National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings, 62912-62913 [2016-21895]

Download as PDF 62912 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices evaluation nor programmatic purposes. HRSA also added questions to the 3Ps Information Form to allow the Form to be used as an all-inclusive data collection instrument for MCHB and Healthy Start grantees. The additional questions extend and refine previously approved content, allowing for the collection of more granular and/or indepth information on existing topics. Adding these questions allows Healthy Start grantees to better assess risk, identify needed services, provide appropriate follow-up activities to program participants, and improve overall service delivery and quality. Need and Proposed Use of the Information: The purpose of the data collection instruments is to obtain consistent information across all grantees about Healthy Start and its outcomes. The data will be used to: (1) Conduct ongoing performance monitoring of the program; (2) provide credible and rigorous evidence of program effect on outcomes; (3) assess the relative contribution of the five program approaches to individual and community-level outcomes; (4) meet program needs for accountability, programmatic decision-making, and ongoing quality assurance; and (5) strengthen the evidence-base, and identify best and promising practices for the program to support sustainability, replication, and dissemination of the program. Likely Respondents: Respondents include project directors and staff for the National Healthy Start Program Survey; representatives from partner organizations for the Community Action Network Survey; program staff, providers, and partners for the Healthy Start Site Visit Protocol; and program participants for the Healthy Start Participant Focus Group Protocol. Respondents for the redesigned 3Ps Information Form (i.e., (1) Demographic Intake; (2) Pregnancy Status/History; (3) Preconception; (4) Prenatal; (5) Postpartum; and (6) Interconception/ Parenting) are pregnant women and women of reproductive age who are served by the Healthy Start Program. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours 3Ps Information Form: 1. Demographic Intake Form ........................................ 2. Pregnancy Status/History ......................................... 3. Preconception ........................................................... 4. Prenatal .................................................................... 5. Postpartum ............................................................... 6. Interconception/Parenting ......................................... National Healthy Start Program Web Survey ...................... CAN member Web Survey .................................................. Healthy Start Site Visit Protocol .......................................... Healthy Start Participant Focus Group Protocol ................. * + 40,675 40,675 * + 20,337 20,337 20,337 20,337 + 100 + 225 + 15 + 180 1 1 1 1 1 1 1 1 1 1 40,675 40,675 20,337 20,337 20,337 20,337 100 225 15 180 0.08 0.17 1.00 1.00 1.00 1.00 2.00 0.75 6.00 1.00 3,254 6,915 20,337 20,337 20,337 20,337 200 169 90 180 Total .............................................................................. 61,532 ........................ 61,532 ........................ 92,156 * The same individuals (40,675) complete the Demographic Intake and Pregnancy Status/History forms, and a subset of these same individuals (20,337) also complete the Preconception, Prenatal, Postpartum, and Interconception/Parenting forms for total of 61,532 respondents and responses. + These are the numbers included in the total respondent count. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016–21889 Filed 9–12–16; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Lhorne on DSK30JT082PROD with NOTICES National Institutes of Health Office of the Director Notice of Charter Renewal In accordance with Title 41 of the U.S. Code of Federal Regulations, Section 102–3.65(a), notice is hereby given that the Charter for the Fogarty International Center Advisory Board VerDate Sep<11>2014 15:27 Sep 12, 2016 Jkt 238001 was renewed for an additional two-year period on August 31, 2016. It is determined that the Fogarty International Center Advisory Board is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed through the advice and counsel of this group. Inquiries may be directed to Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail code 4875), Telephone (301) 496– 2123, or spaethj@od.nih.gov. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Dated: September 6, 2016. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2016–21899 Filed 9–12–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\13SEN1.SGM 13SEN1 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices 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. Lhorne on DSK30JT082PROD with NOTICES Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Cell Replacement Technology for Type 1 Diabetes (SBIR). Date: October 4, 2016. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Thomas A. Tatham, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7021, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–3993, tathamt@mail.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK Ancillary Studies (R01). Date: October 27, 2016. Time: 11:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jason D. Hoffert, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7343, 6707 Democracy Boulevard, Bethesda, MD 20817, 301–496–9010, hoffertj@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: September 7, 2016. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–21895 Filed 9–12–16; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 15:27 Sep 12, 2016 Jkt 238001 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 invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development. ADDRESSES: Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850–9702. FOR FURTHER INFORMATION CONTACT: Information on licensing and codevelopment research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850–9702, Tel. 240–276–5515 or email ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. Title of invention: Analogues of Withanolide E Sensitize Cancer Cells to Apoptosis. Keywords: TRAIL, TLR3, apoptosis, immunotherapy, tumor necrosis factor, TNF. Description of Technology: The tumor necrosis factor (TNF)-related apoptosisinducing ligand (TRAIL) protein has been a target of interest in cancer therapy because it plays a large role in inducing cell apoptosis in cancer cells but not in normal cells. Although TRAIL has been reported to successfully target certain tumor cells which are resistant to traditional chemotherapy or radiation, TRAIL resistance has also been widely observed. Similarly, Tolllike receptor (TLR) 3 ligands such as poly I:C have also been reported to promote apoptosis in certain cancer cells, though the apoptotic signaling in SUMMARY: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 62913 most cancer cells was weak and was only significant following longer term incubations. Thus, there is a need to develop compounds that can sensitize cancer cells to apoptosis inducing ligands, such as poly I:C and TRAIL. In collaboration with the University of Arizona, NCI investigators have discovered a series of compounds in the withanolide family that synergistically enhance the response of cancer cells to treatment with an apoptosis-inducing ligand. The compounds each show a 4to 10-fold increase in potency compared to withanolide E alone in promoting death ligand-mediated cancer cell death. One biotinylated analogue in particular is at least 15-fold more potent than withanolide E in promoting apoptosis in human melanoma cells when used in combination with either poly I:C or TRAIL. A selection of active compounds were tested in murine xenograft models of human melanoma and showed decreased tumor growth and tumor regression. Potential Commercial Applications • Potential therapeutic for the treatment of cancer either alone or in combination with an apoptosis inducing agent such as TRAIL receptor or TLR 3 agonists by directly promoting tumor cell apoptosis. • Possible indirect enhancement of cancer immunotherapy due to release of cancer cell antigens in the presence of the powerful immune-adjuvant effects of TLR3 agonists. Value Proposition • Withanolide E derivatives enhance the anti-cancer activity of known apoptosis inducing ligands such as TRAIL or poly I:C and may be used to enhance efficacy of TRAIL receptor or poly I:C agonists that are currently under development. Development Stage: Pre-clinical (in vivo validation). Inventor(s): Thomas Sayers (NCI), Alan Brooks (NCI), Curtis Henrich (NCI), Poonam Tewary (NCI), James McMahon (NCI), Leslie Gunatilaka (University of Arizona), Ya-ming Xu (University of Arizona), and E.M. Kithsiri Wijeratne (University of Arizona). Intellectual Property: US Provisional Application No. 62/292,974, entitled ‘‘Method of Sensitizing Cancer Cells to The Cytotoxic Effects of Apoptosis Inducing Ligands in Cancer Treatment,’’ filed February 9, 2016. Publications 1. Tewary P., Gunatilaka A.A. and Sayers T.J. (2016) Using natural products to promote caspase-8- E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62912-62913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21895]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Diabetes and Digestive and Kidney Diseases; 
Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as

[[Page 62913]]

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 Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; Cell Replacement 
Technology for Type 1 Diabetes (SBIR).
    Date: October 4, 2016.
    Time: 12:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Thomas A. Tatham, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7021, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 
594-3993, tathamt@mail.nih.gov.

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; NIDDK Ancillary Studies 
(R01).
    Date: October 27, 2016.
    Time: 11:00 a.m. to 12:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Jason D. Hoffert, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7343, 6707 Democracy Boulevard, Bethesda, MD 20817, 301-496-
9010, hoffertj@niddk.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.847, 
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive 
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology 
and Hematology Research, National Institutes of Health, HHS)

    Dated: September 7, 2016.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-21895 Filed 9-12-16; 8:45 am]
 BILLING CODE 4140-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.