[Federal Register Volume 73, Number 106 (Monday, June 2, 2008)]
[Proposed Rules]
[Pages 31390-31392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11909]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 73, No. 106 / Monday, June 2, 2008 / Proposed
Rules
[[Page 31390]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 801
[Docket No. FDA-2008-N-0148]
Medical Devices; Hearing Aids; Technical Data Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations governing hearing aid labeling to reference the most
recent version of the consensus standard used to determine the
technical data to be included in labeling for hearing aids. We are
proposing to amend the regulations to require manufacturers to use
state-of-the-art methods to provide technical data in hearing aid
labeling. FDA is also proposing to amend the regulations to update an
address and remove an outdated requirement. This proposed rule is a
companion document to the direct final rule published elsewhere in this
issue of the Federal Register.
DATES: Submit written or electronic comments by August 18, 2008. The
Director of the Office of the Federal Register approves the
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51 of certain publications in Sec. 801.420(c)(4) (21 CFR
801.420(c)(4)) as of October 15, 2008.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0148, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No. for this rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Eric A. Mann, Center for Devices and
Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4242.
SUPPLEMENTARY INFORMATION:
I. Why Is This Proposed Rule Being Issued as a Companion Proposed Rule?
This proposed rule is a companion to the direct final rule that is
published in the final rules section of this issue of the Federal
Register. The direct final rule amends the regulations governing
hearing aid labeling to reference the most recent version of the
consensus standard used to determine the technical data to be included
in labeling for hearing aids. We are amending this rule to require
manufacturers to use state-of-the-art methods to provide technical data
in hearing aid labeling. FDA also is amending the rule to update an
address and eliminate an outdated provision. The direct final rule and
this companion proposed rule are identical. We are publishing the
direct final rule because we believe the rule contains noncontroversial
changes and we anticipate that it will receive no significant adverse
comment. A detailed discussion of the rule is set forth in the preamble
of the direct final rule. If no significant adverse comment is received
in response to the direct final rule, no further action will be taken
related to this proposed rule. Instead, we will publish a confirmation
document within 30 days after the comment period ends confirming when
the direct final rule will go into effect.
You can find additional information about FDA's direct final
rulemaking procedures in the guidance document entitled ``Guidance for
FDA and Industry: Direct Final Rule Procedures'' (62 FR 62466, November
21, 1977). This guidance document may be accessed at http://www.fda.gov/opacom/morechoices/industry/guidance.htm.
If we receive any significant adverse comment regarding the direct
final rule, we will withdraw the direct final rule within 30 days after
the comment period ends and proceed to respond to all of the comments
under this companion proposed rule using usual notice-and-comment
rulemaking procedures under the Administrative Procedure Act (APA) (5
U.S.C. 552a et seq.). The comment period for this companion proposed
rule runs concurrently with the direct final rule's comment period. Any
comments received under this companion proposed rule will also be
considered as comments regarding the direct final rule.
A significant adverse comment is defined as a comment that explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change. In determining whether an adverse comment is
significant and warrants terminating a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the APA (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered adverse
[[Page 31391]]
under this procedure. For example, a comment recommending an additional
change to the rule will not be considered a significant adverse
comment, unless the comment states why the rule would be ineffective
without the additional change. In addition, if a significant adverse
comment applies to part of a rule and that part can be severed from the
remainder of the rule, we may adopt as final those parts of the rule
that are not the subject of a significant adverse comment.
II. What Is the Background of the Rulemaking?
In the Federal Register of February 15, 1977 (the 1977 final rule)
(42 FR 9286), FDA published a final rule establishing requirements for
professional and patient labeling of hearing aids and governing
conditions for sale of hearing aids (Sec. 801.420 and Sec. 801.421
(21 CFR 801.421)). The regulations became effective on August 15, 1977.
Section 801.421(b)(1) of the current regulations provides that, before
the sale of a hearing aid to a prospective user, a hearing aid
dispenser is to provide the prospective user with a copy of the User
Instructional Brochure. Current Sec. 801.420(c)(4) requires that
technical data useful in selecting, fitting, and checking the
performance of a hearing aid be provided in the brochure or in separate
labeling that accompanies the device. The 1977 final rule further
required that the technical data values provided in the brochure or
other labeling be determined according to the test procedures
established by the Acoustical Society of America (ASA) in the American
National Standard ``Specification of Hearing Aid Characteristics,''
ANSI S3.22-1976 (ASA 70-1976), which was incorporated by reference in
the regulation.
ANSI S3.22 (ASA 70-1976) established measurement methods and
specifications for several important hearing aid characteristics. The
standard provided a method of ascertaining whether a hearing aid, after
being manufactured and shipped, met the specifications and design
parameters stated by the manufacturer for a particular model, within
the tolerance stated by the standard.
In 1982, ASA revised the standard (ANSI S3.22-1982) (ASA 70-1982).
In a final rule published in the Federal Register of July 24, 1985 (50
FR 30153), FDA incorporated the revised standard into Sec.
801.420(c)(4). ASA revised the standard again in 1987 (ANSI S3.22-1987)
(ASA 70-1987). In a final rule published in the Federal Register of
December 21, 1989 (54 FR 52395), FDA incorporated the revised standard
into Sec. 801.420(c)(4). In 1996, ASA revised the standard again (ANSI
S3.22-1996) (ASA 70-1996). In a final rule published in the Federal
Register of November 3, 1999 (64 FR 59618), FDA incorporated the
revised standard into Sec. 801.420(c)(4).
In 2003, ASA revised the standard again (ANSI S3.22-2003). The 1996
version of the standard was written prior to the development of digital
hearing aids. Therefore, some of the test procedures described in the
1996 version of the standard, designed for assessment of analogue
hearing aids, were modified to accommodate digital technology. The
major differences between the two versions of the standard are as
follows:
In the 1996 standard, the gain control was set to a
specific reference test position for automatic gain control (AGC)
hearing aids and for all other types of hearing aids. In the 2003
standard, AGC hearing aids are tested in AGC mode only for those tests
associated with AGC functions and are operated in non-AGC mode for all
other tests.
In the 2003 standard, the tolerance for setting the gain
control to reference test setting (RTS) has been widened to 1.5 dB from 1.0 dB.
FDA is now incorporating the 2003 standard into Sec.
801.420(c)(4).
III. What Does This Companion Proposed Rule Do?
In this rule, FDA is proposing to:
Amend Sec. 801.420(c)(4) to change the identification of
the standard from ``American National Standard `Specification of
Hearing Aid Characteristics,' ANSI S3.22-1996 (ASA 70-1996) (Revision
of ANSI S3.22-1987)'' to ``American National Standard `Specification of
Hearing Aid Characteristics,' ANSI S3.22-2003 (Revision of ANSI S3.22-
1996)''. FDA is also proposing to update an address in this section,
changing ``1350 Piccard Dr., rm. 240,'' to ``1350 Piccard Dr., rm.
150,''.
Remove Sec. 801.420(d). This section requires that
manufacturers submit to FDA for review their User Instructional
Brochure and other labeling for each type of hearing aid on or before
August 15, 1977. This section was included with the initial hearing aid
rule in 1977. It was intended to provide for an initial FDA review of
the labeling to meet the new requirements. This section is outdated and
is no longer necessary.
IV. What is the Legal Authority for This Proposed Rule?
This proposed rule is authorized by sections 201, 301, 501, 502,
701, and 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 331, 351, 352, 371, and 374).
V. What is the Environmental Impact of This Proposed Rule?
The agency has determined under 21 CFR 25.30(k) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. What is the Economic Impact of This Proposed Rule?
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The proposed rule would amend the existing hearing
aid regulation to refer to the updated consensus standard that is used
to determine the technical data in hearing aid labeling. It does not
impose any new requirements. Communications from manufacturers to FDA
show that they are prepared to comply with this standard immediately.
The agency, therefore, certifies that the proposed rule will not have a
significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation)
[[Page 31392]]
in any one year.'' The current threshold after adjustment for inflation
is $127 million, using the most current (2006) Implicit Price Deflator
for the Gross Domestic Product. FDA does not expect this proposed rule
to result in any 1-year expenditure that would meet or exceed this
amount.
VII. How Does the Paperwork Reduction Act of 1995 Apply to This
Proposed Rule?
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information addressed in the companion direct
final rule have been approved by OMB in accordance with the PRA under
the regulations governing labeling of medical devices (21 CFR part 801,
OMB control number 0910-0485).
VIII. What Are the Federalism Impacts of This Proposed Rule?
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
IX. How Do You Submit Comments on This Proposed Rule?
Interested persons may submit to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, written or electronic comments on this
recommendation. Submit electronic comments to http://www.regulations.gov. Two copies of any written comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the name of the device and the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
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://www.regulations.gov.
List of Subjects in 21 CFR Part 801
Incorporation by reference, Labeling, Medical devices, Reporting
and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 801 be amended as follows:
PART 801--LABELING
1. The authority citation for 21 CFR part 801 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.
2. Section 801.420 is amended by revising the second and third
sentences of and adding a new fourth sentence to paragraph (c)(4)
introductory text and by removing paragraph (d) to read as follows:
Sec. 801.420 Hearing aid devices; professional and patient labeling.
* * * * *
(c) * * *
(4) * * * The determination of technical data values for the
hearing aid labeling shall be conducted in accordance with the test
procedures of the American National Standard ``Specification of Hearing
Aid Characteristics,'' ANSI S3.22-2003 (Revision of ANSI S3.22-1996)
(Includes April 2007 Erratum). The Director of the Office of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the
Standards Secretariat of the Acoustical Society of America, 120 Wall
St., New York, NY 10005-3993, or are available for inspection at the
Regulations Staff, CDRH (HFZ-215), FDA, 1350 Piccard Dr., rm. 150,
Rockville, MD 20850, or at the National Archives and Records
Administration (NARA). * * *
* * * * *
Dated: May 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11909 Filed 5-30-08; 8:45 am]
BILLING CODE 4160-01-S