National Heart, Lung, and Blood Institute; Notice of Closed Meetings, 60705 [2012-24417]
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Federal Register / Vol. 77, No. 193 / Thursday, October 4, 2012 / Notices
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1650, Silver Spring,
MD 20993–0002, 301–796–6570.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
60705
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from April 1, 2012, through
June 30, 2012. There were no denial
actions during this period. The list
provides the manufacturer’s name, the
product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1,
2012, THROUGH JUNE 30, 2012
PMA No., Docket No.
Applicant
Trade name
P020018/S040, FDA–2012–
M–0371.
P110029, FDA–2012–M–0372
Cook, Inc ................................
P110004, FDA–2012–M–0407
P110035, FDA–2012–M–0373
P090015, FDA–2012–M–0390
P110010/S001, FDA–2012–
M–0562.
Medinol Ltd. ...........................
Boston Scientific Corp ...........
Leica Biosystems ...................
Boston Scientific Corp ...........
P090026, FDA–2012–M–0638
Beckman Coulter, Inc ............
Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent).
ARCHITECT HBsAg Qualitative, ARCHITECT HBsAg Qualitative Confirmatory, ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent, ARCHITECT HBsAg Qualitative
Calibrators, and ARCHITECT HBsAg Qualitative Controls.
PresillionTM plus CoCr Coronary Stent on RX System .........
EpicTM Vascular Self-Expanding Stent System .....................
BONDTM ORACLETM HER2 IHC System ..............................
PROMUS® ElementTM Plus Everolimus-Eluting Platinum
Chromium Coronary Stent System (MonorailTM and Overthe-Wire).
Access® Hybritech® p2PSA on the Access Immunoassay
Systems.
Abbot Laboratories ................
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.
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
PMAApprovals/default.htm.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Minority Institutional Training.
Date: October 25, 2012.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Chang Sook Kim, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7179, Bethesda, MD 20892–7924, 301–435–
0287, carolko@mail.nih.gov.
Dated: September 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–24479 Filed 10–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
emcdonald on DSK67QTVN1PROD with NOTICES
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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
VerDate Mar<15>2010
15:21 Oct 03, 2012
Jkt 229001
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Program Project for Triglyceride
Metabolism.
Date: October 26, 2012.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Conference Room 9091,
Bethesda, MD 20892.
Contact Person: Melissa E Nagelin, Ph.D.,
Scientific Review Officer, Office of Scientific
PO 00000
Frm 00035
Fmt 4703
Sfmt 9990
Approval date
April 4, 2012.
April 12, 2012.
April 12, 2012.
April 13, 2012.
April 18, 2012.
June 1, 2012.
June 14, 2012.
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Rm.
7202, Bethesda, MD 20892, 301–435–0297,
nagelinmh2@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI SBIR Phase II Contract Review.
Date: October 26, 2012.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: YingYing Li-Smerin,
Ph.D., MD, Scientific Review Officer, Office
of Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7184, Bethesda, MD 20892–
7924, 301–435–0277, lismerin@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: September 28, 2012.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–24417 Filed 10–3–12; 8:45 am]
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[Federal Register Volume 77, Number 193 (Thursday, October 4, 2012)]
[Notices]
[Page 60705]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24417]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed
Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
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 Heart, Lung, and Blood Institute
Special Emphasis Panel; Minority Institutional Training.
Date: October 25, 2012.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Chang Sook Kim, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7179, Bethesda, MD
20892-7924, 301-435-0287, carolko@mail.nih.gov.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel; NHLBI Program Project for Triglyceride
Metabolism.
Date: October 26, 2012.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Conference Room 9091, Bethesda, MD 20892.
Contact Person: Melissa E Nagelin, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Rm. 7202, Bethesda, MD 20892,
301-435-0297, nagelinmh2@nhlbi.nih.gov.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel; NHLBI SBIR Phase II Contract Review.
Date: October 26, 2012.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: YingYing Li-Smerin, Ph.D., MD, Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD
20892-7924, 301-435-0277, lismerin@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: September 28, 2012.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-24417 Filed 10-3-12; 8:45 am]
BILLING CODE 4140-01-P
