[Federal Register Volume 62, Number 136 (Wednesday, July 16, 1997)]
[Notices]
[Pages 38097-38098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0265]


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, 
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.

Investigational Device Exemptions Reports and Records (21 CFR Part 
812) (OMB Control Number 0910-0078--Reinstatement)

    This information is collected under the statutory authority of the 
Federal Food, Drug, and Cosmetic Act (the act) regarding 
investigational devices (section 520(g) (21 U.S.C. 360j(g))). An 
investigational device exemption (IDE) allows a device, which would 
otherwise be subject to provisions of the act such as premarket 
notification or premarket approval, to be used in investigations 
involving human subjects in which the safety and effectiveness of the 
device is being studied. The purpose of this section, as explained in 
part 812 (21 CFR part 812) in Sec. 812.1, is to encourage, to the 
extent consistent with the protection of public health and safety and 
with ethical standards, the discovery and development of useful devices 
intended for human use. Under Secs. 812.20, 812.25, and 812.27, 
information collected in the application includes sponsor information; 
a report of prior investigations including reports of all prior 
clinical, animal, and laboratory testing of the device, a bibliography 
of all publications, and a summary of all other unpublished 
information; an investigational plan including study, purpose, 
protocol, risk analysis, device description, and monitoring procedures; 
a description of the methods, facilities, and controls used for the 
manufacture, processing, packing, and storage of the device; 
investigator information including agreements and certifications; 
institutional review board (IRB) information; information on the amount 
to be charged for the device; device labeling; and informed consent 
materials.
     Section 812.10, regarding waiver of IDE requirements, states that 
if a sponsor does not wish to comply with certain requirements of part 
812, the sponsor may voluntarily submit a waiver request.
     Under Sec. 812.35, when an investigational plan changes, a sponsor 
is required to submit a supplemental application to FDA, and the 
sponsor may not begin a part of an investigation at a facility until 
the IRB has approved the investigation, FDA has received the 
certification of IRB approval, and FDA has approved the supplemental 
application relating to that part of the investigation.
     Section 812.140 requires investigators to maintain records, 
including correspondence and reports concerning the study; records of 
receipt, use or disposition of devices; records of each subject's case 
history and exposure to the device; informed consent documentation; 
study protocol and documentation of any deviation from the protocol. 
Sponsors are required, under the same section, to maintain records 
including correspondence and reports concerning the study; records of 
shipment and disposition; signed investigator agreements; adverse 
device effects information; and, if of nonsignificant risk, an 
explanation of nonsignificant risk determination, records on device 
name and intended use, study objectives, investigator information, IRB 
information, and statement on the extent that good manufacturing 
practices will be followed.
     Section 812.150 requires investigators to submit reports on 
unanticipated adverse device effects, withdrawal of IRB approval, 
progress reports, deviations from investigational plan, failure to 
obtain informed consent, and final report. Sponsors are required to 
submit reports on unanticipated adverse device effects, withdrawal of 
IRB approval, withdrawal of FDA approval, current investigator lists, 
progress reports, notification of recall and device disposition, final 
report, failure to obtain informed consent, and significant risk device 
determination.
     The following parts of the IDE regulations are covered by other 
sections of part 812, and thus are not mentioned as separate reporting 
or recordkeeping burden requirements. The requirements for Sec. 812.18, 
regarding import and export requirements for IDE's, are already covered 
under Sec. 812.20(b)(1). Section 812.18 states that foreign companies 
are required to be sponsored by a U.S. agent, whose identity is 
required under the IDE application. This is not an additional 
information collection, and a separate requirement for information is 
not essential just because this is an imported device. Sections 812.40, 
812.45, and 812.46, regarding the general responsibilities of sponsors, 
are described under Secs. 812.20, regarding actual application and 
812.150, regarding recordkeeping.
     Section 812.5, regarding the labeling of investigational devices, 
is included under Sec. 812.20(b)(10), where the submitter is required 
to enclose a copy of the label that bears information required by 
Sec. 812.5 (i.e., name and place of business of manufacturer, packer, 
or distributor, the quantity of contents if appropriate, and the 
following statement: ``CAUTION--Investigational device. Limited by 
Federal (or United States) law to investigational use''). This label 
shall describe all relevant contraindications, hazards, adverse 
effects, interfering substances or devices, warnings, and precautions. 
The label will also not bear any statement that is false or misleading 
in any particular and shall not represent that the device is safe or 
effective for the purposes for which it is being investigated. If the 
device is being used solely for animal research, the label shall bear 
the following statement: ``CAUTION--Device for investigational use in 
laboratory animals or other tests that do not involve human subjects.'' 
This section's burden is required under Sec. 812.20(b)(10), therefore a 
separate burden estimate is not required.

[[Page 38098]]

    This information will allow FDA to collect data to ensure that the 
use of the device will not present an unreasonable risk for the subject 
enrolled in the study and will not violate the subject's rights.
     The likely respondents to this information collection will 
primarily be medical device manufacturers, investigators, hospitals, 
health maintenance organizations, and businesses.
     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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812.10 (waiver requests)                0.0             0.0             0.0             0.50\1\         0.1\2\  
812.20, 812.25, and 812.27                                                                                      
 (original application)               500               0.428         214              80          17,120       
812.35 and 812.150 (amendments                                                                                  
 and supplements)                     500               6.86        3,430               6          20,580       
Total                                                                                              37,700       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   
\1\ FDA's best estimate given the fact that no waiver request has ever been submitted.                          
\2\ FDA's best estimate given the fact that no sponsor has submitted such a request between fiscal years 1991   
  and 1995.                                                                                                     

     Based on past conversations with manufacturers, industry and trade 
association representatives, and businesses, FDA has estimated that the 
annual reporting burden for one IDE original application takes 
approximately 80 hours to complete, and the annual reporting burden for 
one IDE amendment and supplement takes approximately 6 hours to 
complete. The number of respondents who annually respond to this 
collection of information has decreased from 700 to 500, due to 
multiple applications received from each respondent.
     Based on an average of IDE's submitted from fiscal years 1991 
through 1995, approximately 500 respondents submit IDE applications 
(originals and supplements) annually. Based on data from fiscal years 
1991 to 1995, an average of 214 original IDE applications are submitted 
annually.
     The reporting burden for nonsignificant risk device studies is 
negligible. Normally, nonsignificant risk device studies are not 
reported to FDA unless a problem is reported such as an unanticipated 
adverse device reaction, failure to obtain informed consent, withdrawal 
of IRB approval, or a recall of a device. In the past, an average of 10 
incidences or less annually have been reported to FDA.

                                                     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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812.140 (original and supplement)                                     500               0.428             214              10               2,140       
                                                                                        6.86            3,430               1               3,430       
812.140 (nonsignificant)                                              500               1                 500               6               3,000       
Total                                                                                                                                       8,570       
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There are no capital costs or operating and maintenance costs associated with this collection of information.                                           

     Over the past several years, in conversations with manufacturers, 
industry trade association groups, and businesses, FDA has estimated 
that the recordkeeping burden for preparing an original IDE submission 
averages 10 hours for each original IDE submission. Similarly, through 
the same conversations mentioned above, FDA has estimated recordkeeping 
for each supplement requires 1 hour.
     The recordkeeping burden for nonsignificant risk device 
investigations is difficult to estimate because nonsignificant risk 
device investigations are not required to be submitted to FDA. The IDE 
staff estimates that the number of nonsignificant risk device 
investigations is equal to the number of active significant risk device 
investigations. The recordkeeping burden, however, is reduced for 
nonsignificant risk device studies.

    Dated: July 7, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-18593 Filed 7-15-97; 8:45 am]
BILLING CODE 4160-01-F