Submission for OMB Review; 30-day Comment Request: The Clinical Trials Reporting Program (CTRP) Database (NCI), 21130-21131 [2013-08270]

Download as PDF 21130 Federal Register / Vol. 78, No. 68 / Tuesday, April 9, 2013 / Notices Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 13, 2013. Oral presentations from the public will be scheduled between approximately 12 p.m. and 1 p.m. on May 21, 2013, and between approximately 10:45 a.m. and 11:45 a.m. on May 22, 2013. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 3, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 6, 2013. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams (Annmarie.williams@fda.hhs.gov, 301– 796–5966) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 4, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. 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. [FR Doc. 2013–08218 Filed 4–8–13; 8:45 am] FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, contact Jose Galvez, Office of the Director, National Cancer Institute, 2115 East Jefferson Street, Rockville, MD 20852 or call nontoll-free number 301–443–6141 or Email your request, including your address to: jose.galvez@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database, 0925–0600, Expiration Date 3/ 31/2013—REINSTATEMENT WITH CHANGE, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Clinical Trials Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported clinical research. This resource allows the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Information is submitted by clinical research administrators as designees of clinical investigators who conduct NCIsupported clinical research. The designees can electronically access the CTRP Web site to complete the initial trial registration. Subsequent to registration, four amendments and four study subject accrual updates occur per trial annually. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 33,000. BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-day Comment Request: The Clinical Trials Reporting Program (CTRP) Database (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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 1, 2013 (Volume 78, Page 7437) and allowed 60-days for public comment. No public comments were received. 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 ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Instrument Clinical Trials .......................................... sroberts on DSK5SPTVN1PROD with NOTICES Type of respondents Initial Registration ....................... Amendment ................................. Accrual Updates ......................... VerDate Mar<15>2010 16:19 Apr 08, 2013 Jkt 229001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Number of responses per respondent 5,500 5,500 5,500 E:\FR\FM\09APN1.SGM 1 4 4 09APN1 Average time per response (in hours) 1 1 15/60 Total annual burden hours 5,500 22,000 5,500 Federal Register / Vol. 78, No. 68 / Tuesday, April 9, 2013 / Notices Dated: April 3, 2013. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, NCI, NIH. [FR Doc. 2013–08270 Filed 4–8–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meetings sroberts on DSK5SPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; NIH Support for Conferences and Scientific Meetings. Date: April 30, 2013. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Mohan Viswanathan, Ph.D., Acting Director, Office of Grants Management & Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1084, Bethesda, MD 20892–4874, 301–435–0829, mv10f@nih.gov. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; NIH Support for Conferences and Scientific Meetings. Date: May 1, 2013. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Mohan Viswanathan, Ph.D., Acting Director, Office of Grants Management & Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1084, Bethesda, MD 20892–4874, 301–435–0829, mv10f@nih.gov. VerDate Mar<15>2010 16:19 Apr 08, 2013 Jkt 229001 Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; NIH Support for Conferences and Scientific Meetings. Date: May 3, 2013. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Mohan Viswanathan, Ph.D., Acting Director, Office of Grants Management & Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1084, Bethesda, MD 20892–4874, 301–435–0829, mv10f@nih.gov. Dated: April 2, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–08149 Filed 4–8–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of An Exclusive Evaluation Option License: Pre-clinical Evaluation of Anti-tyrosine Kinase-like Orphan Receptor 1 Immunotoxins for the Treatment of Human Cancers AGENCY: National Institutes of Health, HHS. ACTION: Notice. SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 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 U.S. Patent Application 61/172,099 entitled ‘‘Anti-human ROR1 Antibodies’’ [HHS Ref. E–097–2009/0– US–01], U.S. Patent Application 60/ 703,798 entitled ‘‘Mutated Pseudomonas Exotoxins with Reduced Antigenicity’’ [HHS Ref. E–262–2005/0– US–01], U.S. Patent Application 60/ 969,929 entitled ‘‘Deletions in Domain II of Pseudomonas Exotoxin A that Remove Immunogenic Epitopes with Affecting Cytotoxic Activity’’ [HHS Ref. E–292–2007/0–US–01], U.S. Patent Application 61/241,620 entitled ‘‘Improved Pseudomonas Exotoxin A with Reduced Immunogenicity’’ [HHS Ref. E–269–2009/0–US–01], U.S. Patent Application 61/483,531 entitled ‘‘Recombinant Immunotoxin Targeting Mesothelin’’ [HHS Ref. E–117–2011/0– US–01], U.S. Patent Application 61/ PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 21131 495,085 entitled ‘‘Pseudomonas Exotoxin A with Less Immunogenic TCell/or B-Cell Epitopes’’ [HHS Ref. E– 174–2011/0–US–01], U.S. Patent Application 61/535,668 entitled ‘‘Pseudomonas Exotoxin A with Less Immunogenic B-Cell Epitopes’’ [HHS Ref. E–263–2011/0–US–01], and all related continuing and foreign patents/ patent applications for the technology family, to SPEED BioSystems, LLC. 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 worldwide and the field of use may be limited to pre-clinical evaluation of lead therapeutic candidates for the development and use of anti-tyrosine kinase-like orphan receptor 1 (ROR1) targeted immunotoxins for the treatment of human ROR1 expressing cancers, wherein the immunotoxin comprises an anti-ROR1 antibody designated as 2A2 and Pseudomonas exotoxin A (PE). Upon expiration or termination of the exclusive evaluation option license, SPEED will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no broader territory than granted in the exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 24, 2013 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, comments, and other materials relating to the contemplated exclusive evaluation option license should be directed to: Jennifer Wong, M.S., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 4633; Facsimile: (301) 402–0220; Email: wongje@od.nih.gov. SUPPLEMENTARY INFORMATION: This invention concerns anti-ROR1 immunotoxin comprising an anti-ROR1 antibody designated as 2A2 and PE as a treatment for human ROR1 expressing cancers. The immunotoxin will comprise a chimeric mouse anti-human receptor tyrosine kinase-like orphan receptor 1 monoclonal antibody whereas the immunotoxin will have a toxin domain derived from PE. PE toxin’s domain have been modified in E:\FR\FM\09APN1.SGM 09APN1

Agencies

[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Notices]
[Pages 21130-21131]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08270]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-day Comment Request: The Clinical 
Trials Reporting Program (CTRP) Database (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 to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on February 1, 2013 (Volume 78, Page 7437) and allowed 60-days 
for public comment. No public comments were received. 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, contact Jose Galvez, Office of the 
Director, National Cancer Institute, 2115 East Jefferson Street, 
Rockville, MD 20852 or call non-toll-free number 301-443-6141 or Email 
your request, including your address to: jose.galvez@nih.gov. Formal 
requests for additional plans and instruments must be requested in 
writing.
    Proposed Collection: The Clinical Trials Reporting Program (CTRP) 
Database, 0925-0600, Expiration Date 3/31/2013--REINSTATEMENT WITH 
CHANGE, National Cancer Institute (NCI), National Institutes of Health 
(NIH).
    Need and Use of Information Collection: The Clinical Trials 
Reporting Program (CTRP) is an electronic resource that serves as a 
single, definitive source of information about all NCI-supported 
clinical research. This resource allows the NCI to consolidate 
reporting, aggregate information and reduce redundant submissions. 
Information is submitted by clinical research administrators as 
designees of clinical investigators who conduct NCI-supported clinical 
research. The designees can electronically access the CTRP Web site to 
complete the initial trial registration. Subsequent to registration, 
four amendments and four study subject accrual updates occur per trial 
annually.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The estimated annualized burden 
hours are 33,000.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
      Type of respondents          Instrument        Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Clinical Trials...............  Initial                    5,500               1               1           5,500
                                 Registration.
                                Amendment.......           5,500               4               1          22,000
                                Accrual Updates.           5,500               4           15/60           5,500
----------------------------------------------------------------------------------------------------------------



[[Page 21131]]

    Dated: April 3, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, NCI, NIH.
[FR Doc. 2013-08270 Filed 4-8-13; 8:45 am]
BILLING CODE 4140-01-P
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