Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations, 36534-36537 [E8-14658]
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36534
Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
511.1(b)(7)(ii)
134
7.46
1,000
3.5
3,500
511.1(b)(8)(i)
134
7.46
1,000
3.5
3,500
Total
11,627
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for reporting
requirements, record preparation, and
maintenance for this collection of
information are based on agency
communication with industry. Based on
the number of sponsors subject to
animal drug user fees, FDA estimates
that there are 134 respondents. We use
this estimate consistently throughout
the table and calculated the ‘‘annual
frequency per respondent’’ by dividing
the total annual responses by number of
respondents. Additional information
needed to make final calculations of the
total burden hours i.e., the number of
respondents, the number of record
keepers, the number of NCIEs received,
etc., was derived from agency records.
Dated: June 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14653 Filed 6–26–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0227]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Labeling Regulations
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
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 July 28,
2008.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
VerDate Aug<31>2005
18:47 Jun 26, 2008
Jkt 214001
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@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:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
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 act) (21 U.S.C.
352), among other things, establishes
requirements for the label or labeling of
a medical device so that it is not
misbranded and subject to a regulatory
action. Certain provisions under section
502 of the act require manufacturers,
importers, and distributors of medical
devices to disclose information about
themselves or the devices, on the labels
or labeling for the devices. Section
502(b) of the 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 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
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Sfmt 4703
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 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 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
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
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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 non-sterile 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 non-sterile 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 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
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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
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 this section.
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
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36535
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.
Recordkeeping Burden
Section 801.150(a)(2) establishes
recordkeeping requirements for reprocessors, re-labelers, or re-packagers
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 (DHHS), 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 the FDA or by
any other officer or employee acting on
behalf of the Secretary of Health and
Human Services.
Section 801.410(f) requires that the
results of impact tests and description of
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Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices
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.
In the Federal Register of April 23,
2008 (73 FR 21959), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
800.10(a)(3) and 800.12(c)
4
10
40
1
40
800.10(b)(2)
4
10
40
40
1,600
801.1
30,000
3.5
105,000
0.1
10,500
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
801.110
10,000
63,000
17.77
1,119,510
50
500,000
0.25
125,000
2
1
2
0.50
1
40
1
40
4
160
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) and (e)(2)
8
5
40
2
80
801.430(f)
8
5
40
80
3,200
135
1
135
96
12,960
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
801.150(e)
801.405(b)(1) and (c)
801.435(b), (c), and (h)
809.10(a) and (b)
3.5
Total
1 There
3,197,416
are no capital costs or operating and maintenance costs associated with this information collection.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
57
1
57
801.410(e) and (f)
jlentini on PROD1PC65 with NOTICES
801.150(a)(2)
30
924,100
27,723,000
801.421(d)
10,000
160
1,600,000
801.435(g)
4
3
0.50
12
.0008
0.25
40
Total Hours
1. There
28
22,178
400,000
480
422,686
are no capital costs or operating and maintenance costs associated with this information collection.
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18:47 Jun 26, 2008
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Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices
This regulation also refers 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); 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)).
jlentini on PROD1PC65 with NOTICES
Reporting
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.
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. In addition, the
Vision Council of America provided the
growth rate used to estimate the burden
under § 801.410(e) and (f).
FDA is correcting its recordkeeping
burden estimate for § 801.410(e) and (f).
In the Federal Register of April 23,
2008, the recordkeeping burden
estimate in Table 2 was overestimated
as 11,935,028 hours. The corrected
recordkeeping burden estimate for this
proposed collection is 422,686 hours.
The correction for the recordkeeping
burden estimate was necessary due to
two errors. First, FDA incorrectly gave
an estimate of 0.25 hours per
recordkeeper for § 801.410(e) and (f).
The corrected estimate is 0.0008 hours
per recordkeeper. Secondly, FDA
inadvertently duplicated the
recordkeeping burden for these sections.
This regulation also refers 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; and the collections of
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18:47 Jun 26, 2008
Jkt 214001
information under § 800.12(e) have been
approved under OMB control number
0910–0231.
The information collection
requirements under §§ 801.22, 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);
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)).
We have not estimated a burden for
information that is disclosed to third
parties, because it is a ‘‘usual and
customary’’ part of a medical device
manufacturer, distributor, or importer’s
normal business activities. Nor have we
estimated a burden for time that is spent
designing labels to improve the format
or presentation.
Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14658 Filed 6–26–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0168]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Records; Electronic Signatures
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 July 28,
2008.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0303. Also
ADDRESSES:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
36537
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Electronic Records; Electronic
Signatures—(OMB Control Number
0910–0303)—Extension
The FDA regulations in part 11 (21
CFR part 11) provide criteria for
acceptance of electronic records,
electronic signatures, and handwritten
signatures executed to electronic
records as equivalent to paper records.
Under these regulations, records and
reports may be submitted to FDA
electronically provided the agency has
stated its ability to accept the records
electronically in an agency-established
public docket and that the other
requirements of part 11 are met.
The recordkeeping provisions in part
11 (§§ 11.10, 11.30, 11.50, and 11.300)
require standard operating procedures
to assure appropriate use of, and
precautions for, systems using
electronic records and signatures; (1)
§ 11.10 specifies procedures and
controls for persons who use closed
systems to create, modify, maintain, or
transmit electronic records; (2) § 11.30
specifies procedures and controls for
persons who use open systems to create,
modify, maintain, or transmit electronic
records; (3) § 11.50 specifies procedures
and controls for persons who use
electronic signatures; and (4) § 11.300
specifies controls to ensure the security
and integrity of electronic signatures
based upon use of identification codes
in combination with passwords. The
reporting provision (§ 11.100) requires
persons to certify in writing to FDA that
they will regard electronic signatures
used in their systems as the legally
binding equivalent of traditional
handwritten signatures.
The burden created by the
information collection provision of this
regulation is a one-time burden
associated with the creation of standard
operating procedures, validation, and
certification. The agency anticipates the
use of electronic media will
substantially reduce the paperwork
burden associated with maintaining
FDA required records.
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]]>Agencies
[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Notices]
[Pages 36534-36537]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14658]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0227]
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 July
28, 2008.
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: 202-395-6974, or e-mailed to baguilar@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: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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 act)
(21 U.S.C. 352), among other things, establishes requirements for the
label or labeling of a medical device so that it is not misbranded and
subject to a regulatory action. Certain provisions under section 502 of
the act require manufacturers, importers, and distributors of medical
devices to disclose information about themselves or the devices, on the
labels or labeling for the devices. Section 502(b) of the 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 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 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 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
[[Page 36535]]
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 non-sterile 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 non-sterile 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
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 this
section.
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.
Recordkeeping Burden
Section 801.150(a)(2) establishes recordkeeping requirements for
re-processors, re-labelers, or re-packagers 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 (DHHS), 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 the FDA or by any other officer or employee acting on
behalf of the Secretary of Health and Human Services.
Section 801.410(f) requires that the results of impact tests and
description of
[[Page 36536]]
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.
In the Federal Register of April 23, 2008 (73 FR 21959), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
800.10(a)(3) and 4 10 40 1 40
800.12(c)
----------------------------------------------------------------------------------------------------------------
800.10(b)(2) 4 10 40 40 1,600
----------------------------------------------------------------------------------------------------------------
801.1 30,000 3.5 105,000 0.1 10,500
----------------------------------------------------------------------------------------------------------------
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) 2 1 2 0.50 1
----------------------------------------------------------------------------------------------------------------
801.405(b)(1) and 40 1 40 4 160
(c)
----------------------------------------------------------------------------------------------------------------
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) and 8 5 40 2 80
(e)(2)
----------------------------------------------------------------------------------------------------------------
801.430(f) 8 5 40 80 3,200
----------------------------------------------------------------------------------------------------------------
801.435(b), (c), 135 1 135 96 12,960
and (h)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Total 3,197,416
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Record Total Hours
----------------------------------------------------------------------------------------------------------------
801.150(a)(2) 57 1 57 0.50 28
----------------------------------------------------------------------------------------------------------------
801.410(e) and 30 924,100 27,723,000 .0008 22,178
(f)
----------------------------------------------------------------------------------------------------------------
801.421(d) 10,000 160 1,600,000 0.25 400,000
----------------------------------------------------------------------------------------------------------------
801.435(g) 4 3 12 40 480
----------------------------------------------------------------------------------------------------------------
Total Hours 422,686
----------------------------------------------------------------------------------------------------------------
\1.\ There are no capital costs or operating and maintenance costs associated with this information collection.
[[Page 36537]]
This regulation also refers to previously approved collections of
information found in FDA regulations. The collections of information
under Sec. 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); 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, agency communications with
industry, 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.
In addition, the Vision Council of America provided the growth rate
used to estimate the burden under Sec. 801.410(e) and (f).
FDA is correcting its recordkeeping burden estimate for Sec.
801.410(e) and (f). In the Federal Register of April 23, 2008, the
recordkeeping burden estimate in Table 2 was overestimated as
11,935,028 hours. The corrected recordkeeping burden estimate for this
proposed collection is 422,686 hours. The correction for the
recordkeeping burden estimate was necessary due to two errors. First,
FDA incorrectly gave an estimate of 0.25 hours per recordkeeper for
Sec. 801.410(e) and (f). The corrected estimate is 0.0008 hours per
recordkeeper. Secondly, FDA inadvertently duplicated the recordkeeping
burden for these sections.
This regulation also refers to previously approved collections of
information found in FDA regulations. 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. 801.22,
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); 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)).
We have not estimated a burden for information that is disclosed to
third parties, because it is a ``usual and customary'' part of a
medical device manufacturer, distributor, or importer's normal business
activities. Nor have we estimated a burden for time that is spent
designing labels to improve the format or presentation.
Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14658 Filed 6-26-08; 8:45 am]
BILLING CODE 4160-01-S
