37154 Federal Register / Vol. 65, No. 114 / Tuesday, June 13, 2000 / Notices

The Director, Management Analysis

and Services Office, has been delegated

the authority to sign Federal Register

notices pertaining to announcements of

meetings and other committee

management activities for both CDC and

the Agency for Toxic Substances and

Disease Registry.

Dated: June 8, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–14945 Filed 6–12–00; 8:45 am]

BILLING CODE 4163–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Advisory Committee on Immunization

Practices: Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following committee

meeting:

Name: Advisory Committee on

Immunization Practices (ACIP).

Times and Dates: 8:30 a.m.–6:30 p.m., June

21, 2000. 8 a.m.–4:30 p.m., June 22, 2000.

Place: Four Points Hotel by Sheraton, 1850

Cotillion Drive, Atlanta, Georgia 30338.

Status: Open to the public, limited only by

the space available.

Purpose: The Committee is charged with

advising the Director, CDC, on the

appropriate uses of immunizing agents. In

addition, under 42 U.S.C. § 1396s, the

Committee is mandated to establish and

periodically review and, as appropriate,

revise the list of vaccines for administration

to vaccine-eligible children through the

Vaccines for Children (VFC) program, along

with schedules regarding the appropriate

periodicity, dosage, and contraindications

applicable to the vaccines.

Matters To Be Discussed: The agenda will

include a discussion on the ACIP policies

and procedures; ACIP recommendations for

the pneumococcal conjugate vaccine; vaccine

additive: aluminum update; vaccine additive:

thimerosal; vaccines and autism; bioterrorism

working group; general recommendations;

anaphylaxis after MMR due to gelatin;

progress report on vaccine identification

standards initiative; status of high-speed

needle-free jet injectors for mass vaccination

campaigns; update on Geneva meeting on

rotavirus vaccination; Vaccines for Children

program update; adult working group:

pneumococcal polysaccharide update; CDC/

FDA report on two dose schedule for

hepatitis B for adolescent; update on

influenza vaccine supply; Global Alliance for

Vaccines and Immunization: progress in

supporting global immunization programs

and introduction of new vaccines; Nabi an

update from the Food and Drug

Administration; update from the National

Center for Infectious Diseases; update from

the National Immunization Program; update

from the Vaccine Injury Compensation

Program; update from the National Vaccine

Program. Other matters of relevance among

the committee’s objectives may be discussed.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Gloria A. Kovach, Program Analyst,

Epidemiology and Surveillance Division,

National Immunization Program, CDC, 1600

Clifton Road, NE, m/s E61, Atlanta, Georgia

30333. Telephone 404/639–8096.

The Director, Management Analysis and

Services office has been delegated the

authority to sign Federal Register notices

pertaining to announcements of meetings and

other committee management activities for

both the Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: June 8, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–14944 Filed 6–12–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 92N–0412]

Rajaram K. Matkari; Conviction

Reversal; Final Order Terminating

Debarment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

order, under the Federal Food, Drug,

and Cosmetic Act (the act), terminating

the debarment of Rajaram K. Matkari,

1304 Riverglen Way, Berthoud, CO

80513. FDA is issuing this order because

the U.S. District Court for the District of

Maryland issued a Writ of Error Coram

Nobis, reversing Mr. Matkari’s

conviction and Mr. Matkari applied for

termination of his debarment on this

basis.

EFFECTIVE DATE: June 13, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

are to be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Leanne Cusumano, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

October 20, 1993 (58 FR 54156),

Rajaram K. Matkari was permanently

debarred from providing services in any

capacity to a person with an approved

or pending drug product application

(sections 306(c)(1)(B) and (c)(2)(A)(ii)

and 201(dd) of the act (21 U.S.C.

335a(c)(1)(B) and (c)(2)(A)(ii) and 21

U.S.C. 321(dd))). The debarment was

based on FDA’s finding that Mr. Matkari

was convicted of a felony under Federal

law for conduct relating to the

development or approval of a drug

product, or otherwise relating to the

regulation of a drug product (section

306(a)(2)(A) and (a)(2)(B) of the act). Mr.

Matkari, the former Vice President for

Regulatory Affairs and Product

Development of Pharmaceutical Basics,

Inc. (PBI), pled guilty to and was

sentenced on July 28, 1989, for giving an

unlawful gratuity, a felony offense

under 18 U.S.C. 201(c)(1)(A). The basis

for this conviction was Mr. Matkari’s

payment of approximately $2,000 to an

FDA chemistry review branch chief who

was responsible for supervising the

chemists who reviewed PBI’s

applications to determine whether those

applications met certain statutory

standards for approval.

On February 22, 2000, the U.S.

District Court for the District of

Maryland issued an order granting Mr.

Matkari’s petition for a Writ of Error

Coram Nobis in his criminal case. A

copy of the court’s order is available in

Docket No. 92N–0412. By this order, the

court reversed Mr. Matkari’s conviction.

On April 18, 2000, Mr. Matkari

petitioned for termination of debarment

under section 306(d)(3)(B)(i) of the act,

as amended by the Generic Drug

Enforcement Act. Section 306(d)(3)(B)(i)

of the act states that ‘‘If the conviction

which served as the basis for the

debarment of an individual under

subsection (a)(2) * * * is reversed, the

Secretary shall withdraw the order of

debarment.’’

Accordingly, the Senior Associate

Commissioner for Policy, Planning, and

Legislation, under section 306(d)(3)(B)(i)

of the act and under authority delegated

to him (21 CFR 5.20), is issuing this

order withdrawing the order of

permanent debarment of Rajaram K.

Matkari, thereby allowing him to

provide services in any capacity to a

person with an approved or pending

drug product application. Rajaram K.

Matkari’s debarment is terminated

Federal Register / Vol. 65, No. 114 / Tuesday, June 13, 2000 / Notices 37155

effective June 13, 2000, (section

306(d)(3)(B)(i) of the act).

Dated: June 6, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–14806 Filed 6–12–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00F–1332]

Ecolab, Inc.; Filing of Food Additive

Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Ecolab, Inc., has filed a petition

proposing that the food additive

regulations be amended to provide for

the safe use of a mixture of peroxyacetic

acid, octanoic acid, acetic acid,

hydrogen peroxide, peroxyoctanoic

acid, and 1-hydroxyethylidene-1,1-

diphosphonic acid as an antimicrobial

agent on red meat carcasses.

DATES: Submit written comments on the

petitioner’s environmental assessment

by July 13, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Robert L. Martin, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204–0001, 202–418–

3074.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 0A4720) has been filed by

Ecolab, Inc., Ecolab Center, 370

Wabasha St., St. Paul, MN 55102. The

petition proposes to amend the food

additive regulations in 21 CFR part 173

(21 CFR part 173) to provide for the safe

use of a mixture of peroxyacetic acid,

octanoic acid, acetic acid, hydrogen

peroxide, peroxyoctanoic acid, and 1-

hydroxyethylidene-1,1-diphosphonic

acid as an antimicrobial agent on red

meat carcasses.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations issued under

the National Environmental Policy Act

(40 CFR 1501.4(b)), the agency is

placing the environmental assessment

submitted with the petition that is the

subject of this notice on public display

at the Dockets Management Branch

(address above) for public review and

comment. Interested persons may

submit to the Dockets Management

Branch written comments by July 13,

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. FDA will also place on

public display any amendments to, or

comments on, the petitioner’s

environmental assessment without

further announcement in the Federal

Register. If, based on its review, the

agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: May 30, 2000.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 00–14906 Filed 6–12–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Gastrointestinal Drugs Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Gastrointestinal

Drugs Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on June 26 and 27, 2000, 8:30 a.m.

to 5:30 p.m.

Location: Marriott Washington Center,

Ballrooms A through E, 9751

Washington Blvd., Gaithersburg, MD.

Contact Person: Thomas H. Perez,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6758, email at PerezT@cder.fda.gov, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12538.

Please call the Information Line for upto-date information on this meeting.

Agenda: On June 26, 2000, the

committee will discuss new drug

application (NDA) 21–200, ZelmacTM

(tegaserod), Novartis Pharmaceuticals

Corp., for the treatment of abdominal

pain and discomfort, bloating and

altered bowel function in patients with

irritable bowel syndrome who have

predominant symptoms of pain,

discomfort, and constipation. On June

27, 2000, the committee will discuss

risk management of post-marketing

adverse events associated with NDA 21–

107, LotronexTM (alosetron) Glaxo

Wellcome.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by June 19, 2000. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before June 19, 2000, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

FDA regrets that it was unable to

publish this notice 15 days prior to the

June 26 and 27, 2000, Gastrointestinal

Drugs Advisory Committee meeting.

Because the agency believes there is

some urgency to bring this issue to

public discussion and qualified

members of the Gastrointestinal Drugs

Advisory Committee were available at

this time, the Commissioner of Food

and Drugs concluded that it was in the

public interest to hold this meeting even

if there was not sufficient time for the

customary 15-day public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).