[Federal Register Volume 78, Number 64 (Wednesday, April 3, 2013)]
[Notices]
[Pages 20115-20116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07696]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1203]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request: Information To 
Accompany Humanitarian Device Exemption Applications and Annual 
Distribution Number Reporting Requirements

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 May 3, 
2013.

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 emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0661. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

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.

Information To Accompany Humanitarian Device Exemption Applications and 
Annual Distribution Number Reporting Requirements (Formerly: 
Humanitarian Device Exemption Holders, Institutional Review Boards, 
Clinical Investigators and FDA Staff Humanitarian Device Exemption 
Regulation: Questions and Answers)--(OMB Control Number 0910-0661)--
Revision

    Under section 520(m) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 360j(m)), FDA is authorized to exempt a 
humanitarian use device (HUD) from the effectiveness requirements in 
sections 514 and 515 of the FD&C 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; (3) the device will not 
expose patients to an unreasonable or significant risk of illness or 
injury; and (4) 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.
    HUDs approved under an HDE cannot be sold for an amount that 
exceeds the costs of research and development, fabrication, and 
distribution of the device (i.e., for profit), except in narrow 
circumstances. Section 613 of the Food and Drug Administration Safety 
and Innovation Act (FDASIA) (Pub. L. 112-144), signed into law on July 
9, 2012, amended section 520(m) of the FD&C Act. Under section 
520(m)(6)(A)(i) of the FD&C Act, as amended by FDASIA, a HUD approved 
under an HDE is eligible to be sold for profit if the device meets the 
following criteria:
     The device is intended for the treatment or diagnosis of a 
disease or condition that occurs in pediatric patients or in a 
pediatric subpopulation, and such device is labeled for use in 
pediatric patients or in a pediatric subpopulation in which the disease 
or condition occurs; or
     the device is intended for the treatment or diagnosis of a 
disease or condition that does not occur in pediatric patients or that 
occurs in pediatric patients in such numbers that the development of 
the device for such patients is impossible, highly impracticable, or 
unsafe.
    Section 520(m)(6)(A)(ii) of the FD&C Act, as amended by FDASIA, 
provides that the Secretary of Health and Human Services (the 
Secretary) will assign an ADN for devices that meet the eligibility 
criteria to be permitted to be sold for profit. The ADN is defined as 
the number of devices ``reasonably needed to treat, diagnose, or cure a 
population of 4,000 individuals in the United States,'' and therefore 
shall be based on the following information in a HDE application: The 
number of devices reasonably necessary to treat such individuals.
    Section 520(m)(6)(A)(iii) of the FD&C Act (http://www.fda.gov/

[[Page 20116]]

RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/
FDCActChapterVDrugsandDevices/default.htm) 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 
FD&C Act provides that an HDE holder may petition to modify the ADN if 
additional information arises.
    On August 5, 2008, FDA issued a guidance entitled ``Guidance for 
HDE Holders, Institutional Review Boards (IRBs), Clinical 
Investigators, and Food and Drug Administration Staff--Humanitarian 
Device Exemption (HDE) Regulation: Questions and Answers'' (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf). The guidance was developed and issued 
prior to the enactment of FDASIA, and certain sections of this guidance 
may no longer be current as a result of FDASIA. The Center for Devices 
and Radiological Health and the Center for Biologics Evaluation and 
Research are currently working on a draft HDE guidance, that when 
finalized, will represent the FDA's current thinking on this topic.
    FDA is requesting OMB approval for the collection of information 
required under the statutory mandate of sections 515A (21 U.S.C. 360e-
1) and 520(m) of the FD&C Act as amended.
    In the Federal Register of December 17, 2012 (77 FR 74667), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
Activity/section of FD&C Act (as     Number of     responses per   Total annual     burden per      Total hours
       amended) or FDASIA           respondents     respondent       responses       response
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Pediatric Subpopulation and                    6               1               6             100             600
 Patient Information--515A(a)(2)
 of the FD&C Act................
Exemption from Profit                          3               1               3              50             150
 Prohibition Information--
 520(m)(6)(A)(i) and (ii) of the
 FD&C Act.......................
Request for Determination of                   2               1               2              10              20
 Eligibility Criteria--613(b) of
 FDASIA.........................
ADN Notification--                             1               1               1             100             100
 520(m)(6)(A)(iii) of the FD&C
 Act............................
ADN Modification--520(m)(6)(C)                 5               1               5             100             500
 of the FD&C Act................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,370
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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 received in the period between October 1, 2008, and 
September 30, 2011. During that time, FDA's Center for Devices and 
Radiological Health received 19 original HDE applications, or about 6 
per year. FDA estimates that for each year we will receive six HDE 
applications and that three of these applications will be indicated for 
pediatric use. The request for determination of eligibility criteria is 
new under section 613(b) of FDASIA. We estimate that we will receive 
approximately two such requests per year. Historically, no companies 
have exceeded the ADN; and under FDASIA the ADN has expanded to a 
minimum of 4,000. Therefore, FDA estimates that very few or no HDE 
holders will notify the Agency that the number of devices distributed 
in the year has exceeded the ADN. FDA estimates that five HDE holders 
will petition to have the ADN modified due to additional information on 
the number of individuals affected by the disease or 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: March 29, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07696 Filed 4-2-13; 8:45 am]
BILLING CODE 4160-01-P