Small Entity Compliance Guide: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Availability, 41089-41090 [E8-16396]

Download as PDF 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 41090 Federal Register / Vol. 73, No. 138 / Thursday, July 17, 2008 / Notices Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use. This final rule became effective April 12, 2004. FDA examined the economic implementation of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601–602) and determined that the final rule would have a significant economic impact on a substantial number of small entities. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104–121), FDA is making available this SECG stating in plain language the requirements of the regulation. FDA is issuing this SECG as a level 2 guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the agency’s current thinking on this subject. 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. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this SECG. 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. The SECG and 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. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.cfsan.fda.gov/guidance.html. VerDate Aug<31>2005 21:03 Jul 16, 2008 Jkt 214001 Dated: July 10, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–16396 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–2008–N–0361] Small Entity Compliance Guide: Standard of Identity for White Chocolate; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of October 4, 2002 (67 FR 62171). This SECG entitled ‘‘Standard of Identity for White Chocolate’’ 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 Office of Nutrition, Labeling, and Dietary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Geraldine June, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2371. SUPPLEMENTARY INFORMATION: FDA examined the economic implementation of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601–602) and determined that the final rule would have a significant economic impact on a substantial number of small entities. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104–121), FDA is making this SECG available by stating, in plain language, the requirements of the regulation. FDA is issuing this SECG as level 2 guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the agency’s current thinking on this subject. 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. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this SECG. Submit a single copy of electronic comments to 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. The SECG and 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. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.cfsan.fda.gov/guidance.html. I. Background In the Federal Register of October 4, 2002, FDA issued a final rule establishing a standard of identity for white chocolate. That final rule became effective January 1, 2004. Dated: July 10, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–16394 Filed 7–16–08; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1

Agencies

[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Notices]
[Pages 41089-41090]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16396]


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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,

[[Page 41090]]

Drug, and Cosmetic Act because they present an unreasonable risk of 
illness or injury under the conditions of use recommended or suggested 
in labeling, or if no conditions of use are suggested or recommended in 
labeling, under ordinary conditions of use. This final rule became 
effective April 12, 2004.
    FDA examined the economic implementation of the final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-602) and 
determined that the final rule would have a significant economic impact 
on a substantial number of small entities. In compliance with section 
212 of the Small Business Regulatory Enforcement Fairness Act (Public 
Law 104-121), FDA is making available this SECG stating in plain 
language the requirements of the regulation.
    FDA is issuing this SECG as a level 2 guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). The 
SECG represents the agency's current thinking on this subject. 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.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this SECG.
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. The SECG and 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.cfsan.fda.gov/guidance.html.

    Dated: July 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16396 Filed 7-16-08; 8:45 am]
BILLING CODE 4160-01-S

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