[Federal Register Volume 63, Number 206 (Monday, October 26, 1998)]
[Notices]
[Pages 57127-57129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28578]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0022]


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 (the PRA).

DATES:  Submit written comments on the collection of information by 
November 25, 1998.
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: 
Desk Officer for FDA.

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:  In compliance with section 3507 of the PRA 
(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 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 requirement, and a statement if the hearing 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

[[Page 57128]]

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.
     In the Federal Register of June 30, 1998 (63 FR 35601), the agency 
requested comments on the proposed collection of information imposed on 
hearing aid manufacturers under Secs.  801.420 and 801.421. FDA 
received one comment from an association representing hearing aid 
manufacturers. The comment stated that FDA underestimated the burden 
for preparing a user instructional brochure as required by 
Sec. 801.420(c). The association stated that their member companies 
produced at least 18 different models of hearing aids and not the 5 
assumed by FDA. The comment further stated that, because some models 
offer different features, their companies produced, on the average, 24 
brochures for their 18 models. Finally, the comment stated that their 
member companies required not 40 hours, but at least 136 hours to 
produce a user instructional brochure.
     FDA agrees in part with the comment. FDA agrees that the number of 
models produced are more than the five originally estimated by FDA. FDA 
notes, however, that the estimates proposed by FDA are annual burdens. 
Not all 18 models and 6 variations cited by the comment are new every 
year. Therefore, it is not necessary to prepare a new user 
instructional brochure for each of these every year. In addition, much 
of the information in the brochure can be transferred from one model 
brochure to the brochure for the successor model.
     Based on premarket notification submissions, FDA estimates that 
approximately half of the models are significantly revised each year 
and others may be revised less significantly. FDA accepts the estimate 
of 136 hours for preparing a new brochure, but believes that an 
estimate of half that time or 68 hours is more appropriate for 
preparing a revised brochure.
     The burden estimate for Sec. 801.420(c) is calculated as follows: 
It is estimated that it will take 40 manufacturers 136 hours each to 
prepare 12 new brochures a year, which calculates to 65,280 hours. It 
is estimated that it will take those 40 manufacturers 68 hours to 
prepare 12 revised brochures a year, which calculates to 32,640 hours. 
Therefore, FDA estimates that it will take an average of 102 hours to 
prepare 24 brochures a year, which calculates to 97,920 hours.
     FDA estimates the total 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
Totals                                                                                            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             162           1,600,000               0.25      400,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

     In the notice published in the Federal Register of June 30, 1998, 
Sec. 801.421(a)(1) and (a)(2) were listed as imposing reporting burdens 
on the public. These provisions have been removed from the burden chart 
in this notice. Section 801.421(a)(1) imposes no reporting requirements 
on hearing aid dispensers, but appears to impose a burden upon 
patients, who must submit to the hearing aid dispenser an evaluation 
form (or a waiver under Sec. 801.421(a)(2)) under this provision prior 
to purchasing a hearing aid. This requirement is exempted from the 
definition of information because it consists of facts obtained from 
individuals in connection with direct treatment of a disorder (5 CFR 
1320.3(h)(5)). Section 801.421(a)(2) requires dispensers to disclose to 
patients, prior to selling a hearing aid, that exercising the waiver of 
the evaluation form ``is not in the patient's best health interest'' 
(801.421(a)(2)(i)). This disclosure does not constitute a ``collection 
of information'' because it is a ``public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)). Hence, the 
burden

[[Page 57129]]

hours for these two provisions have been removed from the chart.
     For the Sec. 801.421(b) estimate in Table 1 of this document, FDA 
assumes that 9,900 hearing aid dispensers will have 162 sales annually 
(1.6 million sales , the current number of annual hearing aid sales, 
divided by 9,900 dispensers). 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.
     The Sec. 801.421(c) estimate in Table 1 of this document assumes 
that 9,900 dispensers (which includes 40 hearing aid manufacturers/
distributors) 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/
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 hearing aid 
dispenser locating the appropriate user instructional brochure for the 
specific model and mailing the brochure to the requester.
     The Sec. 801.421(d) recordkeeping estimate in Table 2 of this 
document 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: October 14, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-28578 Filed 10-23-98; 8:45 am]
BILLING CODE 4160-01-F