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
21358 Federal Register / Vol. 73, No. 77 / Monday, April 21, 2008 / Notices 

view received comments at http:// 

www.regulations.gov. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA only through FDMS at http:// 

www.regulations.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDAAA was signed into law by the 

President on September 27, 2007 (Public 

Law 110–85). FDAAA Section 1002(a) 

directs that within 2 years, FDA must 

establish pet food ingredient standards 

and definitions, processing standards, 

and updated standards for pet food 

labeling that include nutritional and 

ingredient information. This same 

provision of the law also directs that, in 

developing these new standards, FDA 

obtain input from its stakeholders, 

including, but not limited to, AAFCO, 

veterinary medical associations, animal 

health organizations, and pet food 

manufacturers. This public meeting is 

an opportunity for interested 

stakeholders to present such input and 

for FDA to hear directly from the public. 

In the Federal Register of January 7, 

2008 (73 FR 1225), FDA announced its 

intention to hold a public meeting 

concerning FDAAA Section 1002(a) to 

gather input from the interested 

stakeholders and other members of the 

public. This announcement includes 

further details regarding the date and 

location of the public meeting, and also 

provides additional information 

regarding the topics and questions to be 

considered. After the meeting, FDA will 

review all of the comments made at the 

meeting and those submitted in writing 

through the mail or electronically to 

Docket No. FDA–2007–N–0442 

(formerly Docket No. 2007N–0487). 

FDA is sponsoring an additional 

public meeting as part of its Animal 

Feed Safety System (AFSS) initiative on 

May 14, 2008, at the same location as 

the May 13, 2008, FDAAA public 

meeting. The AFSS is a system that FDA 

is developing to minimize the risk to 

animals and public health through the 

use of risk-based, preventive, and 

comprehensive animal feed control 

measures. The purpose of the additional 

meeting will be for the agency to present 

the third draft of the AFSS Framework 

and work-in-progress on a method for 

ranking animal feed hazards by their 

risks to animal and human health. 

The revised Framework document 

includes, among other things, 

recognition of FDA’s Food Protection 

Plan, which was announced in 

November 2007, and changes to the 

document necessitated by FDAAA. The 

ranking scheme for estimating risks 

posed by feed hazards to animal and 

human health consists of two 

components, health consequence 

scoring and exposure scoring, which 

were previously presented. At the May 

14, 2008, public meeting, FDA will 

describe methods for ranking risks 

associated with biological and chemical 

hazards in feed, using swine feed 

examples. 

Background material relating to AFSS, 

including previous drafts of the AFSS 

Framework document, is available at 

http://www.fda.gov/cvm/AFSS.htm. 

II. Topics and Questions for 

Consideration at the May 13, 2008, 

Public Meeting: 

FDA seeks input from stakeholders 

and other members of the public on the 

topics and questions discussed below. 

Given that time will be limited at the 

public meeting, FDA encourages all 

interested persons to submit their 

comments in writing to Docket No. 

FDA–2007–N–0442 to ensure that their 

comments are considered. 

A. Scope of Meeting. 

In enacting FDAAA Section 1002(a), 

Congress specifically directed FDA to 

establish, in consultation with relevant 

stakeholders and other members of the 

public, ingredient standards and 

definitions, processing standards, and 

updated labeling standards for pet food. 

FDA seeks input from stakeholders and 

other members of the public on the 

development of such standards for pet 

food, including on the specific 

questions listed below. 

In addition, because pet food is wellintegrated into the overall animal foods 

and feeds industry, FDA is concerned 

that certain new requirements, if limited 

to pet food only, would be impractical 

to implement, difficult to enforce, and 

would not effectively provide the safety 

enhancements intended by FDAAA. 

Furthermore, because the standards 

mandated by FDAAA do not currently 

exist for any animal food or feed, 

limiting new requirements to pet food 

only would fail to address the broader 

food safety concerns associated with 

food intended for other animal species, 

particularly food-producing animals. 

FDA is interested in obtaining input 

from interested stakeholders and the 

public as to whether the ingredient 

standards and definitions and 

processing standards should be 

developed for all animal feeds. There 

appears to be little or no difference 

between ingredients intended for use in 

pet foods and those intended for use in 

other animal foods and feeds. Therefore, 

the agency believes the most 

appropriate course of action is to 

develop ingredient standards and 

definitions and processing standards for 

all animal feeds, including pet food. 

FDA believes that such an approach 

would more effectively carry out the 

safety objectives of FDAAA, and the 

broader human food safety provisions of 

the Federal Food, Drug, and Cosmetic 

Act. The agency also seeks comment on 

this or other alternative approaches for 

implementing Section 1002(a) of 

FDAAA. 

B. Pet Food Labeling. 

1. How could the nutritional 

information (e.g., guaranteed analysis, 

nutritional adequacy statements/lifestage claims) already present on pet 

food labels be improved? 

2. How could the ingredient 

information already present on pet food 

labels (i.e., the ingredient list) be 

improved? 

3. How could the current feeding 

instructions/recommendations section 

already present on pet food labels be 

improved? 

4. Should feeding recommendations 

be required on the labels for all types of 

pet food? 

5. Should a Nutrition Facts box, 

similar to the format that appears on 

human food labels, replace the current 

Guaranteed Analysis that currently 

appears on pet food labels? If so, how 

could this Nutrition Facts box be made 

to clearly distinguish it from human 

food labeling? 

6. What other information should be 

required on pet food labels that is not 

generally present on pet food products 

sold in the United States? 

7. Are there existing state laws, 

regulations, guidelines, or other models 

that FDA should consider when drafting 

the proposed pet food labeling? 

C. Pet Food Ingredient Standards and 

Definitions. 

1. What kind of ingredient definitions 

would provide adequate information to 

ensure the safe and suitable use of the 

ingredients in pet foods? Should 

ingredient definitions also be developed 

for other animal feeds in addition to pet 

food? 

2. Should formal standards be a part 

of ingredient definitions? If so, what 

information should be considered to 

establish a standard? Should such 

standards be developed for ingredients 

intended for other animal feeds in 

addition to pet food? 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 73, No. 77 / Monday, April 21, 2008 / Notices 21359 

D. Pet Food Processing Standards 

The AFSS initiative is intended to 

cover 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. Some basic elements 

of an animal feed safety system are 

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

dockets/98fr/03n–0312–bkg0002.pdf. 

Would standards based on a riskbased, preventive, and comprehensive 

feed control measures approach, such as 

the approach described as an element of 

FDA’s AFSS initiative, adequately 

address the processing standards 

requirement of section 1002(a) of 

FDAAA? If so, what aspects of 

procurement, processing and 

distribution should be included in such 

an approach? Should such standards be 

developed and applied to all animal 

feeds rather than be limited to pet food? 

III. Other Information for the Public 

Meeting 

FDA has posted additional 

information for the May 13, 2008, public 

meeting on the CVM Web site at http:// 

www.fda.gov/cvm. The agency may 

make additional background material 

available to the public and will post that 

information on the CVM Web site as 

well. Additionally, background material 

relating to AFSS, including previous 

drafts of the AFSS Framework 

document, is available at http:// 

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

IV. Transcripts 

FDA will prepare a meeting transcript 

that will be entered into the docket. 

FDA anticipates that transcripts will be 

available approximately 30 business 

days after the meeting. The transcript 

will also be available for public 

examination at the Division of Dockets 

Management (HFA–305), 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

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

through Friday. 

Dated: April 15, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 08–1155 Filed 4–16–08; 3:48 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Pregnancy and 

Neonatology Study Section, June 2, 

2008, 8 a.m. to June 3, 2008, 3 p.m., 

Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC, 20015 which was 

published in the Federal Register on 

April 4, 2008, 73 FR 18539–18542. 

The meeting will be held one day 

only June 2, 2008, from 8 a.m. to 5 p.m. 

The meeting location remains the same. 

The meeting is closed to the public. 

Dated: April 14, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–8450 Filed 4–18–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Office of 

Biotechnology Activities; Recombinant 

DNA Research; Notice of a Meeting of 

an NIH Blue Ribbon Panel 

There will be a meeting of the NIH 

Blue Ribbon Panel to advise on the Risk 

Assessment of the National Emerging 

Infectious Diseases Laboratories (NEIDL) 

at the Boston Medical Center. The 

meeting will be held on Friday, May 2, 

2008, at the National Institutes of 

Health, Building 31, Floor 6C, 

Conference Room 10, 31 Center Drive, 

Bethesda, Maryland 20892, from 8:30 

a.m. to approximately 11:30 a.m. 

The National Research Council 

Committee that provided technical 

input on the NIH’s Draft Supplementary 

Risk Assessments and Site Suitability 

Analyses for the NEIDL will participate 

in discussions with Panel members 

regarding the scope and design of 

additional studies that may be needed to 

assess risk associated with the siting 

and operation of the NEIDL. 

For further information concerning 

this meeting contact Ms. Laurie 

Lewallen, Advisory Committee 

Coordinator, Office of Biotechnology 

Activities, Office of the Director, 

National Institutes of Health, 6705 

Rockledge Drive, Room 750, Bethesda, 

MD 20892–7985, 301–496–9838, 

lewallla@od.nih.gov. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed above in 

advance of the meeting. Any interested 

person may file written comments with 

the panel by forwarding the statement to 

the Contact Person listed on this notice. 

The statement should include the name, 

address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

NIH campus security procedures 

require that all visitor vehicles, 

including taxicabs and hotel and airport 

shuttles will be inspected before being 

allowed on campus. Visitors will be 

asked to show one form of identification 

(for example, a government-issued 

photo ID, driver’s license, or passport) 

and to state the purpose of their visit. 

An agenda and any additional 

information for the meeting will be 

posted on the agency’s Web site: 

http://www.nih.gov/about/director/acd/ 

index.htm. 

Background information may be 

obtained by contacting NIH OBA by email oba@od.nih.gov. 

Dated: April 14, 2008. 

Amy P. Patterson, 

Director, Office of Biotechnology Activities. 

[FR Doc. E8–8474 Filed 4–18–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice; 30-day notice and 

request for comments; Telephone 

Survey, OMB 1660–0057, Revision of a 

currently approved collection. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) has 

submitted the following information 

collection to the Office of Management 

and Budget (OMB) for review and 

clearance in accordance with the 

requirements of the Paperwork 

Reduction Act of 1995. The submission 

describes the nature of the information 

collection, the categories of 

respondents, the estimated burden (i.e., 

the time, effort and resources used by 

respondents to respond) and cost, and 


rwilkins on PROD1PC63 with NOTICES