Notice of Office of Urban Indian Health Programs Strategic Plan, 61703-61704 [2016-21485]

Download as PDF 61703 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices An Internal Journal for Rapid Communication of Synthetic Organic Chemistry, vol. 24, no. 6, 1994. 7. U.S. Patent and Trademark Office, ‘‘Process of Preparation of Vincamine from Tabersonine.’’ Retrieved from: http:// www.google.com/patents/US3892755. Dated: August 31, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–21350 Filed 9–6–16; 8:45 am] BILLING CODE 4164–01–P Submit your comments to Information.CollectionClearance@ hhs.gov or by calling (202) 690–6162. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, Information.CollectionClearance@ hhs.gov or (202) 690–6162. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the document identifier HHS–OS–0990– new–60D for reference. Information Collection Request Title: National Tissue Recovery through Utilization Survey. Abstract: Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, requesting the Office of Management ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: HHS–OS–0990–new– 60D] Agency Information Collection Activities; Proposed Collection; Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate below or any other aspect of the ICR. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on the ICR must be received on or before [November 7, 2016]. In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection SUMMARY: and Budget (OMB) approval on a new (ICR). This survey is being conducted to generate national estimates of recovery through utilization activity; of donated human tissue for calendar years 2012 and 2015, and to compare metrics across three data collection periods that includes results from a 2007 survey, the most recent year these data were collected. The survey and data collection and analysis methods will be similar to the 2007 survey. The general categories of information to be collected are listed under the Survey Section of the Annualized Burden Hour table below. Policy advice provided by the HHS Advisory Committee on Blood and Tissue Safety and Availability to the HHS Secretary and Assistant Secretary for Health is used to direct departmental efforts to address transfusion and transplantation issues; such as emergency preparedness and infectious disease transmission related to donated human tissue. Likely Respondents: Respondents for this survey would be U.S. tissue banks that screen and recover tissue from living and deceased donors, and process, store, and/or distribute tissues grafts for transplantation from these donors. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Survey section Type of respondent Tissue bank activities, tissue types handled, and inspections. Referrals, authorization, and informed consent; tissue recovery and acquisition. Tissue processing ............................. Tissue storage .................................. Tissue distribution ............................. Communicable disease testing and adverse outcome reports. All tissue banks ................................ 110 5 5/60 46 Tissue banks that handle referrals, Recover/acquire tissue. 80 36 30/60 1440 Tissue banks that process tissue .... Tissue banks that store tissue ......... Tissue banks that distribute tissue .. Tissue banks that have donor infectious disease testing performed and may handle adverse outcome reports. 35 65 58 35 17 4 16 4 30/60 10/60 15/60 30/60 298 5 232 70 ........................................................... ........................ ........................ ........................ 2091 mstockstill on DSK3G9T082PROD with NOTICES Total ........................................... OS 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Terry S. Clark, Asst Information Collection Clearance Officer. Indian Health Service [FR Doc. 2016–21360 Filed 9–6–16; 8:45 am] BILLING CODE 4150–28–P Notice of Office of Urban Indian Health Programs Strategic Plan Indian Health Service, Department of Health and Human Services. AGENCY: Notice and request for comments. ACTION: VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1 61704 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices Indian Health Service (IHS) has entered into a contract with the National Academy of Public Administration (the Academy) to assist in the development of a five-year strategic plan. Funding for this project was provided by Congress in the 2016 Consolidated Appropriations Act, which directs IHS to develop the plan in consultation with urban Indians and the Academy. As part of this project, the Academy project team is in the process of conducting extensive outreach to IHS/ Office of Urban Indian Health Programs (OUIHP) leadership and employees, as well as conferring with urban Indian organizations and other key external stakeholder groups. The final product will be a strategic plan to guide the work of the headquarters office of OUIHP, area urban coordinators, and urban Indian organizations participating in IHS programs. The strategic plan will be completed by the end of December 2016. IHS is requesting input on the strategic planning process, the strengths and weaknesses of OUIHP, and the opportunities and threats facing the program. Comments will be used to help develop the mission, goals, objectives, and strategies to be included in the strategic plan. DATES: Submit your input to the Academy no later than September 16, 2016. All comments submitted to the Academy are not for attribution. Written Comments: Send input by email to UIOconfer@napawash.org with the subject line: UIHP Strategic Plan. FOR FURTHER INFORMATION CONTACT: Pamela Haze, Project Director, National Academy of Public Administration, 1600 K St. NW., Suite 400, Washington, DC 20006, (201) 204–3682. SUMMARY: Dated: August 26, 2016. Elizabeth A. Fowler, Deputy Director for Management Operations, Indian Health Service. [FR Doc. 2016–21485 Filed 9–6–16; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK3G9T082PROD with NOTICES National Institutes of Health Prospective Grant of Exclusive Patent License: The Development of an AntiCD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers AGENCY: National Institutes of Health, HHS. ACTION: Notice. VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 This 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 of an exclusive patent license to practice the inventions embodied in the following Patents and Patent Applications and all continuing U.S. and foreign patents/patent applications to Sangamo BioSciences, Inc. located in Richmond, California, USA: SUMMARY: Intellectual Property U.S. Provisional Patent Application 62/006,313, filed 2 June 2014 and entitled ‘‘Chimeric Antigen Receptors Targeting CD–19’’ [HHS Ref. E–042– 2014/0–US–01]; and PCT Patent Application PCT/US2015/033473, filed 1 June 2015 and entitled ‘‘Chimeric Antigen Receptors Targeting CD–19’’ [HHS Ref. E–042–2014/0–PCT–02]. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: ‘‘The integration of a monospecific anti-CD19 chimeric antigen receptor (CAR) into genomeedited, allogeneic T cells (where the donor and recipient are different), where the monospecific CAR has at least: (a) The complementary determining region (CDR) sequences of the anti-CD19 47G4 antibody; and (b) a T cell signaling domain, for the prophylaxis and treatment of CD19positive malignancies.’’ DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before September 22, 2016 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, National Cancer Institute, 9609 Medical Center Drive, Rm. 1–E530 MSC9702, Rockville, MD 20850–9702, Email: david.lambertson@nih.gov. SUPPLEMENTARY INFORMATION: This invention concerns an anti-CD19 chimeric antigen receptor (CAR) and methods of using the CAR for the treatment of CD19-expressing cancers, including B cell malignancies. With regard to the proposed license, the CAR covered by the invention will be integrated into a genome-edited allogeneic (where the donor and PO 00000 Frm 00043 Fmt 4703 Sfmt 9990 recipient of the T cell are different individuals) T cell, and the resulting anti-CD19 CAR-expressing genomeedited allogeneic T cell will be introduced into a cancer patient to exhibit a therapeutic effect. CD19 is a cell surface antigen that is preferentially expressed on certain types of cancer cells, particularly cancers of B cell origin such as Non-Hodgkin’s Leukemia (NHL), acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). The anti-CD19 CARs of this technology contain (1) antigen recognition sequences that bind specifically to CD19 and (2) signaling domains that can activate the cytotoxic functions of a T cell. The anti-CD19 CAR can be integrated into genomeedited allogeneic T cells; from there, genome-edited allogeneic T cells expressing the anti-CD19 CAR are selected, expanded and then introduced into a patient. Once the anti-CD19 CARexpressing genome-edited allogeneic T cells are introduced into the patient, the T cells can selectively bind to CD19expressing cancer cells through its antigen recognition sequences, thereby activating the T cell through its signaling domains to selectively kill the cancer cells. Through this mechanism of action, the selectivity of the a CAR allows the T cells to kill cancer cells while leaving healthy, essential cells unharmed. This can result in an effective therapeutic strategy with fewer side effects due to less non-specific killing of cells. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, 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 404.7. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License Agreement. 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: August 31, 2016. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016–21366 Filed 9–6–16; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\07SEN1.SGM 07SEN1

Agencies

[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Pages 61703-61704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Notice of Office of Urban Indian Health Programs Strategic Plan

AGENCY: Indian Health Service, Department of Health and Human Services.

ACTION: Notice and request for comments.

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[[Page 61704]]

SUMMARY: Indian Health Service (IHS) has entered into a contract with 
the National Academy of Public Administration (the Academy) to assist 
in the development of a five-year strategic plan. Funding for this 
project was provided by Congress in the 2016 Consolidated 
Appropriations Act, which directs IHS to develop the plan in 
consultation with urban Indians and the Academy.
    As part of this project, the Academy project team is in the process 
of conducting extensive outreach to IHS/Office of Urban Indian Health 
Programs (OUIHP) leadership and employees, as well as conferring with 
urban Indian organizations and other key external stakeholder groups. 
The final product will be a strategic plan to guide the work of the 
headquarters office of OUIHP, area urban coordinators, and urban Indian 
organizations participating in IHS programs. The strategic plan will be 
completed by the end of December 2016.
    IHS is requesting input on the strategic planning process, the 
strengths and weaknesses of OUIHP, and the opportunities and threats 
facing the program. Comments will be used to help develop the mission, 
goals, objectives, and strategies to be included in the strategic plan.

DATES: Submit your input to the Academy no later than September 16, 
2016. All comments submitted to the Academy are not for attribution.
    Written Comments: Send input by email to UIOconfer@napawash.org 
with the subject line: UIHP Strategic Plan.

FOR FURTHER INFORMATION CONTACT: Pamela Haze, Project Director, 
National Academy of Public Administration, 1600 K St. NW., Suite 400, 
Washington, DC 20006, (201) 204-3682.

    Dated: August 26, 2016.
Elizabeth A. Fowler,
Deputy Director for Management Operations, Indian Health Service.
[FR Doc. 2016-21485 Filed 9-6-16; 8:45 am]
 BILLING CODE 4165-16-P