[Federal Register: April 23, 2008 (Volume 73, Number 79)]
[Notices]
[Page 21959-21962]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ap08-84]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0227]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 written or electronic comments on the collection of
information by June 23, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1772.
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--21 CFR Parts 800, 801, and 809
(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
[[Page 21960]]
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 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
[[Page 21961]]
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 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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses 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 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) 40 1 40 4 160
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.405(c) 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) 8 5 40 2 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.430(e)(2) 8 5 40 2 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 21962]]
801.430(f) 8 5 40 80 3,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.435(b), (c), and (h) 135 1 135 96 12,960
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency
21 CFR Section No. of per Total Annual Hours per Record Total Hours
Recordkeepers Recordkeeping Records
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.150(a)(2) 57 1 57 0.50 28
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.410(e) 30 769,000 23,070,000 0.25 5,767,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.410(f) 30 769,000 23,070,000 0.25 5,767,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.421(d) 10,000 160 1,600,000 0.25 400,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours 11,935,028
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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) and (d)(3),
and 809.30(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) through (f).
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) and (d)(3),
and 809.30(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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Dated: April 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8710 Filed 4-22-08; 8:45 am]
BILLING CODE 4160-01-S