Colorcon, Inc.; Filing of Color Additive Petition, 63062 [2014-25089]

Download as PDF 63062 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Proposed Rules Issued in Washington, DC, on October 10, 2014. John Barbagallo, Deputy Director, FAA Flight Standards Service. Dated: October 16, 2014. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2014–25060 Filed 10–21–14; 8:45 am] BILLING CODE 4164–01–P [FR Doc. 2014–25089 Filed 10–21–14; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF EDUCATION DEPARTMENT OF HEALTH AND HUMAN SERVICES 34 CFR Parts 75 and 77 Food and Drug Administration [Docket ID ED–2014–OII–0116] 21 CFR Part 73 Direct Grant Programs and Definitions That Apply to Department Regulations [Docket No. FDA–2014–C–1552] AGENCY: RIN 1855–AA10 Colorcon, Inc.; Filing of Color Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules. SUMMARY: The color additive petition was filed on September 22, 2014. DATES: FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740– 3835, 240–402–1075. 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 4C0300), submitted by Colorcon, Inc., 275 Ruth Rd., Harleysville, PA 19438. 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 spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules. We have determined under 21 CFR 25.32(r) 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. tkelley on DSK3SPTVN1PROD with PROPOSALS SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:12 Oct 21, 2014 Jkt 235001 Office of Innovation and Improvement, Department of Education. ACTION: Notice of proposed rulemaking. On August 13, 2013, the Department of Education (the Department) published a notice of final regulations in the Federal Register to amend our Education Department General Administrative Regulations (EDGAR). In this document, the Department proposes to further amend EDGAR to add a definition of ‘‘What Works Clearinghouse Evidence Standards’’ (WWC Evidence Standards) in our regulations to standardize references to this term. In addition, the Department proposes to amend the definition of ‘‘large sample’’ in our regulation. We also propose technical edits to our regulations to improve the consistency and clarity of the regulations. Finally, we propose to redesignate our regulations and to include in that redesignated section an additional provision that would allow the Secretary to give special consideration to projects supported by evidence of promise. DATES: We must receive your comments on or before December 8, 2014. ADDRESSES: Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments. • Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under ‘‘Are you new to the site?’’ SUMMARY: PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 • Postal Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments about these proposed regulations, address them to Alli Moss, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W319, Washington, DC 20202. Privacy Note: The Department’s policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available. FOR FURTHER INFORMATION CONTACT: Allison Moss, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W319, Washington, DC 20202. Telephone: (202) 205–7726 or by email: allison.moss@ed.gov. If you use a telecommunications device for the deaf (TDD) or text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1–800–877– 8339. SUPPLEMENTARY INFORMATION: The Department published a notice of final regulations in the Federal Register (78 FR 49338) on August 13, 2013 to amend EDGAR. In this document, we propose further amendments to EDGAR to standardize a term and make other amendments to improve the consistency and clarity of these regulations. Invitation to Comment: We invite you to submit comments regarding these proposed regulations. To ensure that your comments have maximum effect in developing the final regulations, we urge you to identify clearly the specific section or sections of the proposed regulations that each of your comments addresses and to arrange your comments in the same order as the proposed regulations. We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from these proposed regulations. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the Department’s programs and activities. During and after the comment period, you may inspect all public comments about these proposed regulations by accessing Regulations.gov. You may also inspect the comments in person in Room 4W335, 400 Maryland Avenue SW., Washington, DC, between 8:30 a.m. and 4:00 p.m., Washington, DC E:\FR\FM\22OCP1.SGM 22OCP1

Agencies

[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Proposed Rules]
[Page 63062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25089]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2014-C-1552]


Colorcon, Inc.; 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 Colorcon, Inc., proposing 
that the color additive regulations be amended to provide for the safe 
use of spirulina extract as a color additive in coating formulations 
applied to dietary supplement and drug tablets and capsules.

DATES: The color additive petition was filed on September 22, 2014.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 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 4C0300), submitted by 
Colorcon, Inc., 275 Ruth Rd., Harleysville, PA 19438. 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 spirulina extract as a color additive in coating 
formulations applied to dietary supplement and drug tablets and 
capsules.
    We have determined under 21 CFR 25.32(r) 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: October 16, 2014.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2014-25089 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P

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