69022 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices

Type of respondent No. of

respondents

No.

of responses/

respondent

Avg. burden/

response

(in hrs.)

Farmers (pretesting) .................................................................................................................... 60 1 .5

Student (pretesting) ..................................................................................................................... 60 1 .5

Farmers ........................................................................................................................................ 300 1 .333

Farmers ........................................................................................................................................ 300 2 .333

Students ....................................................................................................................................... 600 1 .5

Dated: November 8, 2000.

Nancy Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 00–29259 Filed 11–14–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–05–01]

Agency Forms Undergoing Paperwork

Reduction Act Review

The Centers for Disease Control and

Prevention (CDC) publishes a list of

information collection requests under

review by the Office of Management and

Budget (OMB) in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

requests, call the CDC Reports Clearance

Officer at (404) 639–7090. Send written

comments to CDC, Desk Officer; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Project

NIOSH Training Grants, 42 CFR Part

86, Application and Regulations (OMB

No. 9020–0261)—Extension—National

Institute for Occupational Safety and

Health (NIOSH). Public law 91–596

requires CDC/NIOSH to provide an

adequate supply of professionals to

carry out the purposes of the Act to

assure a safe and healthful work

environment. NIOSH supports

educational programs through training

grant awards to academic institutions

for the training of industrial hygienists,

occupational physicians, occupational

health nurses and safety professionals.

Grants are provided to 15 Education and

Research Centers (ERCs) which provide

multi-disciplinary graduate academic

and research training for professionals,

continuing education for practicing

professionals and outreach programs in

the Region. There are also currently 41

Training Project Grants (TPGs) which

provide single discipline academic and

technical training throughout the

country. 42 CFR Part 86, Grants for

Education Programs in Occupational

Safety and Health, Subpart B—

Occupational Safety and Health

Training, provides guidelines for

implementing Public Law 91–596.

The training grant application form

(CDC2.145.A) is used by the National

Institute of Occupational Safety and

Health to collect information from new

grant applicants submitting competing

applications, and from existing

applicants for competing renewal

grants. The information is used to

determine the eligibility of applicants

for grant review and by peer reviewers

during the peer review process to

evaluate the merit of the proposed

training project. CDC Form 2.145B is

used for non-competing awards to

evaluate the annual progress of the

applicant during the approved project

period.

Extramural training grant awards are

made annually following an extramural

review process of the training grant

applications, review by an internal

Training Grants Council and an internal

review of non-competing applicants.

The estimated annualized burden is

6,161 hours.

Respondents No. of

respondents

No. of

responses/

respondent

Avg. burden

per response

(in hrs)

Universities .................................................................................................................................. 61 1 101

Dated: November 8, 2000.

Nancy Cheal,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 00–29260 Filed 11–14–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0530]

FDA Modernization Act of 1997:

Modifications to the List of Recognized

Standards, Recognition List Number:

004

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 will recognize for use in

premarket reviews (FDA Recognized

Consensus Standards). This publication

entitled ‘‘Modifications to the List of

Recognized Standards, Recognition List

Number: 004’’ (Recognition List

Number: 004) will assist manufacturers

who elect to declare conformity with

consensus standards to meet certain

requirements for medical devices.

DATES: Written comments concerning

this document may be submitted at any

time. See section VI 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:

Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices 69023

004,’’ 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 selfaddressed adhesive labels to assist that

office in processing your requests, or fax

your request to 301–443–8818. Written

comments concerning this document

must be submitted to the contact person

(address below). Comments should be

identified with the docket number

found in brackets in the heading of this

document. This document may also be

accessed on FDA’s Internet site at http:/

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

section V of this document for

electronic access to the searchable data

base for the current list of ‘‘FDA

Recognized Consensus Standards,’’

including Recognition List Number: 004

modifications, and other standards

related information.

FOR FURTHER INFORMATION CONTACT: To

comment on this document and/or to

recommend additional standards for

recognition: Donald E. Marlowe, Center

for Devices and Radiological Health

(HFZ–100), Food and Drug

Administration, 12725 Twinbrook

Pkwy., Rockville, MD 20852, 301–827–

4777.

SUPPLEMENTARY INFORMATION:

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.’’ This

notice described how FDA will

implement its standards program

recognizing the use of certain standards

and provided the initial list of

recognized standards.

In Federal Register notices published

on October 16, 1998 (63 FR 55617) and

July 12, 1999 (64 FR 37546), FDA

modified its initial list of recognized

standards. These notices described the

addition, withdrawal, and revision of

certain standards recognized by FDA.

When these notices were published, the

agency maintained ‘‘html’’ and ‘‘pdf’’

versions of the list of ‘‘FDA Recognized

Consensus Standards.’’ Both versions

were publicly accessible at the agency’s

Internet site. The agency maintains the

current list in a searchable data base

accessible to the public. See section V

of this document for electronic access

information.

II. Discussion of Modifications to the

List of Recognized Standards,

Recognition List Number: 004

FDA is announcing the addition,

withdrawal, correction, and revision of

certain consensus standards the agency

will recognize for use in satisfying

premarket reviews for devices. FDA will

incorporate these modifications in the

list of ‘‘FDA Recognized Consensus

Standards’’ in the agency’s searchable

data base. FDA will use the term

‘‘Recognition List Number: 004’’ to

identify supplementary information

sheets for standards added to the list for

the first time, standards added to

replace withdrawn standards, and still

recognized standards for which minor

revisions are made to clarify the

application of the standards.

At the end of this notice, FDA lists

modifications the agency is making that

involve: (1) The initial addition of

standards not previously recognized by

FDA and (2) the addition of standards

in conjunction with the withdrawal of

other standards that are replaced by

these later, or amended, or different

standards.

Under headings ‘‘A’’ through ‘‘L’’

below, FDA describes modifications that

involve: (1) The withdrawal of

standards and their replacement by

others (‘‘replacement’’ standards are

included in the list at the end of this

notice, but not ‘‘withdrawn’’ standards);

(2) the correction of errors made in

previously recognized standards, e.g.,

the name of the standard; (3) the

withdrawal of standards not replaced;

and (4) the minor revision of

supplementary information sheets for

standards that FDA still recognizes, e.g.,

to clarify the extent of recognition, or

applicable devices.

Item numbers discussed below

identify entries in the searchable data

base list of ‘‘FDA Recognized Consensus

Standards.’’ ‘‘Previous item’’ refers to

entries in the list after modification on

July 12, 1999 (64 FR 37546). ‘‘Current

item’’ refers to entries in the list after

Recognition List Number: 004

modifications are included. Within each

category of standards, entries begin (or

began) with item 1. Item numbers are

not repeated if an entry is withdrawn,

replaced, or added.

A. Biocompatibility

1. ASTM E1397–91 is withdrawn

under previous item 5. ASTM E1397–91

(1998) is added under current item 37.

2. ASTM E1398–91 is withdrawn

under previous item 6. ASTM E1398–91

(1998) is added under current item 38.

3. ASTM F763–87 (1993) is

withdrawn under previous item 35.

ASTM F763–99 is added under current

item 40.

4. ASTM F981–93 is withdrawn

under previous item 14. ASTM F981–99

is added under current item 41.

5. USP 23, ‘‘Biological Reactivity

Tests, In Vitro-Direct Contact Test (87),’’

is withdrawn under previous item 23.

The USP 24 version, Biological Tests

<87>, is added under current item 46.

6. USP 23, ‘‘Biological Reactivity

Tests, In Vitro-Elution Test (87),’’ is

withdrawn under previous item 24. The

USP 24 version, Biological Tests <87> is

added under current item 47.

7. USP 23 (1988), ‘‘Biological

Reactivity Tests, In Vivo, Classification

of Plastics Sample Preparation,’’ is

withdrawn under previous item 31. The

USP 24 version, Biological Tests <88>,

is added under current item 48.

8. USP 23, ‘‘Biological Reactivity Test,

In Vivo, Classification of PlasticsIntracutaneous Test (88),’’ is withdrawn

under previous item 25. The USP 24

version, Biological Tests <88>, is added

under current item 49.

9. USP 23, ‘‘Biological Reactivity

Tests, In Vivo-Systemic Injection Test

(88),’’ is withdrawn under previous item

27. The USP 24 version, Biological Tests

<88>, is added under current item 50.

B. Cardiovascular/Neurology

1. ASTM F1058–91 is withdrawn

under previous item 13. ASTM F1058–

97 is added under current item 28.

2. IEC 60601–2–30 (1995–03) is

withdrawn, under previous item 19. IEC

60601–2–30: 1999–12 is added under

current item 29.

3. IEC 60601–2–25 (1993–03) is

withdrawn under previous item 17. IEC

60601–2–25 Amendment 1 (1999) is

added under current item 30.

C. Dental/ENT

1. ANSI/ADA Specification No.15a

(1992) is withdrawn under previous

item 47. ANSI/ADA Specification No.

15: 1999 is added under current item 85.

2. ANSI/ADA Specification No. 38

(1991) is withdrawn under previous

item 54. ANSI/ADA Specification No.

38: 2000 is added under current item 86.

3. ANSI/ADA Specification No. 69

(1991) is withdrawn under previous

item 57. ANSI/ADA Specification No.

69: 1999 is added under current item 87.

69024 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices

4. ANSI/ADA Specification No. 78

(1994) is withdrawn under previous

item 58. ANSI/ADA Specification No.

78: 2000 is added under current item 88.

D. General (General Applicability)

1. ANSI/AAMI/ISO 10993–1 (1997) is

withdrawn under previous item 13.

ANSI/AAMI/ISO 10993–1 (1997) is

added back to the list as current item 51

under the Biocompatibility category of

standards.

E. General Plastic Surgery/General

Hospital

1. ASTM D6124–97 is withdrawn

under previous item 45. ASTM D6124–

00 is added under current item 51.

2. ASTM D5250 (1992) is withdrawn

under previous item 35. ASTM D5250–

00 is added under current item 52.

3. ASTM D5151 (1992) is withdrawn

under previous item 34. ASTM D5151–

99 is added under current item 53.

4. ASTM D3578 (1995) is withdrawn

under previous item 31. ASTM D3578–

00 is added under current item 54.

5. ASTM D3577 (1998) is withdrawn

under previous item 30. ASTM D3577–

00 is added under current item 55.

6. USP 23 <11>, ‘‘Sterile Sodium

Chloride for Injection,’’ is withdrawn.

The USP 24 <11> version of this

standard is added under current item

56.

7. USP 23 <11>, ‘‘Sterile Water for

Injection,’’ is withdrawn under previous

item 28. The USP 24 <11> version of

this standard is added under current

item 57.

8. USP 23, ‘‘Absorbable Surgical

Sutures,’’ is withdrawn under previous

item 40. The USP 24 version of this

standard is added under current item

58.

9. USP 23, ‘‘Tensile Strength,’’ is

withdrawn under previous item 44. The

USP 24 version of this standard is added

under current item 59.

10. USP 23, ‘‘Sutures-Diameter

<861>,’’ is withdrawn under previous

item 42. The USP 24 <861> version of

this standard is added under current

item 60.

11. USP 23, ‘‘Suture Needle

Attachment <871>,’’ is withdrawn

under previous item 43. The USP 24

<871> version of this standard is added,

under current item 61.

F. In Vitro Devices

1. NCCLS standard M11–A3 (1993) is

withdrawn under previous item 9. FDA

intended to replace this standard with

NCCLS standard M11–A4 (1997), which

it added to the list on July 12, 1999 (64

FR 37546) and which remains as current

item 45.

G. OB GYN/Gastroenterology

1. In the supplementary information

sheet(s) for IEC 60601–2–18: 1996,

which was identified under previous

item 5, minor revisions are made to the

devices affected, related Code of Federal

Regulations (CFR) citation(s) and

procode(s), and relevant guidance. This

standard remains recognized and

identified under current item 5.

H. Ophthalmic

1. ISO 9394: 1994 is withdrawn under

previous item 6, from the list of

recognized consensus standards. ISO

9394: 1998 is added under current item

15.

I. Orthopaedics

1. ASTM F75–92 is withdrawn under

previous item 2. ASTM F75–98 is added

under current item 86.

2. ASTM F90–96 is withdrawn under

previous item 4. ASTM F90–97 is added

under current item 87.

3. ASTM F136–96 is withdrawn

under previous item 5. ASTM F136–98

is added under current item 88.

4. ASTM F138–92 is withdrawn

under previous item 6. ASTM F138–97

is added under current item 89.

5. ASTM F560–92 is withdrawn

under previous item 9. ASTM F560–98

is added under current item 90.

6. ASTM F561–87 is withdrawn

under previous item 10. ASTM F561–97

is added under current item 91.

7. ASTM F565–85 (R1996) is

withdrawn under previous item 12.

ASTM F565–85 (1996)(e1) is added

under current item 92.

8. ASTM F601–86 (1992) is

withdrawn under previous item 13.

ASTM F601–98 is added under current

item 93.

9. ASTM F603–83 is withdrawn

under previous item 14. ASTM F603–83

(1995) is added under current item 94.

10. ASTM F620–96 is withdrawn

under previous item 16. ASTM F620–97

is added under current item 96.

11. ASTM F621–92 is withdrawn

under previous item 17. ASTM F621–97

is added under current item 97.

12. ASTM F629–86 is withdrawn

under previous item 18. ASTM F629–97

is added under current item 98.

13. ASTM F648–84 is withdrawn

under previous item 19. ASTM F648–98

is added under current item 99, with

changes to the extent of recognition

made in the supplementary information

sheet(s).

14. ASTM F746–87 is withdrawn

under previous item 22. ASTM F746–87

(1994) is added under current item 100.

15. ASTM F786–82 is withdrawn

under previous item 23. It is not

replaced.

16. ASTM F787–82, is withdrawn

under previous item 24. It is not

replaced.

17. ASTM F897–84 (R1993) is

withdrawn under previous item 26.

ASTM F897–84 (1997) is added under

current item 101.

18. The title of ASTM F961–96,

identified under previous item 28, is

corrected to read ‘‘Standard

Specification for Cobalt-35 Nickel-20

Chromium-10 Molybdenum Alloy

Forgings for Surgical Implants

(R30035).’’ It remains identified as

current item 28.

19. ASTM F983–86 is withdrawn

under previous item 29. ASTM F983–86

(1996) is added under current item 102.

20. ASTM F1089–87 is withdrawn

under previous item 32. ASTM F1089–

87 (1994) is added, under current item

104.

21. ASTM F1091–91 (R1996) is

withdrawn under previous item 33.

ASTM F1091–91 (1996) E01 is added

under current item 105.

22. ASTM F1147–95 is withdrawn

under previous item 35. ASTM F1147–

99 is added under current item 107.

23. ASTM F1160–91 is withdrawn

under previous item 36. ASTM F1160–

98 is added under current item 108.

24. ASTM F1185–88 (1993) is

withdrawn under previous item 37.

ASTM F1185–88 (1993) E01 is added

under current item 109.

25. ASTM F1264–96a is withdrawn

under previous item 38. ASTM F1264–

99 is added under current item 110.

26. ASTM F1350–96 is withdrawn

under previous item 42. ASTM F1350–

91 (1996) E01 is added under current

item 112.

27. ASTM F1377–92 is withdrawn

under previous item 43. ASTM F1377–

98a is added under current item 113.

28. In the supplementary information

sheet(s) for ASTM F1672–95, identified

under previous item 55, minor changes

are made to the extent of recognition,

devices affected, and related CFR

citation(s) and procode(s). This standard

remains recognized and identified

under current item 55.

29. ASTM F1798 is withdrawn under

previous item 59. ASTM F1798–97 is

added under current item 114.

30. ASTM F1800 is withdrawn under

previous item 60. ASTM F1800–97 is

added under current item 115.

31. ASTM F1801 is withdrawn under

previous item 61. ASTM F1801–97 is

added under current item 116.

32. ISO 5832–2: 1993 is withdrawn

under previous item 63. ISO 5832–

2:1999 is added under current item 117.

33. ISO 5832–9: 1992 is withdrawn

under previous item 68. ISO 5832–

9:1995 is added under current item 118.

Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices 69025

34. ISO 5832–10: 1996 is withdrawn

under previous item 69. It is not

replaced.

35. ISO 5834–2: 1985 is withdrawn

under previous item 72. ISO 5834–2:

1998 is added under current item 119.

36. In the supplementary information

sheets for ISO 7206–4: 1989 and ISO

7206–8: 1995, which were identified

under previous items 78 and 79,

respectively, minor changes are made to

the devices affected, processes

impacted, type of standards, and related

CFR citations and procodes. They

remain recognized and identified under

current items 78 and 79.

J. Radiology

1. UL–122 is withdrawn under

previous item 30. UL–122 (Fourth

Edition) is added under current item 50.

2. UL–187 is withdrawn under

previous item 31. UL–187 (Seventh

Edition) is added under current item 51.

3. UL–544 (Third Edition) is

withdrawn under previous item 32. UL–

544 (Fourth Edition) is added under

current item 52.

4. IEC 60601–2–8 (1987–04) is

withdrawn under previous item 35. IEC

60601–2–8 (1999–04) is added under

current item 54.

5. IEC 60601–2–29 (1993–04) is

withdrawn under previous item 41. IEC

60601 2–9 (1999–01) is added under

current item 55.

K. Software

1. In the supplementary information

sheets for ISO/IEC 12207 and IEEE/EIA

12207.0–1996, which were identified

under previous items 1 and 3,

respectively, minor changes are made to

the identities of organizations associated

with the standards and the extent of

recognition. These standards remain

recognized and identified under current

items 1 and 3.

L. Sterility

1. ANSI/AAMI ST24: 1992 is

withdrawn under previous item 13.

ANSI/AAMI ST24: 1999 is added under

current item 38.

2. USP 23: 1995, is withdrawn under

previous item 29. USP 24: 2000 is added

under current item 39.

3. USP 23: 1995, ‘‘Biological Indicator

for Dry-Heat Sterilization, Paper Strip,’’

is withdrawn under previous item 30.

The USP 24: 2000 version of this

standard is added under current item

40.

4. USP 23: 1995, ‘‘Biological Indicator

for Ethylene Oxide Sterilization, Paper

Strip,’’ is withdrawn under previous

item 31. The USP 24: 2000 version of

this standard is added under current

item 41.

5. USP 23: 1995, ‘‘Microbial Limits

Test <61>,’’ is withdrawn under

previous item 32. The USP 24: 2000

<61> version of this standard is added

under current item 42.

6. USP 23: 1995, ‘‘Microbiological

Tests, Sterility Tests <71>,’’ is

withdrawn under previous item 33. The

USP 24: 2000 <71> version of this

standard is added under current item

43.

7. USP 23: 1995, ‘‘Biological Tests and

Assays, Bacterial Endotoxin Test (LAL)

<85>,’’ is withdrawn under previous

item 34. The USP 24: 2000 <85> version

of this standard is added under current

item 44.

8. USP 23: 1995, ‘‘Pyrogen Test (USP

Rabbit Test) <151>,’’ is withdrawn

under previous item 35. The USP 24:

2000 <151> version of this standard is

added under current item 45.

9. USP 23: 1995, ‘‘Sterilization and

Sterility Assurance of Compendial

Articles <1211>,’’ is withdrawn under

previous item 36. The USP 24: 2000

<1211> version of this standard is

added under current item 46.

III. List of Recognized Standards

FDA maintains the agency’s current

list of ‘‘FDA Recognized Consensus

Standards’’ in a searchable data base

that may be accessed directly at FDA’s

Intranet site at http://

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

cfdocs/cfStandards/search.cfm. The

modifications and minor revisions

described in this notice will be

incorporated into the data base and,

upon publication in the Federal

Register, this recognition of consensus

standards will be effective.

Additional modifications and minor

revisions as needed, to the list of

recognized consensus standards, will be

announced in the Federal Register once

a year, or more often, if necessary.

IV. 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 (address above). To be properly

considered, such recommendations

should contain, at a minimum, the

following information: (1) Title of

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.

V. Electronic Access

In order to receive ‘‘Guidance on the

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. 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.

Persons interested in obtaining a copy

of ‘‘Guidance on the Recognition and

Use of Consensus Standards’’ may also

do so by using the Internet. CDRH

maintains a site on the Internet for easy

access to information including text,

graphics, and files that may be

downloaded to a personal computer

with access to the Internet. Updated on

a regular basis, the CDRH home page

includes this 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:

004’’ will be available on the CDRH

home page.

The CDRH home page may be

accessed at http://www.fda.gov/cdrh.

The ‘‘Guidance on the Recognition and

Use of Consensus Standards,’’ and the

searchable data base for ‘‘FDA

Recognized Consensus Standards,’’ may

be accessed through hyper links at http:/

/www.fda.gov/cdrh/stdsprog.html. This

Federal Register notice of modifications

in FDA’s recognition of consensus

standards will be available, upon

publication, at http://www.fda.gov/

cdrh/fedregin.html.

VI. Submission of Comments and

Effective Date

Interested persons may, at any time,

submit to the contact person (address

above) written comments regarding this

document. 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 listing of ‘‘Modifications to the

List of Recognized Standards,

Recognition list: 004.’’

The recognition of standards

announced in this notice of

modifications will become effective on

69026 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices

[insert date of publication in the Federal

Register].

VII. Listing of New Entries

The list of new entries and consensus

standards added as ‘‘Modifications to

the List of Recognized Standards,’’

under Recognition List Number: 004, is

as follows:

Item

Number Title of Standard Reference Number and Date

Biocompatibility

37 Standard Practice for the In Vitro Rat Hepatocyte DNA Repair

Assay

ASTM E1397–91 (1998)

38 Standard Practice for the In Vivo Rat Hepatocyte DNA Repair

Assay

ASTM E1398–91 (1998)

39 Standard Practice for Selecting Generic Biological Test Methods for Materials and DevicesASTM F748–98

40 Standard Practice for Short-Term Screening of Implant MaterialsASTM F763–99

41 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials

on Muscle and Bone

ASTM F981–99

42 Standard Practice for Testing for Whole Complement Activation

in Serum by Solid Materials

ASTM F1984–99

43 Standard Practice for Testing for Biological Responses to Particles In VitroASTM F1903–98

44 Standard Practice for Testing for Biological Responses to Particles In VivoASTM F1904–98

45 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant ApplicationsASTM F1983–99

46 Biological Reactivity Test, In Vitro—Direct Contact Test USP 24 Biological Tests <87>

47 Biological Reactivity Test, In Vitro—Elution Test USP 24 Biological Tests <87>

48 Biological Reactivity Test, In Vivo—Procedure—Preparation of

Sample

USP 24 Biological Test <88>

49 Biological Reactivity Test, In Vivo—Intracutaneous Test USP 24 Biological Tests <88>

50 Biological Reactivity Tests, In Vivo—Systemic Injection Test USP 24 Biological Test <88>

51 Biological Evaluation of Medical Devices—Part 1: Evaluation

and Testing

ANSI/AAMI/ISO 10993–1 (1997)

Cardiovascular/ Neurology

25 Cardiac Defibrillators—Connector Assembly for Implantable

Defibrillators-Dimensional and Test Requirements

ISO 11318–93/Amendment 1:1996 (E)

26 Medical Electrical Equipment, Part 2: Particular Requirements

for the Safety of Transcutaneous Partial Pressure Monitoring

Equipment

IEC 60601–2–23: 1993

27 Medical Electrical Equipment, Part 2: Particular Requirements

for the Safety of Direct Blood Pressure Monitoring Equipment

IEC 60601–2–34 (1994–12)

28 Standard Specification for Wrought Cobalt-Chromium-NickelMolybdenum-Iron Alloys for Surgical Implant Applications

(UNS R30003 and UNS R30008)

ASTM F1058–97

29 Medical Electrical Equipment, Part 2: Particular Requirements

for the Safety, Including Essential Performance, of Automatic

Cycling Non-Invasive Blood Pressure Monitoring Equipment

IEC 60601–2–30: 1999–12

30 Medical Electrical Equipment, Part 2: Particular Requirements

for the Safety of Electrocardiographs

IEC 60601–2–25 Amendment 1 (1999)

Dental/ ENT

85 Synthetic Resin Teeth ANSI/ADA Specification No. 15: 1999

86 Metal-Ceramic Systems ANSI/ADA Specification No. 38: 2000

87 Dental Ceramic ANSI/ADA Specification No. 69: 1999

88 Endodontic Obturating Points ANSI/ADA Specification No. 78: 2000

89 Polymer-Based Crown and Bridge Resins ANSI/ADA Specification No. 53: 1999

90 Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)ANSI/ASA S3.39: 1996

General (Generally Applicable)

22 General Tolerances—Part 1: Tolerances for Linear and Angular

Dimensions Without Individual Tolerance Indications

ISO 2768–1 (1989)

23 General Tolerances—Part 2: Geometrical Tolerances for Features Without Individual Tolerance IndicationsISO 2768–2 (1989)

24 Analysis Techniques for System Reliability—Procedure for Failure Modes and Effects Analysis (FMEA)IEC 60812 (1985)

Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices 69027

Item

Number Title of Standard Reference Number and Date

General Plastic Surgery/ General Hospital

46 Medical Electrical Equipment—Part 2: Particular Requirements

for the Safety of High Frequency Surgical Equipment

IEC 60601–2–2: Third Edition 1998–09

47 Standard Test Method for Analysis of Protein in Natural Rubber

and its Products Using the Modified Lowry Method

ASTM D5712–99

48 Standard Test Method for the Immunological Measurement of

Antigenic Protein in Natural Rubber and its Products

ASTM D6499–00

49 Standard Test Method for Human Repeat Insult Patch Testing

or Medical Gloves

ASTM D6355–98

50 Standard Specification for Nitrile Examination Gloves for Medical ApplicationASTM D6319–00

51 Standard Test Method for Residual Powder on Medical Gloves ASTM D6124–00

52 Standard Specification for Poly (Vinyl Chloride) Gloves for

Medical Application

ASTM D5250–00

53 Standard Test Method for Detection of Holes in Medical Gloves ASTM D5151–99

54 Standard Specification for Rubber Examination Gloves ASTM D3578–00

55 Standard Specification for Rubber Surgical Gloves ASTM D3577–00

56 Sterile Sodium Chloride For Irrigation USP 24 <11>

57 Sterile Water for Injection USP 24 <11>

58 Absorbable Surgical Sutures USP 24

59 Tensile Strength USP 24

60 Sutures—Diameters USP 24 <861>

61 Sutures Needle Attachment USP 24 <871>

OB GYN/ Gastroenterology

19 Optical and Optical Instruments—Medical Endoscopes and

Endoscopic Accessories—Part 1: General Requirements

ISO 8600–1: 1997

20 Optical and Optical Instruments—Medical Endoscopes and

Endoscopic Accessories—Part 3: Determination of Field of

View and Direction of View of Endoscopes with Optics

ISO 8600–3: 1997

21 Optical and Optical Instruments—Medical Endoscopes and

Certain Accessories—Part 4: Determination of Maximum

Width of Insertion Portion

ISO 8600–4: 1997

22 Standard Practice for Cleaning and Disinfecting of Flexible

Fiberoptic and Video Endoscopes Used in the Examination

of Hollow Viscera

ASTM F1518–94

Ophthalmic

15 Optics and Optical Instruments—Determination of Biological

Compatibility of Contact Lens Material—Testing of the Contact Lens System by Ocular Study with Rabbit Eyes

ISO 9394–1998

16 Optics and Optical Instruments—Contact Lenses—Part 2: Determination of Oxygen Permeability and Transmissibility by

the Coulometeric Method

ISO 9913–2: 2000

17 Optics and Optical Instruments—Ophthalmic Instruments—SlitLamp MicroscopesISO 10939: 1998

18 Optics and Optical Instruments—Ophthalmic Instruments—Indirect OphthalmoscopesISO 10943: 1999

19 Ophthalmic Optics—Contact Lenses—Classification of Contact

Lenses and Contact Lens Materials

ISO 11539: 1999

20 Ophthalmic Implants—Intraocular Lenses—Part 1: Vocabulary ISO 11979–1: 1999

21 Ophthalmic Implants—Intraocular Lenses—Part 2: Optical

Properties and Tests Methods

ISO 11979–2: 2000

22 Ophthalmic Implants—Intraocular Lenses—Part 3: Mechanical

Properties and Test Methods

ISO 11979–3: 1999

23 Ophthalmic Optics—Contact Lenses and Contact Lens Care

Products—Determination of Physical Compatibility of Contact

Lens Care Products with Contact Lenses

ISO 11981–1999

24 Ophthalmic Optics—Contact Lenses and Contact Lens Care

Products—Guidelines for Determination of Preservative Uptake and Release

ISO 11986: 1999

25 Optics and Optical Instruments—Ophthalmic Instruments—

Retinoscopes

ISO 12865: 1998

26 Ophthalmic Optics—Contact Lens Care Products—Guidelines

for Determination of Shelf-Life

ISO 13212: 1999

69028 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices

Item

Number Title of Standard Reference Number and Date

Orthopaedics

86 Standard Specification for Cobalt-28 Chromium-6 Molybdenum

Casting Alloy and Cast Products for Surgical Implants (UNS

R30075)

ASTM F75–98

87 Standard Specification for Wrought Cobalt-20 Chromium-15

Tungsten-10 Nickel Alloy for Surgical Implant Applications

(UNS R30605)

ASTM F90–97

88 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (R56401) for Surgical Implant ApplicationsASTM F136–98

89 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5

Molybdenum Stainless Steel Bar and Wire For Surgical Implants (UNS S31673)

ASTM F138–97

90 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R 05200, UNS R05400)ASTM F560–98

91 Recommended Practice for Retrieval and Analysis of Implanted

Medical Devices, and Associated Tissues

ASTM F561–97

92 Standard Practice for Care and Handling of Orthopedic Implants and InstrumentsASTM F 565–85 (1996) (e1)

93 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsASTM F601–98

94 Standard Specification for High-Purity Dense Aluminum Oxide

for Surgical Implant Application

ASTM F603–83 (1995)

95 Standard Test Method for Constant Amplitude Bending Fatigue

Tests of Metallic Bone Staples

ASTM F1539–95

96 Standard Specification for Titanium-6 Aluminum-4 Vanadium

ELI Alloy Forgings for Surgical Implants (UNS R56401)

ASTM F620–97

97 Standard Specification for Stainless Steel Forgings for Surgical

Implants

ASTM F621–97

98 Standard Practice for Radiography of Cast Metallic Surgical ImplantsASTM F629–97

99 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsASTM F648–98

100 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsASTM F746–87 (1994)

101 Standard Test Method for Measuring Fretting Corrosion of

Osteosynthesis Plates and Screws

ASTM F897–84 (1997)

102 Standard Practice for Permanent Marking of Orthopaedic Implant ComponentsASTM F983–86 (1996)

103 Standard Test Method for Pull-Out Fixation Strength of Metallic

Bone Staples

ASTM F1540–95

104 Standard Test Method for Corrosion of Surgical Instruments ASTM F1089–87 (1994)

105 Standard Specification for Wrought Cobalt-Chromium Alloy Surgical Fixation WireASTM F1091–91 (1996) E01

106 Standard Test Method for Determining Axial Pull-Out Strength

of Medical Bone Screws

ASTM F1691–96

107 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic CoatingsASTM F1147–99

108 Standard Test Method for Shear and Bending Fatigue Testing

of Calcium Phosphate and Metallic Medical Coatings

ASTM F1160–98

109 Standard Specification for Composition of Ceramic

Hydroxylapatite for Surgical Implants

ASTM F1185–88 (1993) E01

110 Standard Specification and Test Methods for Intramedullary

Fixation Devices

ASTM F1264–99

111 Standard Guide for Evaluating Modular Hip and Knee Joint

Components

ASTM F1814–97a

112 Standard Specification for Stainless Steel Surgical Fixation

Wire

ASTM F1350–91 (1996) E01

113 Standard Specification for Cobalt-28 Chromium-6 Molybdenum

Powder for Coating of Orthopedic Implants (UNS R30075)

ASTM F1377–98a

114 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies

Used in Spinal Arthrodesis Implants

ASTM F1798–97

115 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial

Tray Components of Total Knee Joint Replacements

ASTM F1800–97

116 Standard Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsASTM F1801–97

117 Implants for Surgery—Metallic Materials—Part 2: Unalloyed TitaniumISO 5832–2:1999

Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices 69029

Item

Number Title of Standard Reference Number and Date

118 Implants for Surgery—Metallic Materials—Part 9: Wrought High

Nitrogen Stainless Steel

ISO 5832–9: 1995

119 Implants for Surgery—Ultra-high-Molecular-Weight Polyethylene—Part 2: Moulded FormsISO 5834–2: 1998

120 Standard Specification and Test Method for Metallic Bone

Plates

ASTM F0382–99

121 Implants for Surgery—Femoral and Tibial Components for Partial and Total Knee Joint Prosthesis—Part 1: Classification,

Definitions and Designation of Dimensions—Second Edition

ISO 7207–1: 1994

122 Implants for Surgery—Components for Partial and Total Knee

Joint Prosthesis—Part 2: Articulating Surfaces Made of

Metal, Ceramic and Plastics Materials

ISO 7207–2: 1994

Radiology

50 Standard for Safety of Photographic Equipment—Fourth Edition UL–122

51 Standard for Safety: X-ray Equipment—Seventh Edition UL–187

52 Standard for Safety: Medical and Dental Equipment—Fourth

Edition

UL–544

53 Radiation Protection—Sealed Radioactive Sources—General

Requirements and Classification

ISO 2919 (1999)

54 Medical Electrical Equipment—Part 2: Particular Requirements

for the Safety of Therapeutic X-ray Equipment Operating in

the Range 10kV to 1MV

IEC 60601–2–8 (1999–04)

55 Medical Electrical Equipment—Part 2: Particular Requirements

for the Safety of Radiotherapy Simulators

IEC 60601–2–29 (1999–01)

56 Medical Electrical Equipment—Dosimeters with Ionization

Chambers and/or Semi-Conductor Detectors as used in Xray Diagnostic Imaging

IEC 61674–1997

57 Medical Electrical Equipment—Dosimeters with Ionization

Chambers as used in Radiotherapy

IEC 60731–1997

58 Classification of Sealed Radioactive Sources ANSI/HPS N43.6–1997

59 Radiotherapy Simulators—Functional Performance Characteristics—First EditionIEC 61168: 1993

60 Radiotherapy Equipment—Coordinates, Movements, and

Scales

IEC 1217–1996

Software

4 Software in Programmable Components ANSI/UL 1998

5 Standard for Developing Software Life Cycle Processes IEEE 1074: 1997

6 Standard for Software Verification and Validation IEEE 1012: 1998

Sterility

38 Automatic General Purpose Ethylene Oxide Sterilizers and

Ethylene Oxide Sterilant Sources Intended for Use in Health

Care Facilities, Third Edition

ANSI/AAMI ST 24: 1999

39 Biological Indicator for Dry-Heat Sterilization, Paper Strip USP 24: 2000

40 Biological Indicator for Ethylene Oxide Sterilization, Paper Strip USP 24: 2000

41 Biological Indicator for Steam Sterilization, Paper Strip USP 24: 2000

42 Microbial Limits Test <61> USP 24: 2000

43 Microbiological Tests, Sterility Tests <71> USP 24: 2000

44 Biological Tests and Assays, Bacterial Endotoxin Test (LAL)

<85>

USP 24: 2000

45 Pyrogen Test (USP Rabbit Test) <151> USP 24: 2000

46 Sterilization and Sterility Assurance of Compendial Articles

<1211>

USP 24: 2000

47 Flash Sterilization: Steam Sterilization of Patient Care Items for

Immediate Use

ANSI/AAMI ST37: 1996

48 Table-Top Dry Heat (Heated Air) Sterilization and Sterility Assurance in Dental and Medical FacilitiesANSI/AAMI ST40: 1992/(R) 1998

49 Ethylene Oxide Sterilization in Health Care Facilities: Safety

and Effectiveness

ANSI/AAMI ST41: 1999

50 Steam Sterilization and Sterility Assurance Using Table-Top

Sterilizers in Office-Based, Ambulatory-Care Medical, Surgical, and Dental Facilities

ANSI/AAMI ST42: 1998

51 Safe Use and Handling of Glutaraldehyde-Based Products in

Health Care Facilities

ANSI/AAMI ST58: 1996

52 Biological Indicators Part 1: General Requirements Sterilization

of Health Care Products

ANSI/AAMI ST59: 1999

69030 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices

Item

Number Title of Standard Reference Number and Date

53 Sterilization of Health Care Products—Chemical Indicators—

Part 2: Class 2 Indicators for Air Removal Test Sheets and

Packs

ANSI/AAMI ST66: 1999

54 Sterilization of Medical Devices—Microbiological Methods—

Part 2: Tests of Sterility Performed in the Validation of a

Sterilization Process

ANSI/AAMI/ISO 11737–2: 1998

55 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin—Validation and Routine Control of

Sterilization by Liquid Chemical Sterilants

ANSI/AAMI/ISO 14160: 1998

56 Standard Test Method for Determination of Leaks in Flexible

Packaging by Bubble Emission

ASTM D3078: 1994

57 Standard Practice for Performance Testing of Shipping Containers and SystemsASTM D4169: 1999

58 Standard Test Method for Seal Strength of Flexible Barrier MaterialsASTM F88: 1999

59 Standard Test Methods for Failure Resistance of Unrestrained

and Nonrigid Packages for Medical Applications

ASTM F1140: 1996

60 Standard Terminology Relating to Barrier Materials for Medical

Packaging

ASTM F1327: 1998

61 Standard Guide for Integrity Testing of Porous Barrier Medical

Packages

ASTM F1585: 1995

62 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)ASTM F1608: 1995

63 Standard Test Method for Determining Integrity of Seals for

Medical Packaging by Visual Inspection

ASTM F1886: 1998

64 Standard Test Method for Detecting Seal Leaks in Porous

Medical Packaging by Dye Penetration

ASTM F1929: 1998

65 Standard Guide for Accelerated Aging of Sterile Medical Device

Packages

ASTM F1980: 1999

66 Transfusion and Infusion Assemblies and Similar Medical Devices <161>USP 24: 2000

Dated: October 31, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–29165 Filed 11–14–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) publishes periodic summaries

of proposed projects being developed

for submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: Scholarship

Program for Students of Exceptional

Financial Need (EFN) and Program of

Financial Assistance for Disadvantaged

Health Professions Students (FADHPS):

Regulatory Requirements (OMB No.

0915–0028)—Reinstatement, with

change.

The EFN Scholarship Program,

authorized by section 736 of the Public

Health Service (PHS) Act, and the

FADHPS Program, authorized by section

740(a)(2)(F) of the PHS Act, provides

financial assistance to schools of

allopathic and osteopathic medicine

and dentistry for awarding tuition

scholarships to health professions

students who are of exceptional

financial need. To be eligible for

support under the FADHPS Program, a

student must also be from a

disadvantaged background. In return for

this support, students of allopathic and

osteopathic medicine must agree to

complete residency training in primary

care in 4 years, and practice in primary

care for 5 years after completing

residency training.

The program regulations contain

recordkeeping requirements designed to

ensure that schools maintain adequate

records for the Government to monitor

program activity and that funds are

spent as intended.

The estimate of burden for the

regulatory requirements of this

clearance are as follows: