[Federal Register Volume 84, Number 48 (Tuesday, March 12, 2019)]
[Notices]
[Pages 8874-8875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04450]



[[Page 8874]]

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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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 May 13, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 13, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 13, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 ``Information To Accompany Humanitarian Device 
Exemption Applications and Annual Distribution Number Reporting 
Requirements.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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, 
[email protected].

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

[[Page 8875]]

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 
(FD&C Act) (21 U.S.C. 360j(m)), as amended by section 3052 of the 21st 
Century 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 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. 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 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 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.
    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.
    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 Food and Drug                         Number of
    Administration Safety and        Number of     responses per   Total annual   Average burden    Total hours
Innovation Act (FDASIA) and 21st    respondents     respondent       responses     per response
        Century 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: March 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04450 Filed 3-11-19; 8:45 am]
 BILLING CODE 4164-01-P