Agency Information Collection Request. 30-Day Public Comment Request, 5634-5635 [2018-02477]
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Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices
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A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product JUBLIA
(efinaconazole). JUBLIA is indicated for
the topical treatment of onychomycosis
of the toenails due to Tricophyton
rubrum and Trichophyton
mentagrophytes. Subsequent to this
approval, the USPTO received a patent
term restoration application for JUBLIA
(U.S. Patent No. 7,214,506) from Kaken
Pharmaceutical Co., Ltd., and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
November 4, 2015, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of JUBLIA
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
JUBLIA is 2,521 days. Of this time,
1,840 days occurred during the testing
phase of the regulatory review period,
while 681 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: July 14,
2007. FDA has verified the applicant’s
claim that the date the investigational
new drug application (IND) became
effective was on July 14, 2007.
2. The date the application was
initially submitted with respect to the
human drug product under section
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505(b) of the FD&C Act: July 26, 2012.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
JUBLIA (NDA 203567) was initially
submitted on July 26, 2012.
3. The date the application was
approved: June 6, 2014. FDA has
verified the applicant’s claim that NDA
203567 was approved on June 6, 2014.
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 application for patent extension,
this applicant seeks 1,601 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: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02522 Filed 2–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: 0937–0191–30D]
Agency Information Collection
Request. 30-Day Public Comment
Request
AGENCY:
PO 00000
Office of the Secretary, HHS.
Frm 00032
Fmt 4703
Sfmt 4703
ACTION:
Notice.
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 12, 2018.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When requesting
information, please include the
document identifier 0937–0191–30D
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 Collection: Application
packets for Real Property for Public
Health Purposes.
Type of Collection: Revision.
OMB No.: 0937–0191–30D—Office
within OS—Office of Assistant
Secretary for Administration, Program
Support Center, Real Estate, Logistics
and Operations Support, Federal
Property Assistance Program.
Abstract: The Office of Assistant
Secretary for Administration, Program
Support Center Federal Property
Assistance Program is requesting
approval by OMB on a revision. Cited,
40 U.S.C. 550, as amended, provides
authority to the Secretary of Health and
Human Services to convey or lease
surplus real property to States and their
political subdivisions and
instrumentalities, to tax-supported
institutions, and to nonprofit
institutions which, (except for
institutions which lease property to
assist the homeless) have been held
exempt from taxation under Section
501(c)(3) of the 1954 Internal Revenue
Code, and 501(c)(19) for veterans
organizations, for public health
purposes. Title V of the McKinneyVento Homeless Assistance Act (Title V)
extended the Secretary’s authority to
SUMMARY:
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Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices
include homeless assistance purposes as
a permissible use under public health.
The Federal Asset and Transfer Act of
2016 (Pub. L. 114–287) streamlined the
Title V process bifurcating the
application process. Transfers are made
to transferees at little or no cost.
determine if institutions/organizations
are eligible to purchase, lease or use
property under the provisions of the
surplus real property program.
Responds are intermittent—only when
an eligible organization requests
acquisition of identified Federal surplus
real property.
We are requesting that the collection
be valid for three years.
Type of respondent: State and local
governments and non-profit institutions
use these applications to apply for
excess/surplus, underutilized/
unutilized and off-site government real
property. These applications are used to
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Number
responses per
respondent
Average
burden per
response
(in hours)
Total
burden hours
Applications for surplus Federal real property .................................................
15
1
200
3,000
Total ..........................................................................................................
15
1
200
3,000
Terry S. Clark,
Office of the Secretary, Asst. Paperwork
Reduction Act Reports Clearance Officer.
[FR Doc. 2018–02477 Filed 2–7–18; 8:45 am]
BILLING CODE 4150–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meetings
daltland on DSKBBV9HB2PROD 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 Center for
Advancing Translational Sciences Special
Emphasis Panel; R13 Conference Grants
Review.
Date: March 6, 2018.
Time: 1:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, Room 1037, 6701
Democracy Boulevard, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Rahat Khan, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Center for Advancing
Translational Sciences, 6701 Democracy
Blvd., Rm. 1078, Bethesda, MD 20892, 301–
594–7319, khanr2@csr.nih.gov.
VerDate Sep<11>2014
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Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; TRND—Contract Review.
Date: March 7, 2018.
Time: 1:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, One
Democracy Plaza, Room 1037, 6701
Democracy Boulevard, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Rahat (Rani) Khan, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Center for Advancing
Translational Sciences, 6701 Democracy
Blvd., Rm. 1078, Bethesda, MD 20892, 301–
894–7319, khanr2@csr.nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; Platform Delivery
Technologies for Nucleic Acid Therapeutics.
Date: March 29, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, Room 1065, 6701
Democracy Boulevard, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Carol Lambert, Ph.D.,
Acting Director, Office of Scientific Review,
National Center for Advancing Translational
Sciences (NCATS), National Institutes of
Health, 6701 Democracy Blvd., Democracy 1,
Room 1076, Bethesda, MD 20892, 301–435–
0814, lambert@mail.nih.gov.
(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: February 1, 2018.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–02492 Filed 2–7–18; 8:45 am]
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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; Member
Conflict: Pain Mechanisms.
Date: March 1, 2018.
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,
(Virtual Meeting).
Contact Person: John Bishop, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7844, Bethesda, MD 20892, (301) 408–
9664, bishopj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Integrative Neuroscience.
Date: March 1, 2018.
Time: 1:00 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).
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]]>Agencies
[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Notices]
[Pages 5634-5635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02477]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: 0937-0191-30D]
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 12,
2018.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When requesting information, please include the
document identifier 0937-0191-30D 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 Collection: Application packets for Real Property for
Public Health Purposes.
Type of Collection: Revision.
OMB No.: 0937-0191-30D--Office within OS--Office of Assistant
Secretary for Administration, Program Support Center, Real Estate,
Logistics and Operations Support, Federal Property Assistance Program.
Abstract: The Office of Assistant Secretary for Administration,
Program Support Center Federal Property Assistance Program is
requesting approval by OMB on a revision. Cited, 40 U.S.C. 550, as
amended, provides authority to the Secretary of Health and Human
Services to convey or lease surplus real property to States and their
political subdivisions and instrumentalities, to tax-supported
institutions, and to nonprofit institutions which, (except for
institutions which lease property to assist the homeless) have been
held exempt from taxation under Section 501(c)(3) of the 1954 Internal
Revenue Code, and 501(c)(19) for veterans organizations, for public
health purposes. Title V of the McKinney-Vento Homeless Assistance Act
(Title V) extended the Secretary's authority to
[[Page 5635]]
include homeless assistance purposes as a permissible use under public
health. The Federal Asset and Transfer Act of 2016 (Pub. L. 114-287)
streamlined the Title V process bifurcating the application process.
Transfers are made to transferees at little or no cost.
We are requesting that the collection be valid for three years.
Type of respondent: State and local governments and non-profit
institutions use these applications to apply for excess/surplus,
underutilized/unutilized and off-site government real property. These
applications are used to determine if institutions/organizations are
eligible to purchase, lease or use property under the provisions of the
surplus real property program. Responds are intermittent--only when an
eligible organization requests acquisition of identified Federal
surplus real property.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number Average burden
Type of respondent Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Applications for surplus Federal real property.. 15 1 200 3,000
---------------------------------------------------------------
Total....................................... 15 1 200 3,000
----------------------------------------------------------------------------------------------------------------
Terry S. Clark,
Office of the Secretary, Asst. Paperwork Reduction Act Reports
Clearance Officer.
[FR Doc. 2018-02477 Filed 2-7-18; 8:45 am]
BILLING CODE 4150-04-P
