82_FR_25015 82 FR 24912 - Glo Eyes, LLC; Filing of Color Additive Petition

82 FR 24912 - Glo Eyes, LLC; Filing of Color Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 103 (May 31, 2017)

Page Range24912-24913
FR Document2017-11165

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Glo Eyes, LLC, proposing that the color additive regulations be amended to provide for the safe use of D&C Yellow No. 8 as a color additive in contact lens solution.

Federal Register, Volume 82 Issue 103 (Wednesday, May 31, 2017) 
[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)]
[Proposed Rules]
[Pages 24912-24913]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. FDA-2017-C-2902]


Glo Eyes, LLC; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice 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 Glo Eyes, LLC, proposing 
that the color additive regulations be amended to provide for the safe 
use of D&C Yellow No. 8 as a color additive in contact lens solution.

DATES: The color additive petition was filed on April 18, 2017.

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 7C0311), submitted by 
Glo Eyes, LLC, 5501 Highway 199, suite 202, Fort Worth, TX 76114. The 
petition proposes to amend the color additive regulations in 21 CFR 
part 74, Listing of Color Additives Subject To Certification, to 
provide for the safe use of D&C Yellow

[[Page 24913]]

No. 8 (principally the disodium salt of fluorescein) as a color 
additive in contact lens solution.
    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: May 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11165 Filed 5-30-17; 8:45 am]
 BILLING CODE 4164-01-P

24912 Federal Register / Vol. 82, No. 103 / Wednesday, May 31, 2017 / Proposed Rules safety in air commerce. This regulation inclusive, 97 through 101 inclusive, 105, and searching for and locating Docket No. FAA– is within the scope of that authority 106. 2017–0502. because it addresses an unsafe condition (2) For more information about this AD, (d) Subject contact Tom Rodriguez, Aerospace Engineer, that is likely to exist or develop on Air Transport Association (ATA) of International Branch, ANM–116, Transport products identified in this rulemaking America Code 51, Structures. Airplane Directorate, FAA, 1601 Lind action. Avenue SW., Renton, WA 98057–3356; (e) Reason Regulatory Findings telephone 425–227–1137; fax 425–227–1149. This AD was prompted by a discovery of (3) For service information identified in We determined that this proposed AD noncompliant rivets in the flight deck upper this AD, contact Dassault Falcon Jet would not have federalism implications skin. We are issuing this AD to prevent Corporation, Teterboro Airport, P.O. Box under Executive Order 13132. This interference between the rivet shank and the 2000, South Hackensack, NJ 07606; flight deck mounted overhead panel when telephone: 201–440–6700; Internet: http:// proposed AD would not have a the flight deck upper skin deforms due to www.dassaultfalcon.com. You may view this substantial direct effect on the States, on impact (e.g., bird strike); a condition, that if service information at the FAA, Transport the relationship between the national not corrected, could affect the functioning of Airplane Directorate, 1601 Lind Avenue SW., Government and the States, or on the essential flight control systems, and result in Renton, WA. For information on the distribution of power and reduced control of the airplane. availability of this material at the FAA, call responsibilities among the various (f) Compliance 425–227–1221. levels of government. Issued in Renton, Washington, on May 18, For the reasons discussed above, I Comply with this AD within the compliance times specified, unless already 2017. certify this proposed regulation: done. Michael Kaszycki, 1. Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (g) Modification Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. 2. Is not a ‘‘significant rule’’ under the Before exceeding 99 months or 4,100 flight DOT Regulatory Policies and Procedures [FR Doc. 2017–10977 Filed 5–30–17; 8:45 am] cycles, whichever occurs first since the date (44 FR 11034, February 26, 1979); of issuance of the original airworthiness BILLING CODE 4910–13–P 3. Will not affect intrastate aviation in certificate or the date of issuance of the Alaska; and original export certificate of airworthiness, 4. Will not have a significant modify the airplane by replacing certain DEPARTMENT OF HEALTH AND economic impact, positive or negative, MGPL type rivets installed on the flight deck HUMAN SERVICES skin panel with solid type-rivets, in on a substantial number of small entities accordance with the Accomplishment under the criteria of the Regulatory Food and Drug Administration Instructions of Dassault Aviation Service Flexibility Act. Bulletin 7X–176, dated February 3, 2016. 21 CFR Part 74 List of Subjects in 14 CFR Part 39 (h) Other FAA AD Provisions [Docket No. FDA–2017–C–2902] Air transportation, Aircraft, Aviation The following provisions also apply to this safety, Incorporation by reference, AD: Glo Eyes, LLC; Filing of Color Additive Safety. (1) Alternative Methods of Compliance (AMOCs): The Manager, International Petition The Proposed Amendment Branch, ANM–116, Transport Airplane AGENCY: Food and Drug Administration, Directorate, FAA, has the authority to HHS. Accordingly, under the authority approve AMOCs for this AD, if requested delegated to me by the Administrator, using the procedures found in 14 CFR 39.19. ACTION: Notice of petition. the FAA proposes to amend 14 CFR part In accordance with 14 CFR 39.19, send your 39 as follows: request to your principal inspector or local SUMMARY: The Food and Drug Flight Standards District Office, as Administration (FDA or we) is PART 39—AIRWORTHINESS appropriate. If sending information directly announcing that we have filed a DIRECTIVES to the International Branch, send it to the petition, submitted by Glo Eyes, LLC, attention of the person identified in proposing that the color additive ■ 1. The authority citation for part 39 paragraph (i)(2) of this AD. Information may regulations be amended to provide for continues to read as follows: be emailed to: 9-ANM-116-AMOC- the safe use of D&C Yellow No. 8 as a REQUESTS@faa.gov. Before using any color additive in contact lens solution. Authority: 49 U.S.C. 106(g), 40113, 44701. approved AMOC, notify your appropriate principal inspector, or lacking a principal DATES: The color additive petition was § 39.13 [Amended] filed on April 18, 2017. inspector, the manager of the local flight ■ 2. The FAA amends § 39.13 by adding standards district office/certificate holding FOR FURTHER INFORMATION CONTACT: the following new airworthiness district office. Molly A. Harry, Center for Food Safety directive (AD): (2) Contacting the Manufacturer: For any and Applied Nutrition, Food and Drug Dassault Aviation: Docket No. FAA–2017– requirement in this AD to obtain corrective Administration, 5001 Campus Dr., 0502; Directorate Identifier 2016–NM– actions from a manufacturer, the action must College Park, MD 20740, 240–402–1075. 120–AD. be accomplished using a method approved by the Manager, International Branch, ANM– SUPPLEMENTARY INFORMATION: Under (a) Comments Due Date 116, Transport Airplane Directorate, FAA; or section 721(d)(1) of the Federal Food, We must receive comments by July 17, EASA; or Dassault Aviation’s EASA Design Drug, and Cosmetic Act (21 U.S.C. 2017. Organization Approval (DOA). If approved by 379e(d)(1)), we are giving notice that we nlaroche on DSK30NT082PROD with PROPOSALS the DOA, the approval must include the have filed a color additive petition (CAP (b) Affected ADs DOA-authorized signature. 7C0311), submitted by Glo Eyes, LLC, None. 5501 Highway 199, suite 202, Fort (i) Related Information (c) Applicability (1) Refer to Mandatory Continuing Worth, TX 76114. The petition proposes This AD applies to Dassault Aviation Airworthiness Information (MCAI) EASA AD to amend the color additive regulations Model FALCON 7X airplanes, certificated in 2016–0124, dated June 22, 2016, for related in 21 CFR part 74, Listing of Color any category, manufacturer serial numbers 15 information. This MCAI may be found on the Additives Subject To Certification, to through 89 inclusive, 92 through 94 Internet at http://www.regulations.gov by provide for the safe use of D&C Yellow VerDate Sep<11>2014 14:38 May 30, 2017 Jkt 241001 PO 00000 Frm 00031 Fmt 4702 Sfmt 4702 E:\FR\FM\31MYP1.SGM 31MYP1

Federal Register / Vol. 82, No. 103 / Wednesday, May 31, 2017 / Proposed Rules 24913 No. 8 (principally the disodium salt of versus goods, for purposes of adopting received in response to this action, no fluorescein) as a color additive in a universal, world-wide standard. further activity is contemplated. If EPA contact lens solution. In order for the Postal Service to meet receives adverse comments, the direct We have determined under 21 CFR this new standard, the contents of First- final rule will be withdrawn and all 25.32(l) that this action is of a type that Class Mail International postcard, letter, public comments received will be does not individually or cumulatively and large envelope (flat) mail; addressed in a subsequent final rule have a significant effect on the human International Priority Airmail (IPA) based on this proposed rule. EPA will environment. Therefore, neither an postcard, letter, and large envelope (flat) not institute a second comment period. environmental assessment nor an mail; and International Surface Air Lift Any parties interested in commenting environmental impact statement is (ISAL) postcard, letter, and large on this action should do so at this time. required. envelope (flat) mail will be limited to documents. DATES: Comments must be received in Dated: May 24, 2017. writing by June 30, 2017. Anna K. Abram, Effective January 1, 2018, mailers who wish to mail any type of goods, ADDRESSES: Submit your comments, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. regardless of shape, must use First Class identified by Docket ID No. EPA–R03– Package International Service or another OAR–2017–0064 at https:// [FR Doc. 2017–11165 Filed 5–30–17; 8:45 am] available service. Technical details and www.regulations.gov, or via email to BILLING CODE 4164–01–P proposed IMM changes will be rehn.brian@epa.gov. For comments published at a later date and before submitted at Regulations.gov, follow the implementation. online instructions for submitting POSTAL SERVICE Stanley F. Mires, comments. Once submitted, comments 39 CFR Part 20 Attorney, Federal Compliance. cannot be edited or removed from Regulations.gov. For either manner of [FR Doc. 2017–11120 Filed 5–30–17; 8:45 am] International Mailing Services: Mailing submission, the EPA may publish any BILLING CODE 7710–12–P Services Rules Changes comment received to its public docket. Do not submit electronically any AGENCY: Postal ServiceTM. information you consider to be ACTION:Advance notice of proposed ENVIRONMENTAL PROTECTION confidential business information (CBI) rulemaking; request for comments. AGENCY or other information whose disclosure is SUMMARY: The Postal Service is restricted by statute. Multimedia 40 CFR Part 52 considering limiting First-Class Mail submissions (audio, video, etc.) must be [EPA–R03–OAR–2017–0064; FRL–9962–76– accompanied by a written comment. International® service to documents Region 3] The written comment is considered the only. official comment and should include DATES: Comments on this advance Approval and Promulgation of Air discussion of all points you wish to notice are due July 17, 2017. Quality Implementation Plans; make. EPA will generally not consider ADDRESSES: Mail or deliver written Pennsylvania; Revisions to Allegheny comments or comment contents located comments to the manager, Product County Health Department Rules outside of the primary submission (i.e. Classification, U.S. Postal Service, 475 AGENCY: Environmental Protection on the web, cloud, or other file sharing L’Enfant Plaza SW., Room 4446, Agency (EPA). system). For additional submission Washington, DC 20260–5015. You may methods, please contact the person ACTION: Proposed rule. inspect and photocopy all written identified in the FOR FURTHER comments at USPS® Headquarters SUMMARY: The Environmental Protection INFORMATION CONTACT section. For the Library, 475 L’Enfant Plaza SW., 11th Agency (EPA) proposes to approve the full EPA public comment policy, Floor North, Washington, DC, by state implementation plan (SIP) revision information about CBI or multimedia appointment only between the hours of submitted by the Commonwealth of submissions, and general guidance on 9 a.m. and 4 p.m., Monday through Pennsylvania for the purpose of making effective comments, please visit Friday. Call 1–202–268–2906 in updating the SIP to include https://www2.epa.gov/dockets/ advance for an appointment. Email administrative and definition commenting-epa-dockets. comments, containing the name and amendments made to Allegheny County address of the commenter, may be sent FOR FURTHER INFORMATION CONTACT: Sara Health Department’s (ACHD) Rules and to: ProductClassification@usps.gov, Calcinore, (215) 814–2043, or by email Regulations Article XXI, Air Pollution with a subject line of ‘‘First-Class Mail at calcinore.sara@epa.gov. Control. The amendments update the International.’’ Faxed comments are not name of the Bureau of Environmental SUPPLEMENTARY INFORMATION: For accepted. Quality to the Bureau of Environmental further information, please see the FOR FURTHER INFORMATION CONTACT: Health and revise the definition of information provided in the direct final Mico Milanovic at (202) 268–5348 or ‘‘County Executive’’ to agree with the action, with the same title, Revisions to Sylvia Baylis at (202) 268–6464. definition contained in the Allegheny Allegheny County Health Department SUPPLEMENTARY INFORMATION: This is an County Home Rule Charter. In the Final Rules, that is located in the ‘‘Rules and advance notice of the Postal Service’s Rules section of this Federal Register, Regulations’’ section of this Federal nlaroche on DSK30NT082PROD with PROPOSALS intent to modify some of its EPA is approving the Commonwealth’s Register publication. Please note that if International Mailing rules to conform SIP submittal as a direct final rule EPA receives adverse comment on an with the new Universal Postal Union without prior proposal because the amendment, paragraph, or section of (UPU) requirements for certain Letter Agency views this as a noncontroversial this rule and if that provision may be Post mail, effective January 1, 2018. submittal and anticipates no adverse severed from the remainder of the rule, After lengthy deliberations, UPU comments. A detailed rationale for the EPA may adopt as final those provisions member countries voted to identify and approval is set forth in the direct final of the rule that are not the subject of an separate items by content as documents rule. If no adverse comments are adverse comment. VerDate Sep<11>2014 14:38 May 30, 2017 Jkt 241001 PO 00000 Frm 00032 Fmt 4702 Sfmt 4702 E:\FR\FM\31MYP1.SGM 31MYP1


Document Created: 2017-05-31 05:59:11
Document Modified: 2017-05-31 05:59:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of petition.
DatesThe color additive petition was filed on April 18, 2017.
ContactMolly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1075.
FR Citation82 FR 24912 
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