[Federal Register Volume 67, Number 147 (Wednesday, July 31, 2002)]
[Notices]
[Pages 49700-49701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0315]


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 information 
collection, 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 and electronic comments on the collection of 
information by September 30, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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 Schlosburg, Office of 
Information Resources Management (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: (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

[[Page 49701]]

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--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 
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 diagnosis 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\
------------------------------------------------------------------------
                                   Annual
                       No. of    Frequency    Total      Hours    Total
  21 CFR Section    Respondents     per       Annual      per     Hours
                                  Response  Responses  Response
------------------------------------------------------------------------
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\
------------------------------------------------------------------------
                               Annual      Total
  21 CFR        No. of     Frequency per   Annual    Hours per    Total
  Section   Recordkeepers  Recordkeeping  Records  Recordkeeper   Hours
------------------------------------------------------------------------
814.126(b)         15              1          15           2         30
 (2)
Total                                                                30
------------------------------------------------------------------------
\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 final rule for HUDs, published in the Federal Register of 
June 26, 1996 (61 FR 33232), FDA based its estimates on comments 
received to the proposed rule, industry contact, and internal FDA 
benchmark factors (such as the number of premarket approval 
applications (PMAs) processed). The numbers generated in the current 
estimate as shown in tables 1 and 2 of this document and described in 
the following paragraphs 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.

    Dated: July 24, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-19243 Filed 7-30-02; 8:45 am]
BILLING CODE 4160-01-S