19972 Federal Register / Vol. 74, No. 82 / Thursday, April 30, 2009 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0196] 

Small Entity Compliance Guide: 

Bottled Water: Arsenic; 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: Arsenic—Small 

Entity Compliance Guide’’ for a final 

rule published in the Federal Register 

of June 9, 2005. 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 June 9, 2005 

(70 FR 33694), FDA issued a final rule 

amending its bottled water quality 

standard regulations by revising the 

existing allowable level for the 

contaminant arsenic. This final rule 

became effective on January 23, 2006. 

FDA examined the economic 

implications of the 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 

June 9, 2006, final rule set forth in 21 

CFR part 165 concerning the 

contaminant arsenic.