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
Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices 41579

patent term restoration. In a letter dated

November 7, 1997, FDA advised the

Patent and Trademark Office that this

animal drug product had undergone a

regulatory review period and that the

approval of Anipryl represented the

first permitted commercial marketing or

use of the product. Shortly thereafter,

the Patent and Trademark Office

requested that FDA determine the

product’s regulatory review period.

FDA has determined that the

applicable regulatory review period for

Anipryl is 2,329 days. Of this time,

2,275 days occurred during the testing

phase of the regulatory review period,

54 days occurred during the approval

phase. These periods of time were

derived from the following dates:

1. The date an exemption under

section 512(j) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360b(j)) became effective: January 15,

1991. The applicant claims December

21, 1990, as the date the investigational

new animal drug application (INAD)

became effective. However, FDA records

indicate that the date of FDA’s letter

assigning a number to the INAD was

January 15, 1991, which is considered to

be the effective date for the INAD.

2. The date the application was

initially submitted with respect to the

animal drug product under section

512(b) of the act: April 7, 1997. The

applicant claims April 2, 1997, as the

date the new animal drug application

(NADA) for Anipryl (NADA 141–080)

was initially submitted. However, a

review of FDA records reveals that the

date of FDA’s official acknowledgement

letter assigning a number to NADA 141–

080 was April 7, 1997, which is

considered to be the initially submitted

date for NADA 141–080.

3. The date the application was

approved: May 30, 1997. FDA has

verified the applicant’s claim that

NADA 141–080 was approved on May

30, 1997.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 448 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before October 5, 1998, submit to

the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,

any interested person may petition FDA,

on or before February 1, 1999, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: July 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–20708 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–0168]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; BeneFIXTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

BeneFIXTM 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 human biological

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 human

biological products, the testing phase

begins when the exemption to permit

the clinical investigations of the

biological becomes effective and runs

until the approval phase begins. The

approval phase starts with the initial

submission of an application to market

the human biological product and

continues until FDA grants permission

to market the biological 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

a human biological product will include

all of the testing phase and approval

phase as specified in 35 U.S.C.

156(g)(1)(B).

FDA recently approved for marketing

the human biological product

BeneFIXTM (coagulation factor IX

(Recombinant)). BeneFIXTM is indicated

for the control and prevention of

hemorrhagic episodes in patients with

hemophilia B, including the perioperative management of hemophilia B

patients undergoing surgery.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

BeneFIXTM (U.S. Patent No. 5,171,569)

from British Technology Group Ltd.,

and the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

May 21, 1997, FDA advised the Patent

and Trademark Office that this human

biological product had undergone a

regulatory review period and that the

approval of BeneFIXTM represented the

first permitted commercial marketing or

use of the product. Shortly thereafter,

the Patent and Trademark Office

requested that FDA determine the

product’s regulatory review period.

FDA has determined that the

applicable regulatory review period for