05-23519. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority

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 January 3, 2006.

ADDRESSES:

OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: [phone].

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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—21 CFR Part 810 (OMB Control Number 0910-0432)—Extension

This collection implements medical device recall authority provisions under section 518(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360h) and part 810 (21 CFR part 810). Section 518(e) of the act gives FDA the authority to issue an order requiring the appropriate person, including manufacturers, importers, distributors, and retailers of a device, to immediately cease distribution of such device, to immediately notify health professionals and device-user facilities of the order, and to instruct such professionals and facilities to cease use of such device, if FDA finds that there is reasonable probability that the device intended for human use would cause serious adverse health consequences or death.

Section 518(e) of the act sets out a three-step procedure for issuance of a mandatory device recall order. First, if there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, FDA may issue a cease distribution and notification order requiring the appropriate person to immediately do the following: (1) Cease distribution of the device, (2) notify health professionals and device user facilities of the order, and (3) instruct those professionals and facilities to cease use of the device. Second, FDA will provide the person named in the cease distribution and notification order with the opportunity for an informal hearing on whether the order should be modified, vacated, or amended to require a mandatory recall of the device. Third, after providing the opportunity for an informal hearing, FDA may issue a mandatory recall order if the agency determines that such an order is necessary.

The information collected under the recall authority will be used by FDA to ensure that all devices entering the market are safe and effective, to accurately and immediately detect serious problems with medical devices, and to remove dangerous and defective devices from the market.

The respondents to this proposed collection of information are manufacturers, importers, distributors, and retailers of medical devices.

In the Federal Register of September 2, 2005 (70 FR 52397), FDA published a 60-day notice requesting public comment 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
810.10(d)	2	1	2	8	16
810.11(a)	1	1	1	8	8
810.12(a) through (b)	1	1	1	8	8
810.14	2	1	2	16	32
810.15(a) through (d)	2	1	2	16	32
810.15(e)	10	1	10	1	10
810.16	2	12	24	40	960
810.17	2	1	2	8	16
Total					1,082
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The following burden estimates are based on FDA's experience with voluntary recalls under 21 CFR part 7. FDA expects no more than two mandatory recalls per year, as most recalls are done voluntarily.

Section 810.10(d)—FDA estimates that it will take approximately 8 hours for the person named in a cease distribution and notification order to gather and submit the information required by this section.

The total estimated annual burden is 16 hours.

Section 810.11(a)—Based on experience in similar situations, FDA expects that there will be only one request for a regulatory hearing per year and that it will take approximately 8 hours to prepare this request.

Section 810.12(a) and (b)—Based on experience in similar situations, FDA expects that there will be only one written request for a review of a cease distribution and notification order per year and that it will take approximately 8 hours to prepare this request.

Section 810.14—Based upon its experience with voluntary recalls, FDA estimates that it will take approximately 16 hours to develop a strategy for complying with the order.

Section 810.15(a) through (d)—Based upon its experience with voluntary recalls, FDA estimates that it will take approximately 16 hours to notify each health professional, user facility, or individual of the order.

Section 810.15(e)—Based upon its experience with voluntary recalls, FDA estimates that there will be approximately five consignees per recall (10 per year) who will be required to notify their consignees of the order. FDA estimates that it will take them about 1 hour to do so.

Section 810.16—FDA estimates that it would take no more than 40 hours to assemble and prepare a written status report required by a recall. The status reports are prepared by manufacturers six to twelve times each year. Therefore, each manufacturer would spend no more than 480 hours each year preparing status reports. If there were two FDA invoked recalls each year, the total burden hours estimated would be 960 hours each year.

Section 810.17—Based on experience with similar procedures, FDA estimates that it would take 8 hours to draft a written request for termination of a cease distribution and notification or mandatory recall order.

Dated: November 23, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.