83 FR 11755 - Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 52 (March 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 52 (March 16, 2018)
| Page Range | 11755-11756 | |
| FR Document | 2018-05413 |
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)] [Notices] [Pages 11755-11756] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 11755
• For written/paper comments Drug Administration, Document Control concept paper. Please provide evidence
submitted to the Dockets Management Center, Bldg. 71, Rm. G335, 10903 New or other information supporting your
Staff, FDA will post your comment, as Hampshire Ave., Silver Spring, MD comments.
well as any attachments, except for 20993–0002. Send one self-addressed
II. Electronic Access
information submitted, marked and adhesive label to assist that office in
identified, as confidential, if submitted processing your request or include a fax Persons with access to the internet
as detailed in ‘‘Instructions.’’ number to which the draft concept may obtain an electronic version of the
Instructions: All submissions received paper may be sent. See the draft concept paper at either https://
must include the Docket No. FDA– SUPPLEMENTARY INFORMATION section for www.regulations.gov or https://
2018–N–0529 for ‘‘Illicit Trade in information on electronic access to the www.fda.gov/TobaccoProducts/
Tobacco Products after Implementation draft concept paper. Labeling/RulesRegulationsGuidance/
of an FDA Product Standard.’’ Received FOR FURTHER INFORMATION CONTACT: default.htm.
comments will be placed in the docket Christopher Griffiths, Center for Dated: March 12, 2018.
and, except for those submitted as Tobacco Products, Food and Drug
‘‘Confidential Submissions,’’ publicly Leslie Kux,
Administration, Document Control Associate Commissioner for Policy.
viewable at https://www.regulations.gov Center, Bldg. 71, Rm. G335, 10903 New
or at the Dockets Management Staff Hampshire Ave., Silver Spring, MD
[FR Doc. 2018–05346 Filed 3–15–18; 8:45 am]
between 9 a.m. and 4 p.m., Monday 20993–0002, 1–877–287–1373, email: BILLING CODE 4164–01–P
through Friday. CTPRegulations@fda.hhs.gov.
• Confidential Submissions—To
submit a comment with confidential SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND
information that you do not wish to be I. Background HUMAN SERVICES
made publicly available, submit your
comments only as a written/paper FDA is announcing the availability of Food and Drug Administration
submission. You should submit two a draft concept paper entitled ‘‘Illicit
copies total. One copy will include the Trade in Tobacco Products after [Docket No. FDA–2018–N–0045]
information you claim to be confidential Implementation of an FDA Product
with a heading or cover note that states Standard.’’ On June 22, 2009, the Family Pediatric Advisory Committee and the
‘‘THIS DOCUMENT CONTAINS Smoking Prevention and Tobacco Endocrinologic and Metabolic Drugs
CONFIDENTIAL INFORMATION.’’ The Control Act (Pub. L. 111–31) (Tobacco Advisory Committee; Amendment of
Agency will review this copy, including Control Act) was enacted. The Tobacco Notice
the claimed confidential information, in Control Act grants FDA authority to
its consideration of comments. The implement a wide variety of product AGENCY: Food and Drug Administration,
second copy, which will have the standards impacting different HHS.
claimed confidential information characteristics of existing and future ACTION: Notice.
redacted/blacked out, will be available tobacco products. This draft concept
for public viewing and posted on paper describes aspects of the tobacco SUMMARY: The Food and Drug
https://www.regulations.gov. Submit product market and consumer behavior Administration (FDA) is announcing an
both copies to the Dockets Management that may be relevant to the development amendment to the notice of meeting of
Staff. If you do not wish your name and of illicit trade markets if FDA the Pediatric Advisory Committee (PAC)
contact information to be made publicly implements a tobacco product standard. and the Endocrinologic and Metabolic
available, you can provide this FDA faces a complex task when Drugs Advisory Committee (EMDAC).
information on the cover sheet and not assessing the potential for an illicit trade This meeting was announced in the
in the body of your comments and you market to develop in response to a Federal Register of January 23, 2018.
must identify this information as tobacco product standard. While it The amendment is being made to reflect
‘‘confidential.’’ Any information marked remains difficult to measure existing a change in the agenda for the open
as ‘‘confidential’’ will not be disclosed illicit trade markets and use existing session of the meeting and to extend the
except in accordance with 21 CFR 10.20 data to reliably predict future illicit amount of time allotted for the closed
and other applicable disclosure law. For markets, it may be possible to isolate session. There are no other changes.
more information about FDA’s posting some of the key factors that may DATES: The meeting will be held on
of comments to public dockets, see 80 encourage or discourage illicit trade in March 22, 2018, from 8 a.m. to 6 p.m.
FR 56469, September 18, 2015, or access tobacco products. This draft concept
paper assists that effort by breaking FOR FURTHER INFORMATION CONTACT:
the information at: https://www.gpo.gov/
down the potential mechanics of an Marieann Brill, Office of the
fdsys/pkg/FR-2015-09-18/pdf/2015-
illicit trade market into various Commissioner, Food and Drug
23389.pdf.
Docket: For access to the docket to components, and examining the factors Administration, 10903 New Hampshire
read background documents or the that could support or hinder the Ave., Bldg. 32, Rm. 5154, Silver Spring,
electronic and written/paper comments establishment of a persistent illicit trade MD 20993, 240–402–3838,
received, go to https:// market in the face of an FDA tobacco marieann.brill@fda.hhs.gov, or FDA
www.regulations.gov and insert the product standard. This paper first Advisory Committee Information Line,
docket number, found in brackets in the discusses the legal authority and general 1–800–741–8138 (301–443–0572 in the
heading of this document, into the approach to establishing tobacco Washington, DC area). Please call the
daltland on DSKBBV9HB2PROD with NOTICES
‘‘Search’’ box and follow the prompts product standards, and then discusses Information Line for up-to-date
and/or go to the Dockets Management the different components of illicit trade information on this meeting.
Staff, 5630 Fishers Lane, Rm. 1061, markets, followed by relevant research SUPPLEMENTARY INFORMATION: In the
Rockville, MD 20852. in consumer behavior and potentially Federal Register of January 23, 2018 (83
Submit written requests for single applicable economic research. FR 3156), FDA announced that a
copies of this draft concept paper to the FDA is providing notice and an meeting of the PAC and EMDAC would
Center for Tobacco Products, Food and opportunity to comment on this draft be held on March 22, 2018.
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![11756 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices
FDA is revising the first paragraph of solicits comments on revisions to Forms identified, as confidential, if submitted
the agenda for that meeting to read as FDA 3500, 3500A, and 3500B used in as detailed in ‘‘Instructions.’’
follows: the FDA Medical Products Reporting Instructions: All submissions received
On Thursday, March 22, 2018, the Program. must include the Docket No. FDA–
PAC and EMDAC will meet to discuss DATES: Submit either electronic or 2014–N–1960 for ‘‘Agency Information
drug development for the treatment of written comments on the collection of Collection Activities; Proposed
children with achondroplasia (ACH). information by May 15, 2018. Collection; Comment Request;
The following topics should be MedWatch: The FDA Medical Products
ADDRESSES: You may submit comments
considered for discussion: Evidence Reporting Program.’’ Received
as follows. Please note that late,
required to establish dose-response, comments, those filed in a timely
untimely filed comments will not be
study design, study duration, intended manner (see ADDRESSES), will be placed
considered. Electronic comments must
population, and endpoints. In the open in the docket and, except for those
be submitted on or before May 15, 2018.
session, the committee does not intend submitted as ‘‘Confidential
The https://www.regulations.gov
to discuss any individual research Submissions,’’ publicly viewable at
electronic filing system will accept
programs. https://www.regulations.gov or at the
comments until midnight Eastern Time
FDA is also changing the meeting Dockets Management Staff between 9
at the end of May 15, 2018. Comments
procedure and closed committee a.m. and 4 p.m., Monday through
received by mail/hand delivery/courier
deliberations as follows: Friday.
(for written/paper submissions) will be
Procedure: On March 22, 2018, from • Confidential Submissions—To
considered timely if they are
12 p.m. to 6 p.m., the meeting is open submit a comment with confidential
postmarked or the delivery service
to the public. information that you do not wish to be
acceptance receipt is on or before that
Closed Committee Deliberations: On made publicly available, submit your
date.
March 22, 2018, from 8 a.m. to 11 a.m., comments only as a written/paper
the meeting will be closed to permit Electronic Submissions submission. You should submit two
committee review and discussion of Submit electronic comments in the copies total. One copy will include the
trade secret and/or confidential following way: information you claim to be confidential
commercial information. • Federal eRulemaking Portal: with a heading or cover note that states
This notice is issued under the https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
Federal Advisory Committee Act (5 instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
U.S.C. app. 2) and 21 CFR part 14, Comments submitted electronically, Agency will review this copy, including
relating to the advisory committees. including attachments, to https:// the claimed confidential information, in
Dated: March 13, 2018. www.regulations.gov will be posted to its consideration of comments. The
Leslie Kux, the docket unchanged. Because your second copy, which will have the
comment will be made public, you are claimed confidential information
Associate Commissioner for Policy.
solely responsible for ensuring that your redacted/blacked out, will be available
[FR Doc. 2018–05413 Filed 3–15–18; 8:45 am]
comment does not include any for public viewing and posted on
BILLING CODE 4164–01–P https://www.regulations.gov. Submit
confidential information that you or a
third party may not wish to be posted, both copies to the Dockets Management
such as medical information, your or Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND
anyone else’s Social Security number, or contact information to be made publicly
HUMAN SERVICES
confidential business information, such available, you can provide this
Food and Drug Administration as a manufacturing process. Please note information on the cover sheet and not
that if you include your name, contact in the body of your comments and you
[Docket No. FDA–2014–N–1960] must identify this information as
information, or other information that
identifies you in the body of your ‘‘confidential.’’ Any information marked
Agency Information Collection as ‘‘confidential’’ will not be disclosed
Activities; Proposed Collection; comments, that information will be
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
Comment Request; MedWatch: The and other applicable disclosure law. For
Food and Drug Administration Medical • If you want to submit a comment
with confidential information that you more information about FDA’s posting
Products Reporting Program of comments to public dockets, see 80
do not wish to be made available to the
AGENCY: Food and Drug Administration, public, submit the comment as a FR 56469, September 18, 2015, or access
HHS. written/paper submission and in the the information at: https://www.gpo.gov/
manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
ACTION: Notice.
Submissions’’ and ‘‘Instructions’’). 23389.pdf.
SUMMARY: The Food and Drug Docket: For access to the docket to
Administration (FDA or Agency) is Written/Paper Submissions read background documents or the
announcing an opportunity for public Submit written/paper submissions as electronic and written/paper comments
comment on the proposed collection of follows: received, go to https://
certain information by the Agency. • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Under the Paperwork Reduction Act of written/paper submissions): Dockets docket number, found in brackets in the
1995 (PRA), Federal Agencies are Management Staff (HFA–305), Food and heading of this document, into the
daltland on DSKBBV9HB2PROD with NOTICES
required to publish notice in the Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
proposed collection of information, • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
including each proposed extension of an submitted to the Dockets Management Rockville, MD 20852.
existing collection of information, and Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
to allow 60 days for public comment in well as any attachments, except for Amber Sanford, Office of Operations,
response to the notice. This notice information submitted, marked and Food and Drug Administration, Three
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Document Created: 2018-03-16 01:11:54
Document Modified: 2018-03-16 01:11:54
| 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 | The meeting will be held on March 22, 2018, from 8 a.m. to 6 p.m. | |
| 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. | |
| FR Citation | 83 FR 11755 |
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