10800 Federal Register / Vol. 87, No. 38 / Friday, February 25, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section and activity Number of 

respondents 

Number of 

responses per 

respondent 2

Total annual 

responses 

Average 

burden 

per response 

(in hours) 

Total hours 

§ 1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial Equivalence Request 

§ 1107.1(c)—Preparation of additional information for tobacco product exemption from substantial equivalence 

request .............................................................................. 150 1 150 3 450 

Total Hours (§ 1107.1(c)) .............................................. ........................ ........................ ........................ ........................ 450 

Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant, and modifications covered by exemptions granted by Secretary under section 905(j)(3) 

Abbreviated report submitted to demonstrate tobacco 

product is modified under section 905(j)(3), modifications are to a product that is commercially marketed and 

compliant, and modifications covered by exemptions 

granted by Secretary under section 905(j)(3) .................. 1,217 1 1,217 2 2,434 

Total Hours (section 905(j)(1)(A)(ii)) of the FD&C Act ........................ ........................ ........................ ........................ 2,434 

Total Hours Exemptions From Substantial Equivalence Requirements .................................................. ........................ ........................ ........................ ........................ 22,372 

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

FDA estimates that we will receive 

812 exemption requests under 

§ 1107.1(b) for 24 hours per response 

including EA for a total of 19,488 hours. 

Since an EA is required for each 

§ 1107.1(b) (Optional Preparation of 

Tobacco Product Exemption From 

Substantial Equivalence Request), the 

burden per response for EAs (12 hours) 

has been combined with the 12 hours 

for an SE request for a total of 24 hours 

per response. 

FDA further estimates that we will 

receive 150 submissions requiring 

additional information in support of the 

initial exemption request, and it is 

expected that it will take an average of 

3 hours to prepare the additional 

information for a total of 450 hours. 

FDA estimates that 1,217 respondents 

will prepare 1,217 responses and each 

response will take approximately 2 

hours to prepare, as required by section 

905(j)(1)(A)(ii) of the FD&C Act, for a 

total of 2,434 hours. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 1,499 hours and 94 

respondents. The estimates reflect a 

decrease of 1,217 hours to account for 

a reduction in average response time for 

preparing an abbreviated report. FDA 

provides a recommended format for 

applicants in the exemption order letter 

that significantly reduces the burden 

hours for preparing the abbreviated 

report. The estimates also reflect a 

decrease of 94 responses for 

submissions requiring additional 

information in support of the initial 

exemption request, which resulted in a 

decrease of 282 hours. We attribute this 

adjustment to the number of 

submissions we received over the last 

few years. Therefore, FDA now 

estimates the burden for exemptions 

from substantial equivalence 

requirements is 22,372 hours. 

Dated: February 16, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03992 Filed 2–24–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0377] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Health 

Document Submission 

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 the information 

collection associated with the tobacco 

health document submission. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 26, 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 April 26, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 26, 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 


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Federal Register / Vol. 87, No. 38 / Friday, February 25, 2022 / Notices 10801 

1FDA announced the availability of a guidance 

on this collection in the Federal Register on April 

20, 2010 (75 FR 20606) (revised December 5, 2016 

(81 FR 87565)). 

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– 

2013–N–0377 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Tobacco 

Health Document Submission.’’ 

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: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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 Health Document Submission 

OMB Control Number 0910–0654— 

Extension 

On June 22, 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (Tobacco Control Act) (Pub. 

L. 111–31) was enacted. The Tobacco 

Control Act amended the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) by 

adding, among other things, a new 

chapter granting FDA important 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect the public health 

generally and to reduce tobacco use by 

minors. Additionally, section 101 of the 

Tobacco Control Act amended the FD&C 

Act by adding, among other things, new 

section 904(a)(4) (21 U.S.C. 387d(a)(4)). 

Section 904(a)(4) of the FD&C Act 

requires each tobacco product 

manufacturer or importer, or agent 

thereof, to submit all documents 

developed after June 22, 2009, ‘‘that 

relate to health, toxicological, 

behavioral, or physiologic effects of 

current or future tobacco products, their 

constituents (including smoke 

constituents), ingredients, components, 

and additives’’ (herein referred to as 

‘‘tobacco health documents’’). 

The guidance document ‘‘Health 

Document Submission Requirements for 

Tobacco Products (Revised)’’ (2017) 

(https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/tobacco-health-documentsubmission) requests health documents 

based on statutory requirements and 

compliance dates.1 As indicated in the 

guidance, all manufacturers and 

importers of tobacco products are now 

subject to the FD&C Act and are 

required to comply with section 

904(a)(4), which requires immediate and 

ongoing submission of health 

documents developed after June 22, 

2009 (the date of enactment of the 

Tobacco Control Act). However, FDA 

generally does not intend to enforce the 

requirement at this time with respect to 


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10802 Federal Register / Vol. 87, No. 38 / Friday, February 25, 2022 / Notices 

all such health documents, so long as a 

specified set of documents, those 

developed between June 23, 2009, and 

December 31, 2009, are provided at least 

90 days prior to the delivery for 

introduction of tobacco products into 

interstate commerce. Thereafter, 

manufacturers should preserve all 

health documents, including those that 

relate to products for further 

manufacturing and those developed 

after December 31, 2009, for future 

submission to FDA. All Agency 

guidance documents are issued in 

accordance with our good guidance 

practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

FDA is planning revisions to the 

guidance to reflect that the deemed 

tobacco product compliance period has 

passed. Additional revisions include 

clarifying and editorial changes to 

promote a better understanding of 

FDA’s interpretation of the ‘‘health, 

toxicological, behavioral, or 

physiologic’’ phrase, examples of 

health, toxicological, behavioral, or 

physiologic effects documents, and 

minor updates to the metadata list. 

FDA has been collecting the 

information submitted pursuant to 

section 904(a)(4) of the FD&C Act 

through a facilitative electronic form 

and through a paper form (Form FDA 

3743) for those individuals who choose 

not to use the electronic method. On 

both forms, FDA is requesting the 

following information from firms that 

have not already reported or still have 

documents to report: 

• Submitter identification 

• Submitter type, company name, 

address, country, company headquarters 

Dun and Bradstreet D–U–N–S number, 

and FDA assigned Facility 

Establishment Identifier (FEI) number 

• Submitter point of contact 

• Contact name, title, position title, 

email, telephone, and Fax 

• Submission format and contents (as 

applicable) 

• Electronic documents: Media type, 

media quantity, size of submission, 

quantity of documents, file type, and 

file software 

• Paper documents: Quantity of 

documents, quantity of volumes, and 

quantity of boxes 

• Whether or not a submission is 

being provided 

• Confirmation statement 

• Identification and signature of 

submitter including name, company 

name, address, position title, email, 

telephone, and Fax 

• Document categorization (as 

applicable): Relationship of the 

document or set of documents to the 

following: 

Æ Health, behavioral, toxicological, or 

physiological effects 

Æ Uniquely identified current or 

future tobacco product(s) 

Æ Category of current or future 

tobacco product(s) 

Æ Specific ingredient(s), 

constituent(s), component(s), or 

additive(s) 

Æ Class of ingredient(s), 

constituent(s), component(s), or 

additive(s) 

• Document readability and 

accessibility: Keywords; glossary or 

explanation of any abbreviations, jargon, 

or internal (e.g., code) names; special 

instructions for loading or compiling 

submission. 

• Document metadata: Date document 

was created, document author(s), 

document recipient(s), document 

custodian, document title or 

identification number, beginning and 

ending Bates numbers, Bates number 

ranges for documents attached to a 

submitted email, document type, and 

whether the document is present in the 

University of California San Francisco’s 

Truth Tobacco Documents database. 

You may access the electronic form 

and paper form on our website, at 

https://www.fda.gov/tobacco-products/ 

manufacturing/submit-documents-ctpportal and https://www.fda.gov/media/ 

78652/download, respectively. In 

addition to the electronic and paper 

forms, FDA issued the guidance on this 

collection to assist persons making 

tobacco health document submissions. 

For further assistance, FDA is providing 

a technical guide, embedded hints, and 

a web tutorial on the electronic portal. 

FDA issued a final rule to deem 

products meeting the statutory 

definition of ‘‘tobacco product’’ to be 

subject to the FD&C Act on May 10, 

2016 (81 FR 28973), which became 

effective on August 8, 2016. The FD&C 

Act provides FDA authority to regulate 

cigarettes, cigarette tobacco, roll-yourown tobacco (RYO), smokeless tobacco, 

and any other tobacco products that the 

Agency by regulation deems to be 

subject to the law. This final rule 

extended the Agency’s ‘‘tobacco 

product’’ authorities to all other 

categories of products that meet the 

statutory definition of ‘‘tobacco 

product’’ in the FD&C Act, except 

accessories of such deemed tobacco 

products. 

For tobacco products subject to the 

deeming rule, FDA understands 

‘‘current or future tobacco products’’ to 

refer to products commercially 

distributed on or after August 8, 2016, 

or products in any stage of research or 

development at any time after August 8, 

2016, including experimental products 

and developmental products intended 

for introduction into the market for 

consumer use. For cigarettes, cigarette 

tobacco, RYO, and smokeless tobacco, 

FDA understands ‘‘current or future 

tobacco products’’ to refer to products 

commercially distributed on or after 

June 23, 2009, or products in any stage 

of research or development at any time 

after June 23, 2009, including 

experimental products and 

developmental products intended for 

introduction into the market for 

consumer use. 

In the guidance on this collection, 

FDA indicated our intent to enforce the 

requirement at this time with respect to 

all such health documents relating to 

the deemed tobacco products, so long as 

a specified set of documents, those 

developed between June 23, 2009, and 

December 31, 2009, were submitted by 

February 8, 2017, or in the case of smallscale deemed tobacco product 

manufacturers (small-scale 

manufacturers), by November 8, 2017 

(81 FR 28973 at 29008 and 29009). 

Additionally, FDA extended the 

compliance deadlines by an additional 

6 months for small-scale manufacturers 

in the areas impacted by natural 

disasters to May 8, 2018. Thereafter, 

FDA’s compliance plan requested 

deemed manufacturers provide tobacco 

health document submissions from the 

specified period, at least 90 days prior 

to the delivery for introduction into 

interstate commerce of tobacco products 

to which the health documents relate. 

Manufacturers or importers of cigarettes, 

cigarette tobacco, RYO, or smokeless 

tobacco products must provide all 

health documents developed between 

June 23, 2009, and December 31, 2009, 

at least 90 days prior to the delivery for 

introduction of tobacco products into 

interstate commerce. 

FDA estimates the burden of this 

collection of information as follows: 


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Federal Register / Vol. 87, No. 38 / Friday, February 25, 2022 / Notices 10803 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

Tobacco Health Document Submissions and Form FDA 

3743 .................................................................................. 10 3.2 32 50 1,600 

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

The number of documents received 

each year since the original collection 

period has fallen to less than 5 percent 

of what was received in the original 

collection period. FDA expects this is 

because documents created within the 

specified period should have already 

been submitted. The Agency bases this 

estimate on the total number of tobacco 

firms it is aware of and its experience 

with document production and the 

number of additional documents that 

have been reported each year since the 

original estimate of the reporting 

burden. 

FDA estimates that a tobacco health 

document submission as required by 

section 904(a)(4) of the FD&C Act, will 

take approximately 50 hours per 

submission based on FDA experience. 

To derive the number of respondents for 

this provision, FDA assumes that very 

few manufacturers or importers, or 

agents thereof, would have health 

documents to submit. We anticipate 

documents will be submitted on an 

annual basis for a total of 10 

respondents. FDA estimates the total 

annual reporting burden to be 1,600 

hours. 

Based on a review of the information 

collection of our current OMB approval, 

we have made no adjustments to our 

burden estimate. 

Dated: February 16, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03994 Filed 2–24–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council for Human Genome Research. 

The meeting will be open to the 

public as indicated below. Individuals 

who plan to view the virtual meeting 

and need special assistance or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. The meeting 

will be videocast and can be accessed 

from https://www.genome.gov/aboutnhgri/Institute-Advisors/NationalAdvisory-Council-for-Human-GenomeResearch. Any member of the public 

may submit written comments no later 

than 15 days after the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council for Human Genome Research. 

Date: May 16–17, 2022. 

Closed: May 16, 2022, 10:00 a.m. to 11:00 

a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Human Genome Research 

Institute, National Institutes of Health, 6700– 

B Rockledge Drive, Suite 1100, Bethesda, MD 

20892 (Virtual Meeting). 

Open: May 16, 2022, 11:30 a.m. to 5:00 

p.m. 

Agenda: Report of Institute Director and 

Institute Staff. 

Place: National Human Genome Research 

Institute, National Institutes of Health, 6700– 

B Rockledge Drive, Suite 1100, Bethesda, MD 

20892 (Virtual Meeting). 

Closed: May 17, 2022, 10:00 a.m. to 5:00 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Human Genome Research 

Institute, National Institutes of Health, 6700– 

B Rockledge Drive, Suite 1100, Bethesda, MD 

20892 (Virtual Meeting). 

Contact Person: Rudy O. Pozzatti, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Human Genome Research 

Institute, National Institutes of Health, 6700– 

B Rockledge Drive, Suite 1100, (301) 402– 

0838, pozzattr@mail.nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: http://

www.genome.gov/council, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: February 18, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–04002 Filed 2–24–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; Exercise and 

Alzheimer’s Disease. 

Date: March 22, 2022. 

Time: 11:30 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Dario Dieguez, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institutes of Health, 

National Institute on Aging, Bethesda, MD 

20814, (301) 827–3101, dario.dieguez@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 


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