[Federal Register Volume 63, Number 125 (Tuesday, June 30, 1998)]
[Notices]
[Pages 35601-35603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17289]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0022]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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 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
requirements by August 31, 1998.
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: Margaret R. 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 collections
of information set forth below.
With respect to the following collections of information, FDA
invites comments on: (1) Whether the proposed collections of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of the agency's estimates of the burdens of the proposed
collections of information, including the validity of the methodologies
and assumptions used; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) ways to minimize
the burdens of the collections 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 Number
0910-0171--Extension)
Under section 520(e) of the Federal Food, Drug, and Cosmetic Act
(the 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
[[Page 35602]]
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 requests 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 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 5 200 40 8,000
801.421(a)(1) 9,900 52 514,800 0.10 51,480
801,421(a)(2) 9,900 97 960,300 0.30 288,090
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
Totals 836,019
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\1\1There 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 of Total Annual Records Hours per Total Hours
Recordkeepers Recordkeeping Recordkeeper
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801.421(d) 9,900 162 1,600,000 0.25 400,000
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\1\1There 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/distributors each distribute 5 different models of
hearing aids. Thus, the 40 hearing aid manufacturers/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 40 staff hours.
Sections 801.421(a)(1) and 801.421(a)(2) estimates are based on
information obtained in the FDA review mentioned previously which
revealed that medical evaluations were obtained in 32 percent of the
sales and signed waivers were obtained in 60 percent of the sales. For
Sec. 801.421(a)(1) estimate, the figure was derived by multiplying the
current number of annual hearing aid sales (1.6 million) by .32 and
then dividing by the number of hearing aid dispensers (9,900). FDA
estimates that it will take hearing aid dispensers .10 hours to request
and obtain the required medical evaluation documentation. For
Sec. 801.421(a)(2) estimate, the figure was derived by multiplying the
current number of hearing aid sales (1.6 million) by .60 and then
dividing by the number of hearing dispensers (9,900). FDA estimates
that it will take hearing aid dispensers .30 hours to articulate the
required disclosure and prepare and make available a waiver form for
adults 18 years of age or older to sign. For Sec. 801.421(b) estimate,
FDA 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/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/distributors, and 9,900 dispensers will provide copies of
the User Instructional Brochure to any health care professional, user,
or prospective user who request a copy in writing. It is estimated that
5 written requests for copies of the brochures will be received by each
hearing aid manufacturer/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/
distributor or
[[Page 35603]]
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. Each
recordkeeping entry is estimated to require 0.25 staff hours.
Dated: June 19, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-17289 Filed 6-29-98; 8:45 am]
BILLING CODE 4160-01-F
