[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)]
[Rules and Regulations]
[Pages 75692-75693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2011-N-0920]


What You Need To Know About the Food and Drug Administration 
Regulation: Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Human Food; 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, the Agency, or we) is 
announcing the availability of a guidance for industry entitled ``What 
You Need To Know About the FDA Regulation: Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human 
Food''--Small Entity Compliance Guide. The small entity compliance 
guide (SECG) is intended to help small entities comply with the final 
rule titled ``Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Human Food.''

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-2011-N-0920 for ``What You Need To Know About the FDA Regulation: 
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food (21 CFR part 117).'' 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 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

[[Page 75693]]

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 SECG to the Office 
of Food Safety, Center for Food Safety and Applied Nutrition, 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: Jenny Scott, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1700.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 17, 2015 (80 FR 55908), we 
issued a final rule titled ``Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' 
(the final rule) in which we modernized the longstanding current good 
manufacturing practice requirements in 21 CFR part 110 and added the 
requirements for facilities subject to registration to establish and 
implement hazard analysis and risk-based preventive controls for human 
food. The final rule, which is codified at part 117 (21 CFR part 117), 
became effective November 16, 2015 (except for the amendment to part 
110 in instruction 13, which is effective September 17, 2018, and 
paragraph (2) of the definition of ``qualified auditor'' in Sec.  
117.3, and Sec. Sec.  117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 
117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2), and 
117.475(c)(13)) but has compliance dates staggered over several years 
after publication of the final rule.
    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 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 
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.

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.

III. Electronic Access

    Persons with access to the Internet may obtain the SECG at either 
http://www.fda.gov/FoodGuidances, 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 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26315 Filed 10-31-16; 8:45 am]
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