[Federal Register Volume 62, Number 14 (Wednesday, January 22, 1997)]
[Notices]
[Pages 3293-3297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0454]


Agency Information Collection Activities: Proposed Collections; 
Comment Request; Reinstatements

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 a notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed reinstatement of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on provisions related to 
investigational device exemptions (IDE) reports and records; 
requirements for premarket notifications and summaries filed under the 
Federal Food, Drug, and Cosmetic Act (the act); and reporting and 
recordkeeping requirements imposed on entities that have had products 
detained during an establishment inspection that are believed to be 
adulterated or misbranded, or have had products banned.

DATES: Submit written comments on the collections of information by 
March 24, 1997.

ADDRESSES: Submit written comments on the collections of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: 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 reinstatement 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 collections 
of information listed below.
    With respect to each of the following collections of information, 
FDA invites comments on: (1) Whether the proposed collections of 
information are necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of the agency's estimates of the burdens of 
the proposed collections of information, including the validity of the 
methodologies and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burdens of the collections of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.

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

    This information is collected under the statutory authority of the 
act regarding investigational devices (section 520(g) (21 U.S.C. 
360j(g))). An 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

[[Page 3294]]

investigations involving human subjects in which the safety and 
effectiveness of the device is being studied. The purpose of this 
section, as explained 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 (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 
(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 (actual application) and 812.150 
(recordkeeping).
    Section 812.5 (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.
    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             0.501           0.12    
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.   
1FDA's best estimate given the fact that no waiver request has ever been submitted.                             
2FDA'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

[[Page 3295]]

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                 
----------------------------------------------------------------------------------------------------------------
812.140 (original and                                                                                           
 supplement)                          500               0.428                                                   
                                                        6.86          214                                       
                                                                    3,430              10                       
                                                                                        1           2,140       
                                                                                                    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.

2. 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 of the act (21 U.S.C. 360), 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 21 CFR 807.92 or a 
510(k) (of the act) 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 3.--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.

[[Page 3296]]



                                 Table 4.--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.   

3. 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 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 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 
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 5.--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 (Sec.  Sec.  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 6.--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 3297]]


    Dated: January 15, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-1481 Filed 1-21-97; 8:45 am]
BILLING CODE 4160-01-F