[Federal Register: November 3, 1999 (Volume 64, Number 212)]
[Rules and Regulations]
[Page 59618-59620]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no99-11]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 99N-2550]


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. This amendment is being
made in order that manufacturers may use state-of-the-art methods to
address technical data in hearing aid labeling. FDA is amending

[[Page 59619]]

the regulations in accordance with its direct final rule procedures.
Elsewhere in this issue of the Federal Register, FDA is publishing a
companion proposed rule under FDA's usual procedures for notice and
comment to provide a procedural framework to finalize the rule in the
event the agency receives a significant adverse comment and withdraws
this direct final rule.

DATES: This regulation is effective March 17, 2000. Submit written
comments on or before January 17, 2000. If FDA receives no significant
adverse comments within the specified comment period, the agency
intends 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 timely significant adverse
comments are received, the agency will publish a document in the
Federal Register withdrawing this direct final rule before its
effective date. 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)), effective March 17, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: David A. Segerson, Center for Devices
and Radiological Health (HFZ-460), Food And Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2080.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 15, 1977 (42 FR 9286), FDA
published final regulations establishing requirements for professional
and patient labeling of hearing aids (Sec. 801.420) and governing
conditions for sale of hearing aids (Sec. 801.421 (21 CFR 801.421)).
The regulations became effective on August 15, 1977. Section
801.421(b)(1) of the 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. Section 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 regulation 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 definitive hearing aid characteristics, and
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 newly revised
standard into Sec. 801.420(c)(4).
    In 1996, ASA revised the standard again (ANSI S3.22-1996) (ASA 70-
1996). The standard describes air-conduction hearing aid measurement
methods that are particularly suitable for specification and tolerance
purposes. Among the test methods described are output sound pressure
level (SPL with a 90-dB input SPL, full-on gain, frequency response,
harmonic distortion, equivalent input noise, current drain, induction-
coil sensitivity, and static and dynamic characteristics of automatic
gain control hearing aids. The standard gives specific configurations
for measuring the input SPL to a hearing aid. The standard also
describes allowable tolerances in relation to values specified by the
manufacturer for certain parameters. Appendices are provided to
describe an equivalent substitution method, characteristics of battery
simulators, and additional tests to characterize the electroacoustic
performance of hearing aids more completely.
    FDA is now incorporating the 1996 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. In addition,
FDA is removing from Sec. 801.420(c)(4) the address for ``American
National Standard Institute'' and is adding in its place the address
for ``Acoustical Society of America.''

II. Rulemaking Action

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA
described when and how FDA will employ direct final rulemaking. FDA
believes that this rule is appropriate for direct final rulemaking
because FDA views this rule as a noncontroversial amendment and
anticipates no significant adverse comments. Consistent with FDA's
procedures on direct final rulemaking, FDA is publishing elsewhere in
this issue of the Federal Register a companion proposed rule to amend
part 801 (21 CFR part 801). The companion proposed rule and the direct
final rule are substantively identical. 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 a
significant adverse comment. The comment period for the direct final
rule runs concurrently with the companion proposed rule. Any comments
to the companion proposed rule will be considered as comments regarding
the direct final rule.
    FDA is providing a comment period on the direct final rule until
January 17, 2000. If the agency receives a significant adverse comment,
FDA intends to withdraw this final rule by publication 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 a significant adverse comment is
sufficient to terminate a direct final rulemaking, FDA will consider
whether the comment raises an issue serious enough to warrant a
substantive response in a notice-and-comment process. 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 requesting a change in provisions of the hearing aid rule
unrelated to the subject matter addressed in the ANSI standard will not
be considered a significant adverse comment, because it is outside the
scope of the rule. On the other hand, a comment recommending an
additional change to the rule may be considered a significant adverse
comment if the comment demonstrates why the rule would be ineffective
without the additional change. In addition, if a significant adverse
comment applies to an amendment, paragraph, or section of this rule and
that provision can be

[[Page 59620]]

severed from the remainder of the rule, FDA may adopt as final those
provisions of the rule that are not the subject of a significant
adverse comment.
    If FDA withdraws the direct final rule, all comments received will
be considered under the proposed rule in developing a final rule in
accordance with usual Administrative Procedure Act notice-and-comment
procedures.
    If FDA receives no significant adverse comment during the specified
comment period, FDA intends to publish a confirmation document within
30 days after the comment period ends confirming the effective date.

III. Environmental Impact

    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.

IV. Analysis of Impacts

    FDA has examined the impact of this direct final rule under
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612) (as amended by subtitle D of the Small Business Regulatory
Fairness Act of 1996 (Public Law 104-121)), 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 consistent with the regulatory philosophy and principles
identified in the Executive Order. In addition, this direct final rule
is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under 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. Communications
from manufacturers to FDA show that they are prepared to be in
compliance with this standard immediately. The agency, therefore,
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities. This direct final
rule also does not trigger the requirement for a written statement
under section 202(a) of the Unfunded Mandates Reform Act because it
does not impose a mandate that results in an expenditure of $100
million or more by State, local, or tribal governments in the
aggregate, or by the private sector, in any one year.

V. Paperwork Reduction Act of 1995

    This direct final rule contains no collection of information.
Therefore clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is no required.

VI. Request for Comments

    Interested persons may, on or before January 17, 2000, submit to
the Docket Management Branch (address above) written comments regarding
this direct final rule. The comment period runs concurrently with the
comment period for the companion proposed rule. Two copies of any
comments are to be submitted, except that individuals may submit one
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 office above between 9 a.m. and 4 p.m., Monday through Friday.
All comments received will be considered as comments regarding the
companion proposed rule and this direct final rule. In the event the
direct final rule is withdrawn, all comments received regarding the
companion proposed rule and this direct final rule will be considered
comments on the proposed rule.

List of Subjects in 21 CFR Part 801

    Hearing aids, Incorporation by reference, Medical devices,
Professional and patient labeling.
    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

    1. The authority section 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 in paragraph (c)(4) 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 S3.22-1996 (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. 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. 240,
Rockville, MD 20850, and at the Office of the Federal Register, 800
North Capitol St. NW., suite 700, Washington, DC. * * *
* * * * *

    Dated: October 19, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-28209 Filed 11-2-99; 8:45 am]
BILLING CODE 4160-01-F