[Federal Register: February 26, 2009 (Volume 74, Number 37)]
[Notices]
[Page 8799-8801]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe09-59]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0631]
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 March
30, 2009.
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,
[[Page 8800]]
OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to oira_
submission@omb.eop.gov. All comments should be identified with the OMB
control number 0910-0432. Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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 of information implements 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) for the medical device recall authority
provisions. Section 518(e) of the 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, (2) immediately
notify health professionals and device-user facilities of the order,
and (3) instruct such professionals and facilities to cease use of such
device.
Further, the provisions under section 518 (e) of the act sets out a
three- step procedure for issuance of a mandatory device recall order
which are: (1) 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: (a) Cease distribution
of the device, (b) notify health professionals and device user
facilities of the order, and (c) instruct those professionals and
facilities to cease use of the device, (2) 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 and, (3) 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 provisions
will be used by FDA to: (1) Ensure that all devices entering the market
are safe and effective, (2) accurately and immediately detect serious
problems with medical devices, and (3) remove dangerous and defective
devices from the market.
In the Federal Register of December 19, 2008 (73 FR 77719), 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 Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
810.10(d) 2 1 2 8 16
----------------------------------------------------------------------------------------------------------------
810.11(a) 1 1 1 8 8
----------------------------------------------------------------------------------------------------------------
810.12(a-b) 1 1 1 8 8
----------------------------------------------------------------------------------------------------------------
810.14 2 1 2 16 32
----------------------------------------------------------------------------------------------------------------
810.15(a-c) 2 1 2 12 24
----------------------------------------------------------------------------------------------------------------
810.15(d) 2 1 2 4 8
----------------------------------------------------------------------------------------------------------------
810.15(e) 10 1 10 1 10
----------------------------------------------------------------------------------------------------------------
810.16(a-b) 2 12 24 40 960
----------------------------------------------------------------------------------------------------------------
810.17(a) 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.
Table 2.--Estimated Annual Recodkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
810.15(b) 2 1 1 8 8
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 8801]]
Explanation for Burden Estimates:
The burden estimates for tables I and II of this document are based
on FDA's experience with voluntary recalls under part 810 of the
regulations. FDA expects no more than two mandatory recalls per year,
as most recalls are done voluntarily. Since the last time this
collection of information was submitted to OMB for renewal/approval,
there have been no mandatory recalls.
Dated: February 18, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4137 Filed 2-25-09; 8:45 am]
BILLING CODE 4160-01-S