National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings, 42104-42105 [2017-18806]

Download as PDF asabaliauskas on DSKBBXCHB2PROD with NOTICES 42104 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices treatment of Attention Deficit Hyperactivity Disorder (ADHD). In a letter dated March 23, 2016, Novartis notified FDA that RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, were being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Abhai, LLC, submitted a citizen petition dated April 19, 2017 (Docket No. FDA–2017–P–2496), under 21 CFR 10.30, requesting that the Agency determine whether RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records, and based on the information we have at this time, FDA has determined under § 314.161 that RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. VerDate Sep<11>2014 17:37 Sep 05, 2017 Jkt 241001 Dated: August 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–18817 Filed 9–5–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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 on Aging Initial Review Group; Clinical Aging Review Committee. Date: October 5–6, 2017. Time: 3:30 p.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. Contact Person: Alicja L. Markowska, Ph.D., DSC, National Institute on Aging, National Institutes of Health, Gateway Building 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301–496–9666, markowsa@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: August 30, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–18805 Filed 9–5–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Advisory Board, September 12, 2017, 1:00 p.m. to September 12, 2017, 4:00 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 p.m., National Cancer Institute—Shady Grove, 9609 Medical Center Drive, Conference Room TE406 and TE408, Rockville, MD, 20850 (Virtual Meeting) which was published in the Federal Register on August 14, 2017, 82 FR 37885. The meeting notice is amended to change the times of the open and closed sessions. The open session will end at 2:15 p.m. The closed session will begin at 2:30 p.m. and end at 3:30 p.m. The meeting is partially closed to the public. Dated: August 30, 2017. Melanie J. Pantoja, Program Analyst Office of Federal Advisory Committee Policy. [FR Doc. 2017–18804 Filed 9–5–17; 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 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; PAR–15–067: NIDDK Multi-Center Clinical Study Cooperative Agreement (U01): CKD and Bone Mineral Disorders in Children. Date: October 2, 2017. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Najma S. Begum, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7349, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8894, begumn@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, PAR–16–126: High Impact, Interdisciplinary Science in NIDDK E:\FR\FM\06SEN1.SGM 06SEN1 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices asabaliauskas on DSKBBXCHB2PROD with NOTICES Research Areas (RC2)—Diabetes, Endocrinology and Metabolic Diseases. Date: October 10, 2017. Time: 3:00 p.m. to 4:30 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: Dianne Camp, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7013, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, 301–594–7682, campd@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR–16–034: Ancillary Studies on Diabetes. Date: October 12, 2017. Time: 1:00 p.m. to 2:00 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: Dianne Camp, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7013, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, 301–594–7682, campd@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; DDK–B Conflict. Date: October 18, 2017. Time: 10:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814. 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 (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: August 30, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–18806 Filed 9–5–17; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 17:37 Sep 05, 2017 Jkt 241001 DEPARTMENT OF HOMELAND SECURITY U.S. Immigration and Customs Enforcement [OMB Control Number 1653–0022] Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Immigration Bond U.S. Immigration and Customs Enforcement, Department of Homeland Security. ACTION: 30-Day notice. AGENCY: The Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (USICE) is submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on June 26, 2017, Vol. 82 FR 28874, allowing for a 60-day public comment period. USICE did not receive any comment in connection with the 60day notice. The purpose of this notice is to allow an additional 30 days for public comments. Written comments and/or suggestions regarding the items contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB Desk Officer for U.S. Immigration and Customs Enforcement, Department of Homeland Security and sent via electronic mail to dhsdeskofficer@ omb.eop.gov. All submissions received must include the agency name and the OMB Control Number 1653–0022. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 42105 technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection (1) Type of Information Collection: Extension, Without Change, of a Currently Approved Collection. (2) Title of the Form/Collection: Immigration Bond. (3) Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection: Form I–352; USICE. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individual or Households, Business or other nonprofit. Form I–352 is used by USICE to ensure the person or company posting the bond is aware of the duties and responsibilities associated with the bond. The collection instrument serves the purpose of instruction in the completion of the form, together with an explanation of the terms and conditions of the bond. Sureties have the capability of accessing, completing and submitting a bond electronically through USICE’s eBonds system, while individuals are required to complete the bond form manually. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 25,000 responses at 30 minutes (.50 hours) per response. (6) An estimate of the total public burden (in hours) associated with the collection: 12,500 annual burden hours. Dated: August 30, 2017. Scott Elmore, PRA Clearance Officer, Office of the Chief Information Officer, U.S. Immigration and Customs Enforcement, Department of Homeland Security. [FR Doc. 2017–18809 Filed 9–5–17; 8:45 am] BILLING CODE 9111–28–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5997–N–49] 30-Day Notice of Proposed Information Collection: Public Housing Financial Management Template Office of the Chief Information Officer, HUD. ACTION: Notice. AGENCY: HUD submitted the proposed information collection requirement described below to the Office of SUMMARY: E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42104-42105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18806]


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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; PAR-15-067: NIDDK Multi-
Center Clinical Study Cooperative Agreement (U01): CKD and Bone 
Mineral Disorders in Children.
    Date: October 2, 2017.
    Time: 11:00 a.m. to 2:00 p.m.
    Agenda: To review and evaluate cooperative agreement 
applications.
    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Najma S. Begum, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7349, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 
594-8894, begumn@niddk.nih.gov.

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel, PAR-16-126: High Impact, 
Interdisciplinary Science in NIDDK

[[Page 42105]]

Research Areas (RC2)--Diabetes, Endocrinology and Metabolic 
Diseases.
    Date: October 10, 2017.
    Time: 3:00 p.m. to 4:30 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: Dianne Camp, Ph.D., Scientific Review Officer, 
Review Branch, DEA, NIDDK, National Institutes of Health, Room 7013, 
6707 Democracy Boulevard, Bethesda, MD 20892-2542, 301-594-7682, 
campd@extra.niddk.nih.gov.

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; PAR-16-034: Ancillary 
Studies on Diabetes.
    Date: October 12, 2017.
    Time: 1:00 p.m. to 2:00 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: Dianne Camp, Ph.D., Scientific Review Officer, 
Review Branch, DEA, NIDDK, National Institutes of Health, Room 7013, 
6707 Democracy Boulevard, Bethesda, MD 20892-2542, 301-594-7682, 
campd@extra.niddk.nih.gov.

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; DDK-B Conflict.
    Date: October 18, 2017.
    Time: 10:00 a.m. to 12:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 
8120 Wisconsin Avenue, Bethesda, MD 20814.
    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

(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: August 30, 2017.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-18806 Filed 9-5-17; 8:45 am]
 BILLING CODE 4140-01-P

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