
[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)]
[Notices]
[Pages 30312-30314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11532]


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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.

[[Page 30313]]


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 June 
15, 2016.

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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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

OMB Control Number 0910-0661--Extension

    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 will assign an 
annual distribution number (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/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.
    In the Federal Register of March 18, 2014 (79 FR 15130), FDA 
announced the availability of the draft guidance entitled 
``Humanitarian Device Exemption: Questions and Answers; Draft Guidance 
for Humanitarian Device Exemption Holders, Institutional Review Boards, 
Clinical Investigators, and Food and Drug Administration Staff'', that 
when finalized, will represent FDA's current thinking on this topic.
    FDA is requesting the extension of 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 January 15, 2016 (81 FR 2220), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received. One comment was 
outside of the scope of the four information collection-related topics 
on which the notice solicits public comment. We did not consider the 
other comment because it was submitted in a foreign language and was 
not accompanied by an English translation as required in 21 CFR 
10.20(c)(2).
    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................

[[Page 30314]]

 
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................
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    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's Center for Devices and Radiological Health receives an 
estimated average of six HDE applications per year. FDA estimates that 
three of these applications will be indicated for pediatric use. We 
estimate that we will receive approximately two requests for 
determination of eligibility criteria per year. 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.

    Dated: May 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11532 Filed 5-13-16; 8:45 am]
BILLING CODE 4164-01-P


