Withdrawal of the Laser Products; Proposed Amendment to Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices, 54891-54892 [2018-23916]
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Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Proposed Rules
54891
TABLE 1—INFORMATION ON PARTICIPATING IN THE PUBLIC MEETINGS AND ON SUBMITTING COMMENTS TO THE PRODUCE
SAFETY RULE DRAFT GUIDANCE DOCKET—Continued
Activity
Date
Electronic address
Address
View webcast .........
December 13,
2018; 8:30 a.m.–
5 p.m.
..............................................................
The webcast will have closed captioning.
Advance registration.
by November 23,
2018.
Individuals who wish to participate by
webcast are asked to preregister at
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NewsEvents/WorkshopsMeetings
Conferences/default.htm.
https://www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
We encourage you to use electronic
registration if possible 1.
There is no registration fee for the
public meetings. Early registration is
recommended because seating is
limited.1
Request to make
an oral presentation.
by November 16,
2018.
Submitting either
electronic or written comments.
Submit comments
https://www.regulations.gov .................
by April 22, 2019.
Request special ac- by November 16,
commodations
2018.
due to a disability.
https://www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/default.htm.
..............................................................
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WorkshopsMeetingsConferences/default.htm.
Dockets Management Staff (HFA–
305), Food and Drug Administration,
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See FOR FURTHER INFORMATION
CONTACT.
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submitting comments.
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IV. Transcripts
Dated: October 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23868 Filed 10–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 179
[Docket No. FDA–2018–F–3932]
Bonamar Corp.; Filing of Food Additive
Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of petition.
The Food and Drug
Administration (FDA or we) is
announcing that we have filed a
petition, submitted by Bonamar Corp.,
proposing that we amend our food
additive regulations to provide for the
safe use of sources of ionizing radiation
to control food-borne pathogens in
finfish and flatfish.
DATES: The food additive petition was
filed on September 27, 2018.
amozie on DSK3GDR082PROD with PROPOSALS1
SUMMARY:
VerDate Sep<11>2014
20:21 Oct 31, 2018
For access to the docket to
read background documents or
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:
Molly A. Harry, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1075.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(section 409(b)(5) (21 U.S.C. 348(b)(5))),
we are giving notice that we have filed
a food additive petition (FAP 8M4822),
submitted by Bonamar Corp., c/o Robert
P. Smith, Department of Biological
Sciences, Nova Southeastern University,
3301 College Ave., Fort Lauderdale, FL
33314. The petition proposes to amend
the food additive regulations in § 179.26
(21 CFR 179.26) Ionizing radiation for
the treatment of food to provide for the
safe use of sources of ionizing radiation
to control food-borne pathogens in: (1)
Chilled or frozen raw finfish and
flatfish; and (2) frozen, raw vacuumpacked finfish and flatfish.
The petitioner has claimed that this
action is categorically excluded from the
need to prepare an environmental
assessment or an environmental impact
statement under 21 CFR 25.32(j),
because the petition requests approval
for a source of irradiation which is a
piece of permanent equipment intended
ADDRESSES:
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. You may also
view the transcript at the Dockets
Management Staff (see ADDRESSES).
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Fmt 4702
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for repeated use. In addition, the
petitioner has stated that, to the
petitioner’s knowledge, no
extraordinary circumstances exist. If
FDA determines a categorical exclusion
applies, neither an environmental
assessment nor an environmental
impact statement is required. If FDA
determines a categorical exclusion does
not apply, we will request an
environmental assessment and make it
available for public inspection.
Dated: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23946 Filed 10–31–18; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA, Agency, we) is
SUMMARY:
E:\FR\FM\01NOP1.SGM
01NOP1
54892
Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Proposed Rules
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
amozie on DSK3GDR082PROD with PROPOSALS1
Title of proposed rule
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, Madhusoodana.Nambiar@
fda.hhs.gov.
In 1990,
FDA began a process of periodically
conducting comprehensive reviews of
its regulation process, including
reviewing the backlog of proposed
SUPPLEMENTARY INFORMATION:
Publication date,
Federal Register citation
Docket No.
Reason for withdrawal
The proposed rule 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.
Several adverse comments challenged the proposed
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.
1. Laser Products; Proposed
Amendment to Performance Standard.
June 24, 2013, 78 FR
37723.
FDA–2011–N–0070 ...........
2. Electronic Submission of
Labeling for Certain
Home-Use Medical Devices.
October 17, 2016, 81 FR
71415.
FDA–2016–N–2491 ...........
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
VerDate Sep<11>2014
20:21 Oct 31, 2018
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 770
[EPA–HQ–OPPT–2018–0174; FRL–9984–14]
RIN 2070–AK47
Technical Issues—Formaldehyde
Emission Standards for Composite
Wood Products
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to amend
the regulations promulgated in a final
rule that published in the Federal
Register on December 12, 2016,
concerning formaldehyde emission
standards for composite wood products.
EPA is publishing these proposed
amendments to address certain
technical issues and to further align the
final rule requirements with the
California Air Resources Board (CARB)
Airborne Toxic Control Measures
(ATCM) Phase II program. Addressing
these technical issues would add clarity
SUMMARY:
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Frm 00010
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:
Fmt 4702
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for regulated entities. These revisions to
the existing rule would also streamline
compliance programs and help to
ensure continued smooth transitions for
supply chains to comply with the
requirements associated with regulated
composite wood products.
DATES: Comments must be received on
or before December 3, 2018.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2018–0174, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
E:\FR\FM\01NOP1.SGM
01NOP1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
----------------------------------------------------------------------------------------------------------------
Publication date,
Title of proposed rule Federal Register Docket No. Reason for withdrawal
citation
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
