[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
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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
