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Your search returned 10 results.
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 |
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| 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. |
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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 |
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| 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. |
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| 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 |
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| 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. |
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| 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 |
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| 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. |
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| TITLE: |
Public Information Regulations |
| SUBJECT CATEGORY: |
Public information; Freedom of Information Act exemptions; implementation |
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| RULE |
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| 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. |
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| 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 |
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| 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. |
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| 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 |
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| 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. |
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| 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 |
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| 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. |
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| 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 |
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| 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. |
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| 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 |
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| 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. |
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