Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations, 48866-48869 [2011-20098]
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48866
Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices
for leaders of Tribal Governments
operating Head Start and Early Head
Start programs in Region X and in
Alaska. The Consultation Session for
Region X will take place Monday,
October 17, 2011, in Seattle,
Washington. The Consultation Session
for the State of Alaska will take place
Wednesday, October 19, 2011, in
Anchorage, Alaska, immediately
preceding the annual Alaska Federation
of Natives convention. We are
convening the OHS Tribal Consultations
in conjunction with other Tribal Leader
events in order to minimize the
financial and travel burden for
participants.
The agendas for both scheduled OHS
Tribal Consultations will be organized
around the statutory purposes of Head
Start Tribal Consultations related to
meeting the needs of American Indian
and Alaska Native children and
families, taking into consideration
funding allocations, distribution
formulas, and other issues affecting the
delivery of Head Start services in their
geographic locations. In addition, OHS
will share actions taken and in progress
to address the issues and concerns
raised in 2010 OHS Tribal
Consultations.
Tribal leaders and designated
representatives interested in submitting
written testimony or proposing specific
agenda topics for the Seattle or
Anchorage Consultation Sessions
should contact Camille Loya at
Camille.Loya@acf.hhs.gov at least three
days in advance of the Session.
Proposals should include a brief
description of the topic area along with
the name and contact information of the
suggested presenter.
The Consultation Sessions will be
conducted with elected or appointed
leaders of Tribal Governments and their
designated representatives [42
U.S.C.9835, Section 640(l)(4)(A)].
Designees must have a letter from the
Tribal Government authorizing them to
represent the Tribe. The letter should be
submitted at least three days in advance
of the Consultation Session to Camille
Loya at (202) 205–9721 (fax). Other
representatives of Tribal organizations
and Native nonprofit organizations are
welcome to attend as observers.
A detailed report of each Consultation
Session will be prepared and made
available within 90 days of the
Consultation Session to all Tribal
Governments receiving funds for Head
Start and Early Head Start programs.
Tribes wishing to submit written
testimony for the report should send
testimony to Camille Loya at
Camille.Loya@acf.hhs.gov either prior to
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the Consultation Session or within 30
days after the meeting.
Oral testimony and comments from
the Consultation Session will be
summarized in the report without
attribution, along with topics of concern
and recommendations. Hotel and
logistical information for all
Consultation Sessions has been sent to
Tribal leaders via e-mail and posted on
the Head Start Resource Center Web site
at https://
www.headstartresourcecenter.org.
Dated: August 1, 2011.
Yvette Sanchez Fuentes,
Director, Office of Head Start.
[FR Doc. 2011–20071 Filed 8–8–11; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0116]
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
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
8, 2011.
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 e-mailed 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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
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
compliance with 44 U.S.C. 3507, FDA
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has submitted the following proposed
collection of information to OMB for
review and clearance.
Medical Device Labeling Regulations—
(OMB Control Number 0910–0485)—
(Extension)
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the 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.
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.
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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 § 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
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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 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.
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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
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 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) provides that
manufacturers of sunlamp products and
ultraviolet lamps are subject to the
labeling regulations under part 801.
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Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices
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 of the hearing aid.
Section 801.435(g) requires latex
condom manufacturers to document and
provide, upon request, an appropriate
justification for the application of the
testing data from one product on any
variation of that product to support
expiration dating in the user labeling.
In the Federal Register of March 14,
2011 (76 FR 13623), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. In response to that notice,
one comment was received. The
comment questioned the accuracy of
FDA’s estimate of the number of
respondents reporting under 21 CFR
1040.20(d) regarding sunlamp labeling
requirements. Specifically, the comment
suggested that the Agency provided a
low estimate, however the comment did
not provide a basis by which FDA may
make an alternative estimate. FDA based
its estimate on the number of sunlamp
manufacturers currently registered in
FDA’s Uniform Registration and Listing
System (FURLS) database.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
responses per
respondent
No. of
respondents
21 CFR section
Total annual
responses
Average burden
per response
(in hours)
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
125000
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.
sroberts on DSK5SPTVN1PROD with NOTICES
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1
No. of recordkeepers
21 CFR section
No. of records
per recordkeeper
57
1,136
10,000
1
924,100
160
801.150(a)(2) .......................................................................
801.410(e) and (f) ................................................................
801.421(d) ............................................................................
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Total annual
records
57
27,723,000
1,600,000
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Average
burden per
recordkeeping
(in hours)
0.50
0.0008
0.25
Total hours
29
22,178
400,000
Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices
48869
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1—Continued
No. of recordkeepers
TOTAL ..........................................................................
1 There
Total annual
records
Average
burden per
recordkeeping
(in hours)
........................
........................
........................
Total hours
422,207
are no capital costs or operating and maintenance costs associated with this collection of information.
The medical device labeling
regulations also refer to currently
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.
Recordkeeping
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No. of records
per recordkeeper
........................
21 CFR section
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),
801.433, 801.437(d) through (g), and
809.30(d)(2), (d)(3), and (e) are not
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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: August 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–20098 Filed 8–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0064]
Ray Nathan; Denial of Hearing; Final
Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is denying Ray
Nathan’s request for a hearing and is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring
Nathan from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Nathan was convicted of a
felony under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product.
Nathan has failed to file with the
Agency information and analysis
sufficient to create a basis for a hearing
concerning this action.
DATES: This order is effective August 9,
2011.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: G.
Matthew Warren, Office of Scientific
Integrity, Food and Drug
Administration, 10903 New Hampshire
SUMMARY:
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Ave., Bldg. 32, rm. 4210, Silver Spring,
MD 20993, 301–796–4613.
SUPPLEMENTARY INFORMATION:
I. Background
On May 3, 2007, the U.S. District
Court for the District of Massachusetts
entered a criminal judgment against
Nathan pursuant to his guilty plea for
wire fraud under 18 U.S.C. 1343 and
1342. The basis for this conviction was
Nathan’s scheme to obtain from Lyne
Laboratories (Lyne) a copy of a
certificate of analysis for the drug
PhosLo to determine how to
manufacture a generic version of the
drug. Nathan, a founder of a startup
drug company named Argus
Therapeutics (Argus), admitted that he
created a fake email account for a senior
employee at Nabi Biopharmaceuticals
(Nabi), a Florida company. In an effort
to obtain the certificate of analysis, he
then sent an email from that account to
an employee at Lyne, which
manufactured PhosLo as a subcontractor
for Nabi. When the Lyne employee
requested a physical address to which
the certificate should be sent, Nathan
provided the address of another
principal at Argus via email. Nathan
subsequently sent a third email from the
fraudulent email account to inquire
about the status of his request.
Nathan is subject to debarment based
on a finding, under section 306(a)(2)(A)
of the FD&C Act (21 U.S.C.
335a(a)(2)(A)), that he was convicted of
a felony under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product. By a
letter dated March 2, 2010, FDA served
Nathan a notice proposing to
permanently debar him from providing
services in any capacity to a person
having an approved or pending drug
product application. In a letter dated
April 6, 2010, Nathan requested a
hearing on the proposal, and he
submitted materials in support of that
request on May 10, 2010. In his request
for a hearing, Nathan acknowledges his
conviction for wire fraud under Federal
law, as alleged by FDA. However, he
argues that the conduct underlying the
conviction does not relate to the
development or approval, including the
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]]>Agencies
[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Notices]
[Pages 48866-48869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0116]
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
September 8, 2011.
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 e-mailed 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: 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 compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Device Labeling Regulations--(OMB Control Number 0910-0485)--
(Extension)
Section 502 of the Federal Food, Drug, and Cosmetic Act (the 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.
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.
[[Page 48867]]
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 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 801.430(f) establishes requirements that manufacturers of
menstrual tampons devise and follow an ongoing sampling plan for
measuring the absorbency of menstrual tampons. Further, manufacturers
must use the method and testing parameters described under 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 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) provides that manufacturers of sunlamp products
and ultraviolet lamps are subject to the labeling regulations under
part 801.
[[Page 48868]]
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 of the hearing aid.
Section 801.435(g) requires latex condom manufacturers to document
and provide, upon request, an appropriate justification for the
application of the testing data from one product on any variation of
that product to support expiration dating in the user labeling.
In the Federal Register of March 14, 2011 (76 FR 13623), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. In response to that notice, one comment was
received. The comment questioned the accuracy of FDA's estimate of the
number of respondents reporting under 21 CFR 1040.20(d) regarding
sunlamp labeling requirements. Specifically, the comment suggested that
the Agency provided a low estimate, however the comment did not provide
a basis by which FDA may make an alternative estimate. FDA based its
estimate on the number of sunlamp manufacturers currently registered in
FDA's Uniform Registration and Listing System (FURLS) database.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
No. of Average burden
21 CFR section No. of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
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 125000
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
------------------------------------------------------------------------------
TOTAL........................ .............. ............. .............. .............. 3,362,477
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Average Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
Average
No. of No. of records Total annual burden per
21 CFR section recordkeepers per records recordkeeping Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
801.150(a)(2).................... 57 1 57 0.50 29
801.410(e) and (f)............... 1,136 924,100 27,723,000 0.0008 22,178
801.421(d)....................... 10,000 160 1,600,000 0.25 400,000
------------------------------------------------------------------------------
[[Page 48869]]
TOTAL........................ .............. .............. .............. ............. 422,207
----------------------------------------------------------------------------------------------------------------
\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 currently
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. 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. 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) 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: August 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20098 Filed 8-8-11; 8:45 am]
BILLING CODE 4160-01-P
