Document ID: FDA-2013-D-1622-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Submitting Food Canning Establishment Registration Form and Food Process Filing Forms to the Food
and Drug Administration in Electronic or Paper Format; Availability
Posted Date: 2014-01-14T05:00Z

[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2448-2449]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00425]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1622]

Draft Guidance for Industry: Submitting Food Canning 
Establishment Registration Form and Food Process Filing Forms to the 
Food and Drug Administration in Electronic or Paper Format; 
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availability of a draft guidance entitled ``Guidance for Industry: 
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.'' The draft 
guidance is intended to alert stakeholders to changes we are planning 
for the administrative procedures currently used by commercial 
processors that manufacture, process, or pack acidified foods (AF) and/
or thermally processed low-acid foods packaged in hermetically sealed 
containers (historically referred to as ``low-acid canned foods'' or 
``LACF''). These changes include new food process filing forms and a 
new ``smart form'' system for electronic submission of these forms. The 
draft guidance, when finalized, will supersede the July 2012 guidance 
entitled ``Guidance for Industry: Submitting Form FDA 2541 (Food 
Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c 
(Food Process Filing Forms) to FDA in Electronic or Paper Format'' when 
the new food process filing forms and the new ``smart form'' electronic 
system become operational.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the Agency considers your comments on 
the draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 
by March 17, 2014.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Submit written requests for single copies of the draft guidance to the 
Office of Food Safety, Center for Food Safety and Applied Nutrition 
(HFS-302), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Susan Brecher, Center for Food Safety 
and Applied Nutrition (HFS-302), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1781.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Guidance for Industry: 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.'' The draft guidance is intended to alert stakeholders 
to changes we are planning for the administrative procedures currently 
used by commercial processors that manufacture, process, or pack AF 
and/or LACF. These changes

[[Page 2449]]

include new food process filing forms and a new ``smart form'' system 
for electronic submission of these forms. The draft guidance, when 
finalized, will supersede the current guidance entitled ``Guidance for 
Industry: Submitting Form FDA 2541 (Food Canning Establishment 
Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing 
Forms) to FDA in Electronic or Paper Format'' (Ref. 1) when the new 
food process filing forms and the new ``smart form'' electronic system 
become operational. We intend to update the process filing regulations 
in 21 CFR 108.25(c)(2) and 108.35(c)(2) to specify the new form 
numbers, and to provide information about how to access the online 
system for electronic submission of these forms, when the new system 
becomes operational, or as soon as possible thereafter.
    The draft guidance is being issued consistent with our good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish 
notice in the Federal Register soliciting public comment on each 
proposed collection of information before submitting the collection to 
OMB for approval. To comply with this requirement, we published a 60-
day notice on the proposed collection of information in the Federal 
Register of September 18, 2013 (78 FR 57391).

III. Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance to http://www.regulations.gov or written comments to 
the Division of Dockets Management (see ADDRESSES). 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or at http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the draft guidance.

V. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this reference section, but we are not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)
    1. FDA, 2012, Guidance for Industry: Submitting Form FDA 2541 (Food 
Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c 
(Food Process Filing Forms) to FDA in Electronic or Paper Format.

    Dated: January 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00425 Filed 1-13-14; 8:45 am]
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