Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 / Notices 29741

part 312). Part 312 must be followed in

the preparation of any IND or eIND

application.

This draft guidance document

represents the agency’s current thinking

with regard to the eIND applications for

biological products. 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 statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this document to be all-inclusive

and cautions that not all information

may be applicable to all situations. The

document is intended to provide

information and does not set forth

requirements.

II. Request for Comments

This draft document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding this draft guidance

document. Written comments may be

submitted at any time, however,

comments should be submitted by July

31, 1998, to ensure adequate

consideration in preparation of the final

document. Two copies of any comments

are to be submitted, except individuals

may submit one copy. Comments

should be identified with the docket

number found in the brackets in the

heading of this document. A copy of the

draft guidance document and received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.

III. Electronic Access

Persons with access to the Internet

may obtain the draft guidance document

by using the World Wide Web (WWW).

For WWW access, connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm’’.

Dated: May 22, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14313 Filed 5–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0316]

Draft ‘‘Guidance for Industry:

Electronic Submissions of a Biologics

License Application (BLA) or Product

License Application (PLA)/

Establishment License Application

(ELA) to the Center for Biologics

Evaluation and Research;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Guidance for

Industry: Electronic Submissions of a

Biologics License Application (BLA) or

Product License Application (PLA)/

Establishment License Application

(ELA) to the Center for Biologics for

Evaluation and Research.’’ The draft

guidance document, when finalized, is

intended to provide information

regarding the electronic submission of a

Biologic License Application (BLA), or

a Product License Application/

Establishment License Application

(PLA/ELA) to the Center for Biologics

Evaluation and Research (CBER). This

draft guidance document is part of

CBER’s continuing effort to develop an

efficient process for electronic

submissions of regulatory information

relating to the development and

marketing of biological products.

Submissions in electronic format are

voluntary.

DATES: Written comments may be

submitted at any time, however,

comments should be submitted by July

31, 1998, to ensure their adequate

consideration in preparation of the final

document.

ADDRESSES: Submit written requests for

single copies of the draft guidance

document entitled ‘‘Guidance for

Industry: Electronic Submissions of a

Biologics License Application (BLA) or

Product License Application (PLA)/

Establishment License Application

(ELA) to the Center for Biologics

Evaluation and Research’’ 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 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your requests.

The draft guidance document may also

be obtained by mail by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800, or by fax by

calling the FAX Information System at

1–888–CBER–FAX or 301–827–3844.

Submit written comments on the draft

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Astrid L. Szeto, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance document entitled

‘‘Guidance for Industry: Electronic

Submissions of a Biologics License

Application (BLA) or Product License

Application (PLA)/Establishment

License Application (ELA) to the Center

for Biologics Evaluation and Research.’’

This draft guidance document, when

finalized, is intended to provide a

degree of uniformity to future

electronically submitted license

applications to assure timely review,

archiving, and retrieval processes for

agency reviewers and to describe those

electronic formats that CBER is

currently able to support for review and

archive. This draft guidance document,

when finalized, is intended to supersede

the guidance manual entitled

‘‘Computer Assisted Product License

Application (CAPLA) Guidance

Manual’’ as announced in the Federal

Register of March 21, 1996 (61 FR

11644).

This draft guidance document

represents the agency’s current thinking

with regard to the electronic

submissions of a Biologics License

Application (BLA) or Product License

Application (PLA)/Establishment

License Application (ELA) to the Center

for Biologics Evaluation and Research. 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 statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this draft guidance document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. The draft guidance document
29742 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 / Notices

is intended to provide information and

does not set forth requirements.

II. Request for Comments

This draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding this draft guidance

document. Written comments may be

submitted at any time, however,

comments should be submitted by July

31, 1998, to ensure adequate

consideration in preparation of the final

guidance document. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments and requests should be

identified with the docket number

found in brackets in the heading of this

document. A copy of the draft 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.

III. Electronic Access

Persons with access to the Internet

may obtain the draft guidance document

by using the World Wide Web (WWW).

For WWW access, connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm’’.

Dated: May 22, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14314 Filed 5–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0315]

Draft ‘‘Guidance for Industry:

Instructions for Submitting Electronic

Lot Release Protocols to the Center for

Biologics Evaluation and Research;’’

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Guidance for

Industry: Instructions for Submitting

Electronic Lot Release Protocols to the

Center for Biologics Evaluation and

Research.’’ The draft guidance

document, when finalized, is intended

to provide instructions to manufacturers

regarding the submission of the

electronic protocols to the Center for

Biologics Evaluation and Research

(CBER). This draft guidance document

is part of CBER’s continuing effort to

develop an efficient process for

electronic submissions of regulatory

information relating to the development

and marketing of biological products.

Submissions in electronic format are

voluntary.

DATES: Written comments may be

submitted at any time, however,

comments should be submitted by July

31, 1998, to ensure their adequate

consideration in preparation of the final

guidance document.

ADDRESSES: Submit written requests for

single copies of the draft guidance

document entitled ‘‘Guidance for

Industry: Instructions for Submitting

Electronic Lot Release Protocols to the

Center for Biologics Evaluation and

Research’’ 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 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your requests.

The draft guidance document may also

be obtained by mail by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800, or by fax by

calling the FAX Information System at

1–888–CBER–FAX or 301–827–3844.

Submit written comments on the draft

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Astrid L. Szeto, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance document entitled

‘‘Guidance for Industry: Instructions for

Submitting Electronic Lot Release

Protocols to the Center for Biologics

Evaluation and Research.’’ Under 21

CFR 610.2(a), samples of any lot of

licensed product, together with the

protocols showing results of applicable

tests, may at any time be required to be

submitted to CBER for review and

confirmatory testing. This draft

guidance document, when finalized, is

intended to assist those manufacturers

who choose to submit the required

protocols electronically.

This draft guidance document

represents the agency’s current thinking

with regard to the submission of

electronic lot release protocols. 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 requirement of the

applicable statute, regulations, or both.

As with other guidance documents,

FDA does not intend this draft guidance

document to be all-inclusive and

cautions that not all information may be

applicable to all situations. The draft

guidance document is intended to

provide information and does not set

forth requirements.

II. Request for Comments

This draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding this draft guidance

document. Written comments may be

submitted at any time, however,

comments should be submitted by July

31, 1998, to ensure adequate

consideration in preparation of the final

guidance document. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments and requests for copies

should be identified with the docket

number found in brackets in the

heading of this document. A copy of the

draft 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.

III. Electronic Access

Persons with access to the Internet

may obtain the draft guidance document

by using the World Wide Web (WWW).

For WWW access, connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm’’.

Dated: May 22, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14312 Filed 5–29–98; 8:45 am]

BILLING CODE 4160–01–F