38160 Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Responses 

per 

respondent 

Average 

annual burden 

hours 

Annual burden 

hours 

Staff, Contractor, and Volunteer Reporting of New Vaccination ..................... 75,000 1 0.6667 50,002.5 

Staff, Contractor, and Volunteer Reporting of Existing Vaccination ............... 320,000 1 0.0833 26,656 

Staff, Contactor, and Volunteer Requesting and Processing Vaccination Exemption ......................................................................................................... 5,000 1 0.5000 2,500 

Grant Recipient Maintaining Vaccination Records .......................................... 1,573 1 6.3573 10,000 

Grant Recipient Establishing COVID–19 Testing Protocol ............................. 1,573 1 3.3333 5,243.3 

Grant Recipient Maintaining COVID–19 Testing Protocol .............................. 1,573 1 1 1,573 

Estimated Total Annual Burden 

Hours: We estimate the one-time and 

ongoing burden to maintain records on 

staff and volunteer vaccination rates and 

establish and maintain a written 

COVID–19 testing protocol will result in 

95,974.8 total annual burden hours. 

(Authority: IFC [86 FR 68052]) 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–13615 Filed 6–24–22; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0977] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco To 

Protect Children and Adolescents 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 collection of 

information entitled, ‘‘Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 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 August 26, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 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– 

2012–N–0977 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Regulations Restricting the Sale and 

Distribution of Cigarettes and Smokeless 

Tobacco to Protect Children and 

Adolescents.’’ 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 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 38161 

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. 

Regulations Restricting the Sale and 

Distribution of Cigarettes and 

Smokeless Tobacco To Protect Children 

and Adolescents—21 CFR Part 1140 

OMB Control Number 0910–0312— 

Extension 

This information collection supports 

regulatory requirements contained in 

part 1140 (21 CFR part 1140) authorized 

under Chapter IX of the FD&C Act. 

Regulations in part 1140 establish 

permissible forms of labeling and 

advertising and include reporting 

requirements directing persons to notify 

FDA if they intend to use a form of 

advertising that is not addressed in the 

regulations. Section 1140.30 requires 

manufacturers, distributors, and 

retailers to: (1) observe certain format 

and content requirements for labeling 

and advertising, and (2) notify FDA if 

they intend to use an advertising 

medium that is not listed in the 

regulations. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

1140.30—Scope of permissible forms of labeling and advertising ............................................................................ 25 1 25 1 25 

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

The burden hour estimates for this 

collection of information were based on 

submissions regarding cigarette and 

smokeless tobacco product advertising 

expenditures. 

FDA estimates that approximately 25 

respondents will submit an annual 

notice of alternative advertising, and the 

Agency has estimated it should take 1 

hour to provide such notice. Therefore, 

the total estimated time required for this 

collection of information is 25 hours. 

Based on a review of the information 

collection and the number of 

notifications received since 2018, we 

have made no adjustments to our 

burden estimate. 

Dated: June 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13630 Filed 6–24–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0235] 

Clinical Pharmacology Considerations 

for the Development of 

Oligonucleotide Therapeutics; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Clinical 

Pharmacology Considerations for the 

Development of Oligonucleotide 

Therapeutics.’’ This draft guidance 

describes FDA’s recommendations 

regarding clinical pharmacology 

considerations during the development 

of oligonucleotide therapeutics, 

including characterizing the potential 

for QT interval prolongation, performing 

immunogenicity risk assessment, 

characterizing the impact of hepatic and 

renal impairment, and assessing the 

potential for drug-drug interactions. The 

intent of this guidance is to assist 

industry in the conduct of these studies. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 26, 2022 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 


jspears on DSK121TN23PROD with NOTICES1