Federal Register, Volume 64 Issue 219 (Monday, November 15, 1999)

[Federal Register Volume 64, Number 219 (Monday, November 15, 1999)]
[Notices]
[Pages 61881-61892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29699]

[[Page 61881]]

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
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 guidance documents or revisions of existing
ones. 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: Submit comments on this list and on agency guidance documents 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:
For general information regarding FDA's GGP's contact: LaJuana D.
Caldwell, Office of Policy (HF-27), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-7010.
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 coming 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, Stephen M. Ripley, Center for
Reworking, and Blending Biologics (HFM-17), Food and Drug
Practices for Biological Bulk Administration, 1401 Rockville
Substances, Final Bulk, and Pike, Rockville, MD 20852-1448,
Finished Products. 301-827-6210.
Compliance Program 7342.002, Do.
Inspection of Source Plasma
Establishments.
Compliance Program, Inspection of Do.
Licensed Vaccine and Related
Product Manufacturers.
Compliance Program 7341.002, Do.
Inspection of Tissue Banking
Establishments.
Compliance Program 7341.003, Do.
Examination of Blood and Blood
Components Offered for Import.
Compliance Program 7342.006, Do.
Inspection of Plasma Derivatives
of Human Origin.
Compliance Program 7342.008, Do.
Inspection of Licensed Viral
Marker Test Kits.
Guidance for the Design, Do.
Installation, and Operations of
Water Systems.
Guidance on Heating, Ventilation, Do.
and Air Conditioning (HVAC) and
the Monitoring of Environments
for the Manufacture of
Biological Substances and
Products.
Guidance for the Validation of Do.
the Limulus Amebocyte Lystate
Test as an End-Product Endotoxin
Test for Human and Animal
Parenteral Drugs, Biological
Products and Medical Devices.
Guidance for Process Validation Do.
Considerations for Biological
Drug Substances and Biological
Drug Products.
Guidance on Lot Release for Do.
Licensed Biological Products
Distributed into Foreign
Markets.
Category--Therapeutics
Guidance for the Chemistry, Do.
Manufacturing and Control
Information on Gene Therapy
Products.

[[Page 61882]]

Guidance to Industry on Do.
Xenotransplantation.
Guidance in the Development of Do.
Products for Chronic Cutaneous
Ulcers and Acute Burn Wounds.
Guidance on Recombinant Biologics Do.
Produced in Plants.
Guidance on the Development of Do.
Products for Systemic Lupus
Erythematosus.
Category--Blood and Blood Do.
Components
Guidance for Collection, Testing Do.
and Release of Autologous Blood.
Guidance for Recommendations for Do.
Donor Testing By Automated
Methods When Using Treponemal
Based Screening Tests for
Syphilis.
Guidance for Reviewer Guidance Do.
for a Pre-Market Notification
Submission for Automated Blood
Establishment Testing
Instruments.
Guidance for HIV Reentry Do.
Algorithms for Deferred Blood
and Plasma Donors.
Guidance for Precautionary Do.
Measures to Reduce the 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 Do.
Recommendations for Donor
Questioning Regarding Travel to
Areas Endemic for Malaria.
Category--Vaccines
Guidance for Immunization of Do.
Human Plasma Donors To Obtain
Source Plasma for Preparation of
Specific Immune Globulins.
Guidance on Assessment of the Do.
Reproductive Toxicity Potential
of Preventative Vaccines for
Infectious Diseases.
Guidance on the U.S. Minimum Do.
Standards (formerly U.S. Minimum
Requirements) for Tetanus and
Diphtheria Toxoid Containing
Products.
Category--Other
Guidance on the Development and Do.
Use of Comparability Protocols.
------------------------------------------------------------------------

III. Center for Devices and Radiololgical Health (CDRH)

[[Page 61883]]

Review Criteria for Assessment of Portable Blood Do.
Glucose In Vitro Diagnostic Devices Using Glucose
Oxidase, Dehydrogenase, or Hexokinase Methodology
(Revision).
Criteria for a Streamline PMA for Early Detection of Peter E. Maxim, Center for Devices and Radiological
PSA. Health (HFZ-440), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-1293.
Abbreviated 510(k) Submission for In Vitro Diagnostic Do.
Antinuclear Antibody (ANA) Immunological Test
Systems.
Points to Consider for Cervical Cytology Devices Do.
(Revision).
Draft Guidance for 510(k) Submission of Lymphocyte Do.
Immunophenotyping IVD's using Monoclonal Antibodies
(Revision).
Review Criteria for Assessment of Antimicrobial Woody Dubois, Center for Devices and Radiological
Susceptibility Devices (Special Control). Health (HFZ-440), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2096.
Premarket Approval Applications for In Vitro Do.
Diagnostics Devices Pertaining to Hepatitis C
Viruses (HCV): Assays Intended for Diagnosis,
Prognosis, or Monitoring of HCV Infection, Hepatitis
C, or Other HCV-associated Disease.
Oral Appliance For Snoring And Sleep Apnea. Sandy L. Shire, Center for Devices and Radiological
Health (HFZ-480), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5283.
General Hospital IV Administration Sets. Pat M. Cricenti, Center for Devices and Radiological
Health (HFZ-480), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-8879.
IV flushes. Do.
Infrared Thermometers. Do.
Jet Injectors. Do.
Infection Control Expiration Dating of Medical Glove. Chiu C. Lin, Center for Devices and Radiological Health
(HFZ-480), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-443-8913.
Biological Indicators. Do.
Chemical Indicators. Do.
Renal Dialyzer Reprocessing. Do.
Liquid Sterilizers and High Level Disinfectants. Do.
General Purpose Washers/Disinfectants. Do.
Heart Valve Guidance (Revision). Thomas J. Callahan, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-8252.
Cardiac Ablation: Atrial Fibrillation Clinical Study Dina J. Fleischer, Center for Devices and Radiological
Design. Health (HFZ-450), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-8517.
Cardiac Ablation: Pre-clinical Testing. Barbara A. Zimmerman, Center for Devices and
Radiological Health (HFZ-450), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-8517.
Cardiac Ablation: SVT Clinical Study Design. Stuart M. Portnoy, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-8517.
Cardiac Ablation: Atrial Flutter Clinical Study Jennifer L. Goode, Center for Devices and Radiological
Design. Health (HFZ-450), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-8517.
Percutaneous Transluminal Angioplasty (PTA) Christopher M. Sloan, Center for Devices and
Catheters. Radiological Health (HFZ-450), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-8243.
Applications for Permanent Pacemaker Leads. Lynette A. Gabriel, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-8243.
Implantable Defibrillator Guidance Document. Doris J. Terry, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-8609.
Replacement Rechargeable Batteries 510(k)s. Charles S. Ho, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-8609.
Extracorporeal Membrane Oxygenators (ECMO). Thinh Nguyen, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-8252.
Compressible Limb Sleeves. Do.
Telemetry Guidance. Do.
Electromagnetic Compatibility Guidance (Revision). Do.
Roller Pump Special Control. Do.
Arrhythmia Detector and Alarm including ST Segment Carole C. Carey, Center for Devices and Radiological
Monitor and Alarm (Revision). Health (HFZ-450), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-8252.

[[Page 61884]]

External Cardiac Defibrillators (including AED's). Do.
Multifunction Electrodes (a subset of the External Do.
Defibrillators).
510k Biopsy Devices Guidance (Revision). Mary Beth Abt, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2194.
510(k) Irrigation Set Checklist (Revision). Do.
Testicular Implant Guidance Document (Revision). John H. Baxley, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2194.
Inflatable Penile Implant Guidance Document Do.
(Revision).
Content of PMA Application for Testicular Implants Do.
(Revised).
Content of PMN for Extracorpreal Shock Wave Do.
(Revised).
Lithrotriptor indicated for the fragmentation of Do.
kidney and ureteral calculi.
510(k) Enuresis Alarm Checklist (Revision). Do.
510(k) Antimicrobial Foley Guidance (Revision). Laura J. Byrd, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2194.
510(k) Electrical Surgical Unit Checklist (Revision). Do.
510(k) Non-implantable Electrical Stim. Checklist Do.
(Revision).
Vesicoureteral Reflux Guidance Doc. (New). Hector H. Herrera, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2194.
510(k) Urodynamic Systems Guidance Document Do.
(Revision).
BPH Guidance Document (Revision). Mil J. Jevtich, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2194.
Urethral Bulking Agent Guidance (Revision). Rao Nimmagadda, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2194.
510(k) Condom Catheter Checklist (Revision). Do.
External Penile Rigidity Device Guidance (New). Jim Seiler, Center for Devices and Radiological Health
(HFZ-470), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-594-2194.
510(k) Urine Drainage Bag Guidance (Revision). Do.
Urethral Stent Guidance Document (Revision). Do.
Artificial Urinary Sphincter Guidance (Revision). Nicole L. Wolanski, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2194.
510(k) Balloon Catheter Guidance Document (Revision). Do.
510(k) Mechanical Lithrotriptor/Stone Dislodger Do.
(Revision).
510(k) Light Sources checklist (Revision). Do.
510(k) Endoscope Guidance (Revision). Mary Jo Cornelius, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2194.
Thermal Endometrial Ablation Devices Submission Veronica A. Price, Center for Devices and Radiological
Guidance for an IDE (Revision). Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-1180.
Guidance for Content of Premarket Notification for Carolyn Y. Neuland, Center for Devices and Radiological
Conventional and High Permeability hemodialysers Health (HFZ-470), Food and Drug Administration, 5600
(Revision). Fishers Lane, Rockville, MD 20857, 301-594-1220.
Guidance for Premarket Notification for Hemodialysis Do.
Delivery System (Revision).
Guidance for Industry and CDRH Rev. of Content of Do.
Premarket Notification for Perioneo-Venous Shunts
(Revision).
Guidance for Content of Premarket Notification of Do.
Body Composition Analyzers (Revision).
Guidance of Content of Investigational Device Do.
Exemption (IDE) for Solutions for hypothermic
flushing, transport and storage of organs and
transplantation (Revision).
Guidance on Devices in Invitro Fertilization and Elisa D. Harvey, Center for Devices and Radiological
other Assisted Reproduction procedures (Revision). Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-1220.
Guidance for Submission of Bone Sonometer Premarket Robert A. Phillips, Center for Devices and Radiological
Applications (PMS's) (Revision). Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-1212.
Guidance for Brachytherapy Source 510(k)s (Revision). Do.
Guidance for Radiation Therapy Systems Software Do.
Testing (Revision).
Diagnostic Ultrasound Guidance (Revision). Do.

[[Page 61885]]

Guidance for Manufacturing of Digital Mammography William M. Sacks, Center for Devices and Radiological
Devices (Revision). Health (HFZ-470), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-1212.
Guidance for Manufacturers of Bone Ultrasound Devices Do.
for Osteoporosis (Revision).
Guidance for Preparation of Bone Sonometer PMA Joe Arnaudo, Center for Devices and Radiological Health
Submissions (Revision). (HFZ-470), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-594-1212.
Guidance for Review of Bone Densitometer 510(k) Do.
Submissions (Revision).
Extended Wear Contact Lens Guidance, Including Karen Warburton, Center for Devices and Radiological
Clinical Studies. Health (HFZ-460), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-1744.
Guidance on Post Market Studies for Extended Wear Do.
Contact Lenses.
Orthokeratology Contact Lens Clinical Study Guidance. Eleanor M. Felton, Center for Devices and Radiological
Health (HFZ-460), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-1744.
Labeling Guidance for UV Absorbing Contact Lenses. Do.
510k Guidance Document for Daily Wear Contacts Do.
(Revision).
Guidance for the Arrangement and Content of a Teri Cygnarowicz, Center for Devices and Radiological
Premarket Approval (PMA) Application for an Health (HFZ-460), Food and Drug Administration, 5600
Implantable Middle Ear Hearing Device. Fishers Lane, Rockville, MD 20857, 301-594-2080.
Guidance for the Arrangement and Content of a Do.
Premarket Approval (PMA) Application for a Cochlear
Implant for Children (Revision).
Guidance for the Arrangement and Content of a Do.
Premarket Approval (PMA) Application for a Cochlear
Implant for Adults (Revision).
Guidance for the Development of a Premarket Karen H. Baker, Center for Devices and Radiological
Notification for a Disposable Sterile Ear, Nose and Health (HFZ-460), Food and Drug Administration, 5600
Throat Endoscope Sheath with Protective Barrier Fishers Lane, Rockville, MD 20857, 301-594-2080.
Claims (Revision).
Guidance for the Development of a Premarket Do.
Notification for Vocal Cord Medialization Devices.
Scanning Laser Ophthalmoscopes. Everette T. Beers, Center for Devices and Radiological
Health (HFZ-460), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2018.
Electrosurgical Devices. Do.
Microkeratomes. Do.
Refractive Lasers (Revision). Do.
Interocular Lenses Guidance Document (Revision). Donna R. Lochner, Center for Devices and Radiological
Health (HFZ-460), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2053.
Refractive Implants Guidance Document. Ashley A. Boulware, Center for Devices and Radiological
Health (HFZ-460), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2053.
Draft Guidance for Industry on the Custom Device Casper Uldrik, Office of Compliance, Center for Devices
Exemption of the Federal Food, Drug, and Cosmetic and Radiological Health (HFZ-300), Food and Drug
Act (Level 1). Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-594-4692.
Draft Guidance for Industry on the Likelihood of Do.
Facilities Inspections When Modifying Devices
Subject to PMA Approval (Level 1).
Draft Guidance for Industry on Quality System Do.
Regulation Information Required for Various
Premarket Submissions. (Level 1).
Draft Compliance Program Guidance Manual: Inspection Do.
of Medical Device Manufacturers (Level 1).
Guidance to Industry on the information to be Do.
provided under 21 CFR 1020.30(g). (Level 1) This
will be effective immediately based on the public
health exemption, per Linda Kahan and Dr. Jacobson.
Guidance to Industry on the alternative use of the Do.
statement ``Rx only.'' (Level 1).
Compliance Guidance: The Mammography Quality Charles A. Finder, Center for Devices and Radiological
Standards Act Final Regulations Document #2 (Final). Health (HFZ-240), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-3332.
Compliance Guidance: The Mammography Quality Do.
Standards Act Final Regulations Document #4.
Compliance Guidance: The Mammography Quality Do.
Standards Act Final Regulations Document #5.
Compliance Guidance: The Mammography Quality Do.
Standards Act Final Regulations Document #6.
Compliance Guidance: The Mammography Quality Do.
Standards Act Final Regulations Document #7.

[[Page 61886]]

Mammography Quality Standards Act (MQSA) Inspections Walid G. Mourad, Center for Devices and Radiological
of Mobile Facilities Under the Final Regulations. Health (HFZ-240), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-3332.
MQSA Inspections of Digital Mammography Systems Under Do.
the Final Regulations.
Bayesian Statistics. Laura Alonge, Office of Surveillance and Biometrics,
Center for Devices and Radiological Health (HFZ-500),
Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2812.
Discrepant Resolution. Do.
Diagnostic Devices (statistics). Do.
Medical Device Reporting (MDR) Regulations: Reporting Do.
Adverse Events Associated with Medical Device
Reprocessing or Medical Device Reuse.
MDR Guidance for Importers. Do.
Non-diagnostic Devices (statistics) (Revision). Do.
MDR Reporting for Endosseous Implants (Revision). Do.
Guidance for Manufacturers for Preparation of Do.
Postmarket Surveillance Plans Required Under Section
522 of the Federal Food, Drug, and Cosmetic Act
(Revision).
----------------------------------------------------------------------------------------------------------------

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, 1451 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.
Continuing Medical Education. Do.
Fair Balance. Do.
Health Related Quality of Life Claims. Do.
Informercials. Do.
Promotion of Investigational Products. Do.
Promotion of Medical Products on the Internet. Do.
Promotion at International Meetings. Do.
Proprietary (Brand) Name & Established (Generic) Name Do.
Placement, Size, & Prominence in Advertising and
Promotional Labeling.
Providing Electronic Submissions to the Division of Do.
Drug Marketing, Advertising, and Communications.
Category--Biopharmaceutics
Food-Effect Bioavailability and Bioequivalence Do.
Studies.
Oral Inhalation Drug Products; In Vivo Do.
Bioavailability and Bioequivalence.
Pharmacokinetics Metrics for Bioavailability/ Do.
Bioequivalence.
Category--Chemistry
BAC PAC II--Bulk Actives Postapproval Changes (Re: Do.
Postapproval Changes from the Final Intermediate to
the Drug Substance).
Comparability Protocol for Making Changes to Do.
Chemistry, Manufacturing, and Controls for Drug and
Biological Products.
Drug Master Files; General Content and Format. Do.
Drug Master Files for Bulk Antibiotic Drug Do.
Substances.
Formal Meetings Between CDER/CBER and Sponsors on Do.
Chemistry, Manufacturing and Controls Information
for IND Studies of Drugs, Including Specified
Therapeutic Biotechnology-Derived Products.
ISPE for SUPAC TDS. Do.
ISPE for SUPAC SS. Do.
Methods Validation for the Assay of Drugs And/or Do.
Metabolites in Human Biological Matrices.
Post Approval Changes for Sterile Aqueous Solutions. Do.
Proprietary Drug Names. Do.
Provides Recommendation Regarding Submission of Do.
Information for Drug Products Containing
Cyclodextrin.
Recombinant DNA Growth Hormone Drug Products. Do.

[[Page 61887]]

Recombinant DNA Human Insulin Drug Products. Do.
Revision to the SUPAC IR Guidance Document That Do.
Published in November 1995.
Submission of Documentation for Antibiotics and Other Do.
Cellular Metabolites Produced by Microorganisms
Modified by the Use of Recombinant DNA Technology.
Submission of CMC Information for Synthetic Peptide Do.
Substances.
Submission of CMC and Biopharm Information for Do.
Liposomal and Lipid-Complexed Drug Products.
Submission of Chemistry, Manufacturing, and Controls Do.
Documentation for Inhalation Drug Products: MDI's
and DPI's.
Submission of CMC Information on Chiral Drugs. Do.
Submitting Manufacturing and Quality Control Do.
Information with INDs, NDAs, ANDA's, and AADA's.
SUPAC TDS. Do.
Category--Clinical/Antimicrobial
Acute Bacterial Arthritis; Developing Antimicrobials Do.
for Treatment.
Agents to Treat Opportunistic Infections Related to Do.
AIDS; Developing Antimicrobials for Treatment.
Agents Used in Surgical Prophylaxis, Developing Do.
Antimicrobials for Treatment.
Agents to Treat Sepsis/Septic Shock; Developing Do.
Antimicrobials for Treatment.
Antifungal Agents; Developing Antimicrobials for Do.
Treatment.
Antimycobacterial Agents; Developing Antimicrobials Do.
for Treatment.
Antiparasitic Agents; Developing Antimicrobials for Do.
Treatment.
Antiviral Agents; Developing Antimicrobials for Do.
Treatment.
Catheter-Related Infections. Do.
Complicated Intra-Abdominal Infections; Developing Do.
Antimicrobials for Treatment.
Clinical Considerations for Accelerated and Do.
Traditional Approval of Antiretroviral Drugs Using
Plasma HIV RNA Measurements.
Dermatologic Surgical Scrubs, Etc., 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.
Nongonoccocal Urethritis/Cervicitis; 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
Clinical Development for Drugs to Treat Urinary Do.
Incontinence.
Clinical Development Programs for MDI and DPI Drug Do.
Products Revised.
Clinical Evaluation of Drugs for the Treatment of Do.
Acute Coronary Syndrome.
Clinical Evaluation of Drugs for the Treatment of Do.
Heart Failure.
Clinical Development Programs for Drugs, Devices, and Do.
Biological Products Intended for the Treatment of
Osteoarthritis.
Clinical Development of Drugs for the Treatment of Do.
Allergic Rhinitis Revised.
Clinical Evaluation of Drugs for Ulcerative Colitis. Do.
Clinical Evaluation of Weight-Control Drugs Revised. Do.
Clinical Development of Products for the Treatment of Do.
Chronic Cutaneous Ulcers and Acute Burn Wounds.
Clinical Evaluation of Lipid-Altering Agents Revised. Do.
Clinical Evaluation of Estrogen--and Estrogen/ Do.
Progestin-Containing Drug Products Used for Hormone
Replacement Therapy in Postmenopausal Women.
Clinical Evaluation of Motility Modifying Drugs. Do.
Clinical Evaluation of Drugs for Crohn's Disease. Do.

[[Page 61888]]

Clinical Development of Drugs for the Treatment of Do.
Chronic Sinusitis (Other than Antimicrobials).
Clinical Evaluation of Potential ECG Effects of New Do.
Antihistamines Revised.
Content and Format of the Clinical Studies Section of Do.
Labeling for Human Drugs and Biologics.
Content and Format for Submission of Carcinogenicity Do.
Protocols for Evaluation.
Content and Format of the Adverse Reactions Section Do.
of the Labeling.
Data Monitoring and Interim Analysis of Clinical Do.
Studies Performed Under an IND.
Design and Endpoint Issues Related to Treatment Do.
Trials for Female Sexual Disfunction.
Developing Clinical Programs for Developing Drugs, Do.
Devices and Biological Products for the Treatment of
Systemic Lupus Erythematosus.
Evaluation of New Treatments for Diabetes Mellitus. Do.
Evaluation of Growth Effects of Orally Inhaled and Do.
Intranasal Corticosteroids in Asthma and Allergic
Rhinitis.
H.Pylori Ulcer. Do.
NSAID Ulcer. Do.
Performance of Clinical Trials for Gastroduodenal Do.
Ulcer Disease.
Postmarketing Adverse Experience Reporting for Human Do.
Drug and Licensed Biological Products.
Preclinical and Clinical Evaluation of Agents Used in Do.
the Prevention or Treatment of Postmenopausal
Osteoporosis Revised.
Preclinical Development of Inhalation Drugs for Do.
Indications in Children 2 Years of Age or Less.
Psoriasis Therapies. Do.
Safety Review of Clinical Data; Reviewer Guidance. Do.
Ulcers Not Due to H.Pylori or NSAID. Do.
Ulcers Without Consideration of Pathogenesis. Do.
Vaginal Contraceptive Drug Development Revised. Do.
Category--Clinical/Pharmacology
Clinical Pharmacology and Biopharmaceutic Data for Do.
Human Drug Products.
Failed Bioequivalence. Do.
Format and Content of the Clinical Pharmacology Do.
Section of Prescription Drug Product Labeling.
General Considerations for Pediatric Pharmacokinetic Do.
Studies.
Immediate Release to Modified Release Dosage Forms. Do.
In Vitro Drug Metabolism/Drug Interaction. Do.
Pharmacokinetics in Patients with Impaired Hepatic Do.
Function: Study Design, Data Analysis, and Impact on
Dosing and Labeling.
Pharmacokinetics and Pharmacodynamics. Do.
Special Initiative: Narrow Therapeutic Index (Range). Do.
Submission of Expanded Synopses for Clinical Do.
Pharmacology and Biopharmaceutics Studies.
Category--Compliance
Civil Money Penalty Cases Under PDMA. Do.
Development, Implementation, and Maintenance of a Do.
Sample Security and Audit System under the
Prescription Drug and Marketing Act of 1987.
First Party Audit. Do.
Information Required for Pre-Approval GMP Do.
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.
Revised.
Submission to an IND of Investigator Information for Do.
Non-US Studies.
Waiver of Informed Consent Requirements for Emergency Do.
Care Research.
Category--Electronic Submissions
Electronic Submission of Adverse Reaction Data via Do.
Physical Media.
Preparing Data for Electronic Submissions of ANDA's. Do.
Standards for Electronic Safety Data Submissions. Do.
Category--Generics
Botanical Drug Products. Do.
Changes in Labeling of ANDA's Subsequent to Revisions Do.
in the RLD Labeling.

[[Page 61889]]

Clindamycin Intravenous Labeling. Do.
OGD's Policy on Inactive Ingredients. Do.
Submitting Documentation to Abbreviated Drug Do.
Applications for Degredation Products in Drug
Products.
Variation in Drug Product That May Be Included in a Do.
Single Application.
Category--Labeling
Content and Format for ``Geriatric Use'' Supplemental Do.
Applications.
Labeling Guidance for Combined Oral Contraceptives-- Do.
Physician Labeling and Instructions for Use Revised.
Topical Corticosteroid Class Labeling. Do.
Category--OTC
Eye Allergy Relief/Allergic Conjunctivitis. Do.
Labeling of OTC Human Drug Products. Do.
Labeling Comprehension Studies for OTC Drug Products. Do.
Manufacturing Issues/Policy for Ophthalmic Drug Do.
Products.
Points to Consider--OTC Actual Use Studies. Do.
Post Cataract Inflammation Studies. Do.
Removal of a Preservative to Create a ``Preservative Do.
Free'' Ophthalmic Solution.
The Small Entity Compliance Guidance On: Regulations Do.
for the Labeling of Over-the-counter Human Drugs.
Uveitis Studies. Do.
Category--Pharmacology/Toxicology
Evaluation of Preclinical Reproductive Toxicology Do.
Data.
Immunotoxicology. Do.
Photo Safety Testing. Do.
Statistical Aspects of Design, Analysis, and Do.
Interpretation of Animal Carcinogenicity Studies.
Testing for Photocarcinogenesis. Do.
Category--Procedural
Available Therapy Guidance (As Defined by CDER and Do.
CBER).
Appeal of Center Regulatory and Scientific Decisions. Do.
Applications Pursuant to 505 (B)(2). Do.
Clarify Requirements for Submission of Supplements. Do.
Formal Meetings Between CDER and Sponsors and Do.
Applicants for PDUFA Products.
Health Care Economic Information. Do.
Meetings Between CDER and External Constituents on Do.
Non-PDUFA Products.
New Drug Evaluation: Refusal to File. Do.
Qualifying for Pediatric Exclusivity Revised. Do.
Reports on the Status of Postmarketing Studies-- Do.
Implementation of Section 130 of FDAMA.
Special Protocols for the Content and Review of Do.
Applications.
Submission of Debarment Certification Statements and Do.
Other Information under the Generic Drug Enforcement
Act of 1992.
Submitting Requests for Waiver or Deferral under the Do.
Pediatric Study Requirements.
Category--User Fees
Assessment of Product, Establishment, and Application Do.
Fees.
User Fee Waivers and Reductions. Do.
----------------------------------------------------------------------------------------------------------------

V. Center for Food Safety and Applied Nutrition (CFSAN)

[[Page 61890]]

Draft Guidance for Preparing a Premarket Notification Mitch A. Cheeseman, Office of Premarket Approval (HFS-
for Food Contact Substances. 215), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, 202-418-3083
Category--Dietary Supplements
Dietary Supplements: Questions and Answers. Ellen M. Anderson, Office of Food Labeling (HFS-165),
Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, 202-205-5562
Dietary Supplements: Identity Testing Guidelines. Karen F. Strauss, Office of Special Nutritionals (HFS-
456), Food and Drug Administration, 200 C St., SW.,
Washington, DC 20204, 202-205-4168
----------------------------------------------------------------------------------------------------------------

VI. 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 Contro 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
Compliance Policy Guide about Microbial Products. Do.
Category--Human Food Safety
Disposition of Animals Used in Research and in the Linda R. Tollefson, Center for Veterinary Medicine (HFV-
Manufacture of Biomedical Products. 200), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6644.
Threshold Assessment Guidance. Devaraya R. Jagannath, Center for Veterinary Medicine
(HFV-153), Food and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 301-827-6982.
Tolerance Guidance. Steven Brynes, Center for Veterinary Medicine (HFV-
151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6975.
Risk Analysis Guidance. Kevin J. Greenlees, Center for Veterinary Medicine (HFV-
153), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6977.
Animal Drug Availability Act Import Tolerance Policy. Do.
Microbiological Testing of Antimicrobial Drug Do.
Residues in Food Guidance.
Category--Substantial Evidence
One v. Multiple Adequate and Well-controlled Studies/ Claire M. Lathers, Center for Veterinary Medicine (HFV-
Field Studies. 100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1620.
Use of Published Studies. 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, 301-827-6966.
Guidance on Chemistry and Manufacturing Changes and Do.
Good Manufacturing Practices Requirements for Minor
Use/Minor Species Drug Products.
Guidance on Chemistry and Manufacturing and Controls Dennis M. Bensley, Center for Veterinary Medicine (HFV-
Changes to an Approved NADA or ANADA. 143), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6956.
Stability Testing of New Drug Substances and Products William G. Marnane, Center for Veterinary Medicine (HFV-
in the Veterinary Field. 140), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6966.
Stability Testing of New Dosage Forms in the Do.
Veterinary Field.
Stability Testing for Medicated Premixes. Do.
Stability Testing: Photostability Testing of New Drug Do.
Substances and Products in the Veterinary Field.
Guidance for Industry, BACPAC I: Intermediates in David R. Newkirk, Center for Veterinary Medicine (HFV-
Drug Substance Synthesis - Bulk Actives Postapproval 140), Food and Drug Administration, 7500 Standish Pl.,
Changes: Chemistry, Manufacturing and Controls Rockville, MD 20855, 301-827-6967.
Documentation.
Category--Target Animal Safety and Effectiveness
Studies for Production Drugs

[[Page 61891]]

Anticoccidials in Poultry Guidance. Jeffrey M. Gilbert, Center for Veterinary Medicine (HFV-
128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0233.
Category--Target Animal Safety and Effectiveness
Studies for Therapeutic Drug Uses
Non-Steroidal Anti-inflammatory Drug Guidance. Elizabeth Reese, Center for Veterinary Medicine (HFV-
114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0132.
Competitive Exclusion Guidance. Steven D. Vaughn, Center for Veterinary Medicine (HFV-
130), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-7580.
Minor Species Simulated Pharmacokinetic Submissions. Marilyn Martinez, Center for Veterinary Medicine (HFV-
130), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-7577.
Category--Other Pre-Marketing
Bioequivalence of Continual Release Drugs Such as Marilyn Martinez, Center for Veterinary Medicine (HFV-
Implant Drugs. 130), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-7577.
Correlation of In-vitro Dissolution and In-vivo Do.
Bioavailability.
FOI Summary Guidance. Steven Vaughn, Center for Veterinary Medicine (HFV-
130), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-7580.
Category--Statistics
Add Log C I Guidance to Bioequivalence Guidance. Anna Nevius, Center for Veterinary Medicine (HFV-124),
Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,301-827-0218.
Principles of Statistical Analysis relevant to Do.
Regulatory Studies.
Category--Electronic Submissions
Submitting a Notice of Final Animal Disposition of Janis R. Messenheimer, Center for Veterinary Medicine
Animals not Intended for Slaughter in Electronic (HFV-135), Food and Drug Administration, 7500 Standish
Format to the CVM via E-Mail. Pl., Rockville, MD 20855, 301-827-7578.
Submitting a Notice of Intent to Slaughter for Human Do.
Purposes in Electronic Format to the CVM and USDA
via E-Mail.
Submitting a Request for Meeting or Teleconference in Do.
Electronic Format to the CVM via E-Mail.
Submitting a Protocol in Electronic Format to the CVM Do.
via E-Mail.
Category--Analytical Methods
Guidance Document on the Validation of Analytical Mary Leadbetter, Center for Veterinary Medicine (HFV-
Procedures for Medicated Feeds. 143), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6964.
Guidance Document on Analytical Method Documents for Do.
Medicated Feeds.
Guidance Document on Protocols for Conduct of Method Do.
Transfer Trials for Medicated Feed Assays.
----------------------------------------------------------------------------------------------------------------

VII. Office of Regulatory Affairs (ORA)

[[Page 61892]]

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 20857, 301-827-5662.
Guide to Inspections of Aseptic Processing and Jody Robinson, Division of Emergency and
Packaging (Food). Investigational Operations (HFC-132), Office of
Regional Operations, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-7691.
Category--Regulatory Procedures Manual
Regulatory Procedures Manual (Revision), Chapter 10, Sharon Sheehan, Division of Compliance Policy (HFC-
Subchapter: Application Integrity Policy. 230), Office of Enforcement, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-0412.
Category--Laboratory Procedures Manual
Chapter 1, Sample Accountability. Jim Yager, Division of Field Science (HFC-140), Office
of Regional Operations, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-1025.
Chapter 2, Sample Analysis. Do.
Chapter 3, Laboratory Reporting. Do.
Chapter 4, Sample Disposition. Do.
Chapter 21, Guidance on the Review of Analytical Data Leonard Valenti, Division of Field Science (HFC-140),
Generated by Private Laboratories. Office of Regional Operations, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-7103.
----------------------------------------------------------------------------------------------------------------

Dated: November 4, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-29699 Filed 11-12-99; 8:45 am]
BILLING CODE 4160-01-F