28528 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

guidance at any time. 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

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.

Dated: May 16, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–12909 Filed 5–22–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0495]

Prescription Drug User Fee Act

(PDUFA) II Five-Year Plan—FY 2001

Update; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of an internal planning

document entitled ‘‘PDUFA II Five-Year

Plan—FY 2001 Update.’’ The updated

plan to achieve PDUFA II goals for the

drug review process takes into account

changes in revenue projections and

workload based on actual revenue and

application receipts in fiscal year (FY)

1998, FY 1999, and FY 2000 and

updated projections for FY 2001 and FY

2002.

DATES: Submit written comments on the

plan at any time. Comments will be

considered as the agency makes annual

adjustments to the plan in the second

quarter of each FY.

ADDRESSES: Submit written requests for

single copies of this plan to the Office

of Management and Systems (HF–300),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

Attn: Frank Claunts. Send a selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the plan 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 plan.

FOR FURTHER INFORMATION CONTACT:

Frank Claunts, Office of Management

Systems (HF–300), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4427.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

an internal planning document entitled

‘‘PDUFA II Five-Year Plan—FY 2001

Update.’’ The Prescription Drug User

Fee Act of 1992 (PDUFA) was amended

and extended through the year 2002 by

the Food and Drug Administration

Modernization Act of 1997. The

amended and extended PDUFA is

referred to as PDUFA II. PDUFA II

authorizes appropriations and fees that

will provide FDA with resources to

sustain the drug review staff developed

through FY 1997 and to achieve the

even more stringent new goals.

The updated FY 2001 plan begins

with a statement of purpose, provides

background information on PDUFA and

a summary of the new goals, and

updates the 10 major assumptions on

which the plan is based. This is the

third update of the plan since it was

initially published in July 1998. The

updated plan summarizes individual

plans of agency components with major

PDUFA responsibilities and also

provides a consolidated agency

summary. The updated plan to achieve

PDUFA II goals for the drug review

process takes into account changes in

revenue projections and workload based

on actual revenue and application

receipts in FY 1998, FY 1999, and FY

2000 and updates projections for FY

2001 and FY 2002. Attachments include

the Federal Register notice of December

18, 2000 (65 FR 79107), establishing

prescription drug user fee rates for FY

2001, updated 5-year estimates of

PDUFA fees and revenues, and the

revised PDUFA II Information

Management Five-Year Plan.

We are making this plan available to

all that have an interest. We welcome

comments and will consider them in the

future as annual adjustments are made

to the plan.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the plan at

any time. 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 FY 2001

update 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 http://

www.fda.gov/oc/pdufa2/5yrplan.html.

Dated: May 17, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13069 Filed 5–22–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of June 2001.

Name: National Advisory Council on the

National Health Service Corps.

Date and Time: June 21, 2001; 3 p.m.–6:30

p.m.; June 22, 2001, 8 a.m.–5 p.m.; June 23,

2001, 9 a.m. to 5:30 p.m.; June 24, 2001, 8

a.m.–10:15 a.m.

Place: Hyatt Regency Hotel, 575 Memorial

Drive, Cambridge, MA 02139–4896, Phone:

(617) 492–1234.

The meeting is open to the public.

Agenda: The Council will focus its agenda

on strategic and operational plans for the

current fiscal year. The Council will be

attending three community meetings in

Raymond, NH, Worcester, MA, and

Providence, RI, on Friday, June 22, to discuss

integrated primary medical care, the

integration of primary care, mental and

behavioral health, and oral health.

Transportation will not be provided to the

general public.

Agenda items and times are subject to

change as priorities dictate.

FOR FURTHER INFORMATION CONTACT: Ms.

Eve Morrow, Division of National

Health Service Corps, at (301) 594–4144.

Dated: May 17, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–12910 Filed 5–22–01; 8:45 am]

BILLING CODE 4160–15–P