Federal Register / Vol. 66, No. 102 / Friday, May 25, 2001 / Notices 28915

Date and Time: The meeting will be

held on June 7, 2001, 8 a.m. to 5:30 p.m.

Location: Holiday Inn, Versailles

Ballroom, 8120 Wisconsin Ave.,

Bethesda, MD.

Contact: Karen M. Templeton-Somers,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

by e-mail at SomersK@cder.fda.gov, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12542. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will discuss

single patient use of nonapproved

oncology drugs and biologics. This is a

continuation of the discussion started at

the December 13 and 14, 2000, meeting.

Procedure: The meeting is open to the

public from 8 a.m. to 1 p.m. Interested

persons may present data, information,

or views, orally or in writing, on issues

pending before the committee. Written

submissions may be made to the contact

person by May 31, 2001. Oral

presentations from the public will be

scheduled between approximately 8:15

a.m. and 9:15 a.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before May 31, 2001, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

Background materials for this meeting

will be posted at the Oncologic Drugs

Advisory Committee dockets Web site at

www.fda.gov/ohrms/dockets/ac/

acmenu.htm. (Click on the year 2001

and scroll down to the Oncologic Drugs

Advisory Committee meetings.) The

slides and transcripts from the meeting

will be posted at this same Web site

about 3 weeks after the meeting.

Closed Committee Deliberations: The

meeting will be closed from 1 p.m. to

5:30 p.m. to permit discussion and

review of trade secret and/or

confidential information (5 U.S.C.

552b(c)(4)).

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

FDA regrets that it was unable to

publish this notice 15 days prior to the

May 23, 2001, Oncologic Drugs

Advisory Committee meeting. Because

there agency believes there is some

urgency to bring these issues to public

discussion and qualified members of the

Oncologic Drugs Advisory Committee

were available at this time, the

Commissioner of Food and Drugs

concluded that it was in the public

interest to hold this meeting even if

there was not sufficient time for the

customary 15-day public notice.

Dated: May 22, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–13368 Filed 5–23–01; 4:15 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–0087]

Guidance for Industry on IND Meetings

for Human Drugs and Biologics;

Chemistry, Manufacturing, and

Controls Information; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘IND Meetings for Human

Drugs and Biologics; Chemistry,

Manufacturing, and Controls

Information.’’ This guidance provides

recommendations to industry on formal

meetings between sponsors of

investigational new drug applications

(INDs) and the Center for Drug

Evaluation and Research (CDER) or the

Center for Biologics Evaluation and

Research (CBER) on chemistry,

manufacturing, and controls (CMC)

information.

DATES: Submit written comments on

agency guidances at any time.

ADDRESSES: Submit written requests for

single copies of this guidance to the

Division of Drug Information (HFD–

240), Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, or to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1488, FAX 1–888–

CBER–FAX or 301–827–3844. Send one

self-addressed adhesive label to assist

the office in processing your requests.

Submit written comments on the

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 guidance

document.

FOR FURTHER INFORMATION CONTACT:

Stephen K. Moore, Center for Drug

Evaluation and Research (HFD–

501), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

6430;

or

Robert A. Yetter, Center for Biologics

and Research (HFM–10), Food and

Drug Administration, Bldg. N29B,

8800 Rockville Pike, Bethesda, MD

20892, 301–827–0373.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a guidance for industry entitled ‘‘IND

Meetings for Human Drugs and

Biologics; Chemistry, Manufacturing,

and Controls Information.’’ This

guidance covers three kinds of meetings

held at specific times between sponsors

and the agency where CMC issues are

discussed: (1) Pre-IND, (2) end-of-phase

2, and (3) pre-new drug application or

prebiologics license application. These

meetings are used to address questions

and scientific issues that arise during

the course of clinical investigations, aid

in the resolution of problems, and

facilitate evaluation of the drug. The

meetings often coincide with critical

points in the drug development and/or

regulatory process. This guidance is

intended to assist in making these

meetings more efficient and effective by

providing information on the: (1)

Purpose, (2) meeting request, (3)

information package, (4) format, and (5)

focus of the meeting.

In the Federal Register of February 4,

2000 (65 FR 5645), FDA announced the

availability of a draft version of this

guidance. The February 4, 2000,

guidance gave interested persons an

opportunity to submit comments

through May 4, 2000. All comments

received during the comment period

have been carefully reviewed and

incorporated in this revised guidance

where appropriate. As a result of the

public comment, the guidance is clearer

and more concise than the draft version.

This level 1 guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

guidance represents the agency’s current

thinking on IND meetings for human

drugs and biologics; chemistry,

manufacturing, and controls

information. 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

28916 Federal Register / Vol. 66, No. 102 / Friday, May 25, 2001 / Notices

such approach satisfies the

requirements of the applicable statutes

and regulations.

II. Comments

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). 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 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, http://www.fda.gov/ohrms/

dockets/default.htm, or http://

www.fda.gov/cber/guidelines.htm.

Dated: May 17, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13249 Filed 5–24–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–216]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, DHHS.

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: Extension of a currently

approved collection; Title of

Information Collection: Procedures for

Advisory Opinions Concerning

Physician Referrals and Supporting

Regulations in 42 CFR 411.370 through

411.389; Form No.: HCFA–R–216

(OMB# 0938–0714); Use: Section 4314

of Public Law 105–33, in establishing

section 1877(g)(6) of the Act, requires

the Department to provide advisory

opinions to the public regarding

whether a physician’s referrals for

certain designated health services are

prohibited under the other provisions in

section 1877 of the Act. These

regulations provide the procedures

under which members of the public may

request advisory opinions from HCFA.

Because all requests for advisory

opinions are purely voluntary,

respondents will only be required to

provide information to us that is

relevant to their individual requests.;

Frequency: On occasion; Affected

Public: Not-for-profit institutions,

Business or other for-profit, and

Individuals and Households; Number of

Respondents: 200; Total Annual

Responses: 200; Total Annual Hours:

2,000.

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: Dawn Willinghan,HCFA–R–

216, Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: May 17, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–13207 Filed 5–24–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–224]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, DHHS. 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: Extension of a currently

approved collection; Title of

Information Collection: Collection of

Managed Care Data Using the Uniform

Institutional Providers Form (HCFA–

1450/UB–92) and Supporting Statute

section 1853(a)(3) of the Balanced

budget Act of 1997; Form No.: HCFA–

R–224 (OMB No. 0938–0711); Use:

Section 1853(a)(3) of the Balanced

Budget Act (BBA) requires

Medicare+Choice organizations, as well

as eligible organizations with risksharing contracts under section 1876, to

submit encounter data. Data regarding

inpatient hospital services are required

for periods beginning on or after July 1,

1997. These data may be collected

starting January 1, 1998. Other data (as

the Secretary deems necessary) may be

required beginning July 1, 1998.

The BBA also requires the Secretary

to implement a risk adjustment

methodology that accounts for variation

in per capita costs based on health

status. This payment method must be

implemented no later than January 1,

2000. The encounter data are necessary

to implement a risk adjustment

methodology.

HCFA continues to require hospital

inpatient encounter data from

Medicare+Choice organizations to