[Federal Register Volume 64, Number 224 (Monday, November 22, 1999)]
[Notices]
[Pages 63817-63818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30302]



[[Page 63817]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
December 22, 1999.
ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.
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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 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.
    In the Federal Register of August 25, 1999 (64 FR 46395), the 
agency requested comments on the proposed collection of information.
    FDA received one comment from an association representing hearing 
aid manufacturers. The comment noted that the association had commented 
in 1998 on this collection of information and had suggested through a 
limited survey of its members that its companies produced 18 models and 
not the 5 estimated by FDA and that it took 136 hours for a company to 
prepare a User Instructional Brochure. The comment noted that FDA used 
a figure of 102 hours and failed to address where this figure came 
from.
    FDA previously addressed this comment in the Federal Register of 
October 26, 1998 (63 FR 57128). FDA agreed with the comment with 
respect to the number of models, and FDA raised its estimate in that 
respect. FDA noted, however, that the comment failed to take into 
account that FDA was estimating an annual burden and not every model 
required a new brochure every year. FDA further noted that much of the 
information in the brochure remains the same from one permutation of a 
model to another and, therefore, it would not take 136 hours to develop 
every brochure. FDA estimated that, for about half of the models, it 
would only take one-half of 136 hours or 68 hours to modify the 
brochure. From this, FDA estimated that the average preparation time 
for all brochures would be 102 hours. FDA believes that this estimate 
is still appropriate.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 63818]]



                                 Table 1.--Estimated Annual Reporting Burden \1\
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                             No. of       Annual Frequency    Total Annual        Hours per
    21 CFR Section         Respondents      per Response        Responses         Response         Total Hours
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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 Burden \1\
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                                          Annual Frequency
    21 CFR Section           No. of              per          Total Annual        Hours per        Total Hours
                          Recordkeepers     Recordkeeping        Records        Recordkeeper
----------------------------------------------------------------------------------------------------------------
801.421(d)                  9,900               162         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: November 10, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-30302 Filed 11-19-99; 8:45 am]
BILLING CODE 4160-01-F