Document ID: FDA-2011-N-0619-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Medical Devices;
Humanitarian Use Devices
Posted Date: 2014-12-01T05:00Z

[Federal Register Volume 79, Number 230 (Monday, December 1, 2014)]
[Notices]
[Pages 71110-71111]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28183]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 31, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0332. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

    This collection of information implements the Humanitarian Use 
Devices (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 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

[[Page 71111]]

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.
    In the Federal Register of June 10, 2014 (79 FR 33197), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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
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    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.

    Dated: November 24, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28183 Filed 11-28-14; 8:45 am]
BILLING CODE 4164-01-P