[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