Document ID: FDA-2008-N-0512-0003
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: 2008-12-16T05:00Z

[Federal Register: December 16, 2008 (Volume 73, Number 242)]
[Notices]               
[Page 76357-76358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de08-56]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0512]

 
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 January 
15, 2009.

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: 202-395-6974, or e-mailed to oira_submissions@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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 Part 814 (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 act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21 
CFR part 814). Under section 520(m) of the act, FDA is authorized to 
exempt a HUD from the effectiveness requirements of sections 514 and 
515 of the 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

[[Page 76358]]

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 a HUD from the effectiveness requirements under 
sections 514 and 515 of the act, provided that the device meets 
requirements set forth under section 520(m) of the 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 a 
HUD is in compliance with the HUD provisions under section 520(m) of 
the act.
    In the Federal Register of October 1, 2008 (73 FR 57108), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. 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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                                                              No. of         Annual Frequency       Total Annual        Hours Per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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814.102                                                                14                     1                 14                 40                560
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814.104                                                                 6                     1                  6                320              1,920
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814.106                                                                 6                     2                 12                 50                600
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814.108                                                                32                     1                 32                 80              2,560
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814.116(e)(3)                                                           1                     1                  1                  1                  1
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814.124(a)                                                              5                     1                  5                  1                  5
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814.124(b)                                                              4                     1                  4                  2                  8
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814.126(b)(1)                                                          45                     1                 45                120              5,400
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Total                                                                                                                                             11,054
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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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                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours Per  Record     Total Hours
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814.126(b)(2)                                                          45                     1                 45                  2                 90
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Total                                                                                                                                                 90
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 year 2005-
2007. The number of annual reports submitted under Sec.  814.126(b)(1) 
in table 1 reflects an increase to 45 respondents with approved HUD 
applications. Likewise, under Sec.  814.126(b)(2) in table 2, the 
number of recordkeepers increased to 45.

    Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29672 Filed 12-15-08; 8:45 am]

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