[Federal Register: February 18, 2010 (Volume 75, Number 32)] [Notices] [Page 7270-7272] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr18fe10-33]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration[Docket No. FDA-2008-D-0434]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Humanitarian Device Exemption Holders, Institutional Review Boards,
Clinical Investigators, and Food and Drug Administration Staff:
Humanitarian Device Exemption Regulation: Questions and Answers;
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by March
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to email@example.com. All
comments should be identified with the OMB control number 0910-NEW and
title 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. Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
P150-400B, Rockville, MD 20850, 301-796-3793.
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.
Guidance for Humanitarian Device Exemption Holders, Institutional
Review Boards , Clinical Investigators, and Food and Drug
Administration Staff: Humanitarian Device Exemption Regulation:
Questions and Answers (OMB Control Number 0910-NEW)–Extension
Title III of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Public Law 110-85) amended chapter V of the Federal Food,
Drug, and Cosmetic Act (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 (21 U.S.C. 360j(m)) include both a description of any
pediatric subpopulation that suffer from: (1) A disease or condition
that the device is intended to treat, diagnose, or cure and (2) the
number of affected pediatric patients.
Title III of FDAAA also amended section 520(m) of the act as
Section 520(m)(6)(A)(ii) provides that the Secretary of Health and
Human Services will assign an annual distribution number (ADN) for
devices indicated for use in a pediatric population or in a pediatric
subpopulation. The ADN shall be based on the following information in a
humanitarian device exemption (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 ADN.
Section 520(m)(6)(C) provides that an HDE holder may petition to
modify the ADN if additional information on the number of individuals
affected by the disease or condition arises.
In the Federal Register of August 5, 2008 (73 FR 45460), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA had previously published a 30-day notice
on September 30, 2009 (74 FR 50214) and is republishing this 30-day
notice to provide a more descriptive response to the comments received
in response to the August 5, 2008, notice.
FDA received 7 letters in response to the August 5, 2008, notice.
Six of the seven comments were substantive, each containing several
comments regarding many of the 66 questions contained in the guidance.
The comments and the agency’s responses are discussed in the following
(Comment) Several of the comments sought clarification regarding
when the Annual Distribution Number (ADN) reporting requirement
(Response) A paragraph was added to clarify that the ADN relates
only to those devices that are on the market through the HDE process
for a disease or condition that occurs in pediatric patients or in a
pediatric subpopulation. The response to Question 27 was augmented to
include the phrase “independent Institutional Review Board (IRB)” to
clarify that not all IRBs are internal bodies within a hospital or
(Comment) Question 31 was augmented to describe the different
reporting requirements for manufacturers and for user facilities.
(Response) Manufacturers must submit reports to FDA and the “IRB
of record” whenever a humanitarian use device (HUD) may have caused or
contributed to a death or serious injury, or has malfunctioned and
would be likely to cause or contribute to a death or serious injury if
the malfunction were to recur (Sec. Sec. 803.50 and 814.126(a) (21 CFR
803.50 and 814.126(a))). User facilities must submit reports to FDA,
the “IRB of record” and the manufacturer whenever a HUD may have
caused or contributed to a death. They must also submit reports to FDA
and the “IRB of record” if the manufacturer is unknown, whenever a
HUD may have caused or contributed to a serious injury (Sec. Sec.
803.30 and 814.126(a)).
(Comment) Some of the comments related to the placement of
information in the draft guidance.
(Response) In Question 40, the statement: “If a HUD is being
investigated in an Investigational Device Exemption, (IDE) Study for a
different indication, does it impact the number of allowable patients
under the HDE” was redesignated as question 35 and moved from the
“IRB Section” of the guidance and placed in the section, “After FDA
Approves an HDE” because it did not pertain directly to IRBs.
(Comment) Changes were made to the section, “The Role of
Institutional Review Boards (IRBs),” question 37 specifically, in
order to clarify the distinction between the terms “use,” “HUD,”
and “investigational use/clinical investigation” of a HUD.
(Response) Specifically, FDA clarified that the term “use” in the
guidance, when unmodified, refers to the use of a HUD according to its
approved labeling and indication(s). If a HUD is being used in a
clinical investigation (i.e., collection of safety and effectiveness
data), whether for its HDE-approved indications or for a different
indication, then this document refers to “investigational use” or
“clinical investigation” of the HUD. Finally in addition to adding
clarifying information, a decision tree was also added to the guidance
for ease of reference for IRBs.
FDA estimates the burden of this collection of information as
Table 1.–Estimated Annual Reporting Burden\1\
Section of the Federal Food, Drug, and No. of Annual Frequency Total Annual
Cosmetic Act Respondents per Response Respondents Hours per Response Total Hours
515A(a)(2) 5 1 5 100 500
520(m)(6)(A)(ii) 3 1 3 50 150
520(m)(6)(A)(iii) 1 1 1 100 100
520(m)(6)(C) 5 1 5 100 500
\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 for the period October 1, 2004, through September 30, 2007.
During that time, CDRH received 16 original HDE applications or about 5
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 ADN and five HDE
holders will petition to have the ADN modified due to additional
information on the number of individuals affected by the disease of
The draft guidance refers also 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 collection 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 collection of information requirements in 21 CFR 10.30 have been
approved under OMB control number 0910-0183.
Dated: February 4, 2010.
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3030 Filed 2-17-10; 8:45 am] BILLING CODE 4160-01-S