6872 Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total Section 904(c)(1) Reporting Burden Hours ........................ ........................ ........................ ........................ 19,193 

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

The burden for this collection of 

information is estimated to be 19,193 

hours. The burden estimate for this 

collection of information includes the 

time it will take to read the instructions, 

test the products, and prepare the HPHC 

report. In arriving at this burden 

estimate, FDA estimated the number of 

tobacco products to be reported under 

the requirements of section 904(c)(1) of 

the FD&C Act annually to FDA. 

Section 1 of table 1 estimates that 424 

respondents (380 cigarettes receiving 

authorizations, 19 RYO tobacco 

receiving authorizations, 25 smokeless 

receiving authorizations) will submit 

424 HPHC reports annually. Each 

respondent represents a statutory 

tobacco product that receives 

authorization from FDA for which 

manufacturers and importers (or their 

agents), must report their product 

information to FDA under section 

904(c)(1) of the FD&C Act at least 90 

days prior to delivery for introduction 

into interstate commerce for all new 

products. This section addresses the 

time required to report their company 

information to FDA through the use of 

the electronic portal or paper forms. 

The company information reported 

includes company name; mailing 

address; telephone and Fax numbers; 

FDA Establishment Identifier number; 

Data Universal Numbering System 

number; and point of contact name, 

mailing address, and telephone and Fax 

numbers, as applicable. It also addresses 

the time required for manufacturers and 

importers to report their product 

information by entering certain testing 

information into the electronic or paper 

forms. 

The product information includes 

brand and subbrand name; unique 

product identification number; type of 

product identification number; product 

category and subcategory; and mean 

weight and standard deviation of 

tobacco in product. 

We estimate that the burden to enter 

both the company and product 

information is no more than 1.82 hours 

per response for cigarettes, 0.43 hours 

per response for RYO, and 0.63 hours 

per response for smokeless tobacco 

products regardless of whether the 

paper or electronic Form FDA series 

3787 is used. The time to report per 

tobacco product types varies because 

the number of HPHCs varies by tobacco 

product category. The total hours 

estimated for this section is 716. 

The estimated number of responses 

under section 904(c)(1) of the FD&C Act 

is based on FDA’s experience, the past 

4 years of tobacco products receiving 

marketing authorizations from FDA, and 

actual responses to FDA under this 

provision of the FD&C Act for statutorily 

regulated products. 

Section 2 of table 1 estimates that 44 

respondents (19 cigarette filler and RYO 

tobacco receiving authorizations and 25 

smokeless receiving authorizations) will 

test quantities of HPHCs in an average 

of 44 products annually. This section 

addresses the time required for 

manufacturers and importers (or their 

agents) who must test HPHC quantities 

in products. The burden estimates 

include the burden to test the tobacco 

products, draft testing reports, and 

submit the report to FDA. The total 

expected burden for this section is 481 

hours. 

Section 3 of table 1 addresses the time 

required for manufacturers and 

importers to test quantities for HPHCs in 

cigarette smoke. The burden estimates 

include: The burden to test the number 

of replicate measurements; test date 

range; manufacture date range; 

extraction method; separation method; 

detection method; and mean quantity 

and standard deviation of HPHCs and 

includes the burden to test the tobacco 

products, draft testing reports, and 

submit the report to FDA. The annual 

burden reflects our estimate of the time 

it takes to test the tobacco products (i.e., 

carry out laboratory work). The burden 

estimate assumes that manufacturers 

and importers report HPHC quantities in 

cigarette mainstream smoke according 

to the two smoking regimens. The total 

expected burden is 17,996 hours for this 

section. 

The total estimated burden for this 

information collection is 19,193 hours 

and 424 respondents. Our estimated 

burden for the information collection 

reflects an overall increase of 269 

respondents and a corresponding 

increase of 16,677 hours. We attribute 

this adjustment to updated methodology 

in which the current estimates are 

derived from historical statutory tobacco 

product applications submitted and 

authorized by FDA in the past 4 years 

as (1) manufacturers and importers (or 

their agents) of authorized products are 

required to submit HPHC reports at least 

90 days prior to delivery for 

introduction into interstate commerce 

for all new products and (2) initial 

reporting under section 904(a)(3) of the 

FD&C Act for statutory products was 

completed in 2012. 

Dated: February 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02478 Filed 2–4–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0961] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Environmental 

Impact Considerations 

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 March 9, 

2022. 

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 0910–0322. Also include 

the FDA docket number found in 


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Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices 6873 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Environmental Impact Considerations 

OMB Control Number 0910–0322— 

Extension 

I. Background 

FDA is requesting OMB approval for 

the reporting requirements contained in 

the FDA collection of information 

‘‘Environmental Impact 

Considerations.’’ The National 

Environmental Policy Act (NEPA) (42 

U.S.C. 4321–4347) states national 

environmental objectives and imposes 

upon each Federal Agency the duty to 

consider the environmental effects of its 

actions. Section 102(2)(C) of NEPA 

requires the preparation of an 

environmental impact statement (EIS) 

for every major Federal action that will 

significantly affect the quality of the 

human environment. 

FDA’s NEPA regulations are in part 25 

(21 CFR part 25). All applications or 

petitions requesting Agency action 

require the submission of a claim for 

categorical exclusion or an 

environmental assessment (EA). A 

categorical exclusion applies to certain 

classes of FDA-regulated actions that 

usually have little or no potential to 

cause significant environmental effects 

and are excluded from the requirements 

to prepare an EA or EIS. Section 

25.15(a) and (d) (21 CFR 25.15(a) and 

(d)) specifies the procedures for 

submitting to FDA a claim for a 

categorical exclusion. Extraordinary 

circumstances (21 CFR 25.21), which 

may result in significant environmental 

impacts, may exist for some actions that 

are usually categorically excluded. An 

EA provides information that is used to 

determine whether an FDA action could 

result in a significant environmental 

impact. Section 25.40(a) and (c) (21 CFR 

25.40(a) and (c)) specifies the content 

requirements for EAs for non-excluded 

actions. 

This collection of information is used 

by FDA to assess the environmental 

impact of Agency actions and to ensure 

that the public is informed of 

environmental analyses. Firms wishing 

to manufacture and market substances 

regulated under statutes for which FDA 

is responsible must, in most instances, 

submit applications requesting 

approval. Environmental information 

must be included in such applications 

for the purpose of determining whether 

the proposed action may have a 

significant impact on the environment. 

Where significant adverse events cannot 

be avoided, the Agency uses the 

submitted information as the basis for 

preparing and circulating to the public 

an EIS, made available through a 

Federal Register document also filed for 

comment at the Environmental 

Protection Agency. The final EIS, 

including the comments received, is 

reviewed by the Agency to weigh 

environmental costs and benefits in 

determining whether to pursue the 

proposed action or some alternative that 

would reduce expected environmental 

impact. 

Any final EIS would contain 

additional information gathered by the 

Agency after the publication of the draft 

EIS, a copy or a summary of the 

comments received on the draft EIS, and 

the Agency’s responses to the 

comments, including any revisions 

resulting from the comments or other 

information. When the Agency finds 

that no significant environmental effects 

are expected, the Agency prepares a 

finding of no significant impact. 

In the Federal Register of August 25, 

2021 (86 FR 47501), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited. 

FDA estimates the burden of this 

collection of information as follows: 

II. Estimated Annual Reporting Burden 

for Human Drugs (Including Biologics 

in the Center for Drug Evaluation and 

Research) 

Under §§ 312.23(a)(7)(iv)(e), 

314.50(d)(1)(iii), and 314.94(a)(9)(i) (21 

CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), 

and 314.94(a)(9)(i)), each investigational 

new drug application (IND), new drug 

application (NDA), and abbreviated new 

drug application (ANDA) must contain 

a claim for categorical exclusion under 

§ 25.30 (21 CFR 25.30) or § 25.31 (21 

CFR 25.31), or an EA under § 25.40. 

Annually, FDA receives approximately 

5,503 INDs from 3,717 sponsors; 142 

NDAs from 111 applicants; 3,285 

supplements to NDAs from 516 

applicants; 35 biologic license 

applications (BLAs) from 32 applicants; 

777 supplements to BLAs from 89 

applicants; 743 ANDAs from 239 

applicants; and 11,438 supplements to 

ANDAs from 482 applicants. FDA 

estimates that it receives approximately 

21,923 claims for categorical exclusions 

as required under § 25.15(a) and (d) and 

13 EAs as required under § 25.40(a) and 

(c). Based on information provided by 

the pharmaceutical industry, FDA 

estimates that it takes sponsors or 

applicants approximately 8 hours to 

prepare a claim for a categorical 

exclusion and approximately 3,400 

hours to prepare an EA. Based on recent 

numbers, we now estimate a total of 

21,936 annual responses and 219,584 

hours for human drugs (an increase of 

6,489 responses and 62,088 hours). 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.15(a) and (d) ................................................................... 5,186 4.2273 21,923 8 175,384 

25.40(a) and (c) ................................................................... 14 0.9285 13 3,400 44,200 

Total .............................................................................. 219,584 ........................ ........................ ........................ ........................

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


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6874 Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices 

III. Estimated Annual Reporting 

Burden for Medical Devices 

Under § 814.20(b)(11) (21 CFR 

814.20(b)(11)), premarket approvals 

(PMAs) (original PMAs and 

supplements) must contain a claim for 

categorical exclusion under § 25.30 or 

21 CFR 25.34 or an EA under § 25.40. 

In 2020, FDA received an average of 62 

claims (original PMAs and 

supplements) for categorical exclusions 

as required under § 25.15(a) and (d), and 

0 EAs as required under § 25.40(a) and 

(c). FDA estimates that approximately 

62 respondents will submit an average 

of 1 application for categorical 

exclusion annually. Based on 

information provided by sponsors, FDA 

estimates that it takes approximately 6 

hours to prepare a claim for a 

categorical exclusion. Based on recent 

numbers, we now estimate a total of 62 

annual responses and 372 hours for 

medical devices (an increase of 12 

responses and 72 hours). 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR MEDICAL DEVICES 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per 

response 

Total hours 

25.15(a) and (d) ................................................................... 62 1 62 6 372 

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

IV. Estimated Annual Reporting Burden 

for Biological Products, Drugs, and 

Medical Devices in the Center for 

Biologics Evaluation and Research 

Under 21 CFR 601.2(a), BLAs as well 

as INDs (§ 312.23), NDAs (§ 314.50), 

ANDAs (§ 314.94), and PMAs (§ 814.20) 

must contain either a claim of 

categorical exclusion under § 25.30 or 

§ 25.32 (21 CFR 25.32) or an EA under 

§ 25.40. Annually, FDA receives 

approximately 11 BLAs from 11 

applicants, 1,080 BLA supplements to 

license applications from 160 

applicants, 7,017 INDs from 2,087 

sponsors, 1 NDA from 1 applicant, 16 

supplements to NDAs from 6 applicants, 

1 ANDA from 1 applicant, 3 

supplements to ANDAs from 2 

applicants, 1 PMA from 1 applicant, and 

79 PMA supplements from 19 

applicants. FDA estimates that 

approximately 10 percent of these 

supplements would be submitted with a 

claim for categorical exclusion or an EA. 

FDA estimates that it has received 

approximately 7,150 claims for 

categorical exclusion as required under 

§ 25.15(a) and (d) annually and 4 EAs as 

required under § 25.40(a) and (c) 

annually. Therefore, FDA estimates that 

approximately 3,575 respondents will 

submit an average of 2 applications for 

categorical exclusion and 4 respondents 

will submit an average of 1 EA. Based 

on information provided by industry, 

FDA estimates that it takes sponsors and 

applicants approximately 8 hours to 

prepare a claim of categorical exclusion 

and approximately 3,400 hours to 

prepare an EA for a biological product. 

Based on recent numbers, we now 

estimate a total of 7,154 annual 

responses and 70,800 hours for human 

drugs (an increase of 6,658 responses 

and 60,048 hours). 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.15(a) and (d) ................................................................... 3,575 2 7,150 8 57,200 

25.40(a) and (c) ................................................................... 4 1 4 3,400 13,600 

Total .............................................................................. ........................ ........................ ........................ ........................ 70,800 

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

V. Estimated Annual Reporting Burden 

for Animal Drugs 

Under 21 CFR 514.1(b)(14), new 

animal drug applications (NADAs) and 

abbreviated new animal drug 

applications (ANADAs); supplemental 

NADAs and ANADAs (21 CFR 

514.8(a)(1)); investigational new animal 

drug applications and generic 

investigational new animal drug 

applications (21 CFR 511.1(b)(10)); and 

food additive petitions (21 CFR 571.1(c)) 

must contain a claim for categorical 

exclusion under § 25.30 or § 25.32 or an 

EA under § 25.40. Annually, FDA’s 

Center for Veterinary Medicine has 

received approximately 1,140 claims for 

categorical exclusion as required under 

§ 25.15(a) and (d) and 9 EAs as required 

under § 25.40(a) and (c). Assuming an 

average of 10 claims per respondent, 

FDA estimates that approximately 114 

respondents will submit an average of 

10 claims for categorical exclusion. FDA 

further estimates that nine respondents 

will submit an average of one EA. FDA 

estimates that it takes sponsors/ 

applicants approximately 3 hours to 

prepare a claim of categorical exclusion 

and an average of 2,160 hours to prepare 

an EA. Based on recent numbers, we 

now estimate a total of 22,860 hours for 

animal drugs (a decrease of 22,860 

hours). 

TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.15(a) and (d) ................................................................... 114 10 1,140 3 3,420 


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Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices 6875 

TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.40(a) and (c) ................................................................... 9 1 9 2,160 19,440 

Total .............................................................................. ........................ ........................ ........................ ........................ 22,860 

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

VI. Estimated Annual Reporting Burden 

for Tobacco Products 

Under sections 905, 910, and 911 of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 387e, 387j, and 387k), 

product applications and supplements, 

premarket tobacco applications 

(PMTAs), substantial equivalences 

(SEs), exemption from SEs, and 

modified risk tobacco product 

applications (MRTPAs) must contain a 

claim for categorical exclusion or an EA. 

The majority of the EA burden for 

tobacco products is covered under 

already existing information collections. 

The burden for SEs is currently 

approved under OMB control number 

0910–0673; the burden for PMTAs are 

currently approved under OMB control 

number 0910–0768; and the burden for 

SE exemptions are currently approved 

under OMB control number 0910–0684. 

FDA’s estimates are based on actual 

report data from fiscal year (FY) 2018 to 

FY 2020. On average, FDA estimated it 

received approximately 14 MRTPAs 

from 14 respondents. Based on updated 

data for this collection, FDA estimates 

14 EAs from 14 respondents. A total of 

14 respondents will submit an average 

of 1 application for environmental 

assessment. Based on FDA’s experience, 

previous information provided by 

potential sponsors and knowledge that 

part of the EA information has already 

been produced in one of the tobacco 

product applications, FDA estimates 

that it takes approximately 80 hours to 

prepare an EA. Based on recent MRTPA 

numbers, we now estimate a total of 14 

annual responses and 1,120 hours for 

Tobacco Products (a decrease of 13 

responses and 1,040 hours). 

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.40(a) and (c) ................................................................... 14 1 14 80 1,120 

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

Since the last OMB approval, we have 

adjusted our burden estimate. We 

estimate the total burden for this 

information collection to be 30,315 

annual responses, and 314,736 hours. 

These estimates reflect an overall 

increase of 13,463 responses and 94,078 

hours. We attribute the adjustments to 

expected fluctuations in the number of 

responses the various centers in FDA 

have received over the last few years. 

Dated: February 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02475 Filed 2–4–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0053] 

Notifying the Food and Drug 

Administration of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the Federal Food, 

Drug, and Cosmetic Act; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice of availability that appeared in 

the Federal Register of January 11, 

2022. In the notice of availability, FDA 

requested comments on draft guidance 

for industry and FDA staff entitled 

‘‘Notifying the Food and Drug 

Administration of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the Federal Food, Drug, 

and Cosmetic Act.’’ The Agency is 

taking this action in response to a 

request for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the document published 

January 11, 2022 (87 FR 1417). Submit 

either electronic or written comments 

on the draft guidance by April 11, 2022, 

to ensure that the Agency considers 

your comment on this draft guidance 

before it begins work on the final 

version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 


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