[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34396-34398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15283]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0976]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance: Emergency 
Use Authorization of Medical Products and Related Authorities

AGENCY: Food and Drug Administration, 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 
19, 2019.

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 oira_submission@omb.eop.gov. 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867 
PRAStaff@fda.hhs.gov.

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.

Guidance: Emergency Use Authorization of Medical Products and Related 
Authorities

OMB Control Number 0910-0595--Extension

    The guidance describes the Agency's policies applicable to the 
authorization of the emergency use of certain medical products 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), as 
amended or added by the Project BioShield Act of 2004 (Pub. L. 108-
276), the Pandemic and All-Hazards Preparedness Reauthorization Act of 
2013 (Pub. L. 113-5), 21st Century Cures Act (Pub. L. 114-255), and 
Public Law 115-92 (2017). The FD&C Act permits the FDA Commissioner 
(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 emergency use authorization (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)). Although the 
exact type and amount of data needed to support an EUA may vary 
depending on the nature of the declared emergency and the nature of the 
candidate product, FDA 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.
    Under section 564 of the FD&C Act, the Commissioner may establish 
conditions on the authorization. Section 564(e) requires the 
Commissioner (to the extent practicable given the circumstances of the 
emergency) to establish certain conditions on an authorization that the 
Commissioner finds necessary or appropriate to protect the public 
health and permits the Commissioner to establish other conditions that 
he or she finds necessary or appropriate to protect the public health. 
Conditions authorized by section 564(e) of the FD&C Act include, for 
example: Requirements for information dissemination to healthcare 
providers or authorized dispensers and product recipients; adverse 
event monitoring and reporting; data collection and analysis; 
recordkeeping and records access; restrictions on product advertising, 
distribution, and administration; and limitations on good manufacturing 
practices requirements. Some conditions, the statute specifies, are 
mandatory to the extent practicable for authorizations of unapproved 
products and discretionary for authorizations of unapproved uses of 
approved products. Moreover, some conditions may apply to manufacturers 
of an EUA product, while other conditions may apply to any person who 
carries out any activity for which the authorization is issued. Section 
564 of the FD&C Act also gives the Commissioner authority to establish 
other conditions on an authorization that he or she finds to be 
necessary or appropriate to protect the public health. Additionally, 
sections 564A and 564B established streamlined mechanisms to facilitate 
preparedness and response activities involving certain FDA-approved 
products without requiring FDA to issue an EUA, including expiration 
date extension authority.
    For purposes of estimating the annual burden of reporting (table 
1), FDA has established four categories of respondents: (1) Those who 
file a request for FDA to issue an EUA or a substantive amendment to an 
EUA that has previously been issued, assuming that a requisite 
declaration under section 564 of the FD&C Act has been made and 
criteria for issuance have been met; (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) manufacturers who carry out an 
activity related to an unapproved EUA product (e.g., administering 
product, disseminating information) who must

[[Page 34397]]

report to FDA regarding such activity; and (4) public health 
authorities (e.g., State, local) who carry out an activity (e.g., 
administering product, disseminating information) related to an 
unapproved EUA product who must report to FDA regarding such activity 
or who submit to FDA an expiration date extension request for an 
approved product.
    In some cases, manufacturers directly submit EUA requests. Often a 
Federal Government entity (e.g., Centers for Disease Control and 
Prevention, Department of Defense) requests that FDA issue an EUA and 
submits pre-EUA packages for FDA to review. In many of these cases, 
manufacturer respondents inform these requests and submissions, which 
are the activities that form the basis of the estimated reporting 
burdens. However, in some cases the Federal Government is the sole 
respondent; manufacturers do not inform these requests or submissions. 
FDA estimates minimal burden when the Federal Government performs the 
relevant activities. In addition to variability based on whether there 
is an active manufacturer respondent, other factors also inject 
significant variability in estimates for annual reporting burdens. A 
second factor is the type of product. For example, FDA estimates 
greater burden for novel therapeutics than for certain unapproved uses 
of approved products. A third significant factor that injects 
variability is the type of submission. For example, FDA estimates 
greater burden for ``original'' EUA and pre-EUA submissions than for 
amendments to them, and FDA estimates minimal burden to issue an EUA 
when there is a previously reviewed pre-EUA package or investigational 
application. For purposes of estimating the reporting burden, FDA has 
calculated the anticipated burden on manufacturers based on the 
anticipated types of responses (i.e., estimated manufacturer input), 
types of product, and types of submission that comprise the described 
reporting activities.
    For purposes of estimating the annual burden of recordkeeping, FDA 
has also calculated the anticipated burden on manufacturers and public 
health officials associated with administration of unapproved products 
authorized for emergency use, recognizing that the Federal Government 
will perform much of the recordkeeping related to administration of 
such products (table 2). FDA is not calculating any recordkeeping 
burden for public health authorities who may need to submit expiration 
date extension requests, as these entities already maintain records for 
the products that they stockpile, which would include records of any 
expiration date request or extension.
    The guidance refers to previously approved collections of 
information. These collections are subject to review by the OMB under 
the PRA. These collections have been approved as follows: Adverse 
experience reporting for biological products is approved under OMB 
control number 0910-0308; adverse drug experience reporting is approved 
under OMB control number 0910-0230; adverse device experience reporting 
is approved under OMB control number 0910-0471; investigational new 
drug (IND) application regulations are approved under OMB control 
number 0910-0014 and investigational device exemption (IDE) reporting 
is approved under OMB control number 0910-0078; current good 
manufacturing practices for finished pharmaceuticals are approved under 
OMB control number 0910-0139, and for devices under OMB control number 
0910-0073; applications for marketing a new drug are approved under OMB 
control number 0910-0001, and for biological products under OMB control 
number 0910-0338. Any additional burden imposed by this proposed 
collection would be minimal.
    In the Federal Register of April 4, 2019 (84 FR 13299), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      No. of                      Average burden
       Type of respondent             No. of       responses per   Total annual     per response    Total hours
                                    respondents     respondent       responses        (hours)
----------------------------------------------------------------------------------------------------------------
Requests to Issue an EUA or a                 12            2.39              29              45           1,305
 Substantive Amendment to an
 Existing EUA...................
FDA Review of a Pre-EUA Package               32            1.79              57              34           1,938
 or an Amendment Thereto........
Manufacturers of an Unapproved                12             5.8              70               2             140
 EUA Product....................
Public Health Authorities;                    30               3              90               2             180
 Unapproved EUA Product.........
Public Health Authorities;                     1               1               1               2               2
 Request for Expiration Date
 Extension......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,565
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  No. of records                  Average burden
       Type of respondent             No. of            per        Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturers of an Unapproved                12               2              24              25             600
 EUA Product....................
Public Health Authorities;                    30               3              90               3             270
 Unapproved EUA Product.........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             870
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 34398]]

    Since the last OMB approval, our estimated annual reporting burden 
for the information collection reflects an increase due to an increase 
in the number of submissions we have received.

    Dated: July 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15283 Filed 7-17-19; 8:45 am]
 BILLING CODE 4164-01-P


