Compliance Policy Guide Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power; Withdrawal of Guidance, 10522 [2023-03509]

Download as PDF 10522 Federal Register / Vol. 88, No. 34 / Tuesday, February 21, 2023 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 21 CFR section or other citation; activity Form FDA No. 680.1(b)(3)(iv); Requirement to notify FDA when certain diseases are detected in source materials. 601.12; Amendments/Resubmissions Section 402(j)(5)(B) of the PHS Act; Certification to accompany biological product applications. Total ........................................... Number of responses per respondent Number of respondents Average burden per response Total annual responses Total hours 2 NA 1 1 1 2 ........................... 2 356h 3674 170 1,291 27.888 1 4741 1,291 20 ......................... 0.28 (17 minutes) 94,820 358 ........................ ........................ ........................ ........................ .............................. 907,806 1 There 2 The are no capital costs or operating and maintenance costs associated with this collection of information. numbers in this column have been rounded to the nearest whole number. TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of disclosures per respondent Number of respondents 21 CFR section; activity 601.6(a); Requirement to notify selling agents and distributors upon suspension of license. 1 Average burden per disclosures Total annual disclosures 20 20 Total hours 2 0.33 (20 minutes) 7 1 There 2 The are no capital costs or operating and maintenance costs associated with this collection of information. number in this column has been rounded to the nearest whole number. Our estimated burden for the information collection reflects an overall increase of 467,907 hours and a corresponding increase in responses. Most of our adjustment reflects an increase in the number of annual submissions that we have received under §§ 601.12(b)(1) and (3), (e), and (f)(4), and 601.45 over the last few years. We attribute the remaining increase (358 hours) to submissions of Form FDA 3674. Dated: February 15, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–03508 Filed 2–17–23; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–0957] Compliance Policy Guide Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power; Withdrawal of Guidance lotter on DSK11XQN23PROD with NOTICES1 Food and Drug Administration, HHS. ACTION: Notice; withdrawal. The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of the compliance policy guide (CPG) Sec. 397.100 Accuracy Requirements for SUMMARY: VerDate Sep<11>2014 17:54 Feb 17, 2023 Jkt 259001 Dated: February 15, 2023. Lauren K. Roth, Associate Commissioner for Policy. The withdrawal is effective February 21, 2023. DEPARTMENT OF HEALTH AND HUMAN SERVICES DATES: FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993–0002, 301–796–6353. We are announcing the withdrawal of the CPG entitled ‘‘Compliance Policy Guide Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power, 21 CFR 1050.10(c)(1)(ii).’’ On January 20, 2023, FDA issued a final rule entitled ‘‘Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products’’ (88 FR 3638). The final rule repealed 21 CFR 1050.10, which includes performance standards for ultrasonic therapy products. Therefore, the policies in CPG Sec. 397.100 are no longer applicable, and this CPG is being withdrawn. SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P AGENCY: Indication of Temporal-Maximum Ultrasonic Power. The Agency is taking this action because the CPG identified in this notice contains policies that have been superseded by a subsequent FDA action. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 [FR Doc. 2023–03509 Filed 2–17–23; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration [Docket No. FDA–2022–P–1939] Determination That TOPAMAX (Topiramate) Sprinkle Capsules, 50 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) has determined that TOPAMAX (topiramate) sprinkle capsules, 50 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for topiramate, sprinkle capsules, 50 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Alexandria Fujisaki, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, SUMMARY: E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Page 10522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0957]


Compliance Policy Guide Sec. 397.100 Accuracy Requirements for 
Indication of Temporal-Maximum Ultrasonic Power; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the withdrawal of the compliance policy guide (CPG) Sec. 397.100 
Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic 
Power. The Agency is taking this action because the CPG identified in 
this notice contains policies that have been superseded by a subsequent 
FDA action.

DATES: The withdrawal is effective February 21, 2023.

FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION: We are announcing the withdrawal of the CPG 
entitled ``Compliance Policy Guide Sec. 397.100 Accuracy Requirements 
for Indication of Temporal-Maximum Ultrasonic Power, 21 CFR 
1050.10(c)(1)(ii).'' On January 20, 2023, FDA issued a final rule 
entitled ``Radiological Health Regulations; Amendments to Records and 
Reports for Radiation Emitting Electronic Products; Amendments to 
Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic 
Products'' (88 FR 3638). The final rule repealed 21 CFR 1050.10, which 
includes performance standards for ultrasonic therapy products. 
Therefore, the policies in CPG Sec. 397.100 are no longer applicable, 
and this CPG is being withdrawn.

    Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03509 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P
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