[Federal Register Volume 67, Number 202 (Friday, October 18, 2002)]
[Notices]
[Pages 64392-64393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26614]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0315]


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

DATES: Submit written comments on the collection of information by 
November 18, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (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-Subpart H 
(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: (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 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: 
(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 humanitarian device exemption (HDE) is in compliance 
with the HDE requirements.
    Description of respondents: Businesses or others for-profit.
    FDA estimates the burden of this collection as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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   21 CFR                             Annual Frequency per   Total Annual
   Section      No. of Respondents          Response           Responses       Hours per response    Total Hours
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814.102                20                      1                 20                  40                800
814.104                15                      1                 15                 320              4,800
814.106                15                      4                 60                  50              3,000
814.108                12                      1                 12                  80                960
814.116(e)(3            1                      1                  1                   1                  1
 )
814.124(a)              5                      1                  5                   1                  5
814.124(b)              1                      1                  1                   2                  2
814.126(b)(1           15                      1                 15                 120              1,800
 )
Total         ......................  ....................  ..............  ......................  11,368
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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   Total Annual
   Section     No. of Recordkeepers       Recordkeeping         Records     Hours per Recordkeeper   Total Hours
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814.126(b)(2           15                      1                 15                   2                 30
 )
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Generally, the information requested from the respondents 
represents an accounting of information already in the possession of 
the applicant.
    In the Federal Register of June 26, 1996 (61 FR 33232), FDA 
published the final rule for HUDs and based its estimates on comments 
received to the proposed rule (57 FR 60491, December 21, 1992); 
industry contact; and internal FDA benchmark factors (such as the 
number of premarket approval applications processed). The numbers 
generated in the current estimate as shown in tables 1 and 2 of this 
document are based upon those prior estimates. This is still a 
relatively new program, and the data acquired from the past several 
years has remained fairly stable and consistent.


[[Page 64393]]


    Dated: October 11, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26614 Filed 10-17-02; 8:45 am]
BILLING CODE 4160-01-S