[Federal Register Volume 74, Number 74 (Monday, April 20, 2009)]
[Notices]
[Pages 17962-17964]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8922]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0163]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Draft Guidance, Emergency Use Authorization of Medical 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the proposed extension of the 
collection of information related to emergency use authorizations 
(EUAs) by the agency.

DATES: Submit written or electronic comments on the collection of 
information by June 19, 2009.

[[Page 17963]]


ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under 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, including 
each proposed extension of an existing 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 (OMB Control Number 0910-0595--Extension)

    The draft guidance describes the agency's general recommendations 
and procedures for issuance of EUAs 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). The 
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 
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 of the act, the Commissioner may establish 
conditions on the approval of an EUA. Section 564(e) of the act 
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: (1) Requirements for information dissemination to 
health care providers or authorized dispensers and product recipients; 
(2) adverse event monitoring and reporting; (3) data collection and 
analysis; (4) recordkeeping and records access; (5) restrictions on 
product advertising, distribution, and administration; and (6) 
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 he 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: (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 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 No. 
0910-0308 through September 30, 2011; Adverse Drug

[[Page 17964]]

Experience Reporting is approved under OMB Control No. 0910-0230 
through April 30, 2009; and IND regulations are approved under OMB 
Control No. 0910-0014 through May 31, 2009) 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\
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                         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
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Request for                        1                  1                  1                 50                 50
 Consideration;
 No Application
 Pending
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Pre-Emergency                     10                  1                 10                 20                200
 Submissions;
 Pending
 Application on
 File
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Pre-Emergency                      3                  1                  3                 75                225
 Submissions; No
 Application
 Pending
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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
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Total                                                                                                        754
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Recordkeeping Annual Burden\1\
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                         No. of        Annual Frequency     Total Annual
                     Recordkeepers    per Recordkeeping       Records       Hours per  Record     Total Hours
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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
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Total                                                                                                        660
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\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.

    Dated: April 10, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8922 Filed 4-17-09; 8:45 am]
BILLING CODE 4160-01-S