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ANIMAL AND PLANT HEALTH INSPECTION SERVICE

TITLE: Tuberculosis in Cattle; Import Requirements
SUBJECT CATEGORY: Exportation and importation of animals and animal products: Tuberculosis in cattle; import requirements
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PROPOSED RULE  
Docket ID: [03-081-3]
CFR Citation: 9 CFR 93
Published: August 24, 2004 [FR Doc. 04-19313]
Comments Due:October 25, 2004
How to Comment:Submit a Comment on this Regulation
You may submit comments by any of the following methods: Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 03-081-3, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 03-081-3. E-mail: Address your comment to regulations@aphis.usda.gov. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and Docket No. 03-081-3 on the subject line. Agency Web site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through the APHIS Web site. Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this docket and submitting comments. 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: You may view APHIS documents published in the Federal Register and related information, including the names of groups and individuals who have commented on APHIS dockets, on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.
TITLE: Interstate Movement of Sheep and Goats; Approved Livestock Facilities, Identification and Recordkeeping Requirements
SUBJECT CATEGORY: Interstate transportation of animals and animal products (quarantine): Sheep and goats; approved livestock facilities; identification and recordkeeping requirements
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PROPOSED RULE  
CFR Citation: 09 CFR 71
Published: August 26, 2004 [FR Doc. 04-19516]
Comments Due:October 25, 2004
How to Comment:Submit a Comment on this Regulation
You may submit comments by any of the following methods: Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 00-094-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 00-094-1. E-mail: Address your comment to regulations@aphis.usda.gov. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and Docket No. 00-094-1 on the subject line. Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through the APHIS Web site. Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this docket and submitting comments. 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: You may view APHIS documents published in the Federal Register and related information, including the names of groups and individuals who have commented on APHIS dockets, on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.
TITLE: Animal Welfare; Regulations and Standards for Birds, Rats, and Mice
SUBJECT CATEGORY: Animal welfare: Birds, rats, and mice; regulations and standards
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PROPOSED RULE  
Docket ID: [0579-AB69]
CFR Citation: 9 CFR 2, 3
Published: July 21, 2004 [FR Doc. 04-16541]
Comments Due:November 01, 2004
How to Comment:Submit a Comment on this Regulation
You may submit comments by any of the following methods: Webform: The preferred method is to use the webform located at http://comments.aphis.usda.gov. This webform is designed to allow commenters to associate each of their comments with the issues identified in the advance notice, and to allow APHIS to more easily analyze the comments received regarding each issue. Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 98-106-4, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 98-106-4. E-mail: Address your comment to regulations@aphis.usda.gov. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and Docket No. 98-106-4 on the subject line. Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this docket and submitting comments. Reading Room: You may read any comments that we receive on Docket No. 98-106-4 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: You may view APHIS documents published in the Federal Register and related information, including the names of groups and individuals who have commented on APHIS dockets, on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

CENTERS FOR MEDICARE AND MEDICAID SERVICES

TITLE: Medicaid Program and State Childrens Health Insurance Program (SCHIP); Payment Error Rate Measurement; Correction
SUBJECT CATEGORY: State Childrens Health Insurance Program: Allotments and grants to States-- Payment error measurement rate; correction
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PROPOSED RULE  
Docket ID: [CMS-6026-CN]
CFR Citation: 42 CFR 431, 457
Published: September 24, 2004 [FR Doc. 04-21198]
Comments Due:October 27, 2004
How to Comment:Submit a Comment on this Regulation
TITLE: Medicare Program; Physicians Referrals to Health Care Entities With Which They Have Financial Relationships (Phase II); Correcting Amendment
SUBJECT CATEGORY: Medicare: Physicians referrals to health care entities with which they have finanncial relationships Correction
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RULE  
Docket ID: [CMS-1810-IFC2]
CFR Citation: 42 CFR 411
Published: September 24, 2004 [FR Doc. 04-21206]
Comments Due:November 23, 2004
How to Comment:Submit a Comment on this Regulation
In commenting, please refer to file code CMS-1810-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of three ways (no duplicates, please): 1. Electronically. You may submit electronic comments on specific issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments. (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 2. By mail. You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1810-IFC2, P.O. Box 8011, Baltimore, MD 21244-8011. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. We are only accepting comments on whether to reinstate the physician self-referral advisory opinion regulations, not on the substance of the regulations themselves. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

DRUG ENFORCEMENT ADMINISTRATION

TITLE: Security Requirements for Handlers of Pseudoephedrine, Ephedrine, and Phenylpropanolamine
SUBJECT CATEGORY: Controlled substances; manufacturers, distributors, and dispensers; registration: Pseudoephedrine, ephedrine, and phenylpropanolamine; security requirements
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PROPOSED RULE  
CFR Citation: 21 CFR 1309
Published: July 30, 2004 [FR Doc. 04-17356]
Comments Due:October 28, 2004
How to Comment:Submit a Comment on this Regulation
To ensure proper handling of comments, please reference Docket No. DEA-211P on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/CCD. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/CCD, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. Comments may be directly sent to DEA electronically by sending an electronic message to dea.diversion.policy@usdoj.gov. Comments may also be sent electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.regulations.gov web site. DEA will accept electronic comments containing MS Word, WordPerfect, Adobe PDF, or Excel files only. DEA will not accept any file format other than those specifically listed here.

FEDERAL TRADE COMMISSION

TITLE: Prescreen Opt-Out Disclosure
SUBJECT CATEGORY: Fair and Accurate Credit Transactions Act; implementation: Prescreen opt-out notices
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PROPOSED RULE  
CFR Citation: 16 CFR 642, 698
Published: October 01, 2004 [FR Doc. 04-22039]
Comments Due:October 28, 2004
How to Comment:Submit a Comment on this Regulation
Interested parties are invited to submit written comments. Comments should refer to FACTA Prescreen Rule, Project No. R411010 to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed to the following address: Federal Trade Commission, FACTA Prescreen Rule, Post Office Box 1030, Merrifield, VA 22116-1030. Please note that courier and overnight deliveries cannot be accepted at this address. Courier and overnight deliveries should be delivered to the following address: Federal Trade Commission/Office of the Secretary, Room H-159 (Annex R), 600 Pennsylvania Avenue, NW., Washington, DC 20580. Comments containing confidential material must be filed in paper form, as explained in the Supplementary Information section. Comments filed in electronic form should be submitted by clicking on the following weblink: https://secure.commentworks.com/ftcprescreen/ and following the instructions on the web-based form. To ensure that the Commission considers an electronic comment, you must file it on the web-based form at the https://secure.commentworks.com/ftcprescreen/ weblink. You may also visit http://www.regulations.gov to read this proposed Rule, and may file an electronic comment through that Web site. The Commission will consider all comments that regulations.gov forwards to it. Comments on any proposed filing, recordkeeping, or disclosure requirements that are subject to paperwork burden review under the Paperwork Reduction Act should be submitted to the FTC as indicated above, and should additionally be submitted to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission. Comments should be submitted via facsimile to (202) 395-6974 because U.S. postal mail at the Office of Management and Budget is subject to lengthy delays due to heightened security precautions. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments received by the Commission, whether filed in paper or in electronic form, will be considered by the Commission, and will be available to the public on the FTC Web site, to the extent practicable, at http://www.ftc.gov. As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from public comments it receives before placing those comments on the FTC Web site. More information, including routine uses permitted by the Privacy Act, may be found in the FTC"s privacy policy, at http://www.ftc.gov/privacy.htm.
TITLE: Trade Regulation Rule on Disclosure Requirements and Prohibitions Concerning Franchising and Business Opportunity Ventures
SUBJECT CATEGORY: Trade regulation rules: Franchising and business opportunity ventures; disclosure requirements and prohibitions
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PROPOSED RULE  
CFR Citation: 16 CFR 436
Published: September 02, 2004 [FR Doc. 04-19969]
Comments Due:November 12, 2004
How to Comment:Submit a Comment on this Regulation
Interested persons are invited to submit written comments on the Staff Report. Comments should refer to Franchise Rule Staff Report, R511003 to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission/Office of the Secretary, Room H-159 (Annex W), 600 Pennsylvania Avenue, NW., Washington, DC 20580. If the comment contains any material for which confidential treatment is requested, it must be filed in paper form, and the first page of the document must be clearly labeled Confidential. The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions. Comments can be filed in electronic form by clicking on the following weblink: https://secure.commentworks.com/ftc-franchisereport/ and following the instructions on the web-based form. To ensure that the Commission considers an electronic comment, you must file it on the web-based form at the https://secure.commentworks.com/ftc-franchisereport/ weblink. If this noticeappears at http://www.regulations.gov, you may also file an electronic comment through that Web site. The Commission will consider all comments that regulations.gov forwards to it. You may also visit the FTC Web site at http://www.ftc.gov/opa/2004/08/franchiserule.htm to read the Staff Report and the news release describing it, and the FTC Web site at http://www.ftc.gov/opa/1999/10/franchise-review3.htm to read the Notice of Proposed Rulemaking and the news release describing this proposed Rule. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments, whether filed in paper or electronic form, will be considered by the Commission, and will be available to the public on the FTC Web site, to the extent practicable, at http://www.ftc.gov. As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC Web site. More information, including routine uses permitted by the Privacy Act, may be found in the FTC"s privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

FOOD AND DRUG ADMINISTRATION

TITLE: Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
SUBJECT CATEGORY: Administrative practice and procedure: New drug applications; complete response letter and amendments to unapproved applications
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PROPOSED RULE  
Docket ID: [2004N-0267]
CFR Citation: 21 CFR 312, 314, ETC.
Published: July 20, 2004 [FR Doc. 04-16476]
Comments Due:October 18, 2004
How to Comment:Submit a Comment on this Regulation
You may submit comments, identified by [Docket No. 2004N-0267], by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Agency Web Site: http://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-0267] 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 No. 2004N-0267] for this rulemaking. All comments received will be posted without change to http://www.fda.gov/dockets/ecomments, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the Request for 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 http://www.fda.gov/dockets/ecomments and/or the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The Office of Management and Budget (OMB) is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.
TITLE: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph for Over-the-Counter Nasal Decongestant Drug Products
SUBJECT CATEGORY: Human drugs: Nasal decongestant drug products (OTC); final monograph amendment
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PROPOSED RULE  
Docket ID: [2004N-0289]
CFR Citation: 21 CFR 310, 341
Published: August 02, 2004 [FR Doc. 04-17445]
Comments Due:November 01, 2004
How to Comment:Submit a Comment on this Regulation
You may submit comments, identified by [Docket No. 2004N-0289 and/or RIN number 0910-AF34], by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Agency Web site: http://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-0289 and/or RIN number 0910-AA01] 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the agency name and Docket No. or Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted without change to http://www.fda.gov/dockets/ecomments, 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 http://www.fda.gov/dockets/ecomments and/or the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
TITLE: Public Information Regulations; Companion Document to Direct Final Rule
SUBJECT CATEGORY: Public information; Freedom of Information Act exemptions; implementation
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PROPOSED RULE  
Docket ID: [2004N-0214]
CFR Citation: 21 CFR 20
Published: September 02, 2004 [FR Doc. 04-19995]
Comments Due:November 16, 2004
How to Comment:Submit a Comment on this Regulation
You may submit comments, identified by [Docket No. 2004N-0214], by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Agency Web site: http://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-0214] 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the agency name andDocket No. 2004N-0214 for this rulemaking. All comments received will be posted without change to http://www.fda.gov/dockets/ecomments, 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 http://www.fda.gov/dockets/ecomments and/or the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
TITLE: Public Information Regulations
SUBJECT CATEGORY: Public information; Freedom of Information Act exemptions; implementation
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RULE  
Docket ID: [2004N-0214]
CFR Citation: 21 CFR 20
Published: September 02, 2004 [FR Doc. 04-19996]
Comments Due:November 16, 2004
How to Comment:Submit a Comment on this Regulation
You may submit comments, identified by [Docket No. 2004N-0214], by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Agency Web site: http://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-0214] 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the agency name and Docket No. 2004N-0214 for this rulemaking. All comments received will be posted without change to http://www.fda.gov/dockets/ecomments, 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 http://www.fda.gov/dockets/ecomments and/or the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
TITLE: Over-the-Counter Human Drugs; Labeling Requirements; Delay of Implementation Date
SUBJECT CATEGORY: Human drugs: Labeling of drug products (OTC)-- Standardized format; implementation date delay
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RULE  
Docket ID: [Docket Nos. 1998N-0337]
CFR Citation: 21 CFR 201
Published: September 03, 2004 [FR Doc. 04-18842]
Comments Due:December 02, 2004
How to Comment:Submit a Comment on this Regulation
You may submit comments, identified by Docket Nos. 1998N-0337, 1996N-0420, 1995N-0259, and 1990P-0201 and/or RIN number 0910-AA79, by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Agency Web site: http://www.fda.gov/docket/ecomments. Follow the instructions for submitting comments on the agency Web site. E-mail: fdadockets@oc.fda.gov. Include Docket Nos. 1998N-0337, 1996N-0420, 1995N-0259, and 1990P-0201 and/or RIN number 0910-AA79 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the agency name and docket numbers or regulatory information number (RIN) for this rulemaking. All comments received will be posted without change to http://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 dockets to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and/or the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
TITLE: Prevention of Salmonella Enteritidis in Shell Eggs During Production
SUBJECT CATEGORY: Food for human consumption: Salmonella; shell egg producers to implement prevention measures
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PROPOSED RULE  
Docket ID: [Docket Nos. 1996P-0418]
CFR Citation: 21 CFR 16, 118
Published: September 22, 2004 [FR Doc. 04-21219]
Comments Due:December 21, 2004
How to Comment:Submit a Comment on this Regulation
You may submit comments, identified by [Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504], by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. E-mail: fdadockets@oc.fda.gov. Include [Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504 and RIN number 0910-AC14] 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the agency name and Docket No. or Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted without change to http://www.fda.gov/dockets/ecomments, 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 http://www.fda.gov/dockets/ecomments and/or the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
TITLE: Egg Safety; Proposed Rule for Prevention of Salmonella Enteritidis in Shell Eggs During Production; Public Meetings
SUBJECT CATEGORY: Food for human consumption: Salmonella; shell egg producers to implement prevention measures Meetings
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PROPOSED RULE  
Docket ID: [Docket Nos. 1996P-0418]
CFR Citation: 21 CFR 16, 118
Published: October 07, 2004 [FR Doc. 04-22476]
Comments Due:December 21, 2004
How to Comment:Submit a Comment on this Regulation
The following are a list of the upcoming meeting locations: 1. Thursday, October 28, 2004, Harvey W. Wiley Federal Building, Auditorium, 5100 Paint Branch Pkwy., College Park, MD. 2. Tuesday, November 9, 2004, Chicago Marriott Downtown Magnificent Mile, 540 North Michigan Ave., Chicago, IL. 3. Tuesday, November 16, 2004, Los Angeles Airport Marriott, 5855 West Century Blvd., Los Angeles, CA. You may submit comments, identified by [Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504], by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. E-mail: fdadockets@oc.fda.gov. Include [Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504 and RIN number 0910-AC14] 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.Instructions: All submissions received must include the agency name and Docket Nos. or Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted without change to http://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 ADDRESSES section of this document.Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and insert the docket number(s), found in brackets in the heading of this document, 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.
TITLE: Microbiology Devices; Reclassification of Hepatitis A Virus (HAV) Serological Assays (IgM Antibody, IgG Antibody and Total Antibodies (IgM and IgG))
SUBJECT CATEGORY: Medical devices: Immunology and microbiology devices-- Hepatitis A virus serological assays; reclassification
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PROPOSED RULE  
Docket ID: [2003P-0564]
CFR Citation: 21 CFR 866
Published: September 30, 2004 [FR Doc. 04-22009]
Comments Due:December 29, 2004
How to Comment:Submit a Comment on this Regulation
Submit written comments 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:// http://www.fda.gov/dockets/ecomments.
TITLE: Radioactive Drugs for Certain Research Uses; Public Meeting
SUBJECT CATEGORY: Human drugs: Radioactive drugs for research uses; meeting
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PROPOSED RULE  
Docket ID: [2004N-0432]
CFR Citation: 21 CFR 361
Published: October 05, 2004 [FR Doc. 04-22354]
Comments Due:January 16, 2005
How to Comment:Submit a Comment on this Regulation
The public meeting will be held at the CDER Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD 20857. You may submit comments, identified by Docket No. 2004N-0432, by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Agency Web site: http://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. 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 No. All comments received will be posted without change to http://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 in the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts, or go to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Transcripts of the public meeting will be available for review at the Division of Dockets Management (see ADDRESSES) and on the Internet at http://www.fda.gov/ohrms/dockets.

FOOD SAFETY AND INSPECTION SERVICE

TITLE: Frequency of Foreign Inspection System Supervisory Visits to Certified Foreign Establishments
SUBJECT CATEGORY: Meat and poultry inspection: Foreign inspection system supervisory visits to certified foreign establishments; frequency
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PROPOSED RULE  
CFR Citation: 09 CFR 327, 381
Published: August 18, 2004 [FR Doc. 04-18889]
Comments Due:October 18, 2004
How to Comment:Submit a Comment on this Regulation
Comments may be submitted by any of the following methods: Mail, including floppy disks or CD-ROM"s, and hand-or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., Room 102 Cotton Annex, Washington, DC 20250. All submissions received must include the Agency name and docket number 03-033P. All comments submitted in response to this Proposal, as well as research and background information used by FSIS in developing this document, will be available for public inspection in the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday. The comments also will be posted on the Agency"s web site at http://www.fsis.usda.gov/OPPDE/rdad/FRDockets.htm.
TITLE: Control of Listeria monocytogenes in Ready-to-Eat Meat and Poultry Products
SUBJECT CATEGORY: Meat and poultry inspection: Ready-to-eat meat and poultry products; listeria monocytogenes control
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RULE  
Docket ID: [0583-AC46]
CFR Citation: 09 CFR 430
Published: June 06, 2003 [FR Doc. 03-14173]
Comments Due:December 08, 2004
How to Comment:Submit a Comment on this Regulation
One original and two copies of each comment should be sent to FSIS Docket 97-013F, U.S. Department of Agriculture, Food Safety and Inspection Service, Room 102 Cotton Annex, 300 12th Street, SW., Washington, DC 20250-3700. Comments will be available for public inspection in the Docket Clerk"s Office between 8:30 and 4:30 p.m., Monday through Friday.




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