Document ID: FDA-2008-D-0434-0011
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and FDA Staff, etc.
Posted Date: 2010-02-18T05:00Z

[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]                         

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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; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
22, 2010.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title Guidance for Humanitarian Device Exemption Holders, Institutional

[[Page 7271]]

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 
follows:
    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 
paragraphs:
    (Comment) Several of the comments sought clarification regarding 
when the Annual Distribution Number (ADN) reporting requirement 
applied.
    (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 
clinic.
    (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 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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   Section of the Federal Food, Drug,  and         No. of         Annual Frequency      Total Annual
                Cosmetic Act                     Respondents        per Response         Respondents      Hours per  Response          Total Hours
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515A(a)(2)                                                   5                     1                 5                      100                      500
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520(m)(6)(A)(ii)                                             3                     1                 3                       50                      150
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[[Page 7272]]

520(m)(6)(A)(iii)                                            1                     1                 1                      100                      100
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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 for the period October 1, 2004, through 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 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 
condition.
    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.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3030 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S