Agency Information Activities; Submission for OMB Review; Comment Request; Advisory Opinion. (29DEC99)
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Agency Information Activities; Submission for OMB Review; Comment Request; Notice of Participation. (29DEC99)
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Removal of Designated Journals. (10DEC99)
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Removal of Designated Journals; Companion Document to Direct Final Rule. (10DEC99)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Citizen Petition. (10DEC99)
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Agency Information Collection Activities; Announcement of OMB Approval; Survey of Manufacturing Practices in the
Dietary Supplement Industry. (07DEC99)
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Supporting Statement
The Survey Questionaire
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Agency Information Collection Activities; Announcement of OMB Approval; Survey of Food Manufacturing Facilities for
Year 2000 Compliance. (02DEC99)
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Supporting Statement
Survey Questionaire |
Citizen Petitions; Actions That Can be Requested by Petition; Denials, Withdrawals, and Referrals for Other
Administrative Action. (30NOV99)
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The 2000 FDA Science Forum--FDA and the Science of Safety: New Perspectives. (23NOV99)
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Public Information Regulations. (04NOV99)
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Delegations of Authority and Organization; Office of the Commissioner and the Center for Drug Evaluation and Research.
(03NOV99)
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Training Programs for Regulatory Project Managers; Information Available to Industry. (03NOV99)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Cosmetic Product Voluntary Reporting
Program. (28OCT99)
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Agency Information Collection Activities; Announcement of OMB Approval; State Enforcement Notification. (27OCT99)
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Prepublication document
Supporting Statement |
Agency Information Collection Activities; Announcement of OMB Approval; State Petitions for Exemption from Preemption. (27OCT99)
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Prepublication document
Supporting Statement |
Agency Information Collection Activities; Announcement of OMB Approval; Temporary Marketing Permit Applications. (27OCT99)
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Prepublication document
Supporting Statement |
Agency Information Collection Activities; Proposed Collection; Comment Request; Filing Objections and Requests for a Hearing on a
Regulation or Order. (25OCT99)
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Notice of Appeal of Order Granting Summary Judgment and Permanent Injunction. (25OCT99)
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Narcotic Drugs in Maintenance and Detoxification Treatment of Narcotic Dependence; Repeal of Current Regulations and Proposal To
Adopt New Regulations; Notice of Public Hearing - Joint Meerting of SAMHSA and FDA. (19OCT99)
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No Prepublication document
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OC 99263. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Quality Mammography
Standards; Lay Summaries for Patients. (18OCT99)
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Consumer Round Table; Notice of Meeting. (06OCT99)
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Agency Information Collection Activities: Proposed
Collection; Comment Request; Advisory Opinions; Extension. (28SEP99)
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Prepublication document |
Agency Information Collection Activities: Proposed
Collection; Comment Request; Notice of Participation; Extension. (28SEP99)
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Prepublication document |
Agency Information Collection Activities; Announcement of OMB Approval; Labeling Requirements for Color Additives (Other Than
Hair Dyes) and Petitions. (21SEP99)
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Prepublication document
Supporting Statement |
Agency Information Collection Activities: Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices.
(17SEP99)
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Delegations of Authority and Organization; Technical Amendment. (13SEP99)
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Request for Nominations for Nonvoting Representatives of Consumer and Industry Interests on Public Advisory Panels or Committees.
(10SEP99)
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Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Temporary Marketing Permit Applications.
(31AUG99)
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Prepublication document |
Prescription Drug User Fee Act (PDUFA) II Five-Year Plan Revision; Availability. (27AUG99)
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Prepublication document
Revised Plan |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Draft Guidance for Industry on Formal
Dispute Resolution; Appeals Above the Division Level. (25AUG99)
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Agency Information Collection Activities: Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program;
Correction. (25AUG99)
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Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Enforcement Notification. (24AUG99)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Petitions for Exemption from
Preemption. (20AUG99)
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Prepublication document |
Evaluation and Processing of Post Donation Information Reports; Compliance Policy Guide; Guidance for FDA Personnel;
Availability; Comment Request. (17AUG99)
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Prepublication documentThe Guidance |
Egg Safety Action Plan; Notice of public meeting on August 26, 1999. (This is a Joint document with USDA/FSIS.). (13AUG99)
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Prepublication document |
Public Health Impact of Foodborne Listeria Monocytogenes. Notice of meeting on September 23, 1999. (13AUG99)
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Agency Information Collection Activities: Proposed Collection; Comment Request; Citizen Petition. (12AUG99)
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Summary judgment and permanent injunction; final amended order (There was no FDA pre-pub or public display on this document).
(12AUG99)
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Foreign Establishment Registration and Listing; Reopening of Comment Period. (09AUG99)
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Agency Information Collection Activities: Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting
Program. (09AUG99)
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Prepublication document |
Agency Information Collection Activities; Submission \ for OMB Review; Comment Request; Labeling requirements for color additives
(other than hair dyes) and Petitions; Correction. (03AUG99)
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Prepublication document |
Food and Drug Administration/Industry Exchange Workshop on Scale-Up and Postapproval Changes, Supplements, and Other Postapproval
Changes; Public Workshop on August 17, 1999. (03AUG99)
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Prepublication document |
Enforcement Policy: Electronic Records; Electronic Signatures_Compliance Policy Guide; Guidance for FDA Personnel. (30JUL99)
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Agency Information Collection Activities: Proposed Collection; Comment Request; State Enforcement Notification; Correction.
(22JUL99)
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Prepublication document |
Statement of Organization, Functions, and Delegations of Authority; Correction. (19JUL99)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Labeling Requirements for Color Additives
(Other Than Hair Dyes) and Petitions. (08JUL99)
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Prepublication document |
Statement of Organization, Functions, and Delegations of Authority. (06JUL99)
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Prepublication document |
Exports: Notification and Record Keeping Requirements: Extension of Comment Period (17JUN99)
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Prepublication document |
Draft Civil Money Penalty Reduction Policy for Small Entities; Correction (15JUN99)
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Open Meeting for Representatives of Health Professional Organizations: Public Meeting. (08JUN99)
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Agency Information Collection Activities: Proposed Collection; Comment Request; State Enforcement Notification. (08JUN99)
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Agency Information Collection Activities: Proposed Collection; Comment Request; Temporary Marketing Permit Applications.
(08JUN99)
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Prepublication document |
Agency Information Collection Activities: Proposed Collection; Comment Request; State Petitions for Exemption from Preemption.
(04JUN99)
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Prepublication document |
Revocation of Advisory opinion Entitled "FD&C Act Trade Correspondence 61" (21MAY99) Click here for txt or pdf |
Draft Civil Money Penalty Reduction Policy for Small Entities. (18MAY99) Click here for txt or pdf |
Changes in the Procedures for Providing Public Notice of the Availability of Completed Environmental Assessments and Findings of
No Significant Impact (10MAY99) Click here for txt or pdf |
The 2000 FDA Science Forum--FDA and the Science of Safety: New Perspectives. (03MAY99) Click here for txt or pdf |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notification of a Health Claim or a
Nutrient Content Claim Based on an Authoritative Statement. [TXT] [PDF] (30 APR99)
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Mercury Compounds in Drugs and Food; Request for Data and Information. [TXT] [PDF] (29APR99)
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Agency Information Collection Activities: Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution
of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents. [TXT] [PDF] (23APR99)
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Drug Repackager Workshop. [TXT] [PDF] (08APR99)
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The Flax Council of Canada; Withdrawal of GRAS Affirmation Petition. Click here for txt or pdf (06APR99) |
Public Input on Public Health; Open Public Forum. Click here for txt or pdf (05APR99) |
Exports: Notification and Recordkeeping Requirements. Click here for txt or pdf (02APR99) |
Nitroglycerin Transdermal System; Opportunity for a Hearing. (25MAR99)
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Vale Chemical Co., Inc., et al.; Withdrawal of Approval of 13 New Drug Applications and 1 Abbreviated New
Drug Application. (24MAR99)
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Agency Emergency Processing Request under OMB Review; Collection; Survey of Manufacturers, Distributors,
Repackagers, and Other Drug Distribution Facilities for Year 2000 Compliance. (22MAR99)
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Draft Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level; Availability.
(19MAR99)
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Guidance . Click here for pdf |
Notice of Listing of Members of the Food and Drug Administration's Senior Executive Service Performance
Review Board. (15MAR99)
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Agency Information Collection Activities; Announcement of OMB Approval; Customer/Partner Satisfaction
Surveys. (10MAR99)
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Supporting Statement . Click here for
PDF |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Adverse Experience
Reporting for Licensed Biological Products, and General Records. (10MAR99)
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List of Drug Products That have been withdrawn or removed From the Market for Reasons of Safety or
Effectiveness. (08MAR99)
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Agency Information Collection Activities; Announcement of OMB Approval; Recordkeeping for Electronic
Products, Specific Product Requirements; Correction. (12FEB99)
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Docket No. 98N-0698, OC98423. Agency Information Collection Activities; Submission for OMB Review; Comment
Request; Survey of Consumer Attitudes Toward Potential Changes in Food Standards of Identity. (09FEB99)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Customer/Partner
Satisfaction Surveys; Correction. (26JAN99)
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Guidance on Amended Procedures for Advisory Panel Meetings; Availability. (26JAN99)
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The Guidance .Click here for pdf |
Open Meeting for Representatives of Health Professional Organizations. (08JAN99)
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Quarterly List of Guidance Documents at the Food and Drug Administration. (06JAN99)
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Agency Information Collection Activities; Announcement of OMB Approval; Recordkeeping for Electronic
Products, Specific Product Requirements. (05JAN99
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SUPPORTING STATEMENT FOR Reporting and Recordkeeping For Electronic Products
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