[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