Document ID: FDA-2016-N-3995-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure
Posted Date: 2016-12-16T05:00Z

[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Notices]
[Pages 91181-91183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30243]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3995]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices; Pediatric Uses of Devices; 
Requirement for Submission of Information on Pediatric Subpopulations 
That Suffer From a Disease or Condition That a Device Is Intended To 
Treat, Diagnose, or Cure

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 
(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 collection 
associated with the requirement for submission of information on 
pediatric subpopulations

[[Page 91182]]

that suffer from a disease or condition that a device is intended to 
treat, diagnose, or cure.

DATES: Submit either electronic or written comments on the collection 
of information by February 14, 2017.

ADDRESSES: You may submit comments as follows:

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): 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-2016-N-3995 for ``Medical Devices; Pediatric Uses of Devices; 
Requirement for Submission of Information on Pediatric Subpopulations 
That Suffer From a Disease or Condition That a Device Is Intended to 
Treat, Diagnose, or Cure.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://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 https://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 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 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, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 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.

Medical Devices; Pediatric Uses of Devices; Requirement for Submission 
of Information on Pediatric Subpopulations That Suffer From a Disease 
or Condition That a Device Is Intended To Treat, Diagnose, or Cure--21 
CFR Part 814--OMB Control Number 0910-0748--Extension

    Section 515A(a) of the FD&C Act requires applicants who submit 
certain medical device applications to include readily available 
information providing a description of any pediatric subpopulations 
that suffer from the disease or condition that the device is intended 
to treat, diagnose, or cure, and the number of affected pediatric 
patients. The information submitted will allow FDA to track the number 
of approved devices for which there is a pediatric subpopulation that 
suffers from the disease or condition that the device is intended to 
treat, diagnose, or cure and the review time for each such device 
application.
    These requirements apply to applicants who submit humanitarian 
device exemption requests (HDEs), premarket approval applications 
(PMAs) or PMA supplements, or a product development protocol (PDP).
    FDA expects to receive approximately 45 original PMA/PDP/HDE 
applications

[[Page 91183]]

each year, 5 of which FDA expects to be HDEs. This estimate is based on 
the average of FDA's receipt of new PMA applications. The Agency 
estimates that 10 of the estimated 40 original PMA submissions will 
fail to provide the required pediatric use information and their 
sponsors will therefore be required to submit PMA amendments. The 
Agency also expects to receive approximately 700 supplements that will 
include the pediatric use information required by section 515A(a) of 
the FD&C Act and part 814 (21 CFR part 814).
    All that is required is to gather, organize, and submit information 
that is readily available, using any approach that meets the 
requirements of section 515A(a) of the FD&C Act and part 814. We 
believe that because the applicant is required to organize and submit 
only readily available information, no more than 8 hours will be 
required to comply. Furthermore, because supplements may include 
readily available information on pediatric populations by referencing a 
previous submission, FDA estimates the average time to obtain and 
submit the required information in a supplement to be 2 hours. FDA 
estimates that the total estimated burden is 1,760 hours.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden1
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                                                            Number of                     Average
         Activity/21 CFR section             Number of    responses per  Total annual   burden per   Total hours
                                            respondents    respondent      responses     response
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Pediatric information in an original PMA             30               1            30             8          240
 or PDP--814.20(b)(13)...................
Pediatric information in a PMA amendment--           10               1            10             8           80
 814.37(b)(2)............................
Pediatric information in a PMA                      700               1           700             2        1,400
 supplement--814.39(c)(2)................
Pediatric information in an HDE--                     5               1             5             8           40
 814.104(b)(6)...........................
                                          ----------------------------------------------------------------------
    Total................................  ............  ..............  ............  ............        1,760
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: December 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30243 Filed 12-15-16; 8:45 am]
 BILLING CODE 4164-01-P