Pediatric Advisory Committee; Establishment of a Public Docket; Request for Comments; Amendment of Notice, 7058-7059 [2018-03231]
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7058
Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–0178 for ‘‘Drugs for Treatment
of Partial Onset Seizures: Full
Extrapolation of Efficacy from Adults to
Pediatric Patients 4 Years of Age and
Older; Draft Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
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the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Billy Dunn, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4332, Silver Spring,
MD 20993–0002, 301–796–2250.
SUPPLEMENTARY INFORMATION:
Seizures: Full Extrapolation of Efficacy
From Adults to Pediatric Patients 4
Years of Age and Older.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
I. Background
AGENCY:
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Drugs for Treatment of Partial Onset
Seizures: Full Extrapolation of Efficacy
from Adults to Pediatric Patients 4
Years of Age and Older.’’ The draft
guidance provides recommendations to
sponsors on the clinical development of
drugs for the treatment of POS in
pediatric patients. Specifically, it
addresses FDA’s thinking regarding
clinical development programs that can
support extrapolation of evidence of
effectiveness in treatment of POS in
adults to pediatric patients 4 years of
age and older.
This draft guidance explains how
efficacy can be extrapolated from adults
to children when it is reasonable to
assume that children, compared with
adults, have a similar progression of
disease, similar response of the disease
to treatment, and similar exposureresponse relationship.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Drugs for Treatment of Partial Onset
HHS.
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II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: February 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03223 Filed 2–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6928]
Pediatric Advisory Committee;
Establishment of a Public Docket;
Request for Comments; Amendment of
Notice
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the Pediatric Advisory Committee
(PAC). This meeting was announced in
the Federal Register of January 2, 2018.
The amendment is being made to reflect
a change in the Center for Devices and
Radiological Health (CDRH) products
portion of the document and to include
the topics that will be discussed during
the meeting. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Marieann Brill, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5154, Silver Spring,
MD 20993, 240–402–3838,
marieann.brill@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 2, 2018 (83
FR 125), FDA announced that a meeting
SUMMARY:
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Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
of the Pediatric Advisory Committee
would be held on March 23, 2018.
FDA will provide updates on the
following topics without vote by the
committee:
• Update regarding labeling change
for inhaled corticosteroid long-acting b2 agonists (ICS/LABAs);
• Safety labeling for gadolinium
products;
• Overview of the FDA Adverse Event
Reporting System (FAERS) and reports
on reduced or lack of efficacy for certain
generic drugs; and
• Generic drug approval process; and
discussion on the differences in the
approval process for brand name drugs
versus generic drugs; exceptions.
On page 126, in the third column, the
CDRH products portion of the document
is changed to read as follows:
The PAC will meet to discuss the
following products (listed by FDA
Center):
(2) Center for Devices and Radiological
Health
a. MEDTRONIC ACTIVA DYSTONIA
THERAPY (Humanitarian Device
Exemption (HDE))
b. LIPOSORBER LA–15 SYSTEM
(HDE)
CDRH will update the committee on the
regulatory status of a previously
reviewed HDE.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: February 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03231 Filed 2–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–2477]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; HYMOVIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
HYMOVIS and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
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SUMMARY:
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Department of Commerce, for the
extension of a patent which claims that
medical device.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 17, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 15, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 17,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 17, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
PO 00000
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Fmt 4703
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7059
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–E–2477 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; HYMOVIS.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7058-7059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03231]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6928]
Pediatric Advisory Committee; Establishment of a Public Docket;
Request for Comments; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Pediatric Advisory Committee
(PAC). This meeting was announced in the Federal Register of January 2,
2018. The amendment is being made to reflect a change in the Center for
Devices and Radiological Health (CDRH) products portion of the document
and to include the topics that will be discussed during the meeting.
There are no other changes.
FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838,
[email protected], or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call
the Information Line for up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 2, 2018
(83 FR 125), FDA announced that a meeting
[[Page 7059]]
of the Pediatric Advisory Committee would be held on March 23, 2018.
FDA will provide updates on the following topics without vote by
the committee:
Update regarding labeling change for inhaled
corticosteroid long-acting [beta]-2 agonists (ICS/LABAs);
Safety labeling for gadolinium products;
Overview of the FDA Adverse Event Reporting System (FAERS)
and reports on reduced or lack of efficacy for certain generic drugs;
and
Generic drug approval process; and discussion on the
differences in the approval process for brand name drugs versus generic
drugs; exceptions.
On page 126, in the third column, the CDRH products portion of the
document is changed to read as follows:
The PAC will meet to discuss the following products (listed by FDA
Center):
(2) Center for Devices and Radiological Health
a. MEDTRONIC ACTIVA DYSTONIA THERAPY (Humanitarian Device Exemption
(HDE))
b. LIPOSORBER LA-15 SYSTEM (HDE)
CDRH will update the committee on the regulatory status of a previously
reviewed HDE.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: February 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03231 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P
