[Federal Register Volume 71, Number 109 (Wednesday, June 7, 2006)]
[Notices]
[Pages 32987-32988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8838]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0220]


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 collection of 
information, 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 or electronic comments on the collection of 
information by August 7, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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 these topics: (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

    The Food and Drug Administration (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)), where officers or employees duly designated by 
the Secretary (FDA investigators) may detain devices during 
establishment inspections which are believed to be adulterated or 
misbranded. On March 9, 1979, FDA issued, under Sec.  800.55 (21 CFR 
800.55), a final regulation on Administrative Detention Procedures (44 
FR 13234), under section 304(g) of the act, which includes certain 
reporting requirements (Sec.  800.55(g)(1) and (g)(2)) 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 
unreasonable and substantial risk of illness or injury, or 
unreasonable, direct, and substantial

[[Page 32988]]

danger to the health of individuals. The final regulation for Banned 
Devices (44 FR 29221), which issued on May 18, 1979 (part 895 (21 CFR 
part 895)), contained certain reporting requirements (Sec. Sec.  
895.21(d) and 895.22(a)).
    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      Total Annual
                21 CFR Section                  No. of Respondents         Response              Responses        Hours per Response      Total Hours
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800.55(g)                                                         1                     1                     1                    25                 25
895.21(d) and 895.22(a)                                          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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                                                                        Annual Frequency per
                 21 CFR Section                   No. of Recordkeepers      Recordkeeper      Total Annual 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.

    FDA's estimate of the burden under the administrative detention 
provision is based on FDA's discussion with the last firm whose devices 
had been detained. Historically, FDA has had very few or no annual 
responses for this information collection.

    Dated: June 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8838 Filed 6-6-06; 8:45 am]
BILLING CODE 4160-01-S