21398 Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual Frequency per

Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours

58.29(b) 300 20 6,000 .21 1,260

58.35(b)(1) through

(b)(6) and (c) 300 270.56 81,228 3.36 279,926

58.63(b) and (c) 300 60 18,000 .09 1,620

58.81(a) through (c) 300 301.8 90,540 .14 12,676

58.90(c) and (g) 300 62.7 18,810 .13 2,445

58.105(a) and (b) 300 5 1,500 11.8 17,700

58.107(d) 300 1 300 4.25 1,275

58.113(a) 300 15.33 4,599 6.8 31,273

58.120 300 15.38 4,614 32.7 150,878

58.195 300 251.5 75,450 3.9 294,255

Total 793,308

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10623 Filed 4–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0178]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Premarket

Notification 510(k) Submissions

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 notice in the Federal Register

concerning each proposed 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

information collection requirements for

premarket notification 510(k)

submissions.

DATES: Submit written or electronic

comments on the collection of

information by June 29, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. 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:

Peggy 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 collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Premarket Notification 510(k)

Submissions (21 CFR Part 807) (OMB

Control No. 0910–0120)—Extension

Section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360(k)) requires a person who

intends to market a medical device to

submit a premarket notification

submission to FDA at least 90 days

before proposing to begin the

introduction, or delivery for

introduction into interstate commerce,

for commercial distribution of a device

intended for human use. The definition

of ‘‘person’’ has been expanded to

include hospitals who reuse or

remanufacture single-use medical

devices. The estimated submissions

below include those submitted by

hospitals remanufacturing single-use

medical devices.

Section 510(k) of the act allows for

exemptions to the 510(k) submissions

(i.e., a premarket notification

submission would not be required if

FDA determines that premarket

notification is not necessary for the

protection of the public health, and they

are specifically exempted through the

regulatory process). Under 21 CFR

807.85, ‘‘Exemption from premarket

notification,’’ a device is exempt from

premarket notification if the device

intended for introduction into

commercial distribution is not generally

available in finished form for purchase

and is not offered through labeling and

advertising by the manufacturer,

importer, or distributor for commercial

distribution. In addition, the device

must meet one of the following

Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices 21399

conditions: (1) It is intended for use by

a patient or dentist (or other specially

qualified persons), or (2) it is intended

solely for use by a physician or dentist

and is not generally available to other

physicians or dentists.

A commercial distributor who places

a device into commercial distribution

for the first time under their own name

and a repackager who places their own

name on a device, and does not change

any other labeling or otherwise affect

the device, shall be exempted from

premarket notification if the device was

legally in commercial distribution

before May 28, 1976, or a premarket

notification was submitted by another

person.

The information collected in a

premarket notification is used by the

medical, scientific, and engineering

staffs of FDA in making determinations

as to whether or not devices can be

allowed to enter the U.S. market. The

premarket notification review process

allows for scientific and/or medical

review of devices, subject to section

510(k) of the act, to confirm that the

new devices are as safe and as effective

as legally marketed predicate devices.

This review process, therefore, prevents

potentially unsafe and/or ineffective

devices, including those with fraudulent

claims, from entering the U.S. market.

This information will allow FDA to

collect data to ensure that the use of the

device will not present an unreasonable

risk for the subject’s rights. The

respondents to this information

collection will primarily be medical

device manufacturers and businesses.

FDA Form 3514 was developed to

assist respondents in organizing 510(k)

data for submission to FDA. This form

also assists respondents in organizing

and submitting data for other FDA

medical device programs such as

premarket approval applications,

investigational device exemptions, and

humanitarian device exemptions.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form No. No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours per

Response Total Hours

807.81 and 807.87

(part 807, subpart E) 4,000 1 4,000 80 320,000

FDA

3514

2,000 1 2,000 .5 1,000

Total 321,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual Frequency

per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

807.93 2,000 10 20,000 0.5 10,000

Total 10,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA has based these estimates on

conversations with industry and trade

association representatives, and from

internal review of the documents listed

in tables 1 and 2 of this document. The

total burden for using voluntary FDA

Form 3514 is estimated to be

approximately 1,000 hours and has been

included in this information collection.

Once this information collection has

been approved, the burden for FDA

Form 3514 will be reported and

approved in each of the following OMB

information collections: 0910–0078,

Investigational Device Exemption

Reports and Records; 0910–0231,

Premarket Approval of Medical Devices;

and 0910–0332, Medical Devices,

Humanitarian Devices.

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10624 Filed 4–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0175]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Survey of SingleUse Medical Device Reuse and

Reprocessing in Hospitals

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 notice in the Federal Register

concerning each proposed collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the proposed voluntary survey of

hospitals to collect information on the

extent and nature of current practice of

reprocessing of single-use medical

devices by these institutions.

DATES: Submit written or electronic

comments on the collection of

information by June 29, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management