E6-18190. 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 November 30, 2006.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: [phone].

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 (the act) (21 U.S.C. 334(g)), where officers or employees (FDA investigators), duly designated by the Secretary of Health and Human Services, may detain during establishment inspections devices that are believed to be adulterated or misbranded. In the Federal Register of March 9, 1979 (44 FR 13234), FDA issued, under § 800.55 (21 CFR 800.55), a final regulation on administrative detention procedures, under section 304(g) of the act, which includes certain reporting requirements (§ 800.55(g)(1) and (g)(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, as well as records of distribution of the detained devices. These recordkeeping requirements for administrative detentions allow 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 act (21 U.S.C. 360f), to ban devices that present substantial deception, or unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial danger to the health of individuals. The final regulation for banned devices (part 895 (21 CFR part 895)), issued in the Federal Register of May 18, 1979 (44 FR 29214), contained certain reporting requirements (§§ 895.21(d) and 895.22(a)).

In the Federal Register of June 7, 2006 (71 FR 32987), FDA published a 60-day notice requesting public comments on the information collection provisions. No comments were received.

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

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
800.55(g)	1	1	1	25	25
895.21(d) 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 Burden¹

21 CFR Section	No. of Recordkeepers	Annual Frequency per Recordkeeper	Total Annual Records	Hours per Record	Total Hours
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.

FDA's estimate of the burden under the administrative detention provision is based on FDA's discussion with the last firm whose devices had been detained. Historically, FDA has had very few or no annual responses for this information collection.

Dated: October 24, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.