2024-12346. Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) 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 information collection provisions related to Medical Device Recall Authority.

DATES:

Either electronic or written comments on the collection of information must be submitted by August 5, 2024.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 5, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received 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-2024-N-2381 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority.” 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 onhttps://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 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, [e-mail].

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.

Medical Device Recall Authority—21 CFR Part 810

OMB Control Number 0910-0432—Extension

This collection of information helps to implement section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and regulations in part 810 (21 CFR part 810) which set forth mandatory medical device recall authority provisions. Section 518(e) of the FD&C Act provides FDA with the authority to issue an order requiring an appropriate person, including manufacturers, importers, distributors, and retailers of a device, if FDA finds that there is reasonable probability that the device intended for human use would cause serious, adverse health consequences or death, to: (1) Immediately cease distribution of such device and (2) immediately notify health professionals and device-user facilities of the order and to instruct such professionals and facilities to cease use of such device.

The person named in the order will have an opportunity for a regulatory hearing or to provide a written request to FDA asking that the order be modified, vacated, or amended. FDA may later amend the order to require a mandatory recall of the device. FDA currently allows for these requests, along with other reports and records concerning mandatory recalls, to be submitted to the agency using electronic methods including email and FDA's eSubmitter program ( https://www.fda.gov/​industry/​fda-esubmitter).

FDA issued part 810 to implement the provisions of section 518 of the FD&C Act. The information collected under the mandatory recall authority provisions is used by FDA to implement mandatory recalls.

Description of Respondents: Respondents for this collection of information are firms, including medical device manufacturers, importers, distributors, and retailers, that have been issued a cease distribution and notification order or mandatory recall order in accordance with the provisions under part 810, during the timeframe(s) specified in the order.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden  ¹

Collection activity—21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Submission of information to FDA about device distribution and remedial actions to be taken, as specified in the order—810.10(d)	2	1	2	8	16
Submission of a written request for regulatory hearing—810.11(a)	1	1	1	8	8
Submission of a written request to FDA asking that the order be modified or vacated—810.12(a-b)	1	1	1	8	8
Submission of a strategy for compliance with cease distribution and notification or mandatory recall order—810.14	2	1	2	16	32
Submission of periodic status reports to FDA to enable the agency to assess progress in compliance with the order—810.16(a-b)	2	12	24	40	960
Submission of a written request to FDA to certify compliance with and terminate the order—810.17(a)	2	1	2	8	16
Total Hours					1,040
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Recordkeeping Burden  ¹

Collection activity—21 CFR section	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
Documentation of communications to appropriate person(s)—810.15(b)	2	1	2	8	16
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 3—Estimated Annual Third-Party Disclosure Burden  ¹

Collection activity—21 CFR section	Number of respondents	Number of disclosures per respondent	Total annual disclosures	Average burden per disclosure	Total hours
Communications to appropriate person(s) concerning a cease distribution and notification or mandatory recall order—810.15(a)-(c)	2	1	2	12	24
Follow up communications to appropriate person(s) who fail to respond to the initial communication—810.15(d)	2	1	2	4	8
Notifications provided by recipients of communications to appropriate consignees—810.15(e)	10	1	10	1	10
Total					42
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden per response, burden per recordkeeping, and burden per disclosure estimates are based on FDA's recent experience with voluntary recalls under 21 CFR part 7. Based on an analysis of cease distribution and notification and mandatory recall order activity over the last 3 years, FDA expects no more than two of such actions per year as a conservative estimate.

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

Dated: May 31, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.