81 FR 15173 - Milton W. Chu, M.D.; Filing of Color Additive Petition
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 55 (March 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 55 (March 22, 2016)
| Page Range | 15173-15173 | |
| FR Document | 2016-06397 |
[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)] [Proposed Rules] [Page 15173] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Proposed Rules 15173
(h) Subject Dated: March 17, 2016. do not wish to be made available to the
Joint Aircraft Service Component (JASC) Dennis M. Keefe, public, submit the comment as a
Code: 6510, Tail Rotor Drive Shaft. Director, Office of Food Additive Safety, written/paper submission and in the
Issued in Fort Worth, Texas, on March 15, Center for Food Safety and Applied Nutrition. manner detailed (see ‘‘Written/Paper
2016. [FR Doc. 2016–06397 Filed 3–21–16; 8:45 am] Submissions’’ and ‘‘Instructions’’).
Scott A. Horn, BILLING CODE 4164–01–P
Written/Paper Submissions
Acting Manager, Rotorcraft Directorate, Submit written/paper submissions as
Aircraft Certification Service.
DEPARTMENT OF HEALTH AND follows:
[FR Doc. 2016–06373 Filed 3–21–16; 8:45 am]
HUMAN SERVICES • Mail/Hand delivery/Courier (for
BILLING CODE 4910–13–P written/paper submissions): Division of
Food and Drug Administration Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
DEPARTMENT OF HEALTH AND 21 CFR Parts 878, 880, and 895 Lane, Rm. 1061, Rockville, MD 20852.
HUMAN SERVICES • For written/paper comments
[Docket No. FDA–2015–N–5017]
submitted to the Division of Dockets
Food and Drug Administration RIN 0910–AH02 Management, FDA will post your
comment, as well as any attachments,
21 CFR Parts 73 and 74 Banned Devices; Proposal To Ban except for information submitted,
Powdered Surgeon’s Gloves, marked and identified, as confidential,
[Docket No. FDA–2016–F–0821]
Powdered Patient Examination Gloves, if submitted as detailed in
Milton W. Chu, M.D.; Filing of Color and Absorbable Powder for ‘‘Instructions.’’
Additive Petition Lubricating a Surgeon’s Glove Instructions: All submissions received
AGENCY: Food and Drug Administration, must include the Docket No. FDA–
AGENCY: Food and Drug Administration, 2015–N–5017 for ‘‘Banned Devices;
HHS. HHS.
Proposal to Ban Powdered Surgeon’s
ACTION: Notice of petition. ACTION: Proposed rule. Gloves, Powdered Patient Examination
SUMMARY: The Food and Drug Gloves, and Absorbable Powder for
SUMMARY: The Food and Drug Lubricating a Surgeon’s Glove.’’
Administration (FDA or we) is Administration (FDA or Agency) has
determined that Powdered Surgeon’s Received comments will be placed in
announcing that we have filed a the docket and, except for those
petition, submitted by Milton W. Chu, Gloves, Powdered Patient Examination
Gloves, and Absorbable Powder for submitted as ‘‘Confidential
M.D., proposing that the color additive Submissions,’’ publicly viewable at
regulations be amended to provide for Lubricating a Surgeon’s Glove present
an unreasonable and substantial risk of http://www.regulations.gov or at the
the safe use of titanium dioxide and Division of Dockets Management
[phthalocyaninato (2-)] copper as illness or injury and that the risk cannot
be corrected or eliminated by labeling or between 9 a.m. and 4 p.m., Monday
orientation marks for intraocular lenses. through Friday.
a change in labeling. Consequently, FDA
DATES: The color additive petition was
is proposing these devices be banned. • Confidential Submissions—To
filed on February 19, 2016. submit a comment with confidential
DATES: Submit either electronic or
FOR FURTHER INFORMATION CONTACT: information that you do not wish to be
written comments by June 20, 2016.
Laura Dye, Center for Food Safety and made publicly available, submit your
ADDRESSES: You may submit comments
Applied Nutrition (HFS–265), Food and comments only as a written/paper
as follows:
Drug Administration, 5100 Paint Branch submission. You should submit two
Pkwy., College Park, MD 20740–3835, Electronic Submissions copies total. One copy will include the
240–402–1275. Submit electronic comments in the information you claim to be confidential
SUPPLEMENTARY INFORMATION: Under following way: with a heading or cover note that states
section 721(d)(1) of the Federal Food, • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
Drug, and Cosmetic Act (21 U.S.C. www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
379e(d)(1)), we are giving notice that we instructions for submitting comments. Agency will review this copy, including
have filed a color additive petition (CAP Comments submitted electronically, the claimed confidential information, in
6C0305), submitted by Milton W. Chu, including attachments, to http:// its consideration of comments. The
M.D., 5800 Santa Rosa Rd., Suite 111, www.regulations.gov will be posted to second copy, which will have the
Camarillo, CA 93012. The petition the docket unchanged. Because your claimed confidential information
proposes to amend the color additive comment will be made public, you are redacted/blacked out, will be available
regulations in § 73.3126 Titanium solely responsible for ensuring that your for public viewing and posted on
dioxide (21 CFR 73.3126) and § 74.3045 comment does not include any http://www.regulations.gov. Submit
[Phthalocyaninato (2-)] copper (21 CFR confidential information that you or a both copies to the Division of Dockets
74.3045) to provide for the safe use of third party may not wish to be posted, Management. If you do not wish your
titanium dioxide and [phthalocyaninato such as medical information, your or name and contact information to be
(2-)] copper as orientation marks for anyone else’s Social Security number, or made publicly available, you can
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
intraocular lenses. confidential business information, such provide this information on the cover
We have determined under 21 CFR as a manufacturing process. Please note sheet and not in the body of your
25.32(l) that this action is of a type that that if you include your name, contact comments and you must identify this
does not individually or cumulatively information, or other information that information as ‘‘confidential.’’ Any
have a significant effect on the human identifies you in the body of your information marked as ‘‘confidential’’
environment. Therefore, neither an comments, that information will be will not be disclosed except in
environmental assessment nor an posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
environmental impact statement is • If you want to submit a comment applicable disclosure law. For more
required. with confidential information that you information about FDA’s posting of
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Document Created: 2018-02-02 15:16:03
Document Modified: 2018-02-02 15:16:03
| 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 | Proposed Rules | |
| Action | Notice of petition. | |
| Dates | The color additive petition was filed on February 19, 2016. | |
| 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. | |
| FR Citation | 81 FR 15173 | |
| CFR Citation | 21
CFR
73 21 CFR 74 |
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