Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices 9195

use from which to estimate the

economic costs to the industry of

mandatory HACCP regulations for foods

other than seafood. FDA will use this

information in tailoring any HACCP

regulations that may issue so that costs

and benefits of such regulations are

appropriately considered.

FDA estimates the burden of this

survey as follows:

ESTIMATED ANNUAL REPORTING BURDEN

Burden Element No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Part 1—Computer Assisted Telephone Interview

(CATI)

Respond to initial recruitment telephone call 1,231 1 1,231 0.2 246.2

Receive and read introductory letter, key term

definitions 1,231 1 1,231 0.25 307.75

Obtain data to prepare for the telephone interview 1,231 1 1,231 0.35 430.85

Respond to telephone interview 1,231 1 1,231 0.5 615.50

Totals 1 1,600.3

Part 2—On-Site Cost Interview

Receive initial recruitment telephone call 17 1 17 0.2 3.4

Receive and read introductory letter and materials 17 1 17 0.25 4.25

Obtain data to prepare for the site visit 17 1 17 0.5 8.5

Respond to questions during site visit 17 1 17 3.0 51.0

Followup questions 17 1 17 0.25 4.25

Total burden hours, on-site interviews 71.4

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

The total burden hours for Part 1—

CATI and Part 2—On-Site Cost

Interview are 1,671.7.

The burden hour estimates are based

on a pretest conducted with three focus

groups.

Dated: February 20, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4955 Filed 2–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0269]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; EXCENEL Sterile

Suspension

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

EXCENEL Sterile Suspension 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,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

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 on

the earlier date when either a major

environmental effects test was initiated

for the drug or when an exemption

under section 512(j) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C.

360b(j)) became 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 EXCENEL

Sterile Suspension (ceftiofur

hydrochloride). EXCENEL Sterile

Suspension is indicated for the

treatment and control of swine bacterial

respiratory disease (swine bacterial

pneumonia) associated with

Actinobacillus (Haemophilus)

pleuropneumoniae, Pastureruella

multocida, Salmonella choleraesuis,

and Streptococcus suis Type 2.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

EXCENEL Sterile Suspension (U.S.

Patent No. 4,902,683) from Pharmacia &

Upjohn Co. and requested FDA’s

assistance in determining the patent’s

eligibility for patent term restoration. In

a letter dated November 21, 1996, FDA

advised the Patent and Trademark

Office that this animal drug product had

undergone a regulatory review period

and that the approval of EXCENEL

Sterile Suspension represented the first
9196 Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices

commercial marketing 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

EXCENEL Sterile Suspension is 900

days. Of this time, 881 days occurred

during the testing phase of the

regulatory review period, while 19 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 became effective:

November 10, 1993. FDA has verified

the applicant’s claim that November 10,

1993, was the date that the

investigational new animal drug

application became effective.

2. The date the application was

initially submitted with respect to the

animal drug product under section

512(b) of the Federal Food, Drug, and

Cosmetic Act: April 8, 1996. The

applicant claims April 3, 1996, as the

date the new animal drug application

(NADA) for EXCENEL Sterile

Suspension (NADA 140–890) was

initially submitted. However, a review

of FDA records reveals that FDA’s

official acknowledgment that the NADA

was sufficiently complete to begin

review was a telephone call requesting

that certain additional information be

added to the NADA on April 8, 1996,

which is considered to be the initially

submitted date for the NADA.

3. The date the application was

approved: April 26, 1996. FDA has

verified the applicant’s claim that

NADA 140–890 was approved on April

26, 1996.

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 1,151 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before April 29, 1997, 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 August 27, 1997, 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: February 20, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–4954 Filed 2–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 94D–0259]

‘‘Points to Consider in the Manufacture

and Testing of Monoclonal Antibody

Products for Human Use (1997);’’

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a points to consider (PTC)

document entitled ‘‘Points to Consider

in the Manufacture and Testing of

Monoclonal Antibody Products for

Human Use (1997).’’ This PTC

document is intended to assist sponsors

and investigators engaged in

monoclonal antibody product

development and it includes

information to submit when filing

investigational new drug applications

and product license applications. The

document revises a 1994 document

entitled ‘‘Draft Points to Consider in the

Manufacture and Testing of Monoclonal

Antibody Products for Human Use.’’

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of the document entitled

‘‘Points to Consider in the Manufacture

and Testing of Monoclonal Antibody

Products for Human Use (1997)’’ to the

Manufacturers Assistance and

Communication Staff (HFM–42), Center

for Biologics Evaluation and Research

(CBER), Food and Drug Administration,

1401 Rockville Pike, Rockville, MD

20852–1448. Send one self-addressed

adhesive label to assist that office in

processing your requests. The document

may also be obtained by mail or fax by

calling the CBER Fax Information

System at 1–888–CBER–FAX or 301–

827–3844.

Persons with access to the Internet

may obtain the document using the

World Wide Web (WWW) or bounceback e-mail. For WWW access, connect

to CBER at ‘‘http://www.fda.gov/cber/

cberftp.html.’’ For bounce back e-mail

send a message to

‘‘ptclmab@al.cber.fda.gov.’’

Submit written comments on the PTC

document to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

PTC document and received comments

are available for public examination in

the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

FOR FURTHER INFORMATION CONTACT:

Sharon A. Carayiannis, Center for

Biologics Evaluation and Research

(HFM–630), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–594–

3074.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a PTC

document entitled ‘‘Points to Consider

in the Manufacture and Testing of

Monoclonal Antibody Products for

Human Use (1997).’’ This PTC

document supersedes the document

entitled ‘‘Draft Points to Consider in the

Manufacture and Testing of Monoclonal

Antibody Products for Human Use’’

announced in the Federal Register of

August 3, 1994 (59 FR 39571), and is

designed to assist sponsors and

investigators engaged in monoclonal

antibody product development.

The PTC revision was undertaken for

reasons that include but are not limited

to: (1) Facilitating initial development of

monoclonal antibodies for serious and

immediately life-threatening

indications; (2) updating and

streamlining information from the 1994

PTC document; and (3) assuring

consistency with current CBER policy

and International Conference on

Harmonisation documents dealing with

this category of products. In the revision

of this document, CBER reviewed and

considered all comments submitted to

the docket.

The PTC document details an

approach for sponsors and investigators

to follow in product manufacturing and

testing, preclinical and clinical studies,

and the information to be provided for