Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67713 

records are both relevant and necessary 

to the litigation. 

B. Additional Provisions Affecting 

Routine Use Disclosures. This system 

contains Protected Health Information 

(PHI) as defined by HHS regulation 

‘‘Standards for Privacy of Individually 

Identifiable Health Information’’ (45 

CFR Parts 160 and 164, Subparts A and 

E , 65 Fed. Reg. 82462 (12–28–00)). 

Disclosures of PHI authorized by these 

routine uses may only be made if, and 

as, permitted or required by the 

‘‘Standards for Privacy of Individually 

Identifiable Health Information.’’

In addition, our policy will be to 

prohibit release even of not directly 

identifiable information, except 

pursuant to one of the routine uses or 

if required by law, if we determine there 

is a possibility that an individual can be 

identified through implicit deduction 

based on small cell sizes (instances 

where the patient population is so small 

that individuals who are familiar with 

the enrollees could, because of the small 

size, use this information to deduce the 

identity of the beneficiary). 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

Computer diskette and on magnetic 

storage media. 

RETRIEVABILITY: 

Information can be retrieved by the 

individual identifiable information of 

the beneficiary. 

SAFEGUARDS: 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against excessive or 

unauthorized use. Personnel having 

access to the system have been trained 

in the Privacy Act and information 

security requirements. Employees who 

maintain records in this system are 

instructed not to release data until the 

intended recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and CMS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations include but 

are not limited to: the Privacy Act of 

1974; the Federal Information Security 

Management Act of 2002; the Computer 

Fraud and Abuse Act of 1986; the 

Health Insurance Portability and 

Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare 

Modernization Act of 2003, and the 

corresponding implementing 

regulations. OMB Circular A–130, 

Management of Federal Resources, 

Appendix III, Security of Federal 

Automated Information Resources also 

applies. Federal, HHS, and CMS 

policies and standards include but are 

not limited to: all pertinent National 

Institute of Standards and Technology 

publications; HHS Information Systems 

Program Handbook and the CMS 

Information Security Handbook. 

RETENTION AND DISPOSAL: 

Records are maintained in a secure 

storage area with identifiers. Disposal 

occurs 6 years and 3 months from the 

time the individual accesses the 

MPDPF. 

SYSTEM MANAGER AND ADDRESS: 

Director, Beneficiary Information 

Services Group, Center for Beneficiary 

Choices, CMS, Mail Stop S1–01–26, 

7500 Security Boulevard, Baltimore, 

Maryland, 21244–1850. 

NOTIFICATION PROCEDURE: 

For purpose of access, the subject 

individual should write to the system 

manager who will require the system 

name, HICN, and for verification 

purposes, the subject individual’s name 

(woman’s maiden name, if applicable). 

RECORD ACCESS PROCEDURE: 

For purpose of access, use the same 

procedures outlined in Notification 

Procedures above. Requestors should 

also reasonably specify the record 

contents being sought. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.5 

(a)(2).) 

CONTESTING RECORD PROCEDURES: 

The subject individual should contact 

the system manager named above, and 

reasonably identify the record and 

specify the information to be contested. 

State the corrective action sought and 

the reasons for the correction with 

supporting justification. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.7.) 

RECORD SOURCE CATEGORIES: 

Sources of information contained in 

this records system include data 

collected from the initial voluntary 

inquiry made by or on behalf of the 

individual and validated through the 

Medicare Beneficiary Database. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 05–22192 Filed 11–7–05; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0226] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

013 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 013’’ (Recognition List 

Number: 013), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Submit written or electronic 

comments concerning this document at 

any time. See section VII of this 

document for the effective date of the 

recognition of standards announced in 

this document. 

ADDRESSES: Submit written requests for 

single copies on a 3.5’’ diskette of 

‘‘Modifications to the List of Recognized 

Standards, Recognition List Number: 

013’’ to the Division of Small 

Manufacturers, International and 

Consumer Assistance, 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 

requests, or FAX your request to 301–

443–8818. Submit written comments 

concerning this document, or 

recommendations for additional 

standards for recognition, to the contact 

person (see FOR FURTHER INFORMATION

CONTACT). Submit electronic comments 

by e-mail: standards@cdrh.fda.gov. This 

document may also be accessed on 

FDA’s Internet site at http:// 

www.fda.gov/cdrh/fedregin.html. See 

section VI of this document for 

electronic access to the searchable 

67714 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 

database for the current list of FDA 

recognized consensus standards, 

including Recognition List Number: 013 

modifications and other standards 

related information. 

FOR FURTHER INFORMATION CONTACT: 

Carol L. Herman, Center for Devices and 

Radiological Health (HFZ–84), Food and 

Drug Administration, 12720 Twinbrook 

Pkwy., MD 20857, 301–827–0021. 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115) 

amended section 514 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360d). Amended section 514 

allows FDA to recognize consensus 

standards developed by international 

and national organizations for use in 

satisfying portions of device premarket 

review submissions or other 

requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Recognition and 

Use of Consensus Standards.’’ The 

notice described how FDA would 

implement its standard recognition 

program and provided the initial list of 

recognized standards. 

In Federal Register notices published 

on October 16, 1998 (63 FR 55617), July 

12, 1999 (64 FR 37546), November 15, 

2000 (65 FR 69022), May 7, 2001 (66 FR 

23032), January 14, 2002 (67 FR 1774), 

October 2, 2002 (67 FR 61893), April 28, 

2003 (68 FR 22391), March 8, 2004 (69 

FR 10712), June 18, 2004 (69 FR 34176), 

and October 4, 2004 (69 FR 59240), FDA 

modified its initial list of FDA 

recognized consensus standards. These 

notices describe the addition, 

withdrawal, and revision of certain 

standards recognized by FDA. The 

agency maintains ‘‘hypertext markup 

language’’ (HTML) and ‘‘portable 

document format’’ (PDF) versions of the 

list of ‘‘FDA Recognized Consensus 

Standards.’’ Both versions are publicly 

accessible at the agency’s Internet site. 

See section VI of this document for 

electronic access information. Interested 

persons should review the 

supplementary information sheet for the 

standard to understand fully the extent 

to which FDA recognizes the standard. 

II. Modifications to the List of 

Recognized Standards, Recognition List 

Number: 013 

FDA is announcing the addition, 

withdrawal, correction, and revision of 

certain consensus standards the agency 

will recognize for use in satisfying 

premarket reviews and other 

requirements for devices. FDA will 

incorporate these modifications in the 

list of FDA Recognized Consensus 

Standards in the agency’s searchable 

database. FDA will use the term 

‘‘Recognition List Number: 013’’ to 

identify these current modifications. 

In table 1 of this document, FDA 

describes the following modifications: 

(1) The withdrawal of standards and 

their replacement by others, (2) the 

correction of errors made by FDA in 

listing previously recognized standards, 

and (3) the changes to the 

supplementary information sheets of 

recognized standards that describe 

revisions to the applicability of the 

standards. 

In section III of this document, FDA 

lists modifications the agency is making 

that involve the initial addition of 

standards not previously recognized by 

FDA. 

TABLE 1. 

Old Item No. Standard Change Replacement Item 

No. 

A. Anesthesia 

52 ASTM F1463–93 (1999), Standard Specification for Alarm Signals 

in Medical Equipment Used in Anesthesia and Respiratory Care 

Withdrawn 

B. Biocompatibility 

1 ASTM E1262–88 (2003), Standard Guide for Performance of the 

Chinese Hamster Ovary Cell/Hypoxanthine Guanine 

Phosphoribosyl Transferase Gene Mutation Assay 

Withdrawn and replaced with 

newer version 

83 

2 ASTM E1263–97 (2003), Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes Withdrawn and replaced with 

newer version 

84 

3 ASTM E1280–97 (2003), Standard Guide for Performing the 

Mouse Lymphoma Assay for Mammalian Cell Mutagenicity 

Withdrawn and replaced with 

newer version 

85 

19 AAMI/ANSI/ISO10993–10: 2002(E), Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization Withdrawn and replaced with 

newer version 

86 

20 AAMI/ANSI/ISO10993–10: 2002(E), Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization—

Maximization Sensitization Test 

Withdrawn and replaced with 

newer version 

87 

21 AAMI/ANSI/ISO10993–11:1993, Biological Evaluation of Medical 

Devices—Part 11: Tests for Systemic Toxicity 

Extent of Recognition and 

Relevant Guidance 

28 AAMI/ANSI/ISO10993–12:2002(E), Biological Evaluation of Medical 

Devices—Part 12: Sample Preparation and Reference Materials 

Withdrawn and replaced with 

newer version 

88 

34 ASTM F749–98 (2002)e2, Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit Withdrawn and replaced with 

newer version 

89 

Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67715 

TABLE 1.—Continued 

Old Item No. Standard Change Replacement Item 

No. 

37 ASTM E1397–91 (2003), Standard Practice for the In Vitro Rat 

Hepatocyte DNA Repair Assay 

Withdrawn and replaced with 

newer version 

90 

38 ASTM E1398–91 (2003), Standard Practice for the In Vivo Rat 

Hepatocyte DNA Repair Assay 

Withdrawn and replaced with 

newer version 

91 

39 ASTM F748–04, Standard Practice for Selecting Generic Biological 

Test Methods for Materials and Devices 

Withdrawn and replaced with 

newer version 

92 

40 ASTM F763–04, Standard Practice for Short-Term Screening of 

Implant Materials 

Withdrawn and replaced with 

newer version 

93 

41 ASTM F981–04, Standard Practice for Assessment of Compatibility 

of Biomaterials for Surgical Implants with Respect to Effect of 

Materials on Muscle and Bone 

Withdrawn and replaced with 

newer version 

94 

42 ASTM F1984–99 (2003), Standard Practice for Testing for Whole 

Complement Activation in Serum by Solid Materials 

Withdrawn and replaced with 

newer version 

95 

43 ASTM F1903–98 (2003), Standard Practice for Testing for Biological Responses to Particles In Vitro Withdrawn and replaced with 

newer version 

96 

45 ASTM F1983–99 (2003), Standard Practice for Assessment of 

Compatibility of Absorbable/Resorbable Biomaterials for Implant 

Applications 

Withdrawn and replaced with 

newer version 

97 

51 AAMI/ANSI/ISO10993–1: 2003(E), Biological Evaluation of Medical 

Devices—Part 1: Evaluation and Testing 

Withdrawn and replaced with 

newer version 

98 

52 ASTM F1904–98e1 (2003), Standard Practice for Testing for Biological Responses to Particles In Vivo Withdrawn and replaced with 

newer version 

99 

53 ASTM E1372–95 (2003), Standard Test Method for Conducting a 

90-Day Oral Toxicity Study in Rats 

Withdrawn and replaced with 

newer version 

100 

70 ASTM F750–87 (2002)e1, Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse Relevant guidance 

74 USP 28–NF21Biological Tests <87>, Biological Reactivity Test, In 

Vitro—Direct Contact Test 

Withdrawn and replaced with 

newer version 

101 

75 USP 28–NF21Biological Tests <87>, Biological Reactivity Test, In 

Vitro—Elution Test 

Withdrawn and replaced with 

newer version 

102 

76 USP 28–NF21Biological Tests <88>, Biological Reactivity Test, In 

Vivo Procedure—Preparation of Sample 

Withdrawn and replaced with 

newer version 

103 

77 USP 28–NF21Biological Tests <88>, Biological Reactivity Test, In 

Vitro, Classification of Plastics—Intracutaneous Test 

Withdrawn and replaced with 

newer version 

104 

78 USP 28–NF21Biological Tests <88>, Biological Reactivity Test, In 

Vitro, Classification of Plastics—Systemic Injection Test 

Withdrawn and replaced with 

newer version 

105 

79 ASTM F619–03, Standard Practice for Extraction of Medical Plastics Withdrawn and replaced with 

newer version 

106 

80 ASTM F1877 (2003)e1, Standard Practice for Characterization of 

Particles 

Withdrawn and replaced with 

newer version 

107 

81 ASTM F1905 (2003)e1, Standard Practice for Selecting Tests for 

Determining the Propensity of Materials to Cause Immunotoxicity 

Withdrawn and replaced with 

newer version 

108 

B. Cardiovascular/Neurology 

4 ANSI/AAMI SP10:2002—Manual, Electronic, or Automated Sphygmomanometers Withdrawn and replaced with 

newer version 

53 

5 ANSI/AAMI/ISO 7198:1998/2001(R) 2004, Cardiovascular Implants—Tubular vascular prostheses Withdrawn and replaced with 

newer version 

54 

67716 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 

TABLE 1.—Continued 

Old Item No. Standard Change Replacement Item 

No. 

14 ASTM F1830:05, Recommended Practice for Selection of Blood for 

In Vitro Hemolytic Evaluation of Blood Pumps 

Withdrawn and replaced with 

newer version 

55 

15 ASTM F1841:05, Recommended Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps Withdrawn and replaced with 

newer version 

56 

48 ASTM F2129:04, Test Method for Conducting Cyclic 

Potentiodynamic Polarization Measurements to Determine the 

Corrosion Susceptibility of Small Implant Devices 

Withdrawn and replaced with 

newer version 

57 

C. Dental/Ear, Nose, and Throat 

29 IEC 60601–2–18:2000 Amendment 1, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of 

Endoscopic Equipment 

Withdrawn and replaced with 

newer version 

122 

40 ANSI/ASA S3.6–2004, Specification for Audiometers Withdrawn and replaced with 

newer version 

123 

41 ANSI/ASA S3.22:2003, Specification of Hearing Aid Characteristics Withdrawn and replaced with 

newer version 

124 

61 ISO 1562:2004, Dentistry—Casting gold alloys Withdrawn and replaced with 

newer version 

125 

82 ISO 10477:2004, Dentistry—Polymer-based crown and bridge materials Withdrawn and replaced with 

newer version 

126 

D. General 

16 ASTM D903:1993, Test Methods for Peel or Stripping Strength of 

Adhesive Bonds 

Contact person 

28 IEC 60601–1–2, (Second Edition), Medical Electrical Equipment—

Part 1–2: General Requirements for Safety—Collateral Standard: 

Electromagnetic Compatibility—Requirements and Tests 

Extent of recognition 

30 AAMI/IEC 60601–1–2, Medical Electrical Equipment—Part 1–2: 

General Requirements for Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 

2:2001) 

Title and extent of recognition 

2 IEC 60601–1, Medical Electrical Equipment—Part 1: General Requirements for Safety Withdrawn 

4 IEC 60601–1, Medical Electrical Equipment—Part 1: General Requirements for Safety, 1988; Amendment 1, l991–11, Amendment 2, 1995–03 Contact person, devices affected and extent of recognition 

E. General Hospital/General Plastic Surgery 

18 ISO 8537:1991 Sterile Single-Use Syringes, With or Without Needle, for Insulin Contact person 

38 ASTM F1671–03: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne 

Pathogens Using Phi-X174 Bacteriophage Penetration as a Test 

System. 

Withdrawn and replaced with 

newer version 

130 

48 ASTM D6499–03 Standard Test Method for the Immunological 

Measurement of Antigenic Protein in Natural Rubber and its 

Products 

Withdrawn and replaced with 

newer version 

131 

31 Ophthalmic 

89 Radiology 

ISO 11810–1:2005: Lasers and Laser-Related Equipment—Test 

Method and Classification for the Laser-Resistance of Surgical 

Drapes and/or Patient-Protective Covers—Part 1: Primary Ignition and Penetration 

Transferred from Ophthalmic 

and Radiology 

132 

97 USP 28: 2005 Nonabsorbable Surgical Suture Withdrawn and replaced with 

newer version 

133 

Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67717 

TABLE 1.—Continued 

Old Item No. Standard Change Replacement Item 

No. 

98 USP 28<11>: 2005 Sterile Sodium Chloride for Irrigation Withdrawn and replaced with 

newer version 

134 

99 USP 28: 2005 Absorbable Surgical Suture Withdrawn and replaced with 

newer version 

135 

100 USP 28<881>: 2005 Tensile Strength Withdrawn and replaced with 

newer version 

136 

101 USP 28<861>: 2005 Sutures—Diameter Withdrawn and replaced with 

newer version 

137 

102 USP 28<871>: 2005 Sutures Needle Attachment Withdrawn and replaced with 

newer version 

138 

103 USP 28<11>: 2005 Sterile Water for Irrigation Withdrawn and replaced with 

newer version 

139 

104 USP 28<11>: 2005 Heparin Lock Flush Solution Withdrawn and replaced with 

newer version 

140 

105 USP 28<11>: 2005 Sodium Chloride Injection Withdrawn and replaced with 

newer version 

141 

11 ISO 594–1:1986 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment—Part 1: 

General Requirements 

Title and contact person 

13 ISO 595–1:1986 Reusable All-Glass or Metal-and-Glass Syringes 

for Medical Use—Part 1: Dimensions 

Title and contact person 

14 ISO 595–2:1987 Reusable All-Glass or Metal-and-Glass Syringes 

for Medical Use—Part 2: Design, Performance Requirements 

and Tests 

Title and contact person 

15 ISO 7864:1993 Sterile Hypodermic Needles for Single Use Contact person 

16 ISO 7886–1:1993 Sterile Hypodermic Syringes for Single Use—

Part 1: Syringes for Manual Use 

Title and contact person 

62 ISO 8536–6:1995 Infusion Equipment for Medical Use—Part 6: 

Freeze Drying Closures for Infusion Bottles 

Title and contact person 

63 ISO 8536–7–1999: Infusion Equipment for Medical Use—Part 7: 

Caps Made of Aluminum-Plastics Combinations for Infusion Bottles 

Contact Person 

64 ISO 8536–3–1999: Infusion Equipment for Medical Use—Part 3: 

Aluminum Caps for Infusion Bottles 

Title and contact person 

66 ISO 8536–1–2000: Infusion equipment for medical use—Part 1: Infusion glass bottles Title and Contact Person 

68 ISO 7886–2–1996: Sterile Hypodermic Syringes for Single Use—

Part 2: Syringes for Use With Power-Driven Syringe Pumps 

Title and contact person ; 

69 ISO 9626–1991: Stainless Steel Needle Tubing for the Manufacture of Medical Devices Title and contact person 

70 ASTM E825–98 (2003) Standard Specification for Phase ChangeType Disposable Fever Thermometer for Intermittent Determination of Human Temperature Contact person 

111 IEC 60601–2–38 Medical Electrical Equipment—Part 2: Particular 

Requirements for the Safety of Electrically Operated Hospital 

Beds 

Contact person 

119 AAMI BF7: (R2002) Blood Transfusion Micro-Filters Contact person 

120 ASTM F1054–01: Standard Specification for Conical Fittings Contact person 

67718 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 

TABLE 1.—Continued 

Old Item No. Standard Change Replacement Item 

No. 

121 ISO 8536–2–2001: Infusion Equipment for Medical Use—Part 2: 

Closures for Infusion Bottles 

Contact person 

122 ISO 8536–5–2004: Infusion Equipment for Medical Use—Part 5: 

Burette Infusion Sets for Single Use, Gravity Feed 

Title and contact person 

126 ISO 8536–4–2004: Infusion Equipment for Medical Use—Part 4: 

Infusion Sets for Single Use, Gravity Feed 

Contact person 

127 ISO 1135–4–2004: Transfusion Equipment for Medical Use—Part 

4: Transfusion Sets for Single Use 

Contact person 

129 ISO 594–2:1998 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment—Part 2: 

Lock Fittings 

Contact person 

F. In Vitro Diagnostic 

65 CLSI EP5–A2, Evaluation of Precision Performance of Quantitative 

Measurement Methods; Approved Guideline—Second Edition 

Withdrawn and replaced with 

new version 

110 

54 CLSI D12–A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved 

Guideline 

Product codes 

G. Materials 

9 ASTM F563–00: Standard Specification for Wrought Cobalt-20 

Nickel-20 Chromium-3.5 Molybdenum-3.5 Tungsten-5 Iron Alloy 

for Surgical Implant Applications (UNS R30563) 

Withdrawn 

13 ASTM F648–04: Standard Specification for Ultra-High-MolecularWeight Polyethylene Powder and Fabricated Form for Surgical 

Implants 

Withdrawn and replaced with 

newer version 

106 

16 ASTM F746–04: Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials Withdrawn and replaced with 

newer version 

107 

25 ASTM F1295–05: Standard Specification for Wrought Titanium–6 

Aluminum–7 Niobium Alloy for Surgical Implant Applications 

(UNS R56700) 

Withdrawn and replaced with 

newer version 

108 

34 ASTM F1659–95: Standard Test Method for Bending and Shear 

Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic 

Substrates 

Withdrawn 

72 ASTM F2213–04: Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic 

Resonance Environment 

Title 

73 ASTM F561–05, Practice for Retrieval and Analysis of Implanted 

Medical Devices, and Associated Tissues 

Withdrawn and replaced with 

newer version 

109 

74 ASTM F1377–04: Standard Specification for Cobalt–28 Chromium–

6 Molybdenum Powder for Coating of Orthopedic Implants (UNS 

R30075) 

Withdrawn and replaced with 

newer version 

110 

75 ASTM F1160–05: Standard Test Method for Shear and Bending 

Fatigue Testing of Calcium Phosphate and Metallic Medical and 

Composite Calcium Phosphate/Metallic Coatings 

Withdrawn and replaced with 

newer version 

111 

80 ASTM F1088–04a: Standard Specification for Beta-Tricalcium 

Phosphate for Surgical Implantation 

Title 

83 ASTM F1044–05: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Withdrawn and replaced with 

newer version 

112 

84 ASTM F1147–05: Standard Test Method for Tension Testing of 

Calcium Phosphate and Metal Coatings 

Withdrawn and replaced with 

newer version 

113 

Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67719 

TABLE 1.—Continued 

Old Item No. Standard Change Replacement Item 

No. 

90 ASTM F2255–05: Standard Test Method for Strength Properties of 

Tissue Adhesives in Lap Shear by Tension Loading 

Withdrawn and replaced with 

newer version 

114 

91 ASTM F2256–05: Standard Test Method for Strength Properties of 

Tissue Adhesives in T-Peel by Tension Loading 

Withdrawn and replaced with 

newer version 

115 

92 ASTM F2258–05: Standard Test Method for Strength Properties of 

Tissue Adhesives in Tension 

Withdrawn and replaced with 

newer version 

116 

93 ASTM F86–04: Standard Practice for Surface Preparation and 

Marking of Metallic Surgical Implants 

Withdrawn and replaced with 

newer version 

117 

H. OB-GYN/Gastroenterology 

1 AAMI RD5:1992: Hemodialysis systems Withdrawn 

17 ASTM D3492–03: Standard Specification for Rubber Contraceptives (Male Condoms) Withdrawn and replaced with 

newer version 

32 

24 ASTM F623–99e1: Standard Performance Specification for Foley 

Catheter 

Withdrawn and replaced with 

newer version 

33 

26 ISO 4074:2002/Cor.1:2003(E): Natural Latex Rubber Condoms—

Requirements and Test Methods, Technical Corrigendum 1 

Withdrawn and replaced with 

newer version 

34 

27 ASTM D6324–99a (Reapproved 2004): Standard Test Methods for 

Male Condoms Made From Synthetic Materials 

Withdrawn and replaced with 

newer version 

35 

I. Ophthalmic 

31 ISO 11810:2002, Optics and Optical Instruments—Lasers and 

Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective Covers 

Withdrawn newer version 

recognized under General 

Hospital/ General Plastic 

Surgery 

J. Orthopedic 

126 ASTM F366–04: Standard Specification for Fixation Pins and 

Wires 

Withdrawn and replaced with 

newer version 

180 

159 ASTM F1717–04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model Withdrawn and replaced with 

newer version 

181 

173 ASTM F1800–04: Standard Test Method for Cyclic Fatigue Testing 

of Metal Tibial Tray Components of Total Knee Joint Replacements 

Withdrawn and replaced with 

newer version 

182 

K. Radiology 

1 ANSI PH 2.43–1982: Method for Sensitometry/Medical X-Ray 

Screen-Film 

Contact person 

2 ANSI IT 1.48–1997 Photography (Films)—Medical Hard Copy Imaging Film-Dimensions and Specifications Title and contact person 

5 ANSI PH 2.50–1983: Method/Sensitometry Direct Exposure Medical/Dental Contact person 

6 IEC 60806 (R1984) Determination of the Maximum Symmetrical 

Radiation Field From a Rotating Anode X-ray Tube for Medical 

Diagnosis 

Title and contact person 

8 IEC 60336 (R1993) Medical Electrical Equipment—X-ray Tube Assemblies for Medical Diagnosis—Characteristics of Focal Spots Title 

23 NEMA XR 10–1986 (R2003) Measurement of the Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube 

Used for Medical Diagnosis 

Reaffirmation 

67720 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 

TABLE 1.—Continued 

Old Item No. Standard Change Replacement Item 

No. 

34 IEC 60601–2–7–1998 Medical Electrical Equipment—Part 2–7: 

Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray Generators 

Tile and contact person 

37 IEC 60601–2–11–2004 Amendment 1—Medical electrical equipment—Part 2–11: Particular requirements for the Safety of 

Gamma Beam Therapy Equipment Withdrawn and Replaced 

With Newer Version 

133 

52 UL 544 (1998): Standard for Medical and Dental Equipment—Ed. 

4.0 

Contact person 

56 IEC 61674–1997 Medical Electrical Equipment—Dosimeters With 

Ionization Chambers and/or Semi-Conductor Detectors as Used 

in X-ray Diagnostic Imaging 

Withdrawn 

57 IEC 60731–1997 Medical Electrical Equipment—Dosimeters With 

Ionization Chambers as Used in Radiotherapy 

Title and devices affected 

61 UL 122 (1999): Standard for Photographic Equipment—Ed. 4.0 Contact person 

62 UL 187 (1998): Standard for X-Ray Equipment—Ed. 7.0 Contact person 

79 NEMA XR 7–1995 (R2000) High-Voltage X-Ray Cable Assemblies 

and Receptacles 

Title and contact person 

80 NEMA XR 9–1984 (R1994, R2000) Power Supply Guidelines for 

X-Ray Machines 

Contact person 

81 NEMA XR 13–1990 (R1995, R2000) Mechanical Safety Standard 

for Power Driven Motions of Electromedical Equipment 

Contact person 

82 NEMA XR 14–1990 (R1995, R2000) Recommended Practices for 

Load Bearing Mechanical Assemblies Used in Diagnostic Imaging 

Contact Person 

89 ISO 11810:2002 Optics and Optical Instruments—Lasers and 

Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective Covers 

Withdrawn Newer version 

recognized under General 

Hospital/General Plastic 

Surgery 

107 ISO 11146–1:2005 Lasers and Laser-Related Equipment—Test 

Methods for Laser Beam Widths, Divergence Angles and Beam 

Propagation Ratios—Part 1: Stigmatic and Simple Astigmatic 

Beams 

Withdrawn and replaced with 

newer version 

134 

119 NEMA PS 3.1—3.18 Digital Imaging and Communications in Medicine (DICOM) Set Title 

126 IEC 60601–2–28–1993 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of X-ray Source Assemblies 

and X-ray Tube Assemblies for Medical Diagnosis—Ed. 1.0 

Title and contact person 

127 IEC 60601–2–32–1994 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Associated Equipment of 

X-ray Equipment—Ed. 1.0 

Title and contact person 

129 NEMA NU 1–2001 (Errata 2004): Performance Measurements of 

Scintillation Cameras 

Title 

131 IEC 61217–2002 Radiotherapy Equipment—Coordinates Movements and Scales Consolidated Ed. 1.1 Title 

132 IEC 60731–2002 Amendment 1—Medical Electrical Equipment—

Dosimeters With Ionization Chambers as Used in Radiotherapy 

Title and devices affected 

L. Sterility 

48 ANSI/AAMI ST40:2004, Table-Top Dry Heat (Heated Air) Sterilization and Sterility Assurance in Dental and Medical Facilities, 2ed Withdrawn and replaced with 

newer version 

152 

Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67721 

TABLE 1.—Continued 

Old Item No. Standard Change Replacement Item 

No. 

52 ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators Part 1: General Title, relevant guidance, and 

contact person 

70 ANSI/AAMI/ISO 14161:2000, Sterilization of Health Care Products—Biological Indicators—Guidance for the Selection, Use, 

and Interpretation of Results, 2ed. 

Contact Person 

71 ANSI/AAMI ST8:2001, Hospital Steam Sterilizers Contact Person 

77 ANSI/AAMI ST24:1999, Automatic, General Purpose Ethylene 

Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended 

for Use in Health Care Facilities, 3ed. 

Title and contact person 

116 ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test Methodologies, 

Routine Monitoring, and Alternatives to Batch Testing 

Relevant guidance 

117 ANSI/AAMI ST35:2003, Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in 

Nonclinical Settings 

Relevant guidance and contact person 

119 ANSI/AAMI ST55:2003, Table-Top Steam Sterilizers, 2ed. Correct title and contact person 

124 USP 28:2005, Biological Indicator for Dry Heat Sterilization, Paper 

Carrier 

Withdrawn and replaced with 

newer version 

153 

125 USP 28:2005, Biological Indicator for Ethylene Oxide Sterilization, 

Paper Carrier 

Withdrawn and replaced with 

newer version 

154 

126 USP 28:2005, Biological Indicator for Steam Sterilization, Paper 

Carrier 

Withdrawn and replaced with 

newer version 

155 

127 USP28:2005, <61> Microbial Limits Test Withdrawn and replaced with 

newer version 

156 

128 USP 28:2005, <71>, Microbiological Tests, Sterility Tests Withdrawn and replaced with 

newer version 

157 

129 USP28:2005, <85>, Biological Tests and Assays, Bacterial 

Endotoxin Test (LAL) 

Withdrawn and replaced with 

newer version 

158 

130 USP28:2005 <151>, Pyrogen Test (USP Rabbit Test) Withdrawn and replaced with 

newer version 

159 

131 USP28:2005 <1211>, Sterilization and Sterility Assurance of 

Compendial Articles 

Withdrawn and replaced with 

newer version 

160 

132 USP28:2005 <161>, Transfusion and Infusion Assemblies and 

Similar Medical Devices 

Withdrawn and replaced with 

newer version 

161 

133 USP 28:2005, Biological Indicator for Steam Sterilization—SelfContained Withdrawn and replaced with 

newer version 

162 

III. Listing of New Entries 

The listing of new entries and 

consensus standards added as 

modifications to the list of recognized 

standards under Recognition List 

Number: 013, follows: 

Item No. Title of Standard Reference No. and Date 

A. Anesthesia 

65 Medical Electrical Equipment—Particular Requirements for the Basic 

Safety and Essential Performance of Respiratory Gas Monitors 

ISO 21647:2005 

66 Medical Electrical Equipment—Particular Requirements for the Basic 

Safety and Essential Performance of Pulse Oximeter Equipment 

for Medical Use 

ISO 9919:2005 

67722 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 

Item No. Title of Standard Reference No. and Date 

B. Dental/Ear, Nose, Throat 

127 Root Canal Files, Type H (Hedstrom) ANSI/ADA Specification No. 58:2004 

128 Dentistry—Elastomeric Impression Materials ISO/4823:2000 Technical Corrigendum 1:2004 

129 Dentistry—Elastomeric Impression Materials ANSI/ADA Specification No. 19:2000 Technical 

Corrigendum 1:2004 

C. General 

34 Medical Electrical Equipment—Part 1–2: General Requirements for 

Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and tests (Edition 2:2001 with Amendment 1:2004; 

Edition 2.1 (Edition 2:2001 Consolidated With Amendment 

1:2004)) 

IEC 60601–1–2:2004 

35 Medical Electrical Equipment—Part 1–2: General Requirements for 

Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004) 

AAMI/IEC 60601–1–2:2001 

D. General Hospital/General Plastic Surgery 

142 Medical Electrical Equipment—Part 2: Particular Requirements for 

Safety of Baby Incubators 

ANSI/AAMI II36:2004 

143 Medical Electrical Equipment—Part 2: Particular Requirements for 

Safety of Transport Incubators 

ANSI/AAMI II51:2004 

E. In Vitro Diagnostic 

109 Laboratory Automation: Data Content for Specimen Identification; 

Approved Standard 

CLSI AUTO7–A:2004 

111 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline—

Fourth Edition 

CLSI H21–A4:2003 

112 Point-of-Care Monitoring of Anticoagulation Therapy; Approved 

Guideline 

CLSI H49–A:2004 

113 Assessing the Quality of Immunoassay Systems: 

Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline 

CLSI I/LA23–A:2004 

114 Standard Specification for Low-Level Protocol to Transfer Messages 

Between Clinical Laboratory Instruments and Computer Systems 

CLSI LIS01–A:2003 

115 Standard Specification for Transferring Information Between Clinical 

Instruments and Computer Systems; Approved Standard—Second 

Edition 

CLSI LIS02–A2:2004 

116 Standard Guide for Selection of a Clinical Laboratory Information 

Management System 

CLSI LIS03–A:2003 

117 Standard Guide for Documentation of Clinical Laboratory Computer 

Systems 

CLSI LIS04–A:2003 

118 Standard Specification for Transferring Clinical Observations Between Independent Computer Systems CLSI LIS05–A:2003 

119 Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems CLSI LIS06–A:2003 

120 Standard Specification for Use of Bar Codes on Specimen Tubes in 

the Clinical Laboratory 

CLSI LIS07–A:2003 

121 Standard Guide for Functional Requirements of Clinical Laboratory 

Information Management Systems 

CLSI LIS08–A:2003 

122 Standard Guide for Coordination of Clinical Laboratory Services 

Within the Electronic Health Record Environment and Networked 

Architectures 

CLSI LIS09–A:2003 

Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67723 

Item No. Title of Standard Reference No. and Date 

123 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine CLSI MM9–A:2004 

F. Materials 

118 Standard Practice for Marking Medical Devices and Other Items for 

Safety in the Magnetic Resonance Environment 

ASTM F2503–05 

G. OB-GYN/Gastroenterology 

36 Mechanical contraceptives—Reusable Natural and Silicone Rubber 

Contraceptive Diaphragms—Requirements and Tests 

ISO 8009:2004(E) 

H. Radiology 

135 Medical electrical equipment—Part 2–5: Particular Requirements for 

the Safety of Ultrasonic Physiotherapy Equipment Ed. 2.0 

IEC 60601–2–5:2000 

I. Sterility 

163 Sterilization of Medical Devices—Microbiological methods—Part 3: 

Guidance on Evaluation and Interpretation of Bioburden Data 

ANSI/AAMI/ISO 11737–3:2004 

164 Sterilization of Medical Devices—Information To Be Provided by the 

Manufacturer for the Processing of Resterilizable Medical Devices 

ANSI/AAMI ST81:2004 

165 Cleanrooms and Associated Controlled Environments—Part 5: Operations ISO 14644–5:2004 

166 Cleanrooms and Associated Controlled Environments—Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and MiniEnvironments) ISO 14644–7:2004 

J. Tissue Engineering 

6 Standard Guide for Assessing Microstructure of Polymeric Scaffolds 

for Use in Tissue Engineered Medical Products 

ASTM F2450–04 

7 Standard Guide for Immobilization or Encapsulation of Living Cells 

or Tissue in Alginate Gels 

ASTM F2315–03 

IV. List of Recognized Standards 

FDA maintains the agency’s current 

list of FDA recognized consensus 

standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http:// 

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. FDA 

will incorporate the modifications and 

minor revisions described in this notice 

into the database and, upon publication 

in the Federal Register, this recognition 

of consensus standards will be effective. 

FDA will announce additional 

modifications and minor revisions to 

the list of recognized consensus 

standards, as needed, in the Federal 

Register once a year, or more often, if 

necessary. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under the new provision of 

section 514 of the act by submitting 

such recommendations, with reasons for 

the recommendation, to the contact 

person (see FOR FURTHER INFORMATION

CONTACT). 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 national or 

international standards development 

organization, (4) a proposed list of 

devices for which a declaration of 

conformity to this standard should 

routinely apply, and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

VI. Electronic Access 

In order to receive ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards’’ on your FAX machine, call 

the Center for Devices and Radiological 

Health (CDRH) Facts-On-Demand 

system at 800–899–0381 or 301–827–

0111 from a touch-tone telephone. Press 

1 to enter the system. At the second 

voice prompt press 1 to order a 

document. Enter the document number 

321 followed by the pound sign. Follow 

the remaining voice prompts to 

complete your request. 

You may also obtain a copy of 

‘‘Guidance on the Recognition and Use 

of Consensus Standards’’ by using the 

Internet. CDRH maintains a site on the 

Internet for easy access to information 

including text, graphics, and files that 

you may download to a personal 

computer with access to the Internet. 

Updated on a regular basis, the CDRH 

home page includes the guidance as 

well as the current list of recognized 

standards and other standards related 

documents. After publication in the 

Federal Register, this notice 

announcing ‘‘Modifications to the List 

of Recognized Standards, Recognition 

List Number: 013’’ will be available on 

the CDRH home page. You may access 

the CDRH home page at http:// 

www.fda.gov/cdrh. 

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for ‘‘FDA Recognized Consensus 

Standards’’ through the hyperlink at 

http://www.fda.gov/cdrh/stdsprog.html. 

67724 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.fda.gov/cdrh/fedregin.html. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) written or 

electronic comments regarding this 

document. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

013. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: October 10, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–22267 Filed 11–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0344] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Tinnitus Masker Devices; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Class II Special Controls 

Guidance Document: Tinnitus Masker 

Devices.’’ The draft guidance describes 

a means by which tinnitus masker 

devices may comply with the 

requirement of special controls for class 

II devices. Elsewhere in this issue of the 

Federal Register, FDA is publishing a 

proposed rule to amend the 

classification regulations for the tinnitus 

masker presently classified into class II 

(special controls: labeling) to designate 

a special control for these devices. The 

draft guidance is neither final, nor is it 

in effect at this time. 

DATES: Submit written or electronic 

comments on this draft guidance by 

February 6, 2006. 

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

draft guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Tinnitus Masker Devices’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–443–8818. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

draft guidance. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Teresa Cygnarowicz, Center for Devices 

and Radiological Health (HFZ–460), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2980. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a proposed 

rule to amend the classification 

regulations for tinnitus masker devices 

presently classified into class II (special 

controls: labeling) to designate a special 

control for the devices. The draft 

guidance document describes a means 

by which the device may comply with 

the requirement of special controls for 

class II devices. Following the effective 

date of a final rule based on the 

proposed rule, any firm submitting a 

510(k) premarket notification for the 

device will need to address the issues 

covered in the special control guidance. 

However, the firm need only show that 

its device meets the recommendations 

of the guidance or in some other way 

provides equivalent assurances of safety 

and effectiveness. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on tinnitus masker 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 an 

approach satisfies the requirements of 

the applicable statute and regulations. 

III. Electronic Access 

To receive ‘‘Class II Special Controls 

Guidance Document: Tinnitus Masker 

Devices’’ by fax, call the CDRH FactsOn-Demand system at 800–899–0381 or 

301–827–0111 from a touch-tone 

telephone. Press 1 to enter the system. 

At the second voice prompt, press 1 to 

order a document. Enter the document 

number (1555) followed by the pound 

sign (#). Follow the remaining voice 

prompts to complete your request. 

Persons interested in obtaining a copy 

of the draft guidance may also do so by 

using the Internet. CDRH maintains an 

entry on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). The 

collections of information addressed in 

the draft guidance document have been 

approved by OMB in accordance with 

the PRA under the regulations 

governing premarket notification 

submissions (21 CFR part 807, subpart 

E), under OMB control number 0910–

0120. The labeling provisions addressed 

in the draft guidance have been 

approved by OMB under OMB control 

number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic