Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices 3461

(1898); DeVeau v. Braisted, 80 S.Ct.

1146 (1960).)

The preclusion of Mr. Girdhari from

providing any type of service to holders

of pending or approved drug product

applications is not excessive in relation

to the remedial goals of the GDEA. As

stated above, the D.C. Circuit has held

that the GDEA’s prohibition on services

in any capacity serves the statute’s

remedial purpose. (DiCola at 507.)

Congress prescribed all services in order

to avoid the serious administrative

difficulties involved in distinguishing

between those positions clearly related

to drug regulation and those not clearly

related. (DiCola at 507; see also Seigel v.

Lyng, 851 F.2d 412, 416 (D.C. Cir.

1988).) Furthermore, the GDEA’s

prohibition ensures that the purposes

underlying the debarment provisions

are not circumvented or undermined.

(DiCola at 507; see also Farlee and

Calfee, Inc. v. USDA, 941 F.2d 964, 968

(9th Cir. 1991).) Finally, as noted above,

the Supreme Court in Hudson v. United

States, 118 S.Ct. 488 (1997), upheld a

similar statute which, for remedial

purposes, imposes a prohibition on

participation in any banking activity.

Under Hudson, debarment pursuant

to the GDEA is not so punitive either in

purpose or effect as to render the

penalty criminal. Thus, Mr. Girdhari’s

argument that debarment under the

GDEA violates the Double Jeopardy

Clause must fail.

E. Conclusion

Mr. Girdhari acknowledges that he

was convicted as alleged by FDA in its

proposal to debar him and has raised no

genuine and substantial issue of fact

regarding this conviction. In addition,

Mr. Girdhari’s legal arguments do not

create a basis for a hearing and, in any

event, are unpersuasive. Accordingly,

the Commissioner denies Mr. Girdhari’s

request for a hearing.

III. Findings and Order

Therefore, the Commissioner, under

section 306(a) of the act, and under

authority delegated to her (21 CFR 5.10),

finds that Premchand Girdhari has been

convicted of a felony under Federal law

for conduct: (1) Relating to the

development or approval, including the

process for development or approval, of

a drug product (section 306(a)(2)(A) of

the act); and (2) relating to the

regulation of a drug product (section

306(a)(2)(B) of the act).

As a result of the foregoing findings,

Premchand Girdhari is permanently

debarred from providing services in any

capacity to a person with an approved

or pending drug product application

under section 505, 512, or 802 of the act,

or under section 351 of the Public

Health Service Act (42 U.S.C. 262),

effective January 21, 2000, (sections

306(c)(1)(B) and (c)(2)(A)(ii) and 201(ee)

of the act). Any person with an

approved or pending drug product

application who knowingly uses the

services of Mr. Girdhari in any capacity,

during his period of debarment, will be

subject to civil money penalties (section

307(a)(7) of the act (21 U.S.C.

335b(a)(7))). In addition, FDA will not

accept or review any abbreviated drug

application submitted by or with Mr.

Girdhari’s assistance during his period

of debarment (section 306(c)(1) of the

act).

Mr. Girdhari may file an application

to attempt to terminate his debarment,

under section 306(d)(4)(A) of the act.

Any such application would be

reviewed under the criteria and

processes set forth in section

306(d)(4)(C) and (d)(4)(D) of the act.

Such an application should be

identified with Docket No. 94N–0162

and sent to the Dockets Management

Branch (address above). All such

submissions are to be filed in four

copies. The public availability of

information in these submissions is

governed by 21 CFR 10.20(j). Publicly

available submissions may be seen in

the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Dated: January 13, 2000.

Bernard A. Schwetz,

Acting Deputy Commissioner for Food and

Drugs.

[FR Doc. 00–1406 Filed 1–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0120]

Safety of Imported Foods; Public

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

two public meetings on the safety of

imported foods. These meetings are

intended to give an overview of, and

discuss the six specific objectives of, the

proposed plan announced by the

President in his radio address of

December 11, 1999. FDA and the U.S.

Customs Service have developed

proposed new operational procedures to

accomplish these objectives. The public

meetings also are intended to give the

public an opportunity to comment on

the proposed procedures.

DATES: See Table 1 in the

SUPPLEMENTARY INFORMATION section of

this document.

ADDRESSES: See Table 1 in the

SUPPLEMENTARY INFORMATION section of

this document. Submit written

comments to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852. 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.

FOR FURTHER INFORMATION CONTACT: For

general information regarding this

document: Mary J. Ayling, Center for

Food Safety and Applied Nutrition

(HFS–32), Food and Drug

Administration, 200 C St. SW., Rm.

3823, Washington, DC 20204, 202–260–

5348, FAX 202–260–9653, e-mail:

mayling@bangate.fda.gov. The

comprehensive plan is available at

http://www.foodsafety.gov.

SUPPLEMENTARY INFORMATION: On July 3,

1999, the President announced an

initiative to ensure the safety of

imported food by directing the

Secretaries of the U.S. Department of

Health and Human Services and the

U.S. Department of Treasury to develop

new operational procedures to protect

public health. This initiative is geared to

optimize the statutory authorities and

resources available to FDA and the U.S.

Customs Service to take whatever steps

are feasible to protect consumers from

unsafe imported foods. The President

directed the agencies to target

unscrupulous importers who violate the

rules and work to subvert the system by

moving unsafe foods into U.S. markets.

The agenda for the public meetings

will include the following six specific

objectives emphasized in the President’s

directive: (1) To prevent distribution of

imported unsafe food by means such as

requiring food to be held until reviewed

by FDA; (2) destroy imported food that

poses a serious public health threat; (3)

prohibit the reimportation of food that

has been previously refused admission

and has not been brought into

compliance and require the marking of

shipping containers and/or papers of

imported food that is refused admission

for safety reasons; (4) set standards for

the use of private laboratories for the

collection and analysis of samples of

imported food for the purpose of gaining

entry into the United States; (5) increase

the amount of the bond posted for

3462 Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices

imported foods when necessary to deter

premature and illegal entry into the

United States; and (6) enhance

enforcement against violations of U.S.

laws related to the importation of foods,

including through the imposition of

civil monetary penalties.

The public meetings also will include

an overview of the President’s directive

and a review of the new operational

procedures proposed to accomplish

each of the six objectives. The meetings

will provide a forum for discussion of

the proposed procedures. In addition to

a plenary session, the meetings will

provide the opportunity for additional

discussion of the specific objectives.

Three breakout sessions to discuss the

following are planned: (A) Secured

storage, increased bonds, enforcement

activities; (B) destruction and marking

of refused foods; and (C) standards for

the use of private laboratories. The U.S.

Customs Service will jointly present the

objectives with FDA. Transcripts of the

public meetings are not planned.

If you would like to attend a public

meeting, send registration information

(including name, title, firm name,

mailing address, telephone number, fax

number, e-mail address, and selection of

breakout session A, B, or C) to the

contact person listed for the meeting

you wish to attend at least 7 days prior

to the meeting date. Attendance will be

limited due to seating capacity. There is

no registration fee for this meeting.

Meeting Address Date and Local Time FDA Contact Person

IRVINE: Los Angeles District Office, 19900

MacArthur Blvd., suite 300, Irvine, CA 92612.

Thursday, February 10, 2000, 9 a.m. to 12

noon.

Irene Gomez, 222 West 6th St., suite 700,

San Pedro, CA 90731, 310–831–6123, ext.

103, e-mail: igomez@ora.fda.gov.

WASHINGTON: Hubert H. Humphrey Bldg.,

200 D St. SW., rm. 800, Washington, DC

20204.

Thursday, February 17, 2000, 9 a.m. to 12

noon.

Peter A. Salsbury, Executive Operations Staff

(HFS–022), 200 C St. SW., Washington,

DC 20204, 202–205–4299, e-mail:

psalsbur@bangate. fda.gov.

Dated: January 12, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–1410 Filed 1–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99P–1720]

Approval of an Alternate Requirement

of the User Labeling Requirements for

Devices Containing Dry Natural

Rubber that Contact Humans;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a document entitled

‘‘Approval of an Alternative

Requirement of the User Labeling

Requirements for Devices that Contain

Dry Natural Rubber that Contact

Humans.’’ FDA granted a petition

submitted by the Health Industry

Manufacturers Association (HIMA), on

behalf of in vitro diagnostic device (IVD)

manufacturers, that requested a variance

from placing the warning statement

about dry natural rubber on the

immediate IVD package (vial) label.

FDA is announcing the availability of its

response to HIMA’s petition in order to

inform affected manufacturers and the

public.

ADDRESSES: Submit written requests for

single copies on a 3.5 diskette of the

document entitled ‘‘Approval of an

Alternate Requirement of the User

Labeling Requirements for Devices that

Contain Dry Natural Rubber that Contact

Humans’’ to the contact person named

below. See the SUPPLEMENTARY

INFORMATION section for information on

electronic access to the alternative

requirement document.

FOR FURTHER INFORMATION CONTACT: John

J. Farnham, Center for Devices and

Radiological Health (HFZ–321), Food

and Drug Administration, 2094 Gaither

Rd., Rockville, MD 20852, 301–594–

4616.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

30, 1997 (62 FR 51021), FDA issued a

final rule, codified in 21 CFR

§ 801.437(e), requiring labeling

statements on medical devices

containing dry natural rubber that are

intended to contact or likely to contact

humans. The rule became effective on

September 30, 1998. On June 3, 1999,

HIMA requested a variance for in vitro

diagnostic products that have vial labels

too small to accommodate the required

statement. The petition said that

manufacturers of the products could

place the warning on the outer package,

as well as on a package insert. On

September 10, 1999, FDA issued a letter

granting HIMA’s petition.

II. Electronic Access

In order to receive the document

entitled ‘‘Approval of an Alternative

Requirement of the User Labeling

Requirements for Devices that Contain

Dry Natural Rubber that Contact

Humans,’’ via your fax machine, call the

CDRH Facts-On-Demand (FOD) system

at 800–899–0381 or 301–827–0111 from

the touch-tone telephone. At the first