26766 Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Notices 

Animal drug manufacturers are 

already required to maintain 

distribution records for their animal 

drug products to comply with FDA’s 

current good manufacturing regulations 

for periodic drug reports under 

§ 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)), 

approved under OMB control number 

0910–0284. Section 512(l)(3) of the 

FD&C Act differs from § 514.80(b)(4)(i) 

in that it requires that records include 

separate information for each month of 

the calendar year. In addition, under 21 

CFR 211.196 (approved under OMB 

control number 0910–0139), 

manufacturers currently are required to 

maintain distribution records that 

include dosage form, and date drug is 

distributed. Based on these 

requirements, FDA believes that 

manufacturers already keep detailed 

records of the dates when antimicrobial 

drugs are distributed for marketing and 

recall purposes from which monthly 

reports can be prepared as part of usual 

and customary business practices. 

However, FDA estimates an additional 

recordkeeping burden of 42 hours for 

further compliance with section 

512(l)(3) of the FD&C Act, as detailed in 

table 2. 

We have adjusted our burden 

estimate, which has resulted in a 

decrease to the currently approved 

burden. We attribute this to respondents 

who reported by paper in previous years 

and are now reporting electronically. 

We also note a decrease in 

recordkeeping respondents. We attribute 

this to the mergers of sponsors over the 

years. 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09632 Filed 5–4–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0350] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Retailer 

Training Programs 

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 provisions associated with 

‘‘Tobacco Retailer Training Programs.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by July 5, 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 July 5, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of July 5, 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– 

2010–D–0350 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Tobacco 

Retailer Training Programs.’’ 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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Notices 26767 

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 Retailer Training Programs 

OMB Control Number 0910–0745— 

Extension 

Tobacco products are governed by 

chapter IX of the Federal Food, Drug, 

and Cosmetic Act (sections 900 through 

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

387u). The FDA intends to issue 

regulations establishing standards for 

approved tobacco retailer training 

programs under section 906(d) of the 

Federal Food, Drug and Cosmetic Act 

(21 U.S.C. 387f(d)). In the interim, FDA 

published a guidance document which 

can be downloaded at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

tobacco-retailer-training-programs. The 

guidance is intended to assist tobacco 

retailers to voluntarily implement 

effective training programs for 

employees. 

The guidance discusses recommended 

elements that should be covered in a 

training program, such as: (1) Federal 

laws restricting the access to, and the 

advertising and promotion of, cigarettes, 

smokeless, and covered tobacco 

products; (2) the health and economic 

effects of tobacco use, especially when 

the tobacco use begins at a young age; 

(3) written company policies against 

sales to youth and other restrictions on 

the access to, and the advertising and 

promotion of, tobacco products; (4) 

identification of the tobacco products 

sold in the retail establishment that are 

subject to the Federal laws and 

regulations prohibiting their sale to 

underage persons; (5) age verification 

methods; (6) practical guidelines for 

refusing sales; and (7) testing to ensure 

that employees have the required 

knowledge. The guidance recommends 

that retailers require current and new 

employees to take a written test prior to 

selling tobacco products and that 

refresher training be provided at least 

annually and more frequently as 

needed. The guidance recommends that 

retailers maintain certain written 

records documenting that all individual 

employees have been trained and that 

retailers retain these records for 4 years 

in order to be able to provide evidence 

of a training program during the 48- 

month time period covered by the civil 

money penalty schedules outlined in 

the law. 

The guidance also recommends that 

retailers implement certain hiring and 

management practices as part of an 

effective retailer training program. The 

guidance suggests that applicants and 

current employees be notified both 

verbally and in writing of the 

importance of complying with laws 

prohibiting the sales of tobacco products 

to underage persons. In addition, FDA 

recommends that retailers implement an 

internal compliance check program and 

document the procedures and corrective 

actions for the program. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; guidance section IV Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Develop training program .................................................... 79,700 1 79,700 16 1,275,200 

Develop written policy against sales to youth and employee acknowledgement ................................................. 79,700 1 79,700 1 79,700 

Develop internal compliance check program ...................... 79,700 1 79,700 8 637,600 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,992,500 

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


lotter on DSK11XQN23PROD with NOTICES1
26768 Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Notices 

1 Deeming Tobacco Products to be Subject to the 

Food, Drug, and Cosmetic Act, as Amended by the 

Family Smoking Prevention and Tobacco Control 

Act: Final Regulatory Impact Analysis, 2016 https:// 

www.fda.gov/downloads/AboutFDA/Reports

ManualsForms/Reports/EconomicAnalyses/ 

UCM500254.pdf. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity; guidance section IV Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeper 

Total hours 

Training program ................................................ 79,700 4 318,800 0.25 (15 minutes) ........... 79,700 

Written policy against sales to youth and employee acknowledgement.79,700 4 318,800 0.10 (6 minutes) ............. 31,880 

Internal compliance check program ................... 79,700 2 159,400 0.5 (30 minutes) ............. 79,700 

Total ............................................................. ........................ ........................ ........................ ......................................... 191,280 

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

FDA’s estimate of the number of 

respondents in tables 1 and 2 is based 

on data from the deeming rule Final 

Regulatory Impact Analysis,1 which 

showed there are an estimated 362,273 

retail establishments that currently sell 

tobacco products. The Agency reviewed 

these numbers again for this notice, and 

believe they are an accurate estimation. 

We assume that 75 percent of tobacco 

retailers already have some sort of age 

and identification verification training 

program in place. We expect that some 

of those retailer training programs 

already meet the elements in the 

guidance, some retailers would update 

their training program to meet the 

elements in the guidance, and other 

retailers would develop a training 

program for the first time. Thus, we 

estimate that two-thirds of tobacco 

retailers would develop a training 

program that meets the elements in the 

guidance (66 percent of 362,273 = 

239,100; then annualized to 79,700). 

We have adjusted our burden estimate 

and the number of respondents, which 

has resulted in a decrease to the 

currently approved burden and 

respondent count. This adjustment is 

based on available data estimating the 

number of retail establishments that sell 

tobacco products in the United States. 

Additionally, the burden chart was 

updated to reflect a change from an 

estimation over the course of 3 years to 

annualized burden. 

Dated: April 28, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09628 Filed 5–4–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: SBIR/STTR Commercialization 

Readiness Pilot (CRP) Program. 

Date: May 17, 2022. 

Time: 2:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Telephone Conference 

Call). 

Contact Person: Allen Richon, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6184, 

MSC 7892, Bethesda, MD 20892, 301–379– 

9351, allen.richon@nih.hhs.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Topics in 

Virology and Viral Pathogenesis. 

Date: May 18, 2022. 

Time: 12:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Kenneth M. Izumi, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3204, 

MSC 7808, Bethesda, MD 20892, 301–496– 

6980, izumikm@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: April 29, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–09591 Filed 5–4–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Generic Clearance for 

Conferences, Meetings, Workshops, 

Poster Sessions and Registrations 

(Office of the Director) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995 to provide 

opportunity for public comment on 

proposed data collection projects, the 

National Institutes of Health Office of 

the Director (OD) will publish periodic 

summaries of proposed projects to be 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 60 days of the date of this 

publication. 


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