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
Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices 41577

with FDA’s decision regarding the

petition may, under § 60.40 (21 CFR

60.40), request an informal hearing for

reconsideration of the due diligence

determination. Petitioners are likely to

include persons or organizations having

knowledge that FDA’s marketing

permission for that product was not

actively pursued throughout the

regulatory review period. The

information collection for which an

extension of approval is being sought is

the use of the statutorily created due

diligence petition.

Since 1992, five requests for revision

of the regulatory review period have

been submitted under § 60.24. One

regulatory review period has been

altered. No due diligence petitions have

been submitted to FDA, under § 60.30,

and consequently there have been no

requests for hearings, under § 60.40,

regarding the decisions on such

petitions.

FDA estimates the burden of this

collection of information as follows:

ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

60.24(a) 1 1 1 100 100

60.30 0 0 0 0 0

60.40 0 0 0 0 0

Total 100

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

Dated: July 29, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20740 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0535]

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, 301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collections of information to OMB for

review and clearance.

Institutional Review Boards—(21 CFR

56.115)—(OMB Control Number 0910–

0130)—Extension

When reviewing clinical research

studies regulated by FDA, institutional

review boards (IRB’s) are required to

create and maintain records describing

their operations, and make the records

available for FDA inspection when

requested. These records include: (1)

Written procedures describing the

structure and membership of the IRB

and the methods which the IRB will use

in performing its functions; (2) the

research protocols, informed consent

documents, progress reports, and

reports of injuries to subjects submitted

by investigators to the IRB; (3) minutes

of meetings showing attendance, votes

and decisions made by the IRB, the

number of votes on each decision for,

against, and abstaining, the basis for

requiring changes in or disapproving

research; (4) records of continuing

review activities; (5) copies of all

correspondence between investigators

and the IRB; (6) statements of significant

new findings provided to subjects of the

research; (7) and a list of IRB members

by name, showing each member’s

earned degrees, representative capacity,

and experience in sufficient detail to

describe each member’s contributions to

the IRB’s deliberations, and any

employment relationship between each

member and the IRB’s institution. This

information is used by FDA in

conducting audit inspections of IRB’s to

determine whether IRB’s and clinical

investigators are providing adequate

protections to human subjects

participating in clinical research.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeper

Total Annual

Records

Hours per

Recordkeeper Total Hours

56.115 2,000 14.6 29,200 4.5 131,400

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

Due to a typographical error, the total

annual records were reported as 10,000

and the hours per recordkeeper were

reported as 65 in a notice issued in the

Federal Register of January 27, 1998 (63

FR 3902), which provided 60 days for

public comment on this collection of

information. The total annual records

has been corrected to 29,200 and the