[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4928-4931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01668]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1048]


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 March 
2, 2015.

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: 202-395-7285, or emailed 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: FDA PRA Staff, Office of Operations, 
Food

[[Page 4929]]

and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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--21 CFR 800, 801, and 809 (OMB 
Control Number 0910-0485)--Extension

    Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
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 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 FD&C 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 FD&C 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 FD&C 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 
FD&C 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.

Recordkeeping Burden

    Section 801.150(a)(2) establishes recordkeeping requirements for 
manufacturers of devices 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 (HHS) who requests them.
    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 FDA or by any other officer or employee acting on behalf of 
the Secretary of HHS.
    Section 801.410(f) requires that the results of impact tests and 
description of the test method and apparatus be retained for a period 
of 3 years.
    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 801.430(f) requires manufacturers of menstrual tampons to 
devise and follow an ongoing sampling plan for measuring the absorbency 
of menstrual tampons. In addition, manufacturers must use the method 
and testing parameters described in Sec.  801.430(f).
    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.

Third-Party Disclosure 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 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 nonsterile 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 nonsterile 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

[[Page 4930]]

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 requirements 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 801.435(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 (IVD) device and the accompanying labeling 
(package insert) must contain information identifying its intended use, 
instructions for use, 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 of 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 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.
    Section 1040.20(d) (21 CFR 1040.20) provides that manufacturers of 
sunlamp products and ultraviolet lamps are subject to the labeling 
regulations under part 801.
    The burden estimates are based on FDA's current registration and 
listing data and shipment information.
    In the Federal Register of August 01, 2014 (79 FR 44782), FDA 
published a 60-day notice requesting public comment 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 Recordkeeping Burden \1\
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                                                     Number of                        Average
     Activity/21 CFR Section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Processing, labeling, or                   4,870             739       3,598,930            0.50       1,799,465
 repacking agreement--
 801.150(a)(2)..................
Impact resistant lenses;                   1,136         924,100      27,723,000          0.0008          22,178
 invoices, shipping documents,
 and records of sale or
 distribution--801.410(e) and
 (f)............................
Hearing aid records--801.421(d).          10,000             160       1,600,000            0.25         400,000
Menstrual tampons, sampling plan              22               8             176              80          14,080
 for measuring absorbency--
 801.430(f).....................
Latex condoms; justification for              63               6             378               1             378
 the application of testing data
 to the variation of the tested
 product--801.435(g)............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       2,236,101
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 4931]]


                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                    Number of                         Average
    Activity/21 CFR section         Number of    disclosures per   Total annual     burden per      Total hours
                                   respondents      respondent      disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
Contact lens cleaning solution               17                8             136               1             136
 labeling--800.10(a)(3) and
 800.12(c).....................
Liquid ophthalmic preparation                17                8             136               1             136
 labeling--800.10(b)(2)........
Manufacturer, packer, or                 13,780                7          96,460               1          96,460
 distributor information--801.1
Adequate directions for use--             6,657                6          39,942           22.35         892,704
 801.5.........................
Statement of identity--801.61..           6,657                6          39,942               1          39,942
Declaration of net quantity of            6,657                6          39,942               1          39,942
 contents--801.62..............
Prescription device labeling--            7,558                6          45,348           17.77         805,834
 801.109.......................
Retail exemption for                     30,000              667      20,010,000            0.25       5,002,500
 prescription devices--801.110.
Processing, labeling, or                    377               34          12,818               4          51,272
 repacking; non-sterile
 devices--801.150(e)...........
Labeling of articles intended                31                1              31               4             124
 for lay use in the repairing
 and/or refitting of dentures--
 801.405(b)(1).................
Dentures; information regarding              31                1              31               4             124
 temporary and emergency use--
 801.405(c)....................
Labeling requirements for                    86               12           1,032              40          41,280
 hearing aids--801.420(c)(1)...
Technical data for hearing                   86               12           1,032              80          82,560
 aids--801.420(c)(4)...........
Hearing aids, opportunity to             10,000              160       1,600,000            0.30         480,000
 review user instructional
 brochure--801.421(b)..........
Hearing aids, availability of            10,000                5          50,000            0.17           8,500
 user instructional brochure--
 801.421(c)....................
User labeling for menstrual                  22                8             176               2             352
 tampons--801.430(d)...........
Menstrual tampons, ranges of                 22                8             176               2             352
 absorbency--801.430(e)(2).....
User labeling for latex                      63                6             378             100          37,800
 condoms--801.435(b), (c), and
 (h)...........................
Labeling for IVDs--809.10(a)              1,700                6          10,200              80         816,000
 and (b).......................
Labeling for general purpose                300                2             600              40          24,000
 laboratory reagents--
 809.10(d)(1)..................
Labeling for analyte specific               300               25           7,500               1           7,500
 reagents--809.10(e)...........
Labeling for OTC test sample                 20                1              20             100           2,000
 collection systems for drugs
 of abuse testing--809.10(f)...
Advertising and promotional                 300               25           7,500               1           7,500
 materials for ASRs--809.30(d).
Labeling of sunlamp products--               30                1              30              10             300
 1040.20(d)....................
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............       8,437,318
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01668 Filed 1-28-15; 8:45 am]
BILLING CODE 4164-01-P