Bonamar Corp.; Filing of Food Additive Petition, 54891 [2018-23946]
Download as PDF
<![CDATA[
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SAFETY RULE DRAFT GUIDANCE DOCKET—Continued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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
