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 

Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices 78337 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information for meetings related to 

generic drug development have been 

approved under OMB control number 

0910–0797.’’ 

Dated: November 30, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26691 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–2019–D–4739] 

Requesting FDA Feedback on 

Combination Products; Guidance for 

Industry and FDA Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry and FDA staff 

entitled ‘‘Requesting FDA Feedback on 

Combination Products.’’ The purpose of 

this guidance is to discuss ways in 

which combination product sponsors 

can obtain feedback from FDA on 

scientific and regulatory questions and 

to describe best practices for FDA and 

sponsors when interacting on these 

topics. These interactions can occur 

through application-based mechanisms, 

such as the pre-submission process used 

in the Center for Devices and 

Radiological Health (CDRH) and the 

Center for Biologics Evaluation and 

Research (CBER) and the formal 

meetings used in the Center for Drug 

Evaluation and Research (CDER) and 

CBER, or through Combination Product 

Agreement Meetings (CPAMs), as 

appropriate. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 4, 2020. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2019–D–4739 for ‘‘Requesting FDA 

Feedback on Combination Products.’’ 

Received comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the to the 

Office of Combination Products, Food 

and Drug Administration, Bldg. 32, Rm. 

5129, 10903 New Hampshire Ave., 

Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Burns, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5125, 301–796– 

5616, melissa.burns@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Requesting FDA Feedback on 

Combination Products.’’ The purpose of 

this guidance is to discuss ways in 

which combination product sponsors 

can obtain feedback from the Agency on 

scientific and regulatory questions. 

These interactions can occur through 

application-based mechanisms, such as 

the pre-submission process used in