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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-N-2381]
 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 October 25, 2024.
 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 
                        ( print page 78314)
                        by using the search function. The OMB control number for this information collection is 0910-0432. Also include the FDA docket number found in brackets in the heading of this document.
 FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
                        *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 Device Recall Authority 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. In the 
                    **Federal Register**
                     of June 5, 2024 (89 FR 48174), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. 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
                             hoursSubmission 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
16Submission of a written request for regulatory hearing—810.11(a)
1
1
1
8
8Submission of a written request to FDA asking that the order be modified or vacated—810.12(a-b)
1
1
1
8
8Submission of a strategy for compliance with cease distribution and notification or mandatory recall order—810.14
2
1
2
16
32Submission 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
960Submission of a written request to FDA to certify compliance with and terminate the order—810.17(a)
2
1
2
8
16Total Hours




1,0401
                         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
                             hoursDocumentation of communications to appropriate person(s)—810.15(b)
2
1
2
8
161
                         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 
                             responses
Average
                             burden per 
                             disclosure
Total
                             hoursCommunications to appropriate person(s) concerning a cease distribution and notification or mandatory recall order—810.15(a)-(c)
2
1
2
12
24Follow up communications to appropriate person(s) who fail to respond to the initial communication—810.15(d)
2
1
2
4
8( print page 78315)Notifications provided by recipients of communications to appropriate consignees—810.15(e)
10
1
10
1
10Total




421
                         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: September 19, 2024. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2024-21904 Filed 9-24-24; 8:45 am] BILLING CODE 4164-01-P