83 FR 4226 - National Center for Advancing Translational Sciences; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 20 (January 30, 2018)

Page Range		4226-4226
FR Document		2018-01822

Federal Register, Volume 83 Issue 20 (Tuesday, January 30, 2018)

[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Page 4226]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01822]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Center for Advancing Translational Sciences; Notice of 
Closed Meetings

    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, [email protected].

    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, [email protected].

(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)

    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]
 BILLING CODE 4140-01-P

4226 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices

IDE was determined substantially Dated: January 24, 2018. (Catalogue of Federal Domestic Assistance
complete for clinical studies to have Leslie Kux, Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
begun on September 17, 2010, which Associate Commissioner for Policy.
Research; 93.350, B—Cooperative
represents the IDE effective date. [FR Doc. 2018–01655 Filed 1–29–18; 8:45 am] Agreements; 93.859, Biomedical Research
2. The date an application was BILLING CODE 4164–01–P and Research Training, National Institutes of
initially submitted with respect to the Health, HHS)
device under section 515 of the FD&C Dated: January 25, 2018.
Act (21 U.S.C. 360e): December 22, DEPARTMENT OF HEALTH AND David Clary,
HUMAN SERVICES
2014. The applicant claims December Program Analyst, Office of Federal Advisory
19, 2014, as the date the premarket Committee Policy.
National Institutes of Health
approval application (PMA) for SAPIEN [FR Doc. 2018–01822 Filed 1–29–18; 8:45 am]
3 TRANSCATHETER HEART VALVE National Center for Advancing BILLING CODE 4140–01–P
(PMA P140031) was initially submitted. Translational Sciences; Notice of
However, FDA records indicate that Closed Meetings
PMA P140031 was submitted on DEPARTMENT OF HEALTH AND
Pursuant to section 10(d) of the HUMAN SERVICES
December 22, 2014. Federal Advisory Committee Act, as
3. The date the application was amended, notice is hereby given of the National Institutes of Health
approved: June 17, 2015. FDA has National Center for Advancing
verified the applicant’s claim that PMA Translational Sciences Special National Institute on Aging; Notice of
P140031 was approved on June 17, Emphasis Panel. Closed Meetings
2015. The meetings will be closed to the Pursuant to section 10(d) of the
This determination of the regulatory public in accordance with the Federal Advisory Committee Act, as
review period establishes the maximum provisions set forth in sections amended, notice is hereby given of the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., following meetings.
potential length of a patent extension.
as amended. The grant applications and The meetings will be closed to the
However, the USPTO applies several
the discussions could disclose public in accordance with the
statutory limitations in its calculations
confidential trade secrets or commercial provisions set forth in sections
of the actual period for patent extension. property such as patentable material, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
In its applications for patent extension, and personal information concerning as amended. The grant applications and
this applicant seeks 250 days of patent individuals associated with the grant the discussions could disclose
term extension. applications, the disclosure of which confidential trade secrets or commercial
III. Petitions would constitute a clearly unwarranted property such as patentable material,
invasion of personal privacy. and personal information concerning
Anyone with knowledge that any of Name of Committee: National Center for individuals associated with the grant
the dates as published are incorrect may Advancing Translational Sciences Special applications, the disclosure of which
submit either electronic or written Emphasis Panel; CTSA Collaborative would constitute a clearly unwarranted
comments and, under 21 CFR 60.24, ask Innovation Award Review. invasion of personal privacy.
for a redetermination (see DATES). Date: February 22–23, 2018.
Name of Committee: National Institute on
Time: 8:00 a.m. to 5:00 p.m.
Furthermore, as specified in § 60.30 (21 Aging Special Emphasis Panel; GEMSSTAR.
Agenda: To review and evaluate grant Date: February 26, 2018.
CFR 60.30), any interested person may applications.
petition FDA for a determination Time: 8:00 a.m. to 6:00 p.m.
Place: National Institutes of Health, Agenda: To review and evaluate grant
regarding whether the applicant for Democracy I, Room 1068, 6701 Democracy applications.
extension acted with due diligence Blvd., Bethesda, MD 20817 (Virtual Meeting). Place: Bethesda Marriott Hotel, 5151 Pooks
during the regulatory review period. To Contact Person: M. Lourdes Ponce, Ph.D., Hill Road, Bethesda, MD 20814.
meet its burden, the petition must Scientific Review Officer, Office of Scientific Contact Person: Isis S. Mikhail, MD, MPH,
Review, National Center for Advancing DRPH, National Institute on Aging, Gateway
comply with all the requirements of Translational Sciences (NCATS), National
§ 60.30, including but not limited to: Building, 7201 Wisconsin Avenue, Suite
Institutes of Health, 6701 Democracy Blvd., 2C212, Bethesda, MD 20892, 301–402–7704,
Must be timely (see DATES), must be Democracy I, Room 1073 Bethesda, MD MIKHAILI@MAIL.NIH.GOV.
filed in accordance with § 10.20, must 20892, 301–435–0810, lourdes.ponce@ Name of Committee: National Institute on
contain sufficient facts to merit an FDA nih.gov. Aging Special Emphasis Panel; Primate
investigation, and must certify that a Name of Committee: National Center for Aging Database and Management.
true and complete copy of the petition Advancing Translational Sciences Special Date: March 1, 2018.
has been served upon the patent Emphasis Panel; Bench Testing. Time: 11:30 a.m. to 12:30 p.m.
Date: February 27, 2018. Agenda: To review and evaluate contract
applicant. (See H. Rept. 857, part 1, 98th Time: 8:00 a.m. to 5:30 p.m. proposals.
Cong., 2d sess., pp. 41–42, 1984.) Agenda: To review and evaluate grant Place: National Institute on Aging,
Petitions should be in the format applications, Gateway Building, Suite 2W233, 7201
specified in 21 CFR 10.30. Place: National Institutes of Health, Wisconsin Avenue, Bethesda, MD 20892
Democracy I, Room 1066, 6701 Democracy (Telephone Conference Call).
Submit petitions electronically to Contact Person: Anita H. Undale, Ph.D.,
Blvd., Bethesda, MD 20817 (Virtual Meeting).
https://www.regulations.gov at Docket
daltland on DSKBBV9HB2PROD with NOTICES

Contact Person: Barbara J. Nelson, Ph.D., MD, Scientific Review Branch, National
No. FDA–2013–S–0610. Submit written Scientific Review Officer, Office of Scientific Institute on Aging, Gateway Building, Suite
petitions (two copies are required) to the Review, National Center for Advancing 2W200, 7201 Wisconsin Avenue, Bethesda,
Dockets Management Staff (HFA–305), Translational Sciences (NCATS), National MD 20892, 240–747–7825, anita.undale@
Food and Drug Administration, 5630 Institutes of Health, 6701 Democracy Blvd., nih.gov.
Fishers Lane, Rm. 1061, Rockville, MD Democracy I, Room 1080, Bethesda, MD (Catalogue of Federal Domestic Assistance
20892–4874, 301–435–0806, nelsonbj@ Program Nos. 93.866, Aging Research,
20852. mail.nih.gov. National Institutes of Health, HHS)

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Document Created: 2018-10-26 10:12:57
Document Modified: 2018-10-26 10:12:57

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
Dates		February 22-23, 2018.
FR Citation		83 FR 4226

83 FR 4226 - National Center for Advancing Translational Sciences; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 20 (January 30, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health