[Federal Register Volume 74, Number 188 (Wednesday, September 30, 2009)]
[Notices]
[Pages 50214-50215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23521]


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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 October 
30, 2009.

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: 202-395-6974, or e-mailed to [email protected]. 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 FDA 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 (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 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 FDA Staff: Humanitarian 
Device Exemption Regulation: Questions and Answers--(OMB Control Number 
0910-NEW)

    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) of the act 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 to treat such individuals.
    Section 520(m)(6)(A)(iii) of the act 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) of the act 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 information 
collection provisions. Seven comments were received in response to the 
60-day notice. Of the seven comments received, six related to the 
guidance and the information collection requests. We received one 
comment that did not address the content of the guidance nor the 
information collection.
    There were a number of comments received that clarified the 
reporting requirements for HDE holders and institutional review boards 
(IRBs). In response to these comments, FDA responded by referring to 
previously approved collections of information found in FDA 
regulations. The collections of information in 21 CFR 803.50 have been 
approved under OMB control number 0910-0437 and the collections of 
information in part 814 (21 CFR part 814) have been approved under OMB 
control number 0910-0332. FDA received comments that sought 
clarification regarding how an IRB distinguishes between the use of a 
humanitarian use device (HUD) and the study of an HUD in a clinical 
investigation. FDA responded by providing additional background 
information related to the collection of safety and effectiveness 
information related to clinical investigation for HDE approved 
indications and referring to previously approved collections of 
information found in FDA regulations. This collection of information is 
approved under OMB control number 0910-0078.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
  Section of the Federal Food, Drug, and Cosmetic Act      Respondents         per Response          Responses           Response         Total Hours
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515A(a)(2)                                                              5                     1                  5                100                500
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[[Page 50215]]

 
520(m)(6)(A)(ii)                                                        3                     1                  3                 50                150
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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 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 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 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 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: September 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23521 Filed 9-29-09; 8:45 am]
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