National Institute on Aging; Notice of Closed Meetings, 4226-4227 [2018-01669]

Download as PDF 4226 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices IDE was determined substantially complete for clinical studies to have begun on September 17, 2010, which represents the IDE effective date. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): December 22, 2014. The applicant claims December 19, 2014, as the date the premarket approval application (PMA) for SAPIEN 3 TRANSCATHETER HEART VALVE (PMA P140031) was initially submitted. However, FDA records indicate that PMA P140031 was submitted on December 22, 2014. 3. The date the application was approved: June 17, 2015. FDA has verified the applicant’s claim that PMA P140031 was approved on June 17, 2015. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 250 days of patent term extension. daltland on DSKBBV9HB2PROD with NOTICES III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 Dated: January 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–01655 Filed 1–29–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the National Center for Advancing Translational Sciences Special Emphasis Panel. 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 Center for Advancing Translational Sciences Special Emphasis Panel; CTSA Collaborative Innovation Award Review. Date: February 22–23, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Democracy I, Room 1068, 6701 Democracy Blvd., Bethesda, MD 20817 (Virtual Meeting). Contact Person: M. Lourdes Ponce, Ph.D., Scientific Review Officer, Office of Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy I, Room 1073 Bethesda, MD 20892, 301–435–0810, lourdes.ponce@ nih.gov. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; Bench Testing. Date: February 27, 2018. Time: 8:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications, Place: National Institutes of Health, Democracy I, Room 1066, 6701 Democracy Blvd., Bethesda, MD 20817 (Virtual Meeting). Contact Person: Barbara J. Nelson, Ph.D., Scientific Review Officer, Office of Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy I, Room 1080, Bethesda, MD 20892–4874, 301–435–0806, nelsonbj@ mail.nih.gov. Frm 00045 Fmt 4703 Sfmt 4703 Dated: January 25, 2018. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–01822 Filed 1–29–18; 8:45 am] National Center for Advancing Translational Sciences; Notice of Closed Meetings PO 00000 (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 on Aging Special Emphasis Panel; GEMSSTAR. Date: February 26, 2018. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Hotel, 5151 Pooks Hill Road, Bethesda, MD 20814. Contact Person: Isis S. Mikhail, MD, MPH, DRPH, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7704, MIKHAILI@MAIL.NIH.GOV. Name of Committee: National Institute on Aging Special Emphasis Panel; Primate Aging Database and Management. Date: March 1, 2018. Time: 11:30 a.m. to 12:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Institute on Aging, Gateway Building, Suite 2W233, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Anita H. Undale, Ph.D., MD, Scientific Review Branch, National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, 240–747–7825, anita.undale@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) E:\FR\FM\30JAN1.SGM 30JAN1 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices Dated: January 24, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–01669 Filed 1–29–18; 8:45 am] 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Development and Maintenance of a Non-Human Primate Tissue Bank. Date: March 1, 2018. Time: 12:30 p.m. to 1:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Institute on Aging, Gateway Building, Suite 2W233, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Anita H. Undale, MD, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, 240–747–7825, anita.undale@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) daltland on DSKBBV9HB2PROD with NOTICES Dated: January 24, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meetings BILLING CODE 4140–01–P [FR Doc. 2018–01670 Filed 1–29–18; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES 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: NIGMS Initial Review Group; Training and Workforce Development Subcommittee—B, Review of T32 Applications. Date: March 2, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase, 4300 Military Road, NW, Washington, DC 20015. Contact Person: Lisa A. Newman, SCD, Scientific Review Officer, Office of Scientific Review, National Institutes of General Medical Sciences, 45 Center Drive, Room 3AN18A, Bethesda, MD 20814, (301) 435– 0965, newmanla2@mail.nih.gov. Name of Committee: NIGMS Initial Review Group; Training and Workforce Development Subcommittee—A, Review of T32 Applications. Date: April 9, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda Downtown, 6711 Democracy Blvd., Bethesda, MD 20817. Contact Person: John J. Laffan, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, Natcher Building, Room 3AN18J, Bethesda, MD 20892, 301–594–2773, laffanjo@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 4227 Dated: January 24, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–01671 Filed 1–29–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2017–0009] Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625– 0120 Coast Guard, DHS. Thirty-day notice requesting comments. AGENCY: ACTION: In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625–0120, U.S. Coast Guard Nonappropriated Fund Employment Application. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties. DATES: Comments must reach the Coast Guard and OIRA on or before March 1, 2018. ADDRESSES: You may submit comments identified by Coast Guard docket number [USCG–2017–0009] to the Coast Guard using the Federal eRulemaking Portal at https://www.regulations.gov. Alternatively, you may submit comments to OIRA using one of the following means: (1) Email: dhsdeskofficer@ omb.eop.gov. (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention Desk Officer for the Coast Guard. A copy of the ICR is available through the docket on the internet at https:// www.regulations.gov. Additionally, copies are available from: Commandant (CG–612), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710, Washington, DC 20593–7710. FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of Information Management, telephone SUMMARY: E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4226-4227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01669]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Aging; 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 on Aging Special Emphasis 
Panel; GEMSSTAR.
    Date: February 26, 2018.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda Marriott Hotel, 5151 Pooks Hill Road, Bethesda, 
MD 20814.
    Contact Person: Isis S. Mikhail, MD, MPH, DRPH, National 
Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 
2C212, Bethesda, MD 20892, 301-402-7704, [email protected].

    Name of Committee: National Institute on Aging Special Emphasis 
Panel; Primate Aging Database and Management.
    Date: March 1, 2018.
    Time: 11:30 a.m. to 12:30 p.m.
    Agenda: To review and evaluate contract proposals.
    Place: National Institute on Aging, Gateway Building, Suite 
2W233, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone 
Conference Call).
    Contact Person: Anita H. Undale, Ph.D., MD, Scientific Review 
Branch, National Institute on Aging, Gateway Building, Suite 2W200, 
7201 Wisconsin Avenue, Bethesda, MD 20892, 240-747-7825, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging 
Research, National Institutes of Health, HHS)


[[Page 4227]]


    Dated: January 24, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-01669 Filed 1-29-18; 8:45 am]
 BILLING CODE 4140-01-P
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