[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60909-60911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25642]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Submitting Food Canning Establishment Registration Form and Food 
Process Filing Forms to the Food and Drug Administration in Electronic 
or Paper Format: Guidance for Industry; 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 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: Guidance for Industry.'' This guidance describes the 
administrative procedures to be 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 registration and food process filing forms 
and a new ``smart form'' system for electronic submission of the 
process filing forms. Registration and process filing are required by 
the AF and LACF provisions of our regulations. This guidance also 
provides general information about how to use FDA's systems for 
electronic submission of the applicable forms. In addition, this 
guidance describes administrative procedures for voluntary registration 
and voluntary submissions when a commercial processor has determined 
that its product is not an acidified food or a low-acid canned food, 
and is therefore not subject to our regulations for AF and LACF. 
Further, this guidance describes a voluntary process whereby, upon 
request, we review data and other information that relate to a new 
processing method or new equipment.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: You may submit comments as follows:
    Electronic Submissions: Submit electronic comments in the following 
way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
    Written/Paper Submissions: Submit written/paper submissions as 
follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-1622 for Submitting Food Canning Establishment Registration 
Form and Food Process Filing Forms to the Food and Drug Administration 
in Electronic or Paper Format: Guidance for Industry; Availability. 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets

[[Page 60910]]

Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the 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: Guidance for 
Industry'' to Office of Food Safety, Center for Food Safety and Applied 
Nutrition (HFS-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 
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 guidance for industry 
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: 
Guidance for Industry.'' This guidance is being issued consistent with 
our good guidance practices regulation (21 CFR 10.115). The guidance 
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.
    This guidance supersedes the previous 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.'' Among other things, it 
provides guidance on administrative procedures related to new process 
filing forms (Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g) 
that will replace the current process filing forms (Forms FDA 2541a and 
2541c). The process filing regulations in 21 CFR 108.25(c)(2) and 
108.35(c)(2) currently specify Form FDA 2541a (food canning 
establishment process filing for all methods except aseptic) or Form 
FDA 2541c (food canning establishment process filing for aseptic 
systems). We intend to update these regulations to specify the new form 
numbers, and to provide information about how to access the online 
system for electronic submission of these forms, as soon as possible.
    This guidance describes: (1) Administrative procedures relating to 
the registration requirements of 21 CFR 108.25(c)(1) (for AF) using 
Form FDA 2541 in both electronic and paper format; (2) administrative 
procedures relating to the registration requirements of Sec.  
108.35(c)(1) (for LACF) using Form FDA 2541 in both electronic and 
paper format; (3) administrative procedures relating to the process 
filing requirements of Sec.  108.25(c)(2) (for AF) using Form FDA 2541e 
in both electronic and paper format; (4) administrative procedures 
relating to the process filing requirements of Sec.  108.35(c)(2) (for 
LACF) using Forms FDA 2541d, FDA 2541f, and FDA 2541g in both 
electronic and paper format; (5) administrative procedures for 
voluntary registration and voluntary process filing submissions when a 
commercial processor has determined that its product is not an 
acidified food (or a low-acid canned food), and is therefore not 
subject to 21 CFR part 113, 21 CFR part 114, or part 108; and (6) a 
voluntary process whereby, upon request, we review data and other 
information that relate to a new processing method or new equipment.
    In the Federal Register of January 14, 2014 (79 FR 2448), we made 
available 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'' and gave interested parties an 
opportunity to submit comments by March 17, 2014, for us to consider 
before beginning work on the final version of the guidance. We received 
a few comments on the draft guidance, largely directed to the specific 
content of the forms discussed in the guidance rather than to the 
procedures described in the guidance, and have not made any 
modifications to the final guidance as a result of these comments. We 
have, however, modified the content of the forms where appropriate. We 
have deleted information, which we had included in the draft guidance, 
explaining how the draft guidance would eventually supersede previous 
administrative guidance associated with previous editions of the forms, 
which are now obsolete. We also have modified the Appendix of the final 
guidance to include additional resources--e.g., instructions for 
submitting process filing forms electronically. The guidance announced 
in this notice finalizes the draft guidance dated January 2014.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in parts 108, 113, and 114 have been 
approved under OMB control number 0910-0037. The collections of 
information related to 21 CFR 1.230 through 1.233 and section 415 of 
the Federal Food, Drug, and Cosmetic Act

[[Page 60911]]

(21 U.S.C. 350d) have been approved under OMB control number 0910-0502.

III. Electronic Access

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

    Dated: October 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25642 Filed 10-7-15; 8:45 am]
BILLING CODE 4164-01-P