[Federal Register Volume 66, Number 200 (Tuesday, October 16, 2001)]
[Notices]
[Pages 52630-52634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25943]


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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.

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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.

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\
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   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)
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800.10(b)(2            4                  10                    40                40                  1,600
 )
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801.1             20,000                   3.5              70,000                 0.1                7,000
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801.5              2,000                   3.5               7,000                22.35             156,450
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801.61             1,000                   3.5               3,500                 1                  3,500
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801.62               200                   5                 1,000                 1                  1,000
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801.109           18,000                   3.5              63,000                17.77           1,119,510
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801.110           10,000                  50               500,000                 0.25             125,000
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801.405(b)            40                   1                    40                 4                    160
----------------------------------------------------------------------------------------------------------------
801.420(c)            40                   5                   200                40                  8,000
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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
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809.10(a)          1,700                   6                10,200                80                816,000
 and (b)
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809.10(d)            300                   2                   600                40                 24,000
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809.10(e)            300                  25                 7,500                 1                  7,500
----------------------------------------------------------------------------------------------------------------
809.10(f)             20                   1                    20               100                  2,000
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809.30(d)            300                  25                 7,500                 1                  7,500
                                                                                           ---------------------
  Total                                                                                           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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   21 CFR          No. of       Annual Frequency per                            Hours per
   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)          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.

    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

[[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
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                Year                      Sales (Millions)          Percent Change         Eyeglass Shipments
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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