
[Federal Register Volume 80, Number 250 (Wednesday, December 30, 2015)]
[Notices]
[Pages 81550-81551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32781]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0434]


Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft 
Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
withdrawal of a draft guidance for industry, entitled ``Draft Guidance 
for Industry: Acidified Foods.'' The draft guidance was intended to 
complement our regulations regarding acidified foods (including 
regulations for specific current good manufacturing practice, 
establishment registration, and process filing) by helping commercial 
food processors

[[Page 81551]]

determine whether their food products are subject to these regulations 
by providing for voluntary submission of process filings by processors 
of non-acidified foods (e.g., some acid foods or fermented foods), and 
by helping processors of acidified foods in ensuring safe 
manufacturing, processing, and packing processes and in employing 
appropriate quality control procedures. We are withdrawing the draft 
guidance, in part, because many of the topics addressed in the draft 
guidance are now being addressed in other documents.

DATES: The withdrawal is effective December 30, 2015.

FOR FURTHER INFORMATION CONTACT: Michael Mignogna, Center for Food 
Safety and Applied Nutrition (HFS-302), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1565.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of September 27, 2010 (75 FR 59268), we announced the 
availability of a draft guidance entitled ``Draft Guidance for 
Industry: Acidified Foods'' and gave interested parties an opportunity 
to submit comments by December 27, 2010, for us to consider before 
beginning work on the final version of the guidance. The draft guidance 
was intended to complement our regulations regarding acidified foods 
(including regulations for specific current good manufacturing practice 
(21 CFR part 114), establishment registration (21 CFR 108.25(c)(1)), 
and process filing (21 CFR 108.25(c)(2)) by helping commercial food 
processors in determining whether their food products are subject to 
these regulations and by providing for voluntary submission of process 
filings by processors who conclude that their products are non-
acidified foods (e.g., acid foods or fermented foods). The draft 
guidance also was intended to help processors of acidified foods in 
ensuring safe manufacturing, processing, and packing processes and in 
employing appropriate quality control procedures.
    We are withdrawing the draft guidance, in part, because the 
procedures for voluntary submission of process filings by processors of 
non-acidified foods are addressed by our recently issued guidance 
entitled ``Submitting Form FDA 2541 (Food Canning Establishment 
Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g 
(Food Process Filing Forms) to FDA in Electronic or Paper Format'' (80 
FR 60909, October 8, 2015). We also are withdrawing the draft guidance, 
in part, because we recently issued a final rule entitled ``Current 
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food'' (80 FR 55908, September 17, 2015), and that 
rule, along with guidance documents we are developing as a companion to 
that rule, should help processors in ensuring safe manufacturing, 
processing, and packing processes and in employing appropriate quality 
control procedures.

    Dated: December 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32781 Filed 12-29-15; 8:45 am]
 BILLING CODE 4164-01-P


