[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Notices]
[Pages 41089-41090]
From the Federal Register Online via the Government Publishing 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.
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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