Medical Devices: Radiology Devices; Class II Special Controls Guidance Document: Bone Sonometers; Guidance for Industry and Food and Drug Administration Staff, 41088-41089 [E8-16094]

Download as PDF 41088 Federal Register / Vol. 73, No. 138 / Thursday, July 17, 2008 / Notices guidance is intended to assist sponsors in the preparation of the clinical/ biostatistical and human pharmacokinetic sections of a BLA. This guidance does not address additional sections of a BLA, such as chemistry, manufacturing, and controls and preclinical toxicology, for an IGIV product for this indication. In the Federal Register of December 1, 2005 (70 FR 72124), FDA announced the availability of the draft guidance of the same title dated November 2005. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. A summary of changes includes: Recommendations for compliance with the Pediatric Research Equity Act of 2007, refinements to the criteria for diagnosing serious infections, refinements to the recommended safety analyses of adverse experiences temporally related to infusions, and additional guidance on the methodology of pharmacokinetic studies. The guidance announced in this notice finalizes the draft guidance dated November 2005. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’s current thinking on this topic. 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 statutes and regulations. mstockstill on PROD1PC66 with NOTICES II. 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 (44 U.S.C. 3501– 3520). The collections of information regarding BLAs (21 CFR part 601) have been approved under OMB control number 0910–0338. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the guidance. 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. A copy of the guidance and received comments are available for public examination in the Division of VerDate Aug<31>2005 21:03 Jul 16, 2008 Jkt 214001 Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/cber/guidelines.htm or https://www.regulations.gov. Dated: July 11, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–16395 Filed 7–16–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2003–D–0434] (formerly Docket No. 2003D–0420) Medical Devices: Radiology Devices; Class II Special Controls Guidance Document: Bone Sonometers; Guidance for Industry and Food and Drug Administration Staff AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.’’ The guidance document describes a means by which bone sonometers 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 reclassifying these devices from class III (premarket approval) into class II (special controls). DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers’’ to the Division of Small Manufacturers, International, and Consumer Assistance PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one selfaddressed 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.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices and Radiological Health (HFZ–470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3666. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 15, 2006 (71 FR 7894), FDA’s Center for Devices and Radiological Health (CDRH) published a proposed rule to reclassify bone sonometers from class III (premarket approval) into class II (special controls) after reviewing current technological and scientific developments. Specifically, CDRH reviewed recent studies addressing performance characteristics of bone sonometers manufactured by different companies and determined that, when combined with mitigation measures to offset the risks of use associated with these devices, special controls would be adequate to assure the safety and effectiveness of bone sonometers. To support the reclassification, CDRH issued a draft class II special controls guidance document entitled ‘‘Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers’’ (71 FR 7976). Interested persons were invited to comment on the proposed rule and guidance by May 16, 2006, and the agency received three comments. The comments FDA received were supportive of the proposed reclassification, but made specific suggestions on the guidance’s content. The agency considered the suggestions and made appropriate revisions. FDA is now identifying the guidance document entitled ‘‘Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Bone Sonometers’’ as the guidance document that will E:\FR\FM\17JYN1.SGM 17JYN1 Federal Register / Vol. 73, No. 138 / Thursday, July 17, 2008 / Notices serve as the special control for these devices. The guidance document provides a means by which bone sonometers may comply with the requirement of special controls for class II devices. Following the effective date of the final reclassification rule, any firm submitting a premarket notification under section 510(k) of the act (21 U.S.C. 360(k)) for bone sonometers will need to address the issues covered in the special controls guidance document. However, the firm need only show that its device meets the recommendation of the guidance document or in some other way provides equivalent assurances of safety and effectiveness. mstockstill on PROD1PC66 with NOTICES II. Significance of the 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 bone sonometers. 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 guidance may do so by using the Internet. To receive ‘‘Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers,’’ you may either send an email 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 (1547) 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 at https://www.regulations.gov. VerDate Aug<31>2005 21:03 Jul 16, 2008 Jkt 214001 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 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 56 have been approved under OMB control number 0910–0130; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; the information collections in 21 CFR part 820 have been approved under OMB control number 0910–0073; and the information collections in 21 CFR parts 1002, 1003, and 1004 have been approved under OMB control number 0910–0025. 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. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. Dated: July 2, 2008. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E8–16094 Filed 7–16–08; 8:45 am] BILLING CODE 4160–01–S PO 00000 41089 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1995–N–0054] (formerly Docket No. 1995N–0304) Small Entity Compliance Guide: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing theavailability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of February 11, 2004 (69 FR 6788), entitled ‘‘Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk.’’ This SECG is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation. DATES: Submit written or electronic comments on the SECG at any time. ADDRESSES: Submit written comments on the SECG to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the SECG to https://www.regulations.gov. Submit written requests for single copies of the SECG to the Division of Dietary Supplement Programs, Office of Nutrition, Labeling, and Dietary Supplements (HFS–810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax your request to 301–436– 2639. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food Safety and Applied Nutrition (HFS–810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2375. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 11, 2004, FDA issued a final rule declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1

Agencies

[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Notices]
[Pages 41088-41089]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16094]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-D-0434] (formerly Docket No. 2003D-0420)


Medical Devices: Radiology Devices; Class II Special Controls 
Guidance Document: Bone Sonometers; Guidance for Industry and Food and 
Drug Administration Staff

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of availability.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Guidance for Industry and FDA 
Staff; Class II Special Controls Guidance Document: Bone Sonometers.'' 
The guidance document describes a means by which bone sonometers 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 reclassifying these devices from class III (premarket 
approval) into class II (special controls).

DATES:  Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES:  Submit written requests for single copies of the guidance 
document entitled ``Guidance for Industry and FDA Staff; Class II 
Special Controls Guidance Document: Bone Sonometers'' 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.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Robert A. Phillips, Center for 
Devices and Radiological Health (HFZ-470), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-
3666.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 15, 2006 (71 FR 7894), FDA's 
Center for Devices and Radiological Health (CDRH) published a proposed 
rule to reclassify bone sonometers from class III (premarket approval) 
into class II (special controls) after reviewing current technological 
and scientific developments. Specifically, CDRH reviewed recent studies 
addressing performance characteristics of bone sonometers manufactured 
by different companies and determined that, when combined with 
mitigation measures to offset the risks of use associated with these 
devices, special controls would be adequate to assure the safety and 
effectiveness of bone sonometers. To support the reclassification, CDRH 
issued a draft class II special controls guidance document entitled 
``Draft Guidance for Industry and FDA Staff; Class II Special Controls 
Guidance Document: Bone Sonometers'' (71 FR 7976). Interested persons 
were invited to comment on the proposed rule and guidance by May 16, 
2006, and the agency received three comments. The comments FDA received 
were supportive of the proposed reclassification, but made specific 
suggestions on the guidance's content. The agency considered the 
suggestions and made appropriate revisions. FDA is now identifying the 
guidance document entitled ``Guidance for Industry and FDA Staff: Class 
II Special Controls Guidance Document: Bone Sonometers'' as the 
guidance document that will

[[Page 41089]]

serve as the special control for these devices.
    The guidance document provides a means by which bone sonometers may 
comply with the requirement of special controls for class II devices. 
Following the effective date of the final reclassification rule, any 
firm submitting a premarket notification under section 510(k) of the 
act (21 U.S.C. 360(k)) for bone sonometers will need to address the 
issues covered in the special controls guidance document. However, the 
firm need only show that its device meets the recommendation of the 
guidance document or in some other way provides equivalent assurances 
of safety and effectiveness.

II. Significance of the 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 bone sonometers. 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 guidance may do so by 
using the Internet. To receive ``Guidance for Industry and FDA Staff; 
Class II Special Controls Guidance Document: Bone Sonometers,'' 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 (1547) 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 at https://www.regulations.gov.

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 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 56 have been approved under 
OMB control number 0910-0130; the collections of information in 21 CFR 
part 801 have been approved under OMB control number 0910-0485; the 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; the information collections in 21 CFR part 820 have 
been approved under OMB control number 0910-0073; and the information 
collections in 21 CFR parts 1002, 1003, and 1004 have been approved 
under OMB control number 0910-0025.

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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at https://www.regulations.gov.

    Dated: July 2, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-16094 Filed 7-16-08; 8:45 am]
BILLING CODE 4160-01-S

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