National Institute of Environmental Health Sciences; Notice of Closed Meetings, 47962 [2019-19606]
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Federal Register / Vol. 84, No. 176 / Wednesday, September 11, 2019 / Notices
jspears on DSK3GMQ082PROD with NOTICES
BIOPROSTHESIS MODEL 11000A and
MODEL 11500A are indicated for the
replacement of native or prosthetic
aortic heart valves. Subsequent to this
approval, the USPTO received patent
term restoration applications for
EDWARDS PERICARDIAL AORTIC
BIOPROSTHESIS MODEL 11000A and
MODEL 11500A (U.S. Patent Nos.
7,972,376; 8,007,992; 8,357,387; and
9,029,418) from Edwards Lifesciences
Corporation, and the USPTO requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated April 5,
2018, FDA advised the USPTO that this
medical device had undergone a
regulatory review period and that the
approval of EDWARDS PERICARDIAL
AORTIC BIOPROSTHESIS represented
the first permitted commercial
marketing or use of the product.
Thereafter, the USPTO requested that
FDA determine the product’s regulatory
review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
EDWARDS PERICARDIAL AORTIC
BIOPROSTHESIS is 1,858 days. Of this
time, 1,491 days occurred during the
testing phase of the regulatory review
period, while 367 days occurred during
the approval phase. These periods of
time were derived from the following
dates:
1. The date an exemption for this
device, under section 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(g)), became
effective: May 30, 2012. FDA has
verified the applicant’s claim that the
date the investigational device
exemption (IDE) for human tests to
begin, as required under section 520(g)
of the FD&C Act, became effective May
30, 2012.
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): June 28, 2016. FDA
has verified the applicant’s claim that
the premarket approval application
(PMA) for EDWARDS PERICARDIAL
AORTIC BIOPROSTHESIS (PMA
P150048) was initially submitted June
28, 2016.
3. The date the application was
approved: June 29, 2017. FDA has
verified the applicant’s claim that PMA
P150048 was approved on June 29,
2017.
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
VerDate Sep<11>2014
17:44 Sep 10, 2019
Jkt 247001
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 572 days, 992 days,
or 1,111 days of patent term extension.
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.
Dated: September 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19600 Filed 9–10–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; 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
PO 00000
Frm 00032
Fmt 4703
Sfmt 9990
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel: Exploratory Research on
RNA Modifications Environment and Disease
(FRAMED).
Date: September 16, 2019.
Time: 8:00 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: DoubleTree by Hilton Hotel,
Raleigh-Durham Airport, 4810 Page Creek
Lane, Durham, NC 27703.
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, National Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, 919/541–0670, worth@niehs.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
Environmental Health Sciences Special
Emphasis Panel: Investigator-Initiated
Functional RNA Modifications Environment
and Disease (FRAMED).
Date: September 16–17, 2019.
Time: 3:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: DoubleTree by Hilton Hotel,
Raleigh-Durham Airport, 4810 Page Creek
Lane, Durham, NC 27703.
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, National Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, 919/541–0670, worth@niehs.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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: September 5, 2019.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–19606 Filed 9–10–19; 8:45 am]
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[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Notices]
[Page 47962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19606]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Environmental Health Sciences; 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 Environmental Health
Sciences Special Emphasis Panel: Exploratory Research on RNA
Modifications Environment and Disease (FRAMED).
Date: September 16, 2019.
Time: 8:00 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant applications.
Place: DoubleTree by Hilton Hotel, Raleigh-Durham Airport, 4810
Page Creek Lane, Durham, NC 27703.
Contact Person: Leroy Worth, Ph.D., Scientific Review Officer,
Scientific Review Branch, Division of Extramural Research and
Training, National Institute of Environmental Health Sciences, P.O.
Box 12233, MD EC-30/Room 3171, Research Triangle Park, NC 27709,
919/541-0670, [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 Environmental Health
Sciences Special Emphasis Panel: Investigator-Initiated Functional
RNA Modifications Environment and Disease (FRAMED).
Date: September 16-17, 2019.
Time: 3:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: DoubleTree by Hilton Hotel, Raleigh-Durham Airport, 4810
Page Creek Lane, Durham, NC 27703.
Contact Person: Leroy Worth, Ph.D., Scientific Review Officer,
Scientific Review Branch, Division of Extramural Research and
Training, National Institute of Environmental Health Sciences, P.O.
Box 12233, MD EC-30/Room 3171, Research Triangle Park, NC 27709,
919/541-0670, [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.
(Catalogue of Federal Domestic Assistance Program Nos. 93.115,
Biometry and Risk Estimation--Health Risks from Environmental
Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund Hazardous Substances--Basic
Research and Education; 93.894, Resources and Manpower Development
in the Environmental Health Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114, Applied Toxicological Research
and Testing, National Institutes of Health, HHS)
Dated: September 5, 2019.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-19606 Filed 9-10-19; 8:45 am]
BILLING CODE 4140-01-P
