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Federal Register / Vol. 72, No.

112 / Tuesday, June 12, 2007 / Notices 32299

Time And Date: 8:30 a.m.–5 p.m., July 11, and Health Research,’’ and PAR 06–552, with provisions set forth in Section
2007 (Closed). ‘‘Exploratory Developmental Grants.’’ 552b(c)(4) and (6), Title 5 U.S.C., and the
Place: CDC Roybal Campus, 1600 Clifton Contact Person for More Information: Determination of the Director, Management
Road, Bldg. 19, Conference Room 232, Stephen Olenchock, Ph.D., Scientific Review Analysis and Services Office, Centers for
Auditorium B2, Atlanta, GA 30333, Administrator, 1095 Willowdale Road, Disease Control and Prevention, pursuant to
Telephone (404) 639–8838. Morgantown, WV 26506, telephone Section 10(d) Public Law 92–463.
Status: The meeting will be closed to the 304.285.6271. Agenda items are subject to change as
public in accordance with provisions set The Director, Management Analysis and priorities dictate.
forth in section 552b(c)(4) and (6), Title 5 Services Office, has been delegated the Contact Person for More Information: Price
U.S.C., and the Determination of the Director, authority to sign Federal Register notices Connor, PhD, NIOSH Health Scientist, 1600
Management Analysis and Services Office, pertaining to announcements of meetings and Clifton Road, NE., Mailstop E–20, Atlanta,
CDC, pursuant to Public Law 92–463. other committee management activities, for Georgia 30333, telephone 404–498–2511, fax
Matters To Be Discussed: The meeting will both CDC and the Agency for Toxic 404–498–2571.
include the review, discussion, and Substances and Disease Registry. The Director, Management Analysis and
evaluation of the ‘‘DGA International Services Office, has been delegated the
Laboratory Branch Review Panel, and the Dated: June 6, 2007. authority to sign Federal Register notices
Extramural Review of Intramural Operational Elaine L. Baker, pertaining to announcements of meetings and
Research.’’ Acting Director, Management Analysis and other committee management activities for
Contact Person for More Information: Services, Office Centers for Disease Control both CDC and the Agency for Toxic
Deborah Birx, Global AIDS Program, Director, and Prevention Substances and Disease Registry.
CDC, Corporate Square, Bldg. 1, Room 1506, [FR Doc. E7–11288 Filed 6–11–07; 8:45 am] Dated: June 5, 2007.
Mail Stop E–04, Atlanta, GA 30329, Elaine L. Baker,
BILLING CODE 4163–18–P
Telephone (404) 639–6137.
The Director, Management Analysis and Acting Director, Management Analysis and
Services Office, has been delegated the Services Office, Centers for Disease Control
authority to sign Federal Register notices DEPARTMENT OF HEALTH AND and Prevention.
pertaining to announcements of meetings and HUMAN SERVICES [FR Doc. E7–11281 Filed 6–11–07; 8:45 am]
other committee management activities, for BILLING CODE 4163–19–P
both CDC and the Agency for Toxic Centers for Disease Control and
Substances and Disease Registry. Prevention
Dated: June 6, 2007. DEPARTMENT OF HEALTH AND
National Institute for Occupational HUMAN SERVICES
Elaine L. Baker, Safety and Health (NIOSH), Safety and
Acting Director, Management Analysis and Occupational Health Study Section Food and Drug Administration
Services Office, Centers for Disease Control (SOHSS)
and Prevention. [Docket No. 2006D–0020]
[FR Doc. E7–11280 Filed 6–11–07; 8:45 am] In accordance with section 10(a)(2) of
BILLING CODE 4163–18–P the Federal Advisory Committee Act Guidance for Industry and Food and
(Pub. L. 92–463), the Centers for Disease Drug Administration Staff; Class II
Control and Prevention (CDC) Special Controls Guidance Document:
DEPARTMENT OF HEALTH AND announces the following meeting of the Intervertebral Body Fusion Device;
HUMAN SERVICES aforementioned committee: Availability
Times and Dates: AGENCY: Food and Drug Administration,
Centers for Disease Control and 8 a.m.–5 p.m., June 28, 2007 (Closed). HHS.
Prevention 8 a.m.–5 p.m., June 29, 2007 (Closed). ACTION: Notice.
Place: Embassy Suites Hotel, 1900
Disease, Disability, and Injury Diagonal Road, Alexandria, Virginia 22314, SUMMARY: The Food and Drug
Prevention and Control Special telephone 703–684–5900, fax 703–684–1403. Administration (FDA) is announcing the
Emphasis Panel; Occupational Safety Purpose: The Safety and Occupational availability of the guidance document
and Health Research, Program Health Study Section will review, discuss, entitled ‘‘Class II Special Controls
Announcement (PA) 07–318, and and evaluate grant application(s) received in
response to the Institute’s standard grants
Guidance Document: Intervertebral
Exploratory Developmental Grants, PA Body Fusion Device.’’ It was developed
PAR–06–552 review and funding cycles pertaining to
research issues in occupational safety and as a special control to support the
In accordance with section 10(a)(2) of health, and allied areas. reclassification of intervertebral body
the Federal Advisory Committee Act It is the intent of NIOSH to support broad- fusion devices that contain bone grafting
(Pub. L. 92–463), the Centers for Disease based research endeavors in keeping with the material from class III (premarket
Control and Prevention (CDC) Institute’s program goals. This will lead to approval) into class II (special controls).
announces the following meeting of the improved understanding and appreciation for The guidance document describes a
the magnitude of the aggregate health burden means by which these intervertebral
aforementioned committee: associated with occupational injuries and
Time and Date: 9 a.m.–5 p.m., July 11, illnesses, as well as to support more focused
body fusion devices may comply with
2007 (Closed). research projects, which will lead to the requirement of special controls for
Place: Marriott Waterfront, 700 Aliceanna improvements in the delivery of occupational class II devices. Elsewhere in this issue
Street, Baltimore, MD 21202. safety and health services, and the of the Federal Register, FDA is
Status: The meeting will be closed to the prevention of work-related injury and illness. publishing a final rule to reclassify the
public in accordance with provisions set It is anticipated that research funded will intervertebral body fusion device that
forth in section 552b(c)(4) and (6), Title 5 promote these program goals. contain bone grafting material from
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U.S.C., and the Determination of the Director, Matters To Be Discussed: The meeting will class III into class II (special controls)
Management Analysis and Services Office, convene to address matters related to the and retain those that contain any
CDC, pursuant to Public Law 92–463. conduct of Study Section business and for
Matters To Be Discussed: The meeting will the study section to consider safety and
therapeutic biologic (e.g., bone
include the review, discussion, and occupational health-related grant morphogenic protein) in class III.
evaluation of research grant applications in applications. These portions of the meeting DATES: Submit written or electronic
response to PA 07–318, ‘‘Occupational Safety will be closed to the public in accordance comments on this guidance at any time.

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32300 Federal Register / Vol. 72, No. 112 / Tuesday, June 12, 2007 / Notices

General comments on agency guidance II. Significance of Guidance V. Comments


documents are welcome at any time. This guidance is being issued Interested persons may submit to the
ADDRESSES: Submit written requests for consistent with FDA’s good guidance Division of Dockets Management (see
single copies of the guidance document practices regulation (21 CFR 10.115). ADDRESSES) written or electronic
entitled ‘‘Class II Special Controls The guidance represents the agency’s comments regarding this document.
Guidance Document: Intervertebral current thinking on intervertebral body Submit a single copy of electronic
Body Fusion Device’’ to the Division of fusion devices. It does not create or comments or two paper copies of any
Small Manufacturers, International, and confer any rights for or on any person mailed comments, except that
Consumer Assistance (HFZ–220), Center and does not operate to bind FDA or the individuals may submit one paper copy.
for Devices and Radiological Health, public. An alternative approach may be Comments are to be identified with the
Food and Drug Administration, 1350 used if such approach satisfies the docket number found in brackets in the
Piccard Dr., Rockville, MD 20850. Send requirements of the applicable statute heading of this document. Received
one self-addressed adhesive label to and regulations. comments may be seen in the Division
assist that office in processing your of Dockets Management between 9 a.m.
request, or fax your request to 240–276– III. Electronic Access
and 4 p.m., Monday through Friday.
3151. See the SUPPLEMENTARY Persons interested in obtaining a copy Dated: May 31, 2007.
INFORMATION section for information on of the draft guidance may do so by using
electronic access to the guidance. Linda S. Kahan,
the Internet. To receive ‘‘Class II Special
Submit written comments concerning Controls Guidance Document: Class II Deputy Director, Center for Devices and
this guidance to the Division of Dockets Radiological Health.
Special Controls Guidance Document:
Management (HFA–305), Food and Drug Intervertebral Body Fusion Device’’ you [FR Doc. E7–11235 Filed 6–11–07; 8:45 am]
Administration, 5630 Fishers Lane, rm. may either send an e-mail request to BILLING CODE 4160–01–S
1061, Rockville, MD 20852. Submit dsmica@fda.hhs.gov to receive an
electronic comments to http:// electronic copy of the document or send
www.fda.gov/dockets/ecomments. a fax request to 240–276–3151 to receive DEPARTMENT OF HOMELAND
Identify comments with the docket a hard copy. Please use the document SECURITY
number found in brackets in the number 1540 to identify the guidance
heading of this document. you are requesting. Coast Guard
FOR FURTHER INFORMATION CONTACT: Jodi CDRH maintains an entry on the [USCG–2007–27657]
N. Anderson, Center for Devices and Internet for easy access to information
Radiological Health (HFZ–410), Food including text, graphics, and files that Cooperative Research and
and Drug Administration, 9200 may be downloaded to a personal Development Agreement: Command
Corporate Blvd., Rockville, MD 20850, computer with Internet access. Updated Center Decision Support Tools and
240–276–3680. on a regular basis, the CDRH home page Concept of Operations
SUPPLEMENTARY INFORMATION: includes device safety alerts, Federal
Register reprints, information on AGENCY: Coast Guard, DHS.
I. Background premarket submissions (including lists ACTION: Notice of intent; request for
In the Federal Register of February 9, of approved applications and public comments.
2006 (71 FR 6778), FDA announced the manufacturers’ addresses), small
availability of the draft guidance manufacturer’s assistance, information SUMMARY: The Coast Guard announces
document entitled ‘‘Class II Special on video conferencing and electronic its intent to enter into a Cooperative
Controls Guidance Document: Class II submissions, Mammography Matters, Research and Development Agreement
Special Controls Guidance Document: and other device-oriented information. (CRADA) with Raytheon Corporation’s
Intervertebral Body Fusion Device.’’ The CDRH Web site may be accessed at Mission Innovation Group, to identify
Interested persons were invited to http://www.fda.gov/cdrh. A search and investigate, via currently available
comment on the draft guidance capability for all CDRH guidance modeling and simulation techniques,
document by May 10, 2006. documents is available at http:// the potential of conceptual Next
In the same Federal Register (71 FR www.fda.gov/cdrh/guidance.html. Generation, Command Center Decision
6710), FDA published a proposed rule Guidance documents are also available Support Tools and Concept of
to reclassify the intervertebral body on the Division of Dockets Management Operations (CONOPS) for enhancing
fusion devices that contain bone grafting Internet site at http://www.fda.gov/ maritime security. The Coast Guard
material, from class III (premarket ohrms/dockets. invites public comment on the proposed
approval) into class II (special controls), CRADA and also invites other non-
and retain those that contain any IV. Paperwork Reduction Act of 1995 Federal participants, who have the
therapeutic biologic (e.g., bone This guidance refers to previously interest and capability to bring similar
morphogenic protein) in class III. FDA approved collections of information in-kind contributions to this type of
received twelve comments on the found in FDA regulations. These research, to be considered for entry into
proposed rule and draft guidance. Ten collections of information are subject to similar CRADAs.
comments were on the proposed rule review by the Office of Management and DATES: Comments and related material
and are addressed in the final rule Budget (OMB) under the Paperwork on the proposed CRADA, and
published elsewhere in this issue of the Reduction Act of 1995 (the PRA) (44 preliminary inquiries about
Federal Register. The two comments on U.S.C. 3501–3520). The collections of participation in CRADAs, must reach
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the draft guidance suggested that FDA information in 21 CFR part 807, subpart the Docket Management Facility on or
clarify its discussion of device E have been approved under OMB before July 12, 2007. Proposals from
sterilization and mechanical testing. control number 0910–0120; and the other potential, non-Federal CRADA
FDA has updated the guidance to clarify collections of information in 21 CFR participants must reach the Docket
its recommendations about these two part 801 have been approved under Management Facility on or before
topics. OMB control number 0910–0485. December 10, 2007.

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