83 FR 46878 - Determination of Status as a Qualified Facility Under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 180 (September 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 180 (September 17, 2018)
| Page Range | 46878-46879 | |
| FR Document | 2018-20109 |
[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)] [Rules and Regulations] [Pages 46878-46879] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20109] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 117 and 507 [Docket No. FDA-2016-D-1164] Determination of Status as a Qualified Facility Under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules; 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 a final guidance for industry entitled ``Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Guidance for Industry.'' This guidance explains our current thinking on how to determine whether a facility is a ``qualified facility'' that is subject to modified requirements under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' (the Preventive Controls for Human Food Rule) or under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals'' (the Preventive Controls for Animal Food Rule). This guidance also explains our current thinking on how a facility would submit Form FDA 3942a, attesting to its status as a qualified facility under the Preventive Controls for Human Food Rule and how a business would submit Form FDA 3942b, attesting to its status as a qualified facility under the Preventive Controls for Animal Food Rule. DATES: The announcement of the guidance is published in the Federal Register on September 17, 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-2016-D-1164 for ``Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; 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 [[Page 46879]] office 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. Submit written requests for single copies of the draft guidance to the Office of Food Safety (HFS-300), 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 draft guidance. FOR FURTHER INFORMATION CONTACT: For questions relating to the guidance as it applies to 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 the guidance as it applies to animal food: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240- 402-6246. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ``Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk- Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Guidance for Industry.'' We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). This guidance 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. In the Federal Register of May 16, 2016 (81 FR 30219), we made available a draft guidance for industry entitled ``Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)'' and gave interested parties an opportunity to submit comments by November 14, 2016, for us to consider before beginning work on the final version of the guidance. We received a couple of comments on the draft guidance and have modified the final guidance where appropriate. Changes to the guidance include: (1) Clarification regarding recordkeeping and FDA review of records, (2) clarification regarding how a facility can meet the definition of a ``very small business,'' (3) addition of new examples of calculations, and (4) explanation of a simpler method for determining whether a facility's 3-year average of food sales and food market value is below the inflation adjusted threshold for a ``very small business.'' In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated May 16, 2016. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that 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 117.201 and 507.7 have been approved under 0910-0854. The guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in part 117 have been approved under OMB control number 0910-0751. The collections of information in part 507 have been approved under OMB control number 0910-0789. III. 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. IV. References The following references are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. FDA 2016: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food): Instructions for Submitting Your Attestation. Accessible at: https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm. 2. FDA 2017: Form FDA 3942a. Accessible at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/ListFormsAlphabetically/default.htm. 3. FDA 2017: Form FDA 3942b. Accessible at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/ListFormsAlphabetically/default.htm. Dated: September 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20109 Filed 9-14-18; 8:45 am] BILLING CODE 4164-01-P
![46878 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations
(3) Misrepresentations as to the time to the provisions of section 46316 of the ADDRESSES: You may submit either
of departure or arrival, points served, Statute; or other lawful sanctions electronic or written comments on
route to be flown, stops to be made, or including revocation of operating Agency guidances at any time as
total trip-time from point of departure to authority. follows:
destination. [FR Doc. 2018–18345 Filed 9–14–18; 8:45 am] Electronic Submissions
(4) Misrepresentations as to the BILLING CODE 4910–9X–P
qualifications of pilots or safety record Submit electronic comments in the
or certification of pilots, aircraft, or air following way:
carriers. • Federal eRulemaking Portal:
(5) Misrepresentations that passengers DEPARTMENT OF HEALTH AND https://www.regulations.gov. Follow the
are directly insured when they are not HUMAN SERVICES instructions for submitting comments.
so insured. For example, where the only Comments submitted electronically,
insurance in force is that protecting the Food and Drug Administration including attachments, to https://
air taxi operator or commuter air carrier www.regulations.gov will be posted to
in the event of liability. 21 CFR Parts 117 and 507 the docket unchanged. Because your
(6) Misrepresentations as to fares or comment will be made public, you are
charges for air transportation or services [Docket No. FDA–2016–D–1164] solely responsible for ensuring that your
in connection therewith. comment does not include any
(7) Misrepresentations as to Determination of Status as a Qualified confidential information that you or a
membership in or involvement with an Facility Under the Current Good third party may not wish to be posted,
organization that audits direct air Manufacturing Practice, Hazard such as medical information, your or
carriers or that the direct air carrier to Analysis, and Risk-Based Preventive anyone else’s Social Security number, or
be used for a flight meets a standard set Controls for Human and Animal Food confidential business information, such
by an auditing organization. Rules; Guidance for Industry; as a manufacturing process. Please note
(8) Representing that a contract for a Availability that if you include your name, contact
specified direct air carrier, aircraft, AGENCY: Food and Drug Administration, information, or other information that
flight, or time has been arranged HHS. identifies you in the body of your
without a binding commitment with a comments, that information will be
direct air carrier for the furnishing of ACTION: Notification of availability. posted on https://www.regulations.gov.
such transportation as represented. SUMMARY: The Food and Drug • If you want to submit a comment
(9) Selling or contracting for air Administration (FDA, we, or Agency) is with confidential information that you
transportation while knowing or having announcing the availability of a final do not wish to be made available to the
reason to know or believe that such air guidance for industry entitled public, submit the comment as a
transportation cannot be legally ‘‘Determination of Status as a Qualified written/paper submission and in the
performed by the direct air carrier or Facility Under Part 117: Current Good manner detailed (see ‘‘Written/Paper
foreign direct air carrier that is to Manufacturing Practice, Hazard Submissions’’ and ‘‘Instructions’’).
perform the air transportation. Analysis, and Risk-Based Preventive
(10) Misrepresentations as to the Written/Paper Submissions
Controls for Human Food and Part 507: Submit written/paper submissions as
requirements that must be met by
Current Good Manufacturing Practice, follows:
charterers in order to qualify for charter
Hazard Analysis, and Risk-Based • Mail/Hand delivery/Courier (for
flights.
Preventive Controls for Food for written/paper submissions): Dockets
(11) Using or displaying or permitting
Animals; Guidance for Industry.’’ This Management Staff (HFA–305), Food and
or suffering to be used or displayed the
guidance explains our current thinking Drug Administration, 5630 Fishers
name, tradename, slogan or any
on how to determine whether a facility Lane, Rm. 1061, Rockville, MD 20852.
abbreviation thereof, of an air charter
is a ‘‘qualified facility’’ that is subject to • For written/paper comments
broker in advertisements, on or in
modified requirements under our rule submitted to the Dockets Management
places of business, or on or in aircraft
entitled ‘‘Current Good Manufacturing Staff, FDA will post your comment, as
or any other place in connection with
Practice, Hazard Analysis, and Risk- well as any attachments, except for
the name of the air taxi or commuter air
Based Preventive Controls for Human information submitted, marked and
carrier in such manner that it may
Food’’ (the Preventive Controls for identified, as confidential, if submitted
mislead or confuse potential consumers
Human Food Rule) or under our rule as detailed in ‘‘Instructions.’’
with respect to the status of the air
entitled ‘‘Current Good Manufacturing Instructions: All submissions received
charter broker.
Practice, Hazard Analysis, and Risk- must include the Docket No. FDA–
§ 298.92 Enforcement. Based Preventive Controls for Food for 2016–D–1164 for ‘‘Determination of
In case of any violation of the Animals’’ (the Preventive Controls for Status as a Qualified Facility Under Part
provisions of the Statute, or this part, or Animal Food Rule). This guidance also 117: Current Good Manufacturing
any other rule, regulation, or order explains our current thinking on how a Practice, Hazard Analysis, and Risk-
issued under the Statute, the violator facility would submit Form FDA 3942a, Based Preventive Controls for Human
may be subject to a proceeding pursuant attesting to its status as a qualified Food and Part 507: Current Good
to section 46101 of the Statute before facility under the Preventive Controls Manufacturing Practice, Hazard
the Department, or sections 46106 for Human Food Rule and how a Analysis, and Risk-Based Preventive
through 46108 of the Statute before a business would submit Form FDA Controls for Food for Animals;
daltland on DSKBBV9HB2PROD with RULES
U.S. District Court, as the case may be, 3942b, attesting to its status as a Guidance for Industry.’’ Received
to compel compliance therewith; or to qualified facility under the Preventive comments will be placed in the docket
civil penalties pursuant to the Controls for Animal Food Rule. and, except for those submitted as
provisions of section 46301 of the DATES: The announcement of the ‘‘Confidential Submissions,’’ publicly
Statute; or, in the case of a willful guidance is published in the Federal viewable at https://www.regulations.gov
violation, to criminal penalties pursuant Register on September 17, 2018. or at the Dockets Management Staff
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![Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 46879
office between 9 a.m. and 4 p.m., Murphy, Center for Veterinary Medicine 21 CFR 117.201 and 507.7 have been
Monday through Friday. (HFV–200), Food and Drug approved under 0910–0854.
• Confidential Submissions—To Administration, 7519 Standish Pl., The guidance also refers to previously
submit a comment with confidential Rockville, MD 20855, 240–402–6246. approved collections of information
information that you do not wish to be SUPPLEMENTARY INFORMATION: found in FDA regulations. The
made publicly available, submit your collections of information in part 117
comments only as a written/paper I. Background have been approved under OMB control
submission. You should submit two We are announcing the availability of number 0910–0751. The collections of
copies total. One copy will include the a guidance for industry entitled information in part 507 have been
information you claim to be confidential ‘‘Determination of Status as a Qualified approved under OMB control number
with a heading or cover note that states Facility Under Part 117: Current Good 0910–0789.
‘‘THIS DOCUMENT CONTAINS Manufacturing Practice, Hazard
CONFIDENTIAL INFORMATION.’’ The III. Electronic Access
Analysis, and Risk-Based Preventive
Agency will review this copy, including Controls for Human Food and Part 507: Persons with access to the internet
the claimed confidential information, in Current Good Manufacturing Practice, may obtain the draft guidance at either
its consideration of comments. The Hazard Analysis, and Risk-Based https://www.fda.gov/FoodGuidances or
second copy, which will have the Preventive Controls for Food for https://www.regulations.gov. Use the
claimed confidential information Animals; Guidance for Industry.’’ We FDA website listed in the previous
redacted/blacked out, will be available are issuing this guidance consistent sentence to find the most current
for public viewing and posted on version of the guidance.
with our good guidance practices
https://www.regulations.gov. Submit
regulation (21 CFR 10.115). This IV. References
both copies to the Dockets Management
guidance represents the current thinking
Staff. If you do not wish your name and The following references are on
of FDA on this topic. It does not
contact information to be made publicly display at the Dockets Management Staff
establish any rights for any person and
available, you can provide this (see ADDRESSES) and are available for
is not binding on FDA or the public.
information on the cover sheet and not viewing by interested persons between
You can use an alternative approach if
in the body of your comments and you 9 a.m. and 4 p.m., Monday through
it satisfies the requirements of the
must identify this information as Friday; they are also available
applicable statutes and regulations. This
‘‘confidential.’’ Any information marked electronically at https://
as ‘‘confidential’’ will not be disclosed guidance is not subject to Executive
Order 12866. www.regulations.gov. FDA has verified
except in accordance with 21 CFR 10.20 the website addresses, as of the date this
and other applicable disclosure law. For In the Federal Register of May 16,
2016 (81 FR 30219), we made available document publishes in the Federal
more information about FDA’s posting Register, but websites are subject to
of comments to public dockets, see 80 a draft guidance for industry entitled
‘‘Qualified Facility Attestation Using change over time.
FR 56469, September 18, 2015, or access
Form FDA 3942a (for Human Food) or 1. FDA 2016: Qualified Facility Attestation
the information at: https://www.gpo.gov/ Using Form FDA 3942a (for Human
fdsys/pkg/FR-2015-09-18/pdf/2015- Form FDA 3942b (for Animal Food)’’
and gave interested parties an Food) or Form FDA 3942b (for Animal
23389.pdf. Food): Instructions for Submitting Your
Docket: For access to the docket to opportunity to submit comments by
Attestation. Accessible at: https://
read background documents or the November 14, 2016, for us to consider www.fda.gov/Food/GuidanceRegulation/
electronic and written/paper comments before beginning work on the final FoodFacilityRegistration/default.htm.
received, go to https:// version of the guidance. We received a 2. FDA 2017: Form FDA 3942a. Accessible at:
www.regulations.gov and insert the couple of comments on the draft https://www.fda.gov/AboutFDA/
docket number, found in brackets in the guidance and have modified the final ReportsManualsForms/Forms/
heading of this document, into the guidance where appropriate. Changes to ListFormsAlphabetically/default.htm.
the guidance include: (1) Clarification 3. FDA 2017: Form FDA 3942b. Accessible at:
‘‘Search’’ box and follow the prompts
regarding recordkeeping and FDA https://www.fda.gov/AboutFDA/
and/or go to the Dockets Management ReportsManualsForms/Forms/
Staff, 5630 Fishers Lane, Rm. 1061, review of records, (2) clarification
ListFormsAlphabetically/default.htm.
Rockville, MD 20852. regarding how a facility can meet the
Submit written requests for single definition of a ‘‘very small business,’’ (3) Dated: September 11, 2018.
copies of the draft guidance to the Office addition of new examples of Leslie Kux,
of Food Safety (HFS–300), Center for calculations, and (4) explanation of a Associate Commissioner for Policy.
Food Safety and Applied Nutrition, simpler method for determining [FR Doc. 2018–20109 Filed 9–14–18; 8:45 am]
Food and Drug Administration, 5001 whether a facility’s 3-year average of BILLING CODE 4164–01–P
Campus Dr., College Park, MD 20740. food sales and food market value is
Send two self-addressed adhesive labels below the inflation adjusted threshold
to assist that office in processing your for a ‘‘very small business.’’ In addition, DEPARTMENT OF HOMELAND
request. See the SUPPLEMENTARY editorial changes were made to improve SECURITY
INFORMATION section for electronic clarity. The guidance announced in this
access to the draft guidance. notice finalizes the draft guidance dated Coast Guard
FOR FURTHER INFORMATION CONTACT: For May 16, 2016.
questions relating to the guidance as it II. Paperwork Reduction Act of 1995 33 CFR Part 117
daltland on DSKBBV9HB2PROD with RULES
applies to human food: Jenny Scott,
This guidance contains information [Docket No. USCG–2018–0761]
Center for Food Safety and Applied
Nutrition (HFS–300), Food and Drug collection provisions that are subject to Drawbridge Operation Regulation;
Administration, 5001 Campus Dr., review by the Office of Management and James River, Isle of Wight and
College Park, MD 20740, 240–402–2166. Budget (OMB) under the Paperwork Newport News, VA
For questions relating to the guidance Reduction Act of 1995 (44 U.S.C. 3501–
as it applies to animal food: Jeanette 3520). The collections of information in AGENCY: Coast Guard, DHS.
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Document Created: 2018-09-15 01:37:46
Document Modified: 2018-09-15 01:37:46
| 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 | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on September 17, 2018. | |
| Contact | For questions relating to the guidance as it applies to 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. | |
| FR Citation | 83 FR 46878 | |
| CFR Citation | 21
CFR
117 21 CFR 507 |
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