[Federal Register: March 17, 2003 (Volume 68, Number 51)]
[Notices]               
[Page 12706-12707]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr03-81]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0075]

 
Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing information 
collection, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for administrative detention and banned medical devices.

DATES: Submit written and electronic comments on the collection of 
information by May 16, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 

to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 

Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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 on March 9, 1979 (44 FR 13234 at 13239) on 
administrative detention procedures, which includes, among other 
things, certain reporting requirements 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 29221) contained certain reporting requirements 
Sec. Sec.  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 document will contain the finding that the 
device presents a substantial deception or an unreasonable and 
substantial risk of illness or injury. 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,

[[Page 12707]]

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 Frequency per
              21 CFR Section                No. of Respondents          Response        Total Annual Records   Hours per Response        Total Hours
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800.55(g)                                           1                      1                     1                    25                    25
895.21(d) and 895.22                               26                      1                    26                    16                   416
  Total                                    ....................  .....................  ....................  ....................         441
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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             21 CFR Section               No. of Recordkeepers  Annual Frequency per  Total Annual Records  Hours per Recordkeeper       Total Hours
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800.55(k)                                          1                     1                     1                     20                     20
  Total                                   ....................  ....................  ....................  ......................          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: March 7, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-6230 Filed 3-14-03; 8:45 am]

BILLING CODE 4160-01-S