Notice: Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices: Humanitarian Use Devices

Federal Register: October 1, 2008 (Volume 73, Number 191)           
                  Page 57108-57109

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.

DATES: Submit written or electronic comments on the collection of 
information by December 1, 2008.

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.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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 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 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

[[Page 57109]]

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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Annual Frequency per      Total Annual
                21 CFR Section                  No. of Respondents         Response              Responses        Hours per 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.24(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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Annual Frequency per
                21 CFR Section                 No. of Recordkeepers      Recordkeeping     Total Annual 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., FY 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

    Dated: September 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22991 Filed 9-30-08; 8:45 am]

BILLING CODE 4160-01-S