Science Board to the Food and Drug Administration; Notice of Meeting, 28499-28500 [E7-9737]

Download as PDF Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 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. pwalker on PROD1PC71 with NOTICES 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, VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 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 https:// 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 Pena, Office of the Commissioner, Food and Drug Administration (HF–33), 5600 Fishers Lane, Rockville, Maryland, 20857, 301– ˜ 827–6687, carlos.Pena@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. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 28499 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 https://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 Pena at least 7 days in advance of the meeting. E:\FR\FM\21MYN1.SGM 21MYN1 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. pwalker on PROD1PC71 with NOTICES 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 VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 INFORMATION CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.gov. This document may also be accessed on FDA’s Internet site at https://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. PO 00000 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) Frm 00039 Fmt 4703 Sfmt 4703 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. E:\FR\FM\21MYN1.SGM 21MYN1

Agencies

[Federal Register Volume 72, Number 97 (Monday, May 21, 2007)]
[Notices]
[Pages 28499-28500]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9737]


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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 https://
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 Pe[ntilde]a, Office of the Commissioner, 
Food and Drug Administration (HF-33), 5600 Fishers Lane, Rockville, 
Maryland, 20857, 301-827-6687, carlos.Pe[ntilde]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 https://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 Pe[ntilde]a 
at least 7 days in advance of the meeting.

[[Page 28500]]

    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

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