[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Proposed Rules]
[Pages 54891-54892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23916]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 807, 1002, 1010, and 1040
[Docket Nos. FDA-2011-N-0070 and FDA-2016-N-2491]
RIN 0910-AG79 and 0910-AF87
Withdrawal of the Laser Products; Proposed Amendment to
Performance Standard and the Electronic Submission of Labeling for
Certain Home-Use Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA, Agency, we) is
[[Page 54892]]
announcing the withdrawal of two proposed rules that published in the
Federal Register. These proposed rules are not currently considered
viable candidates for final action. FDA is taking this action because
these proposed rules need to be reconsidered based on public comments
received and new information developed after the publication of the
proposed rules.
DATES: As of November 1, 2018, the proposed rules published on June 24,
2013, at 78 FR 37723, and October 17, 2016, at 81 FR 71415 are
withdrawn.
ADDRESSES: For access to the docket, 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: Madhusoodana Nambiar, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5518, Silver Spring, MD 20993-0002,
301-796-5837, [email protected].
SUPPLEMENTARY INFORMATION: In 1990, FDA began a process of periodically
conducting comprehensive reviews of its regulation process, including
reviewing the backlog of proposed rulemakings that had not been
finalized. As FDA removed many proposed rules not finalized, the Agency
implemented a process of reviewing existing proposed rules every 5
years.
As part of this process and the Agency's regulatory reform
initiative, we continue to conduct reviews of existing proposed rules.
The review determines if the proposals are outdated, unnecessary, or
should be revised to reduce regulatory burden while allowing FDA to
achieve our public health mission and fulfill statutory obligations.
As part of these efforts, FDA is withdrawing the following proposed
rules:
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Publication date,
Title of proposed rule Federal Register Docket No. Reason for withdrawal
citation
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1. Laser Products; Proposed June 24, 2013, 78 FR FDA-2011-N-0070....... The proposed rule
Amendment to Performance Standard. 37723. referenced an
international performance
standard. That
international standard is
now being revised to
reflect advancements in
technology. FDA wants to
have the most current
international standard as
a reference before
publishing a final rule on
laser products.
2. Electronic Submission of October 17, 2016, 81 FDA-2016-N-2491....... Several adverse comments
Labeling for Certain Home-Use FR 71415. challenged the proposed
Medical Devices. FDA-managed labeling
database as being unduly
burdensome on both FDA and
on industry, without
efficiently enhancing
public health.
Additionally, concerns
regarding the proposed
format and potential costs
for industry to fully
implement were also
raised. Based on the
adverse comments, this
rulemaking would benefit
from being withdrawn at
this time and
reconsidered. The Agency
plans to reconsider its
approach and solicit
further public input at a
future date.
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The withdrawal of these proposals identified in this document does
not preclude the Agency from reinstituting rulemaking concerning the
issues addressed in the proposals listed in the chart. Should we decide
to undertake such rulemakings in the future, we will re-propose the
actions and provide new opportunities for comment. Furthermore, this
withdrawal of the proposed rules is only intended to address the
specific actions identified in this document, and not any other pending
proposals that the Agency has issued or is considering. If you need
additional information about the subject matter of the withdrawn
proposed rules, you may review the Agency's website (https://www.fda.gov) for any current information on the matter.
Dated: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23916 Filed 10-31-18; 8:45 am]
BILLING CODE 4164-01-P