[Federal Register Volume 83, Number 103 (Tuesday, May 29, 2018)]
[Notices]
[Pages 24479-24480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11419]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1468]


Registration of Food Facilities: What You Need To Know About the 
Food and Drug Administration Regulation; Small Entity Compliance Guide; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry entitled ``Registration 
of Food Facilities: What You Need To Know About the FDA Regulation--
Small Entity Compliance Guide.'' The small entity compliance guide 
(SECG) is intended to help small entities comply with a final rule we 
issued in the Federal Register of July 14, 2016, entitled ``Amendments 
to Registration of Food Facilities.'' The final rule amends the 
registration of food facilities regulations.

DATES: The announcement of the guidance is published in the Federal 
Register on May 29, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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

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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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-D-1468 for ``Registration of Food Facilities: What You Need To 
Know About the FDA Regulation--Small Entity Compliance Guide.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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.'' We will review 
this copy, including the claimed confidential information, in our 
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 https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. 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: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the SECG to the Office 
of Compliance, Center for Food Safety and Applied Nutrition (HFS-800), 
Food and Drug Administration, 5001 Campus Dr., 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 SECG.

FOR FURTHER INFORMATION CONTACT: Courtney Buchanan, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2487.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) added section 
415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 415 
of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign 
facilities that manufacture, process, pack, or hold food for human or 
animal consumption in the United States to register with FDA.
    On October 10, 2003, we issued an interim final rule (68 FR 58894) 
to implement section 415 of the FD&C Act. That rule established the 
food facility registration regulations in part 1, subpart H (21 CFR 
1.225 through 1.243). Previously, this guidance restated FDA's food 
facility registration regulations. This guidance also served as FDA's 
SECG for part 1, subpart H.
    The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 
2011, amended section 415 of the FD&C Act to require that facilities 
engaged in manufacturing, processing, packing, or holding food for 
consumption in the United States submit additional registration 
information to FDA, including an assurance that FDA will be permitted 
to inspect the facility at the times and in the manner permitted by the 
FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also 
requires food facilities required to register with FDA to renew such 
registrations every other year, and provides FDA with authority to 
suspend the registration of a food facility in certain circumstances.
    On July 14, 2016, we published a final rule (81 FR 45912) that 
amended our food facility registration regulations to reflect, among 
other things, the FSMA amendments to section 415 of the FD&C Act. 
Accordingly, FDA is revising this SECG to provide guidance intended to 
help small entities comply with the revised registration of food 
facilities requirements in part 1, subpart H.
    We examined the economic implications of the final rule as required 
by the Regulatory Flexibility Act (5 U.S.C. 601-612). Although we 
stated that we did not believe that the final rule that amended our 
registration of food facilities regulations would have a significant 
economic impact on a substantial number of small entities, we analyzed 
various regulatory options to examine the impact on small entities. 
Consistent with section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-
28), we are making available the SECG to explain the actions that a 
small entity must take to comply with the rule.
    We are issuing the SECG consistent with our good guidance practices 
regulation (21 CFR 10.115(c)(2)). The SECG represents the current 
thinking of FDA on this topic. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.

II. Paperwork Reduction Act of 1995

    The guidance refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
part 1, subpart H have been approved under the Office of Management and 
Budget control number 0910-0502.

III. Electronic Access

    Persons with access to the internet may obtain the SECG at either 
https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use 
the FDA website listed in the previous sentence to find the most 
current version of the guidance.

    Dated: May 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11419 Filed 5-25-18; 8:45 am]
 BILLING CODE 4164-01-P