[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Notices]
[Pages 9561-9569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4843]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0085]


FDA Modernization Act of 1997: Guidance for the Recognition and 
Use of Consensus Standards; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is: (1) Announcing the 
availability of a guidance entitled ``Guidance on the Recognition and 
Use of Consensus Standards,'' the purpose of which is to provide 
guidance to industry and reviewers within the Center for Devices and 
Radiological Health (CDRH) on the use of recognized consensus 
standards, including declarations of conformity to the standards, 
during the evaluation of premarket submissions for medical devices; (2) 
publishing the initial list of standards that will be recognized for 
use in the premarket review process; and (3) announcing the agency's 
policy on updating the list of recognized standards. This guidance will 
assist manufacturers who elect to declare conformity with consensus 
standards to meet all or part of medical device review requirements.

DATES: This guidance is effective on February 19, 1998; however, 
written comments concerning this guidance may be submitted at any time.

ADDRESSES: Written comments concerning this guidance must be submitted 
to the first contact person listed below. Comments should be identified 
with the docket number found in brackets in the heading of this 
document. Submit written requests for single copies of ``Recognition 
and Use of Consensus Standards'' to the Division of Small Manufacturers 
Assistance (DSMA), Center for Devices and Radiological Health (HFZ-
220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send two self-addressed adhesive labels to assist that office in 
processing your request, or fax your request to 301-443-8818. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance. This guidance document may also be accessed via the Internet 
at FDA's web site ``http://www.fda.gov/cdrh''.

FOR FURTHER INFORMATION CONTACT:
    To comment on this guidance: Melvyn R. Altman, Associate Director 
for Standards Policy, enter for Devices and Radiological Health (HFZ-
101),

[[Page 9562]]

Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 301-594-4766, ext. 103.
    To recommend additional standards for recognition:
    James J. McCue, Director, Standards Program Coordination Staff, 
enter for Devices and Radiological Health (HFZ-101), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
4766, ext. 137.

SUPPLEMENTARY INFORMATION:

I. Background

    Many domestic and international consensus standards address 
relevant aspects of safety and/or effectiveness of medical devices. 
Many of these consensus standards have been developed with the 
participation of FDA staff. Section 204 of the Food and Drug 
Administration Modernization Act of 1997, Pub. L. 105-115, 111 Stat. 
2296 (1997) (FDAMA) amends section 514 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360d), allowing the agency to 
recognize consensus standards established by international and national 
standards development organizations that may be used to satisfy 
identified portions of device review requirements. This notice 
announces the availability of a guidance document entitled ``Guidance 
on the Recognition and Use of Consensus Standards,'' which describes 
how FDA will implement that part of the FDAMA.
    The agency has adopted Good Guidance Practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). Although ``Guidance on the Recognition and Use of Consensus 
Standards'' is Level 1 guidance under the GGP's, this guidance will 
become effective upon issuance. Under the GGP's the agency may elect 
not to solicit public comment prior to implementation when there is a 
new statutory requirement * * * that requires immediate implementation 
and guidance is needed to help effect such implementation'' (62 FR 8961 
at 8968). However, comments may be submitted at any time by interested 
parties, and these comments will be considered in any future revisions 
to the guidance.
    This guidance document may contain collections of information that 
require OMB clearance under the Paperwork Reduction Act of 1995. FDA 
will seek such approval and provide an opportunity for comment, as 
appropriate.

II. Use of Recognized Standards

    A person required to submit a premarket application (i.e., 
Premarket Notification (510(k)), Investigational Device Exemptions 
application (IDE), Premarket Approval application (PMA), Humanitarian 
Device Exemption application (HDE), or Product Development Protocol 
(PDP)) must provide information as required by the statute and 
regulations to allow FDA to make an appropriate decision regarding the 
clearance or approval of the submission. This guidance document 
describes how FDA will recognize consensus standards and use 
conformance with recognized standards to satisfy review requirements. 
It does not affect FDA's ability to obtain any information authorized 
by the statute or regulations. Use of consensus standards in this 
manner is authorized by section 514 of the act, as amended by FDAMA.
    FDA believes that conformance with applicable recognized consensus 
standards can provide a reasonable assurance of safety and/or 
effectiveness for many devices. Therefore, information submitted on 
conformance with such standards will have a direct bearing on 
determinations of safety and effectiveness made during the review of 
IDE's, HDE's, PMA's, and PDP's. In case of 510(k)s, information on 
conformance with recognized consensus standards may help establish the 
substantial equivalence of a new device to a legally marketed predicate 
device. This information can serve as a surrogate for comparative 
information to show that the new device is as safe and effective as the 
predicate in the areas covered by the standards. Moreover, if a 
premarket submission contains a declaration of conformity to recognized 
consensus standards, this will, in most cases, eliminate the need to 
review actual test data for those aspects of the device addressed by 
the standards. The content of a declaration of conformity is described 
in the guidance document and is consistent with the ISO/IEC Guide 22.
    Conformance with recognized consensus standards in and of itself, 
however, may not always be a sufficient basis for regulatory decisions. 
For example, a specific device may raise a safety or effectiveness 
issue not addressed by any standard, or a specific FDA regulation may 
require additional information beyond that which conformity to the 
recognized consensus standards provides. Under such circumstances, 
conformity with recognized standards will not satisfy all requirements 
for marketing, or investigating, the product in the United States.
    The guidance document, ``Guidance on the Recognition and Use of 
Consensus Standards'', represents the agency's current thinking on the 
use of recognized consensus standards for medical devices. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statute, 
regulations, or both.

III. List of Recognized Standards

    The initial list of consensus standards to be recognized for use in 
premarket review is presented at the end of this document. This list is 
also maintained on the FDA web site ``http://www.fda.gov/cdrh''. Also 
posted on the web site are supplemental data sheets for each recognized 
standard. These data sheets list the address(es) where the standard can 
be obtained, information on any limitations to the application of the 
standard in medical device review, and a list of devices for which 
declarations of conformity with the recognized standard will be 
routinely accepted by agency reviewers. In addition to these documents, 
the web site contains answers to frequently asked questions regarding 
the use of recognized standards.

IV. Recommendation of Standards for Recognition by FDA

    Modifications to the list of recognized consensus standards related 
to medical devices will be announced in the Federal Register at least 
once a year, or more often if necessary. FDA intends that the next 
revision to the list of recognized standards will include standards to 
be recognized by the Center for Biologics Evaluation and Research as 
well as by CDRH.
    Any person may recommend consensus standards as candidates for 
recognition under new paragraph  of section 514 of the act, 
by submitting such recommendations, with justification, to the address 
identified at the beginning of this document. To be properly 
considered, such recommendations should contain at a minimum the 
following information: (1) Title of the standard, (2) any reference 
number and date, (3) name and address of the nationally or 
internationally recognized standards development organization, (4) a 
proposed list of devices for which a declaration of conformity should 
routinely apply, and (5) a brief identification of the testing or 
performance or other characteristics of

[[Page 9563]]

the device(s) that would be addressed by a declaration of conformity.

V. Electronic Access

    In order to receive the guidance document ``Recognition and Use of 
Consensus Standards,'' via your fax machine, call the CDRH Facts-On-
Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. At the first voice prompt press 1 to access DSMA Facts, at 
the second voice prompt press 2, and then enter the document number 
321, followed by the pound sign (#). Then follow the remaining voice 
prompts to complete your request. Persons interested in obtaining a 
copy of the guidance may also do so by using the World Wide Web (WWW). 
CDRH maintains an entry on the WWW for easy access to information 
including text, graphics, and files that may be downloaded to a 
personal computer with access to the Web. Updated on a regular basis, 
the CDRH Home Page includes the guidance Document ``Guidance on the 
Recognition and Use of Consensus Standards'', as well as the list of 
recognized standards and details on their application and information 
on obtaining copies. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press Enter 
several times and then select menu choice 1: FDA Bulletin Board 
Service. From there follow instructions for logging in, and at the BBS 
TOPICS PAGE, arrow down to the FDA home page (do not select the first 
CDRH entry). Then select Medical Devices and Radiological Health. From 
there select Center for Devices and Radiological Health for general 
information, or arrow down for specific topics.

VI. Comments

    Interested persons may, at any time, submit to the contact person 
listed above written comments regarding the guidance. Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments will be 
considered in determining whether to amend the current guidance.

----------------------------------------------------------------------------------------------------------------
                                                                                           Name of standards    
                        Title of standard             Reference number and date         development organization
----------------------------------------------------------------------------------------------------------------
                                         Generally Applicable Standards                                         
----------------------------------------------------------------------------------------------------------------
1.................  Biological Evaluation of   ANSI/AAMI/ISO 10993-1                   Association for the      
                     Medical Devices--Part 1:                                           Advancement of Medical  
                     Guidance on Selection of                                           Instrumentation.        
                     Tests--First Edition.                                                                      
2.................  Medical Electrical         IEC 60601-1                             International            
                     Equipment--Part 1:                                                 Electrotechnical        
                     General Requirements for                                           Commission (IEC).       
                     Safety.\1\.                                                                                
3.................  Biological Evaluation of   ISO 10993-1                             International            
                     Medical Devices--Part 1:                                           Organization for        
                     Guidance on Selection of                                           Standardization (ISO).  
                     Tests--First Edition                                                                       
                     (Corrigendum 1-1992)(CEN                                                                   
                     EN 30993-1:1994).                                                                          
----------------------------------------------------------------------------------------------------------------
                                                In Vitro Devices                                                
----------------------------------------------------------------------------------------------------------------
1.................  How to Define, Determine   C28-A (1995)                            National Committee for   
                     and Utilize Reference                                              Clinical Laboratory     
                     Intervals in the                                                   Standards (NCCLS).      
                     Clinical Laboratory;                                                                       
                     Approved Guideline.                                                                        
2.................  Method Comparison and      EP9-A (1995)                            NCCLS.                   
                     Bias Estimation Using                                                                      
                     Patient Samples;                                                                           
                     Approved Guideline.                                                                        
3.................  Assessment of the          GP-10-A (1995)                          NCCLS.                   
                     Clinical Accuracy of                                                                       
                     Laboratory Tests Using                                                                     
                     Receiver Operating                                                                         
                     Characteristic (ROC)                                                                       
                     Plots; Approved                                                                            
                     Guideline.                                                                                 
4.................  Labeling of Home-Use In    GP14-A (1996)                           NCCLS.                   
                     Vitro Testing Products;                                                                    
                     Approved Guideline.                                                                        
5.................  Procedures for the         H18-A (1990)                            NCCLS.                   
                     Handling and Processing                                                                    
                     of Blood Specimens;                                                                        
                     Approved Guidelines.                                                                       
6.................  Specifications for         ILA18-A (1994)                          NCCLS.                   
                     Immunological Testing                                                                      
                     for Infectious Diseases;                                                                   
                     Approved Guideline.                                                                        
7.................  Assessing the Quality of   LAI-A2 (1994)                           NCCLS.                   
                     Radioimmunassay Systems--                                                                  
                     Second Edition; Approved.                                                                  
8.................  Performance Standards for  M2-A6 (1997)                            NCCLS.                   
                     Antimicrobial Disk                                                                         
                     Susceptibility Tests--                                                                     
                     Sixth Edition; Approved                                                                    
                     Standard.                                                                                  
9.................  Methods for Antimicrobial  M11-A3 (1993)                           NCCLS.                   
                     Susceptibility Testing                                                                     
                     of Anaerobic Bacteria--                                                                    
                     Third Edition; Approved                                                                    
                     Standard.                                                                                  
10................  Development of In Vitro    M23A                                    NCCLS.                   
                     Susceptibility Testing                                                                     
                     Criteria and Quality                                                                       
                     Control Parameters.                                                                        
11................  Molecular Diagnostic       MM3-(1995)                              NCCLS.                   
                     Methods for Infectious                                                                     
                     Diseases; Approved                                                                         
                     Guideline.                                                                                 
----------------------------------------------------------------------------------------------------------------
                                             OB-GYN/Gastroenterology                                            
----------------------------------------------------------------------------------------------------------------
1.................  Hemodialysis Systems.....  ANSI/AAMI RD5-1992                      Association for the      
                                                                                        Advancement of Medical  
                                                                                        Instrumentation (AAMI). 
2.................  Standard Performance       ASTM-D3492-96                           American Society for     
                     Specifications for                                                 Testing and Materials   
                     Rubber Contraceptives                                              (ASTM).                 
                     (Male Condom).                                                                             
3.................  Standard Performance       ASTM F623-89                            ASTM.                    
                     Specifications for Foley                                                                   
                     Catheters.                                                                                 
----------------------------------------------------------------------------------------------------------------

[[Page 9564]]

                                                                                                                
                                                   Ophthalmic                                                   
----------------------------------------------------------------------------------------------------------------
1.................  Optics and Optical         ISO 9338:1996                           International            
                     Instruments--Contact                                               Organization for        
                     Lenses--Determination of                                           Standardization (ISO).  
                     the Diameters.                                                                             
2.................  Optics and Optical         ISO 9339-1:1996                         ISO.                     
                     Intruments--Contact                                                                        
                     Lenses--Determination of                                                                   
                     the Thickness--Part 1:                                                                     
                     Rigid Contact Lenses.                                                                      
3.................  Optics and Optical         ISO 9340:1996                           ISO.                     
                     Intruments--Contact                                                                        
                     Lenses--Determination of                                                                   
                     Strains for Rigid                                                                          
                     Contact Lenses.                                                                            
4.................  Optics and Optical         ISO 9341:1996                           ISO.                     
                     Intruments--Contact                                                                        
                     Lenses--Determination of                                                                   
                     Inclusions and Surface                                                                     
                     Imperfections for Rigid                                                                    
                     Contact Lens.                                                                              
5.................  Optics and Optical         ISO 9363-1:1994                         ISO.                     
                     Intruments--Contact                                                                        
                     Lenses--Determination of                                                                   
                     Cytotoxicity of Contact                                                                    
                     Lens Material--Part 1:                                                                     
                     Agar Overlay Test and                                                                      
                     Growth Inhibition Test.                                                                    
6.................  Optics and Optical         ISO 9394:1994                           ISO.                     
                     Intruments--Contact                                                                        
                     Lenses--Determination of                                                                   
                     Biological Compatibility                                                                   
                     of Contact Lens                                                                            
                     Material--Testing of the                                                                   
                     Contact Lens System by                                                                     
                     Ocular Study with Rabbit                                                                   
                     Eyes.                                                                                      
7.................  Optics and Optical         ISO 9913-1:1996                         ISO.                     
                     Intruments--Contact                                                                        
                     Lenses--Determination of                                                                   
                     Oxygen Permeability and                                                                    
                     Transmissibility with                                                                      
                     the FATT Method.                                                                           
8.................  Optics and Optical         ISO 10338:1996                          ISO.                     
                     Intruments--Contact                                                                        
                     Lenses--Determination of                                                                   
                     Curvature.                                                                                 
9.................  Optics and Optical         ISO 10339:1997                          ISO.                     
                     Intruments--Contact                                                                        
                     Lenses--Determination of                                                                   
                     Water Content of                                                                           
                     Hydrogel Lenses.                                                                           
10................  Optics and Optical         ISO 10340:1995                          ISO.                     
                     Intruments--Contact                                                                        
                     Lenses--Method for                                                                         
                     Determining the                                                                            
                     Extractable Substances.                                                                    
11................  Optics and Optical         ISO 10344:1996                          ISO.                     
                     Intruments--Contact                                                                        
                     Lenses--Saline Solution                                                                    
                     for Contact Lens Testing.                                                                  
12................  Optics and Optical         ISO 11980:1997                          ISO.                     
                     Intruments--Contact                                                                        
                     Lenses and Contact Lens                                                                    
                     Care Products-- Guidance                                                                   
                     for Clinical                                                                               
                     Investigations.                                                                            
----------------------------------------------------------------------------------------------------------------
                                                  Orthopaedics                                                  
----------------------------------------------------------------------------------------------------------------
1.................  Standard Specifications    ASTM F67-95                             American Society for     
                     for Unalloyed Titanium                                             Testing and Materials   
                     for Surgical Implant                                               (ASTM)                  
                     Applications.                                                                              
2.................  Standard Specifications    ASTM F75-92                             ASTM.                    
                     for Cast Cobalt-Chromium-                                                                  
                     Molybdenum Alloy for                                                                       
                     Surgical Implant                                                                           
                     Applications.                                                                              
3.................  Standard Practice for      ASTM F86-91                             ASTM.                    
                     Surface Preparation and                                                                    
                     Marking of Metallic                                                                        
                     Surgical Implants.                                                                         
4.................  Standard Specification     ASTM F90-96                             ASTM.                    
                     for Wrought Cobalt-20                                                                      
                     Chromium-15 Tungsten-10                                                                    
                     Nickel Alloy for                                                                           
                     Surgical Implant                                                                           
                     Aplications (UNS R30605).                                                                  
5.................  Standard Specification     ASTM F136-96                            ASTM.                    
                     for Wrought Titanium-6                                                                     
                     Aluminum-4 Vanadium ELI                                                                    
                     (Extra Low Interstitial)                                                                   
                     Alloy (R56401) for                                                                         
                     Surgical Implant                                                                           
                     Applications.                                                                              
6.................  Standard Specification     ASTM F138-92                            ASTM.                    
                     for Stainless Steel Bar                                                                    
                     and Wire for Surgical                                                                      
                     Implants (Special                                                                          
                     Quality).                                                                                  
7.................  Standard Specification     ASTM F-139-96                           ASTM.                    
                     for Wrought-18 Chromium-                                                                   
                     14 Nickel-2.5 Molybdenum                                                                   
                     Stainless Sheet and                                                                        
                     Strip for Surgical                                                                         
                     Implants (UNS S31673).                                                                     
8.................  Standard Specification     ASTM F366-82(r1993)                     ASTM.                    
                     for Fixation Pins and                                                                      
                     Wires.                                                                                     
9.................  Standard Specification     ASTM F560-92                            ASTM.                    
                     for Unalloyed Tantalum                                                                     
                     for Surgical Implant                                                                       
                     Applications.                                                                              
10................  Standard Practice for      ASTM F561-87                            ASTM.                    
                     Analysis of Retrieved                                                                      
                     Metallic Orthopaedic                                                                       
                     Implants.                                                                                  
11................  Wrought Cobalt-35 Nickel-  ASTM F562-95                            ASTM.                    
                     20 Chromium-10                                                                             
                     Molybdenum Alloy for                                                                       
                     Surgical Implant                                                                           
                     Applications.                                                                              
12................  Standard Practice for      ASTM F565                               ASTM.                    
                     Care and Handling of                                                                       
                     Orthopaedic Implants and                                                                   
                     Instruments.                                                                               
13................  Standard Practice for      ASTM F601-86(1992)                      ASTM.                    
                     Fluorescent Penetrant                                                                      
                     Inspection of Metallic                                                                     
                     Surgical Implants.                                                                         

[[Page 9565]]

                                                                                                                
14................  Standard Specification     ASTM F603                               ASTM.                    
                     for High-Purity Dense                                                                      
                     Aluminum Oxide for                                                                         
                     Surgical Implants.                                                                         
15................  Standard Specification     ASTM F604                               ASTM.                    
                     Classifications for                                                                        
                     Silicone Elastomers Used                                                                   
                     in Medical Applications.                                                                   
16................  Standard Specification     ASTM F620                               ASTM.                    
                     for Titanium 6A1-4V E11                                                                    
                     Alloy Forgings for                                                                         
                     Surgical.                                                                                  
17................  Standard Specification     ASTM F621                               ASTM.                    
                     for Stainless Steel                                                                        
                     Forgings for Surgical                                                                      
                     Implants.                                                                                  
18................  Standard Practice for      ASTM F629-86                            ASTM.                    
                     Radiography of Cast                                                                        
                     Metallic Surgical                                                                          
                     Implants.                                                                                  
19................  Standard Specification     ASTM F648-84                            ASTM.                    
                     for Ultra-High-Molecular-                                                                  
                     Weight Polyethylene                                                                        
                     Powder and Fabricated                                                                      
                     Form for Surgical                                                                          
                     Implants.                                                                                  
20................  Standard Specification     ASTM F688-95                            ASTM.                    
                     for Wrought Cobalt-35                                                                      
                     Nickel-20 Chromium-10                                                                      
                     Molybdenum Alloy Plate,                                                                    
                     Sheet, and Foil for                                                                        
                     Surgical Implants.                                                                         
21................  Standard Specification     ASTM F745-95                            ASTM.                    
                     for 18 Chromium--12.5                                                                      
                     Molybdenum Stainless                                                                       
                     Steel for Cast and                                                                         
                     Solution-Annealed                                                                          
                     Surgical Implant                                                                           
                     Applications.                                                                              
22................  Standard Test Method for   ASTM F746-87                            ASTM.                    
                     Pitting or Crevice                                                                         
                     Corrosion of Metallic                                                                      
                     Surgical Implant                                                                           
                     Materials.                                                                                 
23................  Standard Specification     ASTM F786-82                            ASTM.                    
                     for Metallic Bone Plates.                                                                  
24................  Standard Specification     ASTM F787-82                            ASTM.                    
                     for Metallic Nail-Plate                                                                    
                     Appliances.                                                                                
25................  Standard Specification     ASTM F799-96                            ASTM.                    
                     for Cobalt-28 Chromium-6                                                                   
                     Molybdenum Alloy                                                                           
                     Forgings for Surgical                                                                      
                     Implants (UNS R31537).                                                                     
26................  Standard Test Method for   ASTM F897-84 (r1993)                    ASTM.                    
                     Measuring Fretting                                                                         
                     Corrosion of                                                                               
                     Osteosynthesis Plates                                                                      
                     and Screws.                                                                                
27................  Standard Specification     ASTM F899-95                            ASTM.                    
                     for Stainless Steel                                                                        
                     Billet, Bar, and Wire                                                                      
                     for Surgical Instruments.                                                                  
28................  Standard Specification     ASTM F961-96                            ASTM.                    
                     for Cobalt-Nickel-                                                                         
                     Chromium-Molybdenum                                                                        
                     Alloy Forgings for                                                                         
                     Surgical Implant                                                                           
                     Applications.                                                                              
29................  Standard Practice for      ASTM F983-86                            ASTM.                    
                     Permanent Marking of                                                                       
                     Orthopaedic Implant                                                                        
                     Components.                                                                                
30................  Standard Test Method for   ASTM F1044-95                           ASTM.                    
                     Shear Testing of Porous                                                                    
                     Metal Coatings.                                                                            
31................  Standard Specification     ASTM F1088-87(R1992)                    ASTM.                    
                     for Beta-Tricalcium                                                                        
                     Phosphate for Surgical                                                                     
                     Implantation.                                                                              
32................  Standard Test Method for   ASTM F1089-87                           ASTM.                    
                     Corrosion of Surgical                                                                      
                     Instruments.                                                                               
33................  Standard Specification     ASTM F1091-91 (R1996)                   ASTM.                    
                     for Wrought Cobalt-20                                                                      
                     Chromium-15 Tungsten-20                                                                    
                     Nickel Alloy Surgical                                                                      
                     Fixation Wire UNS R30605.                                                                  
34................  Standard Specification     ASTM F1108-97                           ASTM.                    
                     for Titanium-6 Aluminum-                                                                   
                     4 Vanadium Alloy                                                                           
                     Castings for Surgical                                                                      
                     Implants (UNS R56406).                                                                     
35................  Standard Test Method for   ASTM F1147-95                           ASTM.                    
                     Tension Testing of                                                                         
                     Porous Metal Coatings.                                                                     
36................  Standard Test Method for   ASTM F1160-91                           ASTM.                    
                     Constant Stree Amplitude                                                                   
                     Fatigue Testing of                                                                         
                     Porous Metal-Coated                                                                        
                     Metallic Materials.                                                                        
37................  Standard Specification...  ASTM F1185-88(1993)                     ASTM.                    
38................  Standard Guide for         ASTM F1264-96a                          ASTM.                    
                     Mechanical Performance                                                                     
                     Considerations for                                                                         
                     Intrameduallary Fixation                                                                   
                     Devices.                                                                                   
39................  Standard Specification     ASTM F1295-97                           ASTM.                    
                     for Wrought Titanium-6                                                                     
                     Aluminum-7 Niobium Alloy                                                                   
                     for Surgical Implant                                                                       
                     Applications.                                                                              
40................  Standard Specification     ASTM F1314-95                           ASTM.                    
                     for Wrought Nitrogen                                                                       
                     Strengthened-22 Chromium-                                                                  
                     12.5 Nickel-5 Manganese-                                                                   
                     2.5 Molybdemum Stainless                                                                   
                     Steel Bar and Wire for                                                                     
                     Surgical Implants.                                                                         
41................  Standard Specification     ASTM F1341-92                           ASTM.                    
                     for Unalloyed Titanium                                                                     
                     Wire for Surgical                                                                          
                     Implant Applications.                                                                      
42................  Standard Specification     ASTM F1350-96                           ASTM.                    
                     for Wrought 18 Chromium-                                                                   
                     14 Nickel-2.5 Molybdenum                                                                   
                     Stainless Steel Surgical                                                                   
                     Fixation Wire (UNS                                                                         
                     S31673).                                                                                   
43................  Standard Specification     ASTM F1377-92                           ASTM.                    
                     for Cobalt-Chromium-                                                                       
                     Molybdenum Powder for                                                                      
                     Coating of Orthopaedic                                                                     
                     Implants.                                                                                  
44................  Standard Specification     ASTM F1472-93                           ASTM.                    
                     for Wrought T1-6A1-4V                                                                      
                     Alloy for Surgical                                                                         
                     Implant Applications.                                                                      

[[Page 9566]]

                                                                                                                
45................  Standard Test Methods for  ASTM F1501-95                           ASTM.                    
                     Tension Testing of                                                                         
                     Calcium Phosphate                                                                          
                     Coatings.                                                                                  
46................  Standard Specification     ASTM F1537-94                           ASTM.                    
                     For Wrought Cobalt-28-                                                                     
                     Chromium-6-Molybdenum                                                                      
                     Alloy for Surgical                                                                         
                     Implants.                                                                                  
47................  Standard Classification    ASTM F1541-94                           ASTM.                    
                     of External Skeletal                                                                       
                     Fixators.                                                                                  
48................  Standard Specification     ASTM F1580-95                           ASTM.                    
                     for Titanium and                                                                           
                     Titanium-6% Aluminum-4%                                                                    
                     Vanadium Alloy Powders                                                                     
                     for Coatings of Surgical                                                                   
                     Implants.                                                                                  
49................  Standard Terminology       ASTM F1582-95                           ASTM.                    
                     Relating to Spinal                                                                         
                     Implants.                                                                                  
50................  Standard Specification     ASTM F1586-95                           ASTM.                    
                     for Wrought Nitrogen                                                                       
                     Strengthened-21 Chromium-                                                                  
                     10 Nickel-3 Manganese-                                                                     
                     2.5 Molybdenum Stainless                                                                   
                     Steel Bar for Surgical                                                                     
                     Implants.                                                                                  
51................  Standard Specification     ASTM F1609-95                           ASTM.                    
                     for Calcium Phosphate                                                                      
                     Coatings for Implantable                                                                   
                     Materials.                                                                                 
52................  Standard Practice for      ASTM F1612-95                           ASTM.                    
                     Cydic Fatigue Testing of                                                                   
                     Metallic Stemmed Hip                                                                       
                     Arthroplasty Femoral                                                                       
                     Components With Torsion.                                                                   
53................  Standard Test Method for   ASTM F1658-95                           ASTM.                    
                     Shear Testing of Calcium                                                                   
                     Phosphate Coatings.                                                                        
54................  Standard Test Method for   ASTM F1659-95                           ASTM.                    
                     Bending and Shear                                                                          
                     Fatigue Testing of                                                                         
                     Calcium Phosphate                                                                          
                     Coatings on Solid                                                                          
                     Metallic Substrates.                                                                       
55................  Standard Specification     ASTM F1672-95                           ASTM.                    
                     for Resurfacing Patellar                                                                   
                     Prosthesis.                                                                                
56................  Standard Specification     ASTM F1713-96                           ASTM.                    
                     for Wrought Titanium-13                                                                    
                     Niobium-13 Zirconium                                                                       
                     Alloy for Surgical                                                                         
                     Implant Applications.                                                                      
57................  Standard Test Methods for  ASTM F1717-96                           ASTM.                    
                     Static and Fatigue for                                                                     
                     Spinal Implant                                                                             
                     Constructs in a                                                                            
                     Corpectomy Model.                                                                          
58................  Standard Specification     ASTM F1781-97                           ASTM.                    
                     for Elastomeric Flexible                                                                   
                     Hinge Finger Total Joint                                                                   
                     Implants.                                                                                  
59................  Standard Test Methods for  ASTM F1798                              ASTM.                    
                     Evaluating the Static                                                                      
                     and Fatigue Properties                                                                     
                     of Interconnection                                                                         
                     Mechanisms and                                                                             
                     Subassemblies Used in                                                                      
                     Spinal Arthrodesis.                                                                        
60................  Cyclic Fatigue Testing of  ASTM F1800                              ASTM.                    
                     Metal Tibial Tray                                                                          
                     Components of TKR.                                                                         
61................  Standard Recommended       ASTM F1801                              ASTM.                    
                     Practice for Corrosion                                                                     
                     Fatigue Testing of                                                                         
                     Metallic Implant                                                                           
                     Materials.                                                                                 
62................  Implants for Surgery--     ISO 5832-1 (1997)                       ISO.                     
                     Metallic Materials--Part                                                                   
                     1: Wrought Stainless                                                                       
                     Steel.                                                                                     
63................  Implants for Surgery--     ISO5832-2-93                            ISO.                     
                     Metallic Materials--Part                                                                   
                     2: Unalloyed Titanium.                                                                     
64................  Implants for Surgery--     ISO 5832-3 (1996)                       ISO.                     
                     Metallic--Part 3:                                                                          
                     Wrought Titanium 6-                                                                        
                     Aluminum 4-Vanadium                                                                        
                     Alloy Third Edition (CAN/                                                                  
                     CSA-Z310.8-M91).                                                                           
65................  Implants for Surgery--     ISO 5832-4-96                           ISO.                     
                     Metallic Materials--Part                                                                   
                     4: Cobalt-Chromium-                                                                        
                     Molybdenum Casting Alloy.                                                                  
66................  Implants for Surgery--     ISO 5832-5-93                           ISO.                     
                     Metal Materials--Part 5:                                                                   
                     Wrought Cobalt-Chromium-                                                                   
                     Tungsten-Nickel Alloy.                                                                     
67................  Implants for Surgery--     ISO 5832-6                              ISO.                     
                     Metallic Materials--Part                                                                   
                     6: Wrought Cobalt-Nickel-                                                                  
                     Chromium-Molybdenum                                                                        
                     Alloy.                                                                                     
68................  Implants for Surgery--     ISO 5832-9 (1992)                       ISO.                     
                     Metallic Materials--Part                                                                   
                     9: Wrought High Nitrogen                                                                   
                     Stainless Steel First                                                                      
                     Edition.                                                                                   
69................  Implants for Surgery--     ISO 5832-10:1996                        ISO.                     
                     Metallic Materials--Part                                                                   
                     10: Wrought Titanium 5-                                                                    
                     Aluminum 2.5-Iron.                                                                         
70................  Implants for Surgery--     ISO 5832-11 (1994)                      ISO.                     
                     Metallic Materials--Part                                                                   
                     11: Wrought Titanium 6-                                                                    
                     Aluminum 7-Niobium Alloy                                                                   
                     First Edition; CABN/CSA-                                                                   
                     Z310.7:M91.                                                                                
71................  Implants for Surgery--     ISO 5832-12-96                          ISO.                     
                     Metalic Materials--Part                                                                    
                     12: Wrought Cobalt-                                                                        
                     Chromium-Molybdenum                                                                        
                     Alloy.                                                                                     
72................  Implants for Surgery--     ISO 5834-2:1985                         ISO.                     
                     Ultra-High Molecular                                                                       
                     Weight Polyethylene--                                                                      
                     Part 2: Moulded Forms.                                                                     
73................  Implants for Surgery--     ISO 5838-1:1995                         ISO.                     
                     Skeletal Pins and Wires--                                                                  
                     Part 1: Material and                                                                       
                     Mechanical Requirements.                                                                   

[[Page 9567]]

                                                                                                                
74................  Implants for Surgery--     ISO 5838-2:1991                         ISO.                     
                     Skeletal Pins and Wires--                                                                  
                     Part 2: Steinmann                                                                          
                     Skeletal Pins--                                                                            
                     Dimensions.                                                                                
75................  Implants for Surgery--     ISO 5838-3:1993                         ISO.                     
                     Skeletal Pins and Wires--                                                                  
                     Part 3: Kirschner                                                                          
                     Skeletal Wires.                                                                            
76................  Implants for Surgery--     ISO 6474-94                             ISO.                     
                     Ceramic Materials Based                                                                    
                     on High Purity Alumina.                                                                    
77................  Surgical Instruments--     ISO 7153-1:1991                         ISO.                     
                     Metallic Materials--Part                                                                   
                     1: Stainless Steel.                                                                        
78................  Implants for Surgery--     ISO 7206-4:1989                         ISO.                     
                     Partial and Total Hip                                                                      
                     Joint Prosthesis--Part                                                                     
                     4: Determination of                                                                        
                     Endurance Properties of                                                                    
                     Stemmed Femoral                                                                            
                     Components with                                                                            
                     Application of Torsion.                                                                    
79................  Implants for Surgery--     ISO 7206-8:1995                         ISO.                     
                     Partial and Total Hip                                                                      
                     Joint Prosthesis--Part                                                                     
                     8: Endurance Performance                                                                   
                     of Stemmed Femoral                                                                         
                     Components with                                                                            
                     Application of Torsion.                                                                    
80................  Implants for Surgery--     ISO 8828                                ISO.                     
                     Guidance on Care and                                                                       
                     Handling of Orthopaedic                                                                    
                     Implants.                                                                                  
81................  Implants for Surgery--Non  ISO 9583:1993                           ISO.                     
                     Destructive Testing--                                                                      
                     Liguid Penetrant                                                                           
                     Inspection of Metallic                                                                     
                     Surgical Implants.                                                                         
82................  Implants for Surgery--Non  ISO 9584:1993                           ISO.                     
                     Destructive Testing--                                                                      
                     Radiological Examination                                                                   
                     of Cast Metallic                                                                           
                     Surgical Implants.                                                                         
83................  Surgical and Dental Hand   ISO 13402                               ISO.                     
                     Instruments--Determinati                                                                   
                     on of Resistance Against                                                                   
                     Autoclaving, Corrosion                                                                     
                     and Thermal Exposure.                                                                      
84................  Implants for Surgery--     ISO 13782: 1996                         ISO.                     
                     Metallic Materials--                                                                       
                     Unalloyed Tantalum for                                                                     
                     Surgical Implant                                                                           
                     Applications.                                                                              
85................  Non-Active Surgical        ISO 14630:1997                          ISO                      
                     Implants--General                                                                          
                     Requirements.                                                                              
----------------------------------------------------------------------------------------------------------------
                                                Physical Medicine                                               
----------------------------------------------------------------------------------------------------------------
1.................  Determination of Static    ANSI/RESNA WC/01-1990                   Rehabilitation           
                     Stability.                                                         Engineering and         
                                                                                        Assistive Technology    
                                                                                        Society of North        
                                                                                        American (RESNA).       
2.................  Determination of Dynamic   ANSI/RESNA WC/02-1991                   RESNA.                   
                     Stability of Electric                                                                      
                     Wheelchairs.                                                                               
3.................  Determination of the       ANSI/RESNA WC/03-1990                   RESNA.                   
                     Effectiveness of Brakes.                                                                   
4.................  Determination of Energy    ANSI/RESNA WC/04-1990                   RESNA.                   
                     Consumption of Electric                                                                    
                     Wheelchairs.                                                                               
5.................  Determination of Overall   ANSI/RESNA WC/05-1990                   RESNA.                   
                     Dimensions, Mass and                                                                       
                     Turning Space--                                                                            
                     Wheelchair.                                                                                
6.................  Determination of Maximum   ANSI/RESNA WC/06-1991                   RESNA.                   
                     Speed, Acceleration, and                                                                   
                     Retardation of Electric                                                                    
                     Wheelchairs.                                                                               
7.................  Wheelchairs--Determinatio  ANSI/RESNA WC/07-1991                   RESNA.                   
                     n of Seating and Wheel                                                                     
                     Dimensions.                                                                                
8.................  Wheelchairs--Static,       ANSI/RESNA WC/08-1991                   RESNA.                   
                     Impact and Fatigue                                                                         
                     Strength Tests.                                                                            
9.................  Climatic Tests for         ANSI/RESNA WC/09-1991                   RESNA.                   
                     Electric Wheelchairs.                                                                      
10................  Determination of the       ANSI/RESNA WC/10-1990                   RESNA.                   
                     Obstacle-Climbing                                                                          
                     Ability of Electric                                                                        
                     Wheelchairs.                                                                               
11................  Wheelchairs--Test Dummies  ANSI/RESNA WC/11-1991                   RESNA.                   
12................  Coefficient of Friction    ANSI/RESNA WC/13-1991                   RESNA.                   
                     of Test Surfaces.                                                                          
13................  Wheelchairs--Testing of    ANSI/RESNA WC/14-1991                   RESNA.                   
                     Power and Control                                                                          
                     Systems for Electric                                                                       
                     Wheelchairs.                                                                               
14................  Wheelchairs--Requirements  ANSI/RESNA WC/15-1991                   RESNA.                   
                     for Information                                                                            
                     Disclosure,                                                                                
                     Documentation and                                                                          
                     Labelling.                                                                                 
15................  Wheelchairs--Determinatio  ANSI/RESNA WC/16-1991                   RESNA.                   
                     n of Flammability.                                                                         
16................  Wheelchairs--Part 1:       ISO 7176-1:1986                         ISO.                     
                     Determination of Static                                                                    
                     Stability.                                                                                 
17................  Wheelchairs--Part 2:       ISO 7176-2:1990                         ISO.                     
                     Determination of Dynamic                                                                   
                     Stability of Electric                                                                      
                     Wheelchairs.                                                                               
18................  Wheelchairs--Part 3:       ISO 7176-3:1988                         ISO.                     
                     Determination of                                                                           
                     Efficiency of Brakes.                                                                      
19................  Wheelchairs--Part 4:       ISO 7176-4:1997                         ISO.                     
                     Energy Consumption of                                                                      
                     Electric Wheelchairs and                                                                   
                     Scooters for                                                                               
                     Determination of                                                                           
                     Theoretical Distance                                                                       
                     Range.                                                                                     
20................  Wheelchairs--Part 5:       ISO 7176-5:1986                         ISO.                     
                     Determination of Overall                                                                   
                     Dimensions, Mass and                                                                       
                     Turning Space.                                                                             

[[Page 9568]]

                                                                                                                
21................  Wheelchairs--Part 6:       ISO 7176-6:1988                         ISO.                     
                     Determination of Maximum                                                                   
                     Speed, Acceleration and                                                                    
                     Retardation of Electric                                                                    
                     Wheelchairs.                                                                               
22................  Wheelchairs--Part 9:       ISO 7176-9:1988                         ISO.                     
                     Climatic Tests for                                                                         
                     Electric Wheelchairs.                                                                      
23................  Wheelchairs--Part 10:      ISO 7176-10:1988                        ISO.                     
                     Determination of                                                                           
                     Obstacle-Climbing                                                                          
                     Ability of Electric                                                                        
                     Wheelchairs.                                                                               
24................  Wheelchairs--Part 11:      ISO 7176-11:1992                        ISO.                     
                     Test Dummies.                                                                              
25................  Wheelchairs--Part 13:      ISO 7176-13:1989                        ISO.                     
                     Determination of                                                                           
                     Coefficient of Friction                                                                    
                     of Test Surfaces.                                                                          
26................  Wheelchairs--Part 14:      ISO 7176-14:1997                        ISO.                     
                     Power and Control                                                                          
                     Systems for Electric                                                                       
                     Wheelchairs--Requirement                                                                   
                     s and Test Methods.                                                                        
27................  Wheelchairs--Part 15:      ISO 7176-15:1996                        ISO.                     
                     Requirements for                                                                           
                     Information Disclosure,                                                                    
                     Documentation and                                                                          
                     Labeling.                                                                                  
28................  Wheelchairs--Part 16:      ISO 7176-16:1997                        ISO.                     
                     Resistance to Ignition                                                                     
                     of Upholstered Parts--                                                                     
                     Requirements and Test                                                                      
                     Methods.                                                                                   
----------------------------------------------------------------------------------------------------------------
                                                    Radiology                                                   
----------------------------------------------------------------------------------------------------------------
1.................  Medical X-Ray Screen-Film- ANSI PH2.43-1982                        American National        
                     Processing Systems,                                                Standards Institute     
                     Method for the                                                     (ANSI).                 
                     Sensitometry.                                                                              
2.................  Photography (films)--      ANSI/NAPM IT1.49-1995                   National Association of  
                     Medical Hard Copy                                                  Photographic            
                     Imaging Films--                                                    Manufacturers, (NAPM).  
                     Dimensions and                                                                             
                     Specifications.                                                                            
3.................  Photography (Films)--      ANSI/NAPM IT1.49-1995                   NAPM.                    
                     Medical Radiographic                                                                       
                     Cassettes/Screens/Films--                                                                  
                     Dimensions.                                                                                
4.................  Medical Ultrasound Safety  AIUM-1994                               American Institute of    
                                                                                        Ultrasound in Medicine  
                                                                                        (AIUM).                 
5.................  Photography-Direct--       ANSI/NAPM IT2.48-1993                   NAPM.                    
                     Exposing Medical and                                                                       
                     Dental Radiographic Film/                                                                  
                     Process Systems--                                                                          
                     Determination of ISO                                                                       
                     Speed and ISO Average                                                                      
                     Gradient.                                                                                  
6.................  Determination of the       IEC 806(R1984)                          IEC.                     
                     Maximum Symmetrical                                                                        
                     Radiation Field from a                                                                     
                     Rotating Anode X-Ray                                                                       
                     Tube for Medical                                                                           
                     Diagnosis.                                                                                 
7.................  Information Technology-    ISO/IEC 10918-1:1994                    ISO or IEC.              
                     Digital Compression and                                                                    
                     Coding of Continuous-                                                                      
                     Tone Still Images:                                                                         
                     Requirements and                                                                           
                     Guidelines.                                                                                
8.................  X-Ray Tube Assemblies for  IEC60336(R1993)                         IEC.                     
                     Medical Diagnosis                                                                          
                     Characteristics of Focal                                                                   
                     Spots.                                                                                     
9.................  Performance Measurements   NEMA NU1-1994                           NEMA.                    
                     of Scintillation Cameras.                                                                  
10................  Determination of Signal    NEMA MS1-1988(R1994)                    NEMA.                    
                     to Noise Ratio (SNR) in                                                                    
                     Magnetic Resonance                                                                         
                     Images.                                                                                    
11................  Determination of Two-      NEMA MS2-1989                           NEMA.                    
                     Dimensional Geometric                                                                      
                     Distortion in Diagnostic                                                                   
                     Magnetic Resonance                                                                         
                     Images.                                                                                    
12................  Determination of Image     NEMA MS3-1989                           NEMA.                    
                     Uniformity in Diagnostic                                                                   
                     Magnetic Resonance                                                                         
                     Images.                                                                                    
13................  Acoustic Noise             NEMA MS4-1989                           NEMA.                    
                     Measurement Procedure                                                                      
                     for Diagnostic Magnetic                                                                    
                     Resonance Imaging                                                                          
                     Devices.                                                                                   
14................  Determination of Slice     NEMA MS5-1991                           NEMA.                    
                     Thickness in Diagnostic                                                                    
                     Magnetic Resonance                                                                         
                     Imaging.                                                                                   
15................  Characterization of        NEMA MS6-1991                           NEMA.                    
                     Special Purpose Coils                                                                      
                     for Diagnostic Magnetic                                                                    
                     Resonance Images.                                                                          
16................  Measurement Procedure for  NEMA MS7-1993                           NEMA.                    
                     Time-Varying Gradiant                                                                      
                     Fields (dB/dt) for                                                                         
                     Magnetic Resonance                                                                         
                     Imaging Systems.                                                                           
17................  Characterization of the    NEMA MS8-1993                           NEMA.                    
                     Specific Absoption Rate                                                                    
                     for Magnetic Resonance                                                                     
                     Imaging Systems.                                                                           
18................  Performance Measurements   NEMA NU2-1994                           NEMA.                    
                     of Positron Emission                                                                       
                     Tomographs.                                                                                
19................  DICOM set--Digital         NEMA PS3 (Set)                          NEMA.                    
                     Imaging and                                                                                
                     Communications in                                                                          
                     Medicine--Set Includes                                                                     
                     PS3.1 through PS3.13.                                                                      
20................  Acoustic Output            NEMA UD2-1992                           NEMA.                    
                     Measurement Standard for                                                                   
                     Diagnostic Ultrasound                                                                      
                     Equipment.                                                                                 
21................  Standard for Real-Time     NEMA UD3-1992                           NEMA.                    
                     Display of Thermal and                                                                     
                     Mechanical Acoustic                                                                        
                     Output.                                                                                    
22................  Measurement of Dimensions  NEMA XR5-1992                           NEMA.                    
                     and Properties of Focal                                                                    
                     Spots of Diagnostic X-                                                                     
                     Ray Tubes.                                                                                 

[[Page 9569]]

                                                                                                                
23................  Measurement of the         NEMA XR10-1986 (R1992)                  NEMA.                    
                     Maximum Symmetrical                                                                        
                     Radiation Field from a                                                                     
                     Rotating Anode X-Ray                                                                       
                     Tube Used for Medical                                                                      
                     Diagnosis.                                                                                 
24................  Test Standard for          NEM XR11-1993                           NEMA.                    
                     Determination of the                                                                       
                     Limiting Spatial                                                                           
                     Resolution of X-Ray                                                                        
                     Image Intensifier                                                                          
                     Systems.                                                                                   
25................  Test Standard for the      NEMA XR15-1991                          NEMA.                    
                     Determination of the                                                                       
                     Visible Entrance Field                                                                     
                     Size of an X-Ray Image                                                                     
                     Intensifier System.                                                                        
26................  Test Standard for the      NEMA XR16-1991                          NEMA.                    
                     Determination of the                                                                       
                     System Contrast Ratio                                                                      
                     and the System Veiling                                                                     
                     Glare Index of an X-Ray                                                                    
                     Image Intensifier System.                                                                  
27................  Test Standard for the      NEMA XR17-1993                          NEMA.                    
                     Measurement for the                                                                        
                     Image Signal Uniformity                                                                    
                     of an X-Ray Image                                                                          
                     Intensifier System.                                                                        
28................  Test Standard for the      NEMA XR18-1993                          NEMA.                    
                     Determination of the                                                                       
                     Radial Image Distortion                                                                    
                     of an X-Ray Image                                                                          
                     Intensifier System.                                                                        
29................  Electrical Thermal and     NEMA XR19-1993                          NEMA.                    
                     Loading Characteristics                                                                    
                     of X-Ray Tubes Used for                                                                    
                     Medical Diagnosis.                                                                         
30................  Standard for Safety:       UL-122                                  Underwriters Laboratory  
                     Photographic Equipment.                                            (UL).                   
31................  Standard for Safety: X-    UL-187                                  UL.                      
                     Ray Equipment.                                                                             
32................  Standard for Safety:       UL-544                                  UL.                      
                     Medical and Dental                                                                         
                     Equipment--Third Edition.                                                                  
----------------------------------------------------------------------------------------------------------------
\1\ The recognition of this standard for all devices was proposed for comment January 13, 1998 (63 FR 1974), and
  is not yet final. This listing applies only to radiological imaging devices.                                  

    Dated: February 13, 1998.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-4843 Filed 2-20-98; 3:59 pm]
BILLING CODE 4160-01-P