81 FR 35786 - Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service Federal Register Volume 81, Issue 107 (June 3, 2016)
Indian Health Service
Federal Register Volume 81, Issue 107 (June 3, 2016)
| Page Range | 35786-35787 | |
| FR Document | 2016-13135 |
[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)] [Notices] [Pages 35786-35787] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13135] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service AGENCY: Indian Health Service (IHS), Department of Health and Human Services. ACTION: Notice of Tribal consultation and urban confer sessions on the state of the Great Plains Area IHS. ----------------------------------------------------------------------- SUMMARY: Notice is hereby given that the Indian Health Service will conduct a 90 day tribal consultation and urban confer regarding the State of the Great Plains Area IHS. The IHS will conduct two telephone tribal consultation and urban confer sessions on June 22, 2016 and August 10, 2016. The IHS will also conduct two on-site tribal consultation and urban confer sessions on July 13, 2016 in Aberdeen, South Dakota and on August 30, 2016 in Rapid City, South Dakota. DATES: The IHS will conduct two telephone Tribal consultation and urban confer sessions on June 22, 2016 and August 10, 2016. The IHS will also conduct two on-site Tribal consultation and urban confer sessions on July 13, 2016 in Aberdeen, South Dakota, and on August 30, 2016 in Rapid City, SD. The on-site meetings in Aberdeen and Rapid City, South Dakota will be conducted at the addresses noted below. Written comments must be received on or before September 1, 2016 at the address below. Conference Call Information: 1-800-369-1747; Pass Code: 1381519. ADDRESSES: The meetings will be held at The Dakota Event Center located at 720 Lamont Street, Aberdeen, South Dakota; and at the Rushmore Plaza Holiday Inn Convention Center located at 505 N. Fifth Street, Rapid City, SD 57701, during the 13th Annual Direct Service Tribes National Meeting. [[Page 35787]] Written Comments: For Tribes: [email protected]. For Urbans: [email protected]. FOR FURTHER INFORMATION CONTACT: CAPT Chris Buchanan, Acting Director, Great Plains Area, Indian Health Service, 115 4th Ave. SE Suite 309 Aberdeen, South Dakota, (605) 226-7584, Fax (605) 226-7541. SUPPLEMENTARY INFORMATION: These meetings are in follow-up to the April 5-7, 2016 IHS Tribal Leaders Briefing in Sioux Falls, South Dakota. The IHS would like to invite the Great Plains Area Tribal Leaders to participate in formal consultation and interested urban Indian organizations to confer with IHS leadership to discuss the state of the Great Plains Area IHS. The purpose of these sessions are to receive feedback on the organization of the IHS Great Plains Area Office in an effort to continue to become more patient-focused in order to better meet the needs of the American Indians in the Great Plains Area. Specific topics will include geographic location of the Great Plains Area Office, centralization or further decentralization of area office services, staffing, budget, local involvement, transparency and oversight, partnerships, accountability, and monitoring. Tribal leaders and designated representatives as well as urban Indian organizations that are interested in submitting written testimony for the on-site or telephonic consultation and urban confer sessions can provide written comments to the following: For Tribes_ [email protected]. For Urbans_[email protected]. The Tribal consultation and urban confer sessions will be conducted with elected or appointed leaders of Tribal governments and their designated representatives [42 U.S.C. 9835, Section 640(l)(4)(A)], and recognized representatives from urban Indian organizations, as defined by 25 U.S.C. 1603(29). Representatives from other Tribal organizations and Native non-profit organizations are welcome to attend as observers. Those wishing to participate in the discussions must have a copy of a letter signed by an elected or appointed official or their designee, which authorizes them to serve as a representative of the Tribe. This should be submitted no later than three days in advance of the Tribal consultation and urban confer session to CAPT Chris Buchanan at (605) 226-7541 (fax). A detailed report of all written comments and comments received through the Tribal consultation and urban confer sessions will be prepared and made available within 90 days of the close of the comment period to all Tribal governments and interested urban Indian organizations within the Great Plains Area. Dated: May 27, 2016. Mary Smith, Principal Deputy Director, Indian Health Service. [FR Doc. 2016-13135 Filed 6-2-16; 8:45 am] BILLING CODE 4165-16-P
![35786 Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices
the related densitometry measurements research, any institution employing her (5) As a condition of the Agreement,
based on the falsified Western blots, and shall ensure that a plan for supervision Respondent agreed to the retraction of
falsified and/or fabricated data for of her duties is submitted to ORI for the JBC 2010 publication.
experiments that were not performed or approval. The supervision plan must be FOR FURTHER INFORMATION CONTACT:
from unrelated experiments. designed to ensure the scientific Director, Office of Research Integrity,
Specifically, Respondent falsified integrity of Respondent’s PHS- 1101 Wootton Parkway, Suite 750,
and/or fabricated data in the following: supported research contribution and Rockville, MD 20852, (240) 453–8200.
• R01 HL107949–01 for: include the specific elements as
D Figure 1B for Western blots of a- outlined below. Respondent agreed that Kathryn M. Partin,
smooth muscle actin (a-SMA), she shall not participate in any PHS- Director, Office of Research Integrity.
Vimentin, Collagen I and supported research until such a [FR Doc. 2016–13072 Filed 6–2–16; 8:45 am]
Glyceraldehyde 3-Phosphate supervision plan is submitted to and BILLING CODE 4150–31–P
Dehydrogenase (GAPDH) expression approved by ORI. Respondent agreed to
in human cardiac fibroblasts isolated maintain responsibility for compliance
from failing left ventricles (HF) and with the agreed upon supervision plan. DEPARTMENT OF HEALTH AND
non-failing heart controls (CF) (2) The requirements for Respondent’s HUMAN SERVICES
D Figure 2A for Western blots of G supervision plan are as follows:
protein-coupled receptor kinase-2 i. A committee of senior faculty Indian Health Service
(GRK2) and GAPDH expression in HF members and officials at the institution
who are familiar with Respondent’s Notice of Tribal Consultation and
and CF, and the related densitometric Urban Confer Sessions on the State of
field of research, but not including
analysis the Great Plains Area Indian Health
Respondent’s supervisor or
• JBC 2011 for: Service
collaborators, will provide oversight and
D Figure 1A for a Western blot of
guidance for two (2) years beginning on
Vimentin expression in HF and CF, AGENCY: Indian Health Service (IHS),
May 6, 2016. The committee will review
and the related densitometric analysis Department of Health and Human
PHS-supported primary data from
D Figures 1D and 2D for Western blots Services.
Respondent and submit a report to ORI
of GAPDH expression in HF and CF, ACTION: Notice of Tribal consultation
at six (6) month intervals, setting forth
and the related densitometric analyses and urban confer sessions on the state
the committee meeting dates,
• JBC 2010 for: of the Great Plains Area IHS.
Respondent’s compliance with
D Figure 7A for Western blots of
appropriate research standards, and
phosphorylated Rhodopsin (Rho) and SUMMARY: Notice is hereby given that
confirming the integrity of Respondent’s
GRK2 expression in non-transgenic the Indian Health Service will conduct
PHS-supported research.
(NTG) (lanes 1–4) and Protein Kinase ii. The committee will conduct an a 90 day tribal consultation and urban
Ca cardiac-specific activation advance review of any PHS grant confer regarding the State of the Great
(PKCaAC) transgenic (lanes 5–6) application (including supplements, Plains Area IHS. The IHS will conduct
mice, and Figure 7B for the related resubmissions, etc.), manuscripts two telephone tribal consultation and
densitometric analysis reporting PHS-funded research urban confer sessions on June 22, 2016
• GC2006, Figure 7, HP2010, Figure 5, submitted for publication, and abstracts. and August 10, 2016. The IHS will also
and CR2009, Slide 15 for: The review will include a discussion conduct two on-site tribal consultation
D Western blots of phosphorylated Rho with Respondent of the primary data and urban confer sessions on July 13,
and GRK2 expression in NTG and represented in those documents and 2016 in Aberdeen, South Dakota and on
PKCaAC transgenic mice, and the will include a certification that the data August 30, 2016 in Rapid City, South
related densitometric analysis presented in the proposed application/ Dakota.
• HP2010 for: publication is supported by the research
D Figure 5 for a Western blot of GRK2 DATES: The IHS will conduct two
record. telephone Tribal consultation and urban
expression in NTG and PKCaAC (3) Respondent agreed that for two (2)
transgenic mice, and the related confer sessions on June 22, 2016 and
years beginning on May 6, 2016, any
densitometric analysis August 10, 2016. The IHS will also
institution employing her shall submit,
Dr. D’Souza has entered into a conduct two on-site Tribal consultation
in conjunction with each application for
Voluntary Settlement Agreement with and urban confer sessions on July 13,
PHS funds, or report, manuscript, or
ORI, in which she voluntarily agreed to 2016 in Aberdeen, South Dakota, and on
abstract involving PHS-supported
the administrative actions set forth August 30, 2016 in Rapid City, SD.
research in which Respondent is
below: involved, a certification to ORI at that The on-site meetings in Aberdeen and
(1) Respondent agreed that for two (2) the data provided by Respondent are Rapid City, South Dakota will be
years beginning on May 6, 2016, any based on actual experiments or are conducted at the addresses noted below.
institution employing her shall submit otherwise legitimately derived and that Written comments must be received on
in conjunction with each application for the data, procedures, and methodology or before September 1, 2016 at the
U.S. Public Health Service (PHS) funds, are accurately reported in the address below.
or report, manuscript, or abstract application, report, manuscript, or Conference Call Information: 1–800–
involving PHS-supported research in abstract. 369–1747; Pass Code: 1381519.
which Respondent is involved, a (4) Respondent agreed to exclude ADDRESSES: The meetings will be held at
mstockstill on DSK3G9T082PROD with NOTICES
supervision plan to ORI. Respondent herself voluntarily from serving in any The Dakota Event Center located at 720
agreed that prior to the submission of an advisory capacity to PHS including, but Lamont Street, Aberdeen, South Dakota;
application for PHS support for a not limited to, service on any PHS and at the Rushmore Plaza Holiday Inn
research project on which the advisory committee, board, and/or peer Convention Center located at 505 N.
Respondent’s participation is proposed review committee, or as a consultant for Fifth Street, Rapid City, SD 57701,
and prior to Respondent’s participation a period of two (2) years, beginning on during the 13th Annual Direct Service
in any capacity on PHS-supported May 6, 2016. Tribes National Meeting.
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![Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices 35787
Written Comments: For Tribes: the close of the comment period to all eliminate the cells which they recognize
consultation@ihs.gov. Tribal governments and interested via the antibody binding fragment of the
For Urbans: urbanconfer@ihs.gov. urban Indian organizations within the CAR. By engineering a T-cell to express
FOR FURTHER INFORMATION CONTACT: Great Plains Area. a CAR that is specific for a certain cell
CAPT Chris Buchanan, Acting Director, Dated: May 27, 2016. surface protein, it is possible to
Great Plains Area, Indian Health Mary Smith, selectively target those cells for
Service, 115 4th Ave. SE Suite 309 Principal Deputy Director, Indian Health
destruction. This is a promising new
Aberdeen, South Dakota, (605) 226– Service. therapeutic approach known as
7584, Fax (605) 226–7541. [FR Doc. 2016–13135 Filed 6–2–16; 8:45 am]
adoptive cell therapy.
SUPPLEMENTARY INFORMATION: These BILLING CODE 4165–16–P CD276 (a.k.a., B7–H3) is a tumor-
meetings are in follow-up to the April associated antigen that is expressed on
5–7, 2016 IHS Tribal Leaders Briefing in the cell surface of several cancers,
Sioux Falls, South Dakota. The IHS DEPARTMENT OF HEALTH AND including neuroblastomas, prostate
would like to invite the Great Plains HUMAN SERVICES cancer, ovarian cancer and some lung
Area Tribal Leaders to participate in cancers. This technology concerns the
formal consultation and interested National Institutes of Health development of CARs comprising an
urban Indian organizations to confer antigen-binding fragment derived from
Government-Owned Inventions; the MGA271 antibody. The resulting
with IHS leadership to discuss the state
Availability for Licensing CARs can be used in adoptive cell
of the Great Plains Area IHS.
The purpose of these sessions are to AGENCY: National Institutes of Health, therapy treatment for neuroblastoma
receive feedback on the organization of HHS. and other tumors which express CD276.
the IHS Great Plains Area Office in an ACTION: Notice. Potential Commercial Applications:
effort to continue to become more • Treatment of cancers associated
patient-focused in order to better meet SUMMARY: The invention listed below is
with expression of CD276.
the needs of the American Indians in owned by an agency of the U.S.
Government and is available for • Specific cancers include
the Great Plains Area. Specific topics
licensing and/or co-development in the neuroblastoma, prostate cancer, ovarian
will include geographic location of the
U.S. in accordance with 35 U.S.C. 209 cancer, lung cancer and other solid
Great Plains Area Office, centralization
and 37 CFR part 404 to achieve tumors.
or further decentralization of area office
services, staffing, budget, local expeditious commercialization of Value Proposition:
involvement, transparency and results of federally-funded research and • MGA271 is a well characterized
oversight, partnerships, accountability, development. Foreign patent anti-CD276 antibody, making it a known
and monitoring. applications are filed on selected quantity regarding safety issues.
Tribal leaders and designated inventions to extend market coverage • High affinity of the MGA271
representatives as well as urban Indian for companies and may also be available antibody for CD276 increases the
organizations that are interested in for licensing and/or co-development. likelihood of successful targeting.
submitting written testimony for the on- ADDRESSES: Invention Development and
• Targeted therapy decreases non-
site or telephonic consultation and Marketing Unit, Technology Transfer specific killing of healthy, essential
urban confer sessions can provide Center, National Cancer Institute, 9609 cells, resulting in fewer non-specific
written comments to the following: For Medical Center Drive, Mail Stop 9702, side-effects and healthier patients.
Tribes—consultation@ihs.gov. For Rockville, MD 20850–9702.
Development Stage: Discovery (Lead
Urbans—urbanconfer@ihs.gov. FOR FURTHER INFORMATION CONTACT:
ID).
The Tribal consultation and urban Information on licensing and co-
confer sessions will be conducted with development research collaborations, Inventor(s): Crystal Mackall.
elected or appointed leaders of Tribal and copies of the U.S. patent Intellectual Property: HHS No. E–243–
governments and their designated applications listed below, may be 2015/0–US–01 U.S. Provisional
representatives [42 U.S.C. 9835, Section obtained by contacting: Attn. Invention Application 62/216,447 (E–243–2015/0–
640(l)(4)(A)], and recognized Development and Marketing Unit, US–01) filed 9/10/2015 titled ‘‘Anti-
representatives from urban Indian Technology Transfer Center, National CD276 Chimeric Antigen Receptors’’.
organizations, as defined by 25 U.S.C. Cancer Institute, 9609 Medical Center Publications: None applicable.
1603(29). Representatives from other Drive, Mail Stop 9702, Rockville, MD Collaboration Opportunity:
Tribal organizations and Native non- 20850–9702, Tel. 240–276–5515 or Researchers at the NCI seek licensing for
profit organizations are welcome to email ncitechtransfer@mail.nih.gov. A chimeric antigen receptors to CD276 for
attend as observers. Those wishing to signed Confidential Disclosure treating cancer.
participate in the discussions must have Agreement may be required to receive Contact Information: Requests for
a copy of a letter signed by an elected copies of the patent applications. copies of the patent application or
or appointed official or their designee, SUPPLEMENTARY INFORMATION: inquiries about licensing, research
which authorizes them to serve as a Technology description follows. collaborations, and co-development
representative of the Tribe. This should Title of invention: Chimeric Antigen opportunities should be sent to John D.
be submitted no later than three days in Receptors to CD276 for treating Cancer. Hewes, Ph.D., email:
advance of the Tribal consultation and Description of Technology: Chimeric
mstockstill on DSK3G9T082PROD with NOTICES
john.hewes@nih.gov.
urban confer session to CAPT Chris antigen receptors (CARs) are hybrid
Buchanan at (605) 226–7541 (fax). proteins consisting of an antibody Dated: May 31, 2016.
A detailed report of all written binding fragment fused to protein John D. Hewes,
comments and comments received signaling domains that cause T-cells Technology Transfer Specialist, Technology
through the Tribal consultation and which express the CAR to become Transfer Center, National Cancer Institute.
urban confer sessions will be prepared cytotoxic. Once activated, these [FR Doc. 2016–13112 Filed 6–2–16; 8:45 am]
and made available within 90 days of cytotoxic T-cells can selectively BILLING CODE 4140–01–P
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Document Created: 2018-02-08 07:29:53
Document Modified: 2018-02-08 07:29:53
| 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 of Tribal consultation and urban confer sessions on the state of the Great Plains Area IHS. | |
| Dates | The IHS will conduct two telephone Tribal consultation and urban confer sessions on June 22, 2016 and August 10, 2016. The IHS will also conduct two on-site Tribal consultation and urban confer sessions on July 13, 2016 in Aberdeen, South Dakota, and on August 30, 2016 in Rapid City, SD. | |
| Contact | CAPT Chris Buchanan, Acting Director, Great Plains Area, Indian Health Service, 115 4th Ave. SE Suite 309 Aberdeen, South Dakota, (605) 226-7584, Fax (605) 226-7541. | |
| FR Citation | 81 FR 35786 |
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