[Federal Register Volume 70, Number 115 (Thursday, June 16, 2005)]
[Notices]
[Pages 35098-35099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-11861]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0216]


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.

DATES: Submit written or electronic comments on the collection of 
information by August 15, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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 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.

[[Page 35099]]

    Description of Respondents: Businesses or others for-profit.
    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         Response              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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 21 CFR                         Annual frequency per
 Section  No. of recordkeepers      recordkeeping     Total annual records    Hours per record      Total hours
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814.126(                    35                     1                    35                     2              70
 b)(2)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: June 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11861 Filed 6-15-05; 8:45 am]
BILLING CODE 4160-01-S