[Federal Register Volume 74, Number 82 (Thursday, April 30, 2009)]
[Notices]
[Page 19972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9867]
[[Page 19972]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0195]
Small Entity Compliance Guide: Bottled Water: Uranium;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Bottled Water:
Uranium--Small Entity Compliance Guide'' for a direct final rule
published in the Federal Register of March 3, 2003. This small entity
compliance guide (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 requests for single copies of the SECG to the
Division of Plant and Dairy Food Safety (HFS-317), Office of Food
Safety, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax
your request to 301-436-2651. Send one self-addressed adhesive label to
assist that office in processing your request.
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. See the SUPPLEMENTARY INFORMATION
section for electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT: Paul South, Center for Food Safety and
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 301-436-1640.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 3, 2003 (68 FR 9873), FDA issued a
direct final rule amending its bottled water quality standard
regulations by establishing an allowable level for the contaminant
uranium. FDA also retained the existing allowable levels for combined
radium-226/-228, gross alpha particle radioactivity, and beta particle
and photon radioactivity. On June 9, 2003, FDA confirmed the effective
date of December 8, 2003, for the direct final rule (68 FR 34272).
FDA examined the economic implications of the direct final rule as
required by the Regulatory Flexibility Act (5. U.S.C. 601-612) and
determined that the 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
legal requirements of the March 3, 2003, direct final rule set forth in
21 CFR part 165 concerning the contaminant uranium.
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 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.
II. 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. 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.cfsan.fda.gov/guidance.html.
Dated: April 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9867 Filed 4-29-09; 8:45 am]
BILLING CODE 4160-01-S