Apr 1998

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April 1998 Federal Register Documents

Monday	Tuesday	Wednesday	Thursday	Friday
4/27	4/28	4/29	4/30
4/20	4/21	4/22	4/23	4/24
4/13	4/14	4/15	4/16	4/17
4/6	4/7	4/8	4/9	4/10
		4/1	4/2	4/3

4/30/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents - No FDA Documents			043098co.pdf

04/29/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			042998co.pdf
96N–0320	Radiology Devices; Classifications for Five Medical Image Management Devices	Final rule.	23385	042998a.pdf
98N–0044	Regulations on Statements Made Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body	Proposed rule.	23624	042998b.pdf
98N–0048	Dietary Supplements; Comments on Report of the Commission on Dietary Supplement Labels	Notice	23633	042998c.pdf

4/28/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			042898co.pdf
95D–0349	Draft Guidance for Industry on SUPAC–IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum; Availability	Notice	23291	042898a.pdf
	Draft Guidance for Industry on SUPAC–IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum	Draft Guidance		95D0349.pdf
98D–0238	Guidance Document for Industry and CDRH Staff for the Preparation of CDRH Investigational Device Exemptions Premarket Approval Applications for Bone Growth Stimulator Devices; Draft; Availability	Notice	23292	042898b.pdf
	Guidance Document for Industry and CDRH Staff for the Preparation of CDRH Investigational Device Exemptions Premarket Approval Applications for Bone Growth Stimulator Devices; Draft	Draft Guidance		98D0238.pdf
98D–0233	Guidance for Industry on PAC–ATLS: Postapproval Changes—Analytical Testing Laboratory Sites; Availability	Notice	23293	042898c.pdf
	Guidance for Industry on PAC–ATLS: Postapproval Changes—Analytical Testing Laboratory Sites	Guidance		98D0233.PDF

4/27/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			042798co.pdf
98N–0168	Medical Devices; 30–Day Notices and 135–Day PMA Supplement Review	Direct final rule.	20530	042798a.pdf
98N–0168	Medical Devices; 30–Day Notices and 135–Day PMA Supplement Review; Companion Document to Direct Final Rule	Proposed final rule.	20558	042798b.pdf
	Gastrointestinal Drugs Advisory Committee; Notice of Meeting	Notice of Meeting	20638	042798c.pdf

4/24/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			042498co.pdf
92F–0290	Indirect Food Additives: Polymers	Final rule.	20313	042498a.pdf
97N–0511	Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice	Proposed rule.	20450	042498b.pdf
97N–0524	Food Labeling: Warning and Notice Statements; Labeling of Juice Products	Proposed rule.	20486	042498c.pdf
	Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting	Notice of Meeting	20414	042498d.pdf
	Science Board to the Food and Drug Administration; Notice of Meeting	Notice of Meeting	20414	042498d.pdf

4/23/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			042398co.pdf
95C–0399	Listing of Color Additives for Coloring Sutures; D&C Violet No. 2	Final rule.	20096	042398a.pdf
94P–0043	Crabmeat; Amendment of Common or Usual Name Regulation	Proposed rule.	20148	042398b.pdf
97N–0531	Agency Information Collection Activities; Announcement of OMB Approval - ‘‘Performance Standard for Electrode Lead Wires and Patient Cables: Petitions for Exemptions and Variances’’ - OMB 0910–0367	Notice	20203	042398c.pdf
97N–0485	Agency Information Collection Activities; Announcement of OMB Approval - ‘‘Shipment of a Blood Product Prior to Completion of Testing for Hepatitis B Surface Antigen (HbsAg), and Shipment of Blood Products Known Reactive for HbsAg’’ - OMB 0910–0168	Notice	20203	042398c.pdf
98N–0046	Comprehensive List of Current Guidance Documents at the Food and Drug Administration; Correction	Notice; correction.	20203	042398c.pdf

4/22/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			042298co.pdf
75N–183F, 75N–183D, and 80N–0280	Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients	Final rule.	19799	042298a.pdf

4/21/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			042198co.pdf
98N–0194]	Agency Information Collection Activities: Proposed Collection; Comment Request - "Voluntary registration of cosmetic product establishments with FDA." - OMB 0910–0027 - Extension)	Notice.	19734	042198a.pdf
98N–0148	International Drug Scheduling; Convention on Psychotropic Substances; Dihydroetorphine, Ephedrine, and Remifentanil; Isomers of Psychotropic Substances	Notice; correction.	19735	042198b.pdf
	Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting	Notice of Meeting	19735	042198b.pdf

4/20/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			042098co.pdf
97N–0449	Revisions to the General Safety Requirements for Biological Products	Direct final rule.	19399	042098a.pdf
97N–0449	Revisions to the General Safety Requirements for Biological Products; Companion to Direct Final Rule	Proposed rule.	19431	042098b.pdf
	Antiviral Drugs Advisory Committee; Notice of Meeting	Notice of Meeting	19501	042098c.pdf

04/17/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			041798co.pdf
	New Animal Drugs For Use In Animal Feeds; Bacitracin Zinc; Technical Policies and Procedures, a finalAmendment	Final rule; technical amendment.	19184	041798a.pdf
98N–0171	Medical Devices; Humanitarian Use of Devices	Direct final rule.	19185	041798b.pdf
98N–0171	Medical Devices; Humanitarian Use of Devices; Companion to Direct Final Rule	Proposed rule.	19196	041798c.pdf
98D–0193	Draft Guidance for Industry on Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients; Availability	Notice	19267	041798d.pdf

04/15/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			041598co.pdf
	Delegations of Authority and Organization	Final rule.	18314	041598a.pdf
97E–0144	Determination of Regulatory Review Period for Purposes of Patent Extension; ZAGAM�	Notice	18431	041598b.pdf
	Pulmonary-Allergy Drugs Advisory Committee Meeting; Cancellation	Notice of Cancellation	18431	041598b.pdf

04/14/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			041498co.pdf
97N–0532	Agency Information Collection Activities: Activities; Submission for OMB Review; Radioactive Drug Research Committees; Comment Request - Radioactive Drug For Certain Research Uses—21 CFR 361.1—(OMB 0910–0053—Reinstatement)	Notice	18203	041498a.pdf
97E–0109	Determination of Regulatory Review Period for Purposes of Patent Extension; LEVAQUIN TM	Notice	18204	041498b.pdf

04/13/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			041398co.pdf
	New Animal Drugs For Use In Animal Feeds; Bacitracin Zinc; Corrections	Final rule; correction.	17947	041398a.pdf
	Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting	Notice of Meeting	18028	041398b.pdf
97N–0451	Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables; Availability	Notice	18029	041398c.pdf
	Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables	Draft Guidance		97N0451.pdf

04/10/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			041098co.pdf
95N–0185	Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; Pharmaceutical GMP Inspection Reports, Medical Device Quality System Evaluation Reports, and Certain Medical Device Premarket Eval	Proposed rule.	17744	041098a.pdf

04/09/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			040998co.pdf
	Oral Dosage Form New Animal Drugs; Neomycin Sulfate Soluble Powder - Abbreviated New Animal Drug Application (ANADA) 200–235	Final rule.	17329	040998a.pdf
96P–0338	Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Coronary Heart Disease; Correction	Final rule; correction.	17327	040998b.pdf
89N–0474	Agency Information Collection Activities: Activities; Submission for OMB Review; Comment Request Geriatric Use Labeling for Human Prescription Drugs—21 CFR 201.57(f)(10)	Notice	17428	040998c.pdf
98D–0149	Guidance for Industry on National Uniformity for Nonprescription Drugs—Ingredient Listing for OTC Drugs; Availability	Notice	17429	040998d.pdf

04/08/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			040898co.pdf
98N–0192	Agency Information Collection Activities: Proposed Collection; Comment Request (OMB Number 0910–0124—Reinstatement) Establishment and Product License Applications: Forms	Notice	17183	040898a.pdf
Meeting	Drug Abuse Advisory Committee; Notice of Meeting	Notice of Meeting	17185	040898b.pdf
Meeting	Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting	Notice of Meeting	17186	040898c.pdf
97D–0381	Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—NDA’s; Availability	Notice	17184	040898d.pdf
	Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—NDA’s	Draft Guidance		97D0381.pdf

04/07/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			040798co.pdf
98N–0182	Bulk Drug Substances To Be Used in Pharmacy Compounding; Request for Nominations	Notice; request for nominations.	17011	040798a.pdf
	Grassroots Regulatory Partnership Workshop	Notice	17012	040798b.pdf

04/06/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			040698co.pdf
21 CFR Parts 606, 610, 640, and 1270	Foods and Drugs; technical amendments.	Final rule; technical amendments.	16685	040698a.pdf

04/03/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			040398co.pdf
87F–0086	Food Additives Permitted for Direct Addition to Food for Human Consumption; Sucralose	Notice	16417	040398a.pdf

04/02/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			040298co.pdf
95F–0174	Ecolab, Inc.; Withdrawal of Food Inc.; Withdrawal of FoodAdditive Petition (FAP) 5B4462	Notice	16264	040298a.pdf

04/01/98
Document Number	Document Name	Action	FRN Page	File Name
	Table of Contents			040198co.pdf
98F–0184	Rohm and Haas Co.; Filing of Food Additive Petition (FAP) 8A4588	Notice	15851	040198a.pdf
98D–0188	Guidance to Industry and CDRH for PMAs and PMA Supplements: Use of Published Literature, Use of PreviouslySubmitted Materials, and Priority Review; Draft; Availability	Notice	15851	040198a.pdf
	Guidance to Industry and CDRH for PMAs and PMA Supplements: Use of Published Literature, Use of PreviouslySubmitted Materials, and Priority Review; Draft;	Draft Guidance		98D0188.pdf

[ Top ] [ Home ] [ Up ] [ Current Month's 1999 FRs ] [ July 1999 ] [ June 1999 ] [ May 1999 ] [ April 1999 ] [ March 1999 ] [ Feb 1999 ] [ Jan 1999 ] [ Dec 1998 ] [ Nov 1998 ] [ Oct 1998 ] [ Sep 1998 ] [ Aug 1998 ] [ Jul 1998 ] [ Jun 1998 ] [ May 1998 ] [ Apr 1998 ]