[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18247-18249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1057]


Notifying the Food and Drug Administration of a Permanent 
Discontinuance or Interruption in Manufacturing Under Section 506C of 
the Federal Food, Drug, and Cosmetic Act; 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 guidance for industry entitled ``Notifying FDA of 
a Permanent Discontinuance or Interruption in Manufacturing Under 
Section 506C of the FD&C Act.'' Due to the Coronavirus Disease 2019 
(COVID-19) pandemic, FDA has been closely monitoring the medical 
product supply chain with the expectation that it may be impacted by 
the COVID-19 outbreak, potentially leading to supply disruptions or 
shortages of drug and biological products in the United States. The 
guidance is intended to assist applicants and manufacturers in 
providing FDA timely, informative notifications about changes in the 
production of certain drugs and biological products that will, in turn, 
help the Agency in its efforts to prevent or mitigate shortages of such 
products. 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. In addition, this 
guidance is intended to remain in effect for the duration of the public 
health emergency related to COVID-19 declared by the Department of 
Health and Human Services (HHS). However, the recommendations and 
processes described in the guidance are expected to assist the Agency 
more broadly in its efforts to prevent and mitigate shortages, 
including under circumstances outside of the COVID-19 public health 
emergency and reflect the Agency's current thinking on this issue. 
Therefore, within 60 days following the termination of the public 
health emergency, FDA intends to revise and replace this guidance with 
any appropriate changes following the public health emergency and in 
consideration of comments received on this guidance and the Agency's 
experience with implementation.

DATES: The announcement of the guidance is published in the Federal 
Register on April 1, 2020. The guidance document is immediately in 
effect, but it remains subject to comment in accordance with the 
Agency's good guidance practices.

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-2020-D-1057 for ``Notifying FDA of a Permanent Discontinuance or 
Interruption in Manufacturing Under Section 506C of the FD&C Act.'' 
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

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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 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the 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; or to 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. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jin Ahn, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 6234, Silver Spring, MD 20993-0002, 301-796-1300; or 
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Notifying FDA of a Permanent Discontinuance or Interruption 
in Manufacturing Under Section 506C of the FD&C Act.'' This guidance 
discusses the requirement in section 506C of the FD&C Act (21 U.S.C. 
356c) and FDA's implementing regulations for applicants and 
manufacturers to notify FDA of a permanent discontinuance in the 
manufacture of certain products or an interruption in the manufacture 
of certain products that is likely to lead to a meaningful disruption 
in supply of that product in the United States. The guidance recommends 
that applicants and manufacturers provide additional details and follow 
additional procedures to ensure FDA has the specific information it 
needs to help prevent or mitigate shortages. The guidance also explains 
how FDA communicates information about products in shortage to the 
public.
    Timely and detailed notifications from applicants and manufacturers 
play a significant role in decreasing the incidence and duration of 
supply disruptions and shortages. Early, informative notifications are 
the best tool FDA has to help prevent a shortage from occurring or to 
mitigate the impact of an unavoidable shortage. When FDA does not 
receive timely, informative notifications, the Agency's ability to 
respond appropriately is limited and a shortage may result. Therefore, 
FDA is issuing this guidance to assist applicants and manufacturers in 
providing early, detailed notifications that will allow FDA to evaluate 
the situation and take appropriate action. Among other things, the 
guidance explains: (1) Who should notify FDA, (2) when and how such 
notifications should be submitted; and (3) what details to include in 
notifications that will ensure FDA has information it needs to help 
prevent or mitigate shortages.
    In light of the public health emergency related to COVID-19 
declared by the Secretary of HHS, FDA has determined that prior public 
participation for this guidance is not feasible or appropriate and is 
issuing this guidance without prior public comment (see section 
701(h)(1)(C)(i) of the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR 
10.115(g)(2)). This guidance document is being implemented immediately, 
but it remains subject to comment in accordance with the Agency's good 
guidance practice statute and regulation.
    This guidance is intended to remain in effect for the duration of 
the public health emergency related to COVID-19 declared by HHS, 
including any renewals made by the Secretary in accordance with section 
319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). 
However, the recommendations and processes described in the guidance 
are expected to assist the Agency more broadly in its efforts to 
prevent and mitigate shortages, including under circumstances outside 
of the COVID-19 public health emergency, and reflect the Agency's 
current thinking on this issue. Therefore, within 60 days following the 
termination of the public health emergency, FDA intends to revise and 
replace this guidance with any appropriate changes based on comments 
received on this guidance and the Agency's experience with 
implementation.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Notifying FDA of a Permanent 
Discontinuance or Interruption in Manufacturing Under Section 506C of 
the FD&C Act.'' 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.

III. Paperwork Reduction Act of 1995

    The 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 (PRA) (44 U.S.C. 3501-3521). Under 
the PRA, Federal Agencies must obtain approval from OMB for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes Agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Health and Human Services Secretary Alex M. Azar II (Secretary) 
determined that, as a result of confirmed cases of 2019 Novel 
Coronavirus (2019-nCoV), a public health emergency (PHE) exists and has 
existed since January 27, 2020. On March 19, 2020, the Secretary 
waived, pursuant to section 319(f) of the PHS Act (42 U.S.C. 247d(f)) 
and the PHE, the requirements of the PRA for information to be 
collected by FDA pertaining to our guidance documents that relate to 
the COVID-19 pandemic public health emergency response. The Secretary 
has posted its determination of the waiver at: https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers. Pursuant to the 
waiver, the requirements of the PRA are not

[[Page 18249]]

applicable with respect to the voluntary collection of information 
contained in the guidance during the immediate investigation of, and 
response to, COVID-19. Furthermore, the requirements of the PRA shall 
not be applicable with respect to the voluntary collection of 
information contained in the guidance during the immediate post-
response review regarding the public health emergency.
    As noted above, while the requested information and process 
described in the guidance are critical during national emergencies, 
such as the COVID-19 outbreak, the guidance recommends submission of 
information that is expected to assist the Agency more broadly in its 
efforts to address shortages. Accordingly, following the termination of 
the PHE, FDA intends to revise and replace the guidance with any 
appropriate changes based on comments received on this guidance and our 
experience with implementation. Upon determining that the circumstances 
necessitating the COVID-19 PRA waiver no longer exist, the Secretary 
will promptly update its website to reflect the termination of the 
waiver. The period of this waiver will not exceed the period of time 
for the public health emergency related to COVID-19, including any 
immediate post-response review. The Secretary will ensure that 
compliance with the requirements of the PRA occurs in as timely a 
manner as possible based on the applicable circumstances, but not to 
exceed 30 calendar days after the expiration of the waiver related to 
COVID-19.
    This guidance also refers to previously approved collections of 
information found in FDA regulations. The guidance describes, among 
other things, the requirements in Sec. Sec.  310.306, 
314.81(b)(3)(iii), and 600.82 (21 CFR 310.306, 314.81(b)(3)(iii), and 
600.82) for applicants or manufacturers of certain drugs and biological 
products to notify FDA of a permanent discontinuance in the manufacture 
of certain products or an interruption in manufacture of certain 
products that is likely to lead to a meaningful disruption in the 
supply of such products in the United States. These notifications must 
provide particular information, including the name of the product and a 
description of the reason for the permanent discontinuance or 
interruption in manufacturing (see Section II of the guidance). The 
collections of information in Sec. Sec.  310.306, 314.81(b)(3)(iii), 
and 600.82 have been approved under OMB control number 0910-0759.

IV. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or 
https://www.regulations.gov.

    Dated: March 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06800 Filed 3-31-20; 8:45 am]
 BILLING CODE 4164-01-P