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 

77470 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2010–N–0190 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Infant 

Formula Requirements.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper 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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Infant Formula Requirements—21 CFR 

Parts 106 and 107 

OMB Control Number 0910–0256— 

Extension 

Statutory requirements for infant 

formula under the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) are 

intended to protect the health of infants 

and include a number of reporting and 

recordkeeping requirements. Among 

other things, section 412 of the FD&C 

Act (21 U.S.C. 350a) requires 

manufacturers of infant formula to 

establish and adhere to quality control 

procedures, notify us when infant 

formula that has left the manufacturers’ 

control may be adulterated or 

misbranded, and keep records of 

distribution. We have issued regulations 

to implement the FD&C Act’s 

requirements for infant formula in parts 

106 and 107 (21 CFR parts 106 and 107). 

We also regulate the labeling of infant 

formula under the authority of section 

403 of the FD&C Act (21 U.S.C. 343). 

Under our labeling regulations for infant 

formula in part 107, the label of an 

infant formula must include nutrient 

information and directions for use. 

Failure to comply with any of the 

applicable labeling regulations will 

render an infant formula misbranded 

under section 403 of the FD&C Act. The 

purpose of these labeling requirements 

is to ensure that consumers have the 

information they need to prepare and 

use infant formula appropriately. 

While the infant formula regulations 

help ensure the consistent production of 

safe and nutritionally adequate infant 

formulas for healthy term infants, they 

apply with one narrow exception. 

Section 412(h)(1) of the FD&C Act 

exempts an infant formula represented 

and labeled for use by an infant with an 

inborn error of metabolism, low birth 

weight, or who otherwise has an 

unusual medical or dietary problem 

from the requirements of subsections 

412(a), (b), and (c) of the FD&C Act. 

These formulas are customarily referred 

to as ‘‘exempt infant formulas.’’ Section 

412(h)(2) of the FD&C Act authorizes us 

to establish terms and conditions for the 

exemption of an infant formula from the 

requirements of subsections 412(a), (b), 

and (c) of the FD&C Act. 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 77471 

In support of exempt infant formulas, 

we have issued the agency guidance 

document entitled, ‘‘Exempt Infant 

Formula Production: Current Good 

Manufacturing Practices (CGMPs), 

Quality Control Procedures, Conduct of 

Audits, and Records and Reports.’’ The 

guidance document includes our 

recommendation that manufacturers of 

exempt infant formulas follow, to the 

extent practicable, subparts A, B, C, D, 

and F of 21 CFR part 106, and is 

available at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/guidanceindustry-exempt-infant-formulaproduction. 

We have also developed electronic 

Form FDA 3978 (Infant Formula 

Tracking System (IFTRACK)) so that 

infant formula manufacturers may 

electronically submit reports and 

notifications in a standardized format to 

FDA. However, manufacturers that 

prefer to submit paper submissions in a 

format of their own choosing will still 

have the option to do so. Form FDA 

3978 prompts a respondent to include 

reports and notifications in a standard 

electronic format and helps the 

respondent organize their submission to 

include only the information needed for 

our review. Screenshots of Form FDA 

3978 and instructions are available at 

http://www.fda.gov/Food/Guidance

Regulation/FoodFacilityRegistration/ 

InfantFormula/default.htm. 

Description of Respondents: 

Respondents to this information 

collection are manufacturers of infant 

formula. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FD&C act or 21 CFR Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Reports; Section 412(d) of the FD&C Act .................... 5 13 65 10 ......................... 650 

Notifications; § 106.120(b) ............................................. 1 1 1 4 ........................... 4 

Reports for exempt infant formula; § 107.50(b)(3) and 

(4).

3 2 6 4 ........................... 24 

Notifications for exempt infant formula; § 107.50(e)(2) 1 1 1 4 ........................... 4 

Requirements for quality factors— growth monitoring 

study exemption; § 106.96(c).

4 9 36 20 ......................... 720 

Requirements for quality factors—PER exemption; 

§ 106.96(g).

1 34 34 12 ......................... 408 

New infant formula registration; § 106.110 ................... 4 9 36 0.50 (30 mins.) ..... 18 

New infant formula submission; § 106.120 ................... 4 9 36 10 ......................... 360 

Total ....................................................................... ........................ ........................ ........................ .............................. 2,188 

1There are no capital or operating and maintenance costs associated with the information collection. 

Based on a review of the information 

collection, we have adjusted our burden 

estimate to correct a nominal 

calculation error. This reflects a 

decrease of 62 annual responses and a 

corresponding decrease of 308 annual 

hours. 

In compiling these estimates, we 

consulted our records of the number of 

infant formula submissions received in 

the past. All infant formula submissions 

may be provided to us in electronic 

format. The hours per response 

reporting estimates are based on our 

experience with similar programs and 

information received from industry. 

The total estimated annual reporting 

burden is 2,188 hours, as shown in table 

1. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2

FD&C act or 21 CFR part Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Burden per 

record Total hours 

Part 106—SUBPART B: CGMP Requirements ................... 5 429.8 2,149 4.4 9,414 

Part 106—SUBPARTS C–G: Quality control; audits; quality factors; records and reports ........................................ 5 726.8 3,634 6 21,818 

Part 107—SUBPART C; Exempt infant formulas ................ 3 10 30 300 9,000 

Exempt infant formula production; GMP; audits, recordkeeping, & reports ............................................................ 3 634 1,902 45 85,590 

Total .............................................................................. ........................ ........................ ........................ ........................ 125,822 

1There are no capital costs or operating and maintenance costs associated with the information. 

2 Numbers have been rounded. 

The total estimated annual 

recordkeeping burden is 125,822 hours, 

as shown in table 2. 

77472 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 

1National HIV Testing Day—June 27, 2019. 

MMWR. 2019;68:561. doi: http://dx.doi.org/ 

10.15585/mmwr.mm6825a1. 2Centers for Disease Control and Prevention. 

Estimated HIV incidence and prevalence in the 

United States, 2014–2018. HIV Surveillance 

Supplemental Report 2020;25(1). Accessed 

September 28, 2020. http://www.cdc.gov/hiv/ 

library/reports/hiv-surveillance.html. 3Harris NS, Johnson AS, Huang YLA, et al. Vital 

Signs: status of human immunodeficiency virus 

testing, viral suppression, and HIV preexposure 

prophylaxis—United States, 2013–2018. MMWR. 

2019;68:1117–1123. doi: http://dx.doi.org/ 

10.15585/mmwr.mm6848e1. 

4Li Z, Purcell DW, Sansom SL, et al. Vital Signs: 

HIV transmission along the continuum of care— 

United States, 2016. MMWR. 2019;68:267–272. 

Figure 1. doi: http://dx.doi.org/10.15585/ 

mmwr.mm6811e1. 

5Harris NS, Johnson AS, Huang YLA, et al. Vital 

Signs: status of human immunodeficiency virus 

testing, viral suppression, and HIV preexposure 

prophylaxis—United States, 2013–2018. MMWR. 

2019;68:1117–1123. doi: http://dx.doi.org/ 

10.15585/mmwr.mm6848e1. 

6Centers for Disease Control and Prevention. HIV 

Surveillance Data Tables (early release): Core 

indicators for monitoring the Ending the HIV 

Epidemic initiative (preliminary data): HIV 

diagnoses and linkage to HIV medical care, 2019 

(reported through December 2019); and preexposure 

prophylaxis (PrEP)—2018, updated. HIV 

Surveillance Data Tables 2020;1(2). Accessed 

October 16, 2020. https://www.cdc.gov/hiv/library/ 

reports/surveillance-data-tables/index.html. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Nutrient labeling; §§ 107.10(a) and 107.20 ......................... 5 13 65 8 520 

1There are no capital costs or operating and maintenance costs associated with the information collection. 

We estimate compliance with our 

infant formula labeling requirements in 

§§ 107.10(a) and 107.20 requires 520 

hours annually. 

Dated: November 23, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26537 Filed 12–1–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Information: HIV National 

Strategic Plan 2021–2025 Available for 

Public Comment 

AGENCY: Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services’ (HHS) Office of 

Infectious Disease and HIV/AIDS Policy 

(OIDP) in the Office of the Assistant 

Secretary for Health (OASH) announces 

the draft HIV National Strategic Plan: A 

Roadmap to End the HIV Epidemic 

(2021–2025) (HIV Plan) available for 

public comment. The draft HIV Plan 

may be reviewed at www.hiv.gov. 

DATES: All comments must be received 

by 5:00 p.m. ET on December 14, 2020 

to be considered. 

ADDRESSES: All comments must be 

submitted electronically to 

HIVPlanComments@hhs.gov to be 

considered. 

FOR FURTHER INFORMATION CONTACT: 

Harold J. Phillips, OIDP, 

Harold.Phillips@hhs.gov, 202–725– 

8872. 

SUPPLEMENTARY INFORMATION: The 

National HIV/AIDS Strategy, first 

released in 2010 and updated in 2015, 

changed the way that Americans talk 

about HIV and the ways that 

stakeholders prioritize and coordinate 

resources and deliver prevention and 

care services that support people with 

HIV or at risk for HIV. As a result, the 

nation’s new HIV infections have 

declined from their peak in the mid1980s—although remaining stable over 

the past decade—and people with HIV 

in care and treatment are living longer, 

healthier lives. In 2018 the estimated 

number of new HIV infections was 

36,400. A robust prevention toolbox that 

includes pre-exposure prophylaxis 

(PrEP), post-exposure prophylaxis 

(PEP), and syringe services programs 

(SSPs) has lowered a person’s risk of 

acquiring HIV. Research in recent years 

has proven that people with HIV who 

take antiretroviral therapy achieve and 

maintain an undetectable viral load, not 

protect their health but also have 

effectively no risk of transmitting HIV 

through sex. 

This stability in the annual number of 

new infections, though, has further 

illuminated opportunities for focused 

efforts. According to the most recent 

available data, less than one-half 

(38.9%) of the U.S. population have 

ever been tested for HIV 1 and an 

estimated 161,800 (14%) people with 

HIV are unaware of their status.2 Only 

63% of people diagnosed with HIV are 

virally suppressed.3 Approximately 

80% of new HIV infections are due to 

people who do not know they have HIV 

or are not receiving regular care,4 and 

only 18% of the approximately 1.2 

million people indicated for PrEP are 

receiving it.5 6

To respond and address the HIV 

public health epidemic, OASH through 

OIDP, in collaboration with a steering 

committee composed of a wide array of 

federal partners, has led and 

coordinated development of the HIV 

Plan. Opportunities for public input 

were provided, and public comments 

received were reviewed and analyzed, 

to help inform development of the 

components of the HIV Plan. The HIV 

Plan covers the entire country, provides 

a roadmap across the federal 

government, non-federal partners and 

stakeholders in all sectors of society, 

and encourages integration of several 

key components that are vital to our 

collective work. 

The HIV Plan is the nation’s third 

consecutive national HIV strategy. It sets 

forth bold targets for ending the HIV 

epidemic in the United States by 2030, 

including a 75% reduction in new HIV 

infections by 2025 and a 90% reduction 

by 2030. The HIV Plan articulates goals, 

objectives, and strategies to prevent new 

infections, treat people with HIV to 

improve health outcomes, reduce HIVrelated disparities, and better integrate 

and coordinate the efforts of all partners 

to end the HIV epidemic in the United 

States. The HIV Plan also establishes 

indicators to measure progress, with 

quantitative targets for each indicator, 

and designates populations 

disproportionately impacted by and at 

risk for HIV as well as key areas of 

focus. 

The order of goals, objectives, and 

strategies does not indicate any 

prioritization, and many are 

intertwined. The following are the HIV 

Plan’s vision and four goals: 

Vision: The United States will be a 

place where new HIV infections are 

prevented, every person knows their 

status, and every person with HIV has 

high-quality care and treatment and 

lives free from stigma and 

discrimination. This vision includes all 

people, regardless of age, sex, gender 

identity, sexual orientation, race,