[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45460-45462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17905]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0434]
Draft Guidance for Humanitarian Device Exemption Holders,
Institutional Review Boards, Clinical Investigators, and Food and Drug
Administration Staff; Humanitarian Device Exemption Regulation:
Questions and Answers; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Humanitarian Device
Exemption (HDE) Regulation: Questions and Answers.'' This draft
guidance answers commonly asked questions about Humanitarian Use
Devices (HUDs) and applications for HDE. This draft guidance is neither
final nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115 (g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by November 3, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Humanitarian Device Exemption (HDE)
Regulation: Questions and Answers'' to the Division of Small
Manufacturers, International, and Consumer Assistance (HFZ-220), Center
for Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit written comments concerning this draft guidance to the
Division of
[[Page 45461]]
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Stephen P. Rhodes, Center for Devices
and Radiological Health (HFZ-403), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4036.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance answers commonly asked questions about HUDs and
applications for HDE authorized by section 510(m)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(m)(2)). This
update of the version issued in 2006 reflects the additional
requirements set forth in the Pediatric Medical Device Safety and
Improvement Act of 2007 (Public Law 110-85). The Pediatric Medical
Device Safety and Improvement Act of 2007 includes a provision
requiring that all original HDE applications include both a description
of any pediatric subpopulations that suffer from the disease or
condition that the device is intended to treat, diagnose, or cure, and
the number of affected pediatric patients (new 515A(a)(2) of the act).
It also amends section 520(m) of the act (21 U.S.C. 360j(m)) to exempt
some HUDs from the prohibition on profit (new section 520(m)(6) of the
act). Specifically, HDE applications indicated for use in pediatric
patients that are approved on or after September 27, 2007, may be
assigned an annual distribution number (ADN) and be sold for profit,
subject to certain restrictions. Finally, the Pediatric Medical Device
Safety and Improvement Act of 2007 includes a provision requiring that
the agency provide guidance to Institutional Review Boards (IRBs) on
the review of HUDs. This update of the HDE guidance includes 30
specific questions and answers for IRBs, as well as guidance to HDE
holders on whether and how they may become eligible to receive profit
from the sale of their device.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the aspects
of HDE regulation discussed in the guidance. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Humanitarian Device Exemption
(HDE) Regulation: Questions and Answers,'' you may either send an e-
mail request to [email protected] to receive an electronic copy of the
document or send a fax request to 240-276-3151 to receive a hard copy.
Please use the document number 1666 to identify the guidance you are
requesting.
CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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. ``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 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 these topics: (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.
Title: Pediatric Use Information to Accompany Humanitarian Device
Exemption Applications.
Description: Title III of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Public Law 110-85) amended chapter V of
the act (21 U.S.C. 351 et seq.) by inserting section 515A Pediatric
Uses of Devices (21 U.S.C. 360e-1).
This new provision requires that new applications under section
520(m) of the act include both a description of any pediatric
subpopulations that suffer from the disease or condition that the
device is intended to treat, diagnose, or cure, and the number of
affected pediatric patients.
Title III of FDAAA also amended section 520(m) of the act as
follows:
Section 520(m)(6)(A)(ii) provides that the Secretary of
Health and Human Services will assign an annual distribution number for
devices indicated for use in pediatric patients or in a pediatric
subpopulation. The ADN shall be based on the following information in
an HDE application: (1) the number of individuals affected by the
disease or condition that such device is intended to treat, diagnose,
or cure, and of that number; (2) the number of individuals likely to
use the device; and (3) the number of devices reasonably necessary to
treat such individuals.
Section 520(m)(6)(A)(iii) provides that an HDE holder
immediately notify the agency if the number of devices distributed
during any calendar year exceeds the annual distribution number.
Section 520(m)(6)(C) provides that an HDE holder may
petition to modify the annual distribution number if additional
information on the number of individuals affected by the disease or
condition arises.
The proposed collections of information are necessary to satisfy
the previously mentioned statutory requirements.
Respondents to this collection of information are holders of HDEs
[[Page 45462]]
indicated for use in pediatric patients or in a pediatric subpopulation
that were approved on or after September, 27, 2007, the enactment date
of the Pediatric Medical Device Safety and Improvement Act of 2007.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
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Section of the
Federal Food, No. of Annual Frequency Total Annual HDE Hours per
Drug, and Applicants per Response Applications Response Total Hours
Cosmetic Act
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515A(a)(2) 5 1 5 100 500
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520(m)(6)(A)(i 3 1 3 50 150
i)
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520(m)(6)(A)(i 1 1 1 100 100
ii)
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520(m)(6)(C) 5 1 5 100 500
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Total 1,250
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on the number of original HDE
applications that the Center for Devices and Radiological Health (CDRH)
received in the period between October 1, 2004, and September 30, 2007.
During that time, CDRH received 16 original HDE applications or about 5
per year.
FDA estimates that for each year CDRH will receive five HDE
applications and that three of these applications will be indicated for
pediatric use. One HDE holder will notify the agency that the number of
devices distributed in the year has exceeded the annual distribution
number and five HDE holders will petition to have the annual
distribution number modified due to additional information on the
number of individuals affected by the disease or condition.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR part 803 have been approved under OMB control number 0910-
0437; the collections of information in 21 CFR part 812 have been
approved under OMB control number 0910-0078; the collections of
information in 21 CFR part 807, subpart E have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
814, subparts A, B, and C have been approved under OMB control number
0910-0231; the collections of information in 21 CFR parts 50 and 56
have been approved under OMB control number 0910-0130; the collections
of information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; the collections of information in 21 CFR part 814,
subpart H have been approved under OMB control number 0910-0332; and
the collections of information in 21 CFR 10.30 have been approved under
OMB control number 0910-0183.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17905 Filed 8-4-08; 8:45 am]
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