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: http:// 

www.cdc.gov/vaccines/acip/index.html. 

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: http://

www.cdc.gov/vaccines/acip/index.html. 

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 

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 http://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 

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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 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 

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. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

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. 

SUPPLEMENTARY INFORMATION: 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. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB 

control No. 

Date approval 

expires 

Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods ......................................................................................................................................... 0910–0037 10/31/2023 

Color Additive Certification Requests and Recordkeeping ..................................................................................... 0910–0216 10/31/2023 

Recordkeeping and Records Access Requirements for Food Facilities ................................................................. 0910–0560 10/31/2023 

Reporting and Recordkeeping Requirements for Reportable Food ........................................................................ 0910–0643 10/31/2023 

Focus Groups as Used by the Food and Drug Administration ............................................................................... 0910–0497 11/30/2023 

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. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

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 

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