[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37314-37315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16244]


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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 August 
30, 2019.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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 
(FD&C Act) (21 U.S.C. 360j(m)), as amended by section 3052 of the 21st 
Century Cures Act (Cures Act) (Pub. L. 114-255), 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 designed to treat or 
diagnose a disease or condition that affects not more than 8,000 
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; and (3) the device will not expose patients to an 
unreasonable or significant risk of illness or injury and 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 a humanitarian device exemption (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. Under section 520(m)(6)(A)(i) of the FD&C Act, 
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, provides that the 
Secretary of Health and Human Services will determine the annual 
distribution number (ADN) for devices that meet the eligibility 
criteria to be permitted to be sold for profit. The Cures Act amended 
the FD&C Act definition of the ADN as the number of devices reasonably 
needed to treat, diagnose, or cure a population of 8,000 individuals in 
the United States.
    Section 520(m)(6)(A)(iii) of the FD&C Act provides that an HDE 
holder immediately notify the Agency if the number of such 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.

[[Page 37315]]

    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.
    In the Federal Register of March 12, 2019 (84 FR 8874), 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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Activity/section of FD&C Act, as
  amended by the Food and Drug                       Number of                        Average
    Administration Safety and        Number of     responses per   Total annual     burden per      Total hours
 Innovation Act (FDASIA) and the    respondents     respondent       responses       response
            Cures Act
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Pediatric Subpopulation and                    1               1               1             100             100
 Patient Information--515A(a)(2)
 of the FD&C Act................
Exemption from Profit                          1               1               1              50              50
 Prohibition Information--
 520(m)(6)(A)(i) and (ii) of the
 FD&C Act.......................
Request for Determination of                   1               1               1              10              10
 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)                 1               1               1             100             100
 of the FD&C Act................
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    Total.......................  ..............  ..............  ..............  ..............             360
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects a 
decrease in the number of responses and corresponding decrease of 1,010 
hours in the total burden since our last OMB approval. We attribute 
this adjustment to a decrease in the number of submissions we received 
over the last few years.

    Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16244 Filed 7-30-19; 8:45 am]
 BILLING CODE 4164-01-P


