Federal Register / Vol. 61, No. 19 / Monday, January 29, 1996 / Proposed Rules 2749

the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Persons with access to INTERNET

may request that the draft guidance

document be sent by return E-mail by

sending a message to

‘‘Character@A1.CBER.FDA.GOV’’. The

draft guidance document may also be

obtained through INTERNET via File

Transfer Protocol (FTP). Requestors

should connect to the Center for Drug

Evaluation and Research (CDER) using

the FTP. The Center for Biologics

Evaluation and Research (CBER)

documents are maintained in a

subdirectory called CBER on the server,

‘‘CDVS2.CDER.FDA.GOV’’

(150.148.24.202). The ‘‘READ.ME’’ file

in that subdirectory describes the

available documents that may be

available as an ASCII text file (*.TXT),

or a WordPerfect 5.1 document (*.w51),

or both. A sample dialogue for obtaining

the READ.ME file with a text-based FTP

program would be:

FTP CDVS2.CDER.FDA.GOV

LOGIN: CHARACTER

<PASSWORD:CHARACTER><‘‘Your Email address’’>

BINARY

CD CBER

GET READ.ME

EXIT

The draft guidance document may also

be obtained by calling the CBER FAX

Information System (FAX-ONDEMAND) at 301–594–1939 from a

touch tone telephone.

FOR FURTHER INFORMATION CONTACT:

Tracey H. Forfa or Timothy W. Beth,

Center for Biologics Evaluation and

Research (HFM–630), Food and

Drug Administration, 1401

Rockville Pike, Rockville, MD

20852–1448, 301–594–3074; or

Yuan Yuan Chiu, Center for Drug

Evaluation and Research (HFD–

510), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–

3510.

Dated: January 16, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–1581 Filed 1–25–96; 10:42 am]

BILLING CODE 4160–01–F

21 CFR Parts 600 and 601

[Docket No. 95D–0052]

Changes To An Approved Application;

Draft Guidance; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; notice of

availability.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Draft Guidance;

Changes to An Approved Application.’’

The draft guidance is intended to assist

applicants in determining how they

should report changes to an approved

license application under the proposed

revision to the biologics regulations

issued elsewhere in this issue of the

Federal Register. FDA does not intend

for this draft guidance to be used at this

time. The agency is providing this

guidance at this time for public

comment only.

DATES: Written comments by April 29,

1996.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Draft Guidance; Changes to An

Approved Application’’ to the

Congressional and Consumer Affairs

Branch (HFM–12), Center for Biologics

Evaluation and Research, Food and

Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448, or call

FDA’s automated information system at

800–835–4709. Send two self-addressed

adhesive labels to assist that office in

processing your requests. Submit

written comments on the draft guidance

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

draft 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.

Persons with access to INTERNET

may request that the draft guidance

document be sent by return E-mail by

sending a message to

‘‘Changes@A1.CBER.FDA.GOV’’. The

draft guidance document may also be

obtained through INTERNET via File

Transfer Protocol (FTP). Requestors

should connect to the Center for Drug

Evaluation and Research (CDER) using

the FTP. The Center for Biologics

Evaluation and Research (CBER)

documents are maintained in a

subdirectory called CBER on the server,

‘‘CDVS2.CDER.FDA.GOV’’

(150.148.24.202). The ‘‘READ.ME’’ file

in that subdirectory describes the

available documents which may be

available as an ASCII text file (*.TXT),

or a WordPerfect 5.1 document (*.w51),

or both. A sample dialogue for obtaining

the READ.ME file with a text-based FTP

program would be:

FTP CDVS2.CDER.FDA.GOV

LOGIN: CHANGES

<PASSWORD:CHANGES> <‘‘Your Email address’’>

BINARY

CD CBER

GET READ.ME

EXIT

The draft guidance document may

also be obtained by calling the CBER

FAX Information System (FAX-ONDEMAND) at 301–594–1939 from a

touch tone telephone.

FOR FURTHER INFORMATION CONTACT:

Tracey H. Forfa or Timothy W. Beth,

Center for Biologics Evaluation and

Research (HFM–630), Food and

Drug Administration, 1401

Rockville Pike, Rockville, MD

20852–1448, 301–594–3074; or

Yuan Yuan Chiu, Center for Drug

Evaluation and Research (HFD–

510), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–

3510.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 6, 1995 (60 FR

17535), FDA published a guidance

document intended to provide guidance

to applicants on which changes in

manufacturing procedures and

establishments may be implemented

with and/or without prior approval by

the Director, CBER under § 601.12 (21

CFR 601.12). The Federal Register

notice and guidance document were

intended to reduce the burden of

reporting changes on manufacturers and

to facilitate the approval process.

In a continuing effort to achieve the

reduction in reporting burden and to

respond to comments received on the

April 6, 1995, guidance document, FDA

is proposing a revision to § 601.12

published elsewhere in this edition of

the Federal Register. In addition, FDA

is announcing the availability of a draft

guidance document entitled, ‘‘Changes

to An Approved Application.’’ The

guidance document sets forth CBER’s

current interpretation of the proposed

rule to amend § 601.12 as it applies to

biologic products other than those

considered to be well-characterized

therapeutic recombinant DNA-derived

and monoclonal antibody biotechnology

products. The reporting mechanisms

proposed in the rule are based on the

potential for the change to affect a

product’s safety, purity, potency, and

effectiveness. In a separate document

also published in this issue of the

Federal Register, FDA is announcing
2750 Federal Register / Vol. 61, No. 19 / Monday, January 29, 1996 / Proposed Rules

the availability of a guidance document

to assist applicants in determining how

they should report changes to an

approved application for a wellcharacterized therapeutic recombinant

DNA-derived and monoclonal antibody

biotechnology product under the

proposed rule.

The guidance document will provide

guidance to applicants in determining

how a change to a product, production

process, equipment, facility, responsible

personnel, or labeling should be

reported to FDA under the proposed

revision to § 601.12.

As stated previously, FDA is

providing this draft guidance document

for comment only. The document is not

intended to be used at this time. FDA

intends to review the comments

received on the proposed rule and this

draft guidance document and issue a

final rule prescribing the requirements

for the reporting changes to an approved

license application. A revised guidance

document would also be made available

at the time of issuance of the final rule.

As with other procedural guidance

documents, FDA does not intend that

this guidance document would be allinclusive. Alternative approaches could

be warranted in specific situations, and

certain aspects might not be applicable

to all situations. If an applicant believed

the reporting procedure described in

this guidance document was

inapplicable to a specific change for a

particular product, the applicant could

provide, for CBER’s consideration,

information supporting an alternative

categorization. An applicant also could

discuss proposed changes with the

agency to prevent expenditure of money

and effort on activities that later might

be determined to be unacceptable by

FDA. The Center for Biologics

Evaluation and Research would

continue to review submissions on a

case-by-case basis. This document

would not bind FDA and would not

create or confer any rights, privileges, or

benefits on or for any person, but would

be intended for guidance.

Interested persons may, on or before

April 29. 1996, submit to the Dockets

Management Branch (address above)

comments on the draft guidance

document. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments and information are to be

identified with the docket number

found in brackets in the heading of this

document. The draft guidance ‘‘Changes

to An Approved Application’’ and

received comments are available for

public examination in the office above

between 9 a.m. and 4 p.m., Monday

through Friday.

FDA plans to hold an open public

meeting during the comment period to

discuss the proposed revision to

§ 601.12 and the draft guidance

document. The time and location of this

meeting will be announced in an

upcoming issue of the Federal Register.

FDA will consider any comments

received in determining whether

revisions to the guidance document are

warranted. FDA will announce the

availability of any revised guidance

document in the Federal Register.

Dated: January 16, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–1583 Filed 1–25–96; 10:43 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Fiscal Service

31 CFR Part 281

RIN 1510–AA48

Foreign Exchange Operations

AGENCY: Financial Management Service,

Fiscal Service, Treasury.

ACTION: Notice of proposed rulemaking.

SUMMARY: This action proposes

regulations to amend the administration

of the purchase, custody, deposit,

transfer, sale and reporting of foreign

exchange (including credits and

currencies) by executive departments

and agencies. The specific section being

amended addresses the limitation on the

purchase of foreign exchange. Currently,

foreign exchange acquired by agencies

shall be placed with accountable

officers. Unless otherwise authorized by

the Secretary of the Treasury, no

accountable officer shall purchase

foreign exchange which, together with

the balance on hand at the time of

purchase, would exceed estimated

requirements for a 30 day period. This

proposed revision would restrict

accountable officers to estimated

requirements for a 5–7 business day

period unless they have obtained a

specific waiver of this requirement from

the Secretary of the Treasury.

DATES: Comments on this proposed rule

must be received on or before February

28, 1996.

ADDRESSES: All written comments on

this proposed rule should be addressed

to Michael C. Salapka, Manager,

International Funds Branch, Financial

Management Service, Prince George

Metro Center II Building, Room 5A19,

3700 East-West Highway, Hyattsville,

MD 20782, or by FAX to the attention

of Bruce Riedl at (202) 874–8023.

FOR FURTHER INFORMATION CONTACT:

Michael C. Salapka, (202) 874–8919,

(Manager, International Funds Branch);

or Bruce Riedl, (202) 874–8918, (Senior

Advisor).

SUPPLEMENTAL INFORMATION:

Background

To protect the Government from risk,

31 CFR § 281.7(c), currently limits

accountable officers to purchasing

foreign exchange only in an amount

which, together with the balance on

hand, does not exceed the estimated

requirements for a 30 day period.

However, risk reduction and

improvements in cash management

dictate that a shorter time period be

established. Specifically, in order to (1)

minimize local currency operating

balances held in designated

depositaries; (2) minimize losses due to

rate devaluations; and, (3) avoid

premature drawdowns on Treasury’s

General Account, all accountable

officers shall ensure that the amount of

foreign exchange purchased with

dollars, together with the balance on

hand, is commensurate with estimated

requirements for a 5–7 business day

period. This will result in interest

savings to the Government. Further,

balances in the local currency operating

account held at designated depositaries

will be kept as close to zero as possible

without incurring overdrafts to the

account.

In certain situations, the

administrative costs, local banking

regulations, or possible volume

discounts appear to require maintaining

balances in excess of the 5–7 day

amount. If circumstances require

exceeding this limit, the accountable

officer must obtain a specific waiver of

this requirement from Treasury.

Rulemaking Analysis

This regulation is not a significant

regulatory action as defined in

Executive Order 12866. Accordingly, a

Regulatory Assessment is not required.

It is hereby certified pursuant to the

Regulatory Flexibility Act that this

revision will not have a significant

economic impact on a substantial

number of small entities. Accordingly, a

Regulatory Flexibility Act analysis is

not required. This change primarily

affects executive departments and

agencies.

List of Subjects in 31 CFR Part 281

Foreign exchange, banks, banking.

Accordingly, part 281 of title 31 is

proposed to be amended as follows: