Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Notices 15497 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Notice of Participation—(OMB Control 

Number 0910–0191)—Extension 

Section 12.45 (21 CFR 12.45), issued 

under section 701 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 371), 

sets forth the format and procedures for 

any interested person to file a petition 

to participate in a formal evidentiary 

hearing, either personally or through a 

representative. Section 12.45 requires 

that any person filing a notice of 

participation, state their specific interest 

in the proceedings, including the 

specific issues of fact about which the 

person desires to be heard. This section 

also requires that the notice include a 

statement that the person will present 

testimony at the hearing and will 

comply with specific requirements in 21 

CFR 12.85, or, in the case of a hearing 

before a Public Board of Inquiry, 

concerning disclosure of data and 

information by participants (21 CFR 

13.25). In accordance with § 12.45(e), 

the presiding officer may omit a 

participant’s appearance. 

The presiding officer and other 

participants will use the collected 

information in a hearing to identify 

specific interests to be presented. This 

preliminary information serves to 

expedite the pre-hearing conference and 

commits participation. 

The respondents are individuals or 

households, State or local governments, 

not-for-profit institutions and 

businesses, or other for-profit groups 

and institutions. 

In the Federal Register of December 

29, 2008 (73 FR 79495), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section 502 of the FFD&C Act/ 

Section 351 of the PHS Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

12.45 8 1 8 3 24 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden estimates for this 

collection of information are based on 

agency records and experience over the 

past 3 years. 

Dated: March 30, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7671 Filed 4–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0166] 

Economically Motivated Adulteration; 

Public Meeting; Request for Comment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comment. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting pertaining to 

economically motivated adulteration 

(EMA). The purpose of the meeting is to 

stimulate and focus a discussion about 

ways in which the food (including 

dietary supplements and animal food), 

drug, medical device, and cosmetic 

industries, regulatory agencies, and 

other parties can better predict and 

prevent economically motivated 

adulteration with a focus on situations 

that pose the greatest public health risk. 

FDA invites interested individuals, 

organizations, and other stakeholders, 

including industry representatives, to 

present information pertaining to 

predicting and preventing EMA of food 

(including dietary supplements and 

animal food), drugs, medical devices, 

and cosmetics. The agency also requests 

interested parties to submit comments 

on this issue to the public docket. 

DATES: The public meeting will be held 

on May 1, 2009, from 9 a.m. to 5 p.m. 

Submit written or electronic comments 

by August 1, 2009. See section I of the 

SUPPLEMENTARY INFORMATION section for 

deadlines regarding the meeting. 

ADDRESSES: The public meeting will be 

held in the Wiley Auditorium, Center 

for Food Safety and Applied Nutrition, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD, 20852. Submit 

electronic comments to the docket at 

http://www.regulations.gov. See section 

V of this document for additional 

information on submitting comments. 

FOR FURTHER INFORMATION CONTACT: 

For registration, requests to make an 

oral presentation, and submission 

of written material for the 

presentation: Deborah Harris, EDJ 

Associates, Inc., 11300 Rockville 

Pike, suite 1001, Rockville, MD 

20852, 240–221–4326, FAX: 301– 

945–4295, e-mail: 

dharris@edjassociates.com. 

For general questions about the 

meeting, to request onsite parking 

for the meeting, or for special 

accommodations due to a 

disability: Juanita Yates, Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration 

(HFS–009), 5100 Paint Branch 

Pkwy., College Park, MD 20740, 

301–436–1731, e-mail: 

Juanita.Yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. How to Participate in the Meeting 

Due to limited space and time, we 

encourage all persons who wish to 

attend the meeting, including those 

requesting an opportunity to make an 

oral presentation at the meeting, to 

register in advance. Attendees may 

register in advance for the meeting by 

April 23, 2009. Requests for oral 

presentations should be made by April 

16, 2009. Presenters should submit final 

presentations by April 23, 2009, in order 

for us to accommodate their request. 

Requests for special accommodations 

due to disability should be made by 

April 23, 2009. Requests for onsite 

parking may be made until April 27, 

2009. 

We encourage attendees to register for 

this meeting electronically at http:// 

www.fda.gov/oc/meetings/ema.html. 

You may also register by mail, fax, email, or telephone by providing 

registration information (including 

name, title, firm name, address, 

telephone number, fax number, and email address) to the contact person (see 

FOR FURTHER INFORMATION CONTACT). 

Attendees will have an opportunity to 

provide oral comments. Depending on 

the number of oral presentations, we 


pwalker on PROD1PC71 with NOTICES
15498 Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Notices 

may need to limit the time of each oral 

presentation (e.g., 5 minutes each). 

Requests to make an oral presentation, 

submission of written material for the 

presentation, requests for special 

accommodations due to disability, and 

requests for onsite parking should be 

directed to the contact person (see FOR

FURTHER INFORMATION CONTACT). 

II. Background on the Meeting 

A. Suspected Economically Motivated 

Adulteration of FDA-Regulated Products 

For purposes of this public meeting, 

FDA proposes a working definition of 

EMA as the fraudulent, intentional 

substitution or addition of a substance 

in a product for the purpose of 

increasing the apparent value of the 

product or reducing the cost of its 

production, i.e., for economic gain. 

EMA includes dilution of products with 

increased quantities of an alreadypresent substance (e.g., increasing 

inactive ingredients of a drug with a 

resulting reduction in strength of the 

finished product, or watering down of 

juice) to the extent that such dilution 

poses a known or possible health risk to 

consumers, as well as the addition or 

substitution of substances in order to 

mask dilution. 

Several recent incidents involving 

FDA-regulated products are suspected 

to be examples of EMA. These incidents 

illustrate the potential for serious public 

health harm from such adulterated 

products. 

In March 2007, FDA received reports 

of kidney failure among cats and dogs 

and a report that cats died during taste 

tests of certain brands of pet food. In the 

subsequent investigation, melamine and 

melamine-related compounds were 

found in products labeled as wheat 

gluten and rice protein concentrate that 

had been imported from China. Wheat 

gluten and rice protein concentrate are 

common ingredients in numerous pet 

food products sold in the United States. 

Melamine and its related compounds 

are not approved for use as an 

ingredient in animal or human food, 

and FDA believes it was these 

contaminants that made the cats and 

dogs sick. At certain exposure levels, 

the interaction of melamine and 

melamine-related compounds appears 

to cause the formation of crystals in the 

kidneys, resulting in kidney damage. 

Based on the information that FDA has, 

it appears that these contaminants were 

added to the products handled by 

Chinese suppliers to increase the 

apparent protein content in those 

products. Consumers and veterinarians 

have since reported many more animal 

illnesses and deaths potentially 

associated with pet foods made from 

these products. Over 150 brands of pet 

food and 1,000 products were 

voluntarily recalled by a number of 

companies. 

In January 2008, FDA received reports 

of adverse reactions in pediatric dialysis 

patients in the U.S. Initial investigations 

by the Centers for Disease Control and 

Prevention indicated that the adverse 

events appeared to be associated with 

heparin manufactured by Baxter 

Healthcare Corp. that was administered 

during the dialysis procedures. In 

January and February 2008, Baxter 

Healthcare Corp. voluntarily recalled all 

of its heparin products. FDA’s 

investigation ultimately identified 

almost 150 U.S. deaths occurring 

between January 1, 2007, and May 31, 

2008, that appeared to be associated 

with the use of these heparin products. 

During the investigation, FDA scientists 

collaborated with academia and 

industry and identified a contaminant 

in the heparin active pharmaceutical 

ingredient (API) obtained from suppliers 

in China. The contaminant was a 

heparin-like molecule whose presence 

in heparin API was not detected by the 

United States Pharmacopoeia (USP) 

release tests for heparin. The 

contaminant was identified as 

oversulfated chondroitin sulfate (OSCS). 

FDA posted two new analytical tests to 

detect the contaminant OSCS on its Web 

site in March 2008, and the agency 

collaborated with USP to revise the test 

methods and modify the monograph for 

heparin to test for OSCS. These new 

tests were used on heparin API 

imported into the United States and 

throughout the world. Contaminated 

heparin API has been found in 11 

countries. 

In September 2008, FDA issued a 

Health Information Advisory in 

response to reports of melamine 

contaminated milk-based infant formula 

manufactured in China. Melamine was 

apparently added to diluted milk in 

order to increase measured nitrogen 

levels (indicators of protein content) 

and thereby inflate the apparent protein 

content found in the product. FDA 

issued further advisories to address 

additional milk-based products. To date, 

official reports from the Chinese 

Ministry of Health state that nearly 

300,000 Chinese infants were sickened 

by the contaminated infant formula, and 

that six infant deaths were likely due to 

the contamination. There have been no 

confirmed illnesses or deaths in the 

United States attributed to melamine in 

products containing milk or milkderived ingredients, although some 

contaminated products were found at 

ethnic markets selling imported 

products. 

Adulteration of glycerin, an 

ingredient in cough syrup and other 

drugs, with diethylene glycol (DEG) has 

resulted in several mass poisonings 

around the world in the past two 

decades. In 1996, contaminated 

acetaminophen syrup was responsible 

for the deaths of more than 70 children 

in Haiti. In 2006, tainted cough syrup 

resulted in dozens of deaths in Panama. 

In Nigeria, between 2008 and 2009, 

more than 50 children died after 

ingesting contaminated teething syrup. 

Incidents of DEG contamination in these 

two decades have not resulted in any 

reported U.S. deaths or illnesses, but in 

2007, foreign-made toothpaste 

contaminated with DEG was reported in 

the United States resulting in recalls 

and restriction on imports of suspect 

toothpastes. FDA has collaborated with 

USP to revise the test methods for 

glycerin and other monographs to test 

for the presence of DEG. 

As the preceding examples illustrate, 

despite longstanding FDA requirements 

to assure the safety of regulated 

products, such as requirements for the 

use of ingredients of known identity and 

quality in drugs, economically 

motivated adulteration remains a public 

health threat. 

B. FDA Science Board Meeting and EMA 

Workgroup 

At the October 31, 2008, meeting of 

the FDA Science Board, FDA presented 

a conceptual model of EMA. The model 

describes circumstances and factors that 

are likely to lead to EMA, and points to 

certain types of information that may be 

useful in trying to prevent EMA. In 

response to the feedback obtained 

during the Science Board Meeting, FDA 

formed an internal working group 

focused on predicting and addressing 

EMA (‘‘EMA Workgroup’’). At the 

February 25, 2009, meeting of the 

Science Board, FDA announced its 

intent to hold a public meeting on EMA. 

III. Purpose of Meeting and Questions 

for Discussion 

The purpose of the public meeting is 

to raise awareness about the potential 

for EMA and solicit input and 

comments on how industry, regulators, 

and other parties can better predict, 

prevent, and address EMA. FDA’s EMA 

Workgroup has developed a set of 

questions to focus discussion on the 

matter. These questions apply to food 

(including dietary supplements and 

animal food), drug, device and cosmetic 

products and their components/ 

ingredients. The EMA Workgroup 

requests comment and input on these 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Notices 15499 

questions, as well as any responses to 

the questions themselves based on 

information that may already be in the 

public domain. The EMA Workgroup 

further requests comment on the utility 

of the working definition of EMA used 

here. A transcript of the public meeting 

will be made available. 

Please note that FDA does not wish to 

publicize sensitive information that 

could potentially be used by those who 

wish to commit EMA or other 

adulteration or that identifies those who 

may be committing adulteration FDA 

would like to remind the public that if 

they have information about these or 

any other problems they have 

encountered with FDA products, they 

may report such information at http:// 

www.fda.gov/opacom/backgrounders/ 

problem.html. In addition, if the public 

has information pertaining to suspected 

criminal activity with regard to FDAregulated products (e.g., information 

about individuals who may be 

committing EMA or other adulteration), 

they may contact FDA’s Office of 

Criminal Investigations at http:// 

www.fda.gov/oci/default.htm in lieu of 

responding publicly to this document. 

(1) General Questions: 

a. What information should U.S. 

regulators seek and from what 

sources to help predict and prevent 

EMA? What further steps can U.S. 

regulators take to predict and 

prevent EMA? 

b. What are members of industry 

doing to prevent EMA? What 

further steps can industry take to 

prevent EMA? 

c. What recent examples of known 

or suspected EMA domestically and 

internationally should U.S. 

regulators study and learn from? 

d. What information do other 

organizations (including, but not 

limited to, trade organizations and 

security service providers) have that 

would be useful in predicting and 

preventing EMA? What are 

members of other organizations 

doing to prevent EMA? 

e. What are other government 

regulators within and outside of the 

United States doing to predict and 

address EMA? 

f. What indicators (economic-based, 

chemistry-based, etc.) might be 

used to detect potential EMA? 

(2) Questions pertaining to attributes of 

products, components/ingredients that 

may be at risk for EMA: 

a. What are attributes of products or 

components/ingredients of products 

that may cause them to be more 

vulnerable to EMA? 

b. What food products are marketed 

based on measured content of 

certain constituents, such as 

content of certain proteins, certain 

fats, or certain sugars? 

(3) Questions pertaining to changes in 

the marketing environment: What 

changes relevant to the risk for EMA 

have occurred recently in: 

a. The marketing environment of 

products or components/ 

ingredients? 

b. The sourcing and/or distribution 

of products? 

c. The prices, output, imports or 

exports of products or components/ 

ingredients? 

d. The supply of components/ 

ingredients or source materials for 

products? 

(4) Questions about detection methods: 

a. What analytical equipment or 

methods currently used by industry 

and regulators to establish the 

identity or quality of a product or 

its conformity to specifications may 

be inadequate to detect evidence of 

EMA or adulterated products or 

ingredients? 

b. Are there appropriate analytical 

methods/equipment that could be 

used instead of, or in addition to, 

existing methods or equipment in 

particular situations? 

c. What rapid methods can be used 

to detect adulteration of products or 

ingredients? 

(5) What systems are currently being 

used to track and verify components/ 

ingredients from their source? 

(6) Are there particular types of industry 

structures or supply chains that are 

especially vulnerable to or secure from 

potential EMA? 

IV. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD-ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper 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 Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 1, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–7843 Filed 4–2–09; 4:15 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases 

Diabetes Mellitus Interagency 

Coordinating Committee; Notice of 

Meeting 

The Diabetes Mellitus Interagency 

Coordinating Committee (DMICC) will 

hold a meeting on May 6, 2009, from 

12:30 to 4:30 p.m. at Building 31C, 

Conference Room 6C, on the NIH 

campus, 9000 Wisconsin Ave., 

Bethesda, MD. The meeting will be open 

to the public, with attendance limited to 

space available. Non-federal individuals 

planning to attend the meeting should 

notify the Contact Person listed on this 

notice at least 2 days prior to the 

meeting. Individuals who plan to attend 

and need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should 

inform the Contact Person listed below 

at least 10 days in advance of the 

meeting. 

The DMICC facilitates cooperation, 

communication, and collaboration on 

diabetes among government entities. 

DMICC meetings, held several times a 

year, provide an opportunity for 

members to learn about and discuss 

current and future diabetes programs in 

DMICC member organizations and to 

identify opportunities for collaboration. 

The May 6, 2009, DMICC meeting will 

discuss ‘‘Federally Supported DiabetesRelated National Education Programs.’’ 

Any member of the public interested 

in presenting oral comments to the 

Committee should notify the Contact 

Person listed on this notice at least 10 

days in advance of the meeting. 

Interested individuals and 

representatives or organizations should 

submit a letter of intent, a brief 

description of the organization 

represented, and a written copy of their 

oral presentation in advance of the 

meeting. Only one representative of an 

organization will be allowed to present 


pwalker on PROD1PC71 with NOTICES