[Federal Register: June 25, 2003 (Volume 68, Number 122)]
[Notices]
[Page 37846-37847]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn03-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0075]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Administrative Detention and Banned Medical
Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below 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 July
25, 2003.
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 written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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.
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)), to detain
during establishment inspections devices that are believed to be
adulterated or misbranded. FDA issued a final rule that published in
the Federal Register of March 9, 1979 (44 FR 13234 at 13239), on
administrative detention procedures, which includes, among other
things, certain reporting requirements under Sec. 800.55(g) and (k)
(21 CFR 800.55(g) and (k)) and recordkeeping requirements. Under Sec.
800.55(g), an applicant of a detention order must show documentation of
ownership if devices are detained at a place other than that of the
appellant. Under Sec. 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
an unreasonable and substantial risk of illness or injury. The final
rule for banned devices that published in the Federal Register of May
18, 1979 (44 FR 29214 at 29221), contained certain reporting
requirements under Sec. Sec. 895.21(d) and 895.22 (21 CFR 895.21(d)
and 895.22). Section 895.21(d) states that if the Commissioner of Food
and Drugs (the Commissioner) decides to initiate a proceeding to make a
device a banned device, a notice of proposed rulemaking will be
published in the Federal Register and this document will contain the
finding that the substantial risk of illness or injury exists. The
document will also contain the reasons why the proceeding was
initiated, an evaluation of data and information obtained under other
provisions of the act, any consultations with the panel, and a
determination as to whether the device could be corrected by labeling
or change of labeling, or change of advertising, and if that labeling
or change of advertising has been made. Under Sec. 895.21(d), any
interested person may request an informal hearing and submit written
comments. Under Sec. 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.
Respondents to this collection of information are those
manufacturers, distributors, or importers whose products FDA seeks to
detain or ban. As previously stated, the collection of data and
information under these regulations is conducted on a very infrequent
basis and only as necessary.
In the Federal Register of March 17, 2003 (68 FR 12706), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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21 CFR Annual Frequency Total Annual Total Hours per
Section No. of Respondents per Response Responses Response Total Hours
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800.55(g) 1 1 1 25 25
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895.21(d) 26 1 26 16 416
and 895.22
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Total .................. .................. .................. .................. 441
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 37847]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
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21 CFR No. of Annual Frequency Total Annual
Section Recordkeepers per Record Records Hours per Record Total Hours
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800.55(k) 1 1 1 20 20
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Over 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. Historically, the Center for Devices and Radiological
Health has had very few or no annual responses for this information
collection and normally reports one response per year.
FDA's estimate of the burden under the administrative detention
provision is based on FDA's discussion with one of the three firms
whose devices had been detained.
Dated: June 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15995 Filed 6-24-03; 8:45 am]
BILLING CODE 4160-01-S