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Notice2023-23677

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry; Availability

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Published
October 26, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities." FDA is issuing this draft guidance to describe how we request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at facilities covered under FDA's bioresearch monitoring program. FDA may consider the use of a remote interactive evaluation for any of the inspection program areas described in the guidance. FDA is also announcing the withdrawal of the guidance entitled "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency."

Full Text

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<title>Federal Register, Volume 88 Issue 206 (Thursday, October 26, 2023)</title>
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[Federal Register Volume 88, Number 206 (Thursday, October 26, 2023)]
[Notices]
[Pages 73602-73603]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-23677]



[[Page 73602]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4416]


Remote Interactive Evaluations of Drug Manufacturing and 
Bioresearch Monitoring Facilities; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Remote 
Interactive Evaluations of Drug Manufacturing and Bioresearch 
Monitoring Facilities.'' FDA is issuing this draft guidance to describe 
how we request and conduct voluntary remote interactive evaluations at 
facilities where drugs are manufactured, processed, packed, compounded, 
or held, and at facilities covered under FDA's bioresearch monitoring 
program. FDA may consider the use of a remote interactive evaluation 
for any of the inspection program areas described in the guidance. FDA 
is also announcing the withdrawal of the guidance entitled ``Remote 
Interactive Evaluations of Drug Manufacturing and Bioresearch 
Monitoring Facilities During the COVID-19 Public Health Emergency.''

DATES: Submit either electronic or written comments on the draft 
guidance by December 26, 2023 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:
    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2023-D-4416 for ``Remote Interactive Evaluations of Drug 
Manufacturing and Bioresearch Monitoring Facilities.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
    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 draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or 
the Policy and Regulations Staff (HFV-6), Center for Veterinary 
Medicine (CVM), 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: Tina Kiang, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 4374, Silver Spring, MD 20993-0002, 301-796-6487; or Anne 
Taylor, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911; or CVM at <a href="/cdn-cgi/l/email-protection#b0f1c3dbf3e6fdf0d6d4d19ed8d8c39ed7dfc6"><span class="__cf_email__" data-cfemail="bdfcced6feebf0fddbd9dc93d5d5ce93dad2cb">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Remote Interactive Evaluations of Drug Manufacturing and 
Bioresearch Monitoring Facilities.'' FDA is issuing this draft guidance 
to describe how we request and conduct voluntary remote interactive 
evaluations at: (1) facilities where drugs are manufactured, processed, 
packed, or held; (2) facilities covered under FDA's bioresearch

[[Page 73603]]

monitoring program; and (3) outsourcing facilities registered under 
section 503B (21 U.S.C. 356b) of the FD&C Act. FDA may consider the use 
of a remote interactive evaluation for any of the inspection program 
areas described in the draft guidance.
    During the Coronavirus Disease 2019 (COVID-19) pandemic, FDA 
expanded our use of alternative tools for evaluating drug manufacturing 
facilities to support regulatory decision-making. When an inspection 
was not feasible or practical because of the public health emergency 
(PHE), FDA used other available tools and information to support 
regulatory decisions and oversight of facilities. FDA announced its 
policy for using these alternative tools in a guidance entitled 
``Remote Interactive Evaluations of Drug Manufacturing and Bioresearch 
Monitoring Facilities During the COVID-19 Public Health Emergency'' 
posted in April 2021 and announced in the Federal Register on May 27, 
2021 (86 FR 28627) (``2021 COVID-19 Remote Interactive Evaluations 
Guidance''). FDA issued the guidance to communicate its policy for the 
duration of the COVID-19 PHE declared by the Secretary of Health and 
Human Services (HHS) on January 31, 2020, including any renewals made 
by the HHS Secretary in accordance with section 319(a)(2) of the Public 
Health Service Act (42 U.S.C. 247d(a)(2)). Furthermore, in the Federal 
Register of March 13, 2023 (88 FR 15417) FDA listed the: (1) guidances 
that will no longer be effective with the expiration of the PHE 
declaration, (2) guidances that FDA was revising to continue in effect 
for 180 days after the expiration of the PHE declaration to provide a 
period for stakeholder transition and then would no longer be in 
effect, and (3) guidances that FDA was revising to continue in effect 
for 180 days after the expiration of the PHE declaration during which 
time FDA planned to further revise the guidances. The 2021 COVID-19 
Remote Interactive Evaluations Guidance is included in the latter 
category and was revised to remain in effect for 180 days post 
expiration of the PHE declaration. Although the HHS Secretary of has 
announced that the COVID-19 public health emergency declaration has 
ended and FDA has largely resumed inspections, FDA has determined that 
continued use of alternative tools, including remote interactive 
evaluations, based on risk and program needs, will enhance our ability 
to assess facilities.
    This draft guidance describes the various remote interactive tools 
we may request to use to conduct an evaluation. In this draft guidance, 
we refer to our use of any combination of these interactive tools as a 
remote interactive evaluation. FDA may request to conduct a remote 
interactive evaluation prior to or following other types of regulatory 
oversight activities (e.g., an inspection or a request for records or 
other information). In preparing this draft guidance, FDA considered 
comments received on the 2021 COVID-19 Remote Interactive Evaluations 
Guidance.
    This 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 ``Remote 
Interactive Evaluations of Drug Manufacturing and Bioresearch 
Monitoring Facilities.'' 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.
    FDA also is announcing that the 2021 COVID-19 Remote Interactive 
Evaluations Guidance will be withdrawn upon publication of this draft 
guidance. FDA has determined that the 2021 COVID-19 Remote Interactive 
Evaluations Guidance is no longer needed because this new draft 
guidance is available and its recommendations, when finalized, will be 
applicable outside the context of the COVID-19 public health emergency.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA). The collections of information in 21 CFR part 312 
have been approved under OMB control number 0910-0014. The collections 
of information in 21 CFR part 314 have been approved under OMB control 
number 0910-0001. The collections of information in 21 CFR part 58 
pertaining to good laboratory practices have been approved under OMB 
control number 0910-0119. The collection of information pertaining to 
current good manufacturing practices have been approved under OMB 
control number 0910-0139. The collections of information relating to 
the registration of human drug compounding outsourcing facilities under 
section 503B of the FD&C Act and associated fees under section 744K of 
the FD&C Act (21 U.S.C. 379j-62) have been approved under OMB control 
number 0910-0776. The collections of information pertaining to human 
drug compounding under sections 503A (21 U.S.C. 356a) and 503B of the 
FD&C Act have been approved under OMB control number 0910-0800. The 
collections of information in 21 CFR part 11 have been approved under 
OMB control number 0910-0303. The collections of information in 21 CFR 
parts 50 and 56 have been approved under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

    Dated: October 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23677 Filed 10-25-23; 8:45 am]
BILLING CODE 4164-01-P


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