[Federal Register Volume 64, Number 205 (Monday, October 25, 1999)]
[Notices]
[Pages 57468-57470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
Review; 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

[[Page 57469]]

that the proposed collection of information listed below has been 
submitted to the Office of Management and Budget (OMB) for review and 
clearance under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 24, 1999.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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--Subpart 
H (OMB Control Number 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 part 814 (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 
an 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.
     In the Federal Register of July 19, 1999 (64 FR 38673), the agency 
requested comments on the proposed collections of information. No 
significant comments were received.
     FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
814.102                                20               1              20              40             800
814.104(b) and (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
814.126(b)                              1               1               1               2               2
814.126(b)(1)                          15               1              15             120           1,800
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 Burden1
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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.

I. Explanation of Reporting Burden Estimate

     Generally, the information requested from respondents represents 
an accounting of information already in the possession of the 
applicant.
     In the Federal Register of June 26, 1996 (61 FR 33232), the agency 
issued a final rule for HUD's. FDA based its estimates on comments 
received on the proposed rule, industry contact, and internal FDA 
benchmark factors (such as the number of premarket approval 
applications 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 (FY) 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

[[Page 57470]]

a larger number of submissions under the provisions discussed as 
follows:
     Section 814.102 estimate assumes 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.
     Section 814.104 estimate assumes that 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.
     Section 814.110(a) requires that a new indication for use of an 
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.
     Section 814.106 estimate assumes 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 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 Tables 1 and 2 of this 
document are included in the burden estimate for Sec. 814.106.
     Section 814.108 estimate assumes 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.
     Section 814.116(d)(3) estimate assumes that it will receive 
approximately one 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.
     Section 814.124(a) estimate assumes that five 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.
     Section 814.124(b) estimate assumes 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.
     Section 814.126(b)(1), following the implementation of the FDA 
Modernization Act, was amended to incorporate section 520(m)(5) of the 
act, 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.

 II. Explanation of Recordkeeping Burden Estimate

     Section 814.126(b)(2) estimate assumes 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.

    Dated: October 18, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-27756 Filed 10-22-99; 8:45 am]
BILLING CODE 4160-01-F