[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,
[email protected].
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