Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations 25641

In addition to the meeting discussed

above and other informal

communications that FDA has had with

industry, industry associations, and

Congress, FDA received a petition for

stay of action requesting that the

relevant provisions of the final rule be

stayed until October 1, 2001. The

agency also received a petition for

reconsideration from the Small Business

Administration (SBA) requesting that

FDA reconsider the final rule and

suspend its effective date based on the

projected severe economic impact it

would have on over 4,000 small

businesses. The petitions argued that

the requirement for a written agreement

in § 203.3(u) is unreasonable because

manufacturers are not willing to enter

such agreements with the majority of

smaller distributors. The petitions also

asserted that authorized wholesalers are

not now able and could not provide, at

a reasonable cost, an identifying

statement to their unauthorized

distributor customers that meets the

requirements of § 203.50 of the final

rule. The SBA petition asserted that, if

the effective date of the final rule is not

stayed, drug products now in the

inventory of wholesalers will have to be

cleared and new orders will have to

cease or be severely limited in order to

comply with the final rule’s December

4, 2000 effective date, with

corresponding disruptions in the

distribution of drugs possible by

summer, 2000.

B. Distribution of Blood Derivatives by

Health Care Entities

Since the time of the proposed rule,

FDA has received 2 letters, one from a

large blood center and the other from an

association representing the blood

center industry, and has held several

meetings to discuss the implications of

the regulations on blood centers that

distribute blood derivative products and

provide health care as a service to the

hospitals and patients they serve. The

blood center industry asserts that the

regulations and, particularly the

definition of ‘‘health care entity,’’ will

severely inhibit their ability to provide

full service care to the detriment of

client hospitals and the patients they

serve, and may disrupt the distribution

of these products to the public. The

agency has also received a letter from a

member of Congress on this issue.

Although the agency was aware of this

issue at the time the final rule was

published, we believed that application

of § 203.3(q) to blood centers would not

result in a disruption in the distribution

of blood derivative products. However,

comments and information provided by

representatives of the blood center

industry have persuaded us that the

final rule could disrupt the availability

of blood derivative products to the

public.

C. Partial Delay of the Effective Date

Based on the concerns expressed by

industry, industry associations, and

Congress about implementing

§§ 203.3(u) and 203.50 by the December

4, 2000, effective date, the agency has

decided to delay the effective date for

those sections of the final rule until

October 1, 2001. Additionally, the

agency has decided to delay the

applicability of § 203.3(q) to wholesale

distribution of blood derivatives by

health care entities, until October 1,

2001. All other provisions of the rule

will become effective on December 4,

2000. This action should not be

construed to indicate that FDA

necessarily agrees with or has made

decisions about the substantive

arguments made in the petitions and

other submissions related to

implementation of §§ 203.3(u) and

203.50 or § 203.3(q), as it applies to

wholesale distribution of blood

derivatives by health care entities.

III. Reopening of the Administrative

Record

The agency believes that providing

additional time before these are to

become effective is appropriate to

permit the agency to obtain more

information about the possible

consequences of implementing these

provisions, to further evaluate the issues

involved, and to seek a legislative

resolution to these issues, if necessary.

Therefore, the agency is reopening the

administrative record to receive

additional comments on these

provisions from interested individuals.

Regarding §§ 203.3(u) and 203.50, the

agency is especially interested in

gaining further insight into the potential

impact of the provisions on the

wholesale distribution system generally,

and on the ability of smaller pharmacies

and other prescription drug retailers to

obtain prescription drugs. In addition,

the agency is seeking comments on the

potential economic impact of the

provisions on smaller wholesale

distributors that are not authorized

distributors of record. Regarding

§ 203.3(q), the agency also invites

comment on the economic and public

health impact of including full service

blood centers under the definition of

‘‘health care entity,’’ thereby prohibiting

the wholesale distribution of blood

derived products by such entities.

Interested persons may submit to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852, written comments regarding

this proposal by July 3, 2000. 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

document. Received comments may be

seen in the Dockets Management Branch

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

through Friday.

This action is being taken under

FDA’s authority under 21 CFR 10.35(a).

The Commissioner of Food and Drugs

finds that this delay of the effective date

is in the public interest.

Dated: April 26, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–10920 Filed 4–28–00; 12:34 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

New Animal Drugs; Change of

Sponsor’s Name and Address

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor’s name and address

for Global Pharmaceutical Corp.

DATES: This rule is effective May 3,

2000.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Global

Pharmaceutical Corp., Castor and

Kensington Aves., Philadelphia, PA

19124, has informed FDA of a change of

sponsor’s name and address to IMPAX

Laboratories, Inc., 30831 Huntwood

Ave., Hayward, CA 94544. Accordingly,

the agency is amending the regulations

in 21 CFR 510.600(c)(1) and (c)(2) to

reflect the change of sponsor’s name and

address.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

25642 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 510 is amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘Global

Pharmaceutical Corp.’’ and by

alphabetically adding an entry for

‘‘IMPAX Laboratories, Inc., 30831

Huntwood Ave., Hayward, CA 94544’’;

and in the table in paragraph (c)(2) in

the entry for ‘‘000115’’ by removing the

sponsor name and address and by

adding their place ‘‘IMPAX

Laboratories, Inc., 30831 Huntwood

Ave., Hayward, CA 94544.

Dated: April 24, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–10932 Filed 5–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Office of Foreign Assets Control

31 CFR Part 560

Iranian Transactions Regulations:

Licensing of Imports of, and Dealings

in, Certain Iranian-Origin Foodstuffs

and Carpets

AGENCY: Office of Foreign Assets

Control, Treasury.

ACTION: Final rule; amendments.

SUMMARY: The Treasury Department is

amending the Iranian Transactions

Regulations to add general licenses

authorizing the importation into the

United States of, and dealings in, certain

Iranian-origin foodstuffs and carpets

and related transactions.

EFFECTIVE DATE: April 28, 2000.

FOR FURTHER INFORMATION CONTACT:

Steven I. Pinter, Chief of Licensing (tel.:

202/622–2480), Barbara C. Hammerle,

Deputy Chief Counsel (tel.: 202/622–

2410), Office of Foreign Assets Control,

U.S. Treasury Department, Washington,

DC 20220.

SUPPLEMENTARY INFORMATION:

Electronic and Facsimile Availability

This document is available as an

electronic file on The Federal Bulletin

Board the day of publication in the

Federal Register. By modem, dial 202/

512–1387 and type ‘‘/GO FAC,’’ or call

202/512–1530 for disk or paper copies.

This file is available for downloading

without charge in ASCII and Adobe

Acrobat readable (*.PDF) formats. For

Internet access, the address for use with

the World Wide Web (Home Page),

Telnet, or FTP protocol is:

fedbbs.access.gpo.gov. This document

and additional information concerning

the programs of the Office of Foreign

Assets Control are available for

downloading from the Office’s Internet

Home Page: http://www.treas.gov/ofac,

or in fax form through the Office’s 24-

hour fax-on-demand service: call 202/

622–0077 using a fax machine, fax

modem, or (within the United States) a

touch-tone telephone.

Background

On March 17, 2000, Secretary of State

Madeleine K. Albright announced that

economic sanctions against Iran would

be eased to allow Americans to

purchase and import carpets and food

products such as dried fruits, nuts, and

caviar from Iran. To implement this

policy, the Treasury Department’s Office

of Foreign Assets Control (‘‘OFAC’’) is

amending the Iranian Transactions

Regulations, 31 CFR part 560 (the

‘‘Regulations’’), to authorize, by general

license, the importation into the United

States of, and dealings in, certain

Iranian-origin foodstuffs and carpets

and related transactions.

Section 560.534(a) of this final rule

authorizes the importation into the

United States of Iranian-origin

foodstuffs intended for human

consumption that are classified under

chapters 2–23 of the Harmonized Tariff

Schedule of the United States (‘‘HTS’’).

Items that are classified in chapters 2–

23 of the HTS that are not foodstuffs

intended for human consumption are

not authorized for importation into the

United States by this section. This final

rule also authorizes the importation into

the United States of Iranian-origin

carpets and other textile floor coverings

and carpets used as wall hangings that

are classified under chapter 57 or

heading 9706.00.0060 of the HTS. Items

that are classified under heading

9706.00.0060 (‘‘Antiques of an age

exceeding one hundred years/Other’’)

that are not carpets and other textile

floor coverings or carpets used as wall

hangings are not authorized for

importation into the United States by

this section.

Section 560.534(b) of this rule

authorizes U.S. persons, wherever

located, to engage in transactions or

dealings in such Iranian-origin

foodstuffs and carpets, provided that

such transactions or dealings do not

involve a prohibited exportation to Iran

or the Government of Iran. Section

560.534(c) sets forth the effect of this

rule on open and closed enforcement

actions initiated by the U.S.

Government prior to the effective date of

this final rule.

Transactions ordinarily incident to

the transactions authorized in § 560.534

and necessary to give effect thereto also

are authorized as set forth in § 560.405.

Section 560.405 is amended to exclude

from the scope of permitted incidental

transactions letter of credit services

relating to transactions authorized in

§ 560.534. See § 560.405(e). Those letter

of credit services that are authorized are

set forth separately in § 560.535. Forms

of financing other than letters of credit

are permitted as incidental transactions

as set forth in § 560.405, provided that

such forms of financing do not involve

a debit or credit to an account of a

person in Iran or of the Government of

Iran maintained on the books of a U.S.

depository institution. See § 560.534(d).

Brokering services relating to

transactions authorized by this final rule

also are authorized. See § 560.535(c).

Examples of transactions permitted

under this final rule are set forth in

§§ 560.534(e) and 560.535(e).

Technical changes are made to

§ 560.405, to clarify that loading of

licensed cargo in Iran is a permitted

incidental transaction, and to § 560.524,

to clarify that the importation into the

United States of qualifying household

goods and personal effects is permitted

regardless of the time elapsed since the

importer’s arrival in the United States

from Iran.

Because the Regulations involve a

foreign affairs function, Executive Order

12866 and the provisions of the

Administrative Procedure Act (5 U.S.C.

553) (the ‘‘APA’’) requiring notice of

proposed rulemaking, opportunity for

public participation, and delay in

effective date, are inapplicable. Because

no notice of proposed rulemaking is

required for this rule, the Regulatory

Flexibility Act (5 U.S.C. 601–612) does

not apply.