Notice2022-14347
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 6, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 128 (Wednesday, July 6, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Pages 40252-40254]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14347]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0117]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Emergency Use
Authorization of Medical Products
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
5, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#b7d8dec5d6e8c4c2d5dadec4c4ded8d9f7d8dad599d2d8c799d0d8c1"><span class="__cf_email__" data-cfemail="27484e5546785452454a4e54544e484967484a450942485709404851">[email protected]</span></a>. All
comments should be identified with the OMB control number 0910-0595.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-45, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#7b2b293a280f1a1d1d3b1d1f1a55131308551c140d"><span class="__cf_email__" data-cfemail="025250435176636464426466632c6a6a712c656d74">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Emergency Use Authorization of Medical Products
OMB Control Number 0910-0595--Extension
This information collection helps support implementation of Agency
policies applicable to the authorization for medical products for use
in emergencies under sections 564, 564A, and 564B of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3, 360bbb-3a, and
360bbb-3b). For more information regarding emergency use authorization
(EUA), visit our website at https://www.fda.gov/
[[Page 40253]]
emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization. The FD&C Act permits the
Commissioner of Food and Drugs (the Commissioner) to authorize the use
of unapproved medical products, or unapproved uses of approved medical
products, during an emergency declared under section 564 of the FD&C
Act. The data to support issuance of an EUA must demonstrate that,
based on the totality of the scientific evidence available to the
Commissioner, including data from adequate and well-controlled clinical
trials (if available), it is reasonable to believe that the product may
be effective in diagnosing, treating, or preventing a serious or life-
threatening disease or condition (21 U.S.C. 360bbb-3(c)).
Also under section 564 of the FD&C Act, the Commissioner may
establish conditions on issuing an authorization that may be necessary
or appropriate to protect the public health. These conditions can
include: (1) requirements to disseminate or disclose information to
healthcare providers or authorized dispensers and product recipients;
(2) adverse event monitoring and reporting; (3) data collection and
analysis; (4) specific recordkeeping and records access; (5)
restrictions on product advertising, distribution, and administration;
and (6) limitations on good manufacturing practice requirements. As
governed by statute, some conditions are mandatory to the extent
practicable for authorizations of unapproved products, and
discretionary for authorizations of unapproved uses of approved
products. Some conditions may apply to manufacturers of an EUA product,
while other conditions may apply to any person who carries out an
activity for which the authorization is issued. Sections 564A and 564B
of the FD&C Act establish streamlined mechanisms intended to facilitate
preparedness and response activities involving certain FDA approved
products without requiring FDA to issue an EUA, and set forth emergency
dispensing order and expiration date extension authority.
The guidance document entitled, ``Emergency Use Authorization of
Medical Products and Related Authorities'' (January 2017), available
for download from our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities</a>, discusses FDA issuance of
Emergency Use Authorizations (EUAs) under section 564 of the FD&C Act;
implementation of the emergency use authorities set forth in section
564A of the FD&C Act; reliance on the governmental pre-positioning
authority set forth in section 564B of the FD&C Act; and related FDA
regulations. As discussed in the guidance document, the specific type
and amount of data needed to support an EUA will vary depending on the
nature of the declared emergency and the nature of the candidate
product. The guidance document encourages early engagement with FDA,
explains mechanisms for communication, and makes content and format
recommendations on submitting information to the Agency. The guidance
document also recommends that a request for consideration for an EUA
include scientific evidence evaluating the product's safety and
effectiveness, including the adverse event profile for diagnosis,
treatment, or prevention of the serious or life-threatening disease or
condition, as well as data and other information on safety,
effectiveness, risks and benefits, and (to the extent available)
alternatives.
In the Federal Register of March 3, 2022 (87 FR 12175), we
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received. One comment
communicated that the information collection has proven useful in
expediting the availability of vaccines during the pandemic, and also
suggested potential modifications. The second comment was not
responsive to the information collection topics solicited in our 60-day
notice. Neither comment offered alternative burden estimates.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Information collection activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Requests for a substantive 2724 2 5448 45 245,160
amendment to an existing EUA...
Pre-EUA submissions or 2001 1 2001 34 68,034
amendments.....................
Submitting information required 36 3 108 8 864
under conditions of
authorization..................
State and local public health 1 1 1 2 2
authority submissions required
under conditions of
authorization for unapproved
EUA product....................
State and local public health 1 1 1 2 2
authority requests for
Emergency Dispensing Order.....
State and local public health 1 1 1 20 20
authority requests for
expiration date extension......
-------------------------------------------------------------------------------
Total....................... .............. .............. 7560 .............. 314,082
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Although we have averaged burden across all respondents, we
categorize reporting activity by the type of EUA-related submission:
(1) those who file a request for FDA to issue an EUA and/or a
substantive amendment to an EUA that has previously been issued; (2)
those who submit a request for FDA to review information/data (i.e., a
pre-EUA package) for a candidate EUA product or a substantive amendment
to an existing pre-EUA package for preparedness purposes; (3) those who
must report on activities related to an unapproved EUA product (e.g.,
administering product, disseminating information) who must report to
FDA regarding such activity; (4) public health authorities (e.g.,
State, local) who must report on certain activities (e.g.,
administering product, disseminating information) related to an
unapproved EUA, and public health authorities who submit an expiration
date extension request for an approved product; (5) those who request
an emergency dispensing order under section 564A; and (6) those who
request
[[Page 40254]]
expiry dating extensions under section 564A of the FDC&C Act. We
attribute greater burden to those requests for FDA to review pre-EUA
packages submitted by product sponsors than burden we attribute to
those submitted by Federal agencies (e.g., Centers for Disease Control
and Prevention, the Department of Defense), and have considered other
factors that contribute to variability in burden for reporting,
including the type of product and whether there is a previously
reviewed pre-EUA package or investigational application.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Records associated with Number of records per Total annual burden per Total hours
conditions of authorization recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
EUA Holders..................... 648 2 1,296 25 32,400
State and local Public Health 1 1 1 3 3
Authorities....................
-------------------------------------------------------------------------------
Total....................... .............. .............. 1,297 .............. 32,403
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We provide a conservative estimate for respondent recordkeeping,
recognizing that the Federal Government performs much of this activity
in conjunction with submissions. We do not include burden for public
health authorities who may need to submit emergency dispensing orders
or expiration date extension requests, assuming covered entities
already maintain these records for the products they stockpile.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dissemination of required information by EUA Holder or Authorized 635 2 1270 5 6350
Stakeholder.......................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our third-party disclosure estimate is based on the number of EUA
holders and authorized stakeholders disseminating information,
including fact sheets, advertising, and promotional materials.
We have increased our burden estimate for the information
collection to reflect the increase in submissions we have received over
the last 3 years.
Dated: June 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14347 Filed 7-5-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 6, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.