Federal Register, Volume 63 Issue 152 (Friday, August 7, 1998)

[Federal Register Volume 63, Number 152 (Friday, August 7, 1998)]
[Notices]
[Pages 42404-42405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21088]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0515]

Agency Information Collection Activities; Submission for OMB
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing 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 (the PRA).

DATES: Submit written comments on the collection of information by
September 8, 1998.

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:
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. 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 section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.

Amendments to Humanitarian Use Device (HUD) Requirements

Section 520(m) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360j(f)) was created as an incentive for the
development of HUD's for use in the treatment or diagnosis of diseases
or conditions affecting fewer than 4,000 individuals in the United
States. FDA is issuing this rule to amend the existing regulations
governing HUD's, found in part 814 (21 CFR part 814), to conform to the
amendments made by the Food and Drug Administration Modernization Act
of 1997 (FDAMA) to section 520(m) of the act.
In the Federal Register of April 17, 1998 (63 FR 19185), the agency
requested comments on the proposed collection of information amending
the regulations governing HUD's. FDA received one comment concerning
the information collection provisions of the rule. A summary of the
comment and FDA's response is provided as follows.
The comment objected to the annual reporting requirement and
suggested that FDA determine the appropriate reporting period at the
time of product approval rather than always requiring reporting on an
annual basis.
FDA has modified the rule in response to this comment. Under the
final rule of June 26, 1996 (61 FR 33232), a humanitarian device
exemption (HDE) holder was required to obtain approval of an extension
request every 18 months in order to continue marketing the HUD. FDAMA
eliminated this requirement but provided that FDA may require the
holder to demonstrate continued compliance with the HDE requirements if
the agency believes that such demonstration is needed to protect the
public health or has reason to believe that the criteria for the
exemption are no longer met.
FDA included a provision for annual reporting in the proposed rule
because the agency believed that annual reporting would be the most
appropriate mechanism for the agency to monitor whether there is reason
to question the continued exemption of the device from the act's
effectiveness requirements. Upon reconsideration, FDA has determined
that the reporting frequency necessary to protect the public health may
vary depending upon the device, its intended use, the affected patient
population, and experience with the device after it is marketed.
Therefore, Sec. 814.126(b)(1) has been modified in the final rule to
state that the frequency of the reports will be specified in the
approval order for the HDE. Ordinarily, FDA does not expect to require
periodic reports to be submitted more frequently than annually. FDA
does believe, however, that it may be appropriate to require reports on
certain HDE's less frequently and that in many cases the frequency of
required reports will decrease after the device has been marketed for a
period of time.
FDA estimates that, due to the nature of some of the devices,
initially 15 HDE holders per year will be required to submit annual
reports. As the agency and industry gain experience with HDE's, FDA
believes the number of HDE holders who will be required to submit
annual reports will decrease. FDA believes that much of the information
will already be in the HDE holder's possession, and the agency
estimates that the reports will take an average of 120 hours per
response.
The same comment also objected to the ``requirement'' that an ``HDE
holder maintain records in perpetuity * * *'' and suggested that a more
appropriate timeframe would be 3-calendar years after the manufacturer
ceases distribution of the product in question.
Section 814.126(b)(2) of the HDE regulation specifies the types of
records that should be maintained by the HDE holder, but does not
specify the

[[Page 42405]]

timeframe for maintaining such records. FDA agrees that a reasonable
timeframe should be established for maintaining such records and
intends to specify such timeframes as part of the approval order.
Accordingly, FDA has modified the regulation to state that records
shall be maintained in accordance with the approval order for the HDE.
Section 814.124(a) is amended to allow physicians in emergency
situations to administer a HUD prior to obtaining institutional review
board (IRB) approval. In such situations, the physician is required to
provide written notification, including the identification of the
patient involved, the date of use, and the reason for use, to the IRB
within 5 days after emergency use. FDA anticipates that five physicians
will use HUD's in emergency situations before obtaining approval from
an IRB. FDA estimates that notifications under this section will take
an average of 1 hour per response.
In addition to the changes required by FDAMA, FDA is amending
Sec. 814.104(b)(5) to allow a sponsor who is charging more than $250
per HUD to submit, in lieu of a report by an independent CPA, an
attestation by a responsible individual of the organization, verifying
that the amount charged does not exceed the device's cost of research,
development, fabrication, and distribution. In addition, the amendments
to Sec. 814.104(b)(5) waive the requirement for submission of any CPA
report or attestation for HUD's for which an HDE applicant is charging
$250 or less. FDA anticipates, based on past experience, that 7 of the
anticipated 15 HDE holders per year will charge less than $250 per HUD,
and thus be exempt from the Sec. 814.104(b)(5) requirement altogether.
For the remaining eight HDE holders, FDA anticipates that all will
submit attestations in lieu of CPA reports, and estimates that these
submissions will require 2 hours to complete.
Description of Respondents: Business or other for profit
organizations.
FDA estimates the burden for this collection of information as
follows:

Table 1.--Estimated Annual Reporting Burden^{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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814.104(b)(5) 8 1 8 2 16
814.124(a) 5 1 5 1 5
814.126(b)(1) 15 1 15 120 1,800
Total 1,821
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\1\ There are no operating and maintenance costs or capital costs associated with this collection of
information.

Table 2.--Estimated Annual Recordkeeping Burden^{1
----------------------------------------------------------------------------------------------------------------
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
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\1\ There are no operating and maintenance costs or capital costs associated with this collection of
information.

Dated: July 31, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-21088 Filed 8-6-98; 8:45 am]
BILLING CODE 4160-01-F}}