[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
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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
