23032 Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices

review in 2002 by the IOM’s Immunization

Safety Review Committee. This will be the

first opportunity for the public to provide

comments on the hypotheses that are being

considered for future review.

Agenda items are subject to change as

priorities dictate. A complete meeting

agenda of the Subcommittee on

VaccineSafety and Communications can

be found on the NationalVaccine

Program Office’s web site at

www.cdc.gov/od/nvpo/calendar.

CONTACT PERSON FOR MORE INFORMATION:

Ms. Shaunette Crawford, Associate

Director for Health Communications

and Legislation, NVPO, CDC, 1600

Clifton Road, NE, M/S D–66, Atlanta,

Georgia 30333, telephone 404/687–

6672.

The Director, Management Analysis

and Services Office, has been delegated

the authority to sign Federal Register

Notices pertaining to announcements of

meetings and other committee

management activities, for both the

Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: May 1, 2001.

John Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention.

[FR Doc. 01–11371 Filed 5–4–01; 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:

005

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: 005’’ (Recognition List

Number: 005) will assist manufacturers

who elect to declare conformity with

consensus standards to meet certain

requirements for medical devices.

DATES: Submit written comments

concerning this document 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

‘‘Modification to the List of Recognized

Standards, Recognition List Number:

005,’’ to the Division of Small

Manufacturers 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 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

database for the current list of ‘‘FDA

Recognized Consensus Standards,’’

including Recognition List Number: 005

modifications, and other standards

related information.

FOR FURTHER INFORMATION CONTACT: To

comment on this document and/or to

recommend additional standards for

recognition: Carol L. Herman, Center for

Devices and Radiological Health (HFZ–

84), Food and Drug Administration,

2094 Gaither Rd., Rockville, MD 20850,

301–594–4766, ext. 156.

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 the 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), July

12, 1999 (64 FR 37546), and November

15, 2000 (65 FR 69022), 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 database

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: 005

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

database. FDA will use the term

‘‘Recognition List Number: 005’’ to

identify: (1) Supplementary information

sheets for standards added to the list for

the first time, (2) standards added to

replace withdrawn standards, and (3)

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, amended, or different

standards.

In this section, FDA describes

modifications that involve the

withdrawal of standards and their

replacement by others. In this notice, all

changes of this type are in the sterility

category of the complete list of

recognized standards.

1. ASTM–F1140:1996 is withdrawn

under previous item 59. ASTM–

F1140:2000 is added under current item

67.

2. ASTM–F1585:1995 is withdrawn

under previous item 61. ASTM

F1585:2000 is added under current item

68.

3. ASTM–1608:1995 is withdrawn

under previous item 62. ASTM

F1608:2000 is added under current item

69.

III. 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

Intranet site at http://

Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices 23033

www.acessdata.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.

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

standards, (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 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:

005’’ 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 database 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 Number: 005.’’

The recognition of standards

announced in this notice of

modifications will become effective on

May 7, 2001.

VII. 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: 005, is as follows:

Item

Number Title of Standards Reference Numberand Date

Anesthesia

34 Standard Test Method for Evaluation the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used

for Medical and Emergency Applications

ASTM PS127:2000

Cardiovascular/Neurology

31 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Applications ASTM F647–94

32 Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips ASTM F1542–94

(2000)

33 Neurosurgical Implants–Sterile, Single-Use Hydrocephalus Shunts and Components ISO 7197:1997

General

25 Standard for the Development of an Electrostatic Discharge Control Program ANSI/ESD S20.20–

1999

26 Medical Devices–Application of Risk Management to Medical Devices ISO 14971:2000

Sterility

67 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical

Applications

ASTM F1140:2000

68 Standard Guide for Integrity Testing of Porous Barrier Medical Packages ASTM F1585:2000

69 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) ASTM F1608:2000

23034 Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices

Dated: April 24, 2001.

David W. Feigal, Jr.,

Director, Center for Devices and Radiological

Health.

[FR Doc. 01–11329 Filed 5–4–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission for OMB Review;

Comment Request; Application for the

Pharmacology Research Associate

Program

SUMMARY: Under the provisions of

Section 3507(a)(1)(D) of the Paperwork

Reduction Act of 1995, the National

Institute of General Medical Sciences

(NIGMS), the National Institutes of

Health (NIH) has submitted to the Office

of Management and Budget (OMB) a

request to review and approve the

information collection listed below.

This proposed information collection

was previously published in the Federal

Register on February 6, 2001, pages

9089–9090, and allowed 60 days for

public comment. No public comments

were received. The purpose of this

notice is to allow an additional 30 days

for public comment. The National

Institutes of Health may not conduct or

sponsor, and the respondent is not

required to respond to, an information

collection that has been extended,

revised, or implemented on or after

October 1, 1995, unless it displays a

currently valid OMB control number.

Proposed Collection: Title:

Application for the Pharmacology

Research Associate Program. Type of

Information Collection Request:

Extension of a currently approved

collection. Need and Use of Information

Collection: The Pharmacology Research

Associate (PRAT) Program will use the

applicant and referee information to

award opportunities for training and

experience in laboratory or clinical

investigation to individuals with a PhD.

degree in pharmacology or a related

science, M.D., or other professional

degree through appointments as PRAT

Fellows at the National Institutes of

Health or the Food and Drug

Administration. The goal of the program

is to develop leaders in pharmacological

research for key positions in academic,

industrial, and Federal research

laboratories. Frequency of Response:

Once a year. Affected Public:

Individuals or households; Businesses

or other for-profit.

The annual reporting burden is as

follows:

Type and numbers of respondents

Estimated

number of

responses per

respondent

Estimated total

responses

Average

burden hours

per

responses

Estimated total

annual burden

hours requested

Applicants—50 ................................................................................................. 1 50 2.00 100

Referees—150 ................................................................................................. 1 150 0.167 25

Total Number of Respondents: 200

Total Number of Responses: 200

Total Hours: 125

The annualized cost to respondents is

estimated at:

Applicants: $5,500.00

Referees: $1,250.00

There are no Capital Costs, Operating

Costs, and/or Maintenance Costs to

report.

Request for Comments:

Written comments and/or suggestions

from the public and affected agencies

should address one or more of the

following points: (1) Evaluate whether

the proposed collection of information

is necessary for the proper performance

of the function of the agency, including

whether the information will have

practical utility; (2) Evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) Enhance the quality, utility, and

clarity of the information to be

collected; and (4) Minimize the burden

of the collection of information on those

who are to respond, including the use

of appropriate automated, electronic,

mechanical or other technological

collection techniques or other forms of

information technology.

Direct Comments to OMB: Written

comments and/or suggestions regarding

the item(s) contained in this notice,

especially regarding the estimated

public burden and associated response

time, should be directed to the: Office

of Management and Budget, Office of

Regulatory Affairs, New Executive

Office Building, Room 10235,

Washington, D.C. 20503, Attention:

Desk Officer for NIH. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact: Ms.

Sally Lee, NIGMS, NIH, Natcher

Building, Room 2AN–18H, 45 Center

Drive, MSC 6200, Bethesda, MD 20892–

6200. Phone (301) 594–2755, facsimile

(301) 402–0156, or electronic mail:

LeeS@nigms.nih.gov.

Comments Due Date:

Comments regarding this information

collection are best assured of having

their full effect if received within 30

days of the date of this publication.

Dated: April 30, 2001.

Martha Pine,

Associated Director for Administration and

Operations, National Institute of General

Medical Sciences.

[FR Doc. 01–11392 Filed 5–4–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission for OMB Review;

Comment Request; Case-Cohort Study

of Cancer and Related Disorders

Among Benzene-Exposed Workers in

China

SUMMARY: Under the provisions of

Section 3507(a)(1)(D) of the Paperwork

Reduction Act of 1995, the National

Cancer Institute (NCI), the National

Institutes of Health (NIH) has submitted

to the Office of Management and Budget

(OMB) a request for review and

approval of the information collection

listed below. This proposed information

collection was previously published in

the Federal Register on December 28,

2000, pages 82382–82383 and allowed

60 days for public comment. No public

comments were received. The purpose

of this notice is to allow an additional

30 days for public comment. The

National Institutes of Health may not

conduct or sponsor, and the respondent

is not required to respond to, an

information collection that has been

extended, revised, or implemented on or

after October 1, 1995, unless it displays

a currently valid OMB control number.

Proposed Collection: Title: CaseCohort (formerly Case-Control) Study of

Cancer and Related Disorders Among