Document ID: FDA-2022-N-0117-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Authorization for Medical Products for Use in Emergencies
Posted Date: 2022-03-03T05:00Z

[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Notices]
[Pages 12175-12178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04496]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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:
     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-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 https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 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, 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, 
[email protected].

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 https://www.fda.gov/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 requirements to

[[Page 12177]]

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities, 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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
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......
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           7,560  ..............         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 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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
     Records associated with         Number of      records per    Total annual         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....................
                                 -------------------------------------------------------------------------------

[[Page 12178]]

 
    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            1,270                5            6,350
 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: 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