Notice2022-04496
Agency Information Collection Activities; Proposed Collection; Comment Request; Authorization for Medical Products for Use in Emergencies
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Published
March 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA Authorization for Medical Products for Use in Emergencies.
Full Text
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<title>Federal Register, Volume 87 Issue 42 (Thursday, March 3, 2022)</title>
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[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Notices]
[Pages 12175-12178]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04496]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0117]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Authorization for Medical Products for Use in
Emergencies
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with FDA Authorization for Medical Products for Use in
Emergencies.
DATES: Submit either electronic or written comments on the collection
of information by May 2, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 2, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 2, 2022. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
[[Page 12176]]
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-N-0117 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Authorization for Medical
Products for Use in Emergencies.'' Received comments, those filed in a
timely manner (see ADDRESSES), 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.
FOR FURTHER INFORMATION CONTACT: 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#36666477654257505076505257185e5e4518515940"><span class="__cf_email__" data-cfemail="df8f8d9e8cabbeb9b99fb9bbbef1b7b7acf1b8b0a9">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the 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, including
each proposed extension of an existing 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, FDA
invites 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.
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 <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>. 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 requirements to
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disseminate or disclose information to healthcare providers or
authorized dispensers and product recipients; adverse event monitoring
and reporting; data collection and analysis; specific recordkeeping and
records access; restrictions on product advertising, distribution, and
administration; and 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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Requests for a substantive 2,724 2 5,448 45 245,160
amendment to an existing EUA...
Pre-EUA submissions or 2,001 1 2,001 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......
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Total....................... .............. .............. 7,560 .............. 314,082
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\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 expiry dating extensions under section 564A. 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\
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Number of Average burden
Records associated with Number of records per Total annual per Total hours
conditions of authorization recordkeepers recordkeeper records recordkeeping
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EUA Holders..................... 648 2 1,296 25 32,400
State and local Public Health 1 1 1 3 3
Authorities....................
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Total....................... .............. .............. 1,297 .............. 32,403
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\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\
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Number of
Information collection activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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Dissemination of required information by EUA Holder or Authorized 635 2 1,270 5 6,350
Stakeholder......................................................
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\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: February 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04496 Filed 3-2-22; 8:45 am]
BILLING CODE 4164-01-P
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