54360 Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices 

1Coordinated Framework for the Regulation of 

Biotechnology: June 26, 1986; 51 FR 23302; 

http://usbiotechreg.nbii.gov/CoordinatedFramework

ForRegulationOfBiotechnology1986.pdf. 

2 In addition to discussing the regulatory 

responsibilities of these agencies for GE organisms 

and other products, the Coordinated Framework 

also discusses the responsibilities of agencies with 

jurisdiction over GE research (the National 

Institutes of Health, the National Science 

Foundation, EPA, and USDA’s Agricultural 

Research Service). 

3 In accordance with the definition of ‘‘new 

animal drug’’ in 21 U.S.C. 321(v). 

OMB Control Number: 0572–0107. 

Summary of Collection: The Rural 

Electrification Act of 1936, 7 U.S.C. 901 

et seq., as amended, (RE ACT) in Sec. 

4 (7 U.S.C. 904) authorizes and 

empowers the Administrator of the 

Rural Utilities Service (RUS) to make 

loans in the several States and 

Territories of the United States for rural 

electrification and the furnishing and 

improving of electric energy to persons 

in rural areas. These loans are for a term 

of up to 35 years and are secured by a 

first mortgage on the borrower’s electric 

system. In the interest of protecting loan 

security and accomplishing the 

statutory objective of a sound program 

of rural electrification, Section 4 of the 

RE Act further requires that RUS make 

or guarantee a loan only if there is 

reasonable assurance that the loan, 

together with all outstanding loans and 

obligations of the borrower, will be 

repaid in full within the time agreed. 

RUS will collect information using 

various RUS forms. 

Need and Use of the Information: 

RUS will collect information to 

implement certain provisions of the 

RUS standard form of loan documents 

regarding the borrower’s purchase of 

materials and equipment and the 

construction of its electric system by 

contract or force account. The 

information will be used by RUS 

electric borrowers and their contractors 

and by RUS. If standard forms were not 

used, borrowers would need to prepare 

their own documents at a significant 

expense; and each document submitted 

by a borrower would require extensive 

and costly review by both RUS and the 

Office of the General Counsel. 

Description of Respondents: Not-forprofit institutions; Business or other forprofit. 

Number of Respondents: 1,210. 

Frequency of Responses: Reporting: 

On occasion. 

Total Burden Hours: 104. 

Charlene Parker, 

Departmental Information Collection 

Clearance Officer. 

[FR Doc. E8–21907 Filed 9–18–08; 8:45 am] 

BILLING CODE 3410–15–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2006–0188] 

RIN 0579–AC37 

Genetically Engineered Animals 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Request for information. 

SUMMARY: The Animal and Plant Health 

Inspection Service (APHIS) is seeking 

public comment and scientific and 

technical empirical data and 

information concerning ongoing and 

future research on genetically 

engineered animals. APHIS’ interest is 

to ensure that genetically engineered 

animals imported into the United States 

or moved interstate do not present risks 

to U.S. livestock health. We also seek 

comment on what types of actions and 

approaches APHIS should consider in 

addressing any such risks that would 

complement the Food and Drug 

Administration’s (FDA’s) oversight, 

described in draft guidance elsewhere in 

this issue of the Federal Register. 

DATES: We will consider all comments 

that we receive on or before November 

18, 2008. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/fdmspublic/

component/main?main=DocketDetail&

d=APHIS–2006–0188 to submit or view 

comments and to view supporting and 

related materials available 

electronically. 

• Postal Mail/Commercial Delivery: 

Please send two copies of your comment 

to Docket No. APHIS–2006–0188, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737–1238. Please state that your 

comment refers to Docket No. APHIS– 

2006–0188. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room is located in room 1141 of the 

USDA South Building, 14th Street and 

Independence Avenue, SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690–2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

http://www.aphis.usda.gov. 

FOR FURTHER INFORMATION CONTACT: 

Biotechnology Regulatory Services, 

APHIS, 4700 River Road Unit 146, 

Riverdale, MD 20737–1236; 301–734– 

5720. 

SUPPLEMENTARY INFORMATION: 

Background 

In 1986, the Office of Science and 

Technology Policy (OSTP) under the 

Executive Office of the President 

published a policy document known as 

the Coordinated Framework for the 

Regulation of Biotechnology (the 

Coordinated Framework).1 This policy 

document describes the system for 

coordinating the activities of the Federal 

agencies responsible for regulating all 

GE organisms:2 The Environmental 

Protection Agency (EPA), the U.S. 

Department of Health and Human 

Services’ (HHS) Food and Drug 

Administration (FDA), and the U.S. 

Department of Agriculture (USDA), 

specifically the Animal and Plant 

Health Inspection Service (APHIS). The 

foundation of the Coordinated 

Framework is that existing health and 

safety laws administered by these 

Federal agencies provide a sound 

network of agency authorities for the 

regulation of GE organisms and 

products. 

Roles of APHIS and Other Agencies in 

the Regulation of GE Animals 

USDA and FDA both have authorities 

relevant to the oversight of GE animals. 

FDA has authority over new animal 

drugs under the Federal Food, Drug, and 

Cosmetic Act (FFDCA, 21 U.S.C. 321 et 

seq.). Elsewhere in the issue of the 

Federal Register, FDA is announcing 

the availability of draft guidance for 

public comment clarifying its oversight 

of GE animals under the new animal 

drug provisions of the FFDCA. The draft 

guidance explains that where a 

recombinant DNA construct in a GE 

animal is intended to affect the structure 

or function of the body of the GE 

animal, that construct is a new animal 

drug 3 regardless of the intended use of 

products that may be produced by the 

GE animal. The FFDCA requires that 

each new animal drug be approved 

through a new animal drug application 

(NADA) based on a demonstration that 

it is safe and effective for its intended 

use. FDA has been working with 

developers of GE animals for almost 20 

years and the draft guidance is intended 

to clarify requirements and 

recommendations for producers and 

developers of GE animals and their 

products. 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices 54361 

The USDA has provided Federal 

leadership in protecting U.S. livestock 

health for more than 120 years. APHIS 

is authorized, under the Animal Health 

Protection Act (AHPA) (7 U.S.C. 8301 et 

seq.), to protect the health of U.S. 

livestock by preventing the introduction 

and spread of livestock diseases and 

pests into and within the United States. 

Based on that authority, APHIS may 

broadly consider the potential effects of 

animals with GE traits on the health of 

the overall U.S. livestock population, 

while FDA is more focused on the direct 

effects of genetic engineering on 

individual animals based on their 

authority under the FFDCA. Given these 

complementary authorities, APHIS and 

FDA have been discussing their 

respective roles in overseeing GE 

animals for some time. FDA’s release for 

public comment of its draft guidance on 

GE animals provides an excellent 

opportunity for APHIS to solicit public 

comment on the potential effects of 

animals with GE traits on U.S. livestock 

health. 

APHIS particularly seeks the 

following information: 

1. What research on GE animals is 

currently being conducted or planned 

for the future? 

2. What, if any, implications would 

activities such as the importation and 

interstate movement of such animals 

have for the health of the U.S. livestock 

population? 

3. What, if any, activities should 

APHIS consider with respect to U.S. 

livestock health under the AHPA that 

would complement the requirements 

and recommendations described in 

FDA’s draft guidance? 

APHIS welcomes comments and 

scientific and technical information and 

data relevant to these issues. We will 

consider all comments and information 

we receive in determining the 

appropriate role for APHIS with regard 

to GE animals and will continue to 

collaborate closely with FDA. 

This action has been determined to be 

significant for the purposes of Executive 

Order 12866 and, therefore, has been 

reviewed by the Office of Management 

and Budget. 

Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 

2.80, and 371. 

Done in Washington, DC, this 16th day of 

September 2008. 

Bruce Knight, 

Under Secretary for Marketing and Regulatory 

Programs. 

[FR Doc. E8–21977 Filed 9–18–08; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2008–0032] 

Codex Alimentarius Commission: 2nd 

Session of the Codex ad hoc 

Intergovernmental Task Force on 

Antimicrobial Resistance 

AGENCY: Office of the Under Secretary 

for Food Safety, USDA. 

ACTION: Notice of public meeting. 

SUMMARY: The Office of the Under 

Secretary for Food Safety, United States 

Department of Agriculture (USDA), and 

the Food and Drug Administration 

(FDA) are sponsoring a public meeting 

on September 25, 2008, to discuss the 

agenda items coming before the 2nd 

session of the Codex ad hoc 

Intergovernmental Task Force on 

Antimicrobial Resistance (AMR) and to 

present draft U.S. positions on the 

agenda items. The 2nd session of the 

AMR will be held in Seoul, Korea, 

October 20–24, 2008. The Under 

Secretary and FDA recognize the 

importance of providing interested 

parties the opportunity to comment on 

the agenda items that will be discussed 

at this forthcoming session of AMR. 

DATES: The public meeting is scheduled 

for Thursday, September 25, 2008, from 

1 p.m. to 3 p.m. 

ADDRESSES: The public meeting will be 

held at FDA, 7519 Standish Place, Room 

152, Rockville, MD. 

Documents related to the 2nd session 

of the AMR will be accessible via the 

World Wide Web at the following 

address: http:// 

www.codexalimentarius.net/ 

current.asp. 

For Further Information About the 2nd 

Session of the AMR Contact: U.S. 

Delegate, Dr. David White, Director, 

National Antimicrobial Resistance 

Monitoring System (NARMS), FDA, 

Center for Veterinary Medicine, Office 

of Research, 8401 Muirkirk Rd., Laurel, 

MD 20798, Phone: (301) 210–4181, 

E-mail: david.white@fda.hhs.gov. 

For Further Information About the 

Public Meeting Contact: Edith Kennard, 

Staff Officer, U.S. Codex Office, Food 

Safety and Inspection Service (FSIS), 

Room 4861, South Building, 1400 

Independence Avenue, SW., 

Washington, DC 20250, Phone: (202) 

720–5261, Fax: (202) 720–3157, E-mail: 

edith.kennard@fsis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Codex Alimentarius (Codex) was 

established in 1963 by two United 

Nations organizations, the Food and 

Agriculture Organization (FAO) and the 

World Health Organization (WHO). 

Through adoption of food standards, 

codes of practice, and other guidelines 

developed by its committees, and by 

promoting their adoption and 

implementation by governments, Codex 

seeks to protect the health of consumers 

and ensure that fair practices are used 

in trade. 

The Codex ad hoc Intergovernmental 

Task Force on AMR was established by 

the 29th Session of the Codex 

Alimentarius Commission in 2006 to 

develop science-based guidance to be 

used to assess the risks to human health 

associated with the presence in food 

and feed, including aquaculture, and the 

transmission through food and feed of 

antimicrobial resistant microorganisms 

and antimicrobial resistance genes. The 

AMR Task Force would also consider 

appropriate risk management options to 

reduce such risk. The Task Force is 

hosted by the Republic of Korea. 

Issues To Be Discussed at the Public 

Meeting 

The following items on the agenda for 

the 2nd session of the AMR will be 

discussed during the public meeting: 

• Matters Referred to the Committee 

from Other Codex Bodies 

• Information on the Work by FAO, 

WHO, and the World Organization for 

Animal Health on Antimicrobial 

Resistance 

• Proposed Draft Risk Assessment 

Guidance Regarding Foodborne 

Antimicrobial Resistant Microorganisms 

(Report of the Working Group) 

• Proposed Draft Guidance on 

Creating Risk Profiles for Antimicrobial 

Resistant Foodborne Microorganisms for 

Setting Risk Assessment and 

Management Priorities (Report of the 

Working Group) 

• Proposed Draft Risk Management 

Guidance to Contain Foodborne 

Antimicrobial Resistant Microorganisms 

(Report of the Working Group) 

Each issue listed will be fully 

described in documents distributed, or 

to be distributed, by the Korean 

Secretariat to the meeting. Members of 

the public may access copies of these 

documents at http:// 

www.codexalimentarius.net/ 

current.asp. 

Public Meeting 

At the September 25, 2008, public 

meeting, draft U.S. positions on these 

agenda items will be described and 

discussed, and attendees will have the 

opportunity to pose questions and offer 

comments. Written comments may be 

offered at the meeting or sent to the U.S. 


jlentini on PROD1PC65 with NOTICES