29740 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 / Notices

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The draft guidance document may also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.

See the SUPPLEMENTARY INFORMATION

section for electronic access to the draft

guidance document.

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.

FOR FURTHER INFORMATION CONTACT:

Astrid L. Szeto, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, 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a draft guidance document entitled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 Case Report Forms

(CRF’s), Case Report Tabulations

(CRT’s) and Data to the Center for

Biologics Evaluation and Research.’’

The draft guidance document is

intended to describe those electronic

formats that CBER is currently able to

support for review and archive of CRF’s

and CRT’s. This draft guidance

document supersedes two previous draft

guidance documents entitled ‘‘Guidance

for Industry: Electronic Submissions of

Case Report Forms and Case Report

Tabulations’’ (November 1996), and

‘‘Guidance for Industry: Submitting

Application Archival Copies in

Electronic Format’’ (November 1996).

This draft guidance document

represents the agency’s current thinking

on electronic submissions of case report

forms, case report tabulations and data

to CBER. 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

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. This draft guidance

document applies only to submissions

made to CBER and not to the Center for

Drug Evaluation and Research.

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

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 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

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. 98–14310 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–0314]

Draft Guidance for Industry: Pilot

Program for Electronic Investigational

New Drug (eIND) Applications for

Biological Products; 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: Pilot Program for electronic

Investigational New Drug (eIND)

Applications for Biological Products.’’

This draft document, when finalized, is

intended to provide guidance to

sponsors on the design, development,

organization, and submission of an eIND

application to the Center for Biologics

Evaluation and Research (CBER) as part

of a pilot eIND program. This draft

document is part of CBER’s effort to

develop, in cooperation with sponsors,

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: Pilot Program for electronic

Investigational New Drug (eIND)

Applications for Biological Products’’ to

the Office of Communication, Training,

and Manufacturers Assistance (HFM–

40), Center for Biologics Evaluation and

Research (CBER), 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 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.

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: Pilot Program

for electronic Investigational New Drug

(eIND) Applications for Biological

Products.’’ This draft guidance

document, when finalized, is intended

to provide sponsors guidance on the

design, development, organization, and

submission of eIND applications. This

draft guidance document does not

address the scientific, clinical, and

regulatory requirements of preparing an

IND submission. These requirements

can be found in Title 21 of the Code of

Federal Regulations, part 312 (21 CFR
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