Agency Information Collection Request; 60-Day Public Comment Request, 15227-15228 [2019-07379]
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Federal Register / Vol. 84, No. 72 / Monday, April 15, 2019 / Notices
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, SYMPROIC
(naldemedine tosylate). SYMPROIC is
indicated for the treatment of opioidinduced constipation in adult patients
with chronic non-cancer pain, including
patients with chronic pain related to
prior cancer or its treatment who do not
require frequent (e.g., weekly) opioid
dosage escalation. Subsequent to this
approval, the USPTO received a patent
term restoration application for
SYMPROIC (U.S. Patent No. RE46365)
from Shionogi & Co., Ltd., and the
USPTO requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
January 9, 2018, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
SYMPROIC represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
amozie on DSK9F9SC42PROD with NOTICES
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
SYMPROIC is 2,523 days. Of this time,
2,157 days occurred during the testing
phase of the regulatory review period,
while 366 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 (FD&C Act) (21 U.S.C.
355(i)) became effective: April 28, 2010.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
April 28, 2010.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: March 23, 2016.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
SYMPROIC (NDA 208854) was initially
submitted on March 23, 2016.
3. The date the application was
approved: March 23, 2017. FDA has
verified the applicant’s claim that NDA
208854 was approved on March 23,
2017.
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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 1,140 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: April 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07459 Filed 4–12–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0390]
Agency Information Collection
Request; 60-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.
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
15227
Comments on the ICR must be
received on or before June 14, 2019.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0390–
60D, and project title for reference, to
Sherrette Funn, the Reports Clearance
Officer, Sherrette.funn@hhs.gov, or call
202–795–7714.
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: Challenge and
Prize Competition Solicitations.
Type of Collection: Reinstatement w/
chg.
OMB No. 0990–0390–OS/Office of the
Assistant Secretary for Administration
(ASA).
Abstract: This request, pursuant to the
requirement of section 3506(c)(2)(A) of
the PRA, is to seek generic clearance for
the collection of routine information
requested of responders to solicitations
HHS makes during the issuance of
challenge and prize competitions posted
on a publicly accessible government
website, such as Challenge.gov. Since
passage of the America COMPETES
Reauthorization Act in 2011, Federal
agencies including HHS were given
prize authority for administering
challenges and prize competitions.
Challenges and prize competitions
enable HHS and its family of agencies
(henceforth referred to broadly as
‘‘HHS’’) to tap into the expertise and
creativity of the public in new ways, as
well as extend awareness of HHS
programs and priorities. HHS’s goal is to
engage a broader number of
stakeholders who are inspired to work
on some of our most pressing health
issues, thus supporting a new ecosystem
of scientists, developers, and
entrepreneurs who can continue to
innovate for public health.
In order for HHS to quickly and
effectively launch challenges and prize
competitions on a continual basis, HHS
seeks generic clearance to collect
DATES:
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15228
Federal Register / Vol. 84, No. 72 / Monday, April 15, 2019 / Notices
information for these challenges and
prize competitions, which will generally
include first name, last name, email,
city, state, and, when applicable, other
demographic information of participants
(or, ‘‘solvers’’) or other stakeholders. It
can also include other information
necessary to evaluate submissions and
understand their impact related to the
general goals of the challenge or prize
competition, as well as additional
information relevant to the particular
challenge or prize competition through
structured questions.
The information collected will be
used to understand whether the
participant has met the technical
requirements for the challenge or prize
competition, assist in the technical
review and judging of the solutions that
are provided, and understand the
impact and consequences of
administering the challenge or prize
competition and developing solutions
for submission. Information may be
collected during the challenge or prize
competition or after its completion.
HHS may also ask for additional
information pertaining to the solver’s
engagement in the challenge or prize
competition, such as how they learned
about the challenge or prize
competition, their technical
background, ethnicity, age range, what
they currently understand about the
HHS agency hosting the challenge or
prize competition, etc. This information
will enable HHS to better understand
the diversity of entrants, the effect of the
challenge or prize competition on
increasing public awareness of HHS
programs and priorities, and generally,
to enable the Department to improve its
outreach strategies to ensure a diverse
and broad innovator constituency is
fostered through the use of challenges
and prize competitions.
The information collected will be
used to understand whether the
participant has met the technical
requirements for the challenge or prize
competition, assist in the technical
review and judging of the solutions that
are provided, and understand the
impact and consequences of
administering the challenge or prize
competition and developing solutions
for submission. Information may be
collected during the challenge or prize
competition or after its completion. The
submissions are evaluated by the agency
hosting the challenge or prize
competition and prizes (monetary or
non-monetary) are awarded to the
winning entries.
Likely Respondents: Likely
respondents include individuals,
businesses, and state and local
governments who choose to participate
in a challenge or prize competition
hosted or overseen (i.e., via contract,
etc.) by HHS.
ANNUALIZED BURDEN HOUR TABLE
Respondents
(if necessary)
Number of
responses per
respondents
Average
burden per
response
(hours)
Total
burden hours
Individuals or Households ...............................................................................
Organizations ...................................................................................................
Businesses .......................................................................................................
State, territory, tribal or local governments .....................................................
1,000
500
440
60
1
1
1
1
10/60
10/60
10/60
10/60
166.7
83.3
73.3
10
Total ..........................................................................................................
........................
2,000
........................
333.3
Terry Clark,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2019–07379 Filed 4–12–19; 8:45 am]
BILLING CODE 4150–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2019–0138]
Boston Area Maritime Security
Advisory Committee; Vacancies, Coast
Guard Sector Boston, MA
Coast Guard, Department of
Homeland Security.
AGENCY:
amozie on DSK9F9SC42PROD with NOTICES
Number of
respondents
ACTION:
Solicitation for membership.
This notice requests
individuals interested in serving on the
Boston Area Maritime Security
Committee (AMSC) to submit their
applications for membership, to the
Captain of the Port (COTP), Boston, MA.
SUMMARY:
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Requests for membership should
reach the U.S. Coast Guard COTP
Boston May 15, 2019.
ADDRESSES: Applications for
membership should be submitted to the
Captain of the Port Boston at the
following address: Commander (sx),
USCG Sector Boston, 427 Commercial
Street, Boston, MA 02109 or by email to
Ronald.J.Catudal@uscg.mil.
FOR FURTHER INFORMATION CONTACT: For
questions about submitting an
application or about the AMSC in
general, contact Mr. Ron Catudal at 617–
223–5727 or by email to
Ronald.J.Catudal@uscg.mil.
SUPPLEMENTARY INFORMATION:
DATES:
Authority
Section 102 of the Maritime
Transportation Security Act (MTSA) of
2002 (Pub. L. 107–295) added section
70112 to Title 46 of the U.S. Code, and
authorized the Secretary of the
Department in which the Coast Guard is
operating to establish Area Maritime
Security Advisory Committees for any
port area of the United States. Under 46
U.S.C. 70112(b)(7), the Federal Advisory
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Fmt 4703
Sfmt 4703
Committee Act (FACA) does not apply
to AMSCs.
Boston AMSC Purpose
The AMSCs shall assist the Captain of
the Port in the development, review,
update, and exercise of the Area
Maritime Security Plan for their area of
responsibility. Such matters may
include, but are not limited to:
Identifying critical port infrastructure
and operations; Identifying risks
(threats, vulnerabilities, and
consequences); Determining mitigation
strategies and implementation methods;
Developing strategies to facilitate the
recovery of the MTS after a
Transportation Security Incident;
Developing and describing the process
to continually evaluate overall port
security by considering consequences
and vulnerabilities, how they may
change over time, and what additional
mitigation strategies can be applied
AMSC Composition
The composition of an AMSC, to
include the Boston AMSC, is prescribed
under 33 CFR 103.305. Pursuant to that
E:\FR\FM\15APN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 72 (Monday, April 15, 2019)]
[Notices]
[Pages 15227-15228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07379]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0390]
Agency Information Collection Request; 60-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 June 14, 2019.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0390-60D, and
project title for reference, to Sherrette Funn, the Reports Clearance
Officer, [email protected], or call 202-795-7714.
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: Challenge and Prize Competition
Solicitations.
Type of Collection: Reinstatement w/chg.
OMB No. 0990-0390-OS/Office of the Assistant Secretary for
Administration (ASA).
Abstract: This request, pursuant to the requirement of section
3506(c)(2)(A) of the PRA, is to seek generic clearance for the
collection of routine information requested of responders to
solicitations HHS makes during the issuance of challenge and prize
competitions posted on a publicly accessible government website, such
as Challenge.gov. Since passage of the America COMPETES Reauthorization
Act in 2011, Federal agencies including HHS were given prize authority
for administering challenges and prize competitions. Challenges and
prize competitions enable HHS and its family of agencies (henceforth
referred to broadly as ``HHS'') to tap into the expertise and
creativity of the public in new ways, as well as extend awareness of
HHS programs and priorities. HHS's goal is to engage a broader number
of stakeholders who are inspired to work on some of our most pressing
health issues, thus supporting a new ecosystem of scientists,
developers, and entrepreneurs who can continue to innovate for public
health.
In order for HHS to quickly and effectively launch challenges and
prize competitions on a continual basis, HHS seeks generic clearance to
collect
[[Page 15228]]
information for these challenges and prize competitions, which will
generally include first name, last name, email, city, state, and, when
applicable, other demographic information of participants (or,
``solvers'') or other stakeholders. It can also include other
information necessary to evaluate submissions and understand their
impact related to the general goals of the challenge or prize
competition, as well as additional information relevant to the
particular challenge or prize competition through structured questions.
The information collected will be used to understand whether the
participant has met the technical requirements for the challenge or
prize competition, assist in the technical review and judging of the
solutions that are provided, and understand the impact and consequences
of administering the challenge or prize competition and developing
solutions for submission. Information may be collected during the
challenge or prize competition or after its completion.
HHS may also ask for additional information pertaining to the
solver's engagement in the challenge or prize competition, such as how
they learned about the challenge or prize competition, their technical
background, ethnicity, age range, what they currently understand about
the HHS agency hosting the challenge or prize competition, etc. This
information will enable HHS to better understand the diversity of
entrants, the effect of the challenge or prize competition on
increasing public awareness of HHS programs and priorities, and
generally, to enable the Department to improve its outreach strategies
to ensure a diverse and broad innovator constituency is fostered
through the use of challenges and prize competitions.
The information collected will be used to understand whether the
participant has met the technical requirements for the challenge or
prize competition, assist in the technical review and judging of the
solutions that are provided, and understand the impact and consequences
of administering the challenge or prize competition and developing
solutions for submission. Information may be collected during the
challenge or prize competition or after its completion. The submissions
are evaluated by the agency hosting the challenge or prize competition
and prizes (monetary or non-monetary) are awarded to the winning
entries.
Likely Respondents: Likely respondents include individuals,
businesses, and state and local governments who choose to participate
in a challenge or prize competition hosted or overseen (i.e., via
contract, etc.) by HHS.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Respondents (if necessary) respondents responses per response hours
respondents (hours)
----------------------------------------------------------------------------------------------------------------
Individuals or Households....................... 1,000 1 10/60 166.7
Organizations................................... 500 1 10/60 83.3
Businesses...................................... 440 1 10/60 73.3
State, territory, tribal or local governments... 60 1 10/60 10
---------------------------------------------------------------
Total....................................... .............. 2,000 .............. 333.3
----------------------------------------------------------------------------------------------------------------
Terry Clark,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2019-07379 Filed 4-12-19; 8:45 am]
BILLING CODE 4150-04-P
