Federal Register / Vol. 73, No. 77 / Monday, April 21, 2008 / Notices 21355 

Dated: April 11, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–8475 Filed 4–18–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Establishment 

of a Community-Clinical Partnership 

for Primary Prevention of Type-2 

Diabetes in Persons at High Risk, 

Potential Extramural Project (PEP) 

2008–R–09 

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 aforementioned meeting. 

Time and Date: 1 p.m.–2:30 p.m., May 20, 

2008 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of ‘‘Establishment of a 

Community-Clinical Partnership for Primary 

Prevention of Type-2 Diabetes in Persons at 

High Risk, PEP 2008–R–09.’’

Contact Person for More Information: 

Linda Shelton, Program Specialist, 

Coordinating Center for Health and 

Information Service, Office of the Director, 

CDC, 1600 Clifton Road, NE., Mailstop E21, 

Atlanta, GA 30333, Telephone (404) 498–

1194. 

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: April 10, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–8478 Filed 4–18–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Evaluation of 

Environmental and Policy 

Interventions To Increase Fruit and 

Vegetable Intake, Potential Extramural 

Project (PEP) 2008–R–11 

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 aforementioned meeting. 

Time and Date: 1 p.m.–3 p.m., May 29, 

2008 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of ‘‘Evaluation of Environmental 

and Policy Interventions to Increase Fruit 

and Vegetable Intake, PEP 2008–R–11.’’

Contact Person for More Information: 

Linda Shelton, Program Specialist, 

Coordinating Center for Health and 

Information Service, Office of the Director, 

CDC, 1600 Clifton Road, NE., Mailstop E21, 

Atlanta, GA 30333, Telephone (404) 498–

1194. 

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: April 10, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–8480 Filed 4–18–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Preparing 

People With Arthritis To Safely Select 

and Self Direct Their Physical Activity, 

Potential Extramural Project (PEP) 

2008–R–16 

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 aforementioned meeting: 

Time and Date: 1 p.m.–2 p.m., May 14, 

2007 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of ‘‘Preparing People with 

Arthritis to Safely Select and Self Direct their 

Physical Activity, PEP 2008–R–16.’’

Contact Person for More Information: 

Linda Shelton, Program Specialist, 

Coordinating Center for Health and 

Information Service, Office of the Director, 

CDC, 1600 Clifton Road, NE., Mailstop E21, 

Atlanta, GA 30333, Telephone (404) 498–

1194. 

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: April 10, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–8483 Filed 4–18–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0189] (formerly 

Docket No. 2003N–0312) 

Meeting to Present Changes to the 

Animal Feed Safety System Project 

and the Ranking of Feed Hazards 

According to the Risks They Pose to 

Animal and Public Health; Part 3: 

Swine Feed Example; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

following public meeting: ‘‘Meeting to 

Present Changes to the Animal Feed 

Safety System (AFSS) Project and the 

Ranking of Feed Hazards According to 

the Risks They Pose to Animal and 

Public Health; Part 3: Swine Feed 

Example.’’ We are holding the public 

meeting in an effort to gather further 

information from you, our stakeholders, 

on changes to AFSS that will help 


rwilkins on PROD1PC63 with NOTICES
21356 Federal Register / Vol. 73, No. 77 / Monday, April 21, 2008 / Notices 

minimize risks to animal and human 

health associated with animal feed. The 

following topics will be discussed: The 

third draft of the AFSS Framework and 

work-in-progress on a method for 

ranking animal feed contaminants by 

their risks to animal and human health. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing a related 

public meeting notice. 

Date and Time: The public meeting 

will be held on May 14, 2008, from 9 

a.m. to 4:30 p.m. 

Location: The public meeting will be 

held at the Gaithersburg Holiday Inn, 2 

Montgomery Village Ave., Gaithersburg, 

MD 20877. There is parking adjacent to 

the building. The building is also 

accessible by public transportation. 

(Take Metro Red Line to Shady Grove 

Station and board Ride-On bus 124 to 

Frederick Rd. at Perry Pkwy. Then, 

cross the roadway and walk 

approximately 1 W blocks north to 

building entrance.) 

Contact Person: For general 

information: Zoe Gill, Center for 

Veterinary Medicine (HFV–226), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 240–453–

6867, FAX 240–453–6882, e-mail: 

zoe.gill@fda.hhs.gov. 

Registration: You may register by 

telephone, fax, or e-mail by contacting 

Nanette Milton, Center for Veterinary 

Medicine (HFV–200), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6840, 

FAX 240–453–6880, e-mail: 

nanette.milton@fda.hhs.gov. Send 

registration information (including 

name, title, firm name, address, 

telephone, and fax number) to Nanette 

Milton. To obtain the registration form 

via the Web site, go to http:// 

www.fda.gov/cvm/AFSS.htm#Meetings. 

Due to limited meeting space, 

registration will be required. We 

strongly encourage early registration. 

Additionally, please notify Nanette 

Milton if you need any special 

accommodations (such as wheelchair 

access or a sign language interpreter) at 

least 7 days in advance of the meeting. 

Comments: Regardless of attendance 

at the public meeting, interested persons 

may submit written or electronic 

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 http:// 

www.regulations.gov. 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. The docket 

will remain open for written or 

electronic comments for 30 days 

following the meeting. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov 

SUPPLEMENTARY INFORMATION: 

I. Background 

AFSS is FDA’s program for animal 

feed aimed at protecting human and 

animal health by ensuring animal feed 

is safe. AFSS covers the entire spectrum 

of agency activities from preapproval of 

food additives for use in feed, to 

establishing limits for feed 

contaminants, providing education and 

training, and conducting inspections 

and taking enforcement actions for 

ensuring compliance with agency 

regulations. It includes oversight of all 

feed ingredients and mixed feeds at all 

stages of manufacture, production, 

distribution, and use, whether at 

commercial or non-commercial 

establishments. Further, AFSS includes 

feed intended for food-producing and 

non-food-producing (companion) 

animals. 

During the past several years, FDA 

has been considering needed changes to 

AFSS to ensure it is comprehensive, 

preventive, and risk-based. As part of 

this effort, the agency released its AFSS 

Framework document in February 2005 

and discussed it at a public meeting 

held in April 2005 in Omaha, NE. 

Subsequently, a revised Framework 

document was made available to the 

public in December 2006. The revised 

Framework document includes, among 

other things, changes necessitated by 

FDA’s Amendments Act of 2007 

(FDAAA), which was signed into law 

September 28, 2007. The ranking 

scheme for estimating risks posed by 

feed contaminants to animal and human 

health consists of two components, 

namely health consequence scoring and 

exposure scoring, which were covered 

at previous meetings in 2006 and 2007, 

respectively. At this meeting, the agency 

will describe the model it has developed 

to rank the risks of the more common 

hazards in swine feed. The Framework 

document identifies numerous projects 

including the development of a model 

for ranking the risks to human and 

animal health of contaminants in animal 

feed. An effective model will permit the 

agency to systematically distinguish 

among feed hazards based on the 

comparative risks they pose to animals 

or humans. Such a model will consider 

the risks of hazards present in incoming 

materials or feed ingredients and will 

also consider how activities during feed 

manufacturing, storage, distribution, or 

transportation may modify such risks. 

For the purpose of AFSS, FDA defines 

a feed hazard as a biological, chemical, 

or physical agent in, or condition of, 

feed with the potential to cause an 

adverse health effect in animals or 

humans. 

Previously, FDA held four public 

meetings to discuss AFSS. The first two 

meetings, held in September 2003 and 

April 2005, focused on obtaining input 

on what was lacking and where and 

how to address identified deficiencies 

in the agency’s feed safety program. At 

the next two meetings, held in 

September 2006 and May 2007, the 

agency covered developmental aspects 

of the AFSS risk-ranking model. To 

determine the comparative risks of 

chemical, physical, and biological 

contaminants in animal feed, 

information about the health 

consequences posed by the contaminant 

(represented by a health consequence 

scoring) is combined with information 

about the amount of the contaminant in 

animal feed (represented by an exposure 

scoring). During the 2006 and 2007 

meetings, we described the methods 

used by the agency to develop scoring 

systems for ranking animal and human 

health consequences arising from feed 

hazards and for ranking exposure to 

those feed hazards, respectively. The 

public meetings included active 

participation by consumers, animal feed 

processors, animal producers, and State 

and other Federal Government agencies. 

Both before and following the meetings, 

we placed a number of documents in 

FDA’s docket (found in brackets in the 

heading of this document) for the AFSS 

project. These documents included 

transcripts of the meetings, summaries 

of breakout discussion groups, 

presentations of invited speakers, and 

meeting summaries. We also placed in 

the docket a number of other documents 

relating to AFSS, including a 

Framework for AFSS listing the 

principal components of AFSS and the 

gaps the agency has identified which are 

being addressed by the agency team 

working on the AFSS project. These 

documents provide excellent, general 

background material on AFSS for the 

public meeting that will be held on May 

14, 2008. 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 73, No. 77 / Monday, April 21, 2008 / Notices 21357 

As a result, in part, of recent actions 

by the Congress and the Administration, 

a third draft of the AFSS Framework 

will be presented at the public meeting. 

We will also discuss in more detail, 

where appropriate, several of the gaps 

identified in the Framework document. 

In addition, we will show how health 

consequence scoring is combined with 

exposure scoring to rank the risks of 

contaminants in animal feed. Swine 

feed will be used as the example. We 

also plan to briefly present the riskbased method being developed to rank 

feed inspectional programs. 

II. Public Meeting 

We are holding the public meeting in 

an effort to gather further information 

from you, our stakeholders, on changes 

to AFSS that will help minimize risks 

to animal and human health associated 

with animal feed. Prior to the public 

meeting, FDA will place in the docket 

(found in brackets in the heading of this 

document) two documents entitled 

‘‘Draft AFSS Framework, 3rd Edition’’

and ‘‘Risk-Ranking of Feed Hazards: 

Swine Feed Example.’’ The Framework 

document will summarize the agency’s 

current efforts to modernize its animal 

feed safety program. The Risk-Ranking 

document will provide the methods for 

ranking potential biological and 

chemical hazards in feed, using swine 

feed as an example. Details of these 

methods will be discussed at the 

meeting. A draft agenda for the meeting 

will also be placed in the docket prior 

to the meeting. 

An additional public meeting 

sponsored by the Center for Veterinary 

Medicine (CVM) will be held on May 

13, 2008, at the same site as the AFSS 

public meeting. The purpose of the 

CVM meeting will be for the agency to 

receive comments on the pet food safety 

section of FDAAA (Public Law 110–85). 

Information on the CVM public meeting 

will be publishing elsewhere in this 

issue of the Federal Register. 

III. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm. It may be 

viewed at the Division of Dockets 

Management (see Comments). 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. 

Dated: April 15, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 08–1154 Filed 4–16–08; 3:47 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Docket No. FDA–2007–N–0442 (formerly 

Docket No. 2007N–0487) 

Opportunity for Public Input on 

Standards for Pet Food and Other 

Animal Feeds; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to obtain input from 

stakeholder groups, including, but not 

limited to, the Association of American 

Feed Control Officials (AAFCO), 

veterinary medical associations, animal 

health organizations, and pet food 

manufacturers, concerning the 

development of ingredient standards 

and definitions, processing standards, 

and labeling standards for pet food. 

These standards were mandated by the 

FDA Amendments Act of 2007 

(FDAAA). We also would like to obtain 

input on whether the ingredient 

standards and definitions and 

processing standards should cover all 

animal feeds. Elsewhere in this issue of 

the Federal Register, FDA is 

announcing a related public meeting 

notice. 

Date and Time: The public meeting 

will be held on May 13, 2008, from 8 

a.m. to 4:30 p.m. 

Location: The public meeting will be 

held at the Gaithersburg Holiday Inn, 2 

Montgomery Village Ave., Gaithersburg, 

MD 20877. There is parking adjacent to 

the building. The building is also 

accessible by public transportation. 

(Take the Metro Red Line to Shady 

Grove Station, then take Ride-On bus 

124 to Frederick Rd. at Perry Pkwy., 

then cross the roadway and walk 

approximately 1 W blocks north to the 

building entrance.) 

Contact Persons: For general 

information, Tracey Forfa, Center for 

Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Place, 

Rockville, MD 20855, 240–276–9000, 

FAX: 240–276–9030, e-mail: 

Tracey.Forfa@fda.hhs.gov; or for 

information on registration, Nanette 

Milton, Center for Veterinary Medicine, 

Food and Drug Administration, 7519 

Standish Place, Rockville, MD 20855, 

240–453–6840, FAX: 240–453–6880, email: Nanette.Milton@fda.hhs.gov. 

Registration: We request that you 

preregister to ensure there is sufficient 

room. Additionally, to assist us in 

scheduling, we ask that you notify us 

through the preregistration process if 

you wish to make a public comment at 

the meeting. To preregister, please send 

an electronic mail message to 

Nanette.Milton@fda.hhs.gov no later 

than May 7, 2008. Your e-mail should 

include the following information: Your 

name, company or association name and 

address as applicable, phone number, 

and e-mail address. Please state whether 

you are speaking on behalf of an 

organization or as an individual. You 

will receive a confirmation within 2 

business days. 

FDA also will accept walk-in 

registration at the meeting site, but 

space is limited. FDA will try to 

accommodate all persons who wish to 

make a public comment at the meeting, 

including those who register at the 

meeting site; however, the time allotted 

for public comments may depend on the 

number of persons who wish to speak. 

Additionally, please notify FDA (see 

Contact Persons) if you need any special 

accommodations (such as wheelchair 

access or a sign language interpreter) at 

least 7 days in advance of the meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced public meeting 

cannot always be published quickly 

enough to provide timely notice. 

Accordingly, you should check the FDA 

Web site at http://www.fda.gov/cvm to 

learn about possible modifications 

before coming to the meeting. 

Comments: To ensure consideration 

of your comments regarding the 

development of standards for pet food, 

you should submit comments by June 

13, 2008. While interested persons may 

comment orally at the public meeting, 

comments may also be submitted in 

writing or electronically in lieu of or in 

addition to oral comments. Send written 

comment submissions to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

All 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. You may also 


rwilkins on PROD1PC63 with NOTICES