Federal Register / Vol. 87, No. 38 / Friday, February 25, 2022 / Notices 10797 

continue to use the ADR through the 

end of their grants. 

The ADR information collection is 

conducted in accordance with sec. 811 

[42 U.S.C. 2992] of the Native American 

Programs Act and will allow ANA to 

report quantifiable results across all 

program areas. It also provides grantees 

with parameters for reporting their 

progress and helps ANA better monitor 

and determine the effectiveness of their 

projects. 

Respondents: Tribal Government, 

Native non-profit organizations, and 

Tribal Colleges and Universities 

receiving ANA funding. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

ANA ADR ......................................................................................................... 80 1 1 80 

Estimated Total Annual Burden 

Hours: 80. 

Authority: 42 U.S.C. 2992. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–03991 Filed 2–24–22; 8:45 am] 

BILLING CODE 4184–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; ACF– 

801: Child Care and Development Fund 

(CCDF) Quarterly Case-Level Report, 

(OMB #0970–0167) 

AGENCY: Office of Child Care, 

Administration for Children and 

Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Office of Child Care 

(OCC), Administration for Children and 

Families (ACF) is requesting a 3-year 

extension of the form ACF–801: CCDF 

Quarterly Case-Level Report (OMB 

#0970–0167, expiration 2/28/2022). 

OCC proposes minor changes to the 

response categories under the following 

three data elements: Child’s gender, 

ethnicity, and race. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. All emailed requests should 

be identified by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: The ACF–801 provides 

monthly case-level data on the children 

and families receiving direct child care 

services under CCDF. The ACF–801 

case-level data are reported either 

monthly or quarterly. OCC added ‘‘no 

response’’ categories under the 

following three data elements: child’s 

gender, ethnicity, and race. 

Respondents: State and Territory Lead 

Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

ACF–801: CCDF Quarterly Case—Level Report ............................................ 56 4 25 5,600 

Estimated Total Annual Burden 

Hours: 5,600. 

Authority: Section 658K of the Child 

Care and Development Block Grant Act 

(42 U.S.C. 9858); regulations 45 CFR 

98.70 and 98.71. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–04000 Filed 2–24–22; 8:45 am] 

BILLING CODE 4184–81–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1588] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Exemptions From 

Substantial Equivalence Requirements 

for Tobacco Products 

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 exemptions from 

substantial equivalence requirements for 

tobacco products. 


lotter on DSK11XQN23PROD with NOTICES1
10798 Federal Register / Vol. 87, No. 38 / Friday, February 25, 2022 / Notices 

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 

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–1588 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Exemptions From Substantial 

Equivalence Requirements for Tobacco 

Products.’’ 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. 

Exemptions From Substantial 

Equivalence Requirements for Tobacco 

Products 

OMB Control Number 0910–0684— 

Extension 

On June 22, 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (Tobacco Control Act) (Pub. 

L. 111–31) was signed into law. The 

Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) by adding a 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. 

The FD&C Act, as amended by the 

Tobacco Control Act, requires that 

before a new tobacco product may be 

introduced or delivered for introduction 

into interstate commerce, the new 

tobacco product must undergo 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 38 / Friday, February 25, 2022 / Notices 10799 

premarket review by FDA. FDA must 

issue an order authorizing the 

commercial distribution of the new 

tobacco product or find the product 

exempt from the requirements of 

substantial equivalence under section 

910(a)(2)(A) of the FD&C Act (21 U.S.C. 

387j(a)(2)(A)), before the product may be 

introduced into commercial 

distribution. 

On May 10, 2016, FDA issued a rule 

extending FDA’s tobacco product 

authority to all products that meet the 

definition of tobacco product in the law 

(except for accessories of newly 

regulated tobacco products), including 

electronic nicotine delivery systems, 

cigars, hookah, pipe tobacco, nicotine 

gels, dissolvables that were not already 

subject to the FD&C Act, and other 

tobacco products that may be developed 

in the future (81 FR 28974) (‘‘the final 

deeming rule’’). 

FDA has established a pathway for 

manufacturers to request exemptions 

from the substantial equivalence 

requirements of the FD&C Act in 

§ 1107.1 (21 CFR 1107.1) of the 

Agency’s regulations. As described in 

§ 1107.1(a), FDA may exempt tobacco 

products that are modified by adding or 

deleting a tobacco additive, or 

increasing or decreasing the quantity of 

an existing tobacco additive, from the 

requirement of demonstrating 

substantial equivalence if the Agency 

determines that: (1) The modification 

would be a minor modification of a 

tobacco product that can be sold under 

the FD&C Act; (2) a report 

demonstrating substantial equivalence 

is not necessary to ensure that 

permitting the tobacco product to be 

marketed would be appropriate for the 

protection of public health; and (3) an 

exemption is otherwise appropriate. 

Section 1107.1(b) states that a request 

for exemption under section 905(j)(3) of 

the FD&C Act (21 U.S.C. 387e(j)(3)) may 

be made only by the manufacturer of a 

legally marketed tobacco product for a 

minor modification to that tobacco 

product and that the manufacturer must 

submit the request and all information 

supporting it to FDA. The request must 

be made in an electronic format that 

FDA can process, review, and archive 

(or a written request must be made by 

the manufacturer explaining in detail 

why the manufacturer cannot submit 

the request in an electronic format and 

requesting an alternative means of 

submission to the electronic format). 

An exemption request must contain: 

(1) The manufacturer’s address and 

contact information; (2) identification of 

the tobacco product(s); (3) a detailed 

explanation of the purpose for the 

modification; (4) a detailed description 

of the modification, including a 

statement as to whether the 

modification involves adding or 

deleting a tobacco additive, or 

increasing or decreasing the quantity of 

the existing tobacco additive; (5) a 

detailed explanation of why the 

modification is a minor modification of 

a tobacco product that can be sold under 

the FD&C Act; (6) a detailed explanation 

of why a report under section 905(j)(1) 

of the FD&C Act intended to 

demonstrate substantial equivalence is 

not necessary to ensure that permitting 

the tobacco product to be marketed 

would be appropriate for protection of 

the public health; (7) a certification (i.e., 

a signed statement by a responsible 

official of the company) summarizing 

the supporting evidence and providing 

the rationale for the official’s 

determination that the modification 

does not increase the tobacco product’s 

appeal to or use by minors, toxicity, 

addictiveness, or abuse liability; (8) 

other information justifying an 

exemption; and (9) an environmental 

assessment (EA) under part 25 (21 CFR 

part 25) prepared in accordance with 

the requirements of § 25.40 (21 CFR 

25.40). 

The National Environmental Policy 

Act of 1969 (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 for every major Federal action 

that will significantly affect the quality 

of the human environment. 

The FDA NEPA regulations are 

contained in part 25. All applications 

for exemption from substantial 

equivalence require the submission of 

an EA. 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) specifies the content 

requirements for EAs for non-excluded 

actions. 

The information required by 

§ 1107.1(b) is submitted to FDA so FDA 

can determine whether an exemption 

from substantial equivalence to the 

product is appropriate for the protection 

of the public health. Section 1107.1(c) 

states that FDA will review the 

information submitted and determine 

whether to grant or deny an exemption 

based on whether the criteria in section 

905(j)(3) of the FD&C Act are met. FDA 

may request additional information if 

necessary, to make a determination and 

may consider the exemption request 

withdrawn if the information is not 

provided within the requested 

timeframe. 

This collection of information 

requires a manufacturer to submit a 

report at least 90 days prior to making 

an introduction or delivery for 

introduction into interstate commerce 

for commercial distribution of a tobacco 

product. Section 905(j)(1)(A)(ii) of the 

FD&C Act states that if an exemption 

has been requested and granted, the 

manufacturer must submit to FDA a 

report that demonstrates that the 

tobacco product is modified within the 

meaning of section 905(j)(3), the 

modifications are to a product that is 

commercially marketed and in 

compliance with the requirements of the 

FD&C Act, and all the modifications are 

covered by exemptions granted by the 

Secretary under section 905(j)(3). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

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(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request Including § 25.40 Preparation of 

an Environmental Assessment 

§ 1107.1(b)—Preparation of tobacco product exemption 

from substantial equivalence request and § 25.40— 

Preparation of an environmental assessment ................. 812 1 812 24 19,488 

Total Hours (§ 1107.1(b)) .............................................. ........................ ........................ ........................ ........................ 19,488 


lotter on DSK11XQN23PROD with NOTICES1
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 


lotter on DSK11XQN23PROD with NOTICES1