41730 Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list REGLAN Injection 

(metoclopramide injection, USP), EQ 5 

mg base/mL and EQ 10 mg base/mL, in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: July 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14929 Filed 7–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0049] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Reporting Harmful 

and Potentially Harmful Constituents 

in Tobacco Products and Tobacco 

Smoke Under the Federal Food, Drug, 

and Cosmetic Act 

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 August 12, 

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 0910–0732. 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. 

Reporting Harmful and Potentially 

Harmful Constituents in Tobacco 

Products and Tobacco Smoke Under 

the Federal Food, Drug, and Cosmetic 

Act 

OMB Control Number 0910–0732— 

Extension 

The Family Smoking Prevention and 

Tobacco Control Act (Pub. L. 111–31) 

(Tobacco Control Act), enacted on June 

22, 2009, amended the Federal Food, 

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

provided FDA with the authority to 

regulate the manufacture, marketing, 

and distribution of cigarettes, cigarette 

tobacco, roll-your-own (RYO) tobacco, 

and smokeless tobacco products to 

protect the public health and to reduce 

tobacco use by minors. The Tobacco 

Control Act also gave FDA the authority 

to issue regulations deeming other 

products that meet the statutory 

definition of a tobacco product to be 

subject to chapter IX of the FD&C Act 

(section 901(b) of the FD&C Act (21 

U.S.C. 387a(b))). 

In accordance with that authority, on 

May 10, 2016, FDA issued a final rule 

deeming all products that meet the 

statutory definition of tobacco product, 

except accessories of newly deemed 

tobacco products, to be subject to FDA’s 

tobacco product authority (final 

deeming rule) (81 FR 28974). 

Chapter IX of the FD&C Act now 

applies to newly regulated products, 

including sections 904(a)(3) and (c)(1) 

(21 U.S.C. 387d(a)(3) and (c)(1)). Section 

904(a)(3) of the FD&C Act requires the 

submission of an initial report from 

each tobacco product manufacturer or 

importer, or agents thereof, listing all 

constituents, including smoke 

constituents as applicable, identified as 

a harmful and potentially harmful 

constituent (HPHC) to health by FDA. 

Reports must be by brand and by 

quantity in each brand and subbrand. 

We note that for cigarettes, smokeless 

tobacco, cigarette filler, and RYO 

tobacco products, this initial reporting 

was completed in 2012. 

Section 904(c)(1) of the FD&C Act 

provides that manufacturers of tobacco 

products not on the market as of June 

22, 2009, must also provide the 

information reportable under section 

904(a)(3) of the FD&C Act at least 90 

days prior to introducing the product 

into interstate commerce. 

FDA has taken several steps to 

identify HPHCs to be reported under 

section 904 of the FD&C Act, including 

issuing a guidance discussing FDA’s 

current thinking on the meaning of the 

term ‘‘harmful and potentially harmful 

constituent’’ in the context of 

implementing the HPHC list 

requirement under section 904(e) of the 

FD&C Act (76 FR 5387, January 31, 

2011, revised guidance issued August 

2016). The guidance is available on the 

internet at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/harmful-andpotentially-harmful-constituentstobacco-products-used-section-904efederal-food-drug. The current 

established list of HPHCs also is 

available on the internet at https://

www.fda.gov/tobacco-products/rulesregulations-and-guidance/harmful-andpotentially-harmful-constituentstobacco-products-and-tobacco-smokeestablished-list (77 FR 20034, April 3, 

2012). 

The purpose of the information 

collection is to collect statutorily 

mandated information regarding HPHCs 

in certain tobacco products and tobacco 

smoke, by brand and by quantity in each 

brand and subbrand. 

To facilitate the submission of HPHC 

information, Forms FDA 3787a-j, for 

cigarettes, smokeless tobacco products, 

and RYO tobacco products, respectively, 

in both paper and electronic formats, are 

available. Additionally, FDA is 

developing forms to facilitate the 

submission of HPHC information for the 

deemed tobacco products. We intend to 

model these forms on the current HPHC 

reporting forms (i.e., Forms FDA 3787a– 

j). A proposed information collection for 

deemed products will be published in a 

separate Federal Register notice, and we 

will solicit comments on that collection 

at that time. 

Manufacturers or importers, or their 

agents, may submit HPHC information 

either electronically or in paper format. 

The FDA eSubmitter tool, available at 

https://www.fda.gov/industry/fdaVerDate Sep<11>2014 18:49 Jul 12, 2022 Jkt 256001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\13JYN1.SGM 13JYN1

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Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 41731 

esubmitter/using-esubmitter-preparetobacco-product-submissions, provides 

electronic forms to streamline the data 

entry and submission process for 

reporting HPHCs for cigarettes, 

smokeless tobacco products, and RYO 

tobacco products. Users of eSubmitter 

may populate an FDA-created Excel file 

and import data into eSubmitter. 

Whether respondents decide to submit 

reports electronically or on paper, each 

form provides instructions for 

completing and submitting HPHC 

information to FDA. The forms contain 

fields for company information, product 

information, and HPHC information. 

In the Federal Register of February 7, 

2022 (87 FR 6869), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

We have adjusted estimates in the 

number of respondents and responses 

per respondent from the 60-day Federal 

Register notice to better align with 

previous assessments that utilized the 

number of entities. The number of 

respondents now reflects the estimated 

number of cigarettes, RYO, and 

smokeless tobacco product 

manufacturers, importers, or their 

agents. The burden totals were 

unchanged from the 60-day notice. 

FDA estimates 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 Total hours 

Reporting for Section 904(c)(1) Products 

1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms 

Cigarette ........................................................................... 48 7.92 380 1.82 692 

RYO ................................................................................. 43 0.44 19 0.43 8 

Smokeless ........................................................................ 34 0.74 25 0.63 16 

Total .......................................................................... ........................ ........................ ........................ ........................ 716 

2. Testing of HPHC Quantities in Products 

Cigarette Filler and RYO ................................................. 43 0.44 19 9.42 179 

Smokeless ........................................................................ 34 0.74 25 12.06 302 

Total .......................................................................... ........................ ........................ ........................ ........................ 481 

3. Testing of HPHC Quantities in Mainstream Smoke 

Cigarette: ISO Regimen ................................................... 48 7.92 380 23.64 8,983 

Cigarette: Health Canada Regimen ................................. 48 7.92 380 23.64 8,983 

Total .......................................................................... ........................ ........................ ........................ ........................ 17,996 

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 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 125 

respondents (48 cigarette, 43 RYO, and 

34 smokeless tobacco product 

manufacturers, importers, or their 

agents) will submit 424 HPHC reports 

annually. Each respondent 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. We have adjusted 

information in the number of 

respondents and responses per 

respondent from the 60-day Federal 

Register notice to better align with 

previous assessments. The number of 

respondents now reflects the estimated 

number of cigarettes, RYO, and 

smokeless tobacco product 

manufacturers, importers, or their 

agents. This section addresses the time 

required to report their company 

information to FDA using 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 total annual responses 

under section 904(c)(1) are based on 

FDA’s experience and the past 4 years 

of tobacco products receiving marketing 

authorizations from FDA, and the 

requirements to submit HPHC data 


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41732 Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 

under this provision of the FD&C Act for 

statutorily regulated products. 

Section 2 of Table 1 estimates that 77 

respondents (43 cigarette filler and RYO 

tobacco and 34 smokeless 

manufacturers, importers, or their 

agents) 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 both the ISO and Health Canada 

smoking regimens. The total expected 

burden is 17,996 hours for this section. 

The total estimated burden for this 

information collection is expected to be 

19,193 hours and 424 annual responses. 

Our estimated burden for the 

information collection reflects an 

overall increase of 354 annual responses 

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: July 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14931 Filed 7–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0002] 

Agency Information Collection 

Request. 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before September 12, 

2022. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 264–0041. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0945–0002–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, or call (202) 

264–0041 the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Civil Rights 

and Conscience Complaint and Health 

Information Privacy & Security 

Complaint 

Type of Collection: Office of Civil 

Rights (OCR)—Extension 

OMB No. 0945–0002 

Abstract: 

ESTIMATED ANNUALIZED BURDEN TABLE

Written forms/electronic forms Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Civil Rights/Conscience Discrimination Complaint.Individuals or households, Not-forprofit institutions.15,446 1 45/60 11,585 

Health Information Privacy Complaint.Individuals or households, Not-forprofit institutions.30,392 1 45/60 22,794 

Total ........................................... ........................................................... 45,838 ........................ 45/60 34,379 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2022–14869 Filed 7–12–22; 8:45 am] 

BILLING CODE 4153–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders; 

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 Deafness and 

Other Communication Disorders 

Advisory Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the contact person listed below in 

advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 


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