Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices 51305 

1After we served Dr. Campbell on March 5, 2007, 

with notice of the agency’s proposal to debar her, 

Dr. Campbell sent a series of letters to the agency—

dated March 9, 2007, April 6, 2007, May 23, 2007, 

July 17, 2007, August 21, 2007, and January 13, 

2008,—and participated in a teleconference with 

FDA on April 9, 2007. Although some of Dr. 

Campbell’s correspondence refers to another 

proceeding the agency initiated against Dr. 

Campbell (investigator disqualification under 21 

CFR 312.70), instead of, or in addition to, the 

proposal to debar her, for the purposes of this order, 

we have taken into account all of Dr. Campbell’s 

correspondence with the agency after March 5, 

2007, as well as the transcript from the April 9, 

2007, teleconference. 

Dated: August 20, 2008. 

Mary M. McGeein, 

Principal Deputy Assistant Secretary for 

Planning and Evaluation. 

[FR Doc. E8–20225 Filed 8–29–08; 8:45 am] 

BILLING CODE 4154–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2006–N–0166] (formerly 

Docket No. 2006N–0238) 

Maria Anne Kirkman Campbell; Denial 

of Hearing; Debarment Order 

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) permanently 

debarring Dr. Maria Anne Kirkman 

Campbell (Dr. Campbell) from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. We base this order 

on a finding that Dr. Campbell was 

convicted of a felony under Federal law 

for conduct relating to the development 

or approval, including the process for 

development or approval, of a drug 

product, and conduct otherwise relating 

to the regulation of a drug product 

under the act. Dr. Campbell failed to 

request a hearing and, therefore, has 

waived her opportunity for a hearing 

concerning this action. Even assuming 

that any statement in Dr. Campbell’s 

correspondence with FDA were to be 

construed as requesting a hearing, Dr. 

Campbell has failed to file with the 

agency information and analyses 

sufficient to create a basis for a hearing 

concerning this action. Therefore, we 

are, in the alternative, issuing an order 

denying any such assumed request for a 

hearing because we find that there is no 

genuine and substantial issue of fact to 

grant a hearing on the debarment, if a 

hearing were requested. 

DATES: This order is effective September 

2, 2008. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Brian Pendleton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6304, 

Silver Spring, MD, 20993–0002, 301–

796–3504. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(A) of the act (21 

U.S.C. 335a(a)(2)(A)) requires debarment 

of an individual if FDA finds that the 

individual has been convicted of a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product. 

Section 306(a)(2)(B) of the act requires 

debarment of an individual if FDA finds 

that the individual has been convicted 

of a felony under Federal law for 

conduct otherwise relating to the 

regulation of any drug product under 

the act. 

On March 25, 2004, the U.S. District 

Court for the Northern District of 

Alabama accepted Dr. Campbell’s plea 

of guilty and convicted her of one count 

of mail fraud, a felony under 18 U.S.C. 

1341 and 2. Specifically, Dr. Campbell 

admitted to submitting a fraudulent case 

report form (reflecting enrollment of a 

nonexistent person) while serving as a 

clinical investigator in a clinical study 

designed to test the safety and 

effectiveness of an antibacterial drug 

product, Ketek (telithromycin), for the 

treatment of respiratory tract infections. 

The clinical study was to be submitted 

to FDA in support of approval of Ketek. 

Accordingly, in a letter dated 

February 28, 2007, and hand delivered 

on March 5, 2007, FDA served Dr. 

Campbell a notice proposing to 

permanently debar her from providing 

services in any capacity to a person 

having an approved or pending drug 

product application. The proposal was 

based on a finding, under section 

306(a)(2)(A) and (a)(2)(B) of the act, that 

Dr. Campbell was convicted of a felony 

under Federal law for conduct relating 

to the development or approval, 

including the process for development 

or approval, of a drug product, and 

conduct otherwise relating to the 

regulation of a drug product. The letter 

offered Dr. Campbell an opportunity to 

request a hearing on the proposal, 

providing her 30 days from the date of 

receipt of the letter in which to file the 

request, and advised her that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. 

The letter also informed Dr. Campbell 

that her request for a hearing could not 

rest upon mere allegations or denials, 

but must present specific facts showing 

that there is a genuine and substantial 

issue of fact requiring a hearing. In 

addition, the letter informed Dr. 

Campbell that the only material issue of 

fact was whether she was convicted as 

alleged in the letter, and that the facts 

underlying her conviction are not at 

issue in this proceeding. The letter also 

informed Dr. Campbell that if it 

conclusively appeared from the face of 

the information and factual analyses in 

her request for a hearing that there was 

no genuine and substantial issue of fact 

that precluded the order of debarment, 

we would deny her request for a hearing 

and enter a final order of debarment. 

Finally, the letter informed Dr. 

Campbell that if she were to file a 

request for a hearing, she was required 

to file, on or before 60 days from the 

date of receipt of the letter, the 

information on which she relied to 

justify a hearing. 

Dr. Campbell has responded to the 

proposal to debar her but has not 

requested a hearing.1 Her failure to 

request a hearing constitutes a waiver of 

her opportunity for a hearing and a 

waiver of any contentions concerning 

her debarment. 

Even assuming that any statement in 

Dr. Campbell’s correspondence with 

FDA were to be construed as requesting 

a hearing, Dr. Campbell has not 

submitted information that would 

justify granting a hearing. Therefore, we 

are, in the alternative, hereby denying 

any such assumed request for a hearing 

because Dr. Campbell has failed to show 

that there is a genuine and substantial 

issue of fact requiring a hearing. Dr. 

Campbell has not offered any 

information or factual analyses to refute 

that she was convicted of mail fraud for 

conduct relating to the development or 

approval of a drug product, or otherwise 

relating to the regulation of a drug 

product under the act. 

II. Findings and Order 

Therefore, the Associate 

Commissioner for Regulatory Affairs, 

under section 306(a)(2)(A) and (a)(2)(B) 

of the act and under authority delegated 

to her, finds that Dr. Maria Anne 

Kirkman Campbell has been convicted 

of a felony under Federal law for 

conduct relating to the development or 

approval, including the process for 


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51306 Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices 

development or approval, of a drug 

product, and conduct otherwise relating 

to the regulation of a drug product 

under the act. 

As a result of the foregoing finding, 

Dr. Maria Anne Kirkman Campbell is 

permanently debarred from providing 

services in any capacity to a person with 

an approved or pending drug product 

application under sections 505, 512, or 

802 of the act (21 U.S.C. 355, 360b, or 

382), or under section 351 of the Public 

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

effective as stated in the DATES section 

of this document (see section 

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

of the act (21 U.S.C. 321(dd))). Any 

person with an approved or pending 

drug product application who 

knowingly uses the services of Dr. 

Campbell in any capacity, during her 

period of debarment, will be subject to 

civil money penalties (section 307(a)(6) 

of the act (21 U.S.C. 335b(a)(6))). If Dr. 

Campbell, during her period of 

debarment, provides services in any 

capacity to a person with an approved 

or pending drug product application, 

she will be subject to civil money 

penalties (section 307(a)(7) of the act). 

In addition, FDA will not accept or 

review any abbreviated new drug 

application submitted by or with the 

assistance of Dr. Campbell during her 

period of debarment (section 

306(c)(1)(B) of the act). 

Any application by Dr. Campbell for 

special termination of debarment under 

section 306(d)(4) of the act should be 

identified with Docket No. FDA–2006–

N–0166 and sent to the Division of 

Dockets Management (see ADDRESSES). 

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 Division of Dockets Management 

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

through Friday. 

Dated: August 22, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20295 Filed 8–29–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0455] 

Guide to Minimize Microbial Food 

Safety Hazards for Fresh Fruits and 

Vegetables; Request for Comments 

and for Scientific Data and Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments 

and for scientific data and information. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

comments and scientific data and 

information that may assist the agency 

to improve the guidance to industry set 

forth in the ‘‘Guide to Minimize 

Microbial Food Safety Hazards for Fresh 

Fruits and Vegetables,’’ issued in 1998. 

Specifically, FDA is seeking information 

about current agricultural practices and 

conditions used to grow, harvest, pack, 

cool, and transport fresh produce; risk 

factors for contamination of fresh 

produce associated with these practices; 

and possible measures that FDA could 

implement that would enhance the 

safety of fresh produce. 

DATES: Submit written comments and 

scientific data and information or 

electronic comments by December 31, 

2008. 

ADDRESSES: Submit written comments 

and scientific data and information to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments and scientific data 

and information to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to this document. 

FOR FURTHER INFORMATION CONTACT: 

Michelle A. Smith, Center for Food 

Safety and Applied Nutrition (HFS–

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–2024. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Food Safety and Fresh Produce 

FDA is responsible for ensuring the 

safety of all domestic and imported 

fresh fruits and vegetables consumed in 

the United States. Fresh fruits and 

vegetables are those that are likely to be 

sold to consumers in an unprocessed or 

minimally processed (i.e., raw) form. 

Fresh fruits and vegetables may be 

intact and whole, such as whole apples, 

or cut in the act of harvest, such as 

heads of lettuce and bunches of 

broccoli. 

Because most fresh produce is grown 

in a natural environment, it is 

vulnerable to contamination with 

pathogens (i.e., bacteria or other 

organisms that can cause disease). 

Factors that may affect the occurrence of 

such contamination include agricultural 

and/or post-harvest water quality, the 

use of manure as fertilizer, the presence 

of wild or domestic animals in or near 

fields or packing areas, worker health 

and hygiene, environmental conditions, 

production activities, and equipment 

and facility sanitation. Consequently, 

the manner in which fresh produce is 

grown, harvested, packed, cooled, and 

transported is crucial to minimizing the 

risk of microbial contamination. (We 

use the term ‘‘microbial contamination’’

to refer to contamination with any 

microorganism.) 

Data reported to the U.S. Centers for 

Disease Control and Prevention (CDC) 

indicate that between 1973 and 1997 

reported outbreaks of foodborne illness 

in the United States associated with 

fresh produce increased in absolute 

numbers and as a proportion of all 

reported foodborne outbreaks (Ref. 1). 

(By ‘‘outbreak,’’ we mean the occurrence 

of two or more cases of a similar illness 

resulting from the ingestion of a 

common food.) Unpublished data 

compiled by FDA indicate that from 

1996 to 2007 there were approximately 

72 reported outbreaks of foodborne 

illness associated with approximately 

20 fresh produce commodities. Of this 

total, 13 outbreaks were associated with 

tomatoes, 11 outbreaks were associated 

with melons, and 24 outbreaks were 

associated with leafy greens such as 

lettuce and spinach (Ref. 2). These 

outbreaks involved a number of 

pathogens, including Escherichia coli 

(E. coli) O157:H7 and Salmonella 

species, and involved both domestic 

and imported produce. These totals 

include only those outbreaks in which 

our investigation has indicated that the 

contamination of the produce was not a 

result of exposure to an infected food 

handler or other unsafe food handling 

practice at the place of preparation and 

consumption (i.e., home or restaurant). 

There have also been a number of 

reported outbreaks associated with fresh 

produce in 2008. 

B. FDA’s GAPs/GMPs Guide 

FDA places a high priority on 

identifying and promoting measures 

that can reduce the incidence of 

foodborne illness associated with fresh 

produce. In 1998, FDA and the U.S. 

Department of Agriculture issued 


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