
[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Pages 2220-2222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00691]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information to accompany 
humanitarian device exemption (HDE) applications and the collection of 
information regarding the annual distribution number (ADN).

DATES: Submit either electronic or written comments on the collection 
of information by March 15, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you

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do not wish to be made available to the public, submit the comment as a 
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-N-1203 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Information to Accompany 
Humanitarian Device Exemption Applications and Annual Distribution 
Number Reporting Requirements''. Received comments will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 
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

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``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.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                     Number of
Activity/section of FD&C Act (as     Number of     responses per   Total annual   Average burden    Total hours
       amended) or FDASIA           respondents     respondent       responses     per 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................
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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: January 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00691 Filed 1-14-16; 8:45 am]
 BILLING CODE 4164-01-P


