83 FR 28651 - Mitigation Strategies To Protect Food Against Intentional Adulteration; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 119 (June 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 119 (June 20, 2018)
| Page Range | 28651-28652 | |
| FR Document | 2018-13222 |
[Federal Register Volume 83, Number 119 (Wednesday, June 20, 2018)] [Notices] [Pages 28651-28652] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-13222] [[Page 28651]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1398] Mitigation Strategies To Protect Food Against Intentional Adulteration; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.'' This draft guidance document, when finalized, will help food facilities that manufacture, process, pack, or hold food, and that are required to register under the Federal Food, Drug, and Cosmetic Act (FD&C Act) comply with the requirements of our regulation entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.'' DATES: Submit either electronic or written comments on the draft guidance by December 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2018-D-1398 for ``Mitigation Strategies to Protect Food Against Intentional Adulteration: 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.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 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Ryan Newkirk, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-3712, [email protected]. 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. FSMA enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA added to the FD&C Act several new sections that reference intentional adulteration. For example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d). Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk. We are announcing the availability of a draft guidance for industry entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.'' This multi-chapter draft guidance for industry is intended to help food facilities required to comply develop and implement some of the components of a food defense plan, and meet other requirements under 21 CFR part 121. We are announcing the availability of the following chapters: Introduction Chapter One--The Food Defense Plan Chapter Two--Vulnerability Assessment to Identify Significant [[Page 28652]] Vulnerabilities and Actionable Process Steps Chapter Three--Mitigation Strategies for Actionable Process Steps Chapter Four--Mitigation Strategies Management Components: Food Defense Monitoring Appendix--Food Defense Plan Worksheets We intend to announce the availability for public comment of additional and expanded 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 food defense measures against intentional adulteration for the regulation ``Mitigation Strategies to Protect Food Against Intentional Adulteration.'' 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 21 CFR 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/RegulatoryInformation/Guidances/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: June 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-13222 Filed 6-19-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 119 / Wednesday, June 20, 2018 / Notices 28651
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper electronic and written/paper comments
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). received, go to https://
www.regulations.gov and insert the
Food and Drug Administration Written/Paper Submissions
docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
[Docket No. FDA–2018–D–1398] follows: ‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for and/or go to the Dockets Management
Mitigation Strategies To Protect Food written/paper submissions): Dockets
Against Intentional Adulteration; Draft Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and Rockville, MD 20852.
Guidance for Industry; Availability Drug Administration, 5630 Fishers You may submit comments on any
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
HHS. • For written/paper comments 10.115(g)(5)).
submitted to the Dockets Management Submit written requests for single
ACTION: Notice of availability. Staff, FDA will post your comment, as copies of the guidance to the Center for
SUMMARY: The Food and Drug well as any attachments, except for Food Safety and Applied Nutrition,
Administration (FDA, we, or Agency) is information submitted, marked and Food and Drug Administration, 5001
announcing the availability of a draft identified, as confidential, if submitted Campus Dr., College Park, MD 20740.
guidance for industry entitled as detailed in ‘‘Instructions.’’ Send two self-addressed adhesive labels
Instructions: All submissions received to assist that office in processing your
‘‘Mitigation Strategies to Protect Food
must include the Docket No. FDA– requests. See the SUPPLEMENTARY
Against Intentional Adulteration:
2018–D–1398 for ‘‘Mitigation Strategies INFORMATION section for electronic
Guidance for Industry.’’ This draft
to Protect Food Against Intentional access to the draft guidance document.
guidance document, when finalized,
Adulteration: Guidance for Industry.’’ FOR FURTHER INFORMATION CONTACT:
will help food facilities that
Received comments will be placed in Ryan Newkirk, Center for Food Safety
manufacture, process, pack, or hold
the docket and, except for those and Applied Nutrition (HFS–005), Food
food, and that are required to register
submitted as ‘‘Confidential and Drug Administration, 5001 Campus
under the Federal Food, Drug, and
Submissions,’’ publicly viewable at Dr., College Park, MD 20740, 240–402–
Cosmetic Act (FD&C Act) comply with
https://www.regulations.gov or at the 3712, ryan.newkirk@fda.hhs.gov.
the requirements of our regulation
Dockets Management Staff between 9
entitled ‘‘Mitigation Strategies to Protect SUPPLEMENTARY INFORMATION:
a.m. and 4 p.m., Monday through
Food Against Intentional Adulteration.’’ I. Background
Friday.
DATES: Submit either electronic or • Confidential Submissions—To The FDA Food Safety Modernization
written comments on the draft guidance submit a comment with confidential Act (FSMA) (Pub. L. 111–353) enables
by December 17, 2018 to ensure that the information that you do not wish to be FDA to better protect public health by
Agency considers your comment on this made publicly available, submit your helping to ensure the safety and security
draft guidance before it begins work on comments only as a written/paper of the food supply. FSMA enables FDA
the final version of the guidance. submission. You should submit two to focus more on preventing food safety
ADDRESSES: You may submit comments copies total. One copy will include the problems rather than relying primarily
on any guidance at any time as follows: information you claim to be confidential on reacting to problems after they occur.
with a heading or cover note that states FSMA added to the FD&C Act several
Electronic Submissions
‘‘THIS DOCUMENT CONTAINS new sections that reference intentional
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The adulteration. For example, section 418
following way: Agency will review this copy, including of the FD&C Act (21 U.S.C. 350g)
• Federal eRulemaking Portal: the claimed confidential information, in addresses intentional adulteration in the
https://www.regulations.gov. Follow the its consideration of comments. The context of facilities that manufacture,
instructions for submitting comments. second copy, which will have the process, pack, or hold food, and that are
Comments submitted electronically, claimed confidential information required to register under section 415
including attachments, to https:// redacted/blacked out, will be available (21 U.S.C. 350d). Section 420 of the
www.regulations.gov will be posted to for public viewing and posted on FD&C Act (21 U.S.C. 350i) addresses
the docket unchanged. Because your https://www.regulations.gov. Submit intentional adulteration in the context
comment will be made public, you are both copies to the Dockets Management of high-risk foods and exempts farms
solely responsible for ensuring that your Staff. If you do not wish your name and except for farms that produce milk.
comment does not include any contact information to be made publicly We are announcing the availability of
confidential information that you or a available, you can provide this a draft guidance for industry entitled
third party may not wish to be posted, information on the cover sheet and not ‘‘Mitigation Strategies to Protect Food
such as medical information, your or in the body of your comments and you Against Intentional Adulteration:
anyone else’s Social Security number, or must identify this information as Guidance for Industry.’’ This multi-
confidential business information, such ‘‘confidential.’’ Any information marked chapter draft guidance for industry is
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed intended to help food facilities required
that if you include your name, contact except in accordance with 21 CFR 10.20 to comply develop and implement some
information, or other information that and other applicable disclosure law. For of the components of a food defense
identifies you in the body of your
sradovich on DSK3GMQ082PROD with NOTICES
more information about FDA’s posting plan, and meet other requirements
comments, that information will be of comments to public dockets, see 80 under 21 CFR part 121. We are
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access announcing the availability of the
• If you want to submit a comment the information at: https://www.gpo.gov/ following chapters:
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- • Introduction
do not wish to be made available to the 23389.pdf. • Chapter One—The Food Defense Plan
public, submit the comment as a Docket: For access to the docket to • Chapter Two—Vulnerability
written/paper submission and in the read background documents or the Assessment to Identify Significant
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![28652 Federal Register / Vol. 83, No. 119 / Wednesday, June 20, 2018 / Notices
Vulnerabilities and Actionable DEPARTMENT OF HEALTH AND maintenance, dissemination and
Process Steps HUMAN SERVICES adoption of named code sets; (3) Discuss
• Chapter Three—Mitigation Strategies opportunities for improved governance,
National Committee on Vital and Health coordination and communication across
for Actionable Process Steps
Statistics: Meeting terminology and vocabulary developers
• Chapter Four—Mitigation Strategies and their stakeholders; (4) Identify top
Management Components: Food Pursuant to the Federal Advisory
priority gaps in the U.S. health
Defense Monitoring Committee Act, the Department of
terminology and vocabulary coverage;
Health and Human Services (HHS)
• Appendix—Food Defense Plan announces the following advisory
and (5) Envision a roadmap for
Worksheets introducing improvements over the next
committee meeting.
Name: National Committee on Vital decade. Invited experts will have the
We intend to announce the
and Health Statistics (NCVHS), opportunity to provide extensive input
availability for public comment of
Standards Subcommittee Meeting. to the subcommittee as it studies these
additional and expanded chapters of the questions and finalizes an
draft guidance as we complete them. Date and Times: Tuesday, July 17,
2018: 9:00 a.m.–5:00 p.m. (EDT), Environmental Scan report of the
II. Significance of Guidance Wednesday, July 18, 2018: 8:30 a.m.– current state of the U.S. health
3:00 p.m. (EDT) terminology and vocabulary (T/V)
This level 1 draft guidance is being Place: U.S. Department of Health and environment.
issued consistent with FDA’s good Human Services, Hubert H. Humphrey The times and topics for this meeting
guidance practices regulation (21 CFR Building, 200 Independence Avenue are subject to change. Please refer to the
10.115). The draft guidance, when SW, Rm. 705A, Washington, DC 20201. posted agenda for any updates.
finalized, will represent the current Status: Open. There will be three Contact Persons for More Information:
thinking of FDA on food defense opportunities for public comment Substantive program information may
measures against intentional during the meeting: At the end of the be obtained from Rebecca Hines, MHS,
adulteration for the regulation first day, at the end of the morning of Executive Secretary, NCVHS, National
‘‘Mitigation Strategies to Protect Food the second day, and prior to the meeting Center for Health Statistics, Centers for
Against Intentional Adulteration.’’ It close on the second day. Disease Control and Prevention, 3311
does not establish any rights for any Purpose: The NCVHS Charter Toledo Road, Hyattsville, Maryland
person and is not binding on FDA or the stipulates that the Committee study the 20782, telephone (301) 458–4715.
public. You can use an alternative issues related to the adoption of uniform Information pertaining to meeting
approach if it satisfies the requirements data standards for patient medical content may be obtained from Vivian
of the applicable statutes and record information and the electronic Auld, National Institutes of Health,
regulations. This guidance is not subject exchange of such information and report National Library of Medicine, 8600
to Executive Order 12866. to the Secretary of Health and Human Rockville Pike, Bethesda, Maryland,
Services (HHS) with recommendations 20894–3833, telephone (301) 496–7974.
III. Paperwork Reduction Act of 1995 and legislative proposals for such Summaries of meetings and a roster of
standards and electronic exchange. Committee members are available on the
This draft guidance refers to NCVHS also is charged with advising NCVHS website: www.ncvhs.hhs.gov,
previously approved collections of HHS on health data collection needs where further information including a
information found in FDA regulations. and strategies, and reviewing and meeting agenda and instructions to
These collections of information are monitoring the Department’s data and access the live audio broadcast of the
subject to review by the Office of information systems to identify needs, meeting will be posted.
Management and Budget (OMB) under opportunities, and problems. Should you require reasonable
the Paperwork Reduction Act of 1995 In this regard, NCVHS is taking a accommodation, please contact the CDC
(44 U.S.C. 3501–3520). The collections contemporary look at the health Office of Equal Employment
of information in 21 CFR part 507 have terminology and vocabulary landscape Opportunity on (770) 488–3210 as soon
been approved under OMB control in order to advise the HHS Secretary as possible.
number 0910–0789. regarding: (1) The changing
Dated: June 14, 2018.
environment and implications for
IV. Electronic Access timing and approach to health Laina Bush,
terminology and vocabulary standards Deputy Assistant Secretary for Planning and
Persons with access to the internet Evaluation, Office of the Assistant Secretary
may obtain the draft guidance at either adoption; (2) Needs, opportunities, and
for Planning and Evaluation.
https://www.fda.gov/Regulatory problems with development,
dissemination, maintenance, and [FR Doc. 2018–13179 Filed 6–19–18; 8:45 am]
Information/Guidances/default.htm or
adoption of health terminology and BILLING CODE 4151–05–P
https://www.regulations.gov. Use the
vocabulary standards; and (3) Actions
FDA website listed in the previous
that HHS might take to improve
sentence to find the most current development, dissemination, DEPARTMENT OF HEALTH AND
version of the guidance. maintenance, and adoption of HUMAN SERVICES
Dated: June 12, 2018. standards. National Institutes of Health
NCVHS is holding an expert
sradovich on DSK3GMQ082PROD with NOTICES
Leslie Kux,
Associate Commissioner for Policy. roundtable meeting, in conjunction with National Cancer Institute; Notice of
the National Library of Medicine (NLM) Closed Meetings
[FR Doc. 2018–13222 Filed 6–19–18; 8:45 am]
in order to: (1) Assess strengths,
BILLING CODE 4164–01–P
weaknesses and gaps in the U.S. health Pursuant to section 10(d) of the
terminology and vocabulary (T/V) Federal Advisory Committee Act, as
environment; (2) Consider areas for near amended, notice is hereby given of the
term improvement in the development, following meetings.
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Document Created: 2018-06-20 00:20:16
Document Modified: 2018-06-20 00:20:16
| 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 December 17, 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 | Ryan Newkirk, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-3712, [email protected] | |
| FR Citation | 83 FR 28651 |
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