[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]


=======================================================================
-----------------------------------------------------------------------

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.

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

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Annual Frequency
              21 CFR Section                No. of Respondents    per Response    Total Annual Responses   Hours per Response        Total Hours
-----------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                                                                                               -----------------------
  Total Hours                                                                                                                    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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  No. of         Annual Frequency per                                Hours per
              21 CFR 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)                                     10,000                   160               1,600,000                     0.25           400,000
                                                                                                                                   ---------------------

[[Page 36287]]

 
  Total Hours                                                                                                                          419,225
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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