Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device; Availability, 32299-32300 [E7-11235]

Download as PDF Federal Register / Vol. 72, No. 112 / Tuesday, June 12, 2007 / Notices Time And Date: 8:30 a.m.–5 p.m., July 11, 2007 (Closed). Place: CDC Roybal Campus, 1600 Clifton Road, Bldg. 19, Conference Room 232, Auditorium B2, Atlanta, GA 30333, Telephone (404) 639–8838. Status: The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of the ‘‘DGA International Laboratory Branch Review Panel, and the Extramural Review of Intramural Operational Research.’’ Contact Person for More Information: Deborah Birx, Global AIDS Program, Director, CDC, Corporate Square, Bldg. 1, Room 1506, Mail Stop E–04, Atlanta, GA 30329, Telephone (404) 639–6137. 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 CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 6, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7–11280 Filed 6–11–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel; Occupational Safety and Health Research, Program Announcement (PA) 07–318, and Exploratory Developmental Grants, PA PAR–06–552 cprice-sewell on PROD1PC67 with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee: Time and Date: 9 a.m.–5 p.m., July 11, 2007 (Closed). Place: Marriott Waterfront, 700 Aliceanna Street, Baltimore, MD 21202. Status: The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of research grant applications in response to PA 07–318, ‘‘Occupational Safety VerDate Aug<31>2005 11:38 Jun 11, 2007 Jkt 211001 and Health Research,’’ and PAR 06–552, ‘‘Exploratory Developmental Grants.’’ Contact Person for More Information: Stephen Olenchock, Ph.D., Scientific Review Administrator, 1095 Willowdale Road, Morgantown, WV 26506, telephone 304.285.6271. 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 CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 6, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services, Office Centers for Disease Control and Prevention [FR Doc. E7–11288 Filed 6–11–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health (NIOSH), Safety and Occupational Health Study Section (SOHSS) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee: Times and Dates: 8 a.m.–5 p.m., June 28, 2007 (Closed). 8 a.m.–5 p.m., June 29, 2007 (Closed). Place: Embassy Suites Hotel, 1900 Diagonal Road, Alexandria, Virginia 22314, telephone 703–684–5900, fax 703–684–1403. Purpose: The Safety and Occupational Health Study Section will review, discuss, and evaluate grant application(s) received in response to the Institute’s standard grants review and funding cycles pertaining to research issues in occupational safety and health, and allied areas. It is the intent of NIOSH to support broadbased research endeavors in keeping with the Institute’s program goals. This will lead to improved understanding and appreciation for the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to support more focused research projects, which will lead to improvements in the delivery of occupational safety and health services, and the prevention of work-related injury and illness. It is anticipated that research funded will promote these program goals. Matters To Be Discussed: The meeting will convene to address matters related to the conduct of Study Section business and for the study section to consider safety and occupational health-related grant applications. These portions of the meeting will be closed to the public in accordance PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 32299 with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, Centers for Disease Control and Prevention, pursuant to Section 10(d) Public Law 92–463. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Price Connor, PhD, NIOSH Health Scientist, 1600 Clifton Road, NE., Mailstop E–20, Atlanta, Georgia 30333, telephone 404–498–2511, fax 404–498–2571. 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 CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 5, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7–11281 Filed 6–11–07; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0020] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ‘‘Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.’’ It was developed as a special control to support the reclassification of intervertebral body fusion devices that contain bone grafting material from class III (premarket approval) into class II (special controls). The guidance document describes a means by which these intervertebral body fusion devices may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify the intervertebral body fusion device that contain bone grafting material from class III into class II (special controls) and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III. DATES: Submit written or electronic comments on this guidance at any time. E:\FR\FM\12JNN1.SGM 12JNN1 32300 Federal Register / Vol. 72, No. 112 / Tuesday, June 12, 2007 / Notices cprice-sewell on PROD1PC67 with NOTICES General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Class II Special Controls Guidance Document: Intervertebral Body Fusion Device’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240–276– 3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jodi N. Anderson, Center for Devices and Radiological Health (HFZ–410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3680. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 9, 2006 (71 FR 6778), FDA announced the availability of the draft guidance document entitled ‘‘Class II Special Controls Guidance Document: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.’’ Interested persons were invited to comment on the draft guidance document by May 10, 2006. In the same Federal Register (71 FR 6710), FDA published a proposed rule to reclassify the intervertebral body fusion devices that contain bone grafting material, from class III (premarket approval) into class II (special controls), and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III. FDA received twelve comments on the proposed rule and draft guidance. Ten comments were on the proposed rule and are addressed in the final rule published elsewhere in this issue of the Federal Register. The two comments on the draft guidance suggested that FDA clarify its discussion of device sterilization and mechanical testing. FDA has updated the guidance to clarify its recommendations about these two topics. VerDate Aug<31>2005 11:38 Jun 11, 2007 Jkt 211001 II. Significance of Guidance V. Comments This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on intervertebral body fusion devices. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive ‘‘Class II Special Controls Guidance Document: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240–276–3151 to receive a hard copy. Please use the document number 1540 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485. PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 Dated: May 31, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7–11235 Filed 6–11–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2007–27657] Cooperative Research and Development Agreement: Command Center Decision Support Tools and Concept of Operations Coast Guard, DHS. Notice of intent; request for public comments. AGENCY: ACTION: SUMMARY: The Coast Guard announces its intent to enter into a Cooperative Research and Development Agreement (CRADA) with Raytheon Corporation’s Mission Innovation Group, to identify and investigate, via currently available modeling and simulation techniques, the potential of conceptual Next Generation, Command Center Decision Support Tools and Concept of Operations (CONOPS) for enhancing maritime security. The Coast Guard invites public comment on the proposed CRADA and also invites other nonFederal participants, who have the interest and capability to bring similar in-kind contributions to this type of research, to be considered for entry into similar CRADAs. DATES: Comments and related material on the proposed CRADA, and preliminary inquiries about participation in CRADAs, must reach the Docket Management Facility on or before July 12, 2007. Proposals from other potential, non-Federal CRADA participants must reach the Docket Management Facility on or before December 10, 2007. E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 72, Number 112 (Tuesday, June 12, 2007)]
[Notices]
[Pages 32299-32300]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11235]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0020]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Intervertebral Body Fusion 
Device; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: Intervertebral Body Fusion Device.'' It was 
developed as a special control to support the reclassification of 
intervertebral body fusion devices that contain bone grafting material 
from class III (premarket approval) into class II (special controls). 
The guidance document describes a means by which these intervertebral 
body fusion devices may comply with the requirement of special controls 
for class II devices. Elsewhere in this issue of the Federal Register, 
FDA is publishing a final rule to reclassify the intervertebral body 
fusion device that contain bone grafting material from class III into 
class II (special controls) and retain those that contain any 
therapeutic biologic (e.g., bone morphogenic protein) in class III.

DATES: Submit written or electronic comments on this guidance at any 
time.

[[Page 32300]]

General comments on agency guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Intervertebral Body Fusion Device'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (HFZ-220), Center 
for Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jodi N. Anderson, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3680.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 9, 2006 (71 FR 6778), FDA 
announced the availability of the draft guidance document entitled 
``Class II Special Controls Guidance Document: Class II Special 
Controls Guidance Document: Intervertebral Body Fusion Device.'' 
Interested persons were invited to comment on the draft guidance 
document by May 10, 2006.
    In the same Federal Register (71 FR 6710), FDA published a proposed 
rule to reclassify the intervertebral body fusion devices that contain 
bone grafting material, from class III (premarket approval) into class 
II (special controls), and retain those that contain any therapeutic 
biologic (e.g., bone morphogenic protein) in class III. FDA received 
twelve comments on the proposed rule and draft guidance. Ten comments 
were on the proposed rule and are addressed in the final rule published 
elsewhere in this issue of the Federal Register. The two comments on 
the draft guidance suggested that FDA clarify its discussion of device 
sterilization and mechanical testing. FDA has updated the guidance to 
clarify its recommendations about these two topics.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on intervertebral body fusion devices. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute 
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Class II Special Controls 
Guidance Document: Class II Special Controls Guidance Document: 
Intervertebral Body Fusion Device'' you may either send an e-mail 
request to dsmica@fda.hhs.gov to receive an electronic copy of the 
document or send a fax request to 240-276-3151 to receive a hard copy. 
Please use the document number 1540 to identify the guidance you are 
requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http:/
/www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807, subpart E 
have been approved under OMB control number 0910-0120; and the 
collections of information in 21 CFR part 801 have been approved under 
OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: May 31, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-11235 Filed 6-11-07; 8:45 am]
BILLING CODE 4160-01-S

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