28526 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: May 4, 2001.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 01–13068 Filed 5–22–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Vaccines and Related Biological

Products Advisory Committee; Notice

of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Vaccines and

Related Biological Products Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on June 11, 2001, 11:30 a.m. to 2:30

p.m.

Location: Food and Drug

Administration, 8800 Wisconsin Ave.,

Bldg. 29–B, conference room 1NN06,

Bethesda, MD. This meeting will be

held via telephone conference call. A

speaker phone will be provided in the

conference room to allow public

participation in the meeting.

Contact: Nancy T. Cherry or Denise H.

Royster, Center for Biologics Evaluation

and Research (HFM–71), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–0314, or

FDA Advisory Committee Information

Line, 1–800–741–8138, (301–443–0572

in the Washington, DC area), code

12391. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will discuss

the intramural scientific research

program of the Laboratory of Pediatric

and Respiratory Viral Diseases.

Procedure: On June 11, 2001, from

11:30 a.m. to 1:30 p.m., the meeting is

open to the public. 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 12:20

p.m. and 1:25 p.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.

Closed Committee Deliberations: On

June 11, 2001, from 1:30 p.m. to 2:30

p.m., the meeting will be closed to

permit discussion where disclosure

would constitute a clearly unwarranted

invasion of personal privacy (5 U.S.C.

552b(c)(6)). The meeting will be closed

to discuss personal information

concerning individuals associated with

the research program.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 17, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–13070 Filed 5–22–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–1195]

Guidance for Industry on Bioanalytical

Method Validation; 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 ‘‘Bioanalytical Method

Validation.’’ This guidance provides

assistance to sponsors of investigational

new drug applications (INDs), new drug

applications (NDAs), abbreviated new

drug applications (ANDAs), and their

supplements in developing validation

information on bioanalytical methods

for pharmacokinetic (PK) evaluation of

human clinical pharmacology,

bioavailability (BA), and bioequivalence

(BE) studies. The guidance also applies

to bioanalytical methods used for

nonhuman pharmacology/toxicology

studies and preclinical studies. For

studies related to the veterinary drug

approval process, this guidance applies

only to blood and urine BA, BE, and PK

studies.

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. Send one selfaddressed adhesive label to assist that

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:

Vinod P. Shah, Center for Drug

Evaluation and Research (HFD–350),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5635.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a guidance for industry entitled

‘‘Bioanalytical Method Validation.’’

This guidance provides

recommendations to sponsors of INDs,

NDAs, ANDAs, and their supplements

in developing validation information for

bioanalytical methods for PK

evaluations of human clinical

pharmacology, BA studies, and BE

studies. The information in this

guidance generally applies to

bioanalytical procedures such as gas

chromatography (GC), high-pressure

liquid chromatography (LC), combined

GC and LC mass spectrometric (MS)

procedures such as LC–MS, LC–MS–

MS, GC–MS, GC–MS–MS, and

immunological and microbiological

procedures performed for quantitative

determination of drugs and or

metabolites in biological matrices such

as serum, plasma, or urine. The

guidance also applies to other

bioanalytical matrices such as tissue

and skin samples.

In the Federal Register of January 5,

1999 (64 FR 517), FDA announced the

availability of a draft guidance entitled

‘‘Bioanalytical Methods Validation for

Human Studies.’’ This January 1999

document gave interested persons an

opportunity to comment through March

8, 1999. The agency received a total of

36 comments. All comments received

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.