[Federal Register Volume 62, Number 178 (Monday, September 15, 1997)]
[Notices]
[Pages 48291-48292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24348]


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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

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 
October 15, 1997.
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, 
Attention: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1479.

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 No. 
0910-0171--Reinstatement)

     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 (the Secretary) 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

[[Page 48292]]

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 user 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 1993, FDA conducted an audit of hearing aid dispensers in four 
FDA districts to determine the level of compliance with existing 
hearing aid requirements. The estimates relating to Sec. 801.421(a)(1) 
and (a)(2) in the reporting and recordkeeping burden tables below are 
based on information obtained in this audit. This audit revealed that 
medical evaluations were obtained in 32 percent of the sales and signed 
waivers were obtained in 60 percent of the sales.
     FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden                                  
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                                               Annual                                                           
     21 CFR Section           No. of       Frequency per      Total Annual        Hours per        Total Hours  
                           Respondents      Respondents        Responses           Response                     
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801.420                        40                5                200                 40            8,000       
801.421(a)(1)               9,900               52            514,800                  0.10        51,480       
801.421(a)(2)              19,900               97            960,300                  0.30       288,090       
801.421(b)                  9,900              162          1,600,000                  0.30       480,000       
801.421(c)                  9,940                5             49,700                  0.17         8,449       
Total Burden Hours                                                                                836,019       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   


                                 Table 2.--Estimated Annual Recordkeeping Burden                                
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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       
Total                                                                                             400,000       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   


    Dated: September 8, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-24348 Filed 9-12-97; 8:45 am]
BILLING CODE 4160-01-F