[Federal Register Volume 73, Number 106 (Monday, June 2, 2008)]
[Rules and Regulations]
[Pages 31358-31360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11910]


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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: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending 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 amending the 
regulations to require that manufacturers may use state-of-the-art 
methods to provide technical data in hearing aid labeling. FDA is also 
amending the regulations to update an address and remove an outdated 
requirement. FDA is amending the regulations in accordance with its 
direct final rule procedures. Elsewhere in this issue of the Federal 
Register, we are publishing a companion proposed rule under FDA's usual 
procedures for notice and comment rulemaking to provide a procedural 
framework to finalize the rule in the event we receive a significant 
adverse comment and withdraw this direct final rule.

DATES: This rule is effective October 15, 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. Submit written or electronic comments by August 18, 
2008. If we receive no significant adverse comments within the 
specified comment period, we intend to publish a document confirming 
the effective date of the final rule in the Federal Register within 30 
days after the comment period on this direct final rule ends. If we 
receive any timely significant adverse comment, we will withdraw this 
final rule in part or in whole by publication of a document in the 
Federal Register within 30 days after the comment period ends.

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. 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).

[[Page 31359]]

    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). This will allow hearing aid manufacturers to use the up-
to-date methods to determine the technical data values for hearing 
aids.

II. What Does This Direct Final Rulemaking Do?

    In this direct final rule, FDA is:
     Amending 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) (Includes April 2007 Erratum)''. FDA also is updating an address 
in this section, changing ``1350 Piccard Dr., rm. 240,'' to ``1350 
Piccard Dr., rm. 150,''.
     Removing 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.

III. What Are the Procedures for Issuing a Direct Final Rule?

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
announced the availability of the guidance document entitled ``Guidance 
for FDA and Industry: Direct Final Rule Procedures'' that described 
when and how FDA will employ direct final rulemaking. We believe that 
this rule is appropriate for direct final rulemaking because it is 
intended to make noncontroversial changes to existing regulations. We 
anticipate no significant adverse comment.
    Consistent with FDA's procedures on direct final rulemaking, 
elsewhere in this issue of the Federal Register, we are publishing a 
companion proposed rule that is identical to this direct final rule. 
The companion proposed rule provides a procedural framework within 
which the rule may be finalized in the event the direct final rule is 
withdrawn because of any significant adverse comment. The comment 
period for this direct final rule runs concurrently with the comment 
period of the companion proposed rule. Any comments received in 
response to the companion proposed rule will also be considered as 
comments regarding this direct final rule.
    If we receive any significant adverse comment, we intend to 
withdraw this final rule before its effective date by publication of a 
notice in the Federal Register within 30 days after the comment period 
ends. 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 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 Administrative Procedure Act (APA) 
(5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside 
the scope of the rule will not be considered significant or adverse 
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.
    If we withdraw the direct final rule, all comments received will be 
considered under the companion proposed rule in developing a final rule 
under the usual notice-and-comment procedures under the APA (5 U.S.C. 
552a et seq.). If we receive no significant adverse comment during the 
specified comment period, we intend to publish a confirmation document 
in the Federal Register within 30 days after the comment period ends.

IV. What is the Legal Authority for This Direct Final Rule?

    This direct final 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 Direct Final 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 Direct Final Rule?

    FDA has examined the impacts of the final 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 direct final 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 direct final rule amends 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 direct final 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

[[Page 31360]]

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) 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 
direct final 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 Direct 
Final Rule?

    This final 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 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 Direct Final Rule?

    FDA has analyzed this direct final 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 Direct Final Rule?

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this direct 
final rule. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with 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 
through FDMS only.

List of Subjects in 21 CFR Part 801

    Incorporation by reference, Labeling, Medical devices, Reporting 
and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
801 is amended as follows:

PART 801--LABELING

0
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.

0
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. E8-11910 Filed 5-30-08; 8:45 am]
BILLING CODE 4160-01-S