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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes

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 cle...

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2011-D-0893]

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 September 21, 2022.

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 0910-0738. 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-45, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, .

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.

Center for Devices and Radiological Health Appeals Processes

OMB Control Number 0910-0738—Extension

This information collection supports implementation of recommendations found in FDA guidance. As discussed in the document entitled “Guidance for ( printed page 51433) Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health (CDRH) Appeals Processes” (July 2019), there are various processes by which appeals requests regarding review of decisions or actions by CDRH may be submitted to the Agency. The guidance is available for download from our website at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​center-devices-and-radiological-health-cdrh-appeals-processes. The guidance document provides general format and content recommendations in this regard, discusses applicable regulations with regard to the timing of such submissions, and describes the collection of information not expressly specified under existing regulations such as the submission of the request for review, minor clarifications as part of the request, and supporting information. While CDRH already possesses in the administrative file the information that would form the basis of a decision on a matter under appeal, the submission of information as recommended in the guidance regarding the appeal request itself, as well as data and information relied on by the requestor in the appeal, will help facilitate timely resolution of the decision under review. We are accounting for burden respondents may incur as a result of these Agency recommendations in this collection request. Additional information about the CDRH appeals process is described in the companion guidance entitled “Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A—Guidance for Industry and Food and Drug Administration Staff” (March 2020), also available for download from our website at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​center-devices-and-radiological-health-cdrh-appeals-processes-questions-and-answers-about-517a.

In the Federal Register of February 18, 2022 (87 FR 9365) we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

We estimate the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden 1
CDRH Appeals Processes: Guidance for Industry and FDA Staff Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours
Recommended format and content elements 35 1 35 8 280
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

We estimate 35 requests will be submitted annually to review decisions and actions by CDRH employees, we attribute one respondent per submission, and we assume each request will take 8 hours to prepare. Based on our evaluation of the information collection since last OMB approval, we have made no adjustments to the currently approved burden estimate.

Dated: August 17, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2022-18065 Filed 8-19-22; 8:45 am]

BILLING CODE 4164-01-P

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Federal Register Citation

Use this for formal legal and research references to the published document.

87 FR 51432

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“Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes,” thefederalregister.org (August 22, 2022), https://thefederalregister.org/documents/2022-18065/agency-information-collection-activities-submission-for-office-of-management-and-budget-review-comment-request-center-fo.