Document ID: FDA-2008-N-0148-0002
Agency: fda
Document Type: Proposed Rule
Title: Medical Devices; Hearing Aids; Technical Data Amendments
Posted Date: 2008-06-02T04:00Z

[Federal Register: June 2, 2008 (Volume 73, Number 106)]
[Proposed Rules]               
[Page 31390-31392]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn08-14]                         

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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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[[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address and remove an outdated requirement.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