[Federal Register Volume 77, Number 84 (Tuesday, May 1, 2012)]
[Notices]
[Page 25721]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10465]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0316]


Small Entity Compliance Guide: Bottled Water: Quality Standard: 
Establishing an Allowable Level for di(2-ethylhexyl)phthalate; 
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: 
Quality Standard: Establishing an Allowable Level for di(2-
ethylhexyl)phthalate--Small Entity Compliance Guide.'' The small entity 
compliance guide (SECG) is being issued for a final rule published in 
the Federal Register of October 19, 2011, and is intended to set forth 
in plain language the requirements of the regulation and to help small 
businesses understand the regulation.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the SECG to the 
Division of Plant and Dairy Food Safety, Office of Food Safety, Center 
for Food Safety and Applied Nutrition, (HFS-317), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. 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.
    Submit electronic comments on the SECG to http://www.regulations.gov. 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.

FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1639.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of October 19, 2011 (76 FR 64810), FDA 
issued a final rule that amended its bottled water standard of quality 
regulations by establishing an allowable level for di(2-
ethylhexyl)phthalate (DEHP). This final rule is effective April 16, 
2012.
    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 will not 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 
(Pub. L. 104-121), FDA is making available this SECG stating in plain 
language the requirements of the regulation.
    FDA is issuing this SECG consistent with FDA's good guidance 
practices regulation (21 CFR 10.115(c)(2)). This SECG represents the 
Agency's current thinking on di(2-ethylhexyl)phthalate in bottled 
water. 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) either electronic or written comments regarding this 
SECG. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. 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 SECG at either 
http://www.fda.gov/RegulatoryInformation/Guidances/default.htm or 
http://www.regulations.gov. Always access an FDA guidance document by 
using FDA's Web site listed previously to find the most current version 
of the guidance.

    Dated: April 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10465 Filed 4-30-12; 8:45 am]
BILLING CODE 4160-01-P