Bonamar Corp.; Filing of Food Additive Petition, 54891 [2018-23946]

Download as PDF Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Proposed Rules 54891 TABLE 1—INFORMATION ON PARTICIPATING IN THE PUBLIC MEETINGS AND ON SUBMITTING COMMENTS TO THE PRODUCE SAFETY RULE DRAFT GUIDANCE DOCKET—Continued Activity Date Electronic address Address View webcast ......... December 13, 2018; 8:30 a.m.– 5 p.m. .............................................................. The webcast will have closed captioning. Advance registration. by November 23, 2018. Individuals who wish to participate by webcast are asked to preregister at https://www.fda.gov/Food/ NewsEvents/WorkshopsMeetings Conferences/default.htm. https://www.fda.gov/Food/NewsEvents/ WorkshopsMeetingsConferences/default.htm. We encourage you to use electronic registration if possible 1. There is no registration fee for the public meetings. Early registration is recommended because seating is limited.1 Request to make an oral presentation. by November 16, 2018. Submitting either electronic or written comments. Submit comments https://www.regulations.gov ................. by April 22, 2019. Request special ac- by November 16, commodations 2018. due to a disability. https://www.fda.gov/Food/NewsEvents/ WorkshopsMeetingsConferences/default.htm. .............................................................. Other information Requests to make oral presentations must be made in advance to https:// www.fda.gov/Food/NewsEvents/ WorkshopsMeetingsConferences/default.htm. Dockets Management Staff (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. See FOR FURTHER INFORMATION CONTACT. See ADDRESSES for information on submitting comments. 1 You may also register via email, mail, or Fax. Please include your name, title, firm name, address, and phone and Fax numbers in your registration information and send to: Melissa Schroeder, SIDEM, 1775 Eye St. NW, Suite 1150, Washington, DC 20006, 240–393–4496, Fax: 202–495–2901, EventSupport@ Sidemgroup.com. Onsite registration will be available at all four meetings, however, please note that if we have reached capacity, we will not be able to accommodate those who have not pre-registered. IV. Transcripts Dated: October 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–23868 Filed 10–31–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 179 [Docket No. FDA–2018–F–3932] Bonamar Corp.; Filing of Food 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 Bonamar Corp., proposing that we amend our food additive regulations to provide for the safe use of sources of ionizing radiation to control food-borne pathogens in finfish and flatfish. DATES: The food additive petition was filed on September 27, 2018. amozie on DSK3GDR082PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 20:21 Oct 31, 2018 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 the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice that we have filed a food additive petition (FAP 8M4822), submitted by Bonamar Corp., c/o Robert P. Smith, Department of Biological Sciences, Nova Southeastern University, 3301 College Ave., Fort Lauderdale, FL 33314. The petition proposes to amend the food additive regulations in § 179.26 (21 CFR 179.26) Ionizing radiation for the treatment of food to provide for the safe use of sources of ionizing radiation to control food-borne pathogens in: (1) Chilled or frozen raw finfish and flatfish; and (2) frozen, raw vacuumpacked finfish and flatfish. The petitioner has claimed that this action is categorically excluded from the need to prepare an environmental assessment or an environmental impact statement under 21 CFR 25.32(j), because the petition requests approval for a source of irradiation which is a piece of permanent equipment intended ADDRESSES: Please be advised that as soon as a transcript is available, it will be accessible at https:// www.regulations.gov. You may also view the transcript at the Dockets Management Staff (see ADDRESSES). Jkt 247001 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 for repeated use. In addition, the petitioner has stated that, to the petitioner’s 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: October 29, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–23946 Filed 10–31–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 807, 1002, 1010, and 1040 [Docket Nos. FDA–2011–N–0070 and FDA– 2016–N–2491] RIN 0910–AG79 and 0910–AF87 Withdrawal of the Laser Products; Proposed Amendment to Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; withdrawal. The Food and Drug Administration (FDA, Agency, we) is SUMMARY: E:\FR\FM\01NOP1.SGM 01NOP1

Agencies

[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Proposed Rules]
[Page 54891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23946]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-2018-F-3932]


Bonamar Corp.; Filing of Food 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 Bonamar Corp., proposing 
that we amend our food additive regulations to provide for the safe use 
of sources of ionizing radiation to control food-borne pathogens in 
finfish and flatfish.

DATES: The food additive petition was filed on September 27, 2018.

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 the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice 
that we have filed a food additive petition (FAP 8M4822), submitted by 
Bonamar Corp., c/o Robert P. Smith, Department of Biological Sciences, 
Nova Southeastern University, 3301 College Ave., Fort Lauderdale, FL 
33314. The petition proposes to amend the food additive regulations in 
Sec.  179.26 (21 CFR 179.26) Ionizing radiation for the treatment of 
food to provide for the safe use of sources of ionizing radiation to 
control food-borne pathogens in: (1) Chilled or frozen raw finfish and 
flatfish; and (2) frozen, raw vacuum-packed finfish and flatfish.
    The petitioner has claimed that this action is categorically 
excluded from the need to prepare an environmental assessment or an 
environmental impact statement under 21 CFR 25.32(j), because the 
petition requests approval for a source of irradiation which is a piece 
of permanent equipment intended for repeated use. In addition, the 
petitioner has stated that, to the petitioner's 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: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23946 Filed 10-31-18; 8:45 am]
BILLING CODE 4164-01-P