83 FR 3163 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 15 (January 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 15 (January 23, 2018)
| Page Range | 3163-3164 | |
| FR Document | 2018-01126 |
[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)] [Notices] [Pages 3163-3164] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01126] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2343] Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry #245 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.'' This draft guidance document, when finalized, will help animal food facilities comply with the requirements for hazard analysis and risk-based preventive controls under our regulation ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.'' DATES: Submit either electronic or written comments on the draft guidance by July 23, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 Food for Animals.'' 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.thefederalregister.org/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 the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Jenny Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public (human and animal) health by helping to ensure the safety and security of the food supply. FSMA enables FDA to focus more on preventing animal food safety problems rather than relying primarily on reacting to problems after they occur. Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with 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 the hazard analysis and risk-based preventive controls requirements within part 507 (21 CFR part 507). We are announcing the availability of a draft guidance for industry #245 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.'' This multi-chapter draft guidance for industry is intended to [[Page 3164]] explain how to comply with the requirements for hazard analysis and risk-based preventive controls for food for animals under part 507. The chapters we are announcing in this document are as follows: Introduction Chapter One--The Food Safety Plan Chapter Two--Conducting a Hazard Analysis Chapter Three--Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Animal Food Chapter Four--Preventive Controls Chapter Five--Overview of Preventive Control Management Components We intend to announce the availability for public comment of additional chapters of the draft guidance as we complete them. 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 how to comply with the hazard analysis and risk-based preventive controls requirements for the regulation ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.'' 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. 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 507 have been approved under OMB control number 0910-0789. IV. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm 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 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01126 Filed 1-22-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3163
Dated: January 17, 2018. comments, that information will be FR 56469, September 18, 2015, or access
Leslie Kux, posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
Associate Commissioner for Policy. • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
[FR Doc. 2018–01119 Filed 1–22–18; 8:45 am] with confidential information that you 23389.pdf.
BILLING CODE 4164–01–P
do not wish to be made available to the Docket: For access to the docket to
public, submit the comment as a read background documents or the
written/paper submission and in the electronic and written/paper comments
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper received, go to https://
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
Written/Paper Submissions docket number, found in brackets in the
Food and Drug Administration heading of this document, into the
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
[Docket No. FDA–2016–D–2343] follows: and/or go to the Dockets Management
• Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061,
Hazard Analysis and Risk-Based written/paper submissions): Dockets
Preventive Controls for Food for Rockville, MD 20852.
Management Staff (HFA–305), Food and You may submit comments on any
Animals; Draft Guidance for Industry; Drug Administration, 5630 Fishers
Availability guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)).
• For written/paper comments
AGENCY: Food and Drug Administration, Submit written requests for single
submitted to the Dockets Management
HHS. copies of the guidance to the Policy and
Staff, FDA will post your comment, as
ACTION: Notice of availability. Regulations Staff (HFV–6), Center for
well as any attachments, except for
Veterinary Medicine, Food and Drug
information submitted, marked and
SUMMARY: The Food and Drug Administration, 7500 Standish Pl.,
identified, as confidential, if submitted
Administration (FDA, we, or Agency) is Rockville, MD 20855. Send one self-
as detailed in ‘‘Instructions.’’
announcing the availability of a draft Instructions: All submissions received addressed adhesive label to assist that
guidance for industry #245 entitled must include the Docket No. FDA– office in processing your requests. See
‘‘Hazard Analysis and Risk-Based 2016–D–2343 for ‘‘Hazard Analysis and the SUPPLEMENTARY INFORMATION section
Preventive Controls for Food for Risk-Based Preventive Controls for Food for electronic access to the draft
Animals.’’ This draft guidance for Animals.’’ Received comments will guidance document.
document, when finalized, will help be placed in the docket and, except for FOR FURTHER INFORMATION CONTACT:
animal food facilities comply with the those submitted as ‘‘Confidential Jenny Murphy, Center for Veterinary
requirements for hazard analysis and Submissions,’’ publicly viewable at Medicine (HFV–200), Food and Drug
risk-based preventive controls under our https://www.regulations.gov or at the Administration, 7519 Standish Pl.,
regulation ‘‘Current Good Dockets Management Staff between 9 Rockville, MD 20855, 240–402–6246,
Manufacturing Practice, Hazard a.m. and 4 p.m., Monday through jenny.murphy@fda.hhs.gov.
Analysis, and Risk-Based Preventive Friday. SUPPLEMENTARY INFORMATION:
Controls for Food for Animals.’’ • Confidential Submissions—To
DATES: Submit either electronic or submit a comment with confidential I. Background
written comments on the draft guidance information that you do not wish to be The FDA Food Safety Modernization
by July 23, 2018 to ensure that the made publicly available, submit your Act (FSMA) (Pub. L. 111–353) enables
Agency considers your comment on this comments only as a written/paper FDA to better protect public (human
draft guidance before it begins work on submission. You should submit two and animal) health by helping to ensure
the final version of the guidance. copies total. One copy will include the the safety and security of the food
ADDRESSES: You may submit comments information you claim to be confidential supply. FSMA enables FDA to focus
on any guidance at any time as follows: with a heading or cover note that states more on preventing animal food safety
‘‘THIS DOCUMENT CONTAINS problems rather than relying primarily
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The on reacting to problems after they occur.
Submit electronic comments in the Agency will review this copy, including Section 103 of FSMA amended the
following way: the claimed confidential information, in Federal Food, Drug, and Cosmetic Act
• Federal eRulemaking Portal: its consideration of comments. The (FD&C Act), by adding section 418 (21
https://www.regulations.gov. Follow the second copy, which will have the U.S.C. 350g) with requirements for
instructions for submitting comments. claimed confidential information hazard analysis and risk-based
Comments submitted electronically, redacted/blacked out, will be available preventive controls for establishments
including attachments, to https:// for public viewing and posted on that are required to register as food
www.regulations.gov will be posted to https://www.regulations.gov. Submit facilities under our regulations in 21
the docket unchanged. Because your both copies to the Dockets Management CFR part 1, subpart H, in accordance
comment will be made public, you are Staff. If you do not wish your name and with section 415 of the FD&C Act (21
solely responsible for ensuring that your contact information to be made publicly U.S.C. 350d). We have established
comment does not include any available, you can provide this regulations to implement the hazard
confidential information that you or a information on the cover sheet and not analysis and risk-based preventive
third party may not wish to be posted, in the body of your comments and you controls requirements within part 507
sradovich on DSK3GMQ082PROD with NOTICES
such as medical information, your or must identify this information as (21 CFR part 507).
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked We are announcing the availability of
confidential business information, such as ‘‘confidential’’ will not be disclosed a draft guidance for industry #245
as a manufacturing process. Please note except in accordance with 21 CFR 10.20 entitled ‘‘Hazard Analysis and Risk-
that if you include your name, contact and other applicable disclosure law. For Based Preventive Controls for Food for
information, or other information that more information about FDA’s posting Animals.’’ This multi-chapter draft
identifies you in the body of your of comments to public dockets, see 80 guidance for industry is intended to
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![3164 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices
explain how to comply with the Dated: January 17, 2018. as a manufacturing process. Please note
requirements for hazard analysis and Leslie Kux, that if you include your name, contact
risk-based preventive controls for food Associate Commissioner for Policy. information, or other information that
for animals under part 507. The [FR Doc. 2018–01126 Filed 1–22–18; 8:45 am] identifies you in the body of your
chapters we are announcing in this BILLING CODE 4164–01–P comments, that information will be
document are as follows: posted on https://www.regulations.gov.
• If you want to submit a comment
• Introduction
DEPARTMENT OF HEALTH AND with confidential information that you
• Chapter One—The Food Safety Plan do not wish to be made available to the
HUMAN SERVICES
• Chapter Two—Conducting a Hazard public, submit the comment as a
Analysis Food and Drug Administration written/paper submission and in the
• Chapter Three—Hazards Associated [Docket No. FDA–2017–D–6702]
manner detailed (see ‘‘Written/Paper
with the Manufacturing, Processing, Submissions’’ and ‘‘Instructions’’).
Packing, and Holding of Animal Food The Least Burdensome Provisions: Written/Paper Submissions
• Chapter Four—Preventive Controls Concept and Principles; Draft
Guidance for Industry and Food and Submit written/paper submissions as
• Chapter Five—Overview of follows:
Drug Administration Staff; Availability;
Preventive Control Management • Mail/Hand delivery/Courier (for
Components Extension of Comment Period
written/paper submissions): Dockets
We intend to announce the AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and
availability for public comment of HHS. Drug Administration, 5630 Fishers
ACTION:Notice of availability; extension Lane, Rm. 1061, Rockville, MD 20852.
additional chapters of the draft guidance
of comment period. • For written/paper comments
as we complete them.
submitted to the Dockets Management
II. Significance of Guidance SUMMARY: The Food and Drug Staff, FDA will post your comment, as
Administration (FDA or the Agency) is well as any attachments, except for
This level 1 draft guidance is being extending the comment period for the information submitted, marked and
issued consistent with FDA’s good notice of availability that appeared in identified, as confidential, if submitted
guidance practices regulation (21 CFR the Federal Register of December 15, as detailed in ‘‘Instructions.’’
10.115). The draft guidance, when 2017. In the notice of availability, FDA Instructions: All submissions received
finalized, will represent the current requested comments on the draft must include the Docket No. FDA–
thinking of FDA on how to comply with guidance for industry and FDA staff 2017–D–6702 for ‘‘The Least
the hazard analysis and risk-based entitled ‘‘The Least Burdensome Burdensome Provisions: Concept and
preventive controls requirements for the Provisions: Concept and Principles.’’ Principles; Draft Guidance for Industry
regulation ‘‘Current Good The Agency is taking this action in and Food and Drug Administration
Manufacturing Practice, Hazard response to a request for an extension to Staff; Availability.’’ Received comments
Analysis, and Risk-Based Preventive allow interested persons additional time will be placed in the docket and, except
Controls for Food for Animals.’’ It does to submit comments. for those submitted as ‘‘Confidential
not establish any rights for any person DATES: FDA is extending the comment Submissions,’’ publicly viewable at
and is not binding on FDA or the public. period on the document published https://www.regulations.gov or at the
You can use an alternative approach if December 15, 2017 (82 FR 59623), by an Dockets Management Staff between 9
it satisfies the requirements of the additional 30 days. Submit either a.m. and 4 p.m., Monday through
applicable statutes and regulations. This electronic or written comments on the Friday.
guidance is not subject to Executive draft guidance by March 15, 2018, to • Confidential Submissions—To
Order 12866. ensure that the Agency considers your submit a comment with confidential
III. Paperwork Reduction Act of 1995 comment on this draft guidance before information that you do not wish to be
it begins work on the final version of the made publicly available, submit your
This draft guidance refers to guidance. comments only as a written/paper
previously approved collections of ADDRESSES: You may submit comments submission. You should submit two
information found in FDA regulations. on any guidance at any time as follows: copies total. One copy will include the
These collections of information are information you claim to be confidential
subject to review by the Office of Electronic Submissions with a heading or cover note that states
Management and Budget (OMB) under Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
the Paperwork Reduction Act of 1995 following way: CONFIDENTIAL INFORMATION.’’ The
(44 U.S.C. 3501–3520). The collections • Federal eRulemaking Portal: Agency will review this copy, including
of information in part 507 have been https://www.regulations.gov. Follow the the claimed confidential information, in
approved under OMB control number instructions for submitting comments. its consideration of comments. The
0910–0789. Comments submitted electronically, second copy, which will have the
IV. Electronic Access including attachments, to https:// claimed confidential information
www.regulations.gov will be posted to redacted/blacked out, will be available
Persons with access to the internet the docket unchanged. Because your for public viewing and posted on
may obtain the draft guidance at either comment will be made public, you are https://www.regulations.gov. Submit
sradovich on DSK3GMQ082PROD with NOTICES
https://www.fda.gov/AnimalVeterinary/ solely responsible for ensuring that your both copies to the Dockets Management
GuidanceComplianceEnforcement/ comment does not include any Staff. If you do not wish your name and
GuidanceforIndustry/default.htm or confidential information that you or a contact information to be made publicly
https://www.regulations.gov. Use the third party may not wish to be posted, available, you can provide this
FDA website listed in the previous such as medical information, your or information on the cover sheet and not
sentence to find the most current anyone else’s Social Security number, or in the body of your comments and you
version of the guidance. confidential business information, such must identify this information as
VerDate Sep<11>2014 17:59 Jan 22, 2018 Jkt 244001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\23JAN1.SGM 23JAN1](https://thefederalregister.org/doc/83_FR_3178/page/2.svg)
Document Created: 2018-01-23 01:08:33
Document Modified: 2018-01-23 01:08:33
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by July 23, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Jenny Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246, [email protected] | |
| FR Citation | 83 FR 3163 |
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