2022-09455. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices

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:

Fax written comments on the collection of information by June 2, 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. All comments should be identified with the OMB control number 0910-0114. 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, [e-mail] .

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.

Administrative Detention and Banned Medical Devices

OMB Control Number 0910-0114—Extension

FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 334(g)) to detain during established inspections devices that are believed to be adulterated or misbranded. Section 800.55 (21 CFR 800.55), on administrative detention, includes among other things certain reporting requirements (§ 800.55(g)(1) and (2)) and recordkeeping requirements (§ 800.55(k)). Under § 800.55(g), an appellant of a detention order must show documentation of ownership if devices are detained at a place other than that of the appellant. Under § 800.55(k), the owner or other responsible person must supply records about how the devices may have become adulterated or misbranded, in addition to records of distribution of the detained devices. These recordkeeping requirements for administrative detentions permit FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.

FDA also has the statutory authority under section 516 of the FD&C Act (21 U.S.C. 360f) to ban devices that present substantial deception or an unreasonable and substantial risk of illness or injury. Section 895.21 (21 CFR 895.21), on banned devices, contains certain reporting requirements. Section 895.21(d) describes the procedures for banning a device when the Commissioner of Food and Drugs (the Commissioner) decides to initiate such a proceeding. Under 21 CFR 895.22, a manufacturer, distributor, or importer of a device may be required to submit to FDA all relevant and available data and information to enable the Commissioner to determine whether the device presents substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial danger to the health of individuals.

In the Federal Register of November 22, 2021 (86 FR 66315), we published a 60-day notice requesting public comment on the proposed collection of information. One comment was received communicating general support for the information collection. Although the comment suggested the Agency's burden estimate may be too low, no figures were provided.

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

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Administrative detention reporting requirements—800.55(g) and (h)	1	1	1	25	25
Banned devices reporting requirements—895.21(d)(8) and 895.22(a)	26	1	26	16	416
Total					441
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Recordkeeping Burden ¹

21 CFR section	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
Records regarding device adulteration or misbranding and records of distribution of detained devices—800.55(k)	1	1	1	20	20
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

During the past several years, there has been an average of less than one new administrative detention action per year. Each administrative detention will have varying amounts of data and information that must be maintained.

Administrative Detention Reporting—§ 800.55(g)(1) and (2): A person who would be entitled to claim the devices, if seized, may appeal a detention order by submitting a written request to the FDA District Director in whose district the devices are located. This written appeal could include a request for an informal hearing as defined in section 201(y) of the FD&C Act (21 U.S.C. 321(y)). In some cases, the appellant must include documents showing that that person has the legal right to appeal this order.

Movement of Detained Devices—§ 800.55(h)(2): If detained devices are not in final form for shipment, the manufacturer may move them within the establishment where they are detained to complete the work needed to put them in final form. As soon as the devices are moved for this purpose, the individual responsible for their movement shall orally notify the FDA representative who issued the detention order, or another responsible district office official, of the movement of the devices. As soon as the devices are put in final form, they shall be segregated from other devices, and the individual responsible for their movement shall orally notify the FDA representative who issued the detention order, or another responsible district office official, of their new location. The devices put in final form shall not be moved further without FDA approval.

Administrative Detention Recordkeeping—§ 800.55(k): The firm shall have, or establish, and maintain records relating to how the detained devices may have become adulterated or misbranded, records on any distribution of the devices before and after the detention period, records on the correlation of any in-process detained devices that are put in final form, records of any changes in, or process of, the devices permitted under the detention order, and records of any movement of the detained devices.

Procedures for Banned Devices Informal Hearing Request—§ 895.21(d)(8): Section 895.21(d) describes the procedures for banning a device when the Commissioner decides to initiate such a proceeding. Under § 895.21(d), the Commissioner may decide to initiate a proceeding to make a device a banned device. In that event, any interested persons may submit written comments and request an informal hearing within 30 days after the date of the publication of the proposed regulation.

Banned Devices Reporting—§ 895.22(a): A manufacturer, distributor, or importer of a device may be required to submit to FDA all relevant and available data and information to enable the Commissioner to determine whether the device presents substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial danger to the health of individuals.

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: April 27, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.