Milton W. Chu, M.D.; Filing of Color Additive Petition, 15173 [2016-06397]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Proposed Rules
(h) Subject
Joint Aircraft Service Component (JASC)
Code: 6510, Tail Rotor Drive Shaft.
Issued in Fort Worth, Texas, on March 15,
2016.
Scott A. Horn,
Acting Manager, Rotorcraft Directorate,
Aircraft Certification Service.
[FR Doc. 2016–06373 Filed 3–21–16; 8:45 am]
BILLING CODE 4910–13–P
Dated: March 17, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. 2016–06397 Filed 3–21–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Parts 878, 880, and 895
Food and Drug Administration
RIN 0910–AH02
21 CFR Parts 73 and 74
Banned Devices; Proposal To Ban
Powdered Surgeon’s Gloves,
Powdered Patient Examination Gloves,
and Absorbable Powder for
Lubricating a Surgeon’s Glove
[Docket No. FDA–2015–N–5017]
[Docket No. FDA–2016–F–0821]
Milton W. Chu, M.D.; Filing of Color
Additive Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or we) is
announcing that we have filed a
petition, submitted by Milton W. Chu,
M.D., proposing that the color additive
regulations be amended to provide for
the safe use of titanium dioxide and
[phthalocyaninato (2-)] copper as
orientation marks for intraocular lenses.
DATES: The color additive petition was
filed on February 19, 2016.
FOR FURTHER INFORMATION CONTACT:
Laura Dye, Center for Food Safety and
Applied Nutrition (HFS–265), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
240–402–1275.
SUPPLEMENTARY INFORMATION: Under
section 721(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
379e(d)(1)), we are giving notice that we
have filed a color additive petition (CAP
6C0305), submitted by Milton W. Chu,
M.D., 5800 Santa Rosa Rd., Suite 111,
Camarillo, CA 93012. The petition
proposes to amend the color additive
regulations in § 73.3126 Titanium
dioxide (21 CFR 73.3126) and § 74.3045
[Phthalocyaninato (2-)] copper (21 CFR
74.3045) to provide for the safe use of
titanium dioxide and [phthalocyaninato
(2-)] copper as orientation marks for
intraocular lenses.
We have determined under 21 CFR
25.32(l) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
SUMMARY:
17:36 Mar 21, 2016
Jkt 238001
Food and Drug Administration,
HHS.
ACTION:
Notice of petition.
VerDate Sep<11>2014
AGENCY:
Proposed rule.
The Food and Drug
Administration (FDA or Agency) has
determined that Powdered Surgeon’s
Gloves, Powdered Patient Examination
Gloves, and Absorbable Powder for
Lubricating a Surgeon’s Glove present
an unreasonable and substantial risk of
illness or injury and that the risk cannot
be corrected or eliminated by labeling or
a change in labeling. Consequently, FDA
is proposing these devices be banned.
DATES: Submit either electronic or
written comments by June 20, 2016.
ADDRESSES: You may submit comments
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
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
PO 00000
Frm 00003
Fmt 4702
Sfmt 4702
15173
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–5017 for ‘‘Banned Devices;
Proposal to Ban Powdered Surgeon’s
Gloves, Powdered Patient Examination
Gloves, and Absorbable Powder for
Lubricating a Surgeon’s Glove.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
E:\FR\FM\22MRP1.SGM
22MRP1
]]>Agencies
[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Proposed Rules]
[Page 15173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06397]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 73 and 74
[Docket No. FDA-2016-F-0821]
Milton W. Chu, M.D.; Filing of Color Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of petition.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by Milton W. Chu, M.D.,
proposing that the color additive regulations be amended to provide for
the safe use of titanium dioxide and [phthalocyaninato (2-)] copper as
orientation marks for intraocular lenses.
DATES: The color additive petition was filed on February 19, 2016.
FOR FURTHER INFORMATION CONTACT: Laura Dye, Center for Food Safety and
Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740-3835, 240-402-1275.
SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice
that we have filed a color additive petition (CAP 6C0305), submitted by
Milton W. Chu, M.D., 5800 Santa Rosa Rd., Suite 111, Camarillo, CA
93012. The petition proposes to amend the color additive regulations in
Sec. 73.3126 Titanium dioxide (21 CFR 73.3126) and Sec. 74.3045
[Phthalocyaninato (2-)] copper (21 CFR 74.3045) to provide for the safe
use of titanium dioxide and [phthalocyaninato (2-)] copper as
orientation marks for intraocular lenses.
We have determined under 21 CFR 25.32(l) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
Dated: March 17, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2016-06397 Filed 3-21-16; 8:45 am]
BILLING CODE 4164-01-P
