81 FR 61703 - Notice of Office of Urban Indian Health Programs Strategic Plan
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service Federal Register Volume 81, Issue 173 (September 7, 2016)
Indian Health Service
Federal Register Volume 81, Issue 173 (September 7, 2016)
| Page Range | 61703-61704 | |
| FR Document | 2016-21485 |
[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)] [Notices] [Pages 61703-61704] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21485] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- [[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 [email protected] 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
![Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61703
An Internal Journal for Rapid Request (ICR), described below, to the and Budget (OMB) approval on a new
Communication of Synthetic Organic Office of Management and Budget (ICR). This survey is being conducted to
Chemistry, vol. 24, no. 6, 1994. (OMB). Prior to submitting the ICR to generate national estimates of recovery
7. U.S. Patent and Trademark Office,
‘‘Process of Preparation of Vincamine from
OMB, OS seeks comments from the through utilization activity; of donated
Tabersonine.’’ Retrieved from: http:// public regarding the burden estimate human tissue for calendar years 2012
www.google.com/patents/US3892755. below or any other aspect of the ICR. and 2015, and to compare metrics across
Prior to submitting the ICR to OMB, OS three data collection periods that
Dated: August 31, 2016. seeks comments from the public includes results from a 2007 survey, the
Leslie Kux, regarding the burden estimate, below, or most recent year these data were
Associate Commissioner for Policy. any other aspect of the ICR. collected. The survey and data
[FR Doc. 2016–21350 Filed 9–6–16; 8:45 am] DATES: Comments on the ICR must be collection and analysis methods will be
BILLING CODE 4164–01–P received on or before [November 7, similar to the 2007 survey. The general
2016]. categories of information to be collected
ADDRESSES: Submit your comments to are listed under the Survey Section of
DEPARTMENT OF HEALTH AND the Annualized Burden Hour table
HUMAN SERVICES Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162. below. Policy advice provided by the
Office of the Secretary FOR FURTHER INFORMATION CONTACT:
HHS Advisory Committee on Blood and
Information Collection Clearance staff, Tissue Safety and Availability to the
[Document Identifier: HHS–OS–0990–new– HHS Secretary and Assistant Secretary
60D] Information.CollectionClearance@
hhs.gov or (202) 690–6162. for Health is used to direct departmental
Agency Information Collection efforts to address transfusion and
SUPPLEMENTARY INFORMATION: When
Activities; Proposed Collection; Public transplantation issues; such as
submitting comments or requesting
Comment Request emergency preparedness and infectious
information, please include the
document identifier HHS–OS–0990– disease transmission related to donated
AGENCY: Office of the Secretary, HHS. human tissue.
ACTION: Notice. new–60D for reference.
Information Collection Request Title: Likely Respondents: Respondents for
SUMMARY: In compliance with section National Tissue Recovery through this survey would be U.S. tissue banks
3506(c)(2)(A) of the Paperwork Utilization Survey. that screen and recover tissue from
Reduction Act of 1995, the Office of the Abstract: Office of HIV/AIDS and living and deceased donors, and
Secretary (OS), Department of Health Infectious Disease Policy, Office of the process, store, and/or distribute tissues
and Human Services, announces plans Assistant Secretary for Health, grafts for transplantation from these
to submit a new Information Collection requesting the Office of Management donors.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per Total burden
Survey section Type of respondent respondents per response hours
respondent (in hours)
Tissue bank activities, tissue types All tissue banks ................................ 110 5 5/60 46
handled, and inspections.
Referrals, authorization, and in- Tissue banks that handle referrals, 80 36 30/60 1440
formed consent; tissue recovery Recover/acquire tissue.
and acquisition.
Tissue processing ............................. Tissue banks that process tissue .... 35 17 30/60 298
Tissue storage .................................. Tissue banks that store tissue ......... 65 4 10/60 5
Tissue distribution ............................. Tissue banks that distribute tissue .. 58 16 15/60 232
Communicable disease testing and Tissue banks that have donor infec- 35 4 30/60 70
adverse outcome reports. tious disease testing performed
and may handle adverse outcome
reports.
Total ........................................... ........................................................... ........................ ........................ ........................ 2091
OS specifically requests comments on technology to minimize the information DEPARTMENT OF HEALTH AND
(1) the necessity and utility of the collection burden. HUMAN SERVICES
proposed information collection for the
Terry S. Clark, Indian Health Service
proper performance of the agency’s
functions, (2) the accuracy of the Asst Information Collection Clearance
Officer. Notice of Office of Urban Indian Health
estimated burden, (3) ways to enhance
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–21360 Filed 9–6–16; 8:45 am] Programs Strategic Plan
the quality, utility, and clarity of the
information to be collected, and (4) the BILLING CODE 4150–28–P
AGENCY: Indian Health Service,
use of automated collection techniques Department of Health and Human
or other forms of information Services.
Notice and request for
ACTION:
comments.
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![61704 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices
SUMMARY: Indian Health Service (IHS) SUMMARY: This notice, in accordance recipient of the T cell are different
has entered into a contract with the with 35 U.S.C. 209 and 37 CFR part 404, individuals) T cell, and the resulting
National Academy of Public that the National Institutes of Health, anti-CD19 CAR-expressing genome-
Administration (the Academy) to assist Department of Health and Human edited allogeneic T cell will be
in the development of a five-year Services, is contemplating the grant of introduced into a cancer patient to
strategic plan. Funding for this project an exclusive patent license to practice exhibit a therapeutic effect. CD19 is a
was provided by Congress in the 2016 the inventions embodied in the cell surface antigen that is preferentially
Consolidated Appropriations Act, following Patents and Patent expressed on certain types of cancer
which directs IHS to develop the plan Applications and all continuing U.S. cells, particularly cancers of B cell
in consultation with urban Indians and and foreign patents/patent applications origin such as Non-Hodgkin’s Leukemia
the Academy. to Sangamo BioSciences, Inc. located in (NHL), acute lymphoblastic leukemia
As part of this project, the Academy Richmond, California, USA: (ALL) and chronic lymphocytic
project team is in the process of leukemia (CLL). The anti-CD19 CARs of
conducting extensive outreach to IHS/ Intellectual Property this technology contain (1) antigen
Office of Urban Indian Health Programs U.S. Provisional Patent Application recognition sequences that bind
(OUIHP) leadership and employees, as 62/006,313, filed 2 June 2014 and specifically to CD19 and (2) signaling
well as conferring with urban Indian entitled ‘‘Chimeric Antigen Receptors domains that can activate the cytotoxic
organizations and other key external Targeting CD–19’’ [HHS Ref. E–042– functions of a T cell. The anti-CD19
stakeholder groups. The final product 2014/0–US–01]; and PCT Patent CAR can be integrated into genome-
will be a strategic plan to guide the Application PCT/US2015/033473, filed edited allogeneic T cells; from there,
work of the headquarters office of 1 June 2015 and entitled ‘‘Chimeric genome-edited allogeneic T cells
OUIHP, area urban coordinators, and Antigen Receptors Targeting CD–19’’ expressing the anti-CD19 CAR are
urban Indian organizations participating [HHS Ref. E–042–2014/0–PCT–02]. selected, expanded and then introduced
in IHS programs. The strategic plan will The patent rights in these inventions into a patient. Once the anti-CD19 CAR-
be completed by the end of December have been assigned and/or exclusively expressing genome-edited allogeneic T
2016. licensed to the Government of the cells are introduced into the patient, the
IHS is requesting input on the United States of America. T cells can selectively bind to CD19-
strategic planning process, the strengths The prospective exclusive license expressing cancer cells through its
and weaknesses of OUIHP, and the territory may be worldwide and the antigen recognition sequences, thereby
opportunities and threats facing the field of use may be limited to the use activating the T cell through its
program. Comments will be used to help of Licensed Patent Rights for the signaling domains to selectively kill the
develop the mission, goals, objectives, following: ‘‘The integration of a cancer cells. Through this mechanism of
and strategies to be included in the monospecific anti-CD19 chimeric action, the selectivity of the a CAR
strategic plan. antigen receptor (CAR) into genome- allows the T cells to kill cancer cells
DATES: Submit your input to the edited, allogeneic T cells (where the while leaving healthy, essential cells
Academy no later than September 16, donor and recipient are different), unharmed. This can result in an
2016. All comments submitted to the where the monospecific CAR has at effective therapeutic strategy with fewer
Academy are not for attribution. least: (a) The complementary side effects due to less non-specific
Written Comments: Send input by determining region (CDR) sequences of killing of cells.
email to UIOconfer@napawash.org with the anti-CD19 47G4 antibody; and (b) a The prospective exclusive license will
the subject line: UIHP Strategic Plan. T cell signaling domain, for the be royalty bearing and will comply with
FOR FURTHER INFORMATION CONTACT: prophylaxis and treatment of CD19- the terms and conditions of 35 U.S.C.
Pamela Haze, Project Director, National positive malignancies.’’ 209 and 37 CFR part 404.7. The
Academy of Public Administration, DATES: Only written comments and/or prospective exclusive license may be
1600 K St. NW., Suite 400, Washington, applications for a license which are granted unless within fifteen (15) days
DC 20006, (201) 204–3682. received by the NIH Office of from the date of this published notice,
Technology Transfer on or before the NIH receives written evidence and
Dated: August 26, 2016.
September 22, 2016 will be considered. argument that establishes that the grant
Elizabeth A. Fowler, of the license would not be consistent
ADDRESSES: Requests for copies of the
Deputy Director for Management Operations, with the requirements of 35 U.S.C. 209
Indian Health Service. patent application, inquiries, comments,
and other materials relating to the and 37 CFR part 404.7.
[FR Doc. 2016–21485 Filed 9–6–16; 8:45 am] Complete applications for a license in
contemplated exclusive license should
BILLING CODE 4165–16–P
be directed to: David A. Lambertson, the prospective field of use that are filed
Ph.D., Senior Licensing and Patenting in response to this notice will be treated
Manager, National Cancer Institute, as objections to the grant of the
DEPARTMENT OF HEALTH AND contemplated Exclusive Patent License
HUMAN SERVICES 9609 Medical Center Drive, Rm. 1–E530
MSC9702, Rockville, MD 20850–9702, Agreement. Comments and objections
Email: david.lambertson@nih.gov. submitted to this notice will not be
National Institutes of Health made available for public inspection
SUPPLEMENTARY INFORMATION: This
Prospective Grant of Exclusive Patent and, to the extent permitted by law, will
invention concerns an anti-CD19
License: The Development of an Anti- not be released under the Freedom of
chimeric antigen receptor (CAR) and
mstockstill on DSK3G9T082PROD with NOTICES
CD19 Chimeric Antigen Receptor Information Act, 5 U.S.C. 552.
methods of using the CAR for the
(CAR) for the Treatment of Human treatment of CD19-expressing cancers, Dated: August 31, 2016.
Cancers including B cell malignancies. With Richard U. Rodriguez,
regard to the proposed license, the CAR Associate Director, Technology Transfer
AGENCY: National Institutes of Health,
covered by the invention will be Center, National Cancer Institute.
HHS.
integrated into a genome-edited [FR Doc. 2016–21366 Filed 9–6–16; 8:45 am]
ACTION: Notice.
allogeneic (where the donor and BILLING CODE 4140–01–P
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Document Created: 2016-09-07 11:50:39
Document Modified: 2016-09-07 11:50:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice and request for comments. | |
| Dates | Submit your input to the Academy no later than September 16, 2016. All comments submitted to the Academy are not for attribution. | |
| Contact | Pamela Haze, Project Director, National Academy of Public Administration, 1600 K St. NW., Suite 400, Washington, DC 20006, (201) 204-3682. | |
| FR Citation | 81 FR 61703 |
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