[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Notices]
[Pages 36534-36537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0227]


Agency Information Collection Activities; Submission for Office 
of Management and Budget 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 a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
28, 2008.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0485. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 Regulations--(OMB Control Number 0910-0485)--
Extension

    Section 502 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 352), among other things, establishes requirements for the 
label or labeling of a medical device so that it is not misbranded and 
subject to a regulatory action. Certain provisions under section 502 of 
the act require manufacturers, importers, and distributors of medical 
devices to disclose information about themselves or the devices, on the 
labels or labeling for the devices. Section 502(b) of the act requires 
that for packaged devices, the label must bear the name and place of 
business of the manufacturer, packer, or distributor as well as an 
accurate statement of the quantity of the contents. Section 502(f) of 
the act requires that the labeling for a device must contain adequate 
directions for use. FDA may however, grant an exemption, if the agency 
determines that the adequate directions for use labeling requirements 
are not necessary for the particular case, as it relates to protection 
of the public health.
    FDA regulations under parts 800, 801, and 809 (21 CFR parts 800, 
801, and 809) require disclosure of specific information by 
manufacturers, importers, and distributors of medical devices about 
themselves or the devices, on the label or labeling for the devices to 
health professionals and consumers. 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 under parts 800, 801, 
and 809 are derived from 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 way, or fails to contain adequate directions for use.

Reporting Burden

    Sections 800.10(a)(3) and 800.12(c) require that the label for 
contact lens cleaning solutions bear a prominent statement alerting 
consumers of the tamper-resistant feature. Further, Sec.  800.12 
requires that packaged contact lens cleaning solutions contain a 
tamper-resistant feature, to prevent malicious adulteration.
    Section 800.10(b)(2) requires that the labeling for liquid 
ophthalmic preparations packed in multiple-dose containers provide 
information on the duration of use and the necessary warning 
information to afford adequate protection from contamination during 
use.
    Section 801.1 requires that the label for a device in package form, 
contain the name and place of business of the manufacturer, packer, or 
distributor.
    Section 801.5 requires that labeling for a device include 
information on intended use as defined under Sec.  801.4 and provide 
adequate directions to assure safe use by the lay consumers.
    Section 801.61 requires that the principal display panel of an 
over-the-counter (OTC) device in package form must bear a statement of 
the identity of the device. The statement of 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 for an OTC device in package 
form, must bear a statement of declaration of the net quantity of 
contents. The label

[[Page 36535]]

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, in which the label for the device must describe the 
application or use of the device, and contain a cautionary statement 
restricting the device for sale by, or on the order of an appropriate 
professional.
    For prescription by a licensed practitioner, Sec.  801.110 
establishes labeling requirements for a prescription device delivered 
to the ultimate purchaser or user.
    The device must be accompanied by labeling bearing the name and 
address of the licensed practitioner, directions for use, and 
cautionary statements if any, provided by the order.
    Section 801.150(e) requires a written agreement between firms 
involved when a non-sterile device is assembled or packaged with 
labeling that identifies the final finished device as sterile, for 
which the device is ultimately introduced into interstate commerce to 
an establishment or contract manufacturer to be sterilized. When a 
written agreement complies with the requirements under Sec.  
801.150(e), FDA takes no regulatory action against the device as being 
misbranded or adulterated. In addition, Sec.  801.150(e) requires that 
each pallet, carton, or other designated unit, be conspicuously marked 
to show its non-sterile nature when introduced into interstate 
commerce, and while being held prior to sterilization.
    Section 801.405(b)(1) provides for labeling requirements for 
articles, including repair kits, re-liners, pads, and cushions, 
intended for use in temporary repairs and refitting of dentures for lay 
persons. Section 801.405(b)(1) also requires that the labeling contain 
the word ``emergency'' preceding and modifying each indication-for-use 
statement for denture repair kits and the word ``temporary'' preceding 
and modifying each indication-for-use statement for re-liners, pads, 
and cushions.
    Section 801.405(c) provides for labeling requirements that contain 
essentially the same information described under Sec.  801.405(b)(1). 
The information is intended to enable a lay person to understand the 
limitations of using OTC denture repair kits, and denture re-liners, 
pads, and cushions.
    Section 801.420(c)(1) requires that manufacturers or distributors 
of hearing aids develop a user instructional brochure to be provided by 
the dispenser of the hearing aid to prospective users. The brochure 
must contain detailed information on the use and maintenance of the 
hearing aid.
    Section 801.420(c)(4) establishes requirements that the user 
instructional brochure or separate labeling, provide for technical data 
elements useful for selecting, fitting, and checking the performance of 
a hearing aid. In addition, Sec.  801.420(c)(4) provides for testing 
requirements to determine that the required data elements must be 
conducted in accordance with the American National Standards 
Institute's (ANSI) ``Specification of Hearing Aid Characteristics,'' 
ANSI S3.22-1996 (ASA 70-1996); (Revision of ANSI S3.22-1987), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51.
    Section 801.421(b) establishes requirement for the hearing aid 
dispenser to provide prospective users with a copy of the user 
instructional brochure along with an opportunity to review comments, 
either orally or by the predominant method of communication used during 
the sale.
    Section 801.421(c) establishes requirements for the hearing aid 
dispenser to provide a copy of the user instructional brochure to the 
prospective purchaser of any hearing aid upon request or, if the 
brochure is unavailable, provide the name and address of the 
manufacturer or distributor from which it may be obtained.
    Section 801.430(d) establishes labeling requirements for menstrual 
tampons to provide information on signs, risk factors, and ways to 
reduce the risk of Toxic Shock Syndrome (TSS).
    Section 801.430(e)(2) requires menstrual tampon package labels to 
provide information on the absorbency term based on testing required 
under Sec.  801.430(f) and an explanation of selecting absorbencies 
that reduce the risk of contracting TSS.
    Section 801.430(f) establishes requirements that manufacturers of 
menstrual tampons devise and follow an ongoing sampling plan for 
measuring the absorbency of menstrual tampons. Further, manufacturers 
must use the method and testing parameters described under this 
section.
    Section 801.435(b), (c), and (h), establishes requirements for 
condom labeling to bear an expiration date that is supported by testing 
that demonstrates the integrity of three random lots of the product.
    Section 809.10(a) and (b) establishes requirements that a label for 
an in vitro diagnostic device and the accompanying labeling (package 
insert), must contain information identifying its intended use, 
instructions for use and lot or control number, and source.
    Section 809.10(d)(1) provides that the labeling requirements for 
general purpose laboratory reagents may be exempt from the requirements 
of Sec.  809.10(a) and (b), if the labeling contains information 
identifying its intended use, instructions for use, lot or control 
number, and source.
    Section 809.10(e) provides that the labeling for ``Analytic 
Specific Reagents'' (ASRs) must provide information identifying the 
quantity or proportion or each reagent ingredient, instructions for 
use, lot or control number, and source.
    Section 809.10(f) provides that, the labeling for OTC test sample 
collection systems for drugs of abuse must include information on the 
intended use, specimen collection instructions, identification system, 
and information about use of the test results. In addition, Sec.  
809.10(f) requires that this information be in a language appropriate 
for the intended users.
    Section 809.30(d) requires that advertising and promotional 
materials for ASRs include the identity and purity of the ASR and the 
identity of the analyte.

Recordkeeping Burden

    Section 801.150(a)(2) establishes recordkeeping requirements for 
re-processors, re-labelers, or re-packagers to retain a copy of the 
agreement containing the specifications for the processing, labeling, 
or repacking of the device for 2 years after the shipment or delivery 
of the device. Section 801.150(a)(2) also requires that the subject 
respondents make copies of this agreement available for inspection at 
any reasonable hour to any officer or employee of the Department of 
Health and Human Services (DHHS), upon their request.
    Section 801.421(d) establishes requirements for hearing aid 
dispensers to retain copies of all physician statements or any waivers 
of medical evaluation for 3 years after dispensing the hearing aid.
    Section 801.410(e) requires copies of invoices, shipping documents, 
and records of sale or distribution of all impact resistant lenses, 
including finished eyeglasses and sunglasses, be maintained for 3 years 
by the retailer and made available upon request by any officer or 
employee of the FDA or by any other officer or employee acting on 
behalf of the Secretary of Health and Human Services.
    Section 801.410(f) requires that the results of impact tests and 
description of

[[Page 36536]]

the test method and apparatus be retained for a period of 3 years.
    Section 801.421(d) requires hearing aid dispensers to retain a copy 
of any written statement from a physician required under Sec.  
801.421(a)(1), or any written statement waiving medical evaluation 
required under Sec.  801.421(a)(2)(iii) for 3 years after the 
dispensing the hearing aid.
    Section 801.435(g) requires latex condom manufacturers to document 
and provide, upon request, an appropriate justification for the 
application of the testing data from one product on any variation of 
that product to support expiration dating in the user labeling.
    In the Federal Register of April 23, 2008 (73 FR 21959), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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800.10(a)(3) and                   4               10                   40               1                    40
 800.12(c)
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800.10(b)(2)                       4               10                   40              40                 1,600
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801.1                         30,000                3.5            105,000               0.1              10,500
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801.5                          5,000                3.5             17,500              22.35            391,125
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801.61                         5,000                3.5             17,500               1                17,500
----------------------------------------------------------------------------------------------------------------
801.62                         1,000                5                5,000               1                 5,000
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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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801.150(e)                         2                1                    2               0.50                  1
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801.405(b)(1) and                 40                1                   40               4                   160
 (c)
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801.420(c)(1)                    275                5                1,375              40                55,000
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801.420(c)(4)                    275                5                1,375              80               110,000
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801.421(b)                    10,000              160            1,600,000               0.30            480,000
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801.421(c)                    10,000                5               50,000               0.17              8,500
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801.430(d) and                     8                5                   40               2                    80
 (e)(2)
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801.430(f)                         8                5                   40              80                 3,200
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801.435(b), (c),                 135                1                  135              96                12,960
 and (h)
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809.10(a) and (b)              1,700                6               10,200              80               816,000
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809.10(d)(1)                     300                2                  600              40                24,000
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809.10(e)                        300               25                7,500               1                 7,500
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809.10(f)                         20                1                   20             100                 2,000
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809.30(d)                        300               25                7,500               1                 7,500
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Total                                                                                                  3,197,416
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                       No. of         Annual Frequency       Total Annual        Hours per
 21 CFR Section    Recordkeepers      per Recordkeeping        Records            Record          Total Hours
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801.150(a)(2)                   57                     1                 57            0.50                   28
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801.410(e) and                  30               924,100         27,723,000             .0008             22,178
 (f)
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801.421(d)                  10,000                   160          1,600,000            0.25              400,000
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801.435(g)                       4                     3                 12           40                     480
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Total Hours                                                                                              422,686
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\1.\ There are no capital costs or operating and maintenance costs associated with this information collection.


[[Page 36537]]

    This regulation also refers to previously approved collections of 
information found in FDA regulations. The collections of information 
under Sec. Sec.  800.12(d) and 801.437(i) have been approved under OMB 
control number 0910-0183; the collections of information under Sec.  
800.12(e) have been approved under OMB control number 0910-0231; and 
the collections of information under Sec.  801.435(g) have been 
approved under OMB control number 0910-0073.
    Further, FDA concludes that labeling statements under Sec. Sec.  
801.63; 801.405(b)(2) and (b)(3); 801.420(c)(2) and (c)(3); 801.430(c) 
and(e)(1); 801.433; 801.437(d) through (g); 809.30(d)(2), (d)(3), and 
(e) do not constitute a ``collection of information'' under the PRA. 
Rather, these labeling statements are ``public disclosure'' of 
information originally supplied by the Federal Government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).

Reporting

    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.

Recordkeeping

    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. 
In addition, the Vision Council of America provided the growth rate 
used to estimate the burden under Sec.  801.410(e) and (f).
    FDA is correcting its recordkeeping burden estimate for Sec.  
801.410(e) and (f). In the Federal Register of April 23, 2008, the 
recordkeeping burden estimate in Table 2 was overestimated as 
11,935,028 hours. The corrected recordkeeping burden estimate for this 
proposed collection is 422,686 hours. The correction for the 
recordkeeping burden estimate was necessary due to two errors. First, 
FDA incorrectly gave an estimate of 0.25 hours per recordkeeper for 
Sec.  801.410(e) and (f). The corrected estimate is 0.0008 hours per 
recordkeeper. Secondly, FDA inadvertently duplicated the recordkeeping 
burden for these sections.
    This regulation also refers to previously approved collections of 
information found in FDA regulations. The collections of information 
under Sec. Sec.  800.12(d) and 801.437(i) have been approved under OMB 
control number 0910-0183; and the collections of information under 
Sec.  800.12(e) have been approved under OMB control number 0910-0231.
    The information collection requirements under Sec. Sec.  801.22, 
801.63, 801.405(b)(2) and (b)(3), 801.420(c)(2) and (c)(3), 801.430(c) 
and (e)(1), 801.433, 801.437(d) through (g); 809.30(d)(2), (d)(3), and 
(e) are not considered information collection because the public 
information is originally supplied by the Federal Government to the 
recipient for the purpose of disclosure to the public (5 CFR 
1320.3(c)(2)).
    We have not estimated a burden for information that is disclosed to 
third parties, because it is a ``usual and customary'' part of a 
medical device manufacturer, distributor, or importer's normal business 
activities. Nor have we estimated a burden for time that is spent 
designing labels to improve the format or presentation.

    Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14658 Filed 6-26-08; 8:45 am]
BILLING CODE 4160-01-S