[Federal Register Volume 62, Number 136 (Wednesday, July 16, 1997)]
[Notices]
[Pages 38095-38097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18592]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0266]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 38096]]
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 (the PRA).
DATES: Submit written comments on the collection of information by
August 15, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC, 20503,
Attention: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1479.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(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 (21 CFR 800.55,
800.55(k), 895.21, and 895.22) (OMB Control Number 0910-0114--
Reinstatement)
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. On March 9, 1979, FDA issued a final
regulation on administrative detention procedures, which includes,
among other things, certain reporting requirements (Sec. 800.55(g) (21
CFR 800.55(g))) and recordkeeping requirements (Sec. 800.55(k)). Under
Sec. 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 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
regulation for banned devices contains certain reporting requirements
(Secs. 895.21(d) and 895.22(a) (21 CFR 895.21(d) and 895.22(a))).
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 notice will contain the finding that the
device presents a substantial deception or an unreasonable and
substantial risk of illness or injury. The notice 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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800.55(g) 1 1 1 25 25
895.21(d) and 895.22(a)\2\ 0 0 0 0 0
Total .............. .............. .............. .............. 25
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\No devices were banned during the past 3 years (Secs. 895.21 and 895.22). Therefore, no burden has been
imposed upon industry. When the prosthetic hair fibers were banned, there were no firms in the United States
that were manufacturing or distributing the products. Thus, FDA has put zeroes in the columns estimating
reporting and recordkeeping burdens.
Table 2.--Estimated Annual Recordkeeping Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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800.55(k) 1 1 1 20 20
Total .............. .............. .............. .............. 20
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There are no capital costs or operating and maintenance costs associated with this collection of information.
Over the past 3 years, there has been an average of one new
administrative detention action per year. Each administrative detention
will have varying amounts of data and information that must be
maintained.
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 over the last 3 years.
[[Page 38097]]
Dated: July 7, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-18592 Filed 7-15-97; 8:45 am]
BILLING CODE 4160-01-F
