Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices 36413

9. What fair information practices

should be implemented (e.g., ability to

correct the record, notice of being put in

registry to parent)?

10. How long should information be

kept in a registry?

11. How will privacy issues affect the

following groups: parents, immigrants,

religious groups, HIV-positive and other

immunocompromised health

conditions, law enforcement, victims of

domestic violence, and custodial

parents?

12. How should registries ensure that

privacy policies are followed?

13. Do you have any comment or

recommendation for NVAC/CDC/HHS

related to the implementation of the

network of state and community-based

registries and do you have any

concerns?

14. Do you feel there is a need for the

Federal Government to provide

leadership in developing state and

community-based immunization

registries? What should the role of the

Federal Government be in this effort?

15. Given the mandate of Health

Insurance Portability and

Accountability Act to create a unique

health identifier, how should that goal

be achieved while minimizing the

probability of inappropriate use of the

identifier?

16. What steps can be taken to prevent

unauthorized re-disclosure of

information already provided to an

organization or person?

17. What legal barriers exist which

prevent data sharing by MCOs and how

can they be obviated?

18. What mechanism should be

available to allow parents to opt out of

the registry?

19. What agency/organization should

be responsible for maintaining registry

information?

20. How should consent for inclusion

in an immunization registry be

obtained? Should it be implicit or

explicit?

21. What information should be

included in an immunization registry?

22. Should registries include (and

release) information on

contraindications, adverse events, etc.?

23. Who should have access to

immunization registry data and how can

restricted access be assured?

24. What information should be

available to persons other than the

client/patient and the direct health care

provider (e.g., schools)?

25. What is the best way to protect

privacy and ensure confidentiality

within a registry?

26. How should individuals/parents

have access to registry information on

themselves/their children?

27. Should data maintained in a state

and community-based immunization

registry be considered public

information?

28. Would national privacy and

confidentiality standards help ensure

that data maintained in an

immunization registry is protected?

Ensuring Provider Participation

Questions to be Considered:

1. What type of resources (e.g.,

hardware, staff, etc.) are needed for you

(provider/organization) to participate in

a computerized registry?

2. What are the cost-related barriers

that keep you (provider/organization)

from participating in an immunization

registry?

3. What cost should providers be

responsible for, pertaining to

participation in immunization registry

systems?

4. What are the cost savings you

would anticipate as a result of

participating in a computerized registry

(e.g., increased return visit form

reminders, less personnel paperwork for

preschool exams, etc.)?

5. How much time would you be

willing to invest per patient visit (e.g.,

additional 1, 5, 7, 10 minutes) in the

overall success of an immunization

registry?

6. What type of user support would be

needed in order for you (provider/

organization) to participate in an

immunization registry?

7. How would you (provider/

organization) encourage providers and

consumers in your community to

participate in an immunization registry?

8. What community support would be

necessary for you to participate in the

immunization registry?

9. What benefits/value (e.g.,

immunization reminders, quick access

to immunization histories, etc.) would a

registry provide that would encourage

your (provider/organization)

participation?

10. What incentives should be offered

to providers/organizations to participate

in an immunization registry?

11. What barriers have you (provider/

organization) encountered that have

prevented you from participating in an

immunization registry?

12. Is provider liability (e.g,

disclosure of sensitive patient

information) a barrier to participating in

an immunization registry? Why?

13. How would an immunization

registry impact your practice/

organization?

14. Do you currently share

immunization data with other providers

electronically? For what purpose (e.g.,

billing, share group data, etc.)?

15. How (e.g., electronic record, paper

record) is medical information

maintained in your practice/

organization?

16. Who should retain ownership of

immunization records as they are

distributed throughout an immunization

registry?

17. How would you (provider/

organization) use the data maintained in

an immunization registry?

18. What type of quality control

process would you (provider/

organization) perform to ensure the

accuracy and completeness of the

immunization data entered into an

immunization registry?

19. What type of security policies and

procedures need to be in place for you

to be confident that data are secure?

20. What functions should a registry

perform in your office in order for you

(provider/organization) to participate?

21. Do you have any advice or

recommendations for NVAC/CDC/HHS

related to the implementation of the

network of state and community-based

registries and do you have any

concerns?

22. Do you feel that there is a need for

the Federal Government to provide

leadership in developing state and

community-based immunization

registries? What should the role of the

Federal Government be in this effort?

23. Have you received training on the

use and maintenance of computerized

medical information? Do you feel this

training is needed to fully support the

development and maintenance of

immunization registries?

Contact Person for More Information:

Robb Linkins, M.P.H., Ph.D., Chief,

Systems Development Branch, Data

Management Division, NIP, CDC, 1600

Clifton Road, NE, M/S E–62, Atlanta,

Georgia 30333, telephone (404) 639–

8728, e-mail rxl3@cdc.gov.

Dated: June 29, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–17763 Filed 7–2–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0046]

Quarterly List of Guidance Documents

at the Food and Drug Administration

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.
36414 Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices

SUMMARY: The Food and Drug

Administration (FDA) is publishing the

first quarterly update of all guidance

documents issued and withdrawn since

the compilation of the comprehensive

list. FDA committed to publishing

quarterly updates in its 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

inform the public of the existence and

availability of guidance documents

issued since the comprehensive list was

compiled. This list also includes some

guidance documents that were

inadvertently not included on the

comprehensive list mentioned

previously.

DATES: General 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. Information

on where to obtain single copies of

listed guidance documents is provided

for each agency center individually in

the specific center’s list of guidance

documents.

FOR FURTHER INFORMATION CONTACT: Lisa

L. Barclay, Office of Policy (HF–22),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–3360.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February

27, 1997 (62 FR 8961), FDA published

a notice announcing its ‘‘Good Guidance

Practices’’ (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 publish an annual

comprehensive list of guidance

documents and quarterly Federal

Register notices that list all guidance

documents that were issued and

withdrawn during that quarter,

including ‘‘Level 2’’ guidance

documents. The following list of

guidance documents represents all

guidances issued by FDA since the

compilation of the February 26, 1998

(63 FR 9795) list and guidance

documents inadvertently not included

in the comprehensive list. The guidance

documents are organized by the issuing

Center or Office within FDA, and are

further grouped by the intended users or

regulatory activities to which they

pertain. Dates provided in the following

list refer to the date of issuance or,

where applicable, the date of last

revision of the document. Document

numbers are provided where available.

II. Guidance Documents Issued by the

Center for Biologics Evaluation and

Research (CBER)

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email, or Internet)

Guidance for Industry: Industry-Supported

Scientific and Educational Activities

November 1997 FDA Regulated IndustryOffice of Communication, Training, and Manufacturers Assistance (HFM–40), Center

for Biologics Evaluation and Research

(CBER), Food and Drug Administration,

1401 Rockville Pike, Rockville, MD

20852–1448, 1–800–835–4709 or 301–

827–1800, FAX Information System: 1–

888–CBER–FAX (within the United States)

or 301–827–3844 (outside of the United

States and local to Rockville, MD). Internet

access: http://www.fda.gov/cber

Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by

Healthcare Organizations or Pharmacy

Benefits Management Companies (PBMS)

December 1997 Do Do

Guidance for Industry: Year 2000 Date

Change for Computer Systems and Software Applications Used in the Manufacture

of Blood Products

January 1998 Do Do

Draft Guidance for Industry: Efficacy Studies

to Support Marketing of Fibrin Sealant

Products Manufactured for Commercial

Use

January 1998 Do Do

Draft Guidance for Industry: Container and

Closure Integrity Testing in Lieu of Sterility

Testing as a Component of the Stability

Protocol for Sterile Products

January 1998 Do Do

Draft Guidance for Industry: Clinical Development of Programs for Drugs, Devices and

Biological Products Intended for Treatment

of Osteoarthritis (OA)

February 1998 Do Do

Draft Guidance for Industry: Environmental

Assessment of Human Drug and Biologics

Applications

November 1997 Do Do
Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices 36415

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email, or Internet)

Guidance for Industry: Implementation of

Section 126, Elimination of Certain Labeling Requirements of the Food and Drug

Administration Modernization Act of 1997

February 1998 Do Do

Guidance for Industry: Clinical Development

Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA)

March 1998 Do Do

Guidance for Industry: Supplemental Testing

and the Notification of Consignees of

Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)

March 1998 Do Do

Guidance for Industry: Guidance for Human

Somatic Cell Therapy and Gene Therapy

March 1998 Do Do

Compliance Program Guidance Manual

(Drugs and Biologics) (Publication No. 94–

920699)

1994 FDA Personnel National Technical Information Service

(NTIS), 5285 Port Royal Rd., Springfield,

VA 22161, 703–605–6050

III. Guidance Documents Issued by the

Center for Devices and Radiological

Health (CDRH)

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email or Internet)

Guidance on Medical Device Tracking (Docket #98D–0132)February 19, 1998 OC Division of Small Manufacturers Assistance,

1–800–638–2041 or 301–827–0111 or

(Fax) Facts-on-Demand at 1–800–899–

0381 or Internet at http://www.fda.gov/cdrh

Guidance on Lead Wires and Patient Cables March 9, 1998 OC Do

Draft Guidance to Industry and CDRH for

PMA’s and PMA Supplements: Use of

Published Literature, Use of Previously

Submitted Materials, and Priority Review

March 20, 1998 ODE Do

PMA/510(k) Expedited Review—Guidance for

Industry and CDRH Staff

March 20, 1998 ODE Do

Guidance on Amended Procedures for Advisory Panel MeetingsMarch 20, 1998 ODE Do

Guidance on IDE Policies and Procedures January 20, 1998 ODE Do

Early Collaboration Meetings Under the FDA

Modernization Act (FDAMA), Guidance for

Industry and CDRH Staff, Final Document

(Docket #98D–0078) (FOD #310)

February 19, 1998 ODE Do

Guidance on PMA Interactive Procedures for

Day-100 Meetings and Subsequent Deficiencies—for Use by CDRH and Industry

(Docket #98D–0079) (FOD #322)

February 19, 1998 ODE Do

Determination of Intended Use for 510(k) Devices: Final Document (Docket #98D–

0081) (FOD #857)

February 19, 1998 ODE Do

30-Day Notices and 135-day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and

CDRH (Docket #98D–0080) (FOD #795)

February 19, 1998 ODE Do

New section 513(f)(2)—Evaluation of Automatic Class III Designation: Guidance for

Industry and CDRH Staff (Docket #98D–

0082) (FOD #199)

February 19, 1998 ODE Do

Procedures for Class II Device Exemptions

from Premarket Notification Guidance for

Industry and CDRH Staff (Docket #98D–

0083) (FOD #159)

February 25, 1998 ODE Do

Electrocardiograph (ECG) Surface Electrode

Tester—Version 1.0

February 11, 1997 ODE/DCRND Do
36416 Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email or Internet)

Guidance for the Submission of 510(k) Premarket Notifications for Cardiovascular

Intravascular Filters

January 1, 1997 ODE/DCRND Do

Guidance Document for Testing Bone Anchor

Devices (FOD #915)

April 20, 1996 ODE/DGRD Do

ORDB 510(k) Sterility Review Guidance

(FOD #659)

July 3, 1997 ODE/DGRD

Guidance for Testing MR Interaction With

Aneurysm Clips (FOD #958)

May 22, 1996 ODE/DGRD Do

Electroencephalograph Device Draft Guidance for 510(k) Content (FOD #767)June 25, 1997 ODE/DGRD Do

Ophthalmic Device Triage List July 25, 1997 ODE/DOD Do

Contact Lenses: The Better the Care the

Safer the Wear (FDA Publication No. 91–

4220)

April 1, 1991 ODE/DOD Do

An FDA Survey of U.S. Contact Lens Wearers (Carol L. Herman) Reprinted from Contact Lens SpectrumJuly 1, 1987 ODE/DOD Do

Facts for Consumers from the Federal Trade

Commission—Eyeglasses

April 1, 1986 ODE/DOD Do

Important Information About Rophae Intraocular LensesAugust 20, 1992 ODE/DOD Do

Intraocular Lens (IOL) Guidance Document October 10, 1997 ODE/DOD Do

FDA Guidance for Multifocal Intraocular Lens

IDE Studies and PMA’s

May 1996 ODE/DOD Do

Premarket Notification[510(k)] Guidance Document on Class II Daily Wear Contact

Lenses

May 12, 1994 ODE/DOD Do

Electrocardiograph (ECG) Electrode—Version 1.0February 11, 1997 ODE/DRAERD Do

Electrocardiograph (ECG) Lead Switching

Adapter—Version 1.0

February 11, 1997 ODE/DRAERD Do

Tympanostomy Tubes, Submission Guidance

for a 510(k) Premarket Notification

January 14, 1998 ODE/DRAERD Do

Guidance for the Content of Premarket Notifications for Metal Expandable Biliary StentsFebruary 5, 1998 ODE/DRAERD Do

FDA Modernization Act of 1997: Guidance

for the Device Industry on Implementation

of Highest Priority Provisions; Availability

February 6, 1998 OHIP/Regs Do

Policy Notebook in a Q/A Format (Update to

existing document)

January 23, 1998 OHIP/DMQRP Do

The Small Entity Compliance Guide January 1998 OHIP/DMQRP Do

Medical Device Appeals and Complaints: A

Guidance on Dispute Resolution

February 19, 1998 OHIP/DSMA Do

Medical Device Quality Systems Manual: A

Small Entity Compliance Guide

December 1, 1996 OHIP/DSMA Do

SMDA to FDAMA: Guidance on FDA’s Transition Plan for Existing Postmarket Surveillance (FOD #318)February 19, 1998 OSB/DPS Do

Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies (FOD #316)February 19, 1998 OSB/DPS Do

Guidance on Procedures for Review of

Postmarket Surveillance Submissions

(FOD #317)

February 19, 1998 OSB/DPS Do

MDR/Policy/Guidance for Endosseus Implant

Devices

December 1992 OSB/DSS Do

MDR Guidance #4—External Defibrillators September 1994 OSB/DSS Do

MDR Guidance—Blood Loss Policy December 1995 OSB/DSS Do

Summary Reporting Approval for Adverse

Events

July 1997 OSB/DSS Do

Common Problems: Baseline Reports and

MedWatch Form 3500A (letter to manufacturers updated)

OSB/DSS Do

Guidance on the Recognition and Use of

Consensus Standards

February 19, 1998 OST Do

Withdrawn
Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices 36417

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email or Internet)

‘‘Draft Guidance for the Content of Preliminary Investigational Device Exemptions

(Pre-IDE) Presentations: Teleconferences,

Meetings and Written Submissions’’

August 22, 1995 ODE/DCRND Do

Preliminary Guidance for Ambulatory Electrocardiograph for Data to be Submitted to

FDA in Support of Premarket Notification

Applications

September 1, 1994 ODE/DCRND Do

Preliminary Guidance for Data to be Submitted in Support of Premarket Notifications

for Analyzing ECG’s/Interpretive ECG’s

December 1, 1994 ODE/DCRND Do

Preliminary Guidance for Data to be Submitted to the FDA in Support of Premarket

Notification Applications for External

Cardioverters and Defibrillators

April 25, 1994 ODE/DCRND Do

Reviewer Checklist for Monitors: EMC, Battery and SoftwareJanuary 24, 1996 ODE/DCRND Do

Medical Device Tracking: Questions and Answers Based on the Final RuleAugust 26, 1993 OC/DOEI Do

510(k) Diagnostic Ultrasound Guidance 4/91

Use of Medical Index in Place of Peak Intensity in Determining Substantial Equivalency for Diagnostic Ultrasound Equip/Access/Rel. Meas. Dev.

February 1993 ODE/DRAERD Do

Review of ‘‘YAG’’ Lasers for Neurosurgery N/A ODE/DGRD Do

FDA Public Health Advisory: Retinal Photic

Injuries from Operating Microscopes During Cataract Surgery

October 16, 1995 ODE/DOD Do

Sterilization: Questions and Answers from

FDA, from Medical Device Diagnostic Industry for January, 1985, page 132

January 1985 OC/DOEII Do

Corrections

Rechargeable Battery Preliminary Guidance

for Data to be Submitted to FDA in Support of Premarket Notification Applications

(FOD #873)

January 1, 1994 ODE/DCRND Do

Review Guidance for Anesthesia Conduction

Catheter (FOD #783)

May 15, 1991 ODE/DCRND Do

Guidance for Peak Flow Meters for Over-theCounter SaleJune 1, 1993 ODE/DCRND Do

Review Guidance for Oxygen Generators

and Oxygen Equipment

Undated ODE/DCRND Do

Guidance for the Preparation and Content of

Applications to the Food and Drug Administration for Ventricular Assist Devices and

Total Artificial Hearts (draft)

December 4, 1987 ODE/DCRND Do

Draft Premarket Notification Review Guidance for Evoked Response Somatosensory

Stimulators

June 1, 1994 ODE/DGRD Do

Draft Version—Guidance on Biocompatibility

Requirements for Long Term Neurological

Implants: Part 3—Implant Model

September 12, 1994 ODE/DGRD Do

Draft Version 1—Biofeedback Devices—Draft

Guidance for 510(k) Content

August 1, 1994 ODE/DGRD Do

Draft Version Cranial Perforator Guidance July 13, 1994 ODE/DGRD Do

Draft Version Guidance for Clinical Data to

be Submitted for Premarket Approval Application for Cranial Electrotherapy

Stimulators

August 20, 1992 ODE/DGRD Do

Draft Version Guide for Cortical Electrode

510(k) Content

August 10, 1992 ODE/DGRD Do

Draft Version Neuro Endoscope Guidance July 7, 1994 ODE/DGRD Do

Galvanic Skin Response Measurement Devices—Draft Guidance for 510(k) ContentAugust 23, 1994 ODE/DGRD Do

Guidance for Studies for Pain Therapy Devices—General Considerations in the Design of Clinical Studies for Pain-Alleviating

Devices

May 12, 1988 ODE/DGRD Do

Guide for 510(k) Review of Processed

Human Dura Mater

June 26, 1990 ODE/DGRD Do
36418 Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email or Internet)

Guide for TENS 510(k) Content (Draft) August 1, 1994 ODE/DGRD Do

Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to

Evoked Response Stimulators

N/A ODE/DGRD Do

Protocol for Dermal Toxicity Testing for Devices in Contact With Skin (Draft)N/A ODE/DGRD Do

Premarket Notification 510(k) Guidance for

Contact Lens Care Products

May 1, 1997 ODE/DOD Do

Amendment 1: Premarket Notification

[510(k)] Guidance Document for Class II

Daily Wear Contact Lenses

June 28, 1994 ODE/DOD Do

Premarket Approval (PMA) Manual (FDA 97–

4214)

July 1, 1997 OHIP/DSMA Do

Required Postmarket Surveillance Section

522(a) Initial Device Categories Revised

September 30, 1997 OSB/DPS Do

Guidance to Manufacturers on the Development of Required Postmarket Surveillance

Study Protocols Under Section 522(a)(1) of

the Federal Food, Drug, and Cosmetic Act

July 16, 1996 OSB/DPS Do

Variance from Manufacturer Report Number

Format

August 12, 1996 OSB/DSS Do

IV. Guidance Documents Issued by the

Center for Drug Evaluation and

Research (CDER)

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, Fax, Email, or Internet)

Level 1 Guidances

Environmental Assessment of Human Drugs

and Biologics Applications

February 12, 1998 Chemistry Office of Training and Communications,

Drug Information Branch, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4573 or Internet at http://www.fda.gov/

cder/guidance/index.htm

PAC-ALTS: Postapproval Changes—Analytical Laboratory Testing SitesApril 28, 1998 Do Do

SUPAC IR/MR: Immediate Release and

Modified Release Solid Oral Dosage

Forms, Manufacturing Equipment Addendum

April 28, 1998 Do Do

Clinical Development Programs for Drugs,

Devices, and Biological Products for the

Treatment of Rheumatoid Arthritis (RA)

March 18, 1998 Clinical Do

Clinical Development Programs for Drugs,

Devices, and Biological Products Intended

for the Treatment of Osteoarthritis (OA)

February 18, 1998 Do Do

Manufacture, Processing or Holding of Active

Pharmaceutical Ingredients

April 17, 1998 Compliance Do

S1B Testing for Carcinogenicity in PharmaceuticalsFebruary 23, 1998 International Conference on HarmonizationDo

Implementation of Section 126, Elimination of

Certain Labeling Requirements, of the FDA

Modernization Act of 1997

February 18, 1998 FDA Modernization

Act

Do

National Uniformity for Nonprescription Drugs

Ingredient Labeling for OTC Drugs

May 5, 1998 Do Do

Repeal of Section 507 of the Federal Food,

Drug, and Cosmetic Act

February 5, 1998 Do Do

Level 2 Guidances

Drug Metabolism/Drug Interaction Studies in

the Drug Development Process: Studies In

Vitro

April 7, 1997 Clinical Do
Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices 36419

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, Fax, Email, or Internet)

Organization of an Abbreviated New Drug

Application and an Abbreviated Antibiotic

Application

April 7, 1997 Generic Drug Do

Aerosol Steroid Product Safety Information in

Prescription Drug Advertising and Promotional Labeling

January 12, 1998 Advertising Do

Withdrawn

Biopharmaceutic Considerations in Designing

and Evaluating Novel Drug Delivery Systems

November 1, 1983 Biopharmaceutic

Clinical Evaluation of Drugs to Prevent Dental CariesNovember 2, 1978 Clinical

Clinical Evaluation of Drugs to Prevent, Control and/or Treat Periodontal DiseaseNovember 1, 1978 Do

Conjugated Estrogens (Tables) In Vivo Bioequivalence and In Vitro Dissolution TestingAugust 21, 1991 Biopharmaceutic

Current Good Manufacturing Practices for

Positron Emission Tomographic (PET)

Drug Products

April 22, 1997 Compliance

Diphenhydramine Hydrochloride Capsules/

Elixir

June 1, 1986 Labeling

Ergotamine Tartrate and Caffeine Tablets

and Suppositories

December 1, 1981 Do

Glyburide Tablets April 1, 1993 Do

Haloperidol Tablets/Oral Solution (Concentrate)February 1, 1990 Do

Regulatory Aspects Pertinent to the Development of Transdermal Drug Delivery SystemsFebruary 2, 1985 Biopharmaceutic

Supplements to New Applications, Abbreviated Antibiotic Applications for Nonsterile

Drug Products

December 12, 1994 Compliance

Terfenadine (Tablets) In Vivo Bioequivalence

and In Vitro Dissolution Testing

September 11, 1995 Biopharmaceutic

Positron Emission Tomography Questions

and Answers 1

October 24, 1996 Generic Drug

Positron Emission Tomography Questions

and Answers 2

April 18, 1997 Do

Submission of an Environmental Assessment

in Human Drug Applications and Supplements

November 13, 1995 Chemistry

Submission of an Environmental Assessment

in Human Drug Applications and Supplements

November 13, 1995 Do

Acetohexamide (tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingAugust 1, 1988 Biopharmaceutic

Allopurinol (tablets) In Vivo Bioequivalence

and In Vitro Dissolution Testing

July 15, 1985 Do

Amiloride Hydrochloride (tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingMarch 29, 1985 Do

Aminophylline (suppositories) In Vivo Bioequivalence and In Vitro Dissolution TestingJuly 5, 1983 Do

Amitriptyline Hydrochloride (tablets) In Vivo

Bioequivalence and In Vitro Dissolution

Testing

July 5, 1983 Do

Amoxicillin (capsules, tablets and suspension) In Vivo Bioequivalence and In Vitro

Dissolution Testing

June 10, 1988 Do

Baclofen (tablets) In Vivo Bioequivalence and

In Vitro Dissolution Testing

May 5, 1988 Do

Cefadroxil (capsules, tablets and suspension)

In Vivo Bioequivalence and In Vitro Dissolution Testing

October 7, 1988 Do

Cephalexin (tablets and capsules) In Vivo

Bioequivalence and In Vitro Dissolution

Testing

March 19, 1987 Do
36420 Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, Fax, Email, or Internet)

Cephradine (Capsule and Suspension) InVivo Bioequivalence StudiesSeptember 10, 1986 Do

Chlordiazepoxide and Chlordiazepoxide HCl

Bioavailability and Dissolution Studies

July 5, 1983 Do

Chlorpropamide In-Vivo Bioavailability StudiesJuly 5, 1983 Do

Chlorthalidone (Tablets) July 5, 1983 Do

Clinical Evaluation of Drugs for the Treatment of Peripheral Vascular DiseaseDo

Clofibrate In Vivo Bioavailability Studies April 7, 1986 Do

Clonidine Hydrochloride Drug Products In

Vivo Bioequivalence Study and In Vitro

Dissolution Testing

December 5, 1984 Do

Clorazepate In Vivo Bioequivalence Study

and In Vitro Dissolution Testing

February 17, 1987 Do

Cyclobenzaprine Hydrochloride (tablets) In

Vivo Bioequivalence and In Vitro Dissolution Testing

January 25, 1988 Do

Desipramine Hydrochloride (Tablets) In Vivo

Bioequivalence Studies

September 22, 1987 Do

Dicyclomine Hydrochloride Drug Products In

Vivo Bioequivalence

August 10, 1984 Do

Dissolution Testing (General) April 1, 1978 Do

Estropipate Tablets In Vivo Bioequivalence

and In Vitro Dissolution Testing (I)

August 26, 1992 Do

Flurazepam Hydrochloride (capsules) In Vivo

Bioequivalence and In Vitro Dissolution

Testing

October 15, 1985 Do

Hydrochlorothiazide (tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingSeptember 28, 1987 Do

Hydroxyzine Hydrochloride (tablets) (dissolution only)March 4, 1986 Do

Indomethacin (capsules) In Vivo Bioequivalence and In Vitro Dissolution TestingJanuary 27, 1988 Do

Isopropamide Iodide (tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingMay 12, 1982 Do

Loxapine Succinate (capsules) In Vivo Bioequivalence and In Vitro Dissolution TestingSeptember 10, 1987 Do

Maprotiline Hydrochloride (tablets) In Vivo

Bioequivalence and In Vitro Dissolution

Testing

August 27, 1987 Do

Meclofenamate Sodium (capsules) In Vivo

Bioequivalence and In Vitro Dissolution

Testing

November 12, 1986 Do

Metaproterenol Sulfate (tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingMarch 18, 1986 Do

Metoclopramide Hydrochloride (tablets) In

Vivo Bioequivalence and In Vitro Dissolution Testing

December 27, 1984 Do

Nalidixic Acid In Vivo Bioequivalence and In

Vitro Dissolution Testing

August 19, 1987 Do

Nitrofurantion Macrocrystalline (capsules) In

Vivo Bioequivalence and In Vitro Dissolution Testing

January 10, 1986 Do

Nitroglycerin Ointment In Vivo Bioequivalence StudiesDecember 17, 1986 Do

Perphenazine (tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingAugust 27, 1987 Do

Perphenazine/Amitriptyline (tablets) In Vivo

Bioequivalence and In Vitro Dissolution

Testing

August 27, 1987 Do

Phenylbutazone Oxyphenbutazone (capsules

and tablets) In Vivo Bioequivalence and In

Vitro Dissolution Testing

September 28, 1987 Do
Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices 36421

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, Fax, Email, or Internet)

Prazepam (capsules and tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingJuly 26, 1988 Do

Prednisone (tablets) (dissolution only) July 10, 1985 Do

Probenecid Drug Products Bioavailability

Study

July 26, 1983 Do

Propoxyphene Napsylate With Acetaminphen

(Tablets)

March 26, 1980 Do

Propranolol Hydrochloride (tablets) In Vivo

Bioequivalence and In Vitro Dissolution

Testing

August 1, 1984 Do

Propylthiouracil (tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingAugust 13, 1986 Do

Quinidine Gluconate (tablets, controlled release) In Vivo Bioequivalence and In Vitro

Dissolution Testing

September 22, 1987 Do

Ritodrine Hydrochloride (tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingAugust 27, 1987 Do

Sulfinpyrazone (Capsules and Tablets) September 25, 1987 Do

Sulfones (tablets) In Vivo Bioequivalence and

In Vitro Dissolution Testing

November 7, 1986 Do

Temazepam In Vivo Bioequivalence Studies

and In Vitro Dissolution Testing

August 8, 1985 Do

Tolazamide (tablets) In Vivo Bioequivalence

and In Vitro Dissolution Testing

May 30, 1986 Do

Tolbutamide (tablets) In Vivo Bioequivalence

and In Vitro Dissolution Testing

December 1, 1983 Do

Trimipramine Maleate (capsules) In Vivo Bioequivalence and In Vitro Dissolution TestingAugust 18, 1987 Do

Verapamil Hydrochloride (tablets) In Vivo

Bioequivalence and In Vitro Dissolution

Testing

July 18, 1985 Do

V. Guidance Documents Issued by the

Center for Food Safety and Applied

Nutrition

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email, or Internet)

Level I Guidance Documents Not Included

in the February 1998 Comprehensive

List

Draft Working Guide to Minimize Microbial

Hazards for Fresh Fruits and Vegetable

1998 Farmers and Food

Packers

Lou Carson, Food Safety Initiative (HFS–3),

FDA–CFSAN, 200 C St. SW., Washington,

DC 20204 or jsaltsman@bangate.fda.gov

Iron-containing Supplements and Drugs:

Label Warning and Unit Dose Packaging;

Small Entity Compliance Guide

1997 Dietary Supplement

Manufacturers;

Small Entities

Office of Special Nutritionals (HFS–450),

FDA–CFSAN, 200 C St. SW., Washington,

DC 20204

Level 2 Guidance Documents

Partial List of Enzyme Preparations That Are

Used in Foods

1998 FDA Regulated IndustryOffice of Premarket Approval (HFS–200),

FDA–CFSAN, 200 C St. SW., Washington,

DC 20204

Partial List of Microorganisms and MicrobialDerived Ingredients That Are Used in Food1998 Do Do

Fish and Fishery Products Hazards and Controls Guide, 2nd Ed.January 1998 Do Office of Seafood (HFS–400), FDA–CFSAN,

200 C St. SW., Washington, DC 20204

HACCP Regulations for Fish and Fishery

Products: Questions and Answers

1997 Do Do
36422 Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices

VI. Guidance Documents Issued by the

Center for Veterinary Medicine (CVM)

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email, or Internet)

Validation of Analytical Procedures; Definition

and Terminology; Draft

December 1997 Regulated Industry Center for Veterinary Medicine (HFV–12),

Communications Staff, Food and Drug Administration, 7500 Standish Pl., Rockville,

MD 20855, 301–594–1755.

Validation of Analytical Procedures; Methodology; DraftDecember 1997 Do Do

Industry-Supported Scientific and Educational

Activities

November 1997 Do Do

Professional Flexible Labeling of Antimicrobial Drugs; DraftJanuary 1998 Do Do

Small Entities Compliance Guide for RenderersFebruary 1998 Do Do

Small Entities Compliance Guide for Protein

Blenders, Feed Manufacturers, and Distributors

February 1998 Do Do

Small Entities Compliance Guide for Feeders

of Ruminant Animals With On-Farm Feed

Mixing Operations

February 1998 Do Do

Small Entities Compliance Guide for Feeders

of Ruminant Animals Without On-Farm

Feed Mixing Operations

February 1998 Do Do

CVM Program Policy and Procedures Manual; Index (Guide No. 1240.0000)March 19, 1998 Do Do

CVM Guidance on Media Inquiries (Guide

No. 1240.2325)

December 17, 1997 Do Do

Requirements for Importation of Investigational New Animal Drugs (Guide No.

1240.3032)

March 27, 1992 Do Do

Animal Drug Applications Expedited Review

(Guide No. 1240.3135)

December 3, 1997 Do Do

CVM Research Activities (Guide No.

1240.3700)

January 6, 1998 Do Do

Initiation and Approval of Research Projects

(Guide No. 1240.3710)

January 6, 1998 Do Do

Ownership Transfer or Corporate Identity

Change of an Application (Guide No.

1240.4150)

March 19, 1998 Do Do

CVM Makes the Analysis of Comments on

the Fluoroquinolone and Glycopeptide Prohibition Available to the Public

January 15, 1998 Do Do

Withdrawn

CVM Program Policy and Procedures Manual; Index (Guide No. 1240.0000)October 29, 1997

CVM Guidance on Media Inquiries (Guide

No. 1240.2325)

July 1, 1997

CVM Research Activities (Guide No.

1240.3700)

November 3, 1993

Initiation and Approval of Research Projects

(Guide No. 1240.3710)

November 3, 1993

Criteria for the Approval of Euthanasia Products (Guide No. 1240.4112)February 13, 1990

Sterility of Ophthalmic Products (Guide No.

1240.4120)

December 7, 1993

Sterility and Pyrogen Requirements for

Injectable Drug Products (Guide No.

1240.4122)

November 27, 1989

Overformulation in Animal Drug Products

(Guide No. 1240.4130)

January 2, 1992

Continuous Use Production Drugs and ShortTerm Therapeutic Treatments in Feeds

(Guide No. 1240.4145)

April 16, 1990

Policy on Sterilization of New Animal Drug

Products and Containers by Irradiation

(Guide No. 1240.4160)

September 10, 1997

CVM Medically Necessary Veterinary Drug

Product Shortage Management (Guide No.

1240.4170)

June 30, 1994
Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices 36423

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email, or Internet)

Small Entities Compliance Guide on Animal

Proteins Prohibited from Animal Feed

June 1997

VII. Guidance Documents Issued by the

Office of Regulatory Affairs

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email, or Internet)

Investigations Operations Manual (PB98–

913399)

January 1998 FDA Staff Personnel National Technical Information Service

(NTIS), 5285 Port Royal Rd., Springfield,

VA 22161, or via Internet at www.fda.gov/

ora/ inspect—ref/iom/iomtc.html

Mammography Quality Standards Act

(MQSA) Auditors Guide (PB98–127178)

January 1998 Do NTIS or via Internet at www.fda.gov/ora/inspect—ref/igs/iglist.html

Guide to Inspections of Electromagnetic

Compatibility Aspects of Medical Device

Quality Systems (PB98–127152)

December 1997 Do Do

Guide to Inspections of Grain Product ManufacturersMarch 1998 Do Division of Emergency and Investigational

Operations (HFC–130), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857

Guide to Bioresearch Monitoring Inspections

of In Vitro Devices

February 1998 Do Do

Guide to Inspections of Viral Clearance Processes for Plasma DerivativesMarch 1998 Do Do

Guide to Inspections of Computerized Systems in the Food Processing IndustryMarch 1998 Do Do

Regulatory Procedures Manual; Update/New

Subchapter; Application Integrity Policy

March 1998 Do Division of Compliance Policy (HFC–230),

Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville,

MD 20857, 301–827–0420 or via Internet

at www.fda.gov/ora/compliancelref/rpm/

rpmtc.html

Regulatory Procedures Manual; Update Subchapter; Warning LettersMarch 1998 Do Do

Regulatory Procedures Manual: Update/Revised Subchapter; Import ProceduresApril 1998 Do Do

Regulatory Procedures Manual: Updated/Revised Subchapter; Priority Enforcement

Strategy for Problem Importers

April 1998 Do Do

Regulatory Procedures Manual: Updated/Revised Subchapter; Import ProceduresApril 1998 Do Do

Regulatory Procedures Manual: Updated/Revised Subchapter; Notice of SamplingApril 1998 Do Do

Regulatory Procedures Manual: Updated/Revised Subchapter; Supervisory ChargesApril 1998 Do Do

Regulatory Procedures Manual: Update/New

Subchapter; Granting and Denying Transportation and Exportation (T&E) Entries

May 1998 Do Do

Import Alerts Continuously Do Freedom of Information Staff (HFI–35), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, or via Internet

at www.fda.gov/ora/fiars/

oralimportslalerts.html

Guidance Documents Not Included in the

February 1998 Comprehensive List

Guideline for the Monitoring of Clinical InvestigationsJanuary 1998 Regulated Industry Division of Compliance Policy (HFC–230),

Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville,

MD 20857, 301–827–0420 or via Internet

at www.fda.gov/ora/compliancelref/rpm/

rpmtc.html

Computerized Systems Used in Clinical

Trials

June 18, 1997 Do Do
36424 Federal Register / Vol. 63, No. 128 / Monday, July 6, 1998 / Notices

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email, or Internet)

Compliance Program 7348.808; Bioresearch

Monitoring; Good Laboratory Practices

(GLP) (Nonclinical)

August 8, 1994 FDA Staff Personnel Do

Food Laboratory Practice Program (Nonclinical Laboratories) 7348.808A: EPA Data

Audit Inspections

October 1, 1991 Do Do

Compliance Program 7348.810: Sponsors,

Contract Research Organizations and

Monitors

August 18, 1994 Do Do

Compliance Program 7348.809: Bioresearch

Monitoring; Institutional Review Board

August 18, 1994 Do Do

Compliance Program 7348.811: Bioresearch

Monitoring; Clinical Investigations

August 18, 1994 Do Do

VIII. International Conference on

Harmonization Guidances (CDER)

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, Email, or Internet)

E2B Data Elements for Transmission of Individual Case Safety ReportsJanuary 15, 1998 Regulated Industry Drug Information Branch (HFD–210), Center

for Drug Evaluation and Research, 5600

Fishers Lane, Rockville, MD 20857, 301–

827–4573 or Office of Communication,

Training, and Manufacturers Assistance

(HFM–40), Center for Biologics Evaluation

and Research (CBER), Food and Drug

Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 1–800–835–4709

or 301–827–1800, FAX Information System: 1–888–CBER–FAX (within the United

States)or 301–827–3844 (outside of the

United States and local to Rockville, MD).

Internet at http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/

publications.htm

E8 General Considerations for Clinical Trials December 17, 1997 Do Do

M3 Timing of Nonclinical Studies for the Conduct of Human Clinical Trials of PharmaceuticalsNovember 25, 1997 Do Do

QC3 Impurities; Residual Solvents December 24, 1997 Do Do

S1B Testing for Carcinogenicity of PharmaceuticalsFebruary 23, 1998 Do Do

S1C(R) Dose Selection for Carcinogenicity

Studies of Pharmaceuticals: Addendum on

a Limit Dose and Related Notes

December 4, 1997 Do Do

Dated: June 25, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–17702 Filed 7–2–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Current List of Laboratories Which

Meet Minimum Standards To Engage in

Urine Drug Testing for Federal

Agencies, and Laboratories That Have

Withdrawn From the Program

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services notifies Federal

agencies of the laboratories currently

certified to meet standards of Subpart C

of Mandatory Guidelines for Federal

Workplace Drug Testing Programs (59

FR 29916, 29925). A similar notice

listing all currently certified laboratories

will be published during the first week

of each month, and updated to include

laboratories which subsequently apply

for and complete the certification

process. If any listed laboratory’s

certification is totally suspended or

revoked, the laboratory will be omitted