Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices 41575

reports and 100 quality system reports

will be generated and required to be

maintained by EC CAB’s annually.

Thus, the agency estimates that 100

records of evaluations of quality systems

and premarket submissions will be

retained by the designated EC CAB’s.

Based on experience with the ThirdParty Review Pilot Program, which was

announced in the Federal Register of

April 3, 1996 (61 FR 14789), the agency

anticipates that each recordkeeper will

require no more than 2 hours of

recordkeeping per review. The agency is

estimating 5 reviews per respondent and

a total of 10 hours per recordkeeper.

Dated: July 24, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20702 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0331]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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

the Third–Party Review Pilot Program

established by FDA’s Center for Devices

and Radiological Health (CDRH) under

the FDA Modernization Act of 1997

(FDAMA). Elsewhere in this issue of the

Federal Register, FDA is publishing a

notice announcing OMB’s approval of

this collection of information (OMB

control number 0910–0375). Since this

was an emergency approval that expires

on November 30, 1998, FDA is

following the normal PRA clearance

procedures by isuing this notice.

DATES: Submit written comments on the

collection of information by October 5,

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 collection of

information set forth below.

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.

Title: Medical Devices; FDAMA

Third–Party Review (OMB Control

Number 0910–0375—Extension)

Description: Section 210 of FDAMA

establishes a new section 523 of the

Federal Food, Drug, and Cosmetic Act

(the act), directing FDA to accredit

persons in the private sector to review

certain premarket applications and

notifications. As with the Third–Party

Review Pilot Program previously

conducted by FDA, participation in this

Third–Party Review Pilot Program by

accredited persons is entirely voluntary.

A third party wishing to participate will

submit a request for accreditation.

Accredited third-party reviewers will

have the ability to review a

manufacturer’s 510(k) submission for

selected devices. After reviewing a

submission, the reviewer will forward a

copy of the 510(k) submission, along

with the reviewer’s documented review

and recommendation, to FDA. Thirdparty reviewers should maintain records

of their 510(k) reviews and a copy of the

510(k) for a reasonable period of time.

This information collection will allow

FDA to implement the Accredited

Person Review Program established by

FDAMA and improve the efficiency of

510(k) review for low to moderate-risk

devices.

Description of Respondents:

Businesses or other for profit

organizations.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Item No. of

Respondents

No. of Responses Per

Respondent

Total Annual

Responses

Hours per

Respondent Total Hours

Requests for accreditation 40 1 40 24 960

510(k) reviews conducted by accredited third parties 35 4 140 40 5,600

Total hours 6,560

1There are no capital costs or operating and maintenance costs associated with this collection of information.
41576 Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Item No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

510(k) reviews 35 4 140 102 3502

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

2 Due to clerical error, the recordkeeping burden hours for 510(k) reviews that appeared in a notice issued in the FEDERAL REGISTER of May 22,

1998 (63 FR 28388) were incorrect. Table 2 of this document contains the correct estimates.

The burdens are explained as follows:

1. Reporting

a. Requests for accreditation: Under

the agency’s Third–Party Review Pilot

Program, the agency received 37

applications for recognition as thirdparty reviewers, of which the agency

recognized 7. Under this expanded

program, the agency anticipates that it

will not see a significant increase in the

number of applicants. Therefore, the

agency is estimating that it will receive

40 applications. The agency anticipates

that it will accredit 35 of the applicants

to conduct third-party reviews.

b. 510(k) reviews conducted by

accredited third parties: In 18 months

under the Third–Party Review Pilot

Program, FDA received only 22 510(k)’s

that were requested and were eligible

for review by third parties. Because the

new program is not as limited in time,

and is expanded in scope, the agency

anticipates that the number of 510(k)’s

submitted for third-party review will

increase. The agency anticipates that it

will receive approximately 140 thirdparty review submissions annually, i.e.,

approximately 4 annual reviews per

each of the estimated 35 accredited

reviewers.

2. Recordkeeping

Third-party reviewers are required to

keep records of their review of each

submission. The agency anticipates

approximately 140 annual submissions

of 510(k)’s for third-party review. The

agency estimates that each third-party

reviewer will require approximately 10

annual hours to maintain records of

their reviews and reports.

Dated: July 24, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20705 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0268]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

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 September

3, 1998.

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, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

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.

Patent Term Restoration, Due Diligence

Petitions, Filing, Format, and Content of

Petitions—(21 CFR Part 60)—(OMB

Control Number 0910–0233)—Extension

FDA’s patent extension activities are

conducted under the authority of the

Drug Price Competition and Patent

Term Restoration Act of 1984 and the

Animal Drug and Patent Term

Restoration Act of 1988 (35 U.S.C. 156).

New human drug, animal drug, human

biological, medical device, food

additive, or color additive products

regulated by FDA must undergo FDA

safety, or safety and effectiveness

review, before marketing is permitted.

Where the product is covered by a

patent, part of the patent’s term may be

consumed during this review, which

diminishes the value of the patent. In

enacting 35 U.S.C. 156, Congress sought

to encourage development of new, safer,

and more effective medical and food

additive products. It did so by

authorizing the U.S. Patent and

Trademark Office (PTO) to extend the

patent term by a portion of the time

during which FDA’s safety and

effectiveness review prevented

marketing of the product. The length of

the patent term extension is generally

limited to a maximum of 5 years, and

is calculated by PTO based on a

statutory formula. When a patent holder

submits an application for patent term

extension to PTO, PTO requests

information from FDA, including the

length of the regulatory review period

for the patented product. If PTO

concludes that the product is eligible for

patent term extension, FDA publishes a

notice which describes the length of the

regulatory review period, and the dates

used to calculate that period. Interested

parties may request, under § 60.24 (21

CFR 60.24), revision of the length of the

regulatory review period, or may

petition, under § 60.30 (21 CFR 60.30),

to reduce the regulatory review period

by any time where marketing approval

was not pursued with ‘‘due diligence.’’

The statute defines due diligence as

‘‘that degree of attention, continuous

directed effort, and timeliness as may

reasonably be expected from, and are

ordinarily exercised by, a person during

a regulatory review period.’’ As

provided in § 60.30(c), a due diligence

petition ‘‘shall set forth sufficient facts,

including dates if possible, to merit an

investigation by FDA of whether the

applicant acted with due diligence.’’

Upon receipt of a due diligence petition,

FDA reviews the petition and evaluates

whether any change in the regulatory

review period is necessary. If so, the

corrected regulatory review period is

published in the Federal Register. A

due diligence petitioner not satisfied