Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 / Notices 29739

submitting a certificate for signature to

FDA is aware of and knows that they are

subject to the provisions of section 1001

of Title 18, U.S. Code. This law provides

that it is a criminal offense to knowingly

and willfully make a false statement or

alter or counterfeit documents in a

matter within the jurisdiction of a U.S.

agency.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Products No. of

Respondents

No. of Responses per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

Shell Eggs 20 1 20 0.25 5

Dairy 100 1 100 0.25 25

Game Meat and Meat Products 20 1 20 0.25 5

Animal Casings 15 1 15 0.25 3.75

Total 38.75

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated number of respondents

is based on volume of exports and

responses received to date. The

estimated number of yearly responses

has been decreased from the estimate in

FDA’s previous notice seeking comment

on this collection of information (61 FR

66671, December 18, 1996) because the

actual number of responses received has

been decreasing. Companies do not

need to reapply unless they have a

compliance problem. An estimate for

processors that export animal casings

has also been added because these

processors are now being included in

the listing process. Finally, the

operating and maintenance cost

estimate included in the previous notice

has been removed because, according to

OMB’s draft guidance on interpretation

of the PRA, the costs listed were not

operating and maintenance costs. The

costs are now listed in FDA’s supporting

statement in the ‘‘Other Non-Labor

Costs’’ category. A copy of the

supporting statement may be obtained

from the contact person listed above.

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN (THIRD PARTY DISCLOSURE)1

Respondents No. of

Respondents

No. of

Responses per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

Trade Association 14 1 14 8 112

State 50 1 50 8 400

Total 512

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimated for the trade

associations assumes the trade

associations will disseminate FDA’s

information request through mass

mailings to their membership or publish

it in their trade magazine or newsletter.

The burden estimated for State

authorities assumes dissemination of

information to the processors or

dissemination of information about the

processors to FDA.

Dated: May 21, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14297 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–0317]

Draft ‘‘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;’’ 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

Case Report Forms (CRF’s), Case Report

Tabulations (CRT’s) and Data to the

Center for Biologics Evaluation and

Research.’’ This draft guidance

document, when finalized, is intended

to provide guidance to industry

regarding the submission of electronic

CRF’s and CRT’s as part of license

applications to the Center for Biologics

Evaluation and Research (CBER). This

draft guidance document is part of

CBER’s effort to provide 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

Case Report Forms (CRF’s), Case Report

Tabulations (CRT’s) and Data 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 (CBER), Food and Drug

Administration, 1401 Rockville Pike,
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