National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings, 66430-66431 [2019-26176]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 66430 Federal Register / Vol. 84, No. 233 / Wednesday, December 4, 2019 / Notices scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: During the morning session, the committee will discuss supplemental new drug application (sNDA) 208558/010 for LYNPARZA (olaparib) tablets, submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic adenocarcinoma of the pancreas whose disease has not progressed on first-line platinum-based chemotherapy. During the afternoon session, the committee will discuss supplemental biologics license application (sBLA) 125514/066 for KEYTRUDA (pembrolizumab) for injection, submitted by Merck Sharpe & Dohme Corp. The proposed indication (use) for this product is for the treatment of patients with bacillus Calmette-Gue´rinunresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. FDA regrets that it was unable to publish this notice 15 days prior to the Oncologic Drugs Advisory Committee due to technical issues. Because the Agency believes there is a need to bring these issues to public discussion and qualified members of the committee were available at this time and already scheduled to participate in the meeting, the Agency concluded that it was in the public interest to hold this meeting without the customary 15-day public notice. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the VerDate Sep<11>2014 21:17 Dec 03, 2019 Jkt 250001 Docket (see ADDRESSES) on or before December 10, 2019, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before December 5, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by December 6, 2019. Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Lauren Tesh Hotaki (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: November 29, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–26222 Filed 11–29–19; 4:15 pm] BILLING CODE 4164–01–P PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 amended, 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; PAR18–108 NIDDK Exploratory Clinical Trials for Small Business (R44). Date: December 9, 2019. Time: 1:00 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: Ann A. Jerkins, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7119, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–2242, jerkinsa@niddk.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK R44 Exploratory Clinical Trials in Kidney, Urology and Hematological Diseases. Date: December 17, 2019. Time: 11:30 a.m. to 3:30 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: Ann A. Jerkins, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7119, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–2242, jerkinsa@niddk.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. E:\FR\FM\04DEN1.SGM 04DEN1 Federal Register / Vol. 84, No. 233 / Wednesday, December 4, 2019 / Notices (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: November 27, 2019. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–26176 Filed 12–3–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF THE INTERIOR Bureau of Land Management [19X.LLUTW01000.L14400000.ET0000, UTU– 78501] Public Land Order No. 7887; Extension of Public Land Order No. 7422, Diamond Fork System, Bonneville Unit of the Central Utah Project; Utah Bureau of Land Management, Interior. ACTION: Public land order. AGENCY: This Public Land Order (PLO) extends the duration of the withdrawal created by PLO No. 7422 for an additional 20-year term. PLO No. 7422 would otherwise expire on December 20, 2019. This extension is necessary to prevent incompatible uses from affecting the operation of the Diamond Fork System of the Central Utah Project, which supports Utah’s use of Colorado River water for irrigation, municipal and industrial needs, hydroelectric power, conservation, and recreation. PLO No. 7422 withdrew approximately 2,795 acres of National Forest System lands from location and entry under the United States mining laws, but not from leasing under the mineral leasing laws. This Order corrects the acreage withdrawn from 2,795 acres to 2,714.22 acres with no change to the legal land description. The lands have been and will remain open to mineral leasing. DATES: This PLO takes effect on December 21, 2019. FOR FURTHER INFORMATION CONTACT: Allison Ginn, Assistant Field Manager, BLM Salt Lake Field Office, 801–977– 4300, or by email utslmail@blm.gov. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1–800– 877–8339 to reach the individual above. The FRS is available 24 hour a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:17 Dec 03, 2019 Jkt 250001 This Order extends the existing withdrawal to prevent incompatible uses from affecting the operation of the Diamond Fork System of the Central Utah Project, which supports Utah’s use of Colorado River water for irrigation, municipal and industrial needs, hydroelectric power, conservation, and recreation. SUPPLEMENTARY INFORMATION: Order By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, it is ordered as follows: 1. Subject to valid existing rights, PLO No. 7422, (64 FR 71467, (1999)), which withdrew National Forest System lands from location and entry under the United States mining laws, but not from leasing under the mineral leasing laws, is hereby extended for an additional 20year period to prevent incompatible uses from affecting the operation of the Diamond Fork System of the Central Utah Project. 2. The withdrawal extended by this Order will expire on December 20, 2039, unless as a result of a review conducted prior to the expiration date, pursuant to Section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f), the Secretary determines that the withdrawal shall be further extended. Dated: November 25, 2019. Timothy R. Petty, Assistant Secretary for Water and Science. [FR Doc. 2019–26212 Filed 12–3–19; 8:45 am] BILLING CODE 4310–HC–P DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLAZ920000.19X.L51010000. ER0000.LVRWA19A3240] Notice of Availability of the Record of Decision for the Ten West Link 500 Kilovolt Transmission Line Project and Land Use Plan Amendments to the Yuma Field Office Resource Management Plan and the California Desert Conservation Area Plan; Maricopa and La Paz Counties, Arizona, and Riverside County, California Bureau of Land Management, Interior. ACTION: Notice of availability. AGENCY: The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD) for the Ten West Link 500 Kilovolt Transmission Line Project and SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 66431 approved Resource Management Plan Amendments for the Yuma Field Office Resource Management Plan (RMP) and the California Desert Conservation Area (CDCA) Plan. The BLM Arizona and California State Directors signed the ROD on November 21, 2019. This constitutes the final decision of the BLM for the approved land use plan amendments and makes them effective immediately. ADDRESSES: Interested persons may review the ROD on the project website at: https://go.usa.gov/xU6Be. Copies of the ROD are available for public review upon request from the BLM Yuma Field Office, 7341 East 30th Street, Suite A, Yuma, AZ 85365, the BLM Arizona State Office, One North Central Avenue, Suite 800, Phoenix, AZ 85004, and the BLM Palm Springs-South Coast Field Office, 1201 Bird Center Drive, Palm Springs, CA 92262. FOR FURTHER INFORMATION CONTACT: Lane Cowger, Project Manager, telephone: 602–417–9612; address: BLM, Arizona State Office, One North Central Avenue, Suite 800, Phoenix, AZ 85004; email: blm_az_azso_10westlink@ blm.gov. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1–800–877–8339 to contact Mr. Cowger. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with Mr. Cowger. You will receive a reply during normal business hours. SUPPLEMENTARY INFORMATION: DCR Transmission submitted a request for a right-of-way (ROW) across public land to construct, operate, maintain, and decommission a 500 kilovolt (kV) transmission line between the Arizona Public Service Delaney substation near Tonopah, in Maricopa County, Arizona, and the Southern California Edison Colorado River Substation near Blythe in Riverside County, California. Portions of the Proposed Action and/or Action Alternatives were not in conformance with the Yuma RMP and the CDCA Plan. Therefore, the BLM considered amending these plans in connection with its consideration of the DCR Transmission ROW application. The BLM analyzed impacts from the proposed ROW project and associated plan amendments in the Final Environmental Impact Statement (EIS) for the proposed Ten West Link 500 Kilovolt Transmission Line Project and proposed Amendments to the Yuma Field Office RMP and the CDCA Plan released on September 13, 2019. Based on the environmental analysis and input from stakeholders, cooperating agencies, and tribes, the BLM has identified the E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 84, Number 233 (Wednesday, December 4, 2019)]
[Notices]
[Pages 66430-66431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26176]


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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 
amended, 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; PAR18-108 NIDDK 
Exploratory Clinical Trials for Small Business (R44).
    Date: December 9, 2019.
    Time: 1:00 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: Ann A. Jerkins, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7119, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 
594-2242, [email protected].

    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; NIDDK R44 Exploratory 
Clinical Trials in Kidney, Urology and Hematological Diseases.
    Date: December 17, 2019.
    Time: 11:30 a.m. to 3:30 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: Ann A. Jerkins, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7119, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 
594-2242, [email protected].

    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.


[[Page 66431]]


(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: November 27, 2019.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-26176 Filed 12-3-19; 8:45 am]
BILLING CODE 4140-01-P
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