Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-N-2844]
 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 17, 2025.
 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 0910-0138. 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. Reclassification Petitions for Medical Devices OMB Control Number 0910-0138—Extension This information collection helps support implementation of statutory provisions found in sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(e) and (f), 21 U.S.C. 360d(b), 21 U.S.C. 360e((b), and 21 U.S.C. 360j(l)) pertaining to the reclassification of medical devices. 
                    ( print page 102911)
                    Specifically, the FD&C Act establishes three tiers of regulatory control for medical devices, by establishing three classes of medical devices, and requiring that all devices be classified into one of these three classes. The classification of a device depends upon the degree of regulatory control necessary to provide a reasonable assurance of the safety and effectiveness of the device. The three tiers of regulatory control are: (1) Class I—general controls, subject to sections 501 adulteration, 502 misbranding, 510 registration, 516 banned devices, 518 notification and other remedies, 519 records and reports, and 520 general provisions of the FD&C Act; (2) Class II—performance standards; and (3) Class III—premarket approval. Implementing regulations in 21 CFR part 860, subpart C (parts 860.120 through 860.136) provide that any person may petition for reclassification of a device from any class to any other class and prescribe requisite format and content elements for reclassification petitions submitted to the Agency. We also provide information on our website at 
                    *https://www.fda.gov/​about-fda/​cdrh-transparency/​reclassification*
                     regarding medical device reclassification, which may serve as a helpful resource to respondents. FDA is responsible for reviewing petitions for reclassification and determining whether the subject device will be reclassified. In some instances, FDA also submits such petitions to one of its medical device advisory panels for review and recommendations. FDA's decision regarding the reclassification of a device is based primarily upon the information contained in the petition. Respondents to the information collection are private sector, for-profit businesses. We have not identified reclassification petitions as a type of submission we are currently prepared to accept electronically. Submission instructions, including addresses, are provided in § 860.123(b). In the 
                    **Federal Register**
                     of July 9, 2024 (89 FR 56390), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received, but it was not related to this information collection. FDA estimates the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden 1
21 CFR part; activity
Number of
                             respondents
Number of
                             responses per 
                             respondent
Total annual
                             responses
Average
                             burden 
                             per response
Total
                             hours§  860.123; supporting data for reclassification petitions
12
1
12
497
5,9641
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 Reclassification petitions must be submitted as set forth in the applicable regulations, which provide for the submission of an original and two copies (§ 860.123(b)(4)). Each petition must include supporting data to show why reclassification of the device type will provide reasonable assurance of the safety and effectiveness of the device type. The principal data in such a petition will typically be reports of clinical trials. Our estimated burden for the information collection reflects an increase of 6 responses and a corresponding increase of 2,982 hours. We attribute this adjustment to an increase in the number of submissions we received over the last few years. Dated: December 11, 2024. P. Ritu Nalubola, Associate Commissioner for Policy.


[FR Doc. 2024-29955 Filed 12-17-24; 8:45 am] BILLING CODE 4164-01-P