[Federal Register Volume 64, Number 137 (Monday, July 19, 1999)]
[Notices]
[Pages 38673-38675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2097]


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

AGENCY: Food and Drug Administration, HHS.

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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 information collection 
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, 21 CFR part 814 subpart H.

DATES: Submit written comments on the collection of information by 
September 17, 1999.
ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (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 Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-26; 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. A 
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: (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--Subpart 
H (OMB No. 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: (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 diagnosis 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 herein will allow FDA to determine 
whether to: (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) grant marketing approval(s) for the HUD. 
Failure to collect this information would prevent FDA from making these 
determinations. Also, this information enables FDA to determine whether 
the holder of a humanitarian device exemption (HDE) is in compliance 
with the HDE requirements.
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 for Humanitarian Device Exemption Sponsors\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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814.102                                20               1              20              40             800
814.104(b) and 814.104(c)              15               1              15             320           4,800
814.106                                15               4              60              50           3,000
814.108                                12               1              12              80             960
814.116(d)(3)                           1               1               1               1               1
814.124(a)                              5               1               5               1               5
814.124(b)                              1               1               1               2               2
814.126(b)(1)                          15               1              15             120           1,800

[[Page 38674]]

 
Total                                                                                              11,368
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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 for Humanitarian Device Exemption Sponsors\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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814.126(b)(2)                          15               1              15               2              30
Total                                                                                                  30
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

A. Explanation of Report Burden Estimate:

    Generally, the information requested from respondents represents an 
accounting of information already in the possession of the applicant.
    In the original publication in the Federal Register of the final 
rule for HUD's on June 26, 1996, FDA based its estimates on comments 
received to the proposed rule, industry contact, and internal FDA 
benchmark factors (such as the number of PMA's processed). The numbers 
generated in the current estimate as shown in Tables 1 and 2 of this 
document and described in the following paragraphs, are based upon 
those prior estimates, and they have only been modified if actual 
numbers over the past 3 years have indicated a significantly different 
trend.
    The first HUD rule became effective in fiscal year 1997, and FDA 
has only a few years of actual data to compare to original estimated 
numbers. Although actual numbers are less than the estimated numbers 
for this information collection, FDA believes that as manufacturers 
become more familiar with the program, FDA will experience a larger 
number of submissions under the provisions discussed as follows:
    Sec. 814.102--It is estimated that 20 sponsors per year will submit 
a request for HUD designation. It is estimated to require 40 staff 
hours to complete each HUD designation request.
    Sec. 814.104--FDA estimates 15 sponsors per year will submit an HDE 
application after receiving HUD designation. FDA estimates that it will 
require an average of 320 staff hours to complete each HDE application. 
Sec. 814.110(a) requires that a new indication for use of a HUD 
approved under this part be submitted as a new HDE application 
complying with Sec. 814.104. All burden under this section is included 
under the estimate for Sec. 814.104.
    Sec. 814.106--It is estimated that 4 times per year FDA will 
request or the sponsor will submit additional information or resubmit 
an HDE or HDE supplement for approximately 15 of the submitted HDE 
applications. FDA estimates that it will require the respondents to 
take an average of 50 staff hours to complete each amendment or 
resubmitted application. If the FDA refuses to file the HDE 
application, requests for an informal conference (under 
Sec. 814.112(b)) will be processed as an HDE amendment. Responses to 
approvable and not approvable letters (Sec. 814.116(b), (c), and (d)) 
will be processed as HDE amendments. A request for an opportunity for 
an informal hearing, prior to FDA issuing an order withdrawing 
approval, under Sec. 814.118(d), will be processed as an HDE amendment. 
Because FDA only tracks amendments, and not the reasons for the 
amendment, the burden estimates for the sections listed in the Tables 1 
and 2 of this document are included in the burden estimate for 
Sec. 814.106.
    Sec. 814.108--FDA anticipates that it will receive approximately 12 
supplements for the submitted HDE applications. It is estimated that it 
will take approximately 80 staff hours to complete each supplemental 
application.
    Sec. 814.116(d)(3)--FDA believes that it will receive approximately 
1 request to withdraw an HDE application per year, based on withdrawals 
submitted in FY 1997 and FY 1998. FDA estimates it will take no longer 
than 1 staff hour to complete each written withdrawal notice.
    Sec. 814.124(a)--FDA anticipates that 5 physicians will use HUD's 
in emergency situations before obtaining institute and review board 
(IRB) approval. FDA estimates that notification under this section will 
take an average of 1 hour per response.
    Sec. 814.124(b)--FDA anticipates that one holder of an approved HDE 
will notify FDA of IRB withdrawal of approval. FDA estimates that it 
will take an average of 2 staff hours to notify FDA of IRB withdrawal.
    Sec. 814.126(b)(1)--Following FDAMA, Sec. 814.126 was amended to 
incorporate section 520(m)(5) of the act (21 U.S.C. 360j), which 
provides FDA the authority to require an HDE applicant to demonstrate 
continued compliance with the HDE requirements, if the agency believes 
that such a demonstration is necessary to protect the public health or 
has reason to believe that the criteria for the HDE exemption are no 
longer met. FDA amended this section to delete the requirement of an 
annual report and to include instead a periodic reporting requirement 
that will be established by the approval order for the HDE. This 
provision permits the agency to obtain sufficient information for it to 
determine whether there is reason to question the continued exemption 
of the device from the act's effectiveness requirements.
    FDA anticipates that because of this amendment, the 15 HDE holders 
will remain active and therefore, estimates that 15 periodic reports 
will be received. FDA also estimates that it will take an average of 
120 staff hours to complete a periodic report as a result of this 
amendment.

B. Explanation of Recordkeeping Burden Estimate:

    Sec. 814.126(b)(2)--FDA anticipates that 15 HDE holders per year 
will maintain records of certain required information. It is estimated 
that it will take an average of 2 staff hours to maintain this 
information.


[[Page 38675]]


    Dated: July 12, 1999.
 Margaret M. Dotzel,
 Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-18234 Filed 7-16-99; 8:45 am]
BILLING CODE 4160-01-F