[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Pages 40252-40254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected]. 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, 
[email protected].

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 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.
    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


