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
41578 Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices

hours per recordkeeper has been

corrected to 4.5. The recordkeeping

requirement burden is based on the

following formula: Approximately 2,000

IRB’s review FDA-regulated research

involving human subjects annually. The

burden for each of the paragraphs under

21 CFR 56.115 has been considered as

one for purposes of estimating the

burden. Each paragraph cannot

reasonably be segregated from one

another because all are interrelated.

FDA has about 2,000 IRB’s in its

inventory. The 2,000 IRB’s meet on an

average of 14.6 times annually. The

mean number of IRB meetings per year

was derived from a study conducted by

the agency and published by the Office

of Planning and Evaluation. The agency

estimates that approximately 4.5 hours

(h) of person time per meeting are

required to transcribe and type the

minutes of the meeting, to maintain

records of continuing review activities,

copies of all correspondence between

the IRB and investigators, member

records, and written IRB procedures

which are approximately five pages per

IRB.

Two comments were received in

response to the January 27, 1998,

Federal Register notice. Both comments

were from major research universities

and both contended that the estimate of

approximately 4.5 h person-time of

recordkeeping burden per meeting was

a large underestimate.

One comment asserted that

production and distribution of minutes

took 40 h per meeting, and continual

processing of documents received and

generated by the IRB required 215 h. It

is assumed that the latter number is

calculated on a per month basis, as the

comment also refers to holding five IRB

meetings per month. The IRB reviews

approximately 2,500 active projects, and

processes approximately 5,000 required

documents annually. An unquantified

amount of additional time is said to be

devoted to maintaining member lists,

written procedures, and forms. The

commenting university is among the top

20, or top 1 percent of IRB’s in terms of

the number of investigational new drug

(IND) studies which it has reviewed.

Studies other than those under IND are

undoubtedly reviewed as well, but the

number of IND studies is taken to be the

best available workload measure. The

median number of IND studies reviewed

by IRB’s is approximately 10. Setting

aside IRB’s which have reviewed three

or fewer IND studies, which can be

considered as inactive in reviewing FDA

regulated studies, the commenting

university is still almost at the 99th

percentile and the median number of

IND studies reviewed is 15. If, as

assumed, IND workload is directly

proportional to overall workload across

all IRB’s, the commenting university’s

workload is 30 times that of the median

IRB.

The second commenting university

claimed that 124.5 h were required for

each meeting. This university is among

the top 50 in terms of IND studies

reviewed, and a similar analysis

estimates its workload as approximately

21 times that of the median IRB.

Translating the first commenting

university’s workload to that of the

median IRB, the comments indicate a

workload of 40 h per meeting plus 215

h divided by 5 h continuous activity, or

81 h per meeting. Eighty-one hours

divided by 30 h equals 2.7 h per

meeting of the median IRB performing

at the same level of efficiency. The

second commenting university’s

workload translates to 124.5 h divided

by 21 h, or 5.9 h per meeting of the

median IRB performing at the same

efficiency. Averaged, these estimated

recordkeeping workloads translate to 2.7

h plus 5.9 h divided by 2 h, or 4.3 h per

meeting.

This number compares with the

FDA’s estimate of 4.5 h per meeting and

supports FDA’s estimate, rather than

disputing it as the raw numbers suggest.

It is undeniable that the recordkeeping

burden on the commenting universities

is high, but it is also true that the

commenting universities have among

the busiest IRB’s in the nation.

Dated: July 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20741 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0338]

Determination of Regulatory Review

Period for Purposes of Patent

Extension: Anipryl

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

Anipryl and is publishing this notice

of that determination as required by

law. FDA has made the determination

because of the submission of an

application to the Commissioner of

Patents and Trademarks, Department of

Commerce, for the extension of a patent

which claims that animal drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6620.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For animal drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the animal drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

an animal drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(4)(B).

FDA recently approved for marketing

the animal drug product Anipryl

(selegiline hydrochloride). Anipryl is

indicated for the control of clinical signs

associated with uncomplicated canine

pituitary-dependent

hyperadrenocorticism (PDH).

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

Anipryl (U.S. Patent No. 5,192,808)

from Deprenyl Animal Health, Inc., and

requested FDA’s assistance in

determining this patent’s eligibility for