[Federal Register: June 16, 2005 (Volume 70, Number 115)]
[Notices]
[Page 35098-35099]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jn05-50]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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