82 FR 4362 - Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 9 (January 13, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and other stakeholders entitled ``Emergency Use Authorization of Medical Products and Related Authorities.'' The purpose of this guidance is to explain FDA's current thinking on the authorization of the emergency use of certain medical products under certain sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats.

[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4362-4364]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00721]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1025]


Emergency Use Authorization of Medical Products and Related 
Authorities; Guidance for Industry and Other Stakeholders; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry and other stakeholders 
entitled ``Emergency Use Authorization of Medical Products and Related 
Authorities.'' The purpose of this guidance is to explain FDA's current 
thinking on the authorization of the emergency use of certain medical 
products under certain sections of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) as amended or added by the Pandemic and All-Hazards 
Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in 
PAHPRA include key legal authorities to sustain and strengthen national 
preparedness for public health, military, and domestic emergencies 
involving chemical, biological, radiological, and nuclear (CBRN) 
agents, including emerging infectious disease threats.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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,

[[Page 4363]]

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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-D-1025 for ``Emergency Use Authorization of Medical Products 
and Related Authorities; Guidance for Industry and Other Stakeholders; 
Availability.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to Office 
of Counterterrorism and Emerging Threats, Office of the Commissioner, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 
4343, Silver Spring, MD 20993-0002, 301-796-8510. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Carol Drew, Office of Counterterrorism 
and Emerging Threats, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 4320, Silver Spring, MD 20993-0002, 301-796-8510 
(this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
other stakeholders entitled ``Emergency Use Authorization of Medical 
Products and Related Authorities.'' This guidance explains FDA's 
general recommendations and procedures applicable to the authorization 
of the emergency use of certain medical products under sections 564, 
564A, and 564B of the FD&C Act \1\ (21 U.S.C. 360bbb-3, 360bbb-3a, and 
360bbb-3b) as amended or added by the Pandemic and All-Hazards 
Preparedness Reauthorization Act of 2013 (PAHPRA) \2\ (Pub. L. 113-5). 
The provisions in PAHPRA include key legal authorities to sustain and 
strengthen national preparedness for public health, military, and 
domestic emergencies involving CBRN agents, including emerging 
infectious disease threats such as pandemic influenza. PAHPRA clarifies 
and enhances FDA's authority to support emergency preparedness and 
response and foster the development and availability of medical 
products for use in these emergencies. These medical products, also 
referred to as ``medical countermeasures'' (MCMs) include drugs (e.g., 
antivirals and antidotes), biological products (e.g., vaccines, blood 
products, and biological therapeutics), and devices (e.g., in vitro 
diagnostics and personal protective equipment).
---------------------------------------------------------------------------

    \1\ Section 564 was first added to the FD&C Act by the Project 
BioShield Act of 2004 (Pub. L. 108-276).
    \2\ Section 3088 of the 21st Century Cures Act, signed into law 
by the President on December 13, 2016, (Pub. L. 114-255) amends 
sections 564, 564A, and 564B of the FD&C Act to add new authorities 
to: (1) Authorize emergency use of unapproved animal drugs; (2) make 
applicable other emergency use authorities (e.g., to issue emergency 
dispensing orders, waive compliance with current good manufacturing 
practices), make available Centers for Disease Control and 
Prevention emergency use instructions, and extend expiration dates 
to approved animal drugs; and (3) allow unapproved animal drugs to 
be held for emergency use. While much of what is described in this 
guidance will apply to these new authorities, this guidance does not 
by its terms reference them; FDA asks anyone interested in utilizing 
these authorities to contact FDA directly to discuss how to proceed. 
FDA plans to review these new authorities and address any new 
procedural issues raised as we develop more experience with these 
new authorities.
---------------------------------------------------------------------------

    This guidance finalizes the draft guidance ``Emergency Use 
Authorization of Medical Products and Related Authorities'' (April 
2016) and replaces the following two guidance documents, ``Emergency 
Use Authorization of Medical Products'' (July 2007) and ``Emergency Use 
Authorization Questions and Answers'' (April 2009). The public comments 
received on the draft guidance have been considered and the guidance 
has been revised to clarify issues raised as appropriate. This guidance 
is intended to inform industry and government sponsors and other 
stakeholders involved in emergency response activities, including 
government agencies and public health and emergency response 
stakeholders, and FDA staff of FDA's general recommendations and 
procedures for:
     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; and
     Reliance on the governmental pre-positioning authority set 
forth in section 564B of the FD&C Act.
    Section 564 of the FD&C Act, as amended by PAHPRA, permits the

[[Page 4364]]

Commissioner to authorize the emergency use of an unapproved medical 
product or an unapproved use of an approved medical product for certain 
emergency circumstances after the Department of Health and Human 
Services (HHS) Secretary has made a declaration of an emergency or 
threat justifying emergency use. That declaration by the HHS Secretary 
must in turn be based on a determination of an emergency or potential 
emergency or material threat associated with the CBRN agent by, 
respectively, the Secretary of Homeland Security, the Secretary of 
Defense, or the HHS Secretary. The Commissioner may issue an EUA to 
allow an MCM to be used in an emergency to diagnose, treat, or prevent 
serious or life-threatening diseases or conditions caused by a CBRN 
agent, or by a product used to diagnose, treat, or prevent such 
diseases or conditions, when available data meet specified criteria to 
support such uses and there are no adequate, approved, and available 
alternatives.
    Section 564A, as added by PAHPRA, establishes streamlined 
mechanisms to facilitate preparedness and response activities involving 
certain FDA-approved MCMs without FDA issuing EUAs, which can be a 
resource-intensive process. These authorities, which apply only to 
eligible FDA-approved medical products intended for use during a CBRN 
emergency, include provisions that:
     Empower FDA to extend the expiration date of an eligible 
FDA-approved MCM stockpiled for use in a CBRN emergency, and establish 
appropriate conditions relating to such extensions, such as appropriate 
storage, sampling, and labeling;
     Permit FDA to waive otherwise applicable current good 
manufacturing practice requirements (e.g., storage or handling) to 
accommodate emergency response needs;
     Allow emergency dispensing of MCMs during an actual CBRN 
emergency event without requiring an individual prescription, or all of 
the information otherwise required, for each recipient of the MCM; and
     Permit the Centers for Disease Control and Prevention to 
create and issue ``emergency use instructions'' concerning the FDA-
approved conditions of use for eligible products.

These authorities, and the definition of eligible products to which 
they apply, are discussed in this guidance.
    To enable stakeholders to prepare for potential rapid deployment of 
MCMs during an actual CBRN emergency, section 564B (also added by 
PAHPRA) permits Federal, State, and local governments to pre-position 
(e.g., stockpile, forward-deploy) MCMs in anticipation of FDA approval 
or clearance, authorization of an investigational use, or the issuance 
of an EUA. This authority is also discussed in this document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on emergency use authorization of medical 
products and related authorities. It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.fda.gov/regulatoryinformation/Guidances/default.htm, http://www.regulations.gov, or http://www.fda.gov/medicalcountermeasures.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). This 
guidance refers to previously approved collections of information. 
These collections of information have been approved under OMB control 
numbers 0910-0308, 0910-0230, 0910-0471, 0910-0014, 0910-0078 and 0910-
0595. The collection of information in this guidance was approved under 
OMB control number 0910-0595.

    Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00721 Filed 1-12-17; 8:45 am]
BILLING CODE 4164-01-P