Notice2022-10698
Risk Management Plans To Mitigate the Potential for Drug Shortages; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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Published
May 20, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Risk Management Plans to Mitigate the Potential for Drug Shortages." This draft guidance is intended to help stakeholders develop, maintain, and implement, as appropriate, risk management plans (RMPs) to proactively assist in the prevention of human drug product and biological product shortages. In March 2020, with the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended to require certain manufacturers to develop, maintain, and implement, as appropriate, a "redundancy risk management plan." This draft guidance provides information about the development and content of RMPs for those manufacturers as well as for other stakeholders. This draft guidance recommends a framework and factors to consider that stakeholders can use to develop RMPs. This draft guidance is relevant for all stakeholders, including those with oversight and control responsibilities for drug quality and contract establishments, and for manufacturers of active pharmaceutical ingredients (APIs), approved or licensed drug and biological products, and drug products marketed without an application.
Full Text
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<title>Federal Register, Volume 87 Issue 98 (Friday, May 20, 2022)</title>
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[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 30963-30966]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10698]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0277]
Risk Management Plans To Mitigate the Potential for Drug
Shortages; Draft Guidance for Industry; Availability; Agency
Information Collection Activities; Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Risk
Management Plans to Mitigate the Potential for Drug Shortages.'' This
draft guidance is intended to help stakeholders develop, maintain, and
implement, as appropriate, risk management plans (RMPs) to proactively
assist in the prevention of human drug product and biological product
shortages. In March 2020, with the enactment of the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act), the Federal Food, Drug,
and Cosmetic Act (FD&C Act) was amended to require certain
manufacturers to develop, maintain, and implement, as appropriate, a
``redundancy risk management plan.'' This draft guidance provides
information about the development and content of RMPs for those
manufacturers as well as for other stakeholders. This draft guidance
recommends a framework and factors to consider that stakeholders can
use to develop RMPs. This draft guidance is relevant for all
stakeholders, including those with oversight and control
responsibilities for drug quality and contract establishments, and for
manufacturers of active pharmaceutical ingredients (APIs), approved or
licensed drug and biological products, and drug products marketed
without an application.
DATES: Submit either electronic or written comments on the draft
guidance by July 19, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by July 19,
2022.
[[Page 30964]]
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-2022-D-0277 for ``Risk Management Plans to Mitigate the Potential
for Drug Shortages.'' 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 this 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; or 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 request or include a Fax number to which the draft guidance may be
sent. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Karen Takahashi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6686, Silver Spring, MD 20993-0002, 301-
796-3191; or Stephen Ripley, 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.
With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, <a href="/cdn-cgi/l/email-protection#a8f8fae9fbdcc9cecee8ceccc986c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="1f4f4d5e4c6b7e79795f797b7e3177776c31787069">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Risk Management Plans to Mitigate the Potential for Drug
Shortages.'' This draft guidance is intended to help stakeholders \1\
develop, maintain, and implement, as appropriate, RMPs to proactively
assist in the prevention of human drug product and biological product
shortages. In March 2020, with the enactment of the CARES Act (Pub. L.
116-136), Congress added section 506C(j) to the FD&C Act, which
requires certain manufacturers to develop, maintain, and implement, as
appropriate, a ``redundancy risk management plan that identifies and
evaluates risks to the supply of the drug, as applicable, for each
establishment in which such drug or active pharmaceutical ingredient of
such drug is manufactured.'' Section 506C(j) of the FD&C Act became
effective September 23, 2020. This guidance provides information about
the development and
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content of RMPs for those manufacturers as well as for other
stakeholders.
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\1\ For the purposes of this guidance, the term stakeholder
includes each manufacturer of a drug described in section 506C(a) of
the FD&C Act (21 U.S.C. 356c(a)) or of any API included in such
drugs. (See generally section 506C(j) of the FD&C Act.) The term
stakeholder also broadly includes any person or entity who has
oversight and control over the manufacture of drugs to ensure
quality or owns or operates an establishment (as defined in 21 CFR
207.1 and 600.3) that manufactures a drug or biological product.
Examples of stakeholders include contract facilities as referenced
in 21 CFR 200.10(b); applicants with an approved new drug
application, abbreviated new drug application, or an approved
biologics license application; manufacturers of drug products
marketed without an approved application; manufacturers of
components, including APIs, intended for use in the manufacture of
drug products; and manufacturers of drug-led, drug-device or
biologic-led, biologic-device combination products (as defined in 21
CFR 3.2(e)) regulated by the Center for Drug Evaluation and Research
or the Center for Biologics Evaluation and Research. This guidance
references specific stakeholders individually where appropriate
(e.g., if a specific section of the guidance is relevant to specific
stakeholders only); otherwise, recommendations that refer to the
manufacture of drugs are generally relevant to all stakeholders with
the roles described above with respect to human drug and biological
products.
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Drug shortages pose a significant public health threat that can
delay, and in some cases even deny, critically needed care for
patients. FDA views RMPs as an important mechanism for stakeholders to
proactively identify, assess, and mitigate the risks that might lead to
a disruption in the supply of drug products, thus preemptively reducing
the probability of a drug shortage, and preserving the private and
public resources used in resolving the shortage.
Based on recent publications and reports, the majority of drug
shortages are associated with quality issues. This guidance proposes a
framework stakeholders can use to develop RMPs that aligns with
principles stated in the International Council for Harmonisation
guidance for industry entitled ``Q9 Quality Risk Management''
(available at <a href="https://www.fda.gov/media/71543/download">https://www.fda.gov/media/71543/download</a>). In addition,
FDA also recommends several factors to consider when developing the
content of the RMPs. This guidance is relevant for all stakeholders,
including those with oversight and control responsibilities for drug
quality and contract establishments, and for manufacturers of APIs,
approved or licensed drug and biological products, and drug products
marketed without an application.
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 ``Risk
Management Plans to Mitigate the Potential for Drug Shortages.'' 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.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (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. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Discontinuance or Interruption in the Production of Life-Saving Drugs
OMB Control Number 0910-0045--Revision
This information collection helps support implementation of
requirements under section 506C(j) of the FD&C Act. Section 506C(j) of
the FD&C Act requires manufacturers of drug products described in
section 506C(a) of the FD&C Act or of any active pharmaceutical
ingredient or any associated medical devices used for preparation or
administration included in the drug to develop, maintain, and
implement, as appropriate, a redundancy RMP that identifies and
evaluates risks to the supply of the drug, as applicable, for each
establishment in which such drug or active pharmaceutical ingredient of
such drug is manufactured.
For purposes of this analysis, respondents are those identified in
the draft guidance, section III.A., Stakeholders in the Manufacturing
Supply Chain. A primary stakeholders is generally the entity that
determines which materials and services are necessary to produce a drug
product. Secondary stakeholders are entities that are expected to have
more detailed insight into specific segments of the supply chain for a
drug product but may not have an understanding of its entirety.
Finally, other stakeholders, such as inactive ingredient manufacturers,
packagers, and distributors, are involved in other segments of the
supply chain. In the draft guidance, section IV., RMP Framework and
Development Strategy, we discuss specific recommendations regarding the
RMP.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
Section 506C(j) of the FD&C Act; Number of records per Total records Average burden per recordkeeping \2\ Total hours
recordkeeping activity recordkeepers recordkeeper
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Developing an RMP; Guidance for 2,600 1 2,600 29.32 (range 25 to 250)........................ 76,250
Industry section IV.B.
Updating an RMP........................ 5,200 1 5,200 2.93 (range 2.5 to 25)......................... 15,250
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Total.............................. .............. .............. .............. ............................................... 91,500
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
\2\ Figure has been rounded.
We assume a total of 2,600 respondents will incur an initial burden
associated with developing an RMP based on recommendations described in
the draft guidance. This figure is comprised of 50 primary
stakeholders; 1,125 secondary stakeholders; and 1,425 other
stakeholders, and represents half the total number of respondents we
identify for each of the three respective categories.
For burden associated with updating an RMP, we include all
respondents in the respective three categories, for a total of 5,200.
We believe the overall burden for collecting information and
preparing
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RMPs depends on the stakeholder type (primary, secondary, or other
stakeholder) and its operation.
We anticipate that stakeholders will be able to leverage
information across products, but we understand that the actual burden
for a given stakeholder will depend on the portfolio of covered
products and the complexity of their operations. Our estimate reflects
what we believe is the average burden among all respondents.
This draft guidance also refers to previously approved FDA
collections of information found in FDA regulations. The collections of
information found in 21 CFR 310.306, 314.81(b)(3)(iii), and 600.82 on
notifying FDA of a permanent discontinuance or an interruption in
manufacturing of certain drugs or biological products, and 21 CFR part
314 new drug and abbreviated new drug applications, and 21 CFR part 600
biologics license applications have been approved under OMB control
numbers 0910-0001 and 0910-0338, respectively; the collections of
information in 21 CFR parts 210 and 211 on current good manufacturing
practice have been approved under OMB control number 0910-0139.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of 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">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</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: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10698 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P
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