76198 Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices 
include one technically qualified 
member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer- oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative. 
Further information regarding the 
most recent charter and other information can be found at https://www.fda.gov/advisory-committees/ cardiovascular-and-renal-drugs- advisory-committee/cardiovascular- and-renal-drugs-advisory-committee- charter or by contacting the Designated 
Federal Officer (see 
FOR FURTHER  
INFORMATION CONTACT ). In light of the 
fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. 
This notice is issued under the 
Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/ AdvisoryCommittees/default.htm. 
Dated: December 8, 2022. 
Lauren K. Roth, 
Associate Commissioner for Policy. 
[FR Doc. 2022–27014 Filed 12–12–22; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
[Docket No. FDA–2012–N–0977] 
Agency Information Collection 
Activities; Submission for Office of Management and Budget Review; 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 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 January 12, 2023. 
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 0910–0312. Also include the FDA docket number found in brackets in the heading of this document. 
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 : In 
compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 
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— 
Revision 
This information collection supports 
FDA regulatory requirements contained 
in part 1140 (21 CFR part 1140) authorized under Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 9) and associated Agency guidance. Regulations in part 1140 establish permissible forms of labeling and advertising for cigarettes or 
smokeless tobacco and include reporting requirements directing persons to notify FDA if they intend to use a form of advertising or labeling that is not addressed in the regulations. Section 1140.30(a)(2) (21 CFR 1140.30(a)(2)) requires tobacco product manufacturers, distributors, and retailers to notify FDA if they intend to use advertising or labeling for cigarettes or smokeless tobacco in a medium that is not listed in the regulations. The notifications must be made 30 days prior to the use of such mediums. 
We allow electronic and written 
submission of these notifications. Respondents can mail notifications as prescribed in section 1140.30(a)(2) to FDA. Instructions providing clarification on how to format the notification may be found in the guidance document entitled ‘‘Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents’’ (2010) (https://www.fda.gov/regulatory- information/search-fda-guidance- documents/compliance-regulations- restricting-sale-and-distribution- cigarettes-and-smokeless-tobacco- protect). 
In the Federal Register of June 27, 
2022 (87 FR 38160), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics solicited. Subsequent to publication of the 60-day notice, we identified the associated guidance as an information collection instrument. 
FDA estimates the burden of this 
collection of information as follows: 
TABLE 1—E STIMATED ANNUAL REPORTING BURDEN1 
21 CFR Section/Guidance Document Section Number of 
respondents Number of 
responses per 
respondent Total 
annual 
responses Average 
burden per 
response Total 
hours 
1140.30(a)(2)—Notification of other advertising or labeling medium ................... 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 or labeling, and the Agency has estimated it should take 1 hour to provide such notice. Therefore, the total estimated 
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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: December 8, 2022. 
Lauren K. Roth, 
Associate Commissioner for Policy. 
[FR Doc. 2022–27011 Filed 12–12–22; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
[Docket No. FDA–2016–N–2544] 
Agency Information Collection 
Activities; Submission for Office of Management and Budget Review; Comment Request; Quality System Regulation 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Notice. 
SUMMARY : The Food and Drug 
Administration (FDA) 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 January 12, 2023. 
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 0910–0073. Also include the FDA docket number found in brackets in the heading of this document. 
FOR FURTHER INFORMATION CONTACT : 
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, 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. 
Medical Devices: Current Good 
Manufacturing Practice Quality System Regulation—21 CFR part 820 
OMB Control Number 0910–0073— 
Extension 
As authorized under section 520(f) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(f)), the Secretary of the Department of Health and Human Services has issued regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a device, but not including an evaluation of the safety and effectiveness of a device), packing, storage, and installation of a device conform to current good manufacturing practice (CGMP) and assure that the device will be safe and effective and otherwise in compliance with the FD&C Act. 
The quality system regulation (QSR) 
under part 820 (21 CFR part 820) sets forth CGMP requirements governing the design, manufacture, packing, labeling, storage, installation, and servicing of all finished medical devices intended for human use. The requirements cover purchasing and service controls, clarify recordkeeping for device failure and complaint investigations, clarify requirements for verifying/validating production processes and process or product changes, and clarify requirements for product acceptance activities, quality data evaluations, and corrections of nonconforming product/ quality problems. In the Federal Register of February 23, 2022 (87 FR 
10119), we proposed to incorporate by reference International Organization for Standardization 13485 (ISO 13485): Medical devices—Quality Management Systems—Requirements for Regulatory Purposes, the 2016 edition, to the QSR (RIN 0910–AH99), to align implementation of requirements. 
Information collection under the QSR 
is intended to assist FDA in assuring the safety of medical devices. Requirements include documenting the establishment of procedures and identifying required records that assist FDA in determining whether firms are in compliance with CGMP. In particular, for example, compliance with CGMP design control requirements should decrease the number of design-related device failures that have resulted in deaths and serious injuries. Records must be made available for review or copying during FDA inspection. The regulations in part 820 apply to approximately 29,424 respondents, based on current data within our device registration and listing database. 
In the Federal Register of August 22, 
2022 (87 FR 51433), we published a 60- day notice soliciting comment on the proposed collection of information. No comments were received. 
We estimate the burden of this 
collection of information as follows: 
TABLE 1—E STIMATED ANNUAL RECORDKEEPING BURDEN1 
21 CFR part 820; 
required records Number of 
recordkeepers Number of 
records per 
recordkeeper Total 
annual 
records Average 
burden per 
recordkeeping Total hours 
Quality System Requirements—Subpart B ....................................................... 29,424 1 29,424 83 2,442,192 
Design Controls—Subpart C ............................................................................. 29,424 1 29,424 132 3,883,968 
Document Controls—Subpart D ....................................................................... 29,424 1 29,424 11 323,664 
Purchasing Controls—Subpart E ...................................................................... 29,424 1 29,424 28 823,872 
Identification and Traceability—Subpart F ........................................................ 29,424 1 29,424 2 58,848 
Production and Process Controls—Subpart G ................................................. 29,424 1 29,424 31 912,144 
Acceptance Activities—Subpart H .................................................................... 29,424 1 29,424 6 176,544 
Nonconforming Product; Corrective and Preventative Action—Subparts I And 
J ..................................................................................................................... 29,424 1 29,424 23 676,752 
Labeling and Packaging Controls—Subpart K ................................................. 29,424 1 29,424 3 88,272 
Handling, Storage, Distribution, and Installation—Subpart L ........................... 29,424 1 29,424 15 441,360 
Records—Subpart M ......................................................................................... 29,424 1 29,424 10 294,240 
Servicing—Subpart N ........................................................................................ 29,424 1 29,424 3 88 ,272 
Statistical Techniques—section 820.250—Subpart O ...................................... 29,424 1 29,424 1 29,424 
Total ........................................................................................................... .......................... .......................... ........................ ........................ 10,239,552 
1There are no capital costs or operating and maintenance costs associated with this collection of information. 
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