Small Entity Compliance Guide: Bottled Water: Arsenic; Availability, 19972-19973 [E9-9870]

Download as PDF 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 https://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). VerDate Nov<24>2008 15:35 Apr 29, 2009 Jkt 217001 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. 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. 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. 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 https://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: III. Electronic Access I. Background Persons with access to the Internet may obtain the document at https:// www.cfsan.fda.gov/guidance.html. 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. II. Comments 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. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\30APN1.SGM 30APN1 Federal Register / Vol. 74, No. 82 / Thursday, April 30, 2009 / Notices 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 https:// www.cfsan.fda.gov/guidance.html. Dated: April 24, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–9870 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–0198] Small Entity Compliance Guide: Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain These Color Additives; 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 ‘‘Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain These Color Additives—Small Entity Compliance Guide.’’ The small entity compliance guide (SECG) is being issued for a final VerDate Nov<24>2008 15:35 Apr 29, 2009 Jkt 217001 rule published in the Federal Register of January 5, 2009, and it 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 Petition Review, Office of Food Additive Safety (HFS–265), 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– 2972. 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 https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: James C. Wallwork, Center for Food Safety and Applied Nutrition (HFS– 265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1303. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 5, 2009 (74 FR 207), FDA issued a final rule requiring the declaration of cochineal extract and carmine by name on the label of all foods and cosmetic products that contain these color additives. This final rule becomes effective January 5, 2011. 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 final rule may 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 January 5, 2009, final rule set forth in 21 CFR parts 73 and 101 concerning cochineal extract and carmine. 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 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 19973 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. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.cfsan.fda.gov/guidance.html. Dated: April 24, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–9868 Filed 4–29–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Statement of Delegation of Authority Notice is hereby given that I have delegated to the Director, National Institutes of Health (NIH), the authorities added to the Public Health Service Act by Section 801 of Public Law 110–85, the Food and Drug Administration Amendments Act of 2007, 42 U.S.C. 282(j), as amended, pertaining to the expansion of the Clinical Trial Registry and Results Data Bank described therein. Specifically, the Director is delegated the following authorities: 1. 402(j)(2)(A)(ii)(IV), 42 U.S.C. 282(j)(2)(A)(ii)(IV): The Secretary may make publicly available certain administrative data collected for the registry, as necessary. 2. 402(j)(3)(A)(i), 42 U.S.C. 282(j)(3)(A)(i): To ensure that the Data Bank includes links to results information for those trials that form the primary basis for an efficacy claim or are performed after clearance or approval of the drug or device, under 42 U.S.C. 282(j)(3)(A)(i). 3. 402(j)(3)(A)(ii)(I), 42 U.S.C. 282(j)(3)(A)(ii)(I): To ensure that the Data Bank includes links to specified FDA information. E:\FR\FM\30APN1.SGM 30APN1

Agencies

[Federal Register Volume 74, Number 82 (Thursday, April 30, 2009)]
[Notices]
[Pages 19972-19973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9870]


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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 https://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.

[[Page 19973]]

    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 
https://www.cfsan.fda.gov/guidance.html.

    Dated: April 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9870 Filed 4-29-09; 8:45 am]
BILLING CODE 4160-01-S

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