Canned Pacific Salmon Deviating From Identity Standard; Amendment of Temporary Marketing Permit, 77468-77469 [2020-26533]
Download as PDF
77468
Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices
being given for this meeting due to the
exceptional circumstances of the
COVID–19 pandemic and rapidly
evolving COVID–19 vaccine
development and regulatory processes.
The Secretary of Health and Human
Services has determined that COVID–19
is a Public Health Emergency. A notice
of this ACIP meeting has also been
posted on CDC’s ACIP website at: https://
www.cdc.gov/vaccines/acip/.
In addition, CDC has sent notice of this
ACIP meeting by email to those who
subscribe to receive email updates about
ACIP.
Purpose: The committee is charged
with advising the Director, CDC, on the
use of immunizing agents. In addition,
under 42 U.S.C. 1396s, the committee is
mandated to establish and periodically
review and, as appropriate, revise the
list of vaccines for administration to
vaccine-eligible children through the
Vaccines for Children (VFC) program,
along with schedules regarding dosing
interval, dosage, and contraindications
to administration of vaccines. Further,
under provisions of the Affordable Care
Act, section 2713 of the Public Health
Service Act, immunization
recommendations of the ACIP that have
been approved by the Director of the
Centers for Disease Control and
Prevention and appear on CDC
immunization schedules must be
covered by applicable health plans.
Matters to be Considered: The agenda
will include discussions on COVID–19
vaccine allocation. A recommendation
vote is scheduled. Agenda items are
subject to change as priorities dictate.
For more information on the meeting
agenda visit https://www.cdc.gov/
vaccines/acip/meetings/meetingsinfo.html.
Meeting Information: The meeting
will be webcast live via the World Wide
Web; for more information on ACIP
please visit the ACIP website: https://
www.cdc.gov/vaccines/acip/.
Public Participation
Interested persons or organizations
are invited to participate by submitting
written views, recommendations, and
data. Please note that comments
received, including attachments and
other supporting materials are part of
the public record and are subject to
public disclosure. Do not include any
information in your comment or
supporting materials that you consider
confidential or inappropriate for public
disclosure. If you include your name,
contact information, or other
information that identifies you in the
body of your comments, that
information will be on public display.
CDC will review all submissions and
VerDate Sep<11>2014
17:39 Dec 01, 2020
Jkt 253001
may choose to redact, or withhold,
submissions containing private or
proprietary information such as Social
Security numbers, medical information,
inappropriate language, or duplicate/
near duplicate examples of a mass-mail
campaign. CDC will carefully consider
all comments submitted into the docket.
CDC does not accept comment by email.
Written Public Comment: Written
comments must be received on or before
December 3, 2020.
Oral Public Comment: This meeting
will include time for members of the
public to make an oral comment. Oral
public comment will occur before any
scheduled votes including all votes
relevant to the ACIP’s Affordable Care
Act and Vaccines for Children Program
roles. Priority will be given to
individuals who submit a request to
make an oral public comment before the
meeting according to the procedures
below.
Procedure for Oral Public Comment:
All persons interested in making an oral
public comment at the December 1,
2020 ACIP meeting must submit a
request at https://www.cdc.gov/vaccines/
acip/meetings/ no later than 11:59 p.m.,
EST, November 30, 2020 according to
the instructions provided.
If the number of persons requesting to
speak is greater than can be reasonably
accommodated during the scheduled
time, CDC will conduct a lottery to
determine the speakers for the
scheduled public comment session.
CDC staff will notify individuals
regarding their request to speak by email
by 12:00 p.m., EST, December 1, 2020.
To accommodate the significant interest
in participation in the oral public
comment session of ACIP meetings,
each speaker will be limited to 3
minutes, and each speaker may only
speak once per meeting.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–26587 Filed 11–30–20; 11:15 am]
BILLING CODE 4163–18–P
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1987–P–0074]
Canned Pacific Salmon Deviating From
Identity Standard; Amendment of
Temporary Marketing Permit
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is amending
Bumble Bee Seafoods Inc.’s temporary
permit to market test canned skinless
and boneless chunk salmon packed in
water that contains sodium
tripolyphosphate to inhibit protein curd
formation during retorting. The
temporary permit is amended to add an
additional manufacturing location. This
amendment will allow the applicant to
continue to test market the test product
and collect data on consumer
acceptance of the test product.
FOR FURTHER INFORMATION CONTACT:
Marjan Morravej, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
2371.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 13, 1987 (52 FR
26186), we issued a notice announcing
that we had issued a temporary permit
to Bumble Bee Seafoods, Inc., San
Diego, CA 92123, to market test
products identified as canned skinless
and boneless chunk salmon packed in
water and containing added sodium
tripolyphosphate to inhibit protein curd
formation during retorting. The permit
allowed for the test product to be
manufactured at a plant located in
Petersburg, AK. We issued the permit to
facilitate market testing of products that
deviate from the requirements of the
standard of identity for canned Pacific
salmon in 21 CFR 161.170, which were
issued under section 401 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
341).
In the Federal Register of April 8,
1988 (53 FR 11710), we issued a notice
announcing that we had amended the
temporary permit to permit the test
product be manufactured at one
additional plant, Chugach Alaska
Fisheries, Inc., Ocean Dock Rd.,
Cordova, AK 99574.
In the Federal Register of September
6, 1988 (53 FR 34354), we issued
another notice announcing that we were
extending the expiration date of the
permit to either the effective date of a
SUMMARY:
E:\FR\FM\02DEN1.SGM
02DEN1
77469
Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices
final rule for any proposal to amend the
standard of identity for canned Pacific
salmon that may result from the
National Food Processors Association’s
petition, submitted on behalf of Bumble
Bee Seafoods, Inc., and other salmon
packers holding temporary permits, or
30 days after termination of such
proposal.
In the Federal Register of April 24,
2020 (85 FR 23047), we issued a notice
announcing that we amended the
temporary permit to allow for the
canned skinless and boneless chunk
salmon packed in water with or without
sodium tripolyphosphate and to allow
the test product to be manufactured
only at one plant, Pataya Food
Industries Ltd., located at 90/6 Moo 7,
Settakit Road, Tambol Tarsai, Amphur
Maung, Samutsakorn 74000, Thailand.
Under our regulations at 21 CFR
130.17(f), we are amending the
temporary permit issued to Bumble Bee
Seafoods, Inc., to allow the test product
to be manufactured at an additional
plant, RS Cannery Company Limited,
located at 255/1 Industrial Soi 3,
Bangpoo Industrial Estate,
Samutprakarn 10280, Thailand. All
other conditions and terms of this
permit remain the same.
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26533 Filed 12–1–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–1119; FDA–
2010–N–0622; FDA–2011–N–0016; FDA–
2009–N–0501; and FDA–2019–N–6098]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
SUMMARY:
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods .........................................................................................................................................
Color Additive Certification Requests and Recordkeeping .....................................................................................
Recordkeeping and Records Access Requirements for Food Facilities .................................................................
Reporting and Recordkeeping Requirements for Reportable Food ........................................................................
Focus Groups as Used by the Food and Drug Administration ...............................................................................
Dated: November 25, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26571 Filed 12–1–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0190]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
VerDate Sep<11>2014
17:39 Dec 01, 2020
Jkt 253001
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of our infant
formula regulations, including infant
formula labeling, quality control
procedures, notification requirements,
and recordkeeping. The notice also
invites comment on electronic Form
FDA 3978 that allows manufacturers of
infant formula to submit reports and
notifications in a standardized format.
DATES: Submit either electronic or
written comments on the collection of
information by February 1, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
0910–0037
0910–0216
0910–0560
0910–0643
0910–0497
Date approval
expires
10/31/2023
10/31/2023
10/31/2023
10/31/2023
11/30/2023
considered. Electronic comments must
be submitted on or before February 1,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 1, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
E:\FR\FM\02DEN1.SGM
02DEN1
Agencies
[Federal Register Volume 85, Number 232 (Wednesday, December 2, 2020)]
[Notices]
[Pages 77468-77469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26533]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1987-P-0074]
Canned Pacific Salmon Deviating From Identity Standard; Amendment
of Temporary Marketing Permit
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending Bumble Bee
Seafoods Inc.'s temporary permit to market test canned skinless and
boneless chunk salmon packed in water that contains sodium
tripolyphosphate to inhibit protein curd formation during retorting.
The temporary permit is amended to add an additional manufacturing
location. This amendment will allow the applicant to continue to test
market the test product and collect data on consumer acceptance of the
test product.
FOR FURTHER INFORMATION CONTACT: Marjan Morravej, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 13, 1987 (52
FR 26186), we issued a notice announcing that we had issued a temporary
permit to Bumble Bee Seafoods, Inc., San Diego, CA 92123, to market
test products identified as canned skinless and boneless chunk salmon
packed in water and containing added sodium tripolyphosphate to inhibit
protein curd formation during retorting. The permit allowed for the
test product to be manufactured at a plant located in Petersburg, AK.
We issued the permit to facilitate market testing of products that
deviate from the requirements of the standard of identity for canned
Pacific salmon in 21 CFR 161.170, which were issued under section 401
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341).
In the Federal Register of April 8, 1988 (53 FR 11710), we issued a
notice announcing that we had amended the temporary permit to permit
the test product be manufactured at one additional plant, Chugach
Alaska Fisheries, Inc., Ocean Dock Rd., Cordova, AK 99574.
In the Federal Register of September 6, 1988 (53 FR 34354), we
issued another notice announcing that we were extending the expiration
date of the permit to either the effective date of a
[[Page 77469]]
final rule for any proposal to amend the standard of identity for
canned Pacific salmon that may result from the National Food Processors
Association's petition, submitted on behalf of Bumble Bee Seafoods,
Inc., and other salmon packers holding temporary permits, or 30 days
after termination of such proposal.
In the Federal Register of April 24, 2020 (85 FR 23047), we issued
a notice announcing that we amended the temporary permit to allow for
the canned skinless and boneless chunk salmon packed in water with or
without sodium tripolyphosphate and to allow the test product to be
manufactured only at one plant, Pataya Food Industries Ltd., located at
90/6 Moo 7, Settakit Road, Tambol Tarsai, Amphur Maung, Samutsakorn
74000, Thailand.
Under our regulations at 21 CFR 130.17(f), we are amending the
temporary permit issued to Bumble Bee Seafoods, Inc., to allow the test
product to be manufactured at an additional plant, RS Cannery Company
Limited, located at 255/1 Industrial Soi 3, Bangpoo Industrial Estate,
Samutprakarn 10280, Thailand. All other conditions and terms of this
permit remain the same.
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26533 Filed 12-1-20; 8:45 am]
BILLING CODE 4164-01-P