Semiannual Guidance Agenda

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0928]

Semiannual Guidance Agenda

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing the first

semiannual guidance document agenda. FDA committed to publishing, on a

semiannual basis, possible guidance topics or documents for development

or revision during the next year, and seeking public comment on

additional ideas for new or revisions of existing guidance documents.

This commitment was made in FDA's February 1997 ``Good Guidance

Practices'' (GGP's), which set forth the agency's policies and

procedures for the development, issuance, and use of guidance

documents. This list is intended to seek public comment on possible

topics for guidance documents and possible revisions to existing

guidances.

DATES: Comments on this list and on agency guidance documents are

welcome at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

[[Page 59318]]

For general information regarding FDA's GGP's contact: Lisa L.

Barclay, Office of Policy (HF-22), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-827-3360.

For information regarding specific topics or guidances, please see

contact persons listed below.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February 27, 1997 (62 FR 8961), FDA

published a notice announcing its GGP's, which set forth the agency's

policies and procedures for the development, issuance, and use of

guidance documents. The agency adopted the GGP's to ensure public

involvement in the development of guidance documents and to enhance

public understanding of the availability, nature, and legal effect of

such guidance.

As part of FDA's effort to ensure meaningful interaction with the

public regarding guidance documents, the agency committed to publishing

a semiannual guidance document agenda of possible guidance topics or

documents for development or revision during the next year. The agency

also committed to soliciting public input regarding these and

additional ideas for new topics or revisions to existing guidance

documents.

The agency is neither bound by this list of possible topics nor

required to issue every guidance document on this list or precluded

from issuing guidance documents not on the list set forth in this

document.

The following list of guidance topics or documents represents

possible new topics or revisions to existing guidance documents that

the agency is considering. The agency solicits comments on the topics

listed in this document and also seeks additional ideas from the

public. On June 1, 1998, the President instructed all Federal agencies

to ensure the use of ``plain language'' in all new documents. As part

of this initiative, FDA is also seeking public comment on the clarity

of its guidance documents.

The guidance documents are organized by the issuing Center or

Office within FDA, and are further grouped by topic categories. The

agency's contact persons are listed for each specific area.

II. Center for Biologics Evaluation and Research (CBER)

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Title/Topic of Guidance Contact

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Category--Compliance and Inspection

Guidance for Reprocessing, Reworking, and Blending Stephen M. Ripley, Center for Biologics (HFM-17), Food

Practices for Biological Bulk Substances, Final and Drug Administration, 1401 Rockville Pike,

Bulk, and Finished Products. Rockville, MD 20852-1448, 301-827-6210.

Guide for Inspection of Blood Banks. Do.

Guide to Inspections of Source Plasma Establishments. Do.

Compliance Program 7342.002, Inspection of Source Do.

Plasma Establishments.

Compliance Program 7342.001, Inspections of Licensed Do.

and Unlicensed Blood Banks.

Compliance Program for Inspections of Allergenic Do.

Product Manufacturers.

Compliance Program for Inspections of Licensed Do.

Therapeutic Products.

Guidance for the Design, Installation, and Operations Do.

of Water Systems.

Guidance on Heating, Ventilation, and Air Do.

Conditioning (HVAC) and the Monitoring of

Environments for the Manufacture of Biological

Substances and Products.

Guidance for the Validation of the Limulus Amebocyte Do.

Lystate Test as an End-Product Endotoxin Test for

Human and Animal Parenteral Drugs, Biological

Products, and Medical Devices.

Category--Therapeutics

Guidance for the Chemistry, Manufacturing and Control Do.

Information on Naturally Derived Proteins.

Guidance for the Chemistry, Manufacturing and Control Do.

Information on Gene Therapy Products.

Guidance on Monoclonal Antibodies and Orphan Drug Do.

Designation.

Guidance to Industry on Xenotransplantation. Do.

Guidance for Industry: Public Health Issues Posed by Do.

the Use of Nonhuman Primate Xenografts in Humans.

Guidance on Clinical Trial Issues in Wound Healing. Do.

Category--Blood and Blood Components

Guidance for Clarification of the December 11, 1996, Do.

Memorandum: ``Revised Precautionary Measures to

Reduce the Possible Risk of Transmission of

Creutzfeldt-Jacob Disease (CDJ) by Blood and Blood

Products.''

Guidance for Collection, Testing and Release of Do.

Autologous Blood.

Guidance for Recommendations for Donor Testing by Do.

Automated Methods When Using Treponemal Based

Screening Tests for Syphilis.

Guidance for Reviewer Guidance for a Premarket Do.

Notification Submission for Automated Blood

Establishment Testing Instruments.

Guidance for Revised Recommendations for the Do.

Invalidation of Test Results When Using Licensed and

510(k) Cleared Bloodborne Pathogen Assays to Test

Donors.

[[Page 59319]]

Guidance for HIV Reentry Algorithms for Deferred Do.

Blood and Plasma Donors.

Guidance for Chemistry, Manufacturing and Control Do.

Information on In Vitro Diagnostic Products.

Guidance for Precautionary Measures to Reduce the Do.

Possible Risk of Transmission of Zoonoses by

Xenograft Recipients and Their Close Contacts,

Through Whole Blood, Blood Components, Source

Plasma, and Source Leukocytes.

Guidance for Additional Recommendations for Donor Do.

Questioning Regarding Travel to Areas Endemic for

Malaria.

Guidance for Platelet Testing and Evaluation of Do.

Platelet Substitute Products.

Guidance for Size Limitations for Human Blood or Do.

Plasma Pools Used to Manufacture Injectable Drug

Products.

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III. Center for Devices and Radiological Health (CDRH)

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Title/Topic of Document Contact

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Guidance on Custom Devices. Wally Pellerite, Center for Devices and Radiological

Health (HFZ-300), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-4692.

Guidance on Medical Device Tracking--Revision (Level Casper Uldriks, Center for Devices and Radiological

1). Health (HFZ-300), Food and Drug Administration, 5600

Fishers Lane, HFZ-300, Rockville, MD 20857, 301-594-

4692.

Guidance on PMA Submissions and Inspectional Quality Wes Morganstern, Center for Devices and Radiological

System Regulation Assessment--Proposal (Level 1). Health (HFZ-305), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-4699.

Guidance on Inspection of Medical Device Do

Manufacturers--Proposal (Level 1).

Compliance Policy Guide on Remanufacturing of Used Do.

Medical Devices--Draft (Level 1).

Guidance on Year 2000 Issues for Medical Device Stewart Crumpler, Center for Devices and Radiological

Manufacturers and Servicers--Proposal (Level 1). Health (HFZ-343), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-4659, or

Thomas Shoppe, Center for Devices and Radiological

Health (HFZ-140), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-443-3314.

Erythropoietin Assay. Joseph L. Hacket, Center for Devices and Radiological

Health (HFZ-440), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-3084.

Fibrin Monomer Paracoagulator Tests. Do.

Kits for Screening Drugs of Abuse To Be Used by the Do.

Consumer.

Assayed and Unassayed Quality Control Material. Do.

Point of Care In Vitro Diagnostic Devices. Do.

Extracorporeal Membrane Oxygenators (ECMO). Lynn A. Reamer, Center for Devices and Radiological

Health (HFZ-450), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-443-8320.

Compressible Limb Sleeves. Do.

Thermal Regulating Devices. Do.

Cardiopulmonary Bypass Roller Pumps. Do.

Guidance for Intraaortic Balloon Pumps. Do.

Cardiac Monitors (including Cardiotachometers and Do.

Rate Alarm).

Electrocardiographs. Do.

Cardiopulmonary Bypass Nonroller-Type Pumps. Do.

Annulolasty Rings. Do.

Vascular Prostheses. Do.

Cardiopulmonary Bypass Arterial Filters. Do.

Cardiopulmonary Bypass Defoamers. Do.

Blood Gas Exchangers (Oxygenators) Used in Do.

Cardiopulmonary Bypass.

Endoscopes. Patricia J. Miller, Center for Devices and Radiological

Health (HFZ-470), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-5072.

Audiometers. Do.

Assistive Listening Devices. Do.

Phonosurgery Implants for Vocal Cord Medialization. Do.

Biocompatibility of Materials in ENT Implants. Do.

[[Page 59320]]

Endoscope Sheaths. Do.

Body Composition Analyzers. Do.

Hemodialysis Blood Access Devices (Level 2). Do.

Blood Lines for Hemodialysis (Level 2). Do.

Nasogastric Feeding Tubes (Level 2). Do.

In Vivo Devices for the Detection of Cervical Cancer Do.

and Its Precursors: IDE.

Intrapartum Fetal Pulse Oximeters--IDE/PMA. Do.

Thermal Endometrial Ablation Systems--IDE/PMA. Do.

Radiation Therapy Treatment Planning. Do.

Linear Accelerator. Do.

Ultrasound Coupling Gel. Do.

Radionuclide Dose Calibrator. Do.

Ultrasound Transducer Probe Covers. Do.

Ultrasound Bone Sonometers. Do.

Bone Densitometry Device Labeling. Do.

Emission Computed Tomography System. Do.

Nuclear Tomography. Do.

Electrohydraulic Lithotripters. Do.

Extracorporeal Shockwave Lithotripters. Do.

Neonatal Incubators and Neonatal Transport Von Nakayama, Center for Devices and Radiological

Incubators. Health (HFZ-480), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-443-8913.

Spinal Assemblies (IDE's). Sammie Niver, Center for Devices and Radiological

Health (HFZ-410), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-2036.

Ophthalmic Camera. Deborah L. Falls, Center for Devices and Radiological

Health, Food and Drug Administration (HFZ-460), 5600

Fishers Lane, Rockville, MD 20857, 301-594-2205.

Keratome. Do.

Refractive Implants. Do.

Intraocular Lens Delivery Systems. Do.

Accountability Analysis for Ophthalmic Devices. Do.

Keratoprosthesis. Do.

Glaucoma Drainage. Do.

Nonprescription Sunglasses. Do.

Patient Labeling Guidance (Level 1). Paula G. Silberberg, Center for Devices and

Radiological Health (HFZ-230), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-594-1217.

Human Factors Data To Be Submitted in Premarket Ronald D. Kaye, Center for Devices and Radiological

Submissions (Level 1). Health (HFZ-230), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-3265.

Questions and Answers About the Mammography Quality Kathleen M. Sheridan, Center for Devices and

Standards Act Final Regulations (Level 1). Radiological Health (HFZ-240), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-594-3275.

Search Engine to Use With Guidance Documents Do.

Developed for Mammography Quality Standards Act

(Level 2).

Guidance for Additional Mammography Review (AMR). Do.

Guidance for Patient Notification Under Mammography Do.

Quality Standards Act.

MDR Reporting for Manufacturers--Revision. Thomas E. Cardamone, Center for Devices and

Radiological Health (HFZ-220), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-443-0806, ext. 117.

MDR A Brief Overview--Revision of Archived Document. Do.

Registration and Listing Instructions--Revision. Do.

Registration and Listing Manual--Revision of Do.

Archived.

Immunotoxicity Testing. John J. Langone, Center for Devices and Radiological

Health (HFZ-113), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-443-7132.

Testing for Infant Apnea Monitors (draft). Jeffrey L. Silberberg, Center for Devices and

Radiological Health (HFZ-141), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-443-2536, ext. 15.

Identification and Evaluation of Candidate Consensus Harvey Rudolph, Center for Devices and Radiological

Standards Recognition. Health (HFZ-100), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-827-4777.

Guidance to Manufacturers for the Development of Laura A. Alonge, Center for Devices and Radiological

Postmarket Surveillance Plans Required Under Section Health (HFZ-543), Food and Drug Administration, 5600

522 of the Federal Food, Drug, and Cosmetic Act Fishers Lane, Rockville, MD 20857, 301-594-0648.

(immediately in effect).

Guidance for Industry on the Testing of Metallic Do.

Plasma Sprayed Coatings on Orthopedic Implants to

Support Reconsideration of Postmarket Surveillance

Requirements (draft).

[[Page 59321]]

Reportability of Incidents Associated With the Use of Do.

Endosseous Implants (final).

Reportability of Incidents Associated With the Use of Do.

External Defibrillators (final).

MDR Questions and Answers. Do.

Reportability of Incidents Associated With the Use of Do.

Implants.

Reuse of Medical Devices. Do.

Statistical Guidance for Clinical Trials of Do.

Nondiagnostic Devices (revised).

Statistical Guidance for Clinical Trials of Do.

Diagnostic Devices.

Statistical Guidance on Bayesian Methods in Medical Do.

Device Clinical Trials.

Guidance for MDR Analysts on Adverse Event Report Do.

Review.

Guidance on MDR Prioritization. Do.

Guidance for Reviewers of Postmarket Surveillance Do.

Submissions.

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IV. Center for Drugs Evaluation and Research (CDER)

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Title/Topic of Document Contact

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Category--Advertising

Accelerated Approval Products: Submission of Nancy E. Derr, Center for Drug Evaluation and Research

Promotional Materials. (HFD-5), Food and Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852, 301-594-5400.

Advertising and Labeling of Treatment IND Protocols. Do.

Anti-Infective Human Drug and Biological Products Do.

Advertising and Promotional Labeling.

Comparative Claims in Advertising and Labeling. Do.

Fair Balance. Do.

Healthcare Economic Information. Do.

Health Related Quality of Life Claims. Do.

Infomercials. Do.

Promotion at International Meetings. Do.

Promotion of Investigational Products. Do.

Promotion of Medical Products on the Internet. Do.

Proprietary (Brand) Name and Established (Generic) Do.

Name Placement, Size, and Prominence in Advertising

and Promotional Labeling.

Providing Electronic Submissions to the Division of Do.

Drug Marketing, Advertising, and Communications.

Category--Biopharmaceutics

Albuterol Inhalation Aerosols; Revision. Do.

Bioavailability/Bioequivalence Studies for NDA's and Do.

ANDA's-Orally Administered Drugs.

Bioanalytical Methods Validation: Bioavailability and Do.

Bioequivalence Studies Based on Drug or Metabolites

Assay in a Biological Matrix.

Conjugated Estrogens Tablets; Revision. Do.

In Vivo Pharmacokinetics and Bioavailability Studies Do.

and In Vitro Dissolution Testing for Levothyroxine

Sodium Tablets.

Nasal Inhalation Aerosols and Metered Dose Spray Do.

Pumps for Local Action.

Oral Inhalation Drug Products for Local Action, Do.

MDI's, DPI's, and Inhalation Solutions.

Pharmacokinetics Metrics for Bioavailability/ Do.

Bioequivalence.

Waiver of In Vivo Bioequivalence Studies for Do.

Immediate Release Solid Oral Dosage Forms.

Category--Chemistry

Bulk Actives Postapproval Changes (BAC PAK I). Do.

Postapproval CMC Changes Prior to the Final

Intermediate.

Bulk Actives Postapproval Changes (BAC PAK II) Bulk Do.

Actives Postapproval Changes, Postapproval Changes

From the Final Intermediate to the Drug Substance.

Botanical Drug Products. Do.

Changes to an Approved NDA or ANDA Description (21 Do.

CFR 314.70; revisions).

[[Page 59322]]

Content and Format of IND's for Phases 2 and 3 Do.

Studies of New Drugs Including Well-Characterized,

Therapeutic, Biotechnology-Derived Products.

Drug Master Files; General Content and Format. Do.

Environmental Assessment Submissions; Revision. Do.

Formal Meetings With CDER/CBER on Chemistry, Do.

Manufacturing and Controls Information for IND

Studies, Including on Specified Therapeutic

Biotechnology-Derived Products.

SUPAC Semisolids, Manufacturing Equipment Addendum. Do.

SUPAC Transdermal Systems, Manufacturing Equipment Do.

Addendum.

Methods Validation. Do.

Monoclonal Antibodies Used as Reagents in Drug Do.

Manufacturing, Recommendations on Tests and

Specifications.

NDA's: Impurities in Drug Substances. Do.

Postapproval Changes for Sterile Aqueous Solutions. Do.

Proprietary and Established Drug Names. Do.

Provides Recommendation Regarding Submission of Do.

Information for Drug Products Containing

Cyclodextrin.

Submission of Chemistry and Biopharmaceutical Do.

Information for Liposomal and Lipid-Complexed Drug

Products.

Submission of Chemistry Information on Chiral Drugs. Do.

Submission of Chemistry, Manufacturing, and Controls Do.

Documentation for Inhalation Drug Products: MDI's

and DPI's.

Submission of Documentation for Antibiotics and Other Do.

Cellular Metabolites Produced by Microorganisms

Modified by the Use of Recombinant DNA Technology.

Submitting Manufacturing and Quality Control Do.

Information With IND's, NDA's, ANDA's, and AADA's.

SUPAC Immediate Release; Revision. Do.

SUPAC Transdermal Systems. Do.

Category--Clinical Antimicrobial

Acute Bacterial Arthritis; Developing Antimicrobials Do.

for Treatment.

Opportunistic Infections Related to Aids; Developing Do.

Antimicrobials for Treatment.

Sepsis/Septic Shock; Developing Antimicrobials for Do.

Treatment.

Surgical Prophylaxis; Developing Antimicrobials for Do.

Treatment.

Antifungal Agents; Developing Antimicrobials for Do.

Treatment.

Antimicrobacterial Agents; Developing Antimicrobials Do.

for Treatment.

Antiparasitic Agents; Developing Antimicrobials for Do.

Treatment.

Antiviral Agents; Developing Antimicrobials for Do.

Treatment.

Complicated Intra-Abdominal Infections; Developing Do.

Antimicrobials for Treatment.

Dermatological Surgical Scrubs; Developing Do.

Antimicrobials for Treatment.

Endocarditis; Developing Antimicrobials for Do.

Treatment.

Gynecologic Infections (Except Sexually Transmitted Do.

Disease and Pelvic Inflammatory Disease); Developing

Antimicrobials for Treatment.

Helicobacter Pylori Infections; Developing Do.

Antimicrobials for Treatment.

Immunologic/Transplant Agents; Developing Do.

Antimicrobials for Treatment.

Osteomyelitis (Acute and Chronic); Developing Do.

Antimicrobials for Treatment.

Pelvic Inflammatory Disease; Developing Do.

Antimicrobials for Treatment.

Uncomplicated Intra-Abdominal Infections; Developing Do.

Antimicrobials for Treatment.

Category--Clinical Medical

Assessment of Reproductivity and Developmental Do.

Toxicity.

Clinical Development of Drugs for the Treatment of Do.

Allergic Rhinitis.

Clinical Development of Drugs for the Treatment of Do.

Chronic Sinusitis (other than antimicrobials).

Clinical Development Programs for MDI and DPI Drug Do.

Products.

Clinical Evaluation of Lipid-Altering Agents. Do.

Clinical Evaluation of Potential ECG Effects of New Do.

Antihistamines.

Clinical Evaluation of Weight-Control Drugs. Do.

Clinical Guidance for Estrogen/Progestin Containing Do.

Drug Products.

Clinical Guidance for Estrogen Drug Products. Do.

Clinical Trials: Hormone Replacement Therapy in Do.

Women.

Content and Format for ``Geriatric Use'' Supplemental Do.

Applications.

[[Page 59323]]

Content and Format of the Adverse Reactions Section Do.

of the Labeling.

Content and Format of the Clinical Studies Section of Do.

Labeling for Human Drugs and Biologics.

Content and Review of Applications. Do.

Developing Clinical Programs for Developing Drugs, Do.

Devices, and Biological Products for the Treatment

of Systemic Lupus Erythematosus.

Development of Medical Imaging Products. Do.

Establishing Pregnancy Registries. Do.

Evaluation of Growth Effects of Orally Inhaled and Do.

Intranasal Corticosteroids in Asthma and Allergic

Rhinitis.

Evaluation of New Treatments for Diabetes Mellitus. Do.

Fast Onset for Analgesic (Rx) Products. Do.

Fast Track Products: Policies and Procedures. Do.

General Guidance for Eye Allergy Relief/Allergic Do.

Conjunctivitis Clinical Trials.

General Guidance for Glaucoma/IOP Lowering Clinical Do.

Trials.

GRP (Good Review Practices) Guidance: Content and Do.

Format of the Clinical Review of a Marketing

Application (will be developed in parts).

GRP Guidance: Safety Review of Clinical Data (1st Do.

part of the GRP guidance).

General Considerations for Pediatric Pharmacokinetic Do.

Studies.

Guidelines for the Clinical Evaluation of Motility Do.

Modifying Drugs.

Guidelines for the Clinical Evaluation of Drugs for Do.

Crohn's Disease.

Guidelines for the Clinical Evaluation of Drugs for Do.

Ulcerative Colitis.

Helicobacter Pylori Ulcers. Do.

Human Pregnancy Outcome Data. Do.

Lupus. Do.

NSAID Ulcers. Do.

NSAID GI-Sparing Study Guidance. Do.

Other Ulcers. Do.

Pain Claim Structure; Acute Versus Chronic Do.

Conditions.

Pediatric Clinical Trial Design. Do.

Performance of Clinical Trials for Gastroduodenal Do.

Ulcer Disease.

Postmarketing Adverse Experience Reporting for Human Do.

Drug and Licensed Biological Products.

Post Cataract Inflammation Studies. Do.

Preclinical and Clinical Evaluation of Agents Used in Do.

the Prevention or Treatment of Postmenopausal

Osteoporosis.

Preclinical Development of Inhalation Drugs for Do.

Indications in Children Two Years of Age or Less.

Psoriasis Therapies. Do.

Uveitis Studies. Do.

Removal of a Preservative to Create a Preservative Do.

Free Ophthalmic Solution.

Submission of Debarment Certification Statements and Do.

Other Information Under The Generic Drug Enforcement

Act of 1992.

Vaginal Contraceptive Drug Development. Do.

Wound Care Products. Do.

Category--Clinical Pharmacology

Clinical Pharmacology and Biopharmaceutical Data for Do.

Human Drug Products.

Failed Bioequivalence. Do.

Format and Content of the Clinical Pharmacology Do.

Section of Prescription Drug Product Labeling.

Immediate Release to Modified Release Dosage Forms. Do.

In Vitro Drug Metabolism/Drug Interaction. Do.

In Vivo Drug Metabolism/Drug Interaction. Do.

Pharmacokinetics and Pharmacodynamics. Do.

Pharmacokinetics in Patients With Impaired Hepatic Do.

Function: Study Design, Data Analysis, and Impact on

Dosing and Labeling.

Submission of Expanded Synopses for Clinical Do.

Pharmacology and Biopharmaceutics Studies.

Category--Compliance

Civil Money Penalty Cases Under the Prescription Drug Do.

Marketing Act (PDMA).

Development, Implementation, and Maintenance of a Do.

Sample Security and Audit System Under the

Prescription Drug and Marketing Act (PDMA).

[[Page 59324]]

Investigating Out of Specification (OOS) Results for Do.

Pharmaceutical Production.

First Party Audit. Do.

Plant Readiness; Preapproval Good Manufacturing Do.

Practices Inspections.

Maintaining Adequate and Accurate Records During Do.

Clinical Investigations.

National Drug Code Number and Drug Product Labels. Do.

Sterile Drug Products Produced by Aseptic Processing; Do.

Revision.

Waiver of Informed Consent Requirements for Emergency Do.

Care Research.

Category--Generics

Changes in Labeling of ANDA's Subsequent to Revisions Do.

in the Reference Listed Drug Labeling.

Clindamycin Intravenous Labeling. Do.

Office of Generic Drugs, Policy on Inactive Do.

Ingredients.

Organization of an Abbreviated New Drug Application; Do.

Revision.

Product Variations Within the Same ANDA. Do.

Submitting Documentation to Abbreviated Drug Do.

Applications for Degradation Products in Drug

Products.

Variations in Drug Product That May Be Included in a Do.

Single Application.

Category--Information Technology.

Computerized Systems Used in Clinical Trials. Do.

Electronic Submission of Adverse Reaction Data Via Do.

Physical Media.

Providing Regulatory Submissions in Electronic Format Do.

(will be completed in parts--the part on the NDA

published 9/97).

Standards for Electronic Safety Data Submissions. Do.

Category--Labeling

Labeling for Combined Oral Contraceptives, Physician Do.

Labeling and Instructions for Use.

Labeling Guidance for Noncontraceptive Estrogen Drug Do.

Products.

Placing the Therapeutic Equivalency Rating on Do.

Prescription Drug Labels.

Topical Corticosteroid Class Labeling. Do.

Category--Over The Counter

Points to Consider for OTC Actual Use Studies; Do.

Revision.

Category--Pharmacology Toxicology.

Statistical Aspects of Design, Analysis, and Do.

Interpretation of Animal Carcinogenicity Studies.

Testing for Photocarcinogenesis. Do.

Category--Procedural

Appealing Center Regulatory and Scientific Decisions. Do.

Clarify Requirements for Submission of Supplements. Do.

Formal Meetings Between CDER and Sponsors and Do.

Applicants for PDUFA Products.

Major Dispute Resolution Involving PDUFA Covered Do.

Products.

Regulatory Considerations for section 505(b)(2) of Do.

the Federal Food, Drug, and Cosmetict Act

Applications.

Scientific Advisory Panels. Do.

Special Protocols for the Content and Review of Do.

Applications.

Category--User Fees

Product, Establishment, and Application Fees, Issues Do.

and Resolutions.

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V. Center for Veterinary Medicine (CVM)

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Title/Topic of Document Contact

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Category--Food Additives

Data Requirements for Demonstrating a Food Additive George Graber, Center for Veterinary Medicine (HFV-

Can Control Salmonella in Feed. 220), Food and Drug Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301-827-6651.

Data Requirements for Demonstrating a Food Additive Do.

Binds Mycotoxins.

Category--Microbial Products in Feeds

[[Page 59325]]

Compliance Policy Guide About Microbial Products. Do.

Category--Human Food Safety

Disposition of Animals Used in Research and in the Linda R. Tollefson or Margaret Miller, Center for

Manufacture of Biomedical Products. Veterinary Medicine (HFV-100), Food and Drug

Administration, 7500 Standish Pl., Rockville, MD

20855, 301-827-6644 or 301-594-1620.

Animal Medicinal Drug Use Clarification Act Safe Do.

Levels Guidance.

Metabolism Guidance. Do.

Threshold Assessment Guidance. Do.

Tolerance Guidance. Do.

Microbiological Tolerances/Withdrawal Times Guidance. Do.

Risk Analysis Guidance. Do.

Animal Drug Availability Act Import Tolerance Policy. Do.

Microbiological Testing of Antimicrobial Drug Do.

Residues in Food Guidance.

Category--Substantial Evidence

One versus Multiple Adequate and Well-Controlled Herman M. Schoenemann, III, Center for Veterinary

Studies/Field Studies. Medicine (HFV-126), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301-827-0220.

Choosing Study Parameters (Direct, Surrogate). Do.

Inferential Value for Conditions, Animal, and Time. Do.

Use of Published Studies. Do.

Use of Foreign Studies. Do.

Number and Types of Studies (By Drug Class) Needed to Do.

Demonstrate Effectiveness.

Principles of Statistical Analysis Relevant to Do.

Regulatory Studies.

Combination New Animal Drugs. Do.

Positive Control. Do.

Dose or Dose Range Characterization. Do.

Category--Manufacturing Chemistry

Stability Guidance. William G. Marnane, Center for Veterinary Medicine (HFV-

140), Food and Drug Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301-594-0678.

Guidance on Chemistry and Manufacturing Changes and Do.

Good Manufacturing Practices Requirements for Minor

Use/Minor Species Drug Products.

Category--Target Animal Safety and Effectiveness

Studies for Production Drugs.

Anticoccidial in Poultry Guidance. Andrew J. Beaulieu, Center for Veterinary Medicine (HFV-

100), Food and Drug Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301-594-1620.

Category--Target Animal Safety and Effectiveness

Studies for Therapeutic Drug Uses

Guidance on Recommended Content and Format for Do.

Investigational New Animal Drug Data Submissions for

HFV-110.

Nonsteroidal Anti-inflammatory Drug Guidance. Do.

Competitive Exclusion Guidance. Do.

Category--Other Premarketing

Bioequivalence of Continual Release Drugs Such as Do.

Implant Drugs.

Correlation of In Vitro Dissolution and In Vivo Do.

Bioavailability.

FOI Summary Guidance. Do.

Category--Statistics

Add Log C I Guidance to Bioequivalence Guidance. Anna B. Nevius, Center for Veterinary Medicine (HFV-

124), Food and Drug Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301-827-0218.

General Statistical Procedures for Designing and Do.

Analyzing Research.

Alternative Methods. Do.

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VI. Office of Regulatory Affairs (ORA)

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Title/Topic of Document Contact

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Category--Compliance Policy Guides

Compliance Policy Guide, Chapter 1, Sec. 140.100, JoAnne C. Marrone, Division of Compliance Policy (HFC-

Seizure of Books That Constitute Misleading Labeling 230), Office of Enforcement, Food and Drug

(CPG 7153.13). Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-827-1242.

[[Page 59326]]

Compliance Policy Guide, Chapter 5, Sec. 540.400, MaryLynn A. Datoc, Division of Compliance Policy (HFC-

Shrimp--Fresh or Frozen, Raw, Headless, Peeled or 230), Office of Enforcement, Food and Drug

Breaded--Adulteration Involving Decomposition (CPG Administration, 5600 Fishers Lane, Rockville, MD

7108.11). 20857, 301-827-0413.

Compliance Policy Guide, Chapter 5, Sec. 540.650, Do.

Sale-Cured, Air-Dried, Uneviscerated Fish (e.g.,

``Kapchunka'') (CPG 7108.17).

Compliance Policy Guide, Chapter 6, Sec. 675.400, Barbara A. Rodgers, Division of Compliance Policy (HFC-

Rendered Animal Feed Ingredients (CPG 7126.24). 230), Office of Enforcement, Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-827-0417.

Compliance Policy Guide: Evaluation and Processing of JoAnne A. Marrone, Division of Compliance Policy (HFC-

Post Donation Reports. 230), Office of Enforcement, Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-827-1242.

Compliance Policy Guide: Summary of Records Do.

Accompanying Human Tissue for Transplantation.

Compliance Policy Guide: Foods Contaminated With Hard MaryLynn A. Datoc.

or Sharp Foreign Objects.

Category--Compliance Programs; Bioresearch Monitoring

Compliance Program 7348.808,Bioresearch Monitoring; James F. McCormack, Division of Compliance Policy (HFC-

Good Laboratory Practices (GLP) (Nonclinical). 230), Office of Enforcement, Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-827-0425.

Food Laboratory Practice Program (Nonclinical Do.

Laboratories) 7348.808A: EPA Data Audit Inspections.

Compliance Program 7348.810: Sponsors, Contract Do.

Research Organizations and Monitors.

Compliance Program 7348.809: Bioresearch Monitoring; Do.

Institutional Review Board.

Compliance Program 7348.811: Bioresearch Monitoring; Do.

Clinical Investigations.

Category--Inspection Guides

Guide to Inspections of Source Plasma Establishments. Elizabeth A. Waltrip, Division of Emergency and

Investigational Operations (HFC-132), Office of

Regional Operations, Food and Drug Administration,

5600 Fishers Lane, Rockville, MD 301-827-5662.

Category--Laboratory Procedures Manual

Laboratory Procedures Manual, Chapter 1, Sample Leonard Valenti, Division of Field Science (HFC-140),

Accountability. Office of Regional Operations, Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-443-7103.

Laboratory Procedures Manual, Chapter 10, Research Lawrence D'Hoostelaere, Division of Field Science (HFC-

Guidelines. 140), Office of Regional Operations, Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-443-3320.

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Dated: October 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-29387 Filed 11-2-98; 8:45 am]

BILLING CODE 4160-01-F