Agency Information Collection Request; 30-Day Public Comment Request, 8881 [2020-03128]
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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
17:48 Feb 14, 2020
Jkt 250001
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
Frm 00077
Fmt 4703
Sfmt 4703
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
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 85, Number 32 (Tuesday, February 18, 2020)]
[Notices]
[Page 8881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03128]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-4040-0019]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Ed Calimag, [email protected] or
(202) 690-7569. When submitting comments or requesting information,
please include the document identifier 4040-0019-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: 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.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average
Forms Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Project Abstract Summary........................ 3,467 1 1 3,467
Total....................................... 3,467 .............. .............. 3,467
----------------------------------------------------------------------------------------------------------------
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
