[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]
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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)
----------------------------------------------------------------------------------------------------------------
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.
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III. Center for Devices and Radiological Health (CDRH)
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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.
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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.
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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.
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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
