Orthopaedic Sensing, Measuring, and Advanced Reporting Technology Devices; Public Workshop; Request for Comments; Amendment of Notice, 13134 [2018-06064]
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Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices
I. General Description of the
Committee’s Duties
The Committee provides advice on
scientific, technical, and medical issues
concerning human drug compounding
under sections 503A and 503B of the
FD&C Act (21 U.S.C. 353a and 353b),
and, as required, any other product for
which FDA has regulatory
responsibility, and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
In implementing sections 503A and
section 503B of the FD&C Act, the
Agency may consult the Committee on:
(1) Drug products for inclusion on a list
of drug products that have been
withdrawn or removed from the market
because such drug products or
components of such drug products have
been found to be unsafe or not effective,
and therefore cannot be compounded;
(2) bulk drug substances for inclusion
on lists of bulk drug substances that
may be used in compounding; and (3)
drug products for inclusion on a list of
drug products that present demonstrable
difficulties for compounding.
Meetings are held approximately two
to three times a year, announced in the
Federal Register, and are open to the
public except as determined otherwise
by the Commissioner or designee in
accordance with the Government in the
Sunshine Act (5 U.S.C. 552b(c)) and the
Federal Advisory Committee Act. Notice
of all meetings shall be given to the
public.
´
´
complete resume or curriculum vitae for
each nominee and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06062 Filed 3–26–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–0943]
Elemental Impurities in Animal Drug
Products—Questions and Answers;
Draft Guidance for Industry;
Availability
AGENCY:
ACTION:
Orthopaedic Sensing, Measuring, and
Advanced Reporting Technology
Devices; Public Workshop; Request
for Comments; Amendment of Notice
HHS.
18:07 Mar 26, 2018
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[Docket No. FDA–2018–N–0235]
AGENCY:
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[FR Doc. 2018–06064 Filed 3–26–18; 8:45 am]
Food and Drug Administration,
HHS.
The Committee consists of a core of
12 voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of pharmaceutical compounding,
pharmaceutical manufacturing,
pharmacy, medicine, and related
specialties. These members will include
representatives from the National
Association of Boards of Pharmacy, the
U.S. Pharmacopeia, pharmacists with
current experience and expertise in
compounding, physicians with
background and knowledge in
compounding, and patient and public
health advocacy organizations. Almost
all non-Federal members of this
committee serve as Special Government
Employees. Members will be invited to
serve for terms of up to 4 years.
Any interested person may nominate
one or more qualified individuals for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
II. Criteria for Voting Members
III. Nomination Procedures
Devices’’ would be held on April 30,
2018. On page 6188, in the third
column, the DATES portion of the
document is changed to reflect new start
and end times to read as follows:
DATES: The public workshop will be
held on April 30, 2018, from 8 a.m. to
5:30 p.m. Submit either electronic or
written comments on this public
workshop by May 29, 2018. See the
SUPLLEMENTARY INFORMATION section for
registration date and information.
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing an amendment to the
notice of public workshop entitled
‘‘Orthopaedic Sensing, Measuring, and
Advanced Reporting Technology
(SMART) Devices.’’ That workshop was
announced in the Federal Register of
February 13, 2018. The amendment is
being made to reflect a change in the
DATES portion of the document. There
are no other changes.
FOR FURTHER INFORMATION CONTACT:
Andrew Baumann, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 2110, Silver Spring,
MD 20993, 301–796–2508,
andrew.baumann@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of February 13, 2018
(83 FR 6188), FDA announced that a
public workshop entitled ‘‘Orthopaedic
Sensing, Measuring, and Advanced
Reporting Technology (SMART)
SUMMARY:
PO 00000
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Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry (GFI) #255
entitled ‘‘Elemental Impurities in
Animal Drug Products—Questions and
Answers.’’ This guidance is intended to
assist sponsors of animal drug products
in addressing changes in the United
States Pharmacopeia (USP)
requirements for the control of
elemental impurities in drug products
marketed in the United States.
DATES: Submit either electronic or
written comments on the draft guidance
by May 29, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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
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[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Page 13134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06064]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0235]
Orthopaedic Sensing, Measuring, and Advanced Reporting Technology
Devices; Public Workshop; Request for Comments; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing an amendment to the notice of public workshop entitled
``Orthopaedic Sensing, Measuring, and Advanced Reporting Technology
(SMART) Devices.'' That workshop was announced in the Federal Register
of February 13, 2018. The amendment is being made to reflect a change
in the DATES portion of the document. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Andrew Baumann, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 2110, Silver Spring, MD 20993, 301-796-2508,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of February 13, 2018
(83 FR 6188), FDA announced that a public workshop entitled
``Orthopaedic Sensing, Measuring, and Advanced Reporting Technology
(SMART) Devices'' would be held on April 30, 2018. On page 6188, in the
third column, the DATES portion of the document is changed to reflect
new start and end times to read as follows:
DATES: The public workshop will be held on April 30, 2018, from 8 a.m.
to 5:30 p.m. Submit either electronic or written comments on this
public workshop by May 29, 2018. See the SUPLLEMENTARY INFORMATION
section for registration date and information.
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06064 Filed 3-26-18; 8:45 am]
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