Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations, 4928-4931 [2015-01668]
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Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices
establish special controls, including
performance standards, postmarket
surveillance, patient registries,
guidelines, and other appropriate
actions it believes necessary to provide
reasonable assurance of the safety and
effectiveness of the device. The special
control guidance serves to support the
reclassification from class III to class II
of the automated blood cell separator
device operating on a centrifugal
separation principle intended for the
routine collection of blood and blood
components as well as the special
control for the automated blood cell
separator device operating on a filtration
separation principle intended for the
routine collection of blood and blood
components reclassified as class II
(§ 864.9245 (21 CFR 864.9245)).
For currently marketed products not
approved under the premarket approval
process, the manufacturer should file
with FDA, for 3 consecutive years, an
annual report on the anniversary date of
the device reclassification from class III
to class II or on the anniversary date of
the 510(k) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360) clearance. Any subsequent
change to the device requiring the
submission of a premarket notification
in accordance with section 510(k) of the
FD&C Act should be included in the
annual report. Also, a manufacturer of a
device determined to be substantially
equivalent to the centrifugal or
filtration-based automated cell separator
device intended for the routine
collection of blood and blood
components should comply with the
same general and special controls.
The annual report should include, at
a minimum, a summary of anticipated
and unanticipated adverse events that
have occurred and that are not required
to be reported by manufacturers under
Medical Device Reporting (MDR) (part
803 (21 CFR part 803)). The reporting of
adverse device events summarized in an
annual report will alert FDA to trends
or clusters of events that might be a
safety issue otherwise unreported under
the MDR regulation.
Reclassification of this device from
class III to class II for the intended use
of routine collection of blood and blood
components relieves manufacturers of
the burden of complying with the
premarket approval requirements of
section 515 of the FD&C Act (21 U.S.C.
360e), and may permit small potential
competitors to enter the marketplace by
reducing the burden. Although the
special control guidance recommends
that manufacturers of these devices file
with FDA an annual report for 3
consecutive years, this would be less
burdensome than the current
postapproval requirements under part
814, subpart E (21 CFR part 814, subpart
E), including the submission of periodic
reports under § 814.84.
Collecting or transfusing facilities and
manufacturers have certain
responsibilities under Federal
regulations. For example, collecting or
transfusing facilities are required to
maintain records of any reports of
complaints of adverse reactions (21 CFR
606.170), while the manufacturer is
responsible for conducting an
investigation of each event that is
reasonably known to the manufacturer
and evaluating the cause of the event
(§ 803.50(b)). In addition, manufacturers
of medical devices are required to
submit to FDA individual adverse event
reports of death, serious injury, and
malfunctions (§ 803.50).
In the special control guidance
document, FDA recommends that
manufacturers include in their three
annual reports a summary of adverse
reactions maintained by the collecting
or transfusing facility, or similar reports
of adverse events collected, in addition
to those required under the MDR
regulation. The MedWatch medical
device reporting code instructions
(https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm106737.htm)
contains a comprehensive list of adverse
events associated with device use,
including most of those events that we
recommend summarizing in the annual
report.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Reporting activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Annual Report ......................................................................
4
1
4
5
20
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are
approximately four manufacturers of
automated blood cell separator devices.
The estimated average burden per
response is based on the time that the
manufacturers will spend preparing and
submitting the annual report.
Other burden hours required for
§ 864.9245 are reported and approved
under OMB control number 0910–0120
(premarket notification submission
501(k), 21 CFR part 807, subpart E), and
OMB control number 0910–0437 (MDR,
part 803).
Dated: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01626 Filed 1–28–15; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1048]
(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.
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 oira_
submission@omb.eop.gov. 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.
ADDRESSES:
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.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
PO 00000
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FDA
PRA Staff, Office of Operations, Food
FOR FURTHER INFORMATION CONTACT:
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Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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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
§ 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,
§ 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.
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4929
Section 801.5 requires that labeling
for a device include information on
intended use as defined under § 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-thecounter (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, § 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 § 801.150(e), FDA
takes no regulatory action against the
device as being misbranded or
adulterated. In addition, § 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
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indication-for-use statement for denture
repair kits, and the word ‘‘temporary’’
preceding and modifying each
indication-for-use statement for reliners, pads, and cushions.
Section 801.405(c) provides for
labeling requirements that contain
essentially the same information
described under § 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, § 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
§ 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
§ 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,
§ 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
Number of
recordkeepers
Activity/21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
4,870
739
3,598,930
0.50
1,799,465
1,136
10,000
924,100
160
27,723,000
1,600,000
0.0008
0.25
22,178
400,000
22
8
176
80
14,080
63
6
378
1
378
Total ..............................................................................
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Processing,
labeling,
or
repacking
agreement—
801.150(a)(2) ....................................................................
Impact resistant lenses; invoices, shipping documents,
and records of sale or distribution—801.410(e) and (f) ...
Hearing aid records—801.421(d) ........................................
Menstrual tampons, sampling plan for measuring absorbency—801.430(f) ..............................................................
Latex condoms; justification for the application of testing
data to the variation of the tested product—801.435(g) ..
........................
........................
........................
........................
2,236,101
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Contact lens cleaning solution labeling—800.10(a)(3) and
800.12(c) ........................................................................
Liquid ophthalmic preparation labeling—800.10(b)(2) .......
Manufacturer, packer, or distributor information—801.1 ...
Adequate directions for use—801.5 ..................................
Statement of identity—801.61 ...........................................
Declaration of net quantity of contents—801.62 ...............
Prescription device labeling—801.109 ..............................
Retail exemption for prescription devices—801.110 .........
Processing, labeling, or repacking; non-sterile devices—
801.150(e) ......................................................................
Labeling of articles intended for lay use in the repairing
and/or refitting of dentures—801.405(b)(1) ....................
Dentures; information regarding temporary and emergency use—801.405(c) ..................................................
Labeling requirements for hearing aids—801.420(c)(1) ....
Technical data for hearing aids—801.420(c)(4) ................
Hearing aids, opportunity to review user instructional brochure—801.421(b) ..........................................................
Hearing aids, availability of user instructional brochure—
801.421(c) ......................................................................
User labeling for menstrual tampons—801.430(d) ............
Menstrual
tampons,
ranges
of
absorbency—
801.430(e)(2) ..................................................................
User labeling for latex condoms—801.435(b), (c), and (h)
Labeling for IVDs—809.10(a) and (b) ...............................
Labeling for general purpose laboratory reagents—
809.10(d)(1) ....................................................................
Labeling for analyte specific reagents—809.10(e) ............
Labeling for OTC test sample collection systems for
drugs of abuse testing—809.10(f) ..................................
Advertising and promotional materials for ASRs—
809.30(d) ........................................................................
Labeling of sunlamp products—1040.20(d) .......................
Total ............................................................................
1 There
[FR Doc. 2015–01668 Filed 1–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0509]
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Appeals of
Science-Based Decisions Above the
Division Level at the Center for
Veterinary Medicine
Food and Drug Administration,
HHS.
ACTION:
Total annual
disclosures
Average
burden per
disclosure
Total hours
17
17
13,780
6,657
6,657
6,657
7,558
30,000
8
8
7
6
6
6
6
667
136
136
96,460
39,942
39,942
39,942
45,348
20,010,000
1
1
1
22.35
1
1
17.77
0.25
136
136
96,460
892,704
39,942
39,942
805,834
5,002,500
377
34
12,818
4
51,272
31
1
31
4
124
31
86
86
1
12
12
31
1,032
1,032
4
40
80
124
41,280
82,560
10,000
160
1,600,000
0.30
480,000
10,000
22
5
8
50,000
176
0.17
2
8,500
352
22
63
1,700
8
6
6
176
378
10,200
2
100
80
352
37,800
816,000
300
300
2
25
600
7,500
40
1
24,000
7,500
20
1
20
100
2,000
300
30
25
1
7,500
30
1
10
7,500
300
........................
..........................
........................
........................
8,437,318
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.
AGENCY:
Number of
disclosures per
respondent
Number of
respondents
Activity/21 CFR section
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
VerDate Sep<11>2014
20:09 Jan 28, 2015
Jkt 235001
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0566. 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
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002 PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
PO 00000
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Fmt 4703
Sfmt 4703
has submitted the following proposed
collection of information to OMB for
review and clearance.
Appeals of Science-Based Decisions
Above the Division Level at CVM—21
CFR 10.75 (OMB Control Number 0910–
0566—Revision)
Respondents: Respondents to this
collection of information are applicants
that wish to submit a request for review
of a scientific dispute.
The Center for Veterinary Medicine’s
(CVM’s) guidance for industry #79
entitled ‘‘Dispute Resolution Procedures
for Science-Based Decisions on Products
Regulated by the Center for Veterinary
Medicine,’’ describes the process by
which CVM formally resolves disputes
relating to scientific controversies. A
scientific controversy involves issues
concerning a specific product regulated
by CVM related to matters of technical
expertise and requires specialized
education, training, or experience to be
understood and resolved. Further, the
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]]>Agencies
[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4928-4931]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01668]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 oira_submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov.
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\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR Section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
