Compliance Policy Guide Regarding Canned Ackee, Frozen Ackee, and Other Ackee Products-Hypoglycin A Toxin; Availability, 21250 [2014-08428]

Download as PDF 21250 Federal Register / Vol. 79, No. 72 / Tuesday, April 15, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hrs.) Type of respondents Form name General public; specifically targeting external governmental and non-governmental organizations including non-profit organizations, trade associations, academic and research institutions, and the private sector. General public; specifically targeting external governmental and non-governmental organizations including non-profit organizations, trade associations, academic and research institutions, and the private sector. Become a Partner .................. 100 1 15/60 Become a Partner Follow-Up Questions. 100 1 30/60 Leroy Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2014–08446 Filed 4–14–14; 8:45 am] BILLING CODE 4163–18–P 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. 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. SUMMARY: 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. mstockstill on DSK4VPTVN1PROD with NOTICES ADDRESSES: VerDate Mar<15>2010 18:06 Apr 14, 2014 Jkt 232001 Submit electronic comments on the CPG to https://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: (see ADDRESSES) or electronic comments regarding the CPG to https:// 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 https:// www.regulations.gov. 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. Persons with access to the Internet may obtain the CPG from FDA’s Office of Regulatory Affairs CPG history page at https://www.fda.gov/ICECI/ ComplianceManuals/CompliancePolicy GuidanceManual/default.htm or from https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. II. Comments Interested persons may submit either written comments regarding the CPG to the Division of Dockets Management PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 III. Electronic Access 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request: NIMH Database of Cognitive Training and Remediation Studies (DCTRS) (NIMH) In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Mental Health (NIMH), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. SUMMARY: E:\FR\FM\15APN1.SGM 15APN1

Agencies

[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Notices]
[Page 21250]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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 https://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 https://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 https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or 
from https://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
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