Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Rules and Regulations 70053

Guides reach small and very small 

establishments. The team also suggested 

that, to be useful to small and very small 

plants, the guidelines be simplified. 

Retail Team 

Finally, the Retail team focused on 

possible means of controlling L. 

monocytogenes in RTE products at retail 

establishments. This team found that 

slicing and packaging deli meats at 

retail establishments represents a 

significant source of exposure of L. 

monocytogenes. The team suggested two 

possible strategies for dealing with this 

problem: (1) education and outreach, 

and (2) use of antimicrobial agents in 

products to be sliced and sold at retail 

establishments. The team also pointed 

to efforts already underway in the 

Agency to compare the risk of listeriosis 

from product sliced in plants with the 

risk from those sliced at retail 

establishments. The results of this 

assessment will be used by the Agency 

in developing its strategy for retail 

establishments. 

Availability of the Complete Team 

Report 

The report on ‘‘Assessing the 

Effectiveness of the Listeria 

monocytogenes Interim Final Rule’’, 

with each of the Project Assessment 

Team’s individual reports, is available 

on the Agency Web site at http://

www.fsis.usda.gov/Frame/

FrameRedirect.asp?main=http://

www.fsis.usda.gov/OPPDE/rdad/

FRPubs/Docs_97–013F.htm.

The complete report may also be 

viewed in the FSIS Docket Room, 300 

12th Street, SW., Room 102 Cotton 

Annex, Washington, DC, 20250 between 

8:30 a.m. to 4:30 p.m. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that the public and in particular 

minorities, women, and persons with 

disabilities, are aware of this notice, 

FSIS will announce it on-line through 

the FSIS Web page located at http://

www.fsis.usda.gov.

FSIS also will make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, recalls, and other 

types of information that could affect or 

would be of interest to our constituents 

and stakeholders. The update is 

communicated via Listserv, a free e-mail 

subscription service consisting of 

industry, trade, and farm groups, 

consumer interest groups, allied health 

professionals, scientific professionals, 

and other individuals who have 

requested to be included. The update 

also is available on the FSIS Web page. 

Through Listserv and the Web page, 

FSIS is able to provide information to a 

much broader, more diverse audience.

Done in Washington, DC, on October 29, 

2004. 

Barbara J. Masters, 

Acting Administrator.

[FR Doc. 04–26515 Filed 12–1–04; 8:45 am] 

BILLING CODE 3410–DM–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration 

14 CFR Part 71

[Docket No. FAA–2004–18827; Airspace 

Docket No. 04–ACE–53] 

Modification of Class E Airspace; 

Hannibal, MO

AGENCY: Federal Aviation 

Administration (FAA), DOT.

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: This document confirms the 

effective date of the direct final rule 

which revises Class E airspace at 

Hannibal, MO.

DATES: Effective 0901 UTC, January 20, 

2005.

FOR FURTHER INFORMATION CONTACT:

Brenda Mumper, Air Traffic Division, 

Airspace Branch, ACE–520A, DOT 

Regional Headquarters Building, Federal 

Aviation Administration, 901 Locust, 

Kansas City, MO 64106; telephone: 

(816) 329–2524.

SUPPLEMENTARY INFORMATION: The FAA 

published this direct final rule with a 

request for comments in the Federal 

Register on October 8, 2004 (69 FR 

60286). The FAA uses the direct final 

rulemaking procedure for a noncontroversial rule where the FAA 

believes that there will be no adverse 

public comment. This direct final rule 

advised the public that no adverse 

comments were anticipated, and that 

unless a written adverse comment, or a 

written notice of intent to submit such 

an adverse comment, were received 

within the comment period, the 

regulation would become effective on 

January 20, 2005. No adverse comments 

were received, and thus this notice 

confirms that this direct final rule will 

become effective on that date.

Issued in Kansas City, MO, on November 

16, 2004. 

Anthony D. Roetzel, 

Acting Area Director, Western Flight Services 

Operations.

[FR Doc. 04–26524 Filed 12–1–04; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

Oral Dosage Form New Animal Drugs; 

Sulfadiazine/Pyrimethamine 

Suspension

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a new animal drug 

application (NADA) filed by Animal 

Health Pharmaceuticals, LLC. The 

NADA provides for veterinary 

prescription use of an oral suspension of 

sulfadiazine and pyrimethamine for the 

treatment of equine protozoal 

myeloencephalitis (EPM).

DATES: This rule is effective December 2, 

2004.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov.

SUPPLEMENTARY INFORMATION: Animal 

Health Pharmaceuticals, LLC, 1805 Oak 

Ridge Circle, suite 101, St. Joseph, MO 

64506, filed NADA 141–240 for 

veterinary prescription use of 

REBALANCE (sulfadiazine/

pyrimethamine) Antiprotozoal Oral 

Suspension for the treatment of EPM 

caused by Sarcocystis neurona. The 

NADA is approved as of November 5, 

2004, and 21 CFR part 520 is amended 

by adding new § 520.2215 to reflect the 

approval. The basis of approval is 

discussed in the freedom of information 

summary.

In addition, Animal Health 

Pharmaceuticals, LLC, is not currently 

listed in the animal drug regulations as 

a sponsor of an approved application. 

At this time, 21 CFR 510.600(c) is being 

amended to add entries for the firm.

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to