Document ID: FDA-2016-N-3995-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Submission of
Information on Pediatric Uses of Medical Devices
Posted Date: 2020-04-16T04:00Z

[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21241-21242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08010]

-----------------------------------------------------------------------

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; Submission of 
Information on Pediatric Uses of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 May 18, 
2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0748. 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.

Submission of Information on Pediatric Uses of Medical 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 Under Section 515A of the Federal Food, Drug, 
and Cosmetic Act--21 CFR 814

OMB Control Number 0910-0748--Extension

    Section 515A(a) of the Food, Drug, and Cosmetic Act (21 U.S.C. 
360e-1) (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 amendments or supplements, or a product development 
protocol (PDP).
    FDA expects to receive approximately 47 original PMA/PDP/HDE 
applications each year, 1 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 11 of the estimated 47 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 928 
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 is a supplement to be 2 hours. FDA 
estimates that the total estimated burden is 2,392 hours.
    Additionally, the document entitled ``Providing Information About 
Pediatric Uses of Medical Devices--Guidance for Industry and Food and 
Drug Administration Staff'' describes how to

[[Page 21242]]

compile and submit the readily available pediatric use information 
required under section 515A(a) of the FD&C Act. Respondents are 
permitted to submit information relating to uses of the device outside 
the approved or proposed indication if such uses are described or 
acknowledged in acceptable sources of readily available information. We 
estimate that 20 percent of respondents submitting information required 
by section 515A(a) of the FD&C Act will choose to submit this 
information and that it will take 30 minutes for them to do so.
    In the Federal Register of December 2, 2019 (84 FR 65986), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
             Activity/21 CFR part                 Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pediatric information in an original PMA or                11               1              11  8........................................              88
 PDP--814.20(b)(13).
Pediatric information in a PMA amendment--                  5               1               5  8........................................              40
 814.37(b)(2).
Pediatric information in a PMA supplement--               928               1             928  2........................................           1,856
 814.39(c)(2)(i).
Pediatric information in an HDE--                           1               1               1  8........................................               8
 814.104(b)(6).
Pediatric information for uses outside                    800               1             800  .5 (30 minutes)..........................             400
 approved indication.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................           2,392
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden and corresponding responses reflect the 
requirements under section 515A(a) of the FD&C Act, in addition to the 
submission of data related to pediatric uses outside an approved 
indication, as described in the document entitled ``Providing 
Information About Pediatric Uses of Medical Devices--Guidance for 
Industry and Food and Drug Administration Staff.'' OMB previously 
approved the information collection related to uses outside an approved 
indication under OMB control number 0910-0762. As the information 
collection uses the same data and relies upon the same legal authority 
as OMB control number 0910-0748, we intend to discontinue OMB control 
number 0910-0762 and consolidate the information collection 
accordingly. Our estimated burden for the information collection 
reflects an overall increase of 632 hours. Additionally, we have 
altered the title of the collection to reflect all collections of 
pediatric uses.
    Our estimated burden for the information collection reflects an 
overall increase of 632 hours and a corresponding increase of 
supplements and of uses outside of approved indications. We attribute 
this adjustment to an increase in the number of supplements we received 
over the last 5 years and merging data from discontinued OMB control 
number 0910-0762.

    Dated: April 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08010 Filed 4-15-20; 8:45 am]
 BILLING CODE 4164-01-P