10572 Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Notices

comments and suggestions submitted

within 60 days of this publication.

Dated: March 3, 1997.

Bob Sargis,

Acting Reports Clearance Officer

[FR Doc. 97–5570 Filed 3–6–97; 8:45 am]

BILLING CODE 4184–01–M

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.
Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Notices 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 §§ 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

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

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

21 CFR Section No. of Recordkeepers Annual Frequency per

Recordkeeping Total Annual Records Hours perRecordkeeper 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

21 CFR Part and Form Number No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

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.
10574 Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Notices

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

§ 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 § 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

21 CFR Section No. of Respondents Annual Frequency per

Response

Total Annual Responses Hours per 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

§ 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

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

of Section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995 for

opportunity for public comment on

proposed data collection projects, the

Health Resources and Services

Administration (HRSA) will publish

periodic summaries of proposed

projects being developed for submission

to OMB under the Paperwork Reduction

Act of 1995. To request more

information on the proposed project or

to obtain a copy of the data collection

plans, call the HRSA Reports Clearance

Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.