Federal Register / Vol. 66, No. 33 / Friday, February 16, 2001 / Notices 10699

Dated: February 12, 2001.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 01–3890 Filed 2–15–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Radiological Devices Panel of the

Medical Devices 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). The meeting will be open to the

public.

Name of Committee: Radiological Devices

Panel of the Medical Devices 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 March 5, 2001, 9 a.m. to 3:30 p.m.

Location: Corporate Bldg., conference room

020B, 9200 Corporate Blvd., Rockville, MD.

Contact: Robert J. Doyle, Center for Devices

and Radiological Health (HFZ–470), Food

and Drug Administration, 9200 Corporate

Blvd., Rockville, MD 20850, 301–594–1212,

or FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12526. Please

call the Information Line for up-to-date

information on this meeting.

Agenda: The committee will discuss, make

recommendations, and vote on a premarket

approval application for a computer-aided

detection device for identifying regions of

interest in chest radiographs.

Procedure: 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 February 26,

2001. Oral presentations from the public will

be scheduled between approximately 9:15

a.m. and 9:45 a.m., and for an additional 30

minutes near the end of the committee

deliberations. Time allotted for each

presentation may be limited. Those desiring

to make formal oral presentations should

notify the contact person before February 26,

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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: February 9, 2001.

Bonnie H. Malkin,

Special Assistant to the Senior Associate

Commissioner.

[FR Doc. 01–4033 Filed 2–15–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D 0994]

Guidance for Industry on BACPAC I:

Intermediates in Drug Substance

Synthesis; Bulk Actives Postapproval

Changes: Chemistry, Manufacturing,

and Controls Documentation;

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 ‘‘BACPAC I: Intermediates in

Drug Substance Synthesis; Bulk Actives

Postapproval Changes: Chemistry,

Manufacturing, and Controls

Documentation.’’ This guidance

provides recommendations to holders of

new drug applications, abbreviated new

drug applications, new animal drug

applications, abbreviated new animal

drug applications, and drug master files

or veterinary master files who intend,

during the postapproval period, to

change the site of manufacture, the scale

of manufacture, the equipment, the

specification(s), and/or the

manufacturing process of intermediates

in the synthetic pathway leading to the

drug substance.

DATES: Submit written comments on

agency guidances at any time.

ADDRESSES: Submit written requests for

single copies of this 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

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:

Kasturi Srinivasachar, Center for Drug

Evaluation and Research (HFD–110),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5376; or Dennis M. Bensley,

Center for Veterinary Medicine (HFV–

143), Food and Drug Administration,

7500 Standish Pl., Rockville, MD 20855,

301–827–6956.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a guidance for industry entitled

‘‘BACPAC I: Intermediates in Drug

Substance Synthesis; Bulk Actives

Postapproval Changes: Chemistry,

Manufacturing, and Controls

Documentation.’’ This guidance

describes chemistry, manufacturing, and

controls information and documentation

in support of each change and provides

recommendations on reporting

categories. The guidance applies to

synthetic drug substances and the

synthetic steps involved in the

preparation of semisynthetic drug

substances. It is limited to structurally

well-characterized drug substances

where impurities can be monitored at

the levels recommended. The guidance

covers changes as follows: (1) Site,

scale, and equipment changes involving

the synthetic steps up to, and including,

the step that produces the final

intermediate; (2) specification changes

for raw materials, starting materials, and

intermediates, excluding the final

intermediate; and (3) manufacturing

process changes involving the synthetic

steps up to and including the final

intermediate. The guidance does not

cover postapproval changes affecting:

(1) Synthetic peptides, (2)

oligonucleotides, (3)

radiopharmaceuticals, (4) drug

substances derived exclusively by

isolation from natural sources or

produced by procedures involving

biotechnology, or (5) nonsynthetic steps

for semisynthetic drug substances. Also

excluded from this guidance are certain

changes in specification and process

associated with the use of raw materials

or starting materials derived from

natural sources or biotechnology.

In the Federal Register of November

30, 1998 (63 FR 65793), FDA announced

the availability of a draft version of this

guidance. The November 1998 guidance

gave interested persons an opportunity

to submit comments through March 31,

1999. 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

10700 Federal Register / Vol. 66, No. 33 / Friday, February 16, 2001 / Notices

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

guidance represents the agency’s current

thinking on intermediates in drug

substance synthesis, bulk actives

postapproval changes, chemistry,

manufacturing, and controls

documentation. 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 guidance.

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

or http://www.fda.gov/cvm.

Dated: February 8, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–3956 Filed 2–15–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1313]

Guidance for Industry on How to Use

E–Mail to Submit a Notice of Final

Disposition of Animals Not Intended

for Immediate Slaughter; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the final guidance for

industry (#86) entitled ‘‘How to Use E–

Mail to Submit a Notice of Final

Disposition of Animals Not Intended for

Immediate Slaughter’’ to the Center for

Veterinary Medicine (CVM). This final

guidance provides guidelines to new

animal drug sponsors (sponsors) on how

to submit a notice of final disposition of

animals not intended for immediate

slaughter (NFDA) as an e-mail

attachment by Internet. This electronic

submission is part of CVM’s ongoing

initiative to provide a method for

paperless submissions. This final

guidance implements provisions of the

Government Paperwork Elimination Act

(GPEA).

DATES: Submit written comments on the

final guidance at any time.

ADDRESSES: Submit written comments

on the final 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

full title of the final guidance and the

docket number found in brackets in the

heading of this document.

Copies of the final guidance

document entitled ‘‘How to Use E–Mail

to Submit a Notice of Final Disposition

of Animals Not Intended for Immediate

Slaughter’’ may be obtained on the

Internet from the CVM home page at

http://www.fda.gov/cvm/. Persons

without Internet access may submit

written requests for single copies of the

final guidance to the Communications

Staff (HFV–12), Center for Veterinary

Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that

office in processing your requests.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578, e-mail: jmessenh@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 29,

2000 (65 FR 40104), FDA published the

notice of availability of the draft

guidance entitled ‘‘How to Use E–Mail

to Submit a Notice of Final Disposition

of Animals Not Intended for Immediate

Slaughter’’ (hereinafter referred to as the

June 2000 notice). Interested persons

were given until August 28, 2000, to

submit comments. FDA received no

comments.

In the Federal Register of March 20,

1997 (62 FR 13430), FDA published the

Electronic Records; Electronic

Signatures final regulation. This

regulation (21 CFR part 11) provides for

the voluntary submission of parts or all

of regulatory records in electronic

format without an accompanying paper

copy. This rule also established docket

number 92S–0251 to provide a

permanent location for a list of the

documents or parts of documents that

are acceptable for submission in

electronic form without paper records

and the agency units to which such

submissions may be made. The docket

is accessible on the Internet at http://

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

92s0251.htm. CVM will identify in this

public docket the types of documents

that may be submitted in electronic

form as those documents are identified

in final guidance or regulations.

The electronic submission of NFDA’s

is part of CVM’s ongoing initiative to

provide a method for paperless

submissions. This initiative reflects the

principles behind the GPEA.

The GPEA of 1998 (Public Law 105–

277) requires Federal agencies, by

October 21, 2003, to provide: (1) For the

option of the electronic maintenance,

submission, or disclosure of

information, if practicable, as a

substitute for paper; and (2) for the use

and acceptance of electronic signatures,

when practicable.

Before submitting NFDA’s by e-mail,

sponsors should first register and follow

the instructions in final guidance for

industry (#108) entitled ‘‘How to Use E–

Mail to Submit Information to the

Center for Veterinary Medicine.’’ This

final guidance is also available at http:/

/www.fda.gov/cvm.

CVM monitors the final disposition of

food animals treated with

investigational new animal drugs in

situations where the treated animals do

not enter the human food chain

immediately at the completion of the

investigational study. Monitoring of the

final disposition of such food animals is

consistent with CVM’s responsibility to

protect the public health under the

Federal Food, Drug, and Cosmetic Act.

In addition, acceptable standards of

study conduct such as those set out in

21 CFR 514.117 include sponsors

accounting for the disposition of all

animals treated with investigational

new animal drugs. Furthermore, CVM

requests this information because some

animals are held for 30 days after the

investigational drug withdrawal period

ends, and CVM does not request a

notice of intent to slaughter for human

food purposes for these animals.

Animals held for this period may still be

sent for slaughter, however. CVM issues

a slaughter authorization letter to

sponsors that sets the terms under

which animals treated with

investigational new animal drugs may

be slaughtered (21 CFR 511.1(b)(5)).

Also in this letter, CVM requests that

sponsors submit NFDA’s for animals

that are treated with investigational new

animal drugs and are not intended for

immediate slaughter. NFDA’s have

historically been submitted to CVM on