[Federal Register Volume 64, Number 164 (Wednesday, August 25, 1999)]
[Notices]
[Pages 46395-46396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21964]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2607]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Hearing Aid Devices: Professional and Patient Package 
Labeling and Conditions for Sale

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish a notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting and recordkeeping 
requirements relating to the manufacture and distribution of hearing 
aid devices.

DATES: Submit written comments on the collection of information by 
October 25, 1999.
ADDRESSES:  Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT:  Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth below.
     With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burdens of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
appropriate automated collection techniques, when appropriate, and 
other forms of information technology.

Hearing Aid Devices: Professional and Patient Package Labeling and 
Conditions for Sale--21 CFR 801.420 and 801.421 (OMB Control No. 
0910-0171--Extension)

     Under section 520(e) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360j(e)), the Secretary of the Department of Health and 
Human Services may, under certain conditions, require by regulation 
that a device be restricted to sale, distribution, or use only upon 
authorization of a licensed practitioner or upon other prescribed 
conditions. Sections 801.420 and 801.421 (21 CFR 801.420 and 801.421) 
implement this authority for hearing aids, which are restricted 
devices. The regulations require that the manufacturer or distributor 
provide to the user data useful in selecting, fitting, and checking the 
performance of a hearing aid

[[Page 46396]]

through distribution of a user instructional brochure. The user 
instructional brochure must also contain technical data about the 
device, instructions for its use, maintenance and care, a warning 
statement, a notice about the medical evaluation requirement, and a 
statement if the aid is rebuilt or used.
     Hearing aid dispensers are required to provide the prospective 
user, before the sale of a hearing aid, with a copy of the user 
instructional brochure for the hearing aid model that has been, or may 
be, selected for the prospective user and to review the contents of the 
brochure with the buyer. In addition, upon request by an individual who 
is considering the purchase of a hearing aid, the dispenser is required 
to provide a copy of the user instructional brochure for that model 
hearing aid or the name and address or telephone number of the 
manufacturer or distributor from whom a user instructional brochure for 
the hearing aid may be obtained. Under conditions of sale of hearing 
aid devices, manufacturers or distributors shall provide sufficient 
copies of the user instructional brochure to sellers for distribution 
to users and prospective users and provide a copy of the user 
instructional brochure to any health care professional, user, or 
prospective users who request a copy in writing. The regulations also 
require that the patient provide a written statement that he or she has 
undergone a medical evaluation within the previous 6 months before the 
hearing aid is dispensed, although informed adults may waive the 
medical evaluation requirement by signing a written statement. Finally, 
the regulation requires that the dispenser retain for 3 years copies of 
all physician statements or any waivers of medical evaluations.
     The information obtained through this collection of information is 
used by FDA to ensure that hearing aids are sold and used in a way 
consistent with the public health.
    The information contained in the user instructional brochure is 
intended not only for the hearing aid user but also for the physician, 
audiologist, and dispenser. The data is used by these health care 
professionals to evaluate the suitability of a hearing aid, to permit 
proper fitting of it, and to facilitate repairs. The data also permits 
the comparison of the performance characteristics of various hearing 
aids. Noncompliance could result in a substantial risk to the hearing 
impaired because the physician, audiologist, or dispenser would not 
have sufficient data to match the aid to the needs of the user.
    The respondents to this collection of information are hearing aid 
manufacturers, distributors, dispensers, health care professionals, or 
other for-profit organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                   Annual
        21 CFR Section             No. of       Frequency per     Total Annual       Hours per      Total Hours
                                 Respondents      Response         Responses         Response
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801.420(c)                          40              24                960             102          97,920
801.421(b)                       9,900             162          1,600,000               0.30      480,000
801.421(c)                       9,900               5             49,700               0.17        8,449
Total                                                                                             586,369
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                Table 2.--Estimated Annual Recordkeeping Burden1
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                                                   Annual
        21 CFR Section             No. of       Frequency per     Total Annual       Hours per      Total Hours
                                Recordkeepers   Recordkeeping       Records        Recordkeeper
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801.421(d)                       9,900              62          1,600,000               0.25      400,000
Total                                                                                             400,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Section 801.420(c) estimate assumes that 40 hearing aid 
manufacturers or distributors each will distribute 5 different models 
of hearing aids. Thus, the 40 hearing aid manufacturers or distributors 
will provide 5 different user instructional brochures to sellers for 
distribution to prospective users and users. The completion of each 
user instructional brochure is estimated to require 102 staff hours.
    Section 801.421(b) estimate assumes that 9,900 hearing aid 
dispensers will have 162 sales annually. For all such sales, the 
dispenser must provide the prospective user a copy of the user 
instructional brochure and the opportunity to read and review the 
contents with him or her orally, or in the predominant method used 
during the sale. FDA estimates that this exchange will involve .30 
staff hours.
    Section 801.421(c) estimate assumes that 40 hearing aid 
manufacturers or distributors and 9,900 dispensers will provide copies 
of the user instructional brochure to any health care professional, 
user, or prospective user who requests a copy in writing. It is 
estimated that five written requests for copies of the brochures will 
be received by each hearing aid manufacturer or distributor and 
dispenser annually. It is estimated that each request for a brochure 
will take .17 staff hours to complete. This effort consists of the 
hearing aid manufacturer or distributor or hearing aid dispenser 
locating the appropriate user instructional brochure for the specific 
model and mailing the brochure to the requester.
    Section 801.421(d) recordkeeping estimate assumes that 9,900 
hearing aid dispensers will each retain 162 records. Each record 
documents the dispensing of a hearing aid to a hearing aid user. The 
recordkeeping entry is estimated to require 0.25 staff hours.

    Dated: August 18, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-21964 Filed 8-24-99; 8:45 am]
BILLING CODE 4160-01-F