[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Notices]
[Page 21250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08428]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0848]


Compliance Policy Guide Regarding Canned Ackee, Frozen Ackee, and 
Other Ackee Products--Hypoglycin A Toxin; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of the Compliance Policy Guide (CPG) Sec. 550.050 Canned 
Ackee, Frozen Ackee, and Other Ackee Products--Hypoglycin A Toxin. The 
CPG provides guidance for FDA staff on our enforcement criteria for 
canned ackee, frozen ackee, and other ackee products that contain 
hypoglycin A.

DATES: Submit either electronic or written comments on the CPG at any 
time.

ADDRESSES: Submit written requests for single copies of the CPG to the 
Office of Policy and Risk Management, Office of Regulatory Affairs, 
Office of Global Regulatory Operations and Policy, Food and Drug 
Administration, 12420 Parklawn Dr., Rockville, MD 20857. Send two self-
addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-827-3670. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.
    Submit electronic comments on the CPG to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Yinqing Ma, Center for Food Safety and 
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 240-402-1700.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of CPG Sec. 550.050 Canned 
Ackee, Frozen Ackee, and Other Ackee Products--Hypoglycin A Toxin. The 
CPG is being issued consistent with our good guidance practices 
regulation (21 CFR 10.115). The CPG represents our 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.
    In the Federal Register of November 8, 2012 (77 FR 67013), we 
announced the availability of draft CPG Sec. 550.050 Canned Ackee, 
Frozen Ackee, and Other Ackee Products--Hypoglycin A Toxin and gave 
interested parties an opportunity to submit comments by January 7, 
2013, for us to consider before beginning work on the final version of 
the CPG. We received one comment that did not pertain to the draft CPG. 
We are issuing the final version of the CPG with editorial changes, but 
with no substantive changes.
    The CPG announced in this notice finalizes the draft CPG dated 
November 2012.

II. Comments

    Interested persons may submit either written comments regarding the 
CPG to the Division of Dockets Management (see ADDRESSES) or electronic 
comments regarding the CPG to http://www.regulations.gov. 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, and will be posted to 
the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the CPG from FDA's 
Office of Regulatory Affairs CPG history page at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or 
from http://www.regulations.gov. Use the FDA Web site listed in the 
previous sentence to find the most current version of the guidance.

    Dated: April 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08428 Filed 4-14-14; 8:45 am]
BILLING CODE 4160-01-P