[Federal Register Volume 66, Number 133 (Wednesday, July 11, 2001)]
[Notices]
[Pages 36285-36287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17406]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0267]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations
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 notice in the
Federal Register concerning each proposed collection of information,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on certain general medical device labeling
provisions.
DATES: Submit written or electronic comments on the collection of
information by September 10, 2001.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
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, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Medical Device Labeling--21 CFR Parts 800, 801, and 809
Section 502 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 352), among other things, establishes requirements that the
label or labeling of a medical device must meet so that it is not
misbranded and subject to regulatory action. Certain of the provisions
of section 502 of the act require that manufacturers, importers, and
distributors of medical devices disclose information about themselves
or their devices on the labels or labeling of the devices. Section
502(b) of the act requires that, if the device is in a package, the
label must contain the name and place of business of the manufacturer,
packer, or distributor and an accurate statement of the quantity of the
contents. Section 502(f) of the act provides that the labeling of a
device must contain adequate directions for use. FDA may grant an
exemption from the adequate directions for use requirement, if FDA
determines that adequate directions for use are not necessary for the
protection of the public health.
FDA regulations in parts 800, 801, and 809 (21 CFR parts 800, 801,
and 809) require manufacturers, importers, and distributors of medical
devices to disclose to health professionals and consumers specific
information about themselves or their devices on the label or labeling
of their devices. FDA issued these regulations under the authority of
sections 201, 301, 502, and 701 of the act (21 U.S.C. 321, 331, 352,
and 371). Most of the regulations in parts 800, 801, and 809 derive
from the requirements of section 502 of the act, which provides, in
part, that a device shall be misbranded if, among other things, its
label or labeling fails to bear certain required information concerning
the device, is false or misleading in any particular, or fails to
contain adequate directions for use.
Sections 800.10(a)(3) and 800.12(c) require that the label of
contact lens cleaning solutions contain a prominent statement alerting
consumers to the tamper-resistant feature required by Sec. 800.12.
Section 800.10(b)(2) requires that the labeling of liquid
ophthalmic preparations packed in multiple-dose containers include
information as to duration of use and necessary warnings to afford
adequate protection from contamination during use.
Section 801.1 requires that the label of a device in package form
contain the name and place of business of the manufacturer, packer, or
distributor.
Section 801.5 requires that the labeling of devices include
directions under which the layman can use a device safely and for the
purposes for which it is intended. Section 801.4 defines intended use.
Where necessary, the labeling should include: (1) Statements of all
conditions, purposes, or uses for which the device is intended, unless
the device is a prescription device subject to the requirements of
[[Page 36286]]
Sec. 801.109; (2) quantity of dose; (3) frequency of administration or
application; (4) duration of administration or application; (5) time of
administration, e.g., in relation to meals, onset of symptoms, etc.;
(6) route of method or application; and (7) preparation for use.
Section 801.61 requires that the principal display panel of an
over-the-counter device in package form must include a statement of the
identity of the device. The statement of the identity of the device
must include the common name of the device followed by an accurate
statement of the principal intended actions of the device.
Section 801.62 requires that the label of an over-the-counter
device in package form must include a declaration of the net quantity
of contents. The label must express the net quantity in terms of
weight, measure, numerical count, or a combination of numerical count
and weight, measure, or size.
Section 801.109 establishes labeling requirements for prescription
devices. A prescription device is defined as a device which, because of
its potentiality for harmful effect, or the method of its use, or the
collateral measures necessary to its use is not safe except under the
supervision of a practitioner licensed by law to use the device and,
therefore, for which adequate directions for use by a lay person cannot
be developed.
Labeling must include information for use, including indications,
effects, routes, methods, and frequency and duration of administration,
and any relevant hazards, contraindications, side effects, and
precautions under which practitioners licensed by law to administer the
device can use the device safely and for the purpose which it is
intended, including all purposes for which it is advertised or
represented.
Section 801.110 establishes a labeling requirement for a
prescription device delivered to the ultimate purchaser or user upon
the prescription of a licensed practitioner. The device must be
accompanied by labeling bearing the name and address of the licensed
practitioner and the directions for use and cautionary statements, if
any, contained in the order.
Section 801.405 establishes labeling requirements for articles
intended for lay use in repairing and refitting dentures.
Section 809.10(a) and (b) provide labeling requirements for in
vitro diagnostic products including the label and a package insert.
These estimates are based on FDA's registration and listing
database for medical device establishments, agency communications with
industry, and FDA's knowledge of and experience with device labeling.
We have not estimated a burden for those requirements where the
information to be disclosed is information that has been supplied by
FDA. Also, we have not estimated a burden for that information that is
disclosed to third parties as a usual and customary part of a medical
device manufacturer, distributor, or importer's normal business
activities. We do not include any burden for time that is spent
designing labels to improve the format or presentation.
From its registration and listing databases, FDA has determined
that there are approximately 20,000 registered device establishments.
About 2,000 of these are distributing over-the-counter devices. About
18,000 are distributing prescription devices. About 1,700
establishments are distributing in vitro diagnostic products.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency
21 CFR Section No. of Respondents per Response Total Annual Responses Hours per Response Total Hours
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800.10(a)(3) and 800.12(c) 4 10 40 1 40
800.10(b)(2) 4 10 40 40 1,600
801.1 20,000 3.5 70,000 0.1 7,000
801.5 2,000 3.5 7,000 22.35 156,450
801.61 1,000 3.5 3,500 1 3,500
801.62 200 5 1,000 1 1,000
801.109 18,000 3.5 63,000 17.77 1,119,510
801.110 10,000 50 500,000 0.25 125,000
801.405(b) 40 1 40 4 160
801.420(c) 40 5 200 40 8,000
801.421(b) 10,000 160 1,600,000 0.30 480,000
801.421(c) 10,000 5 49,500 0.17 8,500
801.435 45 1 45 96 4,320
809.10(a) and (b) 1,700 6 10,200 80 816,000
809.10(d) 300 2 600 40 24,000
809.10(e) 300 25 7,500 1 7,500
809.10(f) 20 1 20 100 2,000
809.30(d) 300 25 7,500 1 7,500
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Total Hours 2,772,080
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency per Hours per
21 CFR Section Recordkeepers Recordkeeping Total Annual Records Recordkeeper Total Hours
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801.410(f) 30 769,000 23,070,000 0.0008 19,225
801.421(d) 10,000 160 1,600,000 0.25 400,000
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[[Page 36287]]
Total Hours 419,225
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-17406 Filed 7-10-01; 8:45 am]
BILLING CODE 4160-01-S