[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]]

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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.

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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