[Federal Register Volume 83, Number 93 (Monday, May 14, 2018)]
[Rules and Regulations]
[Pages 22193-22194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10148]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 
129, 179, 211, and 507

[Docket No. FDA-2018-D-1378]


The Food and Drug Administration Food Safety Modernization Act; 
Extension and Clarification of Compliance Dates for Certain Provisions 
of Four Implementing Rules: 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.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a guidance for industry entitled ``The 
FDA Food Safety Modernization Act; Extension and Clarification of 
Compliance Dates for Certain Provisions of Four Implementing Rules: 
What You Need to Know About the Food and Drug Administration 
Regulation--Small Entity Compliance Guide.'' The small entity 
compliance guide (SECG) is intended to help small entities comply with 
the final rule entitled ``The Food and Drug Administration Food Safety 
Modernization Act; Extension and Clarification for Certain Provisions 
of Four Implementing Rules.''

DATES: The announcement of the guidance is published in the Federal 
Register on May 14, 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 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-1378 for ``The FDA Food Safety Modernization Act; Extension 
and Clarification of Compliance Dates for Certain Provisions of Four 
Implementing Rules: What You Need to Know About the Food and Drug 
Administration 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

[[Page 22194]]

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 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 guidance to Office 
of Food Safety, Center for Food Safety and Applied Nutrition (HFS-300), 
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 guidance.

FOR FURTHER INFORMATION CONTACT: 
    For questions relating to Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Human Food: 
Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
240-402-2166.
    For questions relating to Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Food for 
Animals: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 
240-402-6246.
    For questions relating to Foreign Supplier Verification Programs 
for Importers of Food for Humans and Animals: Rebecca Buckner, Office 
of Foods and Veterinary Medicine, Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4576.
    For questions relating to Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption: Samir Assar, 
Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of August 24, 2016 (81 FR 57784), we issued 
a final rule entitled ``The Food and Drug Administration Food Safety 
Modernization Act; Extension and Clarification for Certain Provisions 
of Four Implementing Rules'' (the final rule) that extended compliance 
dates to address concerns about the practicality of compliance with 
certain provisions, consider changes to the regulatory text, and better 
align compliance dates across the rules. The final rule became 
effective August 24, 2016.
    We examined the economic implications of the final rule as required 
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined 
that the final rule will not have a significant economic impact on a 
substantial number of small entities. In compliance 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 
reduce the burden of determining how to comply by further explaining 
and clarifying the actions that a small entity must take to comply with 
the rule.
    We are issuing this SECG consistent with our good guidance 
practices regulation (21 CFR 10.115(c)(2)). This 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

    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 21 CFR part 117 have been approved under 
OMB control number 0910-0751. The collections of information in 21 CFR 
part 507 have been approved under OMB control number 0910-0789. The 
collections of information in 21 CFR part 1, subpart L have been 
approved under OMB control number 0910-0752. The collections of 
information in 21 CFR part 112 have been approved under OMB control 
number 0910-0816.

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 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10148 Filed 5-11-18; 8:45 am]
 BILLING CODE 4164-01-P