78334 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices 

65 or reach the 25th month of disability 

benefit entitlement. These individuals 

do not file a separate application for 

Medicare Part A because their 

application for Social Security or RRB 

benefits is also an application for Part A. 

The form is for individuals who are not 

eligible for Social Security for RRB 

benefits, but may qualify for premiumfree Medicare Part A based on certain 

requirements outlined in § 406.11 and 

406.15 or for certain disabled 

individuals who may enroll in premium 

Medicare Part A based on certain 

requirements outlined in § 406.20. 

Individuals may also choose to enroll in 

Medicare Part B at the same time they 

apply for Medicare Part A. 

The Application for Enrollment in 

Medicare Part A (CMS–18F5 and CMS– 

18F5–SP) was designed to capture all 

the information needed to make a 

determination of an individual’s 

entitlement to Part A. This Information 

Collection Request (ICR) adds the 

collection instruments SSA uses to 

collect information from individuals 

who are filing an Application for 

Hospital Insurance, updates the burden 

information. CMS will begin reporting 

for additional collection instruments, 

including the internet Claim System 

(iClaim), Modernized Claims System 

(MCS), and the Consolidated Claims 

Experience (CCE). Form Number: CMS– 

18F5 (OMB control number: 0938– 

0251); Frequency: Annually; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

1,394,264; Total Annual Responses: 

1,394,264; Total Annual Hours: 348,566. 

(For policy questions regarding this 

collection contact Carla Patterson at 

410–786–1000.) 

Dated: December 1, 2020. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2020–26756 Filed 12–3–20; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6397] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Labeling; 

Calorie Labeling of Articles of Food in 

Vending Machines and Nutrition 

Labeling of Standard Menu Items in 

Restaurants and Similar Retail Food 

Establishments 

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 information 

collection provisions for calorie labeling 

of articles of food in vending machines 

and nutrition labeling of standard menu 

items in restaurants and similar retail 

food establishments. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 2, 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 2, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 2, 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 

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– 

2017–N–6397 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food 

Labeling; Calorie Labeling of Articles of 

Food in Vending Machines and 

Nutrition Labeling of Standard Menu 

Items in Restaurants and Similar Retail 

Food Establishments.’’ 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 

Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices 78335 

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. 

Food Labeling; Calorie Labeling of 

Articles of Food in Vending Machines 

and Nutrition Labeling of Standard 

Menu Items in Restaurants and Similar 

Retail Food Establishments 

OMB Control Number 0910–0782— 

Extension 

This information collection supports 

FDA regulations under part 101 (21 CFR 

part 101) and the associated collection 

instrument Form FDA 3757. The 

Federal Food, Drug, and Cosmetic Act 

requires the disclosure of certain calorie 

labeling of articles of food in vending 

machines, as well as nutrition 

information for standard menu items in 

certain restaurants and retail food 

establishments. Sections 101.8 and 

101.11 provides that respondents with a 

chain of 20 or more locations will 

disclose nutritional information of 

certain foods for consumers of food 

products for the purpose of making 

informed dietary choices. We also offer 

registration for respondents who wish to 

voluntarily participate with this 

information collection activity, for 

which we developed Form FDA 3757 

entitled, ‘‘DHHS/FDA Menu and 

Vending Machine Labeling Voluntary 

Registration’’ to assist respondents in 

this regard. To keep the registration 

active, a respondent renews their 

registration every other year within 60 

days prior to the expiration of the 

respondent’s current registration with 

FDA, or it will automatically expire. 

We use the collection of information 

to help determine compliance with 

regulatory requirements. Third-party 

disclosure requirements are used by 

consumers of food products for the 

purpose of making informed dietary 

choices. 

Description of Respondents: 

Respondents to this collection of 

information are vending machine 

operators and restaurants or other 

similar food establishments that are 

subject to the requirements of part 101 

as well as those entities that voluntarily 

participate with the provisions of this 

collection of information. 

78336 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices 

We estimate the burden of the 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity using form FDA 3757; 21 CFR Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 

(in hours) 

Total hours 

Initial Registration for Vending Machine Labeling; 101.8(d) ................. 13 1 13 2 ..................................... 26 

Registration Renewal for Vending Machine Labeling; 101.8(d) ........... 19 1 19 0.5 (30 minutes) ............ 9.5 

Initial Registration for Menu Labeling; 101.11(d) .................................. 3,559 1 3,559 2 ..................................... 7,118 

Registration Renewal for Menu Labeling; 101.11(d) ............................ 5,340 1 5,340 0.5 (30 minutes) ............ 2,670 

Total ............................................................................................... ........................ ........................ ........................ ........................................ 9,823.5 

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

TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1

Activity; 21 CFR Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per record 

(in hours) 

Total hours 

Initial Burden (Annualized over 3 years) 

Initial Nutrition Analysis; 101.8(c)(2)(i)(A) ............................................. 69,017 1 69,017 0.25 (15 minutes) .......... 17,254 

Annual Burden 

Recurring Nutrition Analysis; 101.8(c)(2)(i)(A) ...................................... 30,059 1 30,059 0.25 (15 minutes) .......... 7,515 

Total ............................................................................................... ........................ ........................ ........................ ........................................ 24,769 

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

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity; 21 CFR Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure 

(in hours) 

Total hours 

Calorie Analysis; 101.8(c)(2)(i) ....................................................... 282 11 3,102 1 ..................................... 3,102 

Calorie Declaration Signage; 101.8(c)(2)(ii) ................................... 3,279 2,122 6,958,038 0.21 (12.5 minutes) ....... 1,461,188 

Vending Operator Contact Information; 101.8(e)(1) ....................... 3,279 125 409,875 0.025 (1.5 minutes) ....... 10,247 

Total ......................................................................................... ........................ .............................. ........................ ........................................ 1,474,537 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: November 30, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26695 Filed 12–3–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5739] 

Formal Meetings Between the Food 

and Drug Administration and 

Abbreviated New Drug Application 

Applicants of Complex Products Under 

Generic Drug User Fee Amendments; 

Guidance for Industry; Availability; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

correcting a notice entitled ‘‘Formal 

Meetings Between the Food and Drug 

Administration and Abbreviated New 

Drug Application Applicants of 

Complex Products Under Generic Drug 

User Fee Amendments; Guidance for 

Industry; Availability’’ that appeared in 

the Federal Register of November 25, 

2020. The document announced the 

availability for a guidance for industry. 

The document was published with 

incorrect information in the Paperwork 

Reduction Act of 1995 section. This 

document corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Giaquinto Friedman, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1670, 

Silver Spring, MD 20993–0002, 240– 

402–7930, elizabeth.giaquinto@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 25, 2020 

(85 FR 75336), in FR Doc. 2020–26050, 

the following correction is made: 

On page 75337, in the third column, 

under the heading, ‘‘II. Paperwork 

Reduction Act of 1995’’, the paragraph 

is corrected to read: 

‘‘While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget