Document ID: FDA-2011-N-0619-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Humanitarian Use Devices
Posted Date: 2014-06-10T04:00Z

[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33197-33198]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13435]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0619]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices; Humanitarian Use Devices

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 information collection 
requirements for humanitarian use devices (HUDs).

DATES: Submit either electronic or written comments on the collection 
of information by August 11, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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.

Medical Devices; Humanitarian Use Devices--21 CFR 814 (OMB Control 
Number 0910-0332)--Extension

    This collection of information implements the HUD provision of 
section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21 CFR part 814). 
Under section 520(m) of the FD&C Act, FDA is authorized to exempt an 
HUD from the effectiveness requirements of sections 514 and 515 of the 
FD&C Act (21 U.S.C. 360d and 360e) provided that the device: (1) Is 
used to treat or diagnose a disease or condition that affects fewer 
than 4,000 individuals in the United States; (2) would not be available 
to a

[[Page 33198]]

person with such a disease or condition unless an exemption is granted 
because there is no comparable device other than another HUD approved 
under this exemption that is available to treat or diagnose the disease 
or condition; and (3) will not expose patients to an unreasonable or 
significant risk of illness or injury with the probable benefit to 
health from using the device outweighing the risk of injury or illness 
from its use. This takes into account the probable risks and benefits 
of currently available devices or alternative forms of treatment.
    The information collected will assist FDA in making determinations 
on the following: (1) Whether to grant HUD designation of a medical 
device; (2) exempt an HUD from the effectiveness requirements under 
sections 514 and 515 of the FD&C Act, provided that the device meets 
requirements set forth under section 520(m) of the FD&C Act; and (3) 
whether to grant marketing approval(s) for the HUD. Failure to collect 
this information would prevent FDA from making a determination on the 
factors listed previously in this document. Further, the collected 
information would also enable FDA to determine whether the holder of an 
HUD is in compliance with the HUD provisions under section 520(m) of 
the FD&C Act.
    The number of respondents in tables 1, 2, and 3 of this document 
are an average based on data for the previous 3 years, i.e., fiscal 
years 2011 through 2013. The number of annual reports submitted under 
Sec.  814.126(b)(1) in table 1 reflects 32 respondents with approved 
HUD applications. Likewise, under Sec.  814.126(b)(2) in table 2, the 
number of recordkeepers is 247.
    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
     Activity/21 CFR Section         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Request for HUD designation--                 16               1              16              40             640
 814.102........................
Humanitarian device exemption                  7               1               7             320           2,240
 (HDE) application--814.104.....
HDE amendments and resubmitted                14               5              70              50           3,500
 HDEs--814.106..................
HDE supplements--814.108........             112               1             112              80           8,960
Notification of withdrawal of an               8               1               8               1               8
 HDE--814.116(e)(3).............
Notification of withdrawal of                  3               1               3               2               6
 institutional review board
 approval--814.124(b)...........
Periodic reports--814.126(b)(1).              32               1              32             120           3,840
���������������������������������
    Total.......................  ..............  ..............  ..............  ..............          19,194
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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 burden
                      Activity/21 CFR Section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers    recordkeeping       records       recordkeeping
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HDE Records--814.126(b)(2).........................................             247                1              247                2              494
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                      Activity/21 CFR Section                           Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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Notification of emergency use--814.124(a)..........................              22                1               22                1               22
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13435 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P