Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28527

during the comment period have been

carefully reviewed and incorporated in

this revised guidance where

appropriate. In addition, a workshop

entitled ‘‘Bioanalytical Method

Validation—A Revisit with a Decade of

Progress’’ was held January 12 to 14,

2000. This guidance also incorporates

the recommendations from the January

2000 workshop.

This 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 the validation of methods

for the assay of drugs and/or metabolites

in human biological matrices. 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, 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 http://

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

Dated: May 11, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12908 Filed 5–22–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1497]

The Mammography Quality Standards

Act Final Regulations Document #4;

Final Guidance for Industry and FDA;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the guidance entitled

‘‘The Mammography Quality Standards

Act Final Regulations Document #4;

Final Guidance for Industry and FDA.’’

The final regulations implementing the

Mammography Quality Standards Act of

1992 (the MQSA) became effective April

28, 1999. The final guidance document

is intended to assist facilities and their

personnel to meet the MQSA final

regulations.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

guidance document entitled ‘‘The

Mammography Quality Standards Act

Final Regulations Document #4; Final

Guidance for Industry and FDA’’ to the

Division of Small Manufacturers

Assistance (HFZ–220), Center for

Devices and Radiological Health, Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. Submit

written comments concerning this

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

should be identified with the docket

number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT:

Charles A. Finder, Center for Devices

and Radiological Health (HFZ–240),

Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301–

594–3332.

SUPPLEMENTARY INFORMATION:

I. Background

The draft guidance document was

issued for public comment in the

Federal Register of September 13, 2000

(65 FR 55265). The comment period

ended on December 13, 2000. The draft

guidance was discussed with the

National Mammography Quality

Assurance Advisory Committee at the

September 28, 2000, meeting. The final

guidance document has been modified

from the original draft guidance to

address the seven public comments

received. There were several clarifying

changes made to the document,

particularly dealing with the issues of

what constitutes a ‘‘major repair’’ and

when the physicist must perform onsite

evaluations. Several decision tree flow

diagrams were added to the document

to help clarify these issues. Overall,

there were no major substantive changes

made to the document.

II. Significance of the Guidance

This guidance document represents

the agency’s current thinking on the

MQSA final regulations guidance. 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 applicable

statutes and regulations.

The agency has adopted the good

guidance practices (GGPs) regulation,

which sets forth the agency’s regulations

for the development, issuance, and use

of guidance documents (21 CFR 10.115;

65 FR 56468, September 19, 2000). This

guidance document is issued as a level

1 guidance consistent with GGPs.

III. Electronic Access

In order to receive ‘‘The

Mammography Quality Standards Act

Final Regulations Document #4; Final

Guidance for Industry and FDA’’ via

your fax machine, call the CDRH FactsOn-Demand system at 800–899–0381 or

301–827–0111 from a touch-tone

telephone. Press 1 to enter the system.

At the second voice prompt press 1 to

order a document. Enter the document

number (1159) followed by the pound

sign (#). Follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy

of the guidance may also do so using the

Internet. CDRH maintains an entry on

the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with Internet access.

Updated on a regular basis, the CDRH

home page includes the civil money

penalty guidance documents package,

device safety alerts, Federal Register

reprints, information on premarket

submissions (including lists of approved

applications and manufacturers’

addresses), small manufacturers’

assistance, information on video

conferencing and electronic

submissions, Mammography Matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. ‘‘The

Mammography Quality Standards Act

Final Regulations Document#4; Final

Guidance for Industry and FDA’’ will

also be available on CDRH’s

mammography Web site at http://

www.fda.gov/cdrh/mammography.

Guidance documents are also available

on the Dockets Management Branch

Web site at http://www.fda.gov.ohrms/

dockets/default.htm.

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