Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 49543 

Administration Amendments Act of 

2007), authorizes FDA to collect user 

fees for certain medical device 

applications. Under this authority, 

companies pay a fee for certain new 

medical device applications or 

supplements submitted to the Agency 

for review. Because the submission of 

user fees concurrently with applications 

and supplements is required, the review 

of an application cannot begin until the 

fee is submitted. Form FDA 3601, the 

‘‘Medical Device User Fee Cover Sheet,’’ 

is designed to provide the minimum 

necessary information to determine 

whether a fee is required for review of 

an application, to determine the amount 

of the fee required, and to account for 

and track user fees. The form provides 

a cross-reference between the fees 

submitted for an application with the 

actual submitted application by using a 

unique number tracking system. The 

information collected is used by FDA’s 

Center for Devices and Radiological 

Health and FDA’s Center for Biologics 

Evaluation and Research to initiate the 

administrative screening of new medical 

device applications and supplemental 

applications. 

We are revising the information 

collection to add Form FDA 3601a, the 

‘‘Device Facility User Fee Cover Sheet.’’ 

Owners or operators of places of 

business (also called establishments or 

facilities) that are involved in the 

production and distribution of medical 

devices intended for use in the United 

States are required to register annually 

with FDA, a process known as 

establishment registration (21 CFR part 

807, subparts A through D). (The 

information collection for medical 

device establishment registration and 

listing is approved under OMB control 

number 0910–0625.) All establishments 

required to register must pay a user fee. 

Form FDA 3601a, the ‘‘Device Facility 

User Fee Cover Sheet,’’ is designed to 

collect payments for the annual 

establishment registration fee for 

medical device establishments. 

The total number of annual responses 

for Form FDA 3601 is based on the 

average number of cover sheet 

submissions received by FDA in recent 

years. The number of received annual 

responses includes cover sheets for 

applications that were qualified for 

small businesses and fee waivers or 

reductions. The estimated hours per 

response are based on past FDA 

experience with the various cover sheet 

submissions and range from 5 to 30 

minutes. For this analysis, we estimate 

18 minutes per coversheet. 

The total number of annual responses 

for Form FDA 3601a is based on the 

average number of cover sheet 

submissions received by FDA in recent 

years. Based on past FDA experience 

with various cover sheet submissions, 

we estimate 10 minutes per response. 

In the Federal Register of June 12, 

2020 (85 FR 35939), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although two comments 

were received, only one was responsive 

to the four collection of information 

topics solicited. 

FDA’s response to the comment is 

that the establishment registration fee is 

not eligible for a reduced small business 

fee. This can be found on our website 

at: https://www.fda.gov/medicaldevices/how-study-and-market-yourdevice/device-registration-and-listing. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2

FDA Form No. Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

3601 ......................................................................... 6,182 1 6,182 0.30 (18 minutes) ...... 1,855 

3601a ....................................................................... 24,086 1 24,086 0.17 (10 minutes) ...... 4,095 

Total .................................................................. ........................ ........................ 30,268 .................................... 5,950 

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

2 Numbers have been rounded. 

Our estimated burden for the 

information collection reflects an 

overall increase of 4,036 hours and a 

corresponding increase of 23,889 

responses/records. We attribute these 

increases to two factors: We have 

revised the burden estimate to include 

Form FDA 3601a and we have adjusted 

the number of respondents for Form 

FDA 3601 to reflect our current data. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19113 Filed 9–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1857] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food, and Current 

Good Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by October 4, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0751. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 


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49544 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Current Good Manufacturing Practice 

and Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food— 

21 CFR Part 117; Current Good 

Manufacturing Practice and Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals—21 CFR 

Part 507 

OMB Control Number 0910–0751— 

Revision 

This information collection supports 

FDA regulations setting forth criteria 

and definitions applicable to human 

food and to animal food, as established 

under the FDA Food Safety and 

Modernization Act (FSMA) (Pub. L. 

111–353). Congress enacted FSMA in 

response to dramatic changes in the 

global food system and in our 

understanding of foodborne illness and 

its consequences, including the 

realization that preventable foodborne 

illness is both a significant public health 

problem and a threat to the economic 

well-being of the food system. The 

purpose of the regulations is to prevent 

the introduction of adulterated and/or 

misbranded products into the 

marketplace and ensure the safety of 

both human foods and animal food in 

accordance with sections 402 and 403 of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 342 and 343). 

Generally, domestic and foreign food 

facilities that are required to register in 

accordance with section 415 of the 

FD&C Act (21 U.S.C. 350d) must comply 

with these requirements, unless an 

exemption applies. It is important to 

note, however, that applicability of the 

current good manufacturing practice 

requirements for animal food is 

dependent upon whether a facility is 

required to register, while the 

applicability of the current good 

manufacturing practice requirements for 

human food is not dependent upon 

whether a facility is required to register. 

Regulations governing human food are 

set forth in part 117 (21 CFR part 117), 

while regulations governing animal food 

are found in part 507 (21 CFR part 507). 

Respondents to the information 

collection are those who manufacture, 

prepare, pack, or hold food intended for 

humans or animals. 

The regulations include 

recordkeeping necessary to demonstrate 

compliance with the requirements; 

however, respondents that meet the 

definition of a ‘‘qualified facility,’’ 

under 21 CFR 117.3 and 507.3, are 

subject to reporting. To be subject to the 

modified requirements set forth in part 

117, subpart D and part 507, subpart A 

for human food and animal food, 

respectively, respondents must attest to 

their status. To assist respondents in 

this regard, we have developed Forms 

FDA 3942a (Quality Facility Attestation: 

Human Food) and 3942b (Quality 

Facility Attestation: Animal Food), 

available for downloading from our 

website at: https://www.fda.gov/food/ 

registration-food-facilities-and-othersubmissions/qualified-facilityattestation. 

Section 418(l)(2)(B)(ii) of the FD&C 

Act (21 U.S.C. 350g(l)(2)(B)(ii)) directs 

us to issue guidance on documentation 

required to determine status as a 

qualified facility. Accordingly, we 

issued a guidance for industry entitled 

‘‘Determination of Status as a Qualified 

Facility Under part 117: Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food and part 507: 

Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Food for 

Animals,’’ also available for 

downloading from our website at: 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industrydetermination-status-qualified-facility. 

The guidance discusses the content, 

format, frequency, and timing of 

submissions. For efficiency of Agency 

operations, we are now accounting for 

burden we attribute to reporting 

associated with Forms FDA 3942a and 

3942b, currently approved under OMB 

control number 0910–0854, with this 

information collection. 

In the Federal Register of March 16, 

2021 (86 FR 14436), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; reporting Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

117.201(c); qualified facility as 

reported on Form FDA 

3942a.

37,134 2 0.5 18,567 0.5 (30 minutes) ...................... 9,284 

507.7(c); qualified facility as reported on Form FDA 3942b.1,120 0.5 560 0.5 (30 minutes) ...................... 280 

Total .................................. .............................. .............................. .............................. .................................................. 9,564 

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

2 Reporting occurs biennially. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN: HUMAN FOODS 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

117.126(c) and 117.170(d); 

food safety plan and reanalysis.

46,685 1 46,685 110 .......................................... 5,135,350 

117.136; assurance records .... 16,285 1 16,285 0.25 (15 minutes) .................... 4,071 

117.145(c); monitoring records 8,143 730 5,944,390 0.05 (3 minutes) ...................... 297,220 


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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 49545 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN: HUMAN FOODS 1—Continued 

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

117.150(d); corrective actions 

and corrections records.

16,285 2 32,570 1 .............................................. 32,570 

117.155(b); verification records 8,143 244 1,986,892 0.05 (3 minutes) ...................... 99,345 

117.160; validation records ...... 3,677 6 22,062 0.25 (15 minutes) .................... 5,515 

117.475(c)(7)–(9); supplier 

records.

16,285 10 162,850 4 .............................................. 651,400 

117.180(d); training records for 

preventive controls qualified 

individual.

46,685 1 46,685 0.25 (15 minutes) .................... 11,671 

Total .................................. .............................. .............................. .............................. .................................................. 6,237,142 

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

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN: ANIMAL FOOD 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 2

Subpart A—General Provisions 

507.4(d); documentation of animal food safety and hygiene 

training.

7,469 0.75 5,579 0.05 (3 minutes) ...................... 279 

Subpart C—Hazard Analysis and Risk-Based Preventive Controls 

507.31 through 507.55; food 

safety plan—including hazard analysis, preventive controls, and procedures for 

monitoring, corrective actions, verification, recall plan, 

validation, reanalysis, modifications, and implementation 

records.

7,469 519 3,876,411 0.1 (6 minutes) ........................ 387,641 

Subpart E—Supply Chain Program 

507.105 through 507.175; written supply-chain program— 

including records documenting program.

7,469 519 3,876,411 0.1 (6 minutes) ........................ 387,641 

Subpart F—Requirements Applying to Records That Must Be Established and Maintained 

507.200 through 507.215; general requirements, additional 

requirements applying to 

food safety plan, requirements for record retention, 

use of existing records, and 

special requirements applicable to written assurance.

7,469 519 3,876,411 0.1 (6 minutes) ........................ 387,641 

Total .................................. .............................. .............................. 11,635,372 .................................................. 1,163,258 

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

2Total hours have been rounded. 


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49546 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 

TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: HUMAN FOODS 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

117.201(e); disclosure of food 

manufacturing facility address.

37,134 1 37,134 0.25 (15 minutes) .................... 9,284 

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

TABLE 5—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: ANIMAL FOOD 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

507.27(b); labeling for the animal food product contains 

the specific information and 

instructions needed so the 

food can be safely used for 

the intended animal species.

330 10 3,300 0.25 (15 minutes) .................... 825 

507.7(e)(1); change labels on 

products with labels.

1,120 4 4,480 1 .............................................. 4,480 

507.7(e)(2); change address 

on labeling (sales documents) for qualified facilities.

974 1 974 1 .............................................. 974 

507.25(a)(2); animal food, including raw materials, other 

ingredients, and rework, is 

accurately identified.

373 312 116,376 0.01 (36 seconds) ................... 1,163.76 

507.28(b); holding and distribution of human food byproducts for use as animal food.40,798 2 81,596 0.25 (15 minutes) .................... 20,399 

Total .................................. .............................. .............................. .............................. .................................................. 27,841.76 

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 slight 

adjustments to reflect a decrease in 

third-party disclosure burden associated 

with animal food. In this submission we 

provide a cumulative estimate for 

related disclosure activities that we had 

previously accounted for separately. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19116 Filed 9–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0897] 

Oncologic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Oncologic Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held on 

October 28, 2021, from 10:30 a.m. to 3 

p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0897. 

The docket will close on October 27, 

2021. Submit either electronic or 

written comments on this public 

meeting by October 27, 2021. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before October 27, 2021. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

October 27, 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. 

Comments received on or before 

October 14, 2021, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 


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