[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
