You are on page 1of 2

24490 Federal Register / Vol. 70, No.

89 / Tuesday, May 10, 2005 / Proposed Rules

stowage bin modules, and consequent injury accordance with Figures 3, 4, and 6 of the • FAX: 301–827–6870.
to passengers and crew and interference with Accomplishment Instructions of the service • Mail/Hand delivery/Courier [For
their ability to evacuate the airplane in an bulletin. paper, disk, or CD-ROM submissions]:
emergency.
Alternative Methods of Compliance Division of Dockets Management (HFA–
Compliance (AMOCs) 305), Food and Drug Administration,
(e) You are responsible for having the (i) The Manager, Seattle Aircraft 5630 Fishers Lane, rm. 1061, Rockville,
actions required by this AD performed within Certification Office (ACO), FAA, has the MD 20852.
the compliance times specified, unless the authority to approve AMOCs for this AD, if Instructions: All submissions received
actions have already been done. requested in accordance with the procedures must include the agency name and
found in 14 CFR 39.19. docket number or regulatory
Inspection To Determine I-beam Part
Number (P/N) Issued in Renton, Washington, on May 3, information number for this rulemaking.
(f) Within 36 months after the effective 2005. All comments received will be posted
date of this AD: Perform a general visual Kalene C. Yanamura, without change to http://www.fda.gov/
inspection of the center overhead stowage Acting Manager, Transport Airplane ohrms/dockets/default.htm, including
bin modules to determine the P/N of each I- Directorate, Aircraft Certification Service. any personal information provided. For
beam and to determine the configuration of [FR Doc. 05–9272 Filed 5–9–05; 8:45 am] detailed instructions on submitting
each center overhead stowage bin module. comments and additional information
BILLING CODE 4910–13–P
Do the inspection in accordance with Boeing on the rulemaking process, see the
Special Attention Service Bulletin 767–25–
‘‘Comments’’ heading of the
0320, dated April 11, 2002.
SUPPLEMENTARY INFORMATION section of
Note 1: For the purposes of this AD, a DEPARTMENT OF HEALTH AND
general visual inspection is: ‘‘A visual HUMAN SERVICES this document.
examination of an interior or exterior area, Docket: For access to the docket to
installation, or assembly to detect obvious Food and Drug Administration read background documents or
damage, failure, or irregularity. This level of comments received, go to http://
inspection is made from within touching 21 CFR Part 1 www.fda.gov/ohrms/dockets/
distance unless otherwise specified. A mirror default.htm and insert the relevant
may be necessary to ensure visual access to [Docket No. 2000N–0504] (formerly Docket docket number, 2000N–0504, into the
all surfaces in the inspection area. This level No. 00N–0504)
‘‘Search’’ box and follow the prompts
of inspection is made under normally
Prevention of Salmonella Enteritidis in and/or go to the Division of Dockets
available lighting conditions such as
daylight, hangar lighting, flashlight, or Shell Eggs During Production; Management, 5630 Fishers Lane, rm.
droplight and may require removal or Reopening of Comment Period 1061, Rockville, MD 20852.
opening of access panels or doors. Stands, FOR FURTHER INFORMATION CONTACT: Lou
ladders, or platforms may be required to gain AGENCY: Food and Drug Administration, Carson, Center for Food Safety and
proximity to the area being checked.’’ HHS. Applied Nutrition (HFS–032), Food and
(g) For any I-beam found having P/N Proposed rule; reopening of
ACTION: Drug Administration, 5100 Paint Branch
412T2040–29 during the inspection required comment period. Pkwy., College Park, MD 20740, 301–
by paragraph (f) of this AD: No further action 436–2130.
is required by this AD for that I-beam only. SUMMARY: The Food and Drug
SUPPLEMENTARY INFORMATION:
Support Strap Installation Administration (FDA) is reopening until
June 9, 2005, the comment period for I. Background
(h) For any I-beam found having a P/N
other than P/N 412T2040–29 during the the agency’s proposed rule entitled In the Federal Register of September
inspection required by paragraph (f) of this ‘‘Prevention of Salmonella Enteritidis in 22, 2004 (69 FR 56824), FDA proposed
AD: Before further flight, do the actions in Shell Eggs During Production’’ that regulations that would require egg safety
paragraph (h)(1) or (h)(2) of this AD, as published in the Federal Register of measures to prevent the contamination
applicable, in accordance with the September 22, 2004 (69 FR 56824). FDA of shell eggs with SE during egg
Accomplishment Instructions of Boeing is reopening the comment period to
Special Attention Service Bulletin 767–25–
production. The proposal would reduce
receive comments and other information SE prevalence in the egg production
0320, dated April 11, 2002. regarding industry practices and
(1) If the forward-most stowage bin module environment and consequently in the
programs that prevent Salmonella eggs themselves. The proposed SE
was inspected: Before further flight, install
support straps having P/N 412T2043–101 Enteritidis (SE)-monitored chicks from prevention measures include: (1)
and 412T2043–102 on the center overhead becoming infected by SE during the Provisions for procurement of chicks
stowage bin module, in accordance with period of pullet rearing until placement and pullets, (2) a biosecurity program,
Figures 3, 4, and 5 of the Accomplishment into laying hen houses. (3) a pest and rodent control program,
Instructions of the service bulletin. DATES: Submit written or electronic (4) cleaning and disinfection of poultry
(2) If the stowage bin module inspected comments by June 9, 2005.
was other than the forward-most stowage bin
houses that have had an environmental
module: Before further flight, do the actions ADDRESSES: You may submit comments, sample or egg test positive for SE, and
specified in paragraph (h)(2)(i) or (h)(2)(ii) of identified by Docket No. 2000N–0504, (5) refrigerated storage of eggs at the
this AD, as applicable. by any of the following methods: farm. In addition, the proposal would
(i) For center overhead stowage bin • Federal eRulemaking Portal: http:// require that producers test the
modules having ‘‘Configuration A,’’ as www.regulations.gov. Follow the environment for SE in poultry houses. If
specified in the service bulletin: Before instructions for submitting comments. the environmental test is positive, the
further flight, do the actions specified in • Agency Web site: http:// proposal would require that egg testing
paragraph (h)(1) of this AD. www.fda.gov/dockets/ecomments. for SE be undertaken, and that if an egg
(ii) For center overhead stowage bin
modules having a configuration other than
Follow the instructions for submitting test is positive, eggs be diverted from
‘‘Configuration A,’’ as specified in the service comments on the agency Web site. the table egg market to a technology or
bulletin: Prior to further flight, install two • E-mail: fdadockets@oc.fda.gov. process that achieves at least a 5-log
support straps having P/N 412T2043–119 on Include Docket No. 2000N–0504 in the destruction of SE for shell eggs, or to
the center overhead stowage bin module, in subject line of your e-mail message. processing in accordance with the Egg

VerDate jul<14>2003 14:32 May 09, 2005 Jkt 205001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\10MYP1.SGM 10MYP1
Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Proposed Rules 24491

Products Inspection Act. The proposed comments regarding this document. • Mail/Hand delivery/Courier (for
rule had a 90-day comment period, Submit a single copy of electronic paper, disk, or CD–ROM submissions):
which ended December 21, 2004. To comments or two paper copies of any Division of Dockets Management (HFA–
discuss the proposed rule and solicit mailed comments, except that 305), Food and Drug Administration,
comments from interested stakeholders, individuals may submit one paper copy. 5630 Fishers Lane, rm. 1061, Rockville,
FDA held three public meetings in 2004: Identify comments with the docket MD 20852.
October 28 in College Park, MD; number found in brackets in the Instructions: All submissions received
November 9 in Chicago, IL; and heading of this document. Received must include the agency name and
November 16 in Los Angeles, CA. comments may be seen in the Division docket number for this proceeding. All
of Dockets Management between 9 a.m. comments received will be posted
II. Request for Comments
and 4 p.m., Monday through Friday. without change to http://www.fda.gov/
Based on comments received in ohrms/dockets/default.htm, including
Dated: May 3, 2005.
response to the proposal, FDA is seeking any personal information provided. For
Jeffrey Shuren,
further comment and information on detailed instructions on submitting
industry practices and programs that Assistant Commissioner for Policy.
comments, see the ‘‘Comments’’ heading
prevent SE-monitored chicks from being [FR Doc. 05–9327 Filed 5–9–05; 8:45 am] in the SUPPLEMENTARY INFORMATION
infected by SE during the period of BILLING CODE 4160–01–S section of this document.
pullet rearing until placement into Docket: For access to the docket to
laying hen houses. Specifically, FDA read background documents or
seeks additional comment and DEPARTMENT OF HEALTH AND comments received, go to http://
supportive data or other information on HUMAN SERVICES www.fda.gov/ohrms/dockets/
the following questions: default.htm and insert Docket No.
1. How many pullet growing facilities Food and Drug Administration
2004N–0432 into the ‘‘Search’’ box and
are there in the United States? What is follow the prompts, or go to the Division
the range in the number of houses on 21 CFR Part 361
of Dockets Management (HFA–305),
those facilities? [Docket No. 2004N–0432] Food and Drug Administration, 5630
• What percentage of pullet growers Fishers Lane, rm. 1061, Rockville, MD
are under programs or have practices Radioactive Drugs for Certain 20852.
aimed at preventing SE-monitored Research Uses; Public Meeting; A transcript of the public meeting is
chicks from becoming infected by SE Reopening of Comment Period available for review at the Division of
during the period of pullet rearing until AGENCY: Food and Drug Administration, Dockets Management and on the
placement into layer hen houses? HHS. Internet at http://www.fda.gov/ohrms/
• Do State or regional Egg Quality dockets.
Assurance Programs include provisions ACTION:Notice of public meeting;
reopening of comment period. FOR FURTHER INFORMATION CONTACT:
to prevent SE-monitored chicks from
Maria R. Walsh, Center for Drug
becoming infected by SE during the SUMMARY: The Food and Drug Evaluation and Research (HFD–103),
period of pullet rearing until placement Administration (FDA) is reopening until Food and Drug Administration, 5600
into layer hen houses? How effective July 11, 2005, the comment period on Fishers Lane, Rockville, MD 20857,
have the pullet programs (whatever the the questions raised and issues 301–827–3139, FAX: 301–480–3761, e-
programs entail—cleaning, testing, etc.) addressed in the notice of public mail: walsh@cder.fda.gov.
been in reducing the prevalence of SE meeting, published in the Federal
in layer flocks? How is effectiveness SUPPLEMENTARY INFORMATION:
Register of October 5, 2004 (69 FR
measured? 59569), on the use of certain radioactive I. Background
2. During pullet rearing, what drugs for research purposes without an
programs or industry practices are In the Federal Register of October 5,
investigational new drug application 2004 (69 FR 59569), we announced a
currently taken to prevent SE-monitored (IND) under the conditions set forth in
chicks from becoming infected by SE public meeting to be held on November
FDA regulations. We are taking this 16, 2004, to discuss research on
during the period of pullet rearing until action in response to requests to extend
placement into layer hen houses? radioactive drugs that is conducted
the comment period and to allow under § 361.1 (21 CFR 361.1). Under
• Are pullets, or their environment, additional time to review agency
tested for SE between the time they are § 361.1, certain radioactive drugs (drugs
guidance on a related matter. that exhibit spontaneous disintegration
procured as chicks and the time they
DATES: Submit written or electronic of unstable nuclei with the emission of
enter layer houses? If so, when? When
tested, approximately how often do comments on the notice and/or public nuclear particles or photons) are
pullets or pullet environments test meeting by July 11, 2005. considered generally recognized as safe
positive? What happens after a positive ADDRESSES: You may submit comments, and effective under specified conditions
test? identified by Docket No. 2004N–0432, of use when administered to human
• Is vaccination used as a preventive by any of the following methods: research subjects for certain basic
measure, if so, when and how? • Federal eRulemaking Portal: http:// research uses. These uses include
• What cleaning and disinfecting www.regulations.gov. Follow the studies intended to obtain basic
practices are common? instructions for submitting comments. information regarding the metabolism
• Are measures taken to reduce the • Agency Web site: http:// (including pharmacokinetics,
prevalence of rodents and pests in the www.fda.gov/dockets/ecomments. distribution, and localization) of a
pullet rearing houses? Follow the instructions for submitting radioactive drug or regarding human
comments on the agency Web site. physiology, pathophysiology, or
III. Comments • E-mail: fdadockets@oc.fda.gov. biochemistry, but not studies intended
Interested persons may submit to the Include Docket No. 2004N–0432 in the for immediate therapeutic, diagnostic,
Division of Dockets Management (see subject line of your e-mail message. or similar purposes or studies intended
ADDRESSES) written or electronic • FAX: 301–827–6870. to determine the safety and effectiveness

VerDate jul<14>2003 14:32 May 09, 2005 Jkt 205001 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\10MYP1.SGM 10MYP1

You might also like