[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44884-44887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19086]


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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 October 
4, 2018.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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 Parts 800, 801, and 809

OMB Control Number 0910-0485--Extension

    Section 502 of the Federal Food, Drug, and Cosmetic Act (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 of 
the FD&C 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 FD&C Act requires that for packaged devices, 
the label must bear 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 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

[[Page 44885]]

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. Most of the 
regulations under parts 800, 801, and 809 are derived from requirements 
of section 502 of the FD&C Act. Section 502 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 final 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 shall 
bear 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, 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.
    Section 801.110 establishes labeling requirements for a 
prescription device delivered to the ultimate purchaser or user, by a 
licensed practitioner. 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 in the assembling or packaging of a nonsterile device 
containing labeling that identifies the final finished device as 
sterile and then shipping such device in interstate commerce prior to 
sterilization. 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. When both requirements are met, FDA 
will take no regulatory action against the device as being misbranded 
or adulterated.
    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 
(ANSI) ``Specification of Hearing Aid Characteristics,'' ANSI S3.22-
2003 (Revision of ANSI S3.22-1996), 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 content, 
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

[[Page 44886]]

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 ranges of absorbency and 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) 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 to 
include, identifying its intended use, instructions for use, lot or 
control number, and source.
    Section 809.10(e) provides that the labeling for analyte specific 
reagents (ASRs) shall provide information to include, identifying the 
quantity, proportion, or concentration 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 shall include, among other 
things, information on the intended use, specimen collection 
instructions, identification system, and information about use of the 
test results.
    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 February 22, 2018 (83 FR 7728), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment regarding 
environmental concerns. We believe this issue is beyond the scope of 
this information request.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                Number of
          Activity/21 CFR section               Number of      records per    Total annual         Average burden per recordkeeping         Total hours
                                              recordkeepers   recordkeeper       records
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Processing, labeling, or repacking                    6,331             887       5,615,597  .5 (30 minutes)............................       2,807,799
 agreement--801.150(a)(2).
Impact resistant lenses; invoices, shipping           1,119          47,050      52,648,950  0.0008 (.05 minutes).......................          42,119
 documents, and records of sale or
 distribution--801.410(e) and (f).
Hearing aid records--801.421(d)............          10,000             160       1,600,000  .25 (15 minutes)...........................         400,000
Menstrual tampons, sampling plan for                     16              11             176  80.........................................          14,080
 measuring absorbency--801.430(f).
Latex condoms; justification for the                     51            3.65             186  1..........................................             186
 application of testing data to the
 variation of the tested product--
 801.435(g).
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  ..............  ..............  ..............  ...........................................       3,264,184
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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 Third-Party Disclosure Burden \1\
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                                                                Number of
                                                Number of      disclosures    Total annual
          Activity/21 CFR section              respondents         per         disclosures          Average burden per disclosure           Total hours
                                                               respondent
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Contact lens cleaning solution labeling--                25               8             200  1..........................................             200
 800.10(a)(3) and 800.12(c).
Liquid ophthalmic preparation labeling--                 25               8             200  1..........................................             200
 800.10(b)(2).
Manufacturer, packer, or distributor                 18,137               7         126,959  1..........................................         126,959
 information--801.1.
Adequate directions for use--801.5.........           8,526               6          51,156  22.35......................................       1,143,337
Statement of identify--801.61..............           8,526               6          51,156  1..........................................          51,156
Declaration of net quantity of contents--             8,526               6          51,156  1..........................................          51,156
 801.62.
Prescription device labeling--801.109......           9,681               6          58,086  17.77......................................       1,032,188
Retail exemption for prescription devices--          30,000             667      20,010,000  .25 (15 minutes)...........................       5,002,500
 801.110.
Processing, labeling, or repacking; non-                453              34          15,402  4..........................................          61,608
 sterile devices--801.150(e).

[[Page 44887]]

 
Labeling of articles intended for lay use                35               1              35  4..........................................             140
 in the repairing and/or refitting of
 dentures--801.405(b)(1).
Dentures; information regarding temporary                35               1              35  4..........................................             140
 and emergency use--801.405(c).
Labeling requirements for hearing aids--                124              12           1,488  40.........................................          59,520
 801.420(c)(1).
Technical data for hearing aids--                       124              12           1,488  80.........................................         119,040
 801.420(c)(4).
Hearing aids, opportunity to review User             10,000             160       1,600,000  .30 (20 minutes)...........................         480,000
 Instructional Brochure--801.421(b).
Hearing aids, availability of User                   10,000               5          50,000  .17........................................           8,500
 Instructional Brochure--801.421(c).                                                         (10 minutes)...............................
User labeling for menstrual tampons--                    16               8             128  2..........................................             256
 801.430(d).
Menstrual tampons, ranges of absorbency--                16               8             128  2..........................................             256
 801.430(e)(2).
User labeling for latex condoms--                        51               6             306  100........................................          30,600
 801.435(b), (c), and (h).
Labeling for IVDs--809.10(a) and (b).......           1,700               6          10,200  80.........................................         816,000
Labeling for general purpose laboratory                 300               2             600  40.........................................          24,000
 reagents--809.10(d)(1).
Labeling for ASRs--809.10(e)...............             300              25           7,500  1..........................................           7,500
Labeling for OTC test sample collection                  20               1              20  100........................................           2,000
 systems for drugs of abuse testing--
 809.10(f).
Advertising and promotional materials for               300              25           7,500  1..........................................           7,500
 ASRs--809.30(d).
Labeling of sunlamp products--1040.20(d)...              19               1              19  10.........................................             190
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  ..............  ..............  ..............  ...........................................       9,024,946
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of recordkeepers/respondents and records/disclosures has 
been adjusted to reflect updated Agency data. These adjustments result 
in an increase of 1,598,48 hours since the last OMB approval.

    Dated: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19086 Filed 8-31-18; 8:45 am]
 BILLING CODE 4164-01-P