[Federal Register: October 16, 2001 (Volume 66, Number 200)]
[Notices]
[Page 52630-52634]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc01-75]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0267]

Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Medical Device Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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.

DATES: Submit written or electronic comments on the collection of
information by November 15, 2001.

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, Attn:
Wendy Taylor, Desk Officer for FDA.

[[Page 52631]]

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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

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
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(b) establishes labeling requirements for articles
intended for lay use in repairing and refitting dentures.
Section 801.410(f) requires that results of impact tests and
description of the test method and apparatus be kept for a period of 3
years.
Section 801.420(c) requires that the manufacturer or distributor of
the hearing aid develop a user instructional brochure, which
accompanies the device and is provided to the user by the dispenser of
the hearing aid.
Section 801.421(b) requires that the hearing aid dispenser provide
the user a copy of the user instructional brochure.
Section 801.421(c) requires the hearing aid dispenser to provide,
upon request, to the purchaser of any hearing aid dispensed a copy of
the a user instructional brochure or the name and address of the
manufacturer of distributor from whom the brochure may be obtained.
Section 801.421(d) requires the hearing aid dispenser to retain for
3 years from the time of dispensing copies of all physician statements
or any waivers of medical evaluation.
Section 801.435(b) requires condom manufacturers to include an
expiration date in the labeling of the condom. The manufacturer must
support the expiration date by data from quality control tests.
Section 809.10(a) and (b) provide labeling requirements for in
vitro diagnostic products including the label and a package insert.
Section 809.10(d) provides that labeling for general purpose
laboratory reagents may be exempt from the labeling requirements in
809.10(a) and (b) under certain conditions.
Section 809.10(e) requires manufacturers of analyte specific
reagents (ASRs) include specific information in their labeling.
Section 809.10(f) requires that labeling for over-the-counter test
collection systems for drugs of abuse testing include specific
information in their labeling.
Section 809.30(d) requires that manufacturers of ASRs assure that
advertising and promotional materials for ASRs contain specific
information.

[[Page 52632]]

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.
In the Federal Register of July 11, 2001 (66 FR 36285), the agency
requested comments on the proposed collection of information. No
comments were received.
FDA estimates the burden of this collection of information as
follows:

Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Total Annual Hours per
Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
800.10(a)(3 4 10 40 1 40
) and
800.12(c)
----------------------------------------------------------------------------------------------------------------
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 50,000 0.17 8,500
----------------------------------------------------------------------------------------------------------------
801.435 45 1 45 96 4,320
----------------------------------------------------------------------------------------------------------------
809.10(a) 1,700 6 10,200 80 816,000
and (b)
----------------------------------------------------------------------------------------------------------------
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
---------------------
Total 2,772,080
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency per Hours per
Section Recordkeepers Recordkeeping Total Annual Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
801.410(f) 30 769,000 23,070,000 0.0008 19,225
----------------------------------------------------------------------------------------------------------------
801.421(d) 9,900 162,160 1,600,000 0.25 400,000
-------------------
Total 419,225
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

[[Page 52633]]

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.

Reporting

FDA believes that the labeling requirements of Secs. 800.10(a)(3)
and 800.12(c) impose a minimal burden. The label must alert consumers
as to the tamper-resistant feature of the packaging. Four
establishments label 40 different versions of contact lens cleaning
solutions. Each manufacturer would most likely have a similar tamper-
resistant feature for each of their products. FDA believes that 1 hour
per product is a reasonable estimate.
These same four establishments would be subject to the requirements
of Sec. 800.10(b)(2). FDA estimates that it would take each
establishment approximately 40 hours per year/per device to develop and
revise, when necessary, the labeling required by this section.
The requirements of Sec. 801.1 also impose a minimal burden. This
section only requires the manufacturer, packer, or distributor of a
device to include their name and address on the labeling of a device.
Obviously, this is information readily available to the establishment
and easily supplied. From its registration and listing databases, FDA
estimates that there are 20,000 establishments that distribute
approximately 70,000 devices.
Section 801.5 requires adequate directions for lay use of a device.
This applies to over-the-counter devices. It does not apply to devices
dispensed upon the prescription of a health professional for use by a
lay person. Section 801.110 applies to labeling for those devices. Many
of the devices that fall into this category would be fairly simple
types of devices (dental floss, ice bags, canes, and crutches) that
would require minimal labeling. On the average, FDA estimates that
approximately half of these devices would require minimal labeling with
a burden of 5 hours per year/per device (3,500 x 5 = 17,500) and that
the other half would require an expenditure of approximately 40 hours
per device/per year (3,500 x 40 = 140,000).
The requirements of Sec. 801.61 apply to over-the-counter devices
in package form. FDA estimates that there are 1,000 establishments
distributing 3,500 types of these devices. FDA estimates that including
the statement of identity in the labeling for these types of devices
would require no more than 1 hour per type of device.
The requirements of Sec. 801.62 also apply to over-the-counter
devices in package form. Again, FDA estimates that this is a minimal
requirement that imposes a burden of no more than 1 hour per year/per
device.
The requirements of Sec. 801.109 apply to prescription devices to
be used by or on the order of a health care professional. The rule
requires that the labeling provide adequate directions for use by
health care professionals but exempts establishments from this
requirement for devices for which the directions, hazards, warnings,
and other information are well known to health care professionals. FDA
estimates that there are 18,000 manufacturers distributing 63,000 such
types of devices. FDA estimates that approximately 90 percent of these
devices are of the type that would require minimal labeling
information, e.g., surgical instruments well known to the health
professional. These would require about 10 hours per year to develop
the labeling. The other 10 percent of these devices would require
somewhat more detailed labeling information. FDA estimates that firms
would expend about 80 hours per device/per year to develop the
labeling. The weighted average hourly burden per device/per year would
be 17.77 hours. The annual burden then would be 1,119,510 hours (63,000
x 17.77).
Section 801.110 applies to the dispensing of a prescription device
to a lay person by a health care professional. FDA assumes that the
manufacturer or distributor would provide this information to a
pharmacy or medical equipment supplier who would pass it on to the
patient. The information would be readily available to the manufacturer
or distributor and could be quickly passed on to the patient. FDA
estimates that there are approximately 10,000 retail facilities
dispensing 500,000 such devices per year. FDA estimates that a retail
facility would expend about 15 minutes per device processing this
information and providing it to the patient. The total annual burden
would be 125,000 hours (500,000 devices x .25 hours per device).
From its registration and listing databases, FDA has determined
that there are 40 establishments manufacturing, packing, or
distributing the emergency denture kits covered by Sec. 801.405(b). The
requirements of this section are rather simple. FDA estimates that it
will take each establishment 4 hours per device/per year to meet these
requirements.
In estimating the burden for the requirement of preparing a user
instructional brochure as required by Sec. 801.420(c), FDA determined
that there were 40 manufacturers of hearing aids in the Unites States
and that the average manufacturer developed 5 new models requiring a
brochure each year. FDA also determined that the manufacturer expended
approximately 40 hours developing each brochure. This results in an
annual burden of 8,000 hours for this requirement (40 manufacturers x 5
brochures x 40 hours).
Under provisions of Sec. 801.421(b), FDA estimates that there are
approximately 10,000 hearing aid dispensers who distribute 1,600,000
hearing aids each year. For all such sales, the dispenser must provide
the prospective user a copy of the user instructional brochure and the
opportunity to read and review the contents with him or her orally, or
in the predominate method of communication used during the sale. FDA
estimates that this exchange will involve 18 minutes (0.3 staff hours).
FDA estimates that approximately 10,000 hearing aid dispensers and
manufacturers will provide copies of the user instructional brochure to
any health care professional, user, or prospective user who requests a
copy under Sec. 801.421(c). FDA estimates that each of these 10,000
firms will receive approximately 5 requests per year. FDA estimates
that the firm will require about 10 minutes (.17 staff hours) to
complete each request. The effort consists of the hearing aid
manufacturer or distributor or hearing aid dispenser locating the
appropriate brochure and mailing it to the requester. Thus, the total
burden for this collection is 8,500 hours (10,000 firms x 5 requests
per year x .17 staff hours).
Through its registration database, FDA determined that there are
approximately 45 manufacturers of condoms that would have to provide
the labeling required by Sec. 801.435. FDA then determined that it
would take a manufacturer 10 staff hours to check the individual data
points that it needs to check in order to complete the tests. Based
upon comments from manufacturers in response to the proposed rule, FDA
estimated that it would take each manufacturer approximately 96 hours
per year to complete the tests required to establish an expiration date
for their condom. Thus, the total burden is 4,320 hours (45
manufacturers x 96 hours).
From its registration and listing databases, FDA has determined
that there are 1,700 establishments distributing 10,200 devices subject
to the labeling requirements of Sec. 809.10(a)

[[Page 52634]]

and (b). FDA estimates that, for each of these devices, an
establishment would expend approximately 80 hours per year/per device
developing and revising the labeling. This would make the annual burden
816,000 hours.
From its registration and listing databases, FDA has determined
that there are approximately 300 establishments engaged in the
manufacture and distribution of approximately 600 general purpose
laboratory reagents subject to the labeling requirements in
Sec. 809.10(d). FDA estimates that these establishments would expend
about 40 hours per year/per device developing and maintaining the
labeling required by this section. This would result in an annual
burden of 24,000 hours.
FDA estimates for each ASR it would take approximately 1 hour to
design a new label to conform with Sec. 809.10(e) and approximately 3
hours to review the new label through to chain of review, including
legal and marketing people. As shown above, FDA estimates that the
total hours to design/review labels is approximately 100 hours per
respondent (25 x 4). The total hours to design/review labels are
estimated at 30,000 (100 x 300). These estimates do not take into
account economies of scale in designing and revising the labeling on
ASRs. FDA estimates that entities work approximately 25 percent of that
time ascertaining that the labeling meets the new requirements.
Consequently, FDA estimates that the total number of reporting hour
burden for designing/review of labeling is approximately 25 hours per
respondent (100 x .25). FDA also estimates that the total reporting
hour burden for Sec. 809.10(e) is approximately 7,500 hours.
Based upon discussions with manufacturers, FDA estimates that it
will take manufacturers of over-the-counter drugs of abuse test kits
approximately 40 hours to gather the information required by
Sec. 809.10(f), another 40 hours to design and prepare the labeling,
and an additional 20 hours per year to review and revise the labeling,
as necessary. Thus, the total burden hours for preparing and reviewing
labeling will be 100 hours per manufacturer. FDA estimates that there
are 20 manufacturers of these devices. This will result in a total
burden of 2,000 hours.
FDA estimates for each ASR it would take approximately 1 hour to
rewrite the professional materials to ascertain compliance with
Sec. 809.30(d). FDA also estimates it would take approximately 4 hours
to review rewritten materials through the chain of review, including
legal and marketing people. As shown above, FDA estimates that the
total number of hours to rewrite/review promotional materials is
approximately 125 hours per respondent (25 x 5). The total reporting
hours for all ASRs is estimated at 37,500 (125 x 300). This estimate
does not take into account economies of scale. Often the promotional
materials are a catalogue of products. FDA estimates that entities work
approximately 20 percent of that time ascertaining that the promotional
materials meet the new requirements. Consequently, FDA estimates that
the total number of reporting hour burden for rewriting/reviewing
promotional materials is approximately 25 (125 x .20) hours per
respondent. FDA estimates that the total reporting hour burden for
promotional materials is approximately 7,500 (37,500 x .20).

Recordkeeping

The Vision Council of America provided sales figures that were used
to estimate the burden for Sec. 801.410(f). Beginning in 1998, the
vision industry has experienced a steady but declining growth rate of
2.6 percent for the distribution of lenses. It is assumed that this
growth rate continued in 1999 and 2000. This resulted in an increase in
the number of eyeglasses shipped annually to 89 million lenses shipped
by the year 2000. The following sales figures were based on the above
assumptions.

Table 3.--Annual Percentage Sales in Eyeglass Shipments
----------------------------------------------------------------------------------------------------------------
Year Sales (Millions) Percent Change Eyeglass Shipments
----------------------------------------------------------------------------------------------------------------
1998 15.8 +2.6 % 84.51
1999 16.2 +2.6 % 86.7
2000 16.6 +2.6 % 89.0
----------------------------------------------------------------------------------------------------------------

By also assuming that the glass/plastic lenses-produced ratio
remained as in previous years (22 percent glass and 78 percent
plastic), that glass lenses must be tested individually, and only 5
percent of the plastic lenses must be tested, then 23,070,000 lenses
should be tested. This figure was derived by taking 22 percent of 89
million glass lenses (19,600,000) and adding it to 5 percent of the
remaining plastic lenses (5% x 69,400,000 = 3,470,000).
Next, divide the total tests (23,070,000) by 30 manufacturers to
return the annual frequency of recordkeeping figure of 769,000.
Previously, FDA and industry experts estimated that, on average, each
test could be completed and recorded in 3 seconds. Industry, therefore,
could complete and record 1,200 tests per hour. It is estimated that
the total burden for this collection is 19,225 hours, which is
calculated by dividing the total records figure (23,070,000) by tests
per hour (1,200). The hours per recordkeeper is calculated by dividing
the total number of hours (19,225) by the number of manufacturers (30).
Under provisions of Sec. 801.421(d), FDA estimates that 10,000
hearing aid dispensers dispense 1,600,000 hearing aids per year. Each
record required by Sec. 801.421(d) documents the dispensing of a
hearing aid to a hearing aid user. FDA estimates that each
recordkeeping entry requires approximately 0.25 staff hours. The total
burden, then, is 400,000 hours (1,600,000 x 0.25).

Dated: October 10, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-25943 Filed 10-15-01; 8:45 am]
BILLING CODE 4160-01-S