[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Pages 65986-65988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25980]
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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; Submission of Information on Pediatric Uses of Medical
Devices
AGENCY: Food and Drug Administration, HHS.
[[Page 65987]]
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 collection associated with the
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.
DATES: Submit either electronic or written comments on the collection
of information by January 31, 2020.
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 January 31, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 31, 2020. 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-2016-N-3995 for ``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, 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. 3501-3521), 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.
[[Page 65988]]
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 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 guidance document entitled ``Providing
Information About Pediatric Uses of Medical Devices--Guidance for
Industry and Food and Drug Administration Staff'' describes how to
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.
FDA estimates the burden of this collection of information as
follows:
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Pediatric information in an 11 1 11 8 88
original PMA or PDP--
814.20(b)(13)..................
Pediatric information in a PMA 5 1 5 8 40
amendment--814.37(b)(2)........
Pediatric information in a PMA 928 1 928 2 1,856
supplement--814.39(c)(2)(i)....
Pediatric information in an HDE-- 1 1 1 8 8
814.104(b)(6)..................
Pediatric information for uses 800 1 800 .5 400
outside approved indication....
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Total....................... .............. .............. .............. .............. 2,392
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\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 guidance 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 have discontinued OMB control
number 0910-0762 and merged the information collection accordingly.
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: November 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25980 Filed 11-29-19; 8:45 am]
BILLING CODE 4164-01-P