[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19191-19194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07478]



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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Authorities; Draft Guidance for Industry and Public Health 
Stakeholders; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry and public health 
stakeholders entitled ``Emergency Use Authorization of Medical Products 
and Related Authorities.'' The purpose of this draft guidance is to 
explain FDA's current thinking about policies 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. This guidance, when finalized, will replace 
the current guidance ``Emergency Use Authorization of Medical 
Products'' (July 2007) and ``Emergency Use Authorization Questions and 
Answers'' (April 2009).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 3, 2016. Submit either electronic or written comments 
on the collection of information by June 3, 2016.

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, 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; Draft Guidance for Industry and Public Health 
Stakeholders.'' 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 draft 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: 
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).
    With regard to the proposed collection of information: FDA PRA 
Staff, Office of Operations, Food and Drug Administration, 8455 
Colesville Rd., COLE-141526, Silver Spring, MD 20993-0002, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and public health stakeholders entitled ``Emergency Use Authorization 
of Medical Products and Related Authorities.'' This draft guidance 
explains FDA's policies

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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 
PAHPRA (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 fosters the development and 
availability of medical products for use in these emergencies. These 
medical products, also referred to as ``medical countermeasures'' 
(MCMs), include drugs, biological products (e.g., vaccines, blood 
products, and biological therapeutics), and devices (e.g., in vitro 
diagnostics and personal protective equipment).
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    \1\ Section 564 was first added to the FD&C Act by the Project 
BioShield Act of 2004 (Pub. L. 108-276). Hereafter in this document, 
statutory references (e.g., ``section __'') are to the FD&C Act, 
except where otherwise indicated.
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    This document is intended to inform industry, government agencies, 
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;
     Implementation of the emergency use authorities set forth 
in section 564A; and
     Reliance on the governmental pre-positioning authority set 
forth in section 564B.
    Section 564, as amended by PAHPRA, permits the 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 
Secretary has made a declaration of an emergency or threat justifying 
emergency use. 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 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 for each 
recipient of the MCM or all of the information otherwise required, or 
by responders who may not otherwise be licensed to dispense if 
permitted by State law in the State where such dispensing occurs, or if 
in accordance with an order issued by FDA; 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 the draft 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 the draft guidance.
    The provisions of this guidance, when finalized, will replace the 
current guidance ``Emergency Use Authorization of Medical Products'' 
(July 2007) and ``Emergency Use Authorization Questions and Answers'' 
(April 2009).

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) 
(the PRA), 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 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.

Reporting and Recordkeeping for Emergency Use Authorization of Medical 
Products and Related Authorities--OMB Control Number 0910-0595

    This guidance explains FDA's policies applicable to the 
authorization of the emergency use of certain medical products under 
sections 564, 564A, and 564B of the FD&C Act as amended or added by 
PAHPRA. FDA has previously submitted, and OMB has approved under OMB 
control number 0910-0595, reporting and recordkeeping burden estimates 
for the EUA provisions of this guidance imposed by section 564 of the 
FD&C Act. This guidance incorporates provisions of the current guidance 
linked to OMB control number 0910-0595, ``Emergency Use Authorization 
of Medical Products'' (July 2007).

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Therefore, we are including in this notice the reporting and 
recordkeeping burden estimates for the EUA provisions included in the 
prior guidance as imposed by section 564 of the FD&C Act. In addition, 
sections 564A and 564B of the FD&C Act, as added by PAHPRA, establish 
streamlined mechanisms to facilitate preparedness and response 
activities involving certain FDA-approved MCMs without requiring FDA to 
issue an EUA. These new FDA authorities include provisions that allow 
FDA to extend the expiration date of an eligible FDA-approved MCM 
stockpiled for use in a CBRN emergency. The expiration date extension 
authority in section 564A applies to any eligible, approved MCM, 
including eligible MCMs tested through the Federal Shelf-Life Extension 
Program (SLEP) and State and local public health authorities who 
maintain their own stockpiles of MCMs.
    At this time FDA is not proposing or recommending any changes to 
the Federal SLEP or procedures for expiration date extensions for 
products tested by FDA through SLEP. Federal participants in SLEP will 
continue to submit requests to extend the expiration date of eligible 
MCMs using established processes.
    For drug products not tested within the SLEP program, this guidance 
recommends that stakeholders consult with the relevant review Center 
regarding extending the useful shelf-life of a particular product. 
Stakeholders may need to submit a request for expiry date extensions 
for stockpiled medical products. Because any such request would be for 
an approved product, the burden on manufacturers making any such 
request would be covered by previously approved collections of 
information, including OMB control number 0910-0139 through May 31, 
2018, and OMB control number 0910-0073 through February 28, 2017. FDA 
anticipates, however, that some requests for expiration date extensions 
may come from public health authorities maintaining non-Federal 
stockpiles of MCMs for emergency uses. Therefore, FDA is calculating 
reporting burden for State and local public health authorities who may 
need to submit such requests. FDA is not calculating any additional 
recordkeeping burden for these non-Federal public health authorities 
because currently these stakeholders maintain records for the MCMs they 
stockpile, which would include records of any expiration date requests 
or extensions.
    This draft guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). These collections have been approved as follows: Adverse 
experience reporting for biological products is approved under OMB 
control number 0910-0308 through February 28, 2018; adverse drug 
experience reporting is approved under OMB control number 0910-0230 
through December 31, 2018; adverse device experience reporting is 
approved under OMB control number 0910-0471 through May 31, 2017; 
investigational new drug application regulations are approved under OMB 
control number 0910-0014 through February 28, 2019; investigational 
device exemption reporting is approved under OMB control number 0910-
0078 through March 31, 2016; current good manufacturing practices for 
finished pharmaceuticals are approved under OMB control number 0910-
0139 through May 31, 2018; quality system regulations for finished 
devices are approved under OMB control number 0910-0073 through 
February 28, 2017; risk evaluation and mitigation strategy requirements 
are approved under OMB control number 0910-0001 for drug products 
through December 31, 2017, for biological products under OMB control 
number 0910-0338 through January 31, 2017, and for devices under OMB 
control numbers 0910-0078 through March 31, 2016 and 0910-0471 through 
May 31, 2017.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
       Type of respondent            Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Manufacturer, Request to Issue                 6               3              18              45             810
 an EUA or a Substantive
 Amendment to an Existing EUA...
Manufacturer, Request for FDA                 13               6              78              34           2,652
 Review of a Pre-EUA Package or
 an Amendment Thereto...........
Manufacturer of an Unapproved                  5               2              10               2              20
 EUA Product; Conditions of
 Authorization..................
Public Health Authority;                      30               3              90               2             180
 Unapproved EUA Product;
 Conditions of Authorization....
Public Health Authority; Request               7               1               7               2              14
 for Expiration Date Extension..
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    Total.......................  ..............  ..............  ..............  ..............           3,676
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
       Type of respondent            Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Manufacturers; Unapproved EUA                  5               2              10              25             250
 Product........................
Public Health Authorities;                    30               3              90               3             270
 Unapproved EUA Product.........
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    Total.......................  ..............  ..............  ..............  ..............             520
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


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IV. Electronic Access

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

    Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07478 Filed 4-1-16; 8:45 am]
 BILLING CODE 4164-01-P