Document ID: FDA-2016-N-3995-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; 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: 2017-03-15T04:00Z

[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Page 13825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05096]

[[Page 13825]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 April 
14, 2017.

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 0910-0748. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

OMB Control Number 0910-0748--Extension

    Section 515A(a) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360e-1) 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 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.
    In the Federal Register of December 16, 2016 (81 FR 91181), 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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                                                     Number of
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Pediatric information in an                   30               1              30               8             240
 original PMA or PDP--
 814.20(b)(13)..................
Pediatric information in a PMA                10               1              10               8              80
 amendment--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: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05096 Filed 3-14-17; 8:45 am]
 BILLING CODE 4164-01-P