[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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