[Federal Register Volume 62, Number 45 (Friday, March 7, 1997)]
[Notices]
[Pages 10572-10574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5646]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0022]


Agency Information Collection Activities: Proposed Collection; 
Reinstatements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 reinstatement 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, 
reporting requirements for firms that provide electronic product 
samples to FDA for research and testing purposes, reporting 
requirements for firms that intend to export certain unapproved medical 
devices, and reporting and recordkeeping requirements relating to 
shipment of nonsterile devices that are to be sterilized elsewhere or 
are shipped to other establishments for further process labeling or 
repacking.

DATES: Submit written comments on the collection of information 
requirements by May 6, 1997.

ADDRESSES: Submit written comments on the collection of information 
requirements to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1479.

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 reinstatement 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 listed below.
    With respect to the following collections of information, FDA 
invites comments on: (1) Whether the proposed collections of 
information are 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.

1. 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 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.

[[Page 10573]]

    The respondents to this collection of information are hearing aid 
manufacturers, distributors, dispensers, health professionals, or other 
for profit organizations.
    On September 29, 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 
Secs. 801.421(a)(1) and 801.420(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                                  
----------------------------------------------------------------------------------------------------------------
                                                Annual                                                          
      21 CFR Section            No. of       Frequency per      Total Annual         Hours per      Total Hours 
                              Respondents      Response           Responses          Response                   
----------------------------------------------------------------------------------------------------------------
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)                    9,940               5             49,700                  0.17        8,449       
----------------------------------------------------------------------------------------------------------------
Total Burden Hours                                                                                836,019       
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.   


                                 Table 2.--Estimated Annual Recordkeeping Burden                                
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per                       
  21 CFR Section     Recordkeepers    per Recordkeeping       Records          Recordkeeper       Total Hours   
----------------------------------------------------------------------------------------------------------------
801.421(d).......      9,900                162          1,600,000                  0.25         400,000        
----------------------------------------------------------------------------------------------------------------
Total............                                                                                400,000        
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.   

2. Notice of Availability of Sample Electronic Product--21 CFR 
Parts 1020, 1030, 1040, and 1050 and FDA Form 2767 (OMB Control No. 
0910-0048--Reinstatement)

    Under sections 532 to 542 of the act (21 U.S.C. 360ii to ss), FDA 
is authorized to protect the public from unnecessary exposure to 
radiation from electronic products. Section 532 of the act directs the 
Secretary to establish and carry out an electronic product radiation 
control program designed to protect the public health and safety from 
electronic radiation, and authorizes the Secretary to procure (by 
negotiation or otherwise) electronic products for research and testing 
purposes and to sell or otherwise dispose of such products.
    The Center for Devices and Radiological Health (CDRH) conducts 
laboratory compliance testing of products covered by regulations for 
product standards in parts 1020, 1030, 1040, and 1050 (21 CFR parts 
1020, 1030, 1040, and 1050). The ``Notice of Availability of Sample 
Electronic Product''(Form FDA 2767) is used to inform CDRH of the 
location of sample products that are being requested for testing to 
confirm that the products comply with performance standards. Form FDA 
2767 is a summary form which reports information required by parts 
1020, 1030, 1040, and 1050.
    FDA also uses this information to locate and select sample products 
to ensure conformance with regulations. In the event this information 
were not collected by CDRH, each manufacturer would have to respond in 
letter format with all the data now being recorded on Form FDA 2767, 
which would require more time and expense. Testing an appropriate 
percentage of these products to protect the public would also be 
hindered by the slower process.
    The respondents to this collection of information are manufacturers 
of electronic products.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 3.--Estimated Annual Reporting Burden                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
   21 CFR Part and Form Number        No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
1020, 1030, 1040, 1050, and Form                                                                                
 FDA 2767                             145              11.03        1,600               0.09          144       
----------------------------------------------------------------------------------------------------------------
Totals                                                                                                144       
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.   


[[Page 10574]]

    FDA's estimates are based on actual data collected from industry 
over the past 3 years, where there has been an average of 1,600 annual 
responses to FDA from 145 respondents each year.

3. Export of Medical Devices--Foreign Letters of Approval--21 
U.S.C. 381(e)(2) (OMB Control No. 0910-0264--Reinstatement)

    Section 801(e)(2) of the act (21 U.S.C. 381(e)(2)) provides for the 
exportation of an unapproved device under certain circumstances if the 
exportation is not contrary to the public health and safety and it has 
the approval of the foreign country to which it is intended for export.
    Requesters communicate (either directly or through a business 
associate in the foreign country) with a representative of the foreign 
government to which they seek exportation, and written authorization 
must be obtained from the appropriate office within the foreign 
government approving the importation of the medical device.
    The written authorization from the foreign country is used by the 
Office of Compliance, CDRH in determining if the foreign country has 
any objection to the importation of the device into their country. In 
FY 95, the Office of Compliance received approximately 800 requests 
from U.S. firms to export medical devices under section 801(e)(2) of 
the act. If approval letters from foreign governments were not 
submitted by the requesting firm, CDRH would then have had to contact 
various embassies (via telephone, for example) to seek their approval, 
which would have been time consuming and costly.
    The respondents to this collection of information are companies 
that seek to export medical devices.
    The foreign letters of approval are submitted under a statutory 
information collection requirement only. Because there is no additional 
burden attributable to a regulation, no burden chart is included.

4. Agreement for Shipment of Devices for Sterilization--21 CFR 
801.150(a)(2) and (e) (OMB Control No. 0910-0131--Reinstatement)

    Under sections 501(c) and 502(a) of the act (21 U.S.C. 351(c) and 
352(a)), nonsterile devices that are labeled as sterile but are in 
interstate transit to a facility to be sterilized are adulterated and 
misbranded. FDA regulations in Sec. 801.150(a)(2) and (e) (21 CFR 
801.150(a)(2) and (e)) establish a control mechanism by which firms may 
manufacture and label medical devices as sterile at one establishment 
and ship the devices in interstate commerce for sterilization at 
another establishment, a practice that facilitates the processing of 
devices and is economically necessary for some firms. Under 
Sec. 801.150(a)(2) and (e), manufacturers and sterilizers may sign an 
agreement containing the following: (1) Instructions for maintaining 
accountability of the number of units in each shipment; (2) 
acknowledgment that the devices are nonsterile, being shipped for 
further processing; and (3) specifications for sterilization 
processing.
    This agreement allows the manufacturer to ship misbranded products 
to be sterilized without initiating regulatory action and provides FDA 
with a means to protect consumers from use of nonsterile products. 
During routine plant inspections, FDA normally reviews agreements that 
must be kept for 2 years after final shipment or delivery of devices. 
To discontinue this reporting and recordkeeping procedure would place 
an economic hardship on the industry and an additional burden on FDA to 
monitor product in interstate commerce for failure to comply with 
adulteration and misbranding provisions of the act.
    The respondents to this collection of information are device 
manufacturers and contract sterilizers.
    FDA estimates the reporting burden of this collection of 
information as follows:

                                   Table 4.--Estimated Annual Reporting Burden                                  
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per                       
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours   
----------------------------------------------------------------------------------------------------------------
801.150..........         90                 20              1,800                  4              7,200        
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.   

    No burden has been estimated for the recordkeeping requirement in 
Sec. 801.150(a)(2) because these records are maintained as a usual and 
customary part of normal business activities. Under 5 CFR 1320.3(b)(2), 
the time, effort, and financial resources necessary to comply with a 
collection of information are excluded from the burden estimate if the 
reporting, recordkeeping, or disclosure activities needed to comply are 
usual and customary because they would occur in the normal course of 
activities.
    FDA's estimate of the burden is based on actual data obtained from 
industry during the past 3 years where there are approximately 90 firms 
subject to this requirement.

    Dated: February 25, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-5646 Filed 3-6-97; 8:45 am]
BILLING CODE 4160-01-F