Practitioner.
Withdrawal from Protocol Health Care 50 12 5/60 50
Participation Form. Practitioner.
Site Addition................. Health Care 25 12 5/60 25
Practitioner.
CTSU Roster Update Form....... Health Care 50 12 4/60 40
Practitioner.
CTSU Radiation Therapy Health Care 20 12 30/60 120
Facilities Inventory Form. Practitioner.

[[Page 69429]]

CTSU IBCSG Drug Accountability Health Care 11 12 10/60 22
Form. Practitioner.
CTSU IBCSG Transfer of Health Care 3 12 20/60 12
Investigational Agent Form. Practitioner.
Site Initiated Data Update Health Care 10 12 10/60 20
Form. Practitioner.
Data Clarification Form....... Health Care 341 12 20/60 1,364
Practitioner.
RTOG 0834 CTSU Data Health Care 60 12 10/60 120
Transmittal Form. Practitioner.
MC0845(8233) CTSU Data Health Care 50 12 10/60 100
Transmittal. Practitioner.
CTSU Generic Data Transmittal Health Care 500 12 10/60 1,000
Form. Practitioner.
CTSU Patient Enrollment Health Care 200 12 10/60 400
Transmittal Form. Practitioner.
CTSU P2C Enrollment Health Care 15 12 10/60 30
Transmittal Form. Practitioner.
CTSU Transfer Form............ Health Care 20 12 10/60 40
Practitioner.
CTSU System Account Request Health Care 20 12 20/60 80
Form. Practitioner.
CTSU Request for Clinical Health Care 75 12 10/60 150
Brochure. Practitioner.
CTSU Supply Request Form...... Health Care 75 12 10/60 150
Practitioner.
CTSU Web Site Customer Health Care 275 1 15/60 69
Satisfaction Survey. Practitioner.
CTSU Helpdesk Customer Health Care 325 1 15/60 81
Satisfaction Survey. Practitioner.
CTSU OPEN Survey.............. Health Care 60 1 15/60 15
Practitioner.
PIO Customer Satisfaction Health Care 100 1 5/60 8
Survey. Practitioner.
Concept Clinical Trial Survey. Health Care 500 1 5/60 42
Practitioner.
Prospective Clinical Trial Health Care 1,000 1 5/60 83
Survey. Practitioner.
Low Accrual Clinical Trial Health Care 1,000 1 5/60 83
Survey. Practitioner.
----------------------------------------------------------------------------------------------------------------

Dated: November 7, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2013-27554 Filed 11-18-13; 8:45 am]
BILLING CODE 4140-01-P

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