[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
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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