[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Notices]
[Pages 55394-55396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22858]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0619]
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
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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 (HUDs).
DATES: Submit either electronic or written comments on the collection
of information by November 7, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[email protected].
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 of information implements the HUD provision of
section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21 CFR part 814).
Under section 520(m) of the FD&C Act, FDA is authorized to exempt an
HUD from the effectiveness requirements of sections 514 and 515 of the
FD&C 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 an exemption is
granted because there is no comparable device other than another HUD
approved under this exemption that is available to treat or diagnose
the disease or condition; and (3) will not expose patients to an
unreasonable or significant risk of illness or injury with the probable
benefit to health from using the device outweighing the risk of injury
or illness from its use. This takes into account the probable risks and
benefits of currently available devices or alternative forms of
treatment.
The information collected will assist FDA in making determinations
on the following: (1) Whether to grant HUD designation of a medical
device; (2) exempt an HUD from the effectiveness requirements under
sections 514 and 515 of the FD&C Act, provided that the device meets
requirements set forth under section 520(m) of the FD&C Act; and (3)
whether to grant marketing approval(s) for the HUD. Failure to collect
this information would prevent FDA from making a determination on the
factors listed previously in this document. Further, the collected
information would also enable FDA to determine whether the holder of an
HUD is in compliance with the HUD provisions under section 520(m) of
the FD&C Act.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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814.102....................................................... 17 1 17 40 680
814.104....................................................... 5 1 5 320 1,600
814.106....................................................... 5 5 25 50 1,250
814.108....................................................... 47 1 47 80 3,760
814.116(e)(3)................................................. 3 1 3 1 3
814.124(a).................................................... 22 1 22 1 22
814.124(b).................................................... 12 1 12 2 24
814.126(b)(1)................................................. 43 1 43 120 5,160
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Total..................................................... ................ ................ ................ ................ 12,499
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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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Number of Number of records Total annual Average burden
21 CFR Section recordkeepers per recordkeeper records per recordkeeping Total hours
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814.126(b)(2)............................................ 43 1 43 2 86
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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The number of respondents in tables 1 and 2 of this document are an
average from data for the previous 3 years, i.e., fiscal years 2008 to
2010. The number of annual reports submitted under Sec. 814.126(b)(1)
in table 1 reflects 43 respondents with approved HUD applications.
Likewise, under Sec. 814.126(b)(2) in table 2, the number of
recordkeepers is 43.
Dated: September 1, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-22858 Filed 9-6-11; 8:45 am]
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