Listing of Color Additives Subject to Certification; D&C Yellow No. 8; Confirmation of Effective Date, 64443 [2018-27234]
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Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Rules and Regulations
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless this AD specifies otherwise.
(i) Airbus Defence and Space Technical
Document DT–86–3001, CN–235
Airworthiness Limitations List, Issue R,
dated March 20, 2018.
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(3) For service information identified in
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email: MTA.TechnicalService@airbus.com.
(4) You may view this service information
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Issued in Des Moines, Washington, on
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James Cashdollar,
Acting Director, System Oversight Division,
Aircraft Certification Service.
[FR Doc. 2018–26621 Filed 12–14–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 74
[Docket No. FDA–2017–C–2902]
Listing of Color Additives Subject to
Certification; D&C Yellow No. 8;
Confirmation of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
List of Subjects in 21 CFR Part 74
Color additives, Cosmetics, Drugs.
Final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA or we) is
confirming the effective date of October
26, 2018, for the final rule that appeared
in the Federal Register of September 25,
2018, and that amended the color
additive regulations to provide for the
expanded safe use of D&C Yellow No. 8
as a color additive in contact lens
solution.
DATES: The effective date of final rule
published in the Federal Register of
September 25, 2018 (83 FR 48373) is
confirmed: October 26, 2018.
ADDRESSES: For access to the docket to
read background documents or
amozie on DSK3GDR082PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:18 Dec 14, 2018
Jkt 247001
comments received, go to https://
www.regulations.gov and insert the
docket number found in brackets in the
heading of this final rule 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: In the
Federal Register of September 25, 2018
(83 FR 48373), we amended the color
additive regulations to add § 74.3708,
‘‘D&C Yellow No. 8,’’ (21 CFR 74.3708)
to provide for the expanded safe use of
D&C Yellow No. 8 as a color additive in
contact lens solution.
We gave interested persons until
October 25, 2018, to file objections or
requests for a hearing. We explained
that, to file an objection, among other
things, persons must specify with
particularity the provision(s) to which
they object. We also explained that if a
person who properly submits an
objection wants a hearing, he or she
must specifically request a hearing and
that failure to do so will constitute a
waiver of the right to a hearing (83 FR
48373 at 48375).
We received seven comments
regarding our decision to amend the
color additive regulations to provide for
the expanded safe use of D&C Yellow
No. 8 as a color additive in contact lens
solution. None of the comments,
however, specified with particularity
the provision(s) of the regulation to
which they objected nor specifically
requested a hearing. Therefore, we find
that the effective date of the final rule
that published in the Federal Register of
September 25, 2018, should be
confirmed.
Therefore, under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321,
341, 342, 343, 348, 351, 352, 355, 361,
362, 371, 379e) and under authority
delegated to the Commissioner of Food
and Drugs, we are giving notice that no
objections or requests for a hearing were
filed in response to the September 25,
2018, final rule. Accordingly, the
amendments issued in the final rule
became effective October 26, 2018.
■
Dated: December 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–27234 Filed 12–14–18; 8:45 am]
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64443
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 860
[Docket No. FDA-2013–N–1529]
RIN 0910–AH75
Medical Device Classification
Procedures: Incorporating Food and
Drug Administration Safety and
Innovation Act Procedures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, the Agency, or
we) is issuing a final rule to amend its
regulations governing classification and
reclassification of medical devices to
conform to the applicable provisions of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) as amended by the Food
and Drug Administration Safety and
Innovation Act (FDASIA). FDA is also
making additional changes unrelated to
the FDASIA requirements, to update its
regulations governing the classification
and reclassification of medical devices.
FDA is taking this action to codify the
procedures and criteria that apply to the
classification and reclassification of
medical devices and to provide for
classification of devices in the lowest
regulatory class consistent with the
public health and the statutory scheme
for device regulation.
DATES: This rule is effective March 18,
2019.
ADDRESSES: 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 final rule into the
‘‘Search’’ box and follow the prompts,
and/or go to Dockets Management Staff,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: For
information concerning the final rule as
it relates to devices regulated by the
Center for Devices and Radiological
Health (CDRH): Ana Loloei, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave, Bldg. 66, Rm. 5452,
Silver Spring, MD 20993–0002.
For information concerning the final
rule as it relates to devices regulated by
the Center for Biologics Evaluation and
Research (CBER): Stephen Ripley,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
SUMMARY:
E:\FR\FM\17DER1.SGM
17DER1
]]>Agencies
[Federal Register Volume 83, Number 241 (Monday, December 17, 2018)]
[Rules and Regulations]
[Page 64443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27234]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 74
[Docket No. FDA-2017-C-2902]
Listing of Color Additives Subject to Certification; D&C Yellow
No. 8; Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is confirming the
effective date of October 26, 2018, for the final rule that appeared in
the Federal Register of September 25, 2018, and that amended the color
additive regulations to provide for the expanded safe use of D&C Yellow
No. 8 as a color additive in contact lens solution.
DATES: The effective date of final rule published in the Federal
Register of September 25, 2018 (83 FR 48373) is confirmed: October 26,
2018.
ADDRESSES: 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 final rule 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: In the Federal Register of September 25,
2018 (83 FR 48373), we amended the color additive regulations to add
Sec. 74.3708, ``D&C Yellow No. 8,'' (21 CFR 74.3708) to provide for
the expanded safe use of D&C Yellow No. 8 as a color additive in
contact lens solution.
We gave interested persons until October 25, 2018, to file
objections or requests for a hearing. We explained that, to file an
objection, among other things, persons must specify with particularity
the provision(s) to which they object. We also explained that if a
person who properly submits an objection wants a hearing, he or she
must specifically request a hearing and that failure to do so will
constitute a waiver of the right to a hearing (83 FR 48373 at 48375).
We received seven comments regarding our decision to amend the
color additive regulations to provide for the expanded safe use of D&C
Yellow No. 8 as a color additive in contact lens solution. None of the
comments, however, specified with particularity the provision(s) of the
regulation to which they objected nor specifically requested a hearing.
Therefore, we find that the effective date of the final rule that
published in the Federal Register of September 25, 2018, should be
confirmed.
List of Subjects in 21 CFR Part 74
Color additives, Cosmetics, Drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under
authority delegated to the Commissioner of Food and Drugs, we are
giving notice that no objections or requests for a hearing were filed
in response to the September 25, 2018, final rule. Accordingly, the
amendments issued in the final rule became effective October 26, 2018.
Dated: December 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27234 Filed 12-14-18; 8:45 am]
BILLING CODE 4164-01-P
