[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Notices]
[Pages 61455-61457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0216]


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

[[Page 61456]]

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 
November 23, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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 implements the humanitarian use device (HUD) 
Provision under section 520(m) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360j(m)) and 21 CFR part 814, subpart H. Under 
section 520(m) of the act, FDA is authorized to exempt an HUD from the 
effectiveness requirements of sections 514 and 515 of the act (21 
U.S.C. 360d and 360e) provided that the device do the following: (1) Is 
used to treat or diagnosis 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 the exemption is 
granted, and there is no comparable device, other than another HUD 
approved under this exemption, available to treat or diagnose the 
disease or condition; and (3) the device will not expose patients to an 
unreasonable or significant risk of illness or injury, and the probable 
benefit to health from using the device outweighs the risk of injury or 
illness from its use, taking into account the probable risks and 
benefits of currently available devices or alternative forms of 
treatment.
    The information collection will allow FDA to determine whether to 
do the following: (1) Grant HUD designation of a medical device, (2) 
exempt a HUD from the effectiveness requirements in sections 514 and 
515 of the act provided that the device meets requirements set forth in 
section 520(m) of the act, and (3) grants marketing approval(s) for the 
HUD. Failure to collect this information would prevent FDA from making 
those determinations. Also, this information enables FDA to determine 
whether the holder of a HUD is in compliance with the HUD requirements.
    Description of Respondents: Businesses or others for-profit.
    In the Federal Register of June 16, 2005 (70 FR 35098), 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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                                                                 Annual Frequency per      Total Annual
             21 CFR Section                 No. of Respondents        Respondent             Responses         Hours per Response        Total Hours
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814.102                                                      20                     1                    20                     40                   800
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814.104                                                       8                     1                     8                    320                 2,560
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814.106                                                       8                     2                    16                     50                   800
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814.108                                                      20                     1                    20                     80                 1,600
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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)                                                    1                     1                     1                      2                     2
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814.126(b)(1)                                                35                     1                    35                    120                 4,200
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Total                                     .....................  ....................  ....................  .....................                 9,968
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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 per                              Hours per
                 21 CFR Section                    Recordkeepers      Recordkeeping     Total Annual Records      Recordkeeper           Total Hours
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814.126(b)(2)                                                 35                     1                    35                     2                    70
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 61457]]

    Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21158 Filed 10-21-05; 8:45 am]
BILLING CODE 4160-01-S