83 FR 13134 - Orthopaedic Sensing, Measuring, and Advanced Reporting Technology Devices; Public Workshop; Request for Comments; Amendment of Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 59 (March 27, 2018)

Page Range		13134-13134
FR Document		2018-06064

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.

Federal Register, Volume 83 Issue 59 (Tuesday, March 27, 2018)

[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Page 13134]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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]
 BILLING CODE 4164-01-P

13134 Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices

I. General Description of the complete résumé or curriculum vitae for Devices’’ would be held on April 30,
Committee’s Duties each nominee and a signed copy of the 2018. On page 6188, in the third
The Committee provides advice on Acknowledgement and Consent form column, the DATES portion of the
scientific, technical, and medical issues available at the FDA Advisory document is changed to reflect new start
concerning human drug compounding Nomination Portal (see ADDRESSES). and end times to read as follows:
under sections 503A and 503B of the Nominations must also specify the DATES: The public workshop will be
FD&C Act (21 U.S.C. 353a and 353b), advisory committee for which the held on April 30, 2018, from 8 a.m. to
and, as required, any other product for nominee is recommended. Nominations 5:30 p.m. Submit either electronic or
which FDA has regulatory must also acknowledge that the written comments on this public
responsibility, and makes appropriate nominee is aware of the nomination workshop by May 29, 2018. See the
recommendations to the Commissioner unless self-nominated. FDA will ask SUPLLEMENTARY INFORMATION section for
of Food and Drugs. potential candidates to provide detailed registration date and information.
In implementing sections 503A and information concerning such matters
Dated: March 21, 2018.
section 503B of the FD&C Act, the related to financial holdings,
Leslie Kux,
Agency may consult the Committee on: employment, and research grants and/or
contracts to permit evaluation of Associate Commissioner for Policy.
(1) Drug products for inclusion on a list [FR Doc. 2018–06064 Filed 3–26–18; 8:45 am]
of drug products that have been possible sources of conflicts of interest.
withdrawn or removed from the market This notice is issued under the BILLING CODE 4164–01–P

because such drug products or Federal Advisory Committee Act (5
components of such drug products have U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees. DEPARTMENT OF HEALTH AND
been found to be unsafe or not effective, HUMAN SERVICES
and therefore cannot be compounded; Dated: March 21, 2018.
(2) bulk drug substances for inclusion Leslie Kux, Food and Drug Administration
on lists of bulk drug substances that Associate Commissioner for Policy.
[Docket No. FDA–2018–D–0943]
may be used in compounding; and (3) [FR Doc. 2018–06062 Filed 3–26–18; 8:45 am]
drug products for inclusion on a list of BILLING CODE 4164–01–P Elemental Impurities in Animal Drug
drug products that present demonstrable Products—Questions and Answers;
difficulties for compounding. Draft Guidance for Industry;
Meetings are held approximately two DEPARTMENT OF HEALTH AND Availability
to three times a year, announced in the HUMAN SERVICES
Federal Register, and are open to the AGENCY: Food and Drug Administration,
public except as determined otherwise Food and Drug Administration HHS.
by the Commissioner or designee in [Docket No. FDA–2018–N–0235] ACTION: Notice of availability.
accordance with the Government in the
Sunshine Act (5 U.S.C. 552b(c)) and the Orthopaedic Sensing, Measuring, and SUMMARY: The Food and Drug
Federal Advisory Committee Act. Notice Advanced Reporting Technology Administration (FDA or Agency) is
of all meetings shall be given to the Devices; Public Workshop; Request announcing the availability of a draft
public. for Comments; Amendment of Notice guidance for industry (GFI) #255
entitled ‘‘Elemental Impurities in
II. Criteria for Voting Members AGENCY: Food and Drug Administration, Animal Drug Products—Questions and
The Committee consists of a core of HHS. Answers.’’ This guidance is intended to
12 voting members including the Chair. ACTION: Notice. assist sponsors of animal drug products
Members and the Chair are selected by in addressing changes in the United
the Commissioner or designee from SUMMARY: The Food and Drug States Pharmacopeia (USP)
among authorities knowledgeable in the Administration (FDA, the Agency, or requirements for the control of
fields of pharmaceutical compounding, we) is announcing an amendment to the elemental impurities in drug products
pharmaceutical manufacturing, notice of public workshop entitled marketed in the United States.
pharmacy, medicine, and related ‘‘Orthopaedic Sensing, Measuring, and DATES: Submit either electronic or
specialties. These members will include Advanced Reporting Technology written comments on the draft guidance
representatives from the National (SMART) Devices.’’ That workshop was by May 29, 2018 to ensure that the
Association of Boards of Pharmacy, the announced in the Federal Register of Agency considers your comment on this
U.S. Pharmacopeia, pharmacists with February 13, 2018. The amendment is draft guidance before it begins work on
current experience and expertise in being made to reflect a change in the the final version of the guidance.
DATES portion of the document. There
compounding, physicians with ADDRESSES: You may submit comments
background and knowledge in are no other changes.
on any guidance at any time as follows:
compounding, and patient and public FOR FURTHER INFORMATION CONTACT:
health advocacy organizations. Almost Andrew Baumann, Center for Devices Electronic Submissions
all non-Federal members of this and Radiological Health, Food and Drug Submit electronic comments in the
committee serve as Special Government Administration, 10903 New Hampshire following way:
Employees. Members will be invited to Ave., Bldg. 62, Rm. 2110, Silver Spring, • Federal eRulemaking Portal:
serve for terms of up to 4 years. MD 20993, 301–796–2508, https://www.regulations.gov. Follow the
amozie on DSK30RV082PROD with NOTICES

andrew.baumann@fda.hhs.gov. instructions for submitting comments.
III. Nomination Procedures SUPPLEMENTARY INFORMATION: In the Comments submitted electronically,
Any interested person may nominate Federal Register of February 13, 2018 including attachments, to https://
one or more qualified individuals for (83 FR 6188), FDA announced that a www.regulations.gov will be posted to
membership on the advisory committee. public workshop entitled ‘‘Orthopaedic the docket unchanged. Because your
Self-nominations are also accepted. Sensing, Measuring, and Advanced comment will be made public, you are
Nominations must include a current, Reporting Technology (SMART) solely responsible for ensuring that your

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Document Created: 2018-03-27 01:26:50
Document Modified: 2018-03-27 01:26:50

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 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.
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]
FR Citation		83 FR 13134

83 FR 13134 - Orthopaedic Sensing, Measuring, and Advanced Reporting Technology Devices; Public Workshop; Request for Comments; Amendment of Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 59 (March 27, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration