[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Proposed Rules]
[Pages 59695-59697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28210]


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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: 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. FDA is 
proposing to amend the regulation in order that manufacturers may use 
state-of-the-art methods to address technical data in hearing aid 
labeling. This proposed rule is a companion document to the direct 
final rule published elsewhere in this issue of the Federal Register.

DATES: Submit written comments on or before January 18, 2000. If FDA 
receives any significant adverse comment regarding this rule, FDA will 
publish a document withdrawing the direct final rule within 30 days 
after the comment period ends. FDA then and will proceed to respond to 
the comments under this proposed rule using the usual notice and 
comment procedures. Any parties interested in commenting on this 
document should do so at this time.
    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 the direct final rule ends. 
The direct final rule will be 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. Regulatory Framework

    This proposed rule is a companion to the direct final rule 
published in the final rules section of this issue of the Federal 
Register. This companion proposed rule is substantively identical to 
the direct final rule. This proposed rule will provide a procedural 
framework to finalize the rule in the event the agency receives a 
significant adverse comment and the direct final rule is withdrawn. FDA 
is publishing the direct final rule because the rule contains 
noncontroversial changes, and FDA anticipates that it will receive no 
significant adverse comments. A detailed discussion of this rule is set 
forth in the preamble of the direct final rule. If no significant 
comment is received in response to the direct final rule, no further 
action will be taken related to this proposed rule. Instead, FDA will 
publish a confirmation document within 30 days after the comment period 
ends confirming that the direct final rule will go into effect on March 
17, 2000. Additional information about FDA's direct final rulemaking 
procedures is set forth in a guidance published in the Federal Register 
of November 21, 1997 (62 FR 62466).

    If FDA receives a significant adverse comment regarding this rule, 
the agency will publish a document withdrawing the direct final rule 
within 30 days after the comment period ends and will proceed to 
respond to the comments under this rule using usual notice-and-comment 
procedures. 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 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 
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 American National Standards Institute's (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 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.

II. 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 (21 CFR 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

[[Page 59696]]

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 Standards Institute'' and is adding in its place the address 
for ``Acoustical Society of America.''

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 the proposed rule under Executive 
Order 12866, 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 proposed rule is consistent 
with the regulatory philosophy and principles identified in the 
Executive Order. In addition, this proposed 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 proposed 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 proposed rule, if finalized, will not have a 
significant economic impact on a substantial number of small entities. 
This proposed 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

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

VI. Request for Comments

    Interested persons may, on or before January 18, 2000, submit to 
the Dockets Management Branch (address above) written comments 
regarding this companion proposed rule. The comment period runs 
concurrently with the comment period for the direct final 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 the brackets in the heading of this document. Comments will be 
considered to determine whether to amend or revoke this proposed rule. 
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 direct final rule and this proposed rule. In 
the event the direct final rule is withdrawn, all comments received 
regarding the direct final rule and this companion proposed rule will 
be considered comments on this 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, 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 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,

[[Page 59697]]

Rockville, MD 20580, and 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. 99-28210 Filed 11-2-99; 8:45 am]
BILLING CODE 4160-01-F