[Federal Register: October 18, 2002 (Volume 67, Number 202)]
[Notices]
[Page 64392-64393]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc02-84]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0315]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Medical Devices: Humanitarian Use Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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.
DATES: Submit written comments on the collection of information by
November 18, 2002.
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:
Stuart Shapiro, 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 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
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 the exemption is
granted, and there is no comparable device, other than another HUD
approved under this exemption, available to treat or diagnose 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 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) grants marketing approval(s) for the HUD. Failure
to collect this information would prevent FDA from making those
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 as follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR Annual Frequency per Total Annual
Section No. of Respondents Response Responses Hours per response Total Hours
----------------------------------------------------------------------------------------------------------------
814.102 20 1 20 40 800
814.104 15 1 15 320 4,800
814.106 15 4 60 50 3,000
814.108 12 1 12 80 960
814.116(e)(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
)
Total ...................... .................... .............. ...................... 11,368
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR Annual Frequency per Total Annual
Section No. of Recordkeepers Recordkeeping Records Hours per Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
814.126(b)(2 15 1 15 2 30
)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Generally, the information requested from the respondents
represents an accounting of information already in the possession of
the applicant.
In the Federal Register of June 26, 1996 (61 FR 33232), FDA
published the final rule for HUDs and based its estimates on comments
received to the proposed rule (57 FR 60491, December 21, 1992);
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 are based upon those prior estimates. This is still a
relatively new program, and the data acquired from the past several
years has remained fairly stable and consistent.
[[Page 64393]]
Dated: October 11, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26614 Filed 10-17-02; 8:45 am]
BILLING CODE 4160-01-S