CooperVision, Inc.; Filing of Color Additive Petition, 20060 [2019-09411]

Download as PDF 20060 Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Proposed Rules Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax: 206–231–3229. Issued in Des Moines, Washington, on May 1, 2019. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service. [FR Doc. 2019–09442 Filed 5–7–19; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA–2019–C–1782] CooperVision, Inc.; Filing of Color 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 CooperVision, Inc., proposing that the color additive regulations be amended to provide for the safe use of disperse orange 3 methacrylamide to color contact lenses. The color additive is intended to be copolymerized with various monomers to produce colored contact lens materials. SUMMARY: The color additive petition was filed on March 28, 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 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 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 9C0315), submitted by CooperVision, Inc., 5870 Stoneridge Dr., Suite 1, Pleasanton, CA 94588. The petition proposes to amend the color additive regulations in 21 CFR part 73, Listing of khammond on DSKBBV9HB2PROD with PROPOSALS DATES: VerDate Sep<11>2014 16:31 May 07, 2019 Jkt 247001 Color Additives Exempt from Certification, to provide for the safe use of disperse orange 3 methacrylamide (CAS Reg. No. 58142–15–7; CAS name 2-propenamide, 2-methyl-N-[4-[2-(4nitrophenyl)diazenyl]phenyl]-) to color contact lenses. The color additive is intended to be copolymerized with various monomers to produce colored contact lens materials. The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(l) because disperse orange 3 methacrylamide is intended for use in contact lenses. In addition, the petitioner has stated that, to their 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: May 2, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–09411 Filed 5–7–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG–2019–0300] RIN 1625–AA08 Special Local Regulations; Festival of Sail Duluth 2019 Parade of Sail, Lake Superior, Duluth, MN Coast Guard, DHS. Notice of proposed rulemaking. AGENCY: ACTION: The Coast Guard is proposing to establish a temporary special local regulation for a designated area of the Duluth Harbor entrance to Superior Bay on Lake Superior during the Festival of Sail 2019 event in Duluth, MN. This action is necessary to provide for the safety of life on these navigable waters around the port of Duluth, MN during a parade of sail event on August 11, 2019. This proposed rulemaking would prohibit persons and vessels from being in the designated region unless authorized by the Captain of the Port Duluth or a designated representative. We invite your comments on this proposed rulemaking. SUMMARY: PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 Comments and related material must be received by the Coast Guard on or before June 7, 2019. ADDRESSES: You may submit comments identified by docket number USCG– 2019–0300 using the Federal eRulemaking Portal at https:// www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments. DATES: If you have questions about this proposed rulemaking, call or email Lieutenant Abbie Lyons, Waterways Management, MSU Duluth, U.S. Coast Guard; telephone 218–725–3818, email Abbie.E.Lyons@uscg.mil. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis On December 11, 2018, Draw Events LLC notified the Coast Guard that it will be conducting a Parade of Sail from 7 a.m. through 1 p.m. on August 11, 2019, as part of the 2019 Festival of Sail event in Duluth, MN from August 11 through August 13, 2019. Hazards from spectator vessels and the limited maneuverability of the sailing vessels exist. The Captain of the Port Duluth (COTP) has determined that potential hazards associated with the parade of sail would be a safety concern for anyone within the route of the parade. The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within the parade route before, during, and immediately after the scheduled event. The legal basis for this proposed rule is the Coast Guard’s authority under 46 U.S.C. 70041; 33 CFR 1.05–1. III. Discussion of Proposed Rule The COTP is proposing to establish a special local regulation from 7 a.m. through 1 p.m. on August 11, 2019. The special local regulation would cover all navigable waters encompassed within the following boundaries: Beginning at position 46°46′48.36″ N, 092°05′16.44″ W, across Duluth Harbor to 46°47′02.76″ N, 092°05′17.88″ W, turning north toward the Duluth Lift Bridge at to 46°47′19.32″ N, 092°04′04.80″ W, to 46°46′50.88″ N, 092°05′17.88″ W, out E:\FR\FM\08MYP1.SGM 08MYP1

Agencies

[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Proposed Rules]
[Page 20060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2019-C-1782]


CooperVision, Inc.; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by CooperVision, Inc., 
proposing that the color additive regulations be amended to provide for 
the safe use of disperse orange 3 methacrylamide to color contact 
lenses. The color additive is intended to be copolymerized with various 
monomers to produce colored contact lens materials.

DATES: The color additive petition was filed on March 28, 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 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 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 9C0315), submitted by 
CooperVision, Inc., 5870 Stoneridge Dr., Suite 1, Pleasanton, CA 94588. 
The petition proposes to amend the color additive regulations in 21 CFR 
part 73, Listing of Color Additives Exempt from Certification, to 
provide for the safe use of disperse orange 3 methacrylamide (CAS Reg. 
No. 58142-15-7; CAS name 2-propenamide, 2-methyl-N-[4-[2-(4-
nitrophenyl)diazenyl]phenyl]-) to color contact lenses. The color 
additive is intended to be copolymerized with various monomers to 
produce colored contact lens materials.
    The petitioner has claimed that this action is categorically 
excluded under 21 CFR 25.32(l) because disperse orange 3 methacrylamide 
is intended for use in contact lenses. In addition, the petitioner has 
stated that, to their 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: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09411 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P

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