Notice: Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices: 
Humanitarian Use Devices

Federal Register: Volume 76, Number 251 (Friday, December 30, 2011)
                  Pages 82301-82302

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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 January 
30, 2012.

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-5156, 
Daniel.Gittleson@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--(OMB Control Number 0910-
0332)--Extension

    This collection of information implements the humanitarian use 
device (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

[[Page 82302]]

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 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 and 2 of this document are an 
average from data for the previous 3 years, i.e., fiscal years 2008 to 
2010. The number of annual reports submitted under section 
814.126(b)(1) in table 1 reflects 43 respondents with approved HUD 
applications. Likewise, under section 814.126(b)(2) in table 2, the 
number of recordkeepers is 43.
    In the Federal Register of September 7, 2011 (76 FR 55394), 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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
814.102.........................              17               1              17              40             680
814.104.........................               5               1               5             320           1,600
814.106.........................               5               5              25              50           1,250
814.108.........................              47               1              47              80           3,760
814.116(e)(3)...................               3               1               3               1               3
814.124(a)......................              22               1              22               1              22
814.124(b)......................              12               1              12               2              24
814.126(b)(1)...................              43               1              43             120           5,160
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          12,499
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeeper    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
814.126(b)(2)...................              43               1              43               2              86
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33551 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P