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 Ex-
emption ......................................................................................................... 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 
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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—E STIMATED ANNUAL REPORTING BURDEN1 
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 ad-
vertising ............................................................................ 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. 
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