Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability, 3449-3450 [2018-01299]

Download as PDF Federal Register / Vol. 83, No. 17 / Thursday, January 25, 2018 / Proposed Rules Dated: January 18, 2018. Leslie Kux, Associate Commissioner for Policy. 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’’). [FR Doc. 2018–01296 Filed 1–24–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 117 [Docket No. FDA–2016–D–2343] Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled ‘‘Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry.’’ This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.’’ The newly available draft chapter is entitled ‘‘Chapter 15—Supply-Chain Program for Human Food Products.’’ DATES: Submit either electronic or written comments by May 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: sradovich on DSK3GMQ082PROD with PROPOSALS SUMMARY: 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 VerDate Sep<11>2014 16:54 Jan 24, 2018 Jkt 244001 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– 2016–D–2343 for ‘‘Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry.’’ 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.’’ 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 PO 00000 Frm 00043 Fmt 4702 Sfmt 4702 3449 ‘‘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/201523389.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 draft guidance to Office of Food Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS–300), 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 draft guidance. FOR FURTHER INFORMATION CONTACT: 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. SUPPLEMENTARY INFORMATION: I. Background The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111–353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Section 103 of FSMA amended section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g) by adding requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations, in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have established regulations to implement these requirements within part 117 (21 CFR part 117). E:\FR\FM\25JAP1.SGM 25JAP1 3450 Federal Register / Vol. 83, No. 17 / Thursday, January 25, 2018 / Proposed Rules In the Federal Register of August 24, 2016 (81 FR 57816), we announced the availability of several chapters (Chapters 1–5) of a multichapter draft guidance for industry entitled ‘‘Hazard Analysis and Risk-Based Preventive Controls for Human Food.’’ In the Federal Register of August 31, 2017 (82 FR 41364), we announced the availability of an additional chapter (Chapter 6). We now are announcing the availability of an additional draft chapter of this multichapter guidance for industry. Dated: January 18, 2018. Leslie Kux, Associate Commissioner for Policy. II. Significance of Guidance [Docket Number USCG–2017–0993] This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Hazard Analysis and Risk-Based Preventive Controls for Human Food’’. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. The multichapter draft guidance for industry is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under part 117, principally in subparts C and G. The chapter that we are announcing in this document is entitled ‘‘Chapter 15—Supply-Chain Program for Human Food Products.’’ We intend to announce the availability for public comment of additional chapters of the draft guidance as we complete them. III. Paperwork Reduction Act of 1995 sradovich on DSK3GMQ082PROD with PROPOSALS This draft 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 part 117 have been approved under OMB control number 0910–0751. IV. Electronic Access 16:54 Jan 24, 2018 BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 RIN 1625–AA00 Special Local Regulation: Fort Lauderdale Air Show; Atlantic Ocean, Fort Lauderdale, FL Coast Guard, DHS. Notice of proposed rulemaking. AGENCY: ACTION: The Coast Guard proposes to establish a recurring special local regulation for navigable waters of the Atlantic Ocean, east of Fort Lauderdale, Florida beginning at the Port Everglades Inlet. This action is necessary to ensure the safety of the general public, spectators, vessels, and the marine environment from potential hazards during aerobatic maneuvers conducted by high-speed, low-flying airplanes and any high speed vessels performing inside of the regulated area during the Fort Lauderdale Air Show. This proposed rulemaking would prohibit persons and non-participant vessels from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the Captain of the Port Miami or a designated representative. We invite your comments on this proposed rulemaking. DATES: Comments and related material must be received by the Coast Guard on or before February 26, 2018. ADDRESSES: You may submit comments identified by docket number USCG– 2017–0993 using the Federal eRulemaking Portal at https:// www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments. SUMMARY: If you have questions about this proposed rulemaking, call or email Petty Officer Mara J. Brown, Sector Miami Waterways Management Division, U.S. Coast Guard; telephone 305–535–4317, email Mara.J.Brown@uscg.mil. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Persons with access to the internet may obtain the draft guidance 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. VerDate Sep<11>2014 [FR Doc. 2018–01299 Filed 1–24–18; 8:45 am] Jkt 244001 PO 00000 Frm 00044 Fmt 4702 Sfmt 4702 I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis The City of Fort Lauderdale notified the Coast Guard that it will be hosting the Fort Lauderdale Air Show annually on one weekend (Saturday and Sunday) during the month of May. The regulated area would cover all navigable waters of the Atlantic Ocean, east of Fort Lauderdale, Florida beginning at the Port Everglades Inlet and continues north for approximately six miles. The regulated area is intended to protect personnel, vessels, and the marine environment from potential hazards during aerobatic maneuvers by high speed, low flying airplanes and high speed vessels during the air show. Over the years, there have been unfortunate instances of aircraft mishaps during performances at various air shows around the world. Occasionally, these incidents result in a wide area of scattered debris in the water that can damage property or cause significant injury or death to the public observing the air shows. The Captain of the Port Miami has determined that a special local regulation is necessary to protect the general public from hazards associated with aerial flight demonstrations. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231. III. Discussion of Proposed Rule This rule establishes a special local regulation on the waters of the Atlantic Ocean, east of Fort Lauderdale, Florida beginning at the Port Everglades Inlet and continuing north for approximately six miles. The duration of the regulated area is intended to ensure the safety of the public during the aerial flight demonstrations and high speed boat races. Non participant vessels are not permitted to enter, transit through, anchor in, or remain within the regulated area without obtaining permission from the Captain of the Port Miami or a designated representative. The Coast Guard will provide notice of the regulated area by Broadcast Notice to Mariners and on-scene designated representatives. The regulatory text we are proposing appears at the end of this document. E:\FR\FM\25JAP1.SGM 25JAP1

Agencies

[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)]
[Proposed Rules]
[Pages 3449-3450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01299]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2016-D-2343]


Hazard Analysis and Risk-Based Preventive Controls for Human 
Food; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
announcing the availability of another draft chapter of a multichapter 
guidance for industry entitled ``Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: Draft Guidance for Industry.'' This 
multichapter draft guidance is intended to explain our current thinking 
on how to comply with the requirements for hazard analysis and risk-
based preventive controls under our rule entitled ``Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food.'' The newly available draft chapter is 
entitled ``Chapter 15--Supply-Chain Program for Human Food Products.''

DATES: Submit either electronic or written comments by May 25, 2018 to 
ensure that the Agency considers your comment on this draft guidance 
before it begins work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive 
Controls for Human Food: Draft Guidance for Industry.'' 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.'' 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 draft guidance to 
Office of Food Safety, Center for Food Safety and Applied Nutrition, 
Food and Drug Administration (HFS-300), 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 draft guidance.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) 
enables FDA to better protect public health by helping to ensure the 
safety and security of the food supply. It enables FDA to focus more on 
preventing food safety problems rather than relying primarily on 
reacting to problems after they occur. FSMA recognizes the important 
role industry plays in ensuring the safety of the food supply, 
including the adoption of modern systems of preventive controls in food 
production.
    Section 103 of FSMA amended section 418 of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 350g) by adding requirements for 
hazard analysis and risk-based preventive controls for establishments 
that are required to register as food facilities under our regulations, 
in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C 
Act (21 U.S.C. 350d). We have established regulations to implement 
these requirements within part 117 (21 CFR part 117).

[[Page 3450]]

    In the Federal Register of August 24, 2016 (81 FR 57816), we 
announced the availability of several chapters (Chapters 1-5) of a 
multichapter draft guidance for industry entitled ``Hazard Analysis and 
Risk-Based Preventive Controls for Human Food.'' In the Federal 
Register of August 31, 2017 (82 FR 41364), we announced the 
availability of an additional chapter (Chapter 6). We now are 
announcing the availability of an additional draft chapter of this 
multichapter guidance for industry.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on ``Hazard 
Analysis and Risk-Based Preventive Controls for Human Food''. It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternate approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.
    The multichapter draft guidance for industry is intended to explain 
our current thinking on how to comply with the requirements for hazard 
analysis and risk-based preventive controls under part 117, principally 
in subparts C and G. The chapter that we are announcing in this 
document is entitled ``Chapter 15--Supply-Chain Program for Human Food 
Products.''
    We intend to announce the availability for public comment of 
additional chapters of the draft guidance as we complete them.

III. Paperwork Reduction Act of 1995

    This draft 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 part 117 have been approved under OMB 
control number 0910-0751.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
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: January 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01299 Filed 1-24-18; 8:45 am]
 BILLING CODE 4164-01-P
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