Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations, 13623-13626 [2011-5739]
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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices
NIOSH recognizes this opportunity
will raise many questions for
prospective partners. In order to give all
involved the greatest opportunity to
understand the process and project
expectations, the NTEA–AMD, our
collaborative partner and host standards
setting body, has agreed to provide a
meeting room for us to hold an
informational meeting to present a
broad overview of the effort and answer
any resulting questions.
To provide us with the best
opportunity to meet the needs of all
prospective partners at each of these
meetings, we request that all interested
parties contact Jim Green, NIOSH
Project Officer, by email at
JGreen@cdc.gov; or telephone (304)
285–5857, by Thursday, March 17,
2011.
CONTACT PERSON FOR MORE INFORMATION:
Jim Green, NIOSH Project Officer, email: JGreen@cdc.gov; telephone (304)
285–5857.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
FOR FURTHER INFORMATION CONTACT:
Dated: March 7, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
Food and Drug Administration
[FR Doc. 2011–5733 Filed 3–11–11; 8:45 am]
BILLING CODE 4163–19–P
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Medical Devices; Third Party Review
Program Under the Food and Drug
Administration Modernization Act’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0116]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Labeling Regulations
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
medical device labeling regulations.
DATES: Submit either electronic or
written comments on the collection of
information by May 13, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
SUMMARY:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Medical Devices; Third Party Review
Program Under the Food and Drug
Administration Modernization Act
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BILLING CODE 4160–01–P
ACTION:
[Docket No. FDA–2010–N–0447]
SUMMARY:
[FR Doc. 2011–5738 Filed 3–11–11; 8:45 am]
HHS.
Food and Drug Administration
ACTION:
Dated: March 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of December 28, 2010
(75 FR 81616), the Agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0375. The
approval expires on February 28, 2014.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
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13623
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, PI50–400B, Food and
Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes Agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal Agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device Labeling Regulations—
(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
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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.
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,
§ 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
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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
indication-for-use statement for denture
repair kits and the word ‘‘temporary’’
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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
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
§ 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
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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 § 801.430(f).
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
§ 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,
§ 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.
Section 1040.20(d) provides that
manufacturers of sunlamp products and
ultraviolet lamps are subject to the
labeling regulations under part 801.
Recordkeeping Burden
Section 801.150(a)(2) establishes
recordkeeping requirements for
reprocessors, relabelers, or repackagers
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), 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 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) requires hearing
aid dispensers to retain a copy of any
written statement from a physician
required under § 801.421(a)(1), or any
written statement waiving medical
evaluation required under
§ 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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21 CFR Section
Annual frequency
of response
Total annual
responses
Hours per response
800.10(a)(3) and 800.12(c) ........................................
800.10(b)(2) ...............................................................
801.1 ..........................................................................
801.5 ..........................................................................
801.61 ........................................................................
801.62 ........................................................................
801.109 ......................................................................
801.110 ......................................................................
801.150(e) ..................................................................
801.405(b)(1) .............................................................
801.405(c) ..................................................................
801.420(c)(1) ..............................................................
801.420(c)(4) ..............................................................
801.421(b) ..................................................................
801.421(c) ..................................................................
801.430(d) ..................................................................
801.430(e)(2) .............................................................
801.430(f) ...................................................................
801.435(b), (c), and (h) ..............................................
809.10(a) and (b) .......................................................
809.10(d)(1) ...............................................................
809.10(e) ....................................................................
809.10(f) .....................................................................
809.30(d) ....................................................................
1040.20(d) ..................................................................
37
37
23,393
5,000
5,000
1,000
18,000
10,000
90
99
99
275
275
10,000
10,000
45
45
45
86
1,700
300
300
20
300
110
100
100
6
3.5
3.5
5
3.5
50
20
1.7
1.7
5
5
160
5
2
2
2
3.4
6
2
25
1
25
1
3,700
3,700
140,358
17,500
17,500
5,000
63,000
500,000
1,800
168
168
1,375
1,375
1,600,000
50,000
90
90
90
292
10,200
600
7,500
20
7,500
110
.1
22.35
1
1
17.77
0.25
4
4
4
40
80
0.30
0.17
2
2
80
100
80
40
1
100
1
10
3,700
3,700
140,036
391,125
17,500
5,000
1,119,510
125,000
7,200
673
673
55,000
110,000
480,000
8,500
180
180
7,200
29,200
816,000
24,000
7,500
2,000
7,500
1,100
Total ....................................................................
........................
............................
........................
..............................
3,362,477
1 There
1
1
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
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TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Annual
frequency of
recordkeeping
801.150(a)(2) .....................................................................
801.410(e) and (f) ..............................................................
801.421(d) ..........................................................................
57
30
10,000
1
924,100
160
57
27,723,000
1,600,000
0.50
0.0008
0.25
29
22,178
400,000
Total ............................................................................
........................
........................
........................
..........................
422,207
21 CFR section
1 There
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
The medical device labeling
regulations also refer to previously
approved collections of information
found in FDA regulations. The
collections of information under
§ 800.12(d) and 801.437(i) have been
approved under OMB control number
0910–0183; the collections of
information under § 800.12(e) have been
approved under OMB control number
0910–0231; and the collections of
information under § 801.435(g) have
been approved under OMB control
number 0910–0073.
Further, FDA concludes that labeling
statements under §§ 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), and
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 and
FDA’s knowledge of and experience
with device labeling.
mstockstill on DSKH9S0YB1PROD with NOTICES
Total annual
records
16:20 Mar 11, 2011
Jkt 223001
Dated: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5739 Filed 3–11–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0129]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Comparing
Nutrition Knowledge, Attitude, and
Behavior Among English-Dominant
Hispanics, Spanish-Dominant
Hispanics, and Other Consumers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a study entitled ‘‘Comparing Nutrition
Knowledge, Attitude, and Behavior
Among English-Dominant Hispanics,
Spanish-dominant Hispanics, and Other
Consumers.’’
DATES: Submit either electronic or
written comments on the collection of
information by May 13, 2011.
ADDRESSES: Submit electronic
comments on the collection of
SUMMARY:
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.
The medical device labeling
regulations also refer to previously
approved collections of information.
The collections of information under
§§ 800.12(d) and 801.437(i) have been
approved under OMB control number
0910–0183; and the collections of
information under § 800.12(e) have been
approved under OMB control number
0910–0231.
The information collection
requirements under §§ 801.63,
801.405(b)(2) and (b)(3), 801.420(c)(2)
and (c)(3), 801.430(c) and (e)(1),
VerDate Mar<15>2010
801.433, 801.437(d) through (g), and
809.30(d)(2), (d)(3), (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)).
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information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes Agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal Agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
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[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13623-13626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5739]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0116]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on medical device labeling
regulations.
DATES: Submit either electronic or written comments on the collection
of information by May 13, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, PI50-400B, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Medical Device Labeling Regulations--(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
[[Page 13624]]
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.
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 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 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
[[Page 13625]]
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 Sec.
801.430(f).
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.
Section 1040.20(d) provides that manufacturers of sunlamp products
and ultraviolet lamps are subject to the labeling regulations under
part 801.
Recordkeeping Burden
Section 801.150(a)(2) establishes recordkeeping requirements for
reprocessors, relabelers, or repackagers 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), 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 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) 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Annual frequency Total annual Hours per
21 CFR Section respondents of response responses response Total hours
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800.10(a)(3) and 800.12(c)......................................... 37 100 3,700 1 3,700
800.10(b)(2)....................................................... 37 100 3,700 1 3,700
801.1.............................................................. 23,393 6 140,358 .1 140,036
801.5.............................................................. 5,000 3.5 17,500 22.35 391,125
801.61............................................................. 5,000 3.5 17,500 1 17,500
801.62............................................................. 1,000 5 5,000 1 5,000
801.109............................................................ 18,000 3.5 63,000 17.77 1,119,510
801.110............................................................ 10,000 50 500,000 0.25 125,000
801.150(e)......................................................... 90 20 1,800 4 7,200
801.405(b)(1)...................................................... 99 1.7 168 4 673
801.405(c)......................................................... 99 1.7 168 4 673
801.420(c)(1)...................................................... 275 5 1,375 40 55,000
801.420(c)(4)...................................................... 275 5 1,375 80 110,000
801.421(b)......................................................... 10,000 160 1,600,000 0.30 480,000
801.421(c)......................................................... 10,000 5 50,000 0.17 8,500
801.430(d)......................................................... 45 2 90 2 180
801.430(e)(2)...................................................... 45 2 90 2 180
801.430(f)......................................................... 45 2 90 80 7,200
801.435(b), (c), and (h)........................................... 86 3.4 292 100 29,200
809.10(a) and (b).................................................. 1,700 6 10,200 80 816,000
809.10(d)(1)....................................................... 300 2 600 40 24,000
809.10(e).......................................................... 300 25 7,500 1 7,500
809.10(f).......................................................... 20 1 20 100 2,000
809.30(d).......................................................... 300 25 7,500 1 7,500
1040.20(d)......................................................... 110 1 110 10 1,100
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Total.......................................................... .............. ................ .............. ................. 3,362,477
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 13626]]
Table 2--Estimated Average Annual Recordkeeping Burden \1\
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Annual
21 CFR section Number of frequency of Total annual Hours per Total hours
recordkeepers recordkeeping records record
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801.150(a)(2)................... 57 1 57 0.50 29
801.410(e) and (f).............. 30 924,100 27,723,000 0.0008 22,178
801.421(d)...................... 10,000 160 1,600,000 0.25 400,000
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Total....................... .............. .............. .............. .............. 422,207
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The medical device labeling regulations also refer to previously
approved collections of information found in FDA regulations. The
collections of information under 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), and 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 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.
The medical device labeling regulations also refer to previously
approved collections of information. 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. 801.63,
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), and 809.30(d)(2), (d)(3), (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)).
Dated: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5739 Filed 3-11-11; 8:45 am]
BILLING CODE 4160-01-P
