24144 Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Notices

(2) (10 points) The extent to which the

applicant has shown that partnerships

have been ongoing and viable and have

included copies of the following: (1)

Agendas for all partnership meetings for

calendar years 1999 and 2000; and (2)

the executive summary and table of

contents from the State Plan for

Arthritis.

c. Surveillance (15 Points)

The extent to which the applicant

describes the status of existing statebased arthritis surveillance. The extent

to which the applicant describes future

surveillance plans including data to be

collected, the rationale for its selection

and its programmatic application.

d. Interventions (25 Points)

The extent to which the applicant

describes the proposed intervention(s)

activity, the rationale for selection, the

target population, the appropriateness of

the intervention for the target

population, and the implementation and

evaluation strategies.

3. Budget (Not Scored)

The extent to which the applicant

provides a detailed budget and narrative

justification consistent with stated

objectives and planned program

activities.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Semi-annual progress reports.

2. Financial status report, no more

than 90 days after the end of the budget

period;

3. Final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment III in the

application kit.

AR–7 Executive Order 12372 Review

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 301(a) and 317 of the Public

Health Service Act, [42 U.S.C. section

241(a) and 247(b)], as amended. The

Catalog of Federal Domestic Assistance

number is 93.945.

J. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements’’. Should you

have questions after reviewing the

contents of all the documents, business

management technical assistance may

be obtained from:

Michelle Copeland, Grants Management

Specialist, Grants Management

Branch, Procurement and Grants

Office, Centers for Disease Control

and Prevention, Program

Announcement 01097, 2920

Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

number: (770) 488–2686,E-mail

address: stc8@cdc.gov

For program technical assistance,

contact: Sakeena Smith, MPH, Senior

Project Officer, Arthritis Program,

National Center for Chronic Disease

Prevention and Health Promotion,

Centers for Disease Control and

Prevention, 4770 Buford Highway, NE,

Mailstop K–45, Atlanta, GA 30341,

Telephone number: (770) 488–5440, Email address: SSmith1@cdc.gov

Dated: May 7, 2001.

Henry S. Cassell III,

Acting Director, Procurement and Grants

Office,Centers for Disease Control and

Prevention (CDC).

[FR Doc. 01–11896 Filed 5–10–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0465]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Baycol

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for Baycol

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 that claims

that human drug product.

ADDRESSES: Submit written comments

and petitions to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Claudia Grillo, Regulatory Policy Staff

(HFD–007), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–5645.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Public Law 98-

417) and the Generic Animal Drug and

Patent Term Restoration Act (Public

Law 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 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 human 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

a human drug 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 drug product Baycol

(cerivastatin sodium). Baycol is

indicated as an adjunct to diet for the

reduction of elevated total and LDL

cholesterol levels in patients with

primary hypercholesterolemia and

mixed dyslipidemia (Frederickson

Types IIa and IIb) when the response to

dietary restriction of saturated fat and

cholesterol and other

nonpharmacological measures alone has

been inadequate. Subsequent to this

approval, the Patent and Trademark

Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Notices 24145

Office received a patent term restoration

application for Baycol (U.S. Patent No.

5,006,530) from Bayer Corp., and the

Patent and Trademark Office requested

FDA’s assistance in determining this

patent’s eligibility for patent term

restoration. In a letter dated September

9, 1998, FDA advised the Patent and

Trademark Office that this human drug

product had undergone a regulatory

review period and that the approval of

Baycol 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

Baycol is 2,262 days. Of this time, 1,896

days occurred during the testing phase

of the regulatory review period, while

366 days occurred during the approval

phase. These periods of time were

derived from the following dates:

1. The date an exemption under

section 505 of the Federal Food, Drug,

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

355) became effective: April 19, 1991.

FDA has verified the applicant’s claim

that the date the investigational new

drug application became effective was

on April 19, 1991.

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: June 26, 1996. FDA has

verified the applicant’s claim that the

new drug application (NDA) for Baycol

(NDA 20–740) was initially submitted

on June 26, 1996.

3. The date the application was

approved: June 26, 1997. FDA has

verified the applicant’s claim that NDA

20–740 was approved on June 26, 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 890 days of patent

term extension.

Anyone with knowledge that any of

the dates as published are incorrect may

submit to the Dockets Management

Branch (address above) written

comments and ask for a redetermination

by July 10, 2001. Furthermore, any

interested person may petition FDA for

a determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period by November 7, 2001. 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. Three copies of any information

are to be submitted, except that

individuals may submit one copy.

Comments are to be 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: March 7, 2001.

Jane A. Axelrad,

Associate Director for Policy, Canter for Drug

Evaluation and Research.

[FR Doc. 01–11961 Filed 5–10–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0177]

Draft Guidance for Industry on

Immunotoxicology Evaluation of

Investigational New Drugs; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Immunotoxicology

Evaluation of Investigational New

Drugs.’’ This draft guidance provides

recommendations for sponsors of

investigational new drugs (INDs) on the

parameters that should be routinely

assessed in toxicology studies to

determine effects on immune function,

when additional specific

immunotoxicity studies should be

conducted, and when additional

mechanistic information could better

evaluate a given effect on the immune

system.

DATES: Submit written comments on the

draft guidance by August 9, 2001.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Submit written requests for

single copies of the draft guidance to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance

document.

FOR FURTHER INFORMATION CONTACT:

Joseph J. DeGeorge, Center for Drug

Evaluation and Research (HFD–24),

Food and Drug Administration, 5600

Fishers Lane,Rockville, MD 20857, 301–

594–5476.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance for industry entitled

‘‘Immunotoxicology Evaluation of

Investigational New Drugs.’’ The

immune system consists of a diffuse and

complex set of cells and organs that

have complicated interactions with each

other and with other physiological

systems. These complexities make the

detection and evaluation of druginduced immunotoxicity in animal

models difficult. Immunotoxicologic

findings could suggest the need for

additional followup studies, particularly

if the observed adverse effects are

serious. The objective of these followup

studies would be to investigate the

nature and mechanism of the

immunotoxic effects. Immunotoxicity

findings could lead to modifications in

proposed clinical trials or could be

included in the investigator’s brochure

or product label. Rarely,

immunotoxicity findings could indicate

that a drug is unsafe for some types of

clinical investigations or certain

indications.

For the safety assessment of INDs,

specific immunotoxicity testing should

be conducted when drugs are to be

administered by inhalation or topically.

Specific immunotoxicity studies should

also be considered for safety assessment

purposes when: (1) The drug has the

potential to elicit an anti-drug immune

response; (2) use of the drug during

pregnancy is likely; (3) there is an

absence of immunotoxicity findings in

the toxicology studies, but there is

significant accumulation or retention of

the drug in immune system tissues; or

(4) the drug will be used to treat an

immune-deficiency disease such as the

human immunodeficiency virus (HIV).

In most other instances, specific

immunotoxicity studies are generally

not needed to support initial clinical

trials or continued development.

This draft guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The