[Federal Register: July 5, 2005 (Volume 70, Number 127)]
[Notices]               
[Page 38689-38692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jy05-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0333]

 
Draft Guidance; Emergency Use Authorization of Medical Products; 
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of draft guidance entitled ``Emergency Use Authorization 
of Medical Products.'' The draft guidance explains FDA's policies for 
authorizing the use of an unapproved medical product or an unapproved 
use of an approved medical product during a declared emergency. The 
draft guidance is not final and is not in effect at this time. FDA also 
is announcing an opportunity for public comment on the proposed 
collection of information related to emergency use authorizations by 
the agency.

DATES:  Submit written or electronic comments on the draft guidance and 
the proposed collection of information by September 6, 2005.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Counterterrorism Policy and Planning (HF-29), 
Food and Drug Administration, 5600 Fishers Lane, rm. 14C-26, Rockville, 
MD 20857. Send a self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-827-5671. Submit 
written comments on the draft guidance and the proposed collection of 
information to the Division of Dockets

[[Page 38690]]

Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 All comments should be identified with 

the docket number found in brackets in the heading of this document. 
See the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    For information on the draft guidance: Charlotte Christin, Office 
of Counterterrorism Policy and Planning (HF-29), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067.
    For information on the proposed collection of information: 
JonnaLynn Capezzuto, Office of Management Programs (HFA-250), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
4659.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of draft guidance for industry, 
government agencies, and FDA staff entitled ``Emergency Use 
Authorization of Medical Products.'' This draft guidance describes the 
agency's general recommendations and procedures for issuance of 
emergency use authorizations (EUA) under section 564 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360bbb-3), which was 
amended by the Project BioShield Act of 2004 (Public Law 108-276).
    Section 564 of the act provides for authorization of ``emergency 
use'' of a medical product, after a declaration of emergency justifying 
an authorization is issued by the Secretary of Health and Human 
Services (the Secretary) based on one of the following grounds: A 
determination by the Secretary of Homeland Security that there is an 
actual or potential ``domestic emergency;'' a determination by the 
Secretary of Defense that there is an actual or potential ``military 
emergency;'' or a determination by the Secretary that there is a public 
health emergency under section 319 of the Public Health Service Act 
that affects or has the significant potential to affect national 
security. The Commissioner of FDA (the Commissioner) may issue an EUA 
for an unapproved drug, device, or biologic, or an unapproved use of an 
approved drug, device, or biologic, during a declared emergency.
    This draft guidance, when finalized, may be supplemented by 
guidance from the FDA Centers that provides additional detail on these 
recommendations and procedures.

II. Paperwork Reduction Act of 1995

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

    The act permits 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 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)). 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, the Commissioner may establish conditions on the 
approval of an EUA. 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 finds necessary 
or appropriate to protect the public health. Conditions authorized by 
section 564(e) of the act include, for example: Requirements for 
information dissemination to health care 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 act also gives the Commissioner authority to establish other 
conditions on an authorization that the Commissioner finds to be 
necessary or appropriate to protect the public health.
    For purposes of estimating the burden of reporting, FDA has 
established six categories of respondents which include: (1) Those who 
file a Request for Consideration for an EUA after a determination of 
actual or potential emergency and, in lieu of submitting the data, 
provide reference to a pending or approved application; (2) those who 
file a Request for Consideration for an EUA and the data after a 
determination of actual or potential emergency, without reference to a 
pending or approved application; (3) those who submit data to FDA on a 
candidate EUA product, which is subject to a pending or approved 
application, prior to a

[[Page 38691]]

determination of actual or potential emergency; (4) those who submit 
data to FDA prior to a determination of actual or potential emergency 
about a candidate EUA product for which there is no pending or approved 
application; (5) manufacturers of an unapproved EUA product who must 
report to FDA regarding such activity; and (6) State and local public 
health officials who carry out an activity related to an unapproved EUA 
product (e.g., administering the product to civilians) and who must 
report to FDA regarding such activity.
    For purposes of estimating the burden of recordkeeping, FDA has 
calculated the anticipated burden on manufacturers of unapproved 
products authorized for emergency use. The agency anticipates that the 
Federal Government will perform some of the additional recordkeeping 
necessary for unapproved products (e.g., related to the administration 
of unapproved EUA products to military personnel). FDA also anticipates 
that some State and local public health officials may be required to 
perform additional recordkeeping (e.g., related to the administration 
of unapproved EUA products to civilians) and calculated a recordkeeping 
burden for those activities.
    No burden was attributed to reporting or recordkeeping for 
unapproved uses of approved products, since those products already are 
subject to approved collections of information (adverse experience 
reporting for biological products is approved under OMB control number 
0910-0308 through May 31, 2005; adverse drug experience reporting is 
approved under OMB control number 0910-0230 through September 30, 2005; 
and investigational new drug applications (IND) regulations are 
approved under OMB control number 0910-0014 through January 31, 2006) 
and any additional burden imposed by this proposed collection would be 
minimal. Thus, FDA estimates the burden of this collection of 
information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours  per
                      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Request for                        1                  1                  1                 15                 15
 Consideration;
 Pending
 application on
 file
----------------------------------------------------------------------------------------------------------------
Request for                        1                  1                  1                 50                 50
 Consideration;
 No application
 pending
----------------------------------------------------------------------------------------------------------------
Pre-emergency                     10                  1                 10                 20                200
 submissions;
 Pending
 application on
 file
----------------------------------------------------------------------------------------------------------------
Pre-emergency                      3                  1                  3                 75                225
 submissions; No
 application
 pending
----------------------------------------------------------------------------------------------------------------
Manufacturers of                   3                  4                 12                  2                 24
 an unapproved
 EUA product
----------------------------------------------------------------------------------------------------------------
State and local                   30                  4                120                  2                240
 public health
 officials;
 Unapproved EUA
 product
----------------------------------------------------------------------------------------------------------------
Total                                                                                                        754
----------------------------------------------------------------------------------------------------------------
\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        Annual Frequency     Total Annual
                     Recordkeepers     of Recordkeeping       Records        Hours per Record     Total Hours
----------------------------------------------------------------------------------------------------------------
Manufacturers of                   3                  4                 12                 25                300
 an unapproved
 EUA product
----------------------------------------------------------------------------------------------------------------
State and local                   30                  4                120                  3                360
 public health
 officials;
 Unapproved EUA
 product
----------------------------------------------------------------------------------------------------------------
Total                                                                                                        660
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The annual burden estimate for this information collection is 1,414 
hours. The estimated reporting burden for this collection is 754 hours 
and the estimated recordkeeping burden is 660 hours.

III. Significance of Guidance

    This draft guidance document is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the agency's current thinking on 
emergency use authorizations of medical products. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statute and regulations.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any

[[Page 38692]]

mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain copies of this draft 
guidance at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/opacom/morechoices/industry/guidedc.htm.


    Dated: June 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-13121 Filed 7-01-05; 8:45 am]

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