Proposed Collection; 60-Day Comment Request; The Genetic Testing Registry, 70194-70195 [2014-27898]

Download as PDF 70194 Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400052 to identify the guidance you are requesting. wreier-aviles on DSK4TPTVN1PROD with NOTICES IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485. In addition, FDA concludes that the labeling statements in the guidance do not constitute a ‘‘collection of information’’ under the Paperwork Reduction Act. Rather, the labeling statements are ‘‘public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public.’’ (5 CFR 1320.3(c)(2)). V. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. VerDate Sep<11>2014 14:41 Nov 24, 2014 Jkt 235001 VI. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http:// www.regulations.gov. (FDA has verified the Web site addresses in this reference section, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. FDA Center for Devices and Radiological Health, Safety Communications Page, ‘‘Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy,’’ (http://www.fda.gov/ medicaldevices/safety/alertsandnotices/ ucm393576.htm). 2. Public meeting in 2014, Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, Federal Register notice, available at http:// www.gpo.gov/fdsys/pkg/FR-2014-06-09/ pdf/2014-13290.pdf. Dated: November 19, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–27857 Filed 11–24–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; The Genetic Testing Registry In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director (OD), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Sarah Carr, Acting Director, Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, 6705 Rockledge Dr., Suite 750, Bethesda, MD 20892, or call nontoll-free number (301) 496–9838, or Email your request, including your address to: OCRBP–OSP@od.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The Genetic Testing Registry, 0925–0651, Expiration Date 02/28/2015—EXTENSION, Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: Clinical laboratory tests are available for more than 5,000 genetic conditions. The Genetic Testing Registry (GTR) provides a centralized, online location for test developers, manufacturers, and researchers to voluntarily submit detailed information about the availability and scientific basis of their genetic tests. The GTR is of value to clinicians by providing information about the accuracy, validity, and usefulness of genetic tests. The GTR also highlights evidence gaps where additional research is needed. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 5,536. E:\FR\FM\25NON1.SGM 25NON1 70195 Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Estimated annual number of respondents Number of responses per respondent Average burden per response (in hours) Total annual burden hours Type of respondent Form name Laboratory Personnel Using Bulk Submission ..... Minimal Fields .............. Optional Fields ............. Minimal Fields .............. 190 159 116 29 29 29 18/60 14/60 30/60 1,653 1,076 1,682 Optional Fields ............. 97 29 24/60 1,125 Laboratory Personnel Not Using Bulk Submission. Dated: November 17, 2014. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2014–27898 Filed 11–24–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Technology descriptions follow. wreier-aviles on DSK4TPTVN1PROD with NOTICES SUMMARY: T-cell Chimeric Receptors of TSLPR for Diagnosis and Immunotherapy of Cancer Description of Technology: T-cellbased immunotherapies allow a patient’s immune system to concentrate its efforts and destroy cancer cells. In the present technology, the researchers VerDate Sep<11>2014 14:41 Nov 24, 2014 Jkt 235001 at the National Cancer Institute have developed chimeric antigen receptors (or CARs), which encode an antigen binding domain specific for thymic stromal lymphopoietin receptor (TSLPR) and a T-cell signaling domain. TSLPR is over-expressed on the surface of approximately 10% of adult and pediatric B-cell precursor acute lymphoblastic leukemias (BCP–ALL). Available for licensing is the abovereference CAR technology as well as methods for diagnosing and treating cancer using these CARs. Potential Commercial Applications: • Immunotherapy against cancer, especially leukemia • Immunotoxins Competitive Advantages: CAR receptors are specific for TSLPR. Development Stage: • In vitro data available • In vivo data available (animal) • Prototype Inventors: Terry Fry and Haiying Qin (NCI). Publication: Qin H, et al. Pre-clinical development of a novel chimerical antigen receptor targeting high-risk pediatric ALL over-expressing Tslpr. Blood 2013 Nov 15;122(21):2665. Intellectual Property: • HHS Reference No. E–008–2014/0— US Provisional Application No. 61/ 912,948 filed 06 Dec 2013 • HHS Reference No. E–008–2014/1— US Provisional Application No. 61/ 991,697 filed 12 May 2014 • HHS Reference No. E–008–2014/2— PCT Application No. PCT/US2014/ 063096 filed 30 Oct 2014 Licensing Contact: Patrick McCue, Ph.D.; 301–435–5560; mccuepat@ mail.nih.gov Novel Bridged Bicyclic Thiazepinone Compounds Description of Technology: The invention is directed to small molecules containing a novel, bridged, bicyclic thiazepinone pharmacophore. Invention compounds inhibit the Nav1.7 sodium channel. Additionally, invention compounds bind the human norepinephrine transporter (NET), with PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 selectivity over the serotonin transporter (SERT) and dopamine transporter (DAT). Invention compounds could be used to treat neuropathic pain associated with diabetes and fibromyalgia, Attention Deficit Hyperactivity Disorder (ADHD), urinary incontinence, depression, anxiety, and other mood disorders. Invention compounds can be conjugated with fluorescent or radioactive tags, and used to probe the structure and activity of the Nav1.7 sodium channel and NET. Potential Commercial Applications: • Therapeutic • Chemical probe Competitive Advantages: • Small molecule compounds made using facile synthesis scheme • Inhibition of Nav1.7 sodium channel • NET inhibition with selectivity over other transporters Development Stage: • Early-stage • In vitro data available Inventors: Hans F. Luecke (NIDDK), Michael T. Scerba (NIDDK), Dongwook Kang (Daegu Catholic University). Intellectual Property: HHS Reference No. E–224–2012/0— • US Application No. 61/876,262 filed 09 Sept 2013 • PCT Application No. PCT/US2014/ 054660 filed 09 Sept 2014 Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074; nguyenantczakla@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Diabetes and Digestive and Kidney Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize use of bridged bicyclic thiazepinones. For collaboration opportunities, please contact Marguerite J. Miller, M.B.A. at marguerite.miller@nih.gov or 301–496– 9003. E:\FR\FM\25NON1.SGM 25NON1

Agencies

[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Pages 70194-70195]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27898]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; The Genetic Testing 
Registry

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the Office of the Director (OD), 
National Institutes of Health (NIH), will publish periodic summaries of 
proposed projects to be submitted to the Office of Management and 
Budget (OMB) for review and approval.
    Written comments and/or suggestions from the public and affected 
agencies are invited on one or more of the following points: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of the function of the agency, including whether the 
information will have practical utility; (2) The accuracy of the 
agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) Ways to minimize the burden of the 
collection of information on those who are to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.
    To Submit Comments and for Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Ms. Sarah 
Carr, Acting Director, Office of Clinical Research and Bioethics 
Policy, Office of Science Policy, NIH, 6705 Rockledge Dr., Suite 750, 
Bethesda, MD 20892, or call non-toll-free number (301) 496-9838, or 
Email your request, including your address to: OCRBP-OSP@od.nih.gov. 
Formal requests for additional plans and instruments must be requested 
in writing.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: The Genetic Testing Registry, 0925-0651, 
Expiration Date 02/28/2015--EXTENSION, Office of the Director (OD), 
National Institutes of Health (NIH).
    Need and Use of Information Collection: Clinical laboratory tests 
are available for more than 5,000 genetic conditions. The Genetic 
Testing Registry (GTR) provides a centralized, online location for test 
developers, manufacturers, and researchers to voluntarily submit 
detailed information about the availability and scientific basis of 
their genetic tests. The GTR is of value to clinicians by providing 
information about the accuracy, validity, and usefulness of genetic 
tests. The GTR also highlights evidence gaps where additional research 
is needed.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 5,536.

[[Page 70195]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                     Estimated       Number of    Average burden
      Type of respondent            Form name      annual number   responses per   per response    Total annual
                                                  of respondents    respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Laboratory Personnel Using      Minimal Fields..             190              29           18/60           1,653
 Bulk Submission.
                                Optional Fields.             159              29           14/60           1,076
Laboratory Personnel Not Using  Minimal Fields..             116              29           30/60           1,682
 Bulk Submission.
                                Optional Fields.              97              29           24/60           1,125
----------------------------------------------------------------------------------------------------------------


    Dated: November 17, 2014.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2014-27898 Filed 11-24-14; 8:45 am]
BILLING CODE 4140-01-P