[Federal Register Volume 77, Number 84 (Tuesday, May 1, 2012)]
[Notices]
[Page 25721]
From the Federal Register Online via the Government Publishing 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