25280 Federal Register / Vol. 87, No. 82 / Thursday, April 28, 2022 / Notices 

NDAs and the collections of information 

and (2) the submissions required by 

section 760 of the FD&C Act for 

nonprescription human drug products 

marketed without an approved 

application have been approved under 

OMB control number 0910–0230. The 

collections of information in 21 CFR 

part 600 for biological drug products 

have been approved under OMB control 

number 0910–0308. The collections of 

information pertaining to the electronic 

submission of adverse event reports in 

21 CFR parts 310, 314, and 329 have 

been approved under OMB control 

number 0910–0645. The collections of 

information pertaining to submissions 

required for outsourcing facilities under 

section 503B of the FD&C Act have been 

approved under OMB control number 

0910–0800. The collections of 

information in 21 CFR part 4 pertaining 

to postmarketing safety information 

sharing by constituent part applicants 

for combination products have been 

approved under OMB control number 

0910–0834. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: April 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09065 Filed 4–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0305] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Products 

Subject to the Federal Food, Drug, and 

Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, we, 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 ‘‘Tobacco 

Products Subject to the Federal Food, 

Drug, and Cosmetic Act.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 27, 2022. 

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 June 27, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 27, 2022. 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– 

2019–N–0305 for ‘‘Tobacco Products 

Subject to the Federal Food, Drug, and 

Cosmetic Act.’’ 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: 

Jonnalynn Capezzuto, Office of 

Operations, Food and Drug 


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Federal Register / Vol. 87, No. 82 / Thursday, April 28, 2022 / Notices 25281 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Tobacco Products Subject to the Federal 

Food, Drug, and Cosmetic Act 

OMB Control Number 0910–0768— 

Extension 

Tobacco products are governed by 

chapter IX of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (sections 

900 through 920) (21 U.S.C. 387 through 

21 U.S.C. 387t). Implementing 

regulations are found in 21 CFR 

subchapter K (21 CFR parts 1100 

through 1150). This information 

collection supports the reporting, 

recordkeeping, and third-party 

disclosure requirements associated with 

statutory requirements applicable to 

tobacco products and set forth in 

Agency regulations. Section 910(a)(1) of 

the FD&C Act (21 U.S.C. 387j(a)(1)) 

defines a ‘‘new tobacco product’’ as a 

tobacco product that was not 

commercially marketed in the United 

States on February 15, 2007, or a 

modification (including a change in 

design, any component, any part, or any 

constituent, including a smoke 

constituent, or in the content, delivery, 

or form of nicotine, or any other 

additive or ingredient) of a tobacco 

product where the modified product 

was commercially marketed in the 

United States after February 15, 2007. 

An order under section 910(c)(1)(A)(i) of 

the FD&C Act is required prior to 

marketing a new tobacco product. This 

requirement applies unless the product 

has been shown to be substantially 

equivalent to a valid predicate product 

or is exempt from substantial 

equivalence (21 CFR 1107.1). 

Section 910(b) of the FD&C Act states 

that a premarket tobacco application 

(PMTA) (21 CFR part 1114) shall 

contain full reports of all investigations 

of health risks; a full statement of all 

components, ingredients, additives, and 

properties, and of the principle or 

principles of operation of such tobacco 

product; a full description of methods of 

manufacturing and processing (which 

includes: a listing of all manufacturing, 

packaging, and control sites for the 

product); an explanation of how the 

product complies with applicable 

tobacco product standards; samples of 

the product and its components; and 

labeling. 

FDA also encourages persons who 

would like to study their new tobacco 

product to meet with the Office of 

Science (OS) in the Center for Tobacco 

Products (CTP) to discuss their 

investigational plan. The request for a 

meeting should be sent in writing to the 

Director of CTP’s Office of Science and 

should include adequate information for 

FDA to assess the potential utility of the 

meeting and to identify FDA staff 

necessary to discuss agenda items. The 

following web page details the process 

for requesting a meeting with OS and 

how FDA will respond: https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

meetings-industry-and-investigatorsresearch-and-development-tobaccoproducts. 

FDA efforts regarding issuance of a 

final guidance for Harmful and 

Potentially Harmful Constituent 

reporting (and later a testing and 

reporting regulation under section 915 

of the FD&C Act) is ongoing, and the 

guidance document will be issued 

consistent with our Good Guidance 

Practice regulations found in 21 CFR 

10.115, which provide for public 

comment at any time. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Obtaining an FDA Order Authorizing Marketing of Tobacco 

Product (PTMA application) and 21 CFR 25.40 Environmental Assessments ........................................................ 200 3.75 750 1,713 1,284,750 

Request for Meeting with CTP’s Office of Science to Discuss Investigational Plan .................................................. 27 1 27 10 270 

§ 1143 Cigar Warning Plans ................................................ 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,285,021 

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

FDA estimates an average burden per 

respondent of 1,500 hours to prepare a 

PMTA seeking an order from FDA 

allowing the marketing of a new tobacco 

product. We assume, on average, an 

additional 213 hours is necessary to 

prepare an environmental assessment in 

accordance with the requirements of 21 

CFR 25.40, for a total of 1,713 hours per 

PMTA application. This average 

represents a wide range of hours that 

will be required for these applications 


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25282 Federal Register / Vol. 87, No. 82 / Thursday, April 28, 2022 / Notices 

under different circumstances, with a 

small number requiring more hours 

(e.g., as many as 5,000 hours for early 

applications that involve complex 

products and for which the company 

has no experience conducting studies or 

preparing analysis of public health 

impacts, or for which reliance on master 

files is not possible) as well as many 

requiring fewer hours (e.g., as few as 50 

hours for applications for products that 

are very similar to other new products). 

A PMTA may require one or more types 

of studies including chemical analysis, 

nonclinical studies, and clinical studies. 

FDA also estimates the number of 

PMTAs that FDA expects to receive 

annually will be 750 (642 electronic 

nicotine delivery systems (ENDS) 

Liquids and 108 ENDS Delivery 

Systems). 

FDA anticipates that the 27 potential 

respondents to this collection may need 

to meet with CTP’s Office of Science to 

discuss their investigational plans. This 

number has been reduced based on the 

average number of meeting requests 

received over the past 3 years. To 

request this meeting, applicants should 

compile and submit information to FDA 

for meeting approval. FDA estimates 

that it will take approximately 270 

hours to compile and request a meeting 

with OS. We have revised the hours per 

response to be consistent with the 

meetings information collection for 

originally regulated products (OMB 

control number 0910–0731). 

Based on the September 2020 order 

vacating the health warning 

requirements for cigars and pipe tobacco 

(set forth in §§ 1143.3 and 1143.5) and 

remanding the Final Deeming Rule’s 

warning requirements for cigars and 

pipe tobacco, we have removed the 

burden associated with this activity. We 

have included one token hour of burden 

associated with the requirements in 

§ 1143 to acknowledge the requirement 

remains in the regulations. 

We have adjusted our burden 

estimate, which has resulted in a 

decrease to the currently approved 

burden. The total estimated burden for 

this information collection is 1,285,021 

reporting hours, and 778 annual 

responses. Our estimated burden for the 

information collection reflects an 

overall decrease of 2,779 hours and a 

corresponding decrease of 262 

responses. We attribute this adjustment 

to updated information in the number of 

meeting requests with CTP’s Office of 

Science to discuss investigational plans, 

the removal of burden for the cigar 

warning plans, the removal of the smallscale manufacturer reporting, and have 

therefore revised the estimated burden 

and number of respondents to the 

information collection. 

Dated: April 22, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09072 Filed 4–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3758] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Expanded Access 

to Investigational Drugs for Treatment 

Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA 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 May 31, 

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 0910–0814. Also include 

the FDA docket number found in 

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. 

Expanded Access to Investigational 

Drugs for Treatment Use 

OMB Control Number 0910–0814— 

Revision 

This information collection supports 

Agency regulations in 21 CFR part 312, 

subpart I, Expanded Access to 

Investigational Drugs for Treatment Use; 

associated guidance; and Form FDA 

3926, Individual Patient Expanded 

Access Investigational New Drug 

Application (IND). The regulations 

govern the use of investigational new 

drugs, biologics, and approved drugs if 

availability is limited by a risk 

evaluation and mitigation strategy, 

when the primary purpose is to 

diagnose, monitor, or treat a patient’s 

disease or condition. The goal of the 

expanded access program is to facilitate 

the availability of such products to 

patients with serious diseases or 

conditions when there is no comparable 

or satisfactory alternative therapy to 

diagnose, monitor, or treat the patient’s 

disease or condition. The regulations 

provide that certain criteria be met, 

establish content and format 

requirements for associated reporting, 

and require that submissions include a 

cover sheet. 

Although we continue to account for 

burden associated with the submission 

of expanded access requests for 

individual patients, we are revising the 

information collection to also account 

for burden attendant to other expanded 

access submissions, including 

commercial investigational new drug 

applications (INDs) that involve large 

groups of patients enrolled for treatment 

use of the investigational drug 

(§§ 312.300 through 312.320 (21 CFR 

312.300 through 312.320)), currently 

approved under OMB control number 

0910–0014. Because of FDA’s long 

history of facilitating expanded access 

to investigational drugs for treatment 

use for patients with serious or 

immediately life-threatening diseases or 

conditions, our efforts in this regard are 

ongoing. 

Form FDA 3926 was developed to 

assist respondents to the information 

collection. Form FDA 3926 requires the 

completion of data fields that enable us 

to uniformly collect the minimum 

information necessary from licensed 

physicians who want to request 

expanded access as prescribed in the 

applicable regulations. To supplement 

the form instructions, we issued 

guidance, most recently updated in 

October 2017, entitled ‘‘Individual 

Patient Expanded Access Applications: 

Form FDA 3926,’’ available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 


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