
[Federal Register: July 17, 2008 (Volume 73, Number 138)]
[Notices]               
[Page 41089-41090]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jy08-85]                         

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

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 http://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 http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://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
