
[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74667-74668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30275]


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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 revision 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 February 15, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 
Daniel.Gittleson@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 revision 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 (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) (21 U.S.C. 360j(m)) of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act), the 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) (Public Law 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.

[[Page 74668]]

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

                                 Table 1--Estimated Annual Reporting Burden \1\
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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 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: December 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30275 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P


