Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 28499 

In its application for patent extension, 

this applicant seeks 1,062 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published is incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by July 20, 2007. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

November 19, 2007. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information 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. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: May 7, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–9720 Filed 5–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0195] 

Science Board to the Food and Drug 

Administration; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Science Board to 

the Food and Drug Administration 

(Science Board). 

General Function of the Committee: 

The Science Board provides advice 

primarily to the Commissioner of Food 

and Drugs and other appropriate 

officials on specific complex and 

technical issues as well as emerging 

issues within the scientific community 

in industry and academia. Additionally, 

the Science Board provides advice to 

the agency on keeping pace with 

technical and scientific evolutions in 

the fields of regulatory science, on 

formulating an appropriate research 

agenda, and on upgrading its scientific 

and research facilities to keep pace with 

these changes. It will also provide the 

means for critical review of agency 

sponsored intramural and extramural 

scientific research programs. 

Date and Time: The meeting will be 

held on June 14, 2007, from 8 a.m. to 4 

p.m. 

Addresses: Electronic comments 

should be submitted to http:// 

www.fda.gov/dockets/ecomments. 

Select Docket No. 2007N–0195—

Science Board and follow prompts to 

submit your statement. Written 

comments should be submitted to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1066, Rockville, 

MD 20852, by close of business on June 

7, 2007. All comments received will be 

posted without change, including any 

personal information provided. 

Comments received on or before June 7, 

2007, will be provided to the committee 

before or at the meeting. 

Location: Holiday Inn Gaithersburg, 

Two Montgomery Village Ave., 

Gaithersburg, MD 20879, Grand 

Ballroom Conference Room. 

Contact Person: Carlos Pen ̃ a, Office of 

the Commissioner, Food and Drug 

Administration (HF–33), 5600 Fishers 

Lane, Rockville, Maryland, 20857, 301–

827–6687, carlos.Pen ̃ a@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512603. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The Science Board will hear 

about and discuss the agency’s 

bioinformatics initiative and fellowship 

program. The Science Board will then 

continue their discussion of the review 

of both the agency’s science programs 

and the National Antimicrobial 

Resistance Monitoring System (NARMS) 

Program, from the March 31, 2006, 

Science Board meeting. Discussions will 

first include a subcommittee update to 

the Science Board on the progress of the 

review of the agency’s science programs. 

The Science Board will then hear about 

and discuss the subcommittee review of 

the NARMS Program including the 

public meeting regarding the NARMS 

Program on April 10, 2007, and 

subsequent deliberations. The Science 

Board will also hear about and discuss 

the agency’s updates on drug safety, 

post approval surveillance, and food 

safety. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2007 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before May 31, 2007. Two 

oral presentations from the public will 

be scheduled between approximately 11 

a.m. and 12 p.m. and 3:15 p.m. and 4:15 

p.m. Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before May 23, 

2007. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing sessions. The contact person 

will notify interested persons regarding 

their request to speak by May 24, 2007. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Carlos Pen ̃ a 

at least 7 days in advance of the 

meeting. 


pwalker on PROD1PC71 with NOTICES
28500 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: May 15, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–9737 Filed 5–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

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: 

017 

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: 017’’ (Recognition List 

Number: 017), 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 of ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 017’’ 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 selfaddressed adhesive labels to assist that 

office in processing your requests, or fax 

your request to 240–276–3151. 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.accessdata.fda.gov/ 

scripts/cdrh/cfdocs/cfTopic/ 

cdrhnew.cfm. See section VI of this 

document for electronic access to the 

searchable database for the current list 

of FDA recognized consensus standards, 

including Recognition List Number: 017 

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, 2098 Gaither 

Road, Rockville, MD 20850, 240–276–

0533. 

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 ‘‘Guidance on the 

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. 

Modifications to the initial list of 

recognized standards, as published in 

the Federal Register, are identified in 

table 1 of this document. 

TABLE 1. 

Federal Register Cite 

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) 

TABLE 1.—Continued 

Federal Register Cite 

June 18, 2004 (69 FR 34176) 

October 4, 2004 (69 FR 59240) 

May 27, 2005 (70 FR 30756) 

November 8, 2005 (70 FR 67713) 

March 31, 2006 (71 FR 16313) 

June 23, 2006 (71 FR 36121) 

November 3, 2006 (71 FR 64718) 

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: 017 

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: 017 to 

identify these current modifications. 

In Table 2 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. 


pwalker on PROD1PC71 with NOTICES