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

24146 Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Notices

draft guidance represents the agency’s

current thinking on immunotoxicology

evaluation of INDs. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the applicable statutes

and regulations.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. Two copies of any comments

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. The draft

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: May 4, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–11879 Filed 5–10–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10040]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, Health and Human

Services.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: New collection; Title of

Information Collection: NMEP Regional

Survey of Medicare Beneficiaries; Form

No.: HCFA–10040 (OMB# 0938–NEW);

Use: HCFA is proposing to conduct a

survey by selecting 2,000 Medicare

beneficiaries per HCFA region from

HCFA’s administrative databases with

oversampling for underserved

populations as a part of the continuous

assessment on the knowledge and

understanding of the Medicare program

and the NMEP/Medicare+Choice

outreach and educational efforts to

systematically quantify current

knowledge and awareness and to assess

future direction; Frequency: On

occasion; Affected Public: Individuals or

households, Business or other for-profit,

Not-for-profit institutions; Number of

Respondents: 20,000; Total Annual

Responses: 20,000; Total Annual Hours:

5,000.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, Room N2–14–

26, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: May 2, 2001.

John P. Burke III,

Reports Clearance Officer, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–11869 Filed 5–10–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

HRSA AIDS Advisory Committee;

Notice of Meeting; Correction

In Federal Register Document 01–

10229 appearing on page 20820 in the

issue for Wednesday, April 25, 2001, the

location of the meeting scheduled on

June 4, 2001, from 8:30 a.m.–5 p.m. has

changed. This meeting will be held at:

Holiday Inn Select (Conference

Plaza),130 Claremont Avenue,Decatur,

Georgia 30030,Telephone: 800–225–

6079.

Dated: May 7, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–11880 Filed 5–10–01; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4650–N–34]

Notice of Submission of Proposed

Information Collection to OMB; Annual

Lead-Based Paint Activity Report

AGENCY: Office of the Chief Information

Officer, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments Due Date: June 11,

2001.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

approval number (2577–0090) and

should be sent to: Joseph F. Lackey, Jr.,

OMB Desk Officer, Office of

Management and Budget, Room 10235,

New Executive Office Building,

Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management

Officer, Q, Department of Housing and

Urban Development, 451 Seventh Street,

Southwest, Washington, DC 20410; email Wayne_Eddins@HUD.gov;

telephone (202) 708–2374. This is not a

toll-free number. Copies of the proposed

forms and other available documents