Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice, 11755-11756 [2018-05413]
Download as PDF
<![CDATA[
daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices
• 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–N–0529 for ‘‘Illicit Trade in
Tobacco Products after Implementation
of an FDA Product Standard.’’ 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
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.
Submit written requests for single
copies of this draft concept paper to the
Center for Tobacco Products, Food and
VerDate Sep<11>2014
21:54 Mar 15, 2018
Jkt 244001
Drug Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your request or include a fax
number to which the draft concept
paper may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
draft concept paper.
FOR FURTHER INFORMATION CONTACT:
Christopher Griffiths, Center for
Tobacco Products, Food and Drug
Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 1–877–287–1373, email:
CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft concept paper entitled ‘‘Illicit
Trade in Tobacco Products after
Implementation of an FDA Product
Standard.’’ On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Pub. L. 111–31) (Tobacco
Control Act) was enacted. The Tobacco
Control Act grants FDA authority to
implement a wide variety of product
standards impacting different
characteristics of existing and future
tobacco products. This draft concept
paper describes aspects of the tobacco
product market and consumer behavior
that may be relevant to the development
of illicit trade markets if FDA
implements a tobacco product standard.
FDA faces a complex task when
assessing the potential for an illicit trade
market to develop in response to a
tobacco product standard. While it
remains difficult to measure existing
illicit trade markets and use existing
data to reliably predict future illicit
markets, it may be possible to isolate
some of the key factors that may
encourage or discourage illicit trade in
tobacco products. This draft concept
paper assists that effort by breaking
down the potential mechanics of an
illicit trade market into various
components, and examining the factors
that could support or hinder the
establishment of a persistent illicit trade
market in the face of an FDA tobacco
product standard. This paper first
discusses the legal authority and general
approach to establishing tobacco
product standards, and then discusses
the different components of illicit trade
markets, followed by relevant research
in consumer behavior and potentially
applicable economic research.
FDA is providing notice and an
opportunity to comment on this draft
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
11755
concept paper. Please provide evidence
or other information supporting your
comments.
II. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
draft concept paper at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
default.htm.
Dated: March 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05346 Filed 3–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0045]
Pediatric Advisory Committee and the
Endocrinologic and Metabolic Drugs
Advisory Committee; Amendment of
Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the Pediatric Advisory Committee (PAC)
and the Endocrinologic and Metabolic
Drugs Advisory Committee (EMDAC).
This meeting was announced in the
Federal Register of January 23, 2018.
The amendment is being made to reflect
a change in the agenda for the open
session of the meeting and to extend the
amount of time allotted for the closed
session. There are no other changes.
DATES: The meeting will be held on
March 22, 2018, from 8 a.m. to 6 p.m.
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 23, 2018 (83
FR 3156), FDA announced that a
meeting of the PAC and EMDAC would
be held on March 22, 2018.
SUMMARY:
E:\FR\FM\16MRN1.SGM
16MRN1
11756
Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices
FDA is revising the first paragraph of
the agenda for that meeting to read as
follows:
On Thursday, March 22, 2018, the
PAC and EMDAC will meet to discuss
drug development for the treatment of
children with achondroplasia (ACH).
The following topics should be
considered for discussion: Evidence
required to establish dose-response,
study design, study duration, intended
population, and endpoints. In the open
session, the committee does not intend
to discuss any individual research
programs.
FDA is also changing the meeting
procedure and closed committee
deliberations as follows:
Procedure: On March 22, 2018, from
12 p.m. to 6 p.m., the meeting is open
to the public.
Closed Committee Deliberations: On
March 22, 2018, from 8 a.m. to 11 a.m.,
the meeting will be closed to permit
committee review and discussion of
trade secret and/or confidential
commercial information.
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: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05413 Filed 3–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1960]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; MedWatch: The
Food and Drug Administration Medical
Products Reporting Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:54 Mar 15, 2018
Jkt 244001
solicits comments on revisions to Forms
FDA 3500, 3500A, and 3500B used in
the FDA Medical Products Reporting
Program.
Submit either electronic or
written comments on the collection of
information by May 15, 2018.
ADDRESSES: 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 May 15, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of May 15, 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.
DATES:
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:
• 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
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–1960 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
MedWatch: The FDA Medical Products
Reporting Program.’’ 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 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
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.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11755-11756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05413]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0045]
Pediatric Advisory Committee and the Endocrinologic and Metabolic
Drugs Advisory Committee; 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) and the Endocrinologic and Metabolic Drugs Advisory Committee
(EMDAC). This meeting was announced in the Federal Register of January
23, 2018. The amendment is being made to reflect a change in the agenda
for the open session of the meeting and to extend the amount of time
allotted for the closed session. There are no other changes.
DATES: The meeting will be held on March 22, 2018, from 8 a.m. to 6
p.m.
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 23, 2018
(83 FR 3156), FDA announced that a meeting of the PAC and EMDAC would
be held on March 22, 2018.
[[Page 11756]]
FDA is revising the first paragraph of the agenda for that meeting
to read as follows:
On Thursday, March 22, 2018, the PAC and EMDAC will meet to discuss
drug development for the treatment of children with achondroplasia
(ACH). The following topics should be considered for discussion:
Evidence required to establish dose-response, study design, study
duration, intended population, and endpoints. In the open session, the
committee does not intend to discuss any individual research programs.
FDA is also changing the meeting procedure and closed committee
deliberations as follows:
Procedure: On March 22, 2018, from 12 p.m. to 6 p.m., the meeting
is open to the public.
Closed Committee Deliberations: On March 22, 2018, from 8 a.m. to
11 a.m., the meeting will be closed to permit committee review and
discussion of trade secret and/or confidential commercial information.
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: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05413 Filed 3-15-18; 8:45 am]
BILLING CODE 4164-01-P
