[Federal Register Volume 62, Number 136 (Wednesday, July 16, 1997)]
[Notices]
[Pages 38098-38099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18595]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0264]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 (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, Attn: 
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, Rockville, MD 20857, 301-827-1479.


[[Page 38099]]


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.

Information Required in a Premarket Notification Submission (21 CFR 
807.87, 807.92, and 807.93) (OMB Control Number 0910-0281--
Reinstatement)

    Under section 510(k) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360(k)), a premarket notification must be filed before the 
introduction or delivery for introduction of a device intended for 
human use. Under Sec. 807.87 (21 CFR 807.87), premarket notifications 
are required to contain certain information, including the device name, 
establishment registration number, class of the device, the device's 
proposed labeling, action taken by the person required to register to 
comply with performance standards, and a 510(k) summary as described in 
Sec. 807.92 (21 CFR 807.92) or a 510(k) statement as described in 
Sec. 807.93 (21 CFR 807.93). In addition, Sec. 807.87(i) requires that 
those filing premarket notification who claim substantial equivalence 
to certain devices as described in Sec. 807.87(i), that are classified 
into class III, must submit to FDA a summary of safety and 
effectiveness problems and a citation to the information upon which the 
summary is based. The premarket notification submitter must also 
furnish FDA with a certification that a reasonable search has been 
conducted of all known information.
    The information collected in the premarket notification is 
necessary to enhance FDA's ability to ensure that only premarket 
notification submissions for devices that are as safe and as effective 
as legally marketed predicate devices are cleared for marketing. In 
addition, FDA makes publicly available this information concerning 
devices for which a marketing order has been issued, in order to 
provide to the public the agency's basis for equivalence 
determinations.
    Respondents to this collection of information are medical device 
manufacturers and distributors.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden                                  
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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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807.87(h) and 807.92 (simple                                                                                    
 510(k) summaries)                  2,592               1           2,592               8          20,736       
807.87(h) and 807.92 (complex                                                                                   
 510(k) summaries)                    247               1             247              12           2,964       
807.87(h) and 807.93 (510(k)                                                                                    
 statements)                        2,896               1           2,896               1           2,896       
807.87(i) and 807.94                                                                                            
 (certifications)                     208               1             208              40           8,320       
Total                                                                                              34,916       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   

    FDA bases these estimates on conversations with industry and trade 
association representatives, and from internal review of the documents 
listed in the table above.
    Under Sec. 807.93, anyone submitting a 510(k) statement must make 
that information available to anyone who requests it.

                                 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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807.93                              2,896              10          28,960               0.5        14,480       
Total                                                                                              14,480       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   


    Dated: July 7, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-18595 Filed 7-15-97; 8:45 am]
BILLING CODE 4160-01-F