National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 8881-8882 [2020-03077]
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8881
Federal Register / Vol. 85, No. 32 / Tuesday, February 18, 2020 / Notices
3. The date the application was
approved: November 16, 2016. FDA has
verified the applicant’s claim that NDA
208470 was approved on November 16,
2016.
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 717 days or 518
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.
690–7569. When submitting comments
or requesting information, please
include the document identifier 4040–
0019–30D and project title for reference.
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collections: Project
Abstract Summary.
Type of Collection: Revision.
OMB No.: 4040–0019.
Abstract: Project Abstract Summary
form provides the Federal grant-making
agencies an alternative to the Standard
Form 424 data set and form. Project
Abstract Summary programs are not
required to collect all the data that is
required on the SF–424 core data set
and form. Grants.gov seeks revision
without renewal and designation as a
Common Form due to updates to the IC.
The IC was modified to remove data
elements. The IC was renewed with an
expiration date of 02/28/2022 and does
not require an extension.
SUPPLEMENTARY INFORMATION:
Dated: February 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03115 Filed 2–14–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0019]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before March 19, 2020.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: Ed
Calimag, ed.calimag@hhs.gov or (202)
SUMMARY:
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Forms
Project Abstract Summary ...............................................................................
Total ..........................................................................................................
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2020–03128 Filed 2–14–20; 8:45 am]
BILLING CODE 4151–AE–P
lotter on DSKBCFDHB2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
VerDate Sep<11>2014
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3,467
3,467
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 Heart, Lung,
and Blood Institute Special Emphasis Panel;
Blood Brain Barrier.
Date: March 19, 2020.
PO 00000
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Number of
responses per
respondent
Average
burden
hours per
response
1
........................
1
........................
Total
burden hours
3,467
3,467
Time: 8:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Michael P. Reilly, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7200, Bethesda, MD
20892, 301–827–7975, reillymp@
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
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Federal Register / Vol. 85, No. 32 / Tuesday, February 18, 2020 / Notices
and Resources Research, National Institutes
of Health, HHS)
Dated: February 11, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–03077 Filed 2–14–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
lotter on DSKBCFDHB2PROD with NOTICES
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
Mental Health Special Emphasis Panel;
BRAIN Initiative: Novel Tools to Probe Cells
and Circuits in the Brain (R01) & Human and
NHP Brain (UG3/UH3).
Date: March 11, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street
NW, Washington, DC 20036.
Contact Person: Erin E. Gray, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
6001 Executive Boulevard, NSC 6152B,
Bethesda, MD 20892, 301–402–8152,
erin.gray@nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
BRAIN Initiative: Advanced Human CellBased Assays to Model Brain Structure and
Function (R01).
Date: March 13, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin Georgetown, 2350 M
Street NW, Washington, DC 20037.
Contact Person: David W. Miller, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6140, MSC 9608,
Bethesda, MD 20892–9608, 301–443–9734,
millerda@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
VerDate Sep<11>2014
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NIMH Clinical Trials Effectiveness Studies
(R34/R01/R01 Collaborative).
Date: March 30, 2020.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street NW, Washington, DC 20037.
Contact Person: Karen Gavin-Evans, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Boulevard, Room 6153, MSC
9606, Bethesda, MD 20892, 301–451–2356,
gavinevanskm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: February 11, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–03078 Filed 2–14–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cell and Molecular Biology.
Date: March 10–11, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Ave. NW, Washington, DC 20037.
Contact Person: Amy Kathleen Wernimont,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6198,
Bethesda, MD 20892, (301) 827–6427,
amy.wernimont@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Infectious
Diseases, Reproductive Health, Asthma and
Pulmonary Conditions: Infectious Disease
Epidemiology.
Date: March 13, 2020.
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Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Lisa Steele, Ph.D.,
Scientific Review Officer, PSE IRG, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 594–
6594, steeleln@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–19–
326: Reducing Stigma to Improve HIV/AIDS
Prevention, Treatment and Care in Low- and
Middle-Income Countries.
Date: March 13, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Shalanda A. Bynum,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206,
Bethesda, MD 20892, (301) 755–4355,
bynumsa@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Dissemination and Implementation Research
in Health Review-Overflow.
Date: March 16, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: John H. Newman, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3222,
MSC 7808, Bethesda, MD 20892, (301) 435–
0628, newmanjh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 17–
190: Maximizing Investigators’ Research
Award for Early Stage Investigators (R35).
Date: March 16–17, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, Bethesda, MD 20814.
Contact Person: Thomas Beres, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 5201,
MSC 7840, Bethesda, MD 20892, (301) 435–
1175, berestm@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Oncology.
Date: March 16–17, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Reigh-Yi Lin, Ph.D.,
Scientific Review Officer, Center for
E:\FR\FM\18FEN1.SGM
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Agencies
[Federal Register Volume 85, Number 32 (Tuesday, February 18, 2020)]
[Notices]
[Pages 8881-8882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03077]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; 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 Heart, Lung, and Blood Institute
Special Emphasis Panel; Blood Brain Barrier.
Date: March 19, 2020.
Time: 8:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda North Marriott Hotel & Conference Center,
Montgomery County Conference Center Facility, 5701 Marinelli Road,
North Bethesda, MD 20852.
Contact Person: Michael P. Reilly, Ph.D., Scientific Review
Officer, Office of Scientific Review, National Heart, Lung, and
Blood Institute, National Institutes of Health, 6701 Rockledge
Drive, Room 7200, Bethesda, MD 20892, 301-827-7975,
[email protected].
(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
[[Page 8882]]
and Resources Research, National Institutes of Health, HHS)
Dated: February 11, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-03077 Filed 2-14-20; 8:45 am]
BILLING CODE 4140-01-P