[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33197-33198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13435]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 (HUDs).
DATES: Submit either electronic or written comments on the collection
of information by August 11, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [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 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
[[Page 33198]]
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.
The number of respondents in tables 1, 2, and 3 of this document
are an average based on data for the previous 3 years, i.e., fiscal
years 2011 through 2013. The number of annual reports submitted under
Sec. 814.126(b)(1) in table 1 reflects 32 respondents with approved
HUD applications. Likewise, under Sec. 814.126(b)(2) in table 2, the
number of recordkeepers is 247.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Request for HUD designation-- 16 1 16 40 640
814.102........................
Humanitarian device exemption 7 1 7 320 2,240
(HDE) application--814.104.....
HDE amendments and resubmitted 14 5 70 50 3,500
HDEs--814.106..................
HDE supplements--814.108........ 112 1 112 80 8,960
Notification of withdrawal of an 8 1 8 1 8
HDE--814.116(e)(3).............
Notification of withdrawal of 3 1 3 2 6
institutional review board
approval--814.124(b)...........
Periodic reports--814.126(b)(1). 32 1 32 120 3,840
���������������������������������
Total....................... .............. .............. .............. .............. 19,194
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeping records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDE Records--814.126(b)(2)......................................... 247 1 247 2 494
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR Section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of emergency use--814.124(a).......................... 22 1 22 1 22
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13435 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P