[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Rules and Regulations]
[Pages 23919-23920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2020-D-1304]


Temporary Policy Regarding Accredited Third-Party Certification 
Program Onsite Observation and Certificate Duration Requirements During 
the COVID-19 Public Health Emergency: Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance for industry entitled 
``Temporary Policy Regarding Accredited Third-Party Certification 
Program Onsite Observation and Certificate Duration Requirements During 
the COVID-19 Public Health Emergency.'' Given the public health 
emergency presented by COVID-19, this guidance document is being 
implemented without prior public comment because FDA has determined 
that prior public participation is not feasible or appropriate, but it 
remains subject to comment in accordance with the Agency's good 
guidance practices. The guidance communicates the Agency's intention 
not to enforce certain requirements for the onsite monitoring 
activities and certificates for the currently recognized accreditation 
bodies (ABs) and accredited third-party certification bodies (CBs) in 
the Accredited Third-Party Certification Program for human and animal 
food in certain circumstances. Because travel restrictions and 
advisories related to COVID-19 may impact the ability of recognized ABs 
and accredited CBs to conduct onsite activities, this guidance provides 
temporary flexibility so that recognized ABs can maintain the 
accreditations of their CBs, and so that already-issued certifications 
need not lapse, in certain circumstances.

DATES: The announcement of the guidance is published in the Federal 
Register on April 30, 2020.

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

[[Page 23920]]

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-2020-D-1304 for ``Temporary Policy Regarding Accredited Third-Party 
Certification Program Onsite Observation and Certificate Duration 
Requirements During the COVID-19 Public Health Emergency.'' 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.govinfo.gov/content/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 Sec.  
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of the guidance to the 
Office of Compliance, Center for Food Safety and Applied Nutrition, 
Food and Drug Administration (HFS-607), 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 guidance.

FOR FURTHER INFORMATION CONTACT: Doriliz De Leon, Center for Food 
Safety and Applied Nutrition (HFS-607), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2772.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Temporary Policy Regarding Accredited Third-Party 
Certification Program Onsite Observation and Certificate Duration 
Requirements During the COVID-19 Public Health Emergency.'' This policy 
relates to the circumstances that gave rise to the public health 
emergency related to COVID-19 declared by the Department of Health and 
Human Services.
    Given this public health emergency this guidance is being 
implemented without prior public comment because FDA has determined 
that prior public participation for this guidance is not feasible or 
appropriate. This guidance document is being implemented immediately, 
but it remains subject to comment in accordance with the Agency's good 
guidance practices. The guidance represents the current thinking of FDA 
on this topic and should be viewed only as recommendations, unless 
specific regulatory or statutory requirements are cited.
    This guidance document concerns certain requirements for the 
recognized ABs and accredited CBs in the Accredited Third-Party 
Certification Program that was established in 21 CFR part 1, subpart M, 
as part of our implementation of the FDA Food Safety Modernization Act 
(Pub. L. 111-353). The Accredited Third-Party Certification Program 
regulation (https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-accredited-third-party-certification) requires 
recognized ABs to monitor the performance of the CB(s) they accredited. 
While some of the monitoring activities can be conducted remotely, some 
of the activities must be conducted onsite. The Accredited Third-Party 
Certification Program regulation also requires that accredited CBs can 
issue certificates for a term only up to 12 months.
    Due to the impact of the travel restrictions and advisories related 
to COVID-19, this guidance provides flexibility to the recognized ABs 
and accredited CBs in the Accredited Third-Party Certification Program 
for certain requirements related to the onsite monitoring activities 
and certificates that have already been issued, in certain 
circumstances.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of 
information. 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. 3501-3521). The collections of information in in 
part 1, subpart M, have been approved under OMB control number 0910-
0750.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/FoodGuidances, https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19 
or https://www.regulations.gov. Use the FDA website listed in the 
previous sentence to find the most current version of the guidance.

    Dated: April 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09169 Filed 4-29-20; 8:45 am]
BILLING CODE 4164-01-P