[Federal Register Volume 63, Number 212 (Tuesday, November 3, 1998)]
[Notices]
[Pages 59317-59326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29387]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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)

----------------------------------------------------------------------------------------------------------------
                Title/Topic of Guidance                                          Contact
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

III. Center for Devices and Radiological Health (CDRH)

----------------------------------------------------------------------------------------------------------------
                Title/Topic of Document                                          Contact
----------------------------------------------------------------------------------------------------------------
  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.
----------------------------------------------------------------------------------------------------------------

IV. Center for Drugs Evaluation and Research (CDER)

----------------------------------------------------------------------------------------------------------------
                Title/Topic of Document                                          Contact
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

V. Center for Veterinary Medicine (CVM)

----------------------------------------------------------------------------------------------------------------
                Title/Topic of Document                                          Contact
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

VI. Office of Regulatory Affairs (ORA)

----------------------------------------------------------------------------------------------------------------
                Title/Topic of Document                                          Contact
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


    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