[Federal Register: December 16, 2008 (Volume 73, Number 242)]
[Notices]
[Page 76357-76358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de08-56]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0512]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices:
Humanitarian Use Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
15, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submissions@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0332.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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 (OMB Control
Number 0910-0332)--Extension
This collection of information implements the humanitarian use
device (HUD) provision of section 520(m) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21
CFR part 814). Under section 520(m) of the act, FDA is authorized to
exempt a 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
[[Page 76358]]
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 a HUD from the effectiveness requirements under
sections 514 and 515 of the act, provided that the device meets
requirements set forth under section 520(m) of the 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 a
HUD is in compliance with the HUD provisions under section 520(m) of
the act.
In the Federal Register of October 1, 2008 (73 FR 57108), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours Per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.102 14 1 14 40 560
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.104 6 1 6 320 1,920
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.106 6 2 12 50 600
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.108 32 1 32 80 2,560
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.116(e)(3) 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.124(a) 5 1 5 1 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.124(b) 4 1 4 2 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.126(b)(1) 45 1 45 120 5,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 11,054
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours Per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.126(b)(2) 45 1 45 2 90
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 90
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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 year 2005-
2007. The number of annual reports submitted under Sec. 814.126(b)(1)
in table 1 reflects an increase to 45 respondents with approved HUD
applications. Likewise, under Sec. 814.126(b)(2) in table 2, the
number of recordkeepers increased to 45.
Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29672 Filed 12-15-08; 8:45 am]
BILLING CODE 4160-01-S