83 FR 5634 - Agency Information Collection Request. 30-Day Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 27 (February 8, 2018)

Page Range		5634-5635
FR Document		2018-02477

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.

Federal Register, Volume 83 Issue 27 (Thursday, February 8, 2018)

[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Notices]
[Pages 5634-5635]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02477]


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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

5634 Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices

A regulatory review period consists of 505(b) of the FD&C Act: July 26, 2012. ACTION: Notice.
two periods of time: A testing phase and FDA has verified the applicant’s claim
an approval phase. For human drug that the new drug application (NDA) for SUMMARY: In compliance with the
products, the testing phase begins when JUBLIA (NDA 203567) was initially requirement of the Paperwork
the exemption to permit the clinical submitted on July 26, 2012. Reduction Act of 1995, the Office of the
investigations of the drug becomes 3. The date the application was Secretary (OS), Department of Health
effective and runs until the approval approved: June 6, 2014. FDA has and Human Services, is publishing the
phase begins. The approval phase starts verified the applicant’s claim that NDA following summary of a proposed
with the initial submission of an 203567 was approved on June 6, 2014. collection for public comment.
application to market the human drug This determination of the regulatory DATES: Comments on the ICR must be
product and continues until FDA grants review period establishes the maximum received on or before March 12, 2018.
permission to market the drug product. potential length of a patent extension. ADDRESSES: Submit your comments to
Although only a portion of a regulatory However, the USPTO applies several OIRA_submission@omb.eop.gov or via
review period may count toward the statutory limitations in its calculations facsimile to (202) 395–5806.
actual amount of extension that the of the actual period for patent extension. FOR FURTHER INFORMATION CONTACT:
Director of USPTO may award (for In its application for patent extension, Sherrette Funn, Sherrette.Funn@hhs.gov
example, half the testing phase must be this applicant seeks 1,601 days of patent or (202) 795–7714. When requesting
subtracted as well as any time that may term extension. information, please include the
have occurred before the patent was document identifier 0937–0191–30D
issued), FDA’s determination of the III. Petitions
and project title for reference.
length of a regulatory review period for Anyone with knowledge that any of
SUPPLEMENTARY INFORMATION: Interested
a human drug product will include all the dates as published are incorrect may
persons are invited to send comments
of the testing phase and approval phase submit either electronic or written
as specified in 35 U.S.C. 156(g)(1)(B). regarding this burden estimate or any
comments and, under 21 CFR 60.24, ask
FDA has approved for marketing the other aspect of this collection of
for a redetermination (see DATES).
human drug product JUBLIA information, including any of the
Furthermore, as specified in § 60.30 (21
(efinaconazole). JUBLIA is indicated for following subjects: (1) The necessity and
CFR 60.30), any interested person may
the topical treatment of onychomycosis utility of the proposed information
petition FDA for a determination
of the toenails due to Tricophyton collection for the proper performance of
regarding whether the applicant for
rubrum and Trichophyton the agency’s functions; (2) the accuracy
extension acted with due diligence
mentagrophytes. Subsequent to this of the estimated burden; (3) ways to
during the regulatory review period. To
approval, the USPTO received a patent enhance the quality, utility, and clarity
meet its burden, the petition must
term restoration application for JUBLIA of the information to be collected; and
comply with all the requirements of
(U.S. Patent No. 7,214,506) from Kaken (4) the use of automated collection
§ 60.30, including but not limited to:
Pharmaceutical Co., Ltd., and the techniques or other forms of information
Must be timely (see DATES), must be
USPTO requested FDA’s assistance in technology to minimize the information
filed in accordance with § 10.20, must
determining this patent’s eligibility for collection burden.
contain sufficient facts to merit an FDA Title of the Collection: Application
patent term restoration. In a letter dated investigation, and must certify that a
November 4, 2015, FDA advised the packets for Real Property for Public
true and complete copy of the petition Health Purposes.
USPTO that this human drug product has been served upon the patent
had undergone a regulatory review Type of Collection: Revision.
applicant. (See H. Rept. 857, part 1, 98th OMB No.: 0937–0191–30D—Office
period and that the approval of JUBLIA Cong., 2d sess., pp. 41–42, 1984.)
represented the first permitted within OS—Office of Assistant
Petitions should be in the format Secretary for Administration, Program
commercial marketing or use of the specified in 21 CFR 10.30.
product. Thereafter, the USPTO Support Center, Real Estate, Logistics
Submit petitions electronically to and Operations Support, Federal
requested that FDA determine the https://www.regulations.gov at Docket
product’s regulatory review period. Property Assistance Program.
No. FDA–2013–S–0610. Submit written Abstract: The Office of Assistant
II. Determination of Regulatory Review petitions (two copies are required) to the Secretary for Administration, Program
Period Dockets Management Staff (HFA–305), Support Center Federal Property
Food and Drug Administration, 5630 Assistance Program is requesting
FDA has determined that the
Fishers Lane, Rm. 1061, Rockville, MD approval by OMB on a revision. Cited,
applicable regulatory review period for
20852. 40 U.S.C. 550, as amended, provides
JUBLIA is 2,521 days. Of this time,
1,840 days occurred during the testing Dated: January 31, 2018. authority to the Secretary of Health and
phase of the regulatory review period, Leslie Kux, Human Services to convey or lease
while 681 days occurred during the Associate Commissioner for Policy. surplus real property to States and their
approval phase. These periods of time [FR Doc. 2018–02522 Filed 2–7–18; 8:45 am] political subdivisions and
were derived from the following dates: BILLING CODE 4164–01–P
instrumentalities, to tax-supported
1. The date an exemption under institutions, and to nonprofit
section 505(i) of the Federal Food, Drug, institutions which, (except for
and Cosmetic Act (the FD&C Act) (21 DEPARTMENT OF HEALTH AND institutions which lease property to
U.S.C. 355(i)) became effective: July 14, HUMAN SERVICES assist the homeless) have been held
daltland on DSKBBV9HB2PROD with NOTICES

2007. FDA has verified the applicant’s exempt from taxation under Section
[Document Identifier: 0937–0191–30D] 501(c)(3) of the 1954 Internal Revenue
claim that the date the investigational
new drug application (IND) became Agency Information Collection Code, and 501(c)(19) for veterans
effective was on July 14, 2007. Request. 30-Day Public Comment organizations, for public health
2. The date the application was Request purposes. Title V of the McKinney-
initially submitted with respect to the Vento Homeless Assistance Act (Title V)
human drug product under section AGENCY: Office of the Secretary, HHS. extended the Secretary’s authority to

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Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices 5635

include homeless assistance purposes as We are requesting that the collection determine if institutions/organizations
a permissible use under public health. be valid for three years. are eligible to purchase, lease or use
The Federal Asset and Transfer Act of Type of respondent: State and local property under the provisions of the
2016 (Pub. L. 114–287) streamlined the governments and non-profit institutions surplus real property program.
Title V process bifurcating the use these applications to apply for Responds are intermittent—only when
application process. Transfers are made excess/surplus, underutilized/ an eligible organization requests
to transferees at little or no cost. unutilized and off-site government real acquisition of identified Federal surplus
property. These applications are used to real property.
ESTIMATED ANNUALIZED BURDEN TABLE
Average
Number
Number of burden per Total
Type of respondent responses per
respondents response burden hours
respondent (in hours)

Applications for surplus Federal real property ................................................. 15 1 200 3,000

Total .......................................................................................................... 15 1 200 3,000

Terry S. Clark, Name of Committee: National Center for DEPARTMENT OF HEALTH AND
Office of the Secretary, Asst. Paperwork Advancing Translational Sciences Special HUMAN SERVICES
Reduction Act Reports Clearance Officer. Emphasis Panel; TRND—Contract Review.
[FR Doc. 2018–02477 Filed 2–7–18; 8:45 am] Date: March 7, 2018. National Institutes of Health
BILLING CODE 4150–04–P
Time: 1:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate contract Center for Scientific Review Notice of
proposals. Closed Meetings
DEPARTMENT OF HEALTH AND Place: National Institutes of Health, One
Democracy Plaza, Room 1037, 6701 Pursuant to section 10(d) of the
HUMAN SERVICES Federal Advisory Committee Act, as
Democracy Boulevard, Bethesda, MD 20892
National Institutes of Health (Telephone Conference Call). amended, notice is hereby given of the
Contact Person: Rahat (Rani) Khan, Ph.D., following meetings.
National Center for Advancing Scientific Review Officer, Office of Scientific The meetings will be closed to the
Translational Sciences; Notice of Review, National Center for Advancing public in accordance with the
Closed Meetings Translational Sciences, 6701 Democracy provisions set forth in sections
Blvd., Rm. 1078, Bethesda, MD 20892, 301– 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Pursuant to section 10(d) of the 894–7319, khanr2@csr.nih.gov. as amended. The grant applications and
Federal Advisory Committee Act, as Name of Committee: National Center for the discussions could disclose
amended, notice is hereby given of the Advancing Translational Sciences Special confidential trade secrets or commercial
following meetings. Emphasis Panel; Platform Delivery property such as patentable material,
The meetings will be closed to the Technologies for Nucleic Acid Therapeutics. and personal information concerning
public in accordance with the Date: March 29, 2018. individuals associated with the grant
provisions set forth in sections Time: 8:00 a.m. to 5:00 p.m. applications, the disclosure of which
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: To review and evaluate grant would constitute a clearly unwarranted
as amended. The grant applications and applications. invasion of personal privacy.
the discussions could disclose Place: National Institutes of Health, One
confidential trade secrets or commercial Name of Committee: Center for Scientific
Democracy Plaza, Room 1065, 6701
property such as patentable material, Review Special Emphasis Panel; Member
Democracy Boulevard, Bethesda, MD 20892
Conflict: Pain Mechanisms.
and personal information concerning (Virtual Meeting). Date: March 1, 2018.
individuals associated with the grant Contact Person: Carol Lambert, Ph.D., Time: 8:00 a.m. to 6:00 p.m.
applications, the disclosure of which Acting Director, Office of Scientific Review, Agenda: To review and evaluate grant
would constitute a clearly unwarranted National Center for Advancing Translational applications.
invasion of personal privacy. Sciences (NCATS), National Institutes of Place: National Institutes of Health, 6701
Health, 6701 Democracy Blvd., Democracy 1, Rockledge Drive, Bethesda, MD 20892,
Name of Committee: National Center for
Advancing Translational Sciences Special Room 1076, Bethesda, MD 20892, 301–435– (Virtual Meeting).
Emphasis Panel; R13 Conference Grants 0814, lambert@mail.nih.gov. Contact Person: John Bishop, Ph.D.,
Review. (Catalogue of Federal Domestic Assistance Scientific Review Officer, Center for
Date: March 6, 2018. Program Nos. 93.859, Pharmacology, Scientific Review, National Institutes of
Time: 1:00 a.m. to 5:00 p.m. Physiology, and Biological Chemistry Health, 6701 Rockledge Drive, Room 5182,
Agenda: To review and evaluate grant MSC 7844, Bethesda, MD 20892, (301) 408–
Research; 93.350, B—Cooperative
applications. 9664, bishopj@csr.nih.gov.
Agreements; 93.859, Biomedical Research
Place: National Institutes of Health, One and Research Training, National Institutes of Name of Committee: Center for Scientific
Democracy Plaza, Room 1037, 6701 Health, HHS) Review Special Emphasis Panel; Member
daltland on DSKBBV9HB2PROD with NOTICES

Democracy Boulevard, Bethesda, MD 20892 Conflict: Integrative Neuroscience.
(Telephone Conference Call). Dated: February 1, 2018. Date: March 1, 2018.
Contact Person: Rahat Khan, Ph.D., David Clary, Time: 1:00 p.m. to 5:00 p.m.
Scientific Review Officer, Office of Scientific Agenda: To review and evaluate grant
Program Analyst, Office of Federal Advisory
Review, National Center for Advancing applications.
Committee Policy.
Translational Sciences, 6701 Democracy Place: National Institutes of Health, 6701
Blvd., Rm. 1078, Bethesda, MD 20892, 301– [FR Doc. 2018–02492 Filed 2–7–18; 8:45 am] Rockledge Drive, Bethesda, MD 20892,
594–7319, khanr2@csr.nih.gov. BILLING CODE 4140–01–P (Virtual Meeting).

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Document Created: 2018-02-08 00:16:27
Document Modified: 2018-02-08 00:16:27

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on the ICR must be received on or before March 12, 2018.
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.
FR Citation		83 FR 5634