Prevention of Salmonella Enteritidis in Shell Eggs During Production; Reopening of Comment Period, 24490-24491 [05-9327]

Download as PDF 24490 Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Proposed Rules stowage bin modules, and consequent injury to passengers and crew and interference with their ability to evacuate the airplane in an emergency. Compliance (e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Inspection To Determine I-beam Part Number (P/N) (f) Within 36 months after the effective date of this AD: Perform a general visual inspection of the center overhead stowage bin modules to determine the P/N of each Ibeam and to determine the configuration of each center overhead stowage bin module. Do the inspection in accordance with Boeing Special Attention Service Bulletin 767–25– 0320, dated April 11, 2002. Note 1: For the purposes of this AD, a general visual inspection is: ‘‘A visual examination of an interior or exterior area, installation, or assembly to detect obvious damage, failure, or irregularity. This level of inspection is made from within touching distance unless otherwise specified. A mirror may be necessary to ensure visual access to all surfaces in the inspection area. This level of inspection is made under normally available lighting conditions such as daylight, hangar lighting, flashlight, or droplight and may require removal or opening of access panels or doors. Stands, ladders, or platforms may be required to gain proximity to the area being checked.’’ (g) For any I-beam found having P/N 412T2040–29 during the inspection required by paragraph (f) of this AD: No further action is required by this AD for that I-beam only. Support Strap Installation (h) For any I-beam found having a P/N other than P/N 412T2040–29 during the inspection required by paragraph (f) of this AD: Before further flight, do the actions in paragraph (h)(1) or (h)(2) of this AD, as applicable, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 767–25– 0320, dated April 11, 2002. (1) If the forward-most stowage bin module was inspected: Before further flight, install support straps having P/N 412T2043–101 and 412T2043–102 on the center overhead stowage bin module, in accordance with Figures 3, 4, and 5 of the Accomplishment Instructions of the service bulletin. (2) If the stowage bin module inspected was other than the forward-most stowage bin module: Before further flight, do the actions specified in paragraph (h)(2)(i) or (h)(2)(ii) of this AD, as applicable. (i) For center overhead stowage bin modules having ‘‘Configuration A,’’ as specified in the service bulletin: Before further flight, do the actions specified in paragraph (h)(1) of this AD. (ii) For center overhead stowage bin modules having a configuration other than ‘‘Configuration A,’’ as specified in the service bulletin: Prior to further flight, install two support straps having P/N 412T2043–119 on the center overhead stowage bin module, in VerDate jul<14>2003 14:32 May 09, 2005 Jkt 205001 accordance with Figures 3, 4, and 6 of the Accomplishment Instructions of the service bulletin. Alternative Methods of Compliance (AMOCs) (i) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19. Issued in Renton, Washington, on May 3, 2005. Kalene C. Yanamura, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 05–9272 Filed 5–9–05; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. 2000N–0504] (formerly Docket No. 00N–0504) Prevention of Salmonella Enteritidis in Shell Eggs During Production; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. Proposed rule; reopening of comment period. ACTION: SUMMARY: The Food and Drug Administration (FDA) is reopening until June 9, 2005, the comment period for the agency’s proposed rule entitled ‘‘Prevention of Salmonella Enteritidis in Shell Eggs During Production’’ that published in the Federal Register of September 22, 2004 (69 FR 56824). FDA is reopening the comment period to receive comments and other information regarding industry practices and programs that prevent Salmonella Enteritidis (SE)-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into laying hen houses. DATES: Submit written or electronic comments by June 9, 2005. ADDRESSES: You may submit comments, identified by Docket No. 2000N–0504, by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Agency Web site: https:// www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. • E-mail: fdadockets@oc.fda.gov. Include Docket No. 2000N–0504 in the subject line of your e-mail message. PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 • FAX: 301–827–6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the agency name and docket number or regulatory information number for this rulemaking. All comments received will be posted without change to https://www.fda.gov/ ohrms/dockets/default.htm, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to https:// www.fda.gov/ohrms/dockets/ default.htm and insert the relevant docket number, 2000N–0504, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lou Carson, Center for Food Safety and Applied Nutrition (HFS–032), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301– 436–2130. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 22, 2004 (69 FR 56824), FDA proposed regulations that would require egg safety measures to prevent the contamination of shell eggs with SE during egg production. The proposal would reduce SE prevalence in the egg production environment and consequently in the eggs themselves. The proposed SE prevention measures include: (1) Provisions for procurement of chicks and pullets, (2) a biosecurity program, (3) a pest and rodent control program, (4) cleaning and disinfection of poultry houses that have had an environmental sample or egg test positive for SE, and (5) refrigerated storage of eggs at the farm. In addition, the proposal would require that producers test the environment for SE in poultry houses. If the environmental test is positive, the proposal would require that egg testing for SE be undertaken, and that if an egg test is positive, eggs be diverted from the table egg market to a technology or process that achieves at least a 5-log destruction of SE for shell eggs, or to processing in accordance with the Egg E:\FR\FM\10MYP1.SGM 10MYP1 Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Proposed Rules Products Inspection Act. The proposed rule had a 90-day comment period, which ended December 21, 2004. To discuss the proposed rule and solicit comments from interested stakeholders, FDA held three public meetings in 2004: October 28 in College Park, MD; November 9 in Chicago, IL; and November 16 in Los Angeles, CA. II. Request for Comments Based on comments received in response to the proposal, FDA is seeking further comment and information on industry practices and programs that prevent SE-monitored chicks from being infected by SE during the period of pullet rearing until placement into laying hen houses. Specifically, FDA seeks additional comment and supportive data or other information on the following questions: 1. How many pullet growing facilities are there in the United States? What is the range in the number of houses on those facilities? • What percentage of pullet growers are under programs or have practices aimed at preventing SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into layer hen houses? • Do State or regional Egg Quality Assurance Programs include provisions to prevent SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into layer hen houses? How effective have the pullet programs (whatever the programs entail—cleaning, testing, etc.) been in reducing the prevalence of SE in layer flocks? How is effectiveness measured? 2. During pullet rearing, what programs or industry practices are currently taken to prevent SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into layer hen houses? • Are pullets, or their environment, tested for SE between the time they are procured as chicks and the time they enter layer houses? If so, when? When tested, approximately how often do pullets or pullet environments test positive? What happens after a positive test? • Is vaccination used as a preventive measure, if so, when and how? • What cleaning and disinfecting practices are common? • Are measures taken to reduce the prevalence of rodents and pests in the pullet rearing houses? III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic VerDate jul<14>2003 14:32 May 09, 2005 Jkt 205001 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. Identify comments 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: May 3, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–9327 Filed 5–9–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 361 [Docket No. 2004N–0432] Radioactive Drugs for Certain Research Uses; Public Meeting; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of public meeting; reopening of comment period. ACTION: SUMMARY: The Food and Drug Administration (FDA) is reopening until July 11, 2005, the comment period on the questions raised and issues addressed in the notice of public meeting, published in the Federal Register of October 5, 2004 (69 FR 59569), on the use of certain radioactive drugs for research purposes without an investigational new drug application (IND) under the conditions set forth in FDA regulations. We are taking this action in response to requests to extend the comment period and to allow additional time to review agency guidance on a related matter. DATES: Submit written or electronic comments on the notice and/or public meeting by July 11, 2005. ADDRESSES: You may submit comments, identified by Docket No. 2004N–0432, by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Agency Web site: https:// www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. • E-mail: fdadockets@oc.fda.gov. Include Docket No. 2004N–0432 in the subject line of your e-mail message. • FAX: 301–827–6870. PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 24491 • Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions): Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the agency name and docket number for this proceeding. All comments received will be posted without change to https://www.fda.gov/ ohrms/dockets/default.htm, including any personal information provided. For detailed instructions on submitting comments, see the ‘‘Comments’’ heading in the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to https:// www.fda.gov/ohrms/dockets/ default.htm and insert Docket No. 2004N–0432 into the ‘‘Search’’ box and follow the prompts, or go to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript of the public meeting is available for review at the Division of Dockets Management and on the Internet at https://www.fda.gov/ohrms/ dockets. FOR FURTHER INFORMATION CONTACT: Maria R. Walsh, Center for Drug Evaluation and Research (HFD–103), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–3139, FAX: 301–480–3761, email: walsh@cder.fda.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of October 5, 2004 (69 FR 59569), we announced a public meeting to be held on November 16, 2004, to discuss research on radioactive drugs that is conducted under § 361.1 (21 CFR 361.1). Under § 361.1, certain radioactive drugs (drugs that exhibit spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons) are considered generally recognized as safe and effective under specified conditions of use when administered to human research subjects for certain basic research uses. These uses include studies intended to obtain basic information regarding the metabolism (including pharmacokinetics, distribution, and localization) of a radioactive drug or regarding human physiology, pathophysiology, or biochemistry, but not studies intended for immediate therapeutic, diagnostic, or similar purposes or studies intended to determine the safety and effectiveness E:\FR\FM\10MYP1.SGM 10MYP1

Agencies

[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Proposed Rules]
[Pages 24490-24491]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9327]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2000N-0504] (formerly Docket No. 00N-0504)


Prevention of Salmonella Enteritidis in Shell Eggs During 
Production; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening until June 
9, 2005, the comment period for the agency's proposed rule entitled 
``Prevention of Salmonella Enteritidis in Shell Eggs During 
Production'' that published in the Federal Register of September 22, 
2004 (69 FR 56824). FDA is reopening the comment period to receive 
comments and other information regarding industry practices and 
programs that prevent Salmonella Enteritidis (SE)-monitored chicks from 
becoming infected by SE during the period of pullet rearing until 
placement into laying hen houses.

DATES: Submit written or electronic comments by June 9, 2005.

ADDRESSES: You may submit comments, identified by Docket No. 2000N-
0504, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: fdadockets@oc.fda.gov. Include Docket No. 2000N-
0504 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number or regulatory information number for this rulemaking. 
All comments received will be posted without change to https://
www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm 
and insert the relevant docket number, 2000N-0504, into the ``Search'' 
box and follow the prompts and/or go to the Division of Dockets 
Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lou Carson, Center for Food Safety and 
Applied Nutrition (HFS-032), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-2130.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 22, 2004 (69 FR 56824), FDA 
proposed regulations that would require egg safety measures to prevent 
the contamination of shell eggs with SE during egg production. The 
proposal would reduce SE prevalence in the egg production environment 
and consequently in the eggs themselves. The proposed SE prevention 
measures include: (1) Provisions for procurement of chicks and pullets, 
(2) a biosecurity program, (3) a pest and rodent control program, (4) 
cleaning and disinfection of poultry houses that have had an 
environmental sample or egg test positive for SE, and (5) refrigerated 
storage of eggs at the farm. In addition, the proposal would require 
that producers test the environment for SE in poultry houses. If the 
environmental test is positive, the proposal would require that egg 
testing for SE be undertaken, and that if an egg test is positive, eggs 
be diverted from the table egg market to a technology or process that 
achieves at least a 5-log destruction of SE for shell eggs, or to 
processing in accordance with the Egg

[[Page 24491]]

Products Inspection Act. The proposed rule had a 90-day comment period, 
which ended December 21, 2004. To discuss the proposed rule and solicit 
comments from interested stakeholders, FDA held three public meetings 
in 2004: October 28 in College Park, MD; November 9 in Chicago, IL; and 
November 16 in Los Angeles, CA.

II. Request for Comments

    Based on comments received in response to the proposal, FDA is 
seeking further comment and information on industry practices and 
programs that prevent SE-monitored chicks from being infected by SE 
during the period of pullet rearing until placement into laying hen 
houses. Specifically, FDA seeks additional comment and supportive data 
or other information on the following questions:
    1. How many pullet growing facilities are there in the United 
States? What is the range in the number of houses on those facilities?
     What percentage of pullet growers are under programs or 
have practices aimed at preventing SE-monitored chicks from becoming 
infected by SE during the period of pullet rearing until placement into 
layer hen houses?
     Do State or regional Egg Quality Assurance Programs 
include provisions to prevent SE-monitored chicks from becoming 
infected by SE during the period of pullet rearing until placement into 
layer hen houses? How effective have the pullet programs (whatever the 
programs entail--cleaning, testing, etc.) been in reducing the 
prevalence of SE in layer flocks? How is effectiveness measured?
    2. During pullet rearing, what programs or industry practices are 
currently taken to prevent SE-monitored chicks from becoming infected 
by SE during the period of pullet rearing until placement into layer 
hen houses?
     Are pullets, or their environment, tested for SE between 
the time they are procured as chicks and the time they enter layer 
houses? If so, when? When tested, approximately how often do pullets or 
pullet environments test positive? What happens after a positive test?
     Is vaccination used as a preventive measure, if so, when 
and how?
     What cleaning and disinfecting practices are common?
     Are measures taken to reduce the prevalence of rodents and 
pests in the pullet rearing houses?

III. 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. 
Identify comments 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: May 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9327 Filed 5-9-05; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.