Document ID: FDA-2009-N-0458-0016
Agency: fda
Document Type: Rule
Title: 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. - CLOSED
Posted Date: 2014-01-10T05:00Z

[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Rules and Regulations]
[Pages 1735-1741]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00267]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2009-N-0458]
RIN 0910-AG29

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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
amending the regulations on premarket approval of medical devices to 
include requirements relating to the submission of information on 
pediatric subpopulations that suffer from the disease or condition that 
a device is intended to treat, diagnose, or cure.

DATES: This rule is effective April 10, 2014.

FOR FURTHER INFORMATION CONTACT: Sheila Brown, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1651, Silver Spring, MD 20993, 301-796-6563.

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration Amendments Act of 2007 (FDAAA) \1\ 
(Pub. L. 110-85) amended the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) by among other things, adding section 515A of the FD&C Act 
(21 U.S.C. 360e-1). Section 515A(a) of the FD&C Act requires persons 
who submit certain medical device applications to include, if readily 
available, 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 under section 515A(a) of the FD&C Act

[[Page 1736]]

will be essential to completing the annual report that FDA is required 
to submit to Congress under section 515A(a)(3) of the FD&C Act, 
including:
---------------------------------------------------------------------------

    \1\ Title III of FDAAA, which includes new section 515A, is also 
known as the Pediatric Medical Device Safety and Improvement Act of 
2007.
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     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.
    On April 1, 2010, FDA published a proposed rule, along with a 
companion direct final rule, with a 75-day comment period to request 
input from interested parties (75 FR 16365, April 1, 2010) as a step 
towards implementing section 515A(a) of the FD&C Act. A few months 
later, FDA withdrew the direct final rule because we received 
significant adverse comment (75 FR 41986, July 20, 2010.)
    Due to the changes made since the April 1, 2010, proposed rule, 
particularly changes to the scope of applications to which this 
requirement applies (see section II), a supplemental notice of proposed 
rulemaking was issued on February 19, 2013 (78 FR 11612 at 11616), to 
allow for public comment on the re-drafted proposed rule. In addition 
to providing FDA's revised proposal for implementing section 515A(a) of 
the FD&C Act, that document served to supplement the proposed rule that 
issued with the companion direct final rule (75 FR 16365, April 1, 
2010). FDA received four additional comments on the supplemental notice 
of proposed rulemaking that were considered when developing this final 
rule.

II. How are pediatric patients and pediatric subpopulations defined?

    Section 515A(c) of the FD&C Act states that, for the purposes of 
that section, the term ``pediatric subpopulation'' has the meaning 
given the term in section 520(m)(6)(E)(ii) of the FD&C Act (21 U.S.C. 
360j(m)(6)(E)(ii)). Section 520(m)(6)(E)(ii) of the FD&C Act defines 
the term ``pediatric subpopulation'' to mean one of the following 
populations:
     Neonates;
     Infants;
     Children; or
     Adolescents.
    Section 515A additionally requires that the descriptions of 
pediatric subpopulations include the number of affected ``pediatric 
patients.'' Section 515A does not define the term ``pediatric 
patients.'' The term ``pediatric patients'', however, is defined for 
purposes of section 520(m)(6)(E)(i) of the FD&C Act (relating to 
humanitarian device exemptions for pediatric patients) as patients who 
are 21 years of age or younger at the time of the diagnosis or 
treatment. The definition for ``pediatric patients'' in section 
520(m)(6)(E)(i) is consistent with the definition of ``pediatric 
subpopulations'' in section 520(m)(6)(E)(ii).
    These definitions of pediatric subpopulation and pediatric patient 
are reflected in FDA's previously issued 2004 guidance on pediatric 
medical devices, which recommended the age range for each of the 
populations included in the term ``pediatric subpopulation.'' Those age 
ranges span from birth to 21 years of age (that is, from birth through 
the 21st year of life, up to but not including the 22nd birthday). See 
``Premarket Assessment of Pediatric Medical Devices'' (May 14, 2004); 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm.
    For purposes of the requirements in this final rule, FDA is 
codifying a definition of the term ``pediatric patients'' as patients 
who are 21 years of age or younger (that is, from birth through the 
21st year of life, up to but not including the 22nd birthday) at the 
time of the diagnosis or treatment.

III. What applications are subject to this final rule?

    In accordance with the FD&C Act, the requirements to include, if 
readily available, 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 
apply to the following applications when submitted on or after the 
effective date of this rule:
     Any request for a humanitarian device exemption (HDE) 
submitted under section 520(m) of the FD&C Act;
     Any premarket approval application (PMA) or supplement to 
a PMA submitted under section 515 of the FD&C Act; and
     Any product development protocol (PDP) submitted under 
section 515 of the FD&C Act.
    FDA concludes that section 515A applies to all submission types 
listed in the statute--PMA, HDE, PDP, and all PMA supplements--not just 
the subset of PMA supplements that propose a new indication for use, as 
was proposed in the April 1, 2010, proposed rule. The Agency also wants 
to clarify that it does not interpret 30-day notices submitted under 
Sec.  814.39(f) (21 CFR 814.39(f)) to be PMA supplements for purposes 
of this final rule. Section 515(d)(6)(A) of the FD&C Act (21 U.S.C. 
360e(d)(6)(A)) distinguishes between modifications to manufacturing 
procedures or methods of manufacture that affect the safety and 
effectiveness of a device subject to an approved PMA, which require the 
submission of a written notice, and other changes that affect safety 
and effectiveness that require the submission of a ``supplemental 
application.'' Because of this statutory distinction, 30-day notices 
are not considered PMA supplements for purposes of this final rule and, 
therefore, are not required to include readily available pediatric 
information.
    Moreover, an applicant submitting a PMA supplement that previously 
submitted information satisfying the pediatric subpopulation 
requirements for the device may include that information by referencing 
the previous application rather than resubmitting the same information. 
However, if additional information has become readily available to the 
applicant since the previous submission, the applicant must submit that 
information as part of the supplement.
    Many premarket approval applications begin with the submission of 
one or more PMA modules; see ``Premarket Approval Application Modular 
Review--Guidance for Industry and FDA Staff,'' available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089764.htm. Applicants who choose to use the 
modular approach should submit the information required by section 
515A(a) of the FD&C Act in the final PMA module (i.e., the module that 
includes final clinical data, proposed labeling, and the Summary of 
Safety and Effectiveness Data).

IV. What does this final rule do?

    This final rule implements section 515A(a) of the FD&C Act by 
amending part 814 (21 CFR part 814), Premarket Approval of Medical 
Devices, to include requirements relating to the submission of readily 
available information on pediatric subpopulations that suffer from the 
disease or condition that a device is intended to treat, diagnose, or 
cure.

A. What information must the applicant provide?

    This final rule requires each applicant who submits an HDE, PMA, 
supplement to a PMA, or PDP to include, if ``readily available,'' 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. FDA is codifying a 
definition of ``readily available'' and

[[Page 1737]]

will be issuing a guidance document entitled ``Guidance for Industry 
and Food and Drug Administration Staff: Providing Information About 
Pediatric Uses of Medical Devices Under Section 515A of the Federal 
Food, Drug, and Cosmetic Act'' to explain the Agency's current thinking 
on the meaning of ``readily available information'' and how to comply 
with the requirements set forth in section 515A of the FD&C Act.

B. What are the consequences of not submitting ``Readily Available'' 
information?

    If the applicant does not submit the information required by 
section 515A(a) of the FD&C Act, FDA may not approve the application 
until the applicant provides the required information. The Agency 
intends to contact the applicant during the normal course of our review 
to inform the applicant that the submission lacks the information 
required by section 515A(a) of the FD&C Act and by this final rule, and 
to ask the applicant to amend the application to provide the required 
information. If the application has no other deficiencies and otherwise 
meets applicable statutory and regulatory requirements for approval, 
but still lacks information required by section 515A(a), the Agency 
intends to send the applicant an ``approvable'' letter informing them 
that FDA will approve the application after the applicant provides the 
information required by section 515A(a). If the application has other 
deficiencies or does not meet all applicable statutory and regulatory 
requirements for approval, the Agency intends to send the applicant a 
``not approvable'' letter or a ``major deficiency'' letter describing 
what information or data the applicant needs to provide before FDA can 
approve the application; the ``not approvable'' or ``major deficiency'' 
letter may cite the absence of section 515A(a) information in the 
section listing minor deficiencies. For additional information 
concerning ``approvable,'' ``not approvable,'' and ``major deficiency'' 
letters, see ``FDA and Industry Actions on Premarket Approval 
Applications (PMAs): Effect on FDA Review Clock and Goals,'' available 
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089733.htm.

V. How has FDA addressed comments received on the proposed rule?

    A number of comments recommended using age 18 as the upper boundary 
for the definition of ``pediatric patients'' instead of age 21 for 
reasons such as attainment of skeletal maturity by age 18 and how the 
phrase is understood in certain professional communities. After 
considering this suggestion, FDA has opted to keep age 21 as the 
definitional upper boundary ``pediatric patients.'' FDA oversees a wide 
array of medical devices and combination products including various 
medical devices that are used in pediatric populations. With this in 
mind, and as part of initiatives designed to help FDA achieve the 
intent of several pediatric provisions added to the FD&C Act by the 
Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250, 
116 Stat. 1588 (2002)), CDRH established the definition of the 
pediatric population in the 2004 Guidance ``Premarket Assessment of 
Pediatric Medical Devices'' (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm). Beyond 
setting the upper age limit, the Guidance document further defines the 
pediatric population as comprising the following subpopulations: 
Neonate, infant, child, and adolescent. The definition mirrors that 
used by the American Academy of Pediatrics and takes into consideration 
the different pediatric subpopulations that make up the pediatric 
population. This definition ensures that the term ``pediatric'' applies 
to populations who may be mature skeletally or according to other 
measures, but who remain developmentally immature in certain anatomical 
or physiological systems.
    This definition reflects the scientific evidence that children are 
not merely young adults, but that there are unique host characteristics 
across the various pediatric subpopulations that should be considered 
before using medical devices in the pediatric population or 
subpopulation. FDA recognizes that not all 18- to 21-year-olds are 
identical: Different rates of pubertal development may be encountered; 
different disease processes may cause delayed maturation, or 
conversely, accelerated maturation (e.g. precocious puberty). Moreover, 
Congress also used age 21 as the upper boundary for a pediatric 
population when it enacted FDAAA (section 303(a)(3)).
    One comment stated that FDA should not have removed the proposed 
requirement on ``potential pediatric uses'' in the supplemental notice 
of proposed rulemaking because providing readily available information 
on potential pediatric uses is easily achievable and would pose no 
serious burden to applicants. FDA declines to accept the recommendation 
in the comment because section 515A of the FD&C Act does not require 
sponsors to speculate as to possible pediatric uses and possible 
subpopulations. However, if such information were readily available and 
provided in a premarket submission, FDA would find the information 
useful in support of advancing pediatric device development. Therefore, 
in the forthcoming guidance document, ``Guidance for Industry and Food 
and Drug Administration: Providing Information About Pediatric Uses of 
Medical Devices Under Section 515A of the Federal Food, Drug, and 
Cosmetic Act,'' FDA invites applicants to include pediatric use 
information for uses of the device outside the approved or proposed 
indication if such uses are described or acknowledged in acceptable 
sources of readily available information.
    One comment proposed that FDA require applicants to state whether 
each new PMA supplement relates to a new device and that PMA applicants 
provide the number of new devices approved under the PMA during the 
preceding year in the PMA annual report. The comment also requested 
that, in order to ease the administrative burden on FDA and applicants, 
PMA supplements filed subsequent to the initial submission of pediatric 
population information update this information only if there is new 
information readily available that results in a change in the 
identification of pediatric subpopulations that suffer from the disease 
or condition that the device is intended to treat, diagnose, or cure, 
or the number of affected pediatric patients. FDA appreciates the 
suggested additions to the rule, but declines to include a requirement 
that applicants state whether each supplement relates to a new device 
because each applicant could interpret the types of changes that could 
be considered a ``new device'' differently. To better ensure 
consistency for reporting purposes, FDA's internal tracking system will 
be used for the collection and compilation of data regarding the number 
of devices approved each year. FDA also declines to require applicants 
to provide information in their PMA annual report regarding the number 
of new devices approved under the PMA in the prior year because, while 
FDA must provide a report to Congress once per year, PMA annual reports 
can be due at different times throughout the calendar year as the 
report is due on the anniversary of the initial PMA approval. Since the 
PMA annual reports would each address different time periods for the 
prior year, this information would not enable FDA to compile the data 
needed for the report to Congress.
    One comment disputed FDA's estimate of the amount of time it will

[[Page 1738]]

take to fulfill the requirements instated by this rule for original HDE 
and PMA applications. The comment states that reading just a single 
article in the medical literature to obtain a thorough understanding of 
a specific situation can take 1 to 2 hours and therefore the estimate 
that 8 hours are needed for an applicant to fulfill the requirement is 
unreasonably low. FDA disagrees that 8 hours is insufficient to fulfill 
the requirements implemented by this final rule because applicants are 
not expected to make an assessment of whether the information is 
clinically appropriate or would support a particular indication; 
rather, when reviewing sources, applicants are only required to 
identify any pediatric subpopulations that suffer from the disease or 
condition that the device is intended to treat, diagnose, or cure, as 
well as the number of affected pediatric patients. Please see the 
forthcoming guidance document, ``Guidance for Industry and Food and 
Drug Administration: Providing Information About Pediatric Uses of 
Medical Devices Under Section 515A of the Federal Food, Drug, and 
Cosmetic Act'' for more information on how to comply with this 
requirement.
    Some comments took the position that by implementing the rule, FDA, 
in effect, would be promoting the off-label use of devices. FDA 
disagrees with this comment. The rule does not ask applicants to 
perform any clinical studies or to use or promote the device outside 
its approved indications for use; rather, the rule requires the 
submission of information already in existence on any pediatric 
subpopulations that suffer from the disease or condition that the 
device is intended to treat, diagnose, or cure.
    One comment stated that if FDA were to request an applicant to 
submit a PMA supplement for a PMA that was approved prior to the 
effective date of FDAAA solely to provide readily available pediatric 
information, then this would be retroactive application of law. FDA 
does not intend to require any applicant to submit a PMA supplement 
solely to provide readily available pediatric information. However, if 
an applicant is submitting a PMA supplement for any of the reasons in 
Sec.  814.39, it must include readily available pediatric information 
as required by Sec.  814.39(c)(2).
    One comment stated that the rule should provide an exemption from 
the requirement of submitting readily available pediatric information 
in instances where the device does not and will never have pediatric 
uses, as well as instances where the device is specifically indicated 
for use in pediatric patients. FDA declines to incorporate this comment 
because an exemption for devices that do not and are thought not to 
ever have pediatric uses undermines the intent of the rule. It is not 
possible to determine whether a device will have pediatric uses in the 
future as modifications to the device (e.g., design or size) and 
advances in medicine could change whether a device could be used in a 
pediatric population. Furthermore, an exemption for devices intended 
specifically for use in pediatric subpopulations would undermine the 
intent of the rule because there could be other pediatric 
subpopulations not included in the proposed or approved indications for 
use that suffer from the disease or condition that the device is 
intended to treat, diagnose, or cure. If there are no pediatric uses of 
the device at the time of the PMA or PMA supplement submission, FDA 
merely expects applicants to state such in the application.

VI. What is the legal authority for this final rule?

    Section 302 of FDAAA amended the FD&C Act by adding, among other 
things, a new section 515A. Section 515A(a) of the FD&C Act requires 
persons who submit certain medical device applications to include, if 
readily available, 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. Therefore, FDA is issuing this final rule under section 
515A(a), and section 701(a) of the FD&C Act (21 U.S.C. 371(a)) (which 
provides FDA the authority to issue regulations for the efficient 
enforcement of the FD&C Act). The Food and Drug Administration Safety 
and Innovation Act (Pub. L. 112-144, section 620(b)) directs FDA to 
issue a final rule implementing section 515A(a) of the FD&C Act by 
December 31, 2013.

VII. What is the environmental impact of this final rule?

    FDA has determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. What is the economic impact of this final rule?

    We have examined the impacts of this final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this final rule is not a significant 
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on a substantial number of small entities. Because this regulation only 
requires some submissions include a small amount of readily available 
information at about $90 per submission, the Agency certifies that the 
final rule does not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2012) Implicit 
Price Deflator for the Gross Domestic Product. We do not expect this 
rule to result in any 1-year expenditure that would meet or exceed this 
amount.
    We believe that the only costs to industry are those that we 
account for in our Paperwork Reduction Act analysis, which immediately 
follows this section. The final rule does not require additional 
clinical research or other costly efforts, and simply requires the 
applicant to briefly summarize readily available information that will 
have been reviewed by the applicant during the course of its 
development of the device and preparation of its application to FDA. As 
explained in the Paperwork Reduction Act analysis, we expect to receive 
annually 40 PMAs and 5 applications for HDE. We also expect to receive 
693 supplements that include the pediatric use information required by 
section 515A(a) of the FD&C Act and this final rule.
    Based on our experience with similar requirements regarding readily 
available information, we estimate it will take 8

[[Page 1739]]

hours to gather and submit information for original applications and 
amendments to those applications. Because supplements can include this 
information by referencing a previous submission, we estimate it will 
take only 2 hours to obtain and submit the required information on 
pediatric populations.
    The estimated time burden for all 45 annual applications is 360 
hours. For the 693 supplements, the time burden is an estimated 1,386 
hours for a total of 1,746 hours. The 2011 median wage for a compliance 
officer in the medical device manufacturing industry is $31.75.\2\ 
Adjusting the wage by average private sector benefits of 29.6 percent 
of total compensation, the benefits-adjusted wage is $45.10.\3\ At this 
wage, the estimated cost of submitting an application with pediatric 
information is $361 or $16,236 for all applications. The estimated cost 
of submitting pediatric information for a supplement is $90 or $62,508 
for all supplements. The estimated cost of this final rule is $78,744.
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    \2\ U.S. Bureau of Labor Statistics, 2011 National Industry-
Specific Occupational Employment and Wage Estimates, SOC 13-1041 
(http://www.bls.gov/oes/current/naics4_339100.htm).
    \3\ U.S. Bureau of Labor Statistics, Employer Costs for Employee 
Compensation, Table 5. Employer costs per hour worked for employee 
compensation and costs as a percent of total compensation: Private 
industry workers, by major occupational group and bargaining unit 
status, June 2012 (http://www.bls.gov/news.release/ecec.t05.htm).
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    We expect FDA's additional costs will be inconsequential, as the 
information required here will be filed and managed as an integral part 
of each submission, using existing filing, storage, and data management 
systems and processes.

IX. How does the Paperwork Reduction Act of 1995 apply to this final 
rule?

    This final rule contains information collection requirements that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection provisions are shown in the following paragraphs with an 
estimate of the annual reporting burden. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: 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.
    Description: Section 515A(a) of the Food and Drug Administration 
Amendments Act of 2007 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.
    Description of Respondents: These requirements apply to applicants 
who submit the following applications on or after the effective date of 
this rule:
     Any request for an HDE submitted under section 520(m) of 
the FD&C Act;
     Any PMA or supplement to a PMA submitted under section 515 
of the FD&C Act;
     Any PDP submitted under section 515 of the FD&C Act.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
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               693               1             693               2           1,386
 supplement--814.39(c)(2).......
Pediatric information in an HDE--              5               1               5               8              40
 814.104(b)(6)..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............             738  ..............           1,746
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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 actual average of FDA's receipt of new PMA 
applications in FY 2010-2011. The Agency estimates that 10 of those 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 693 supplements that 
will include the pediatric use information required by section 515A(a) 
of the FD&C Act and this final rule.
    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 this final rule. We 
believe that because the final rule requires that the applicant 
organize and submit only readily available information, no more than 8 
hours will be required to comply with section 515A(a) of the FD&C Act 
and this final rule for original applications and amendments to those 
applications. 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 information required by this final rule in a supplement to 
be 2 hours. FDA estimates that the total burden created by this final 
rule is 1,746 hours.
    We estimate the ``Average Burden per Response'' based on our 
experience with similar information collection requirements and on 
consultations with the Interagency Pediatric Devices Working Group that 
includes the Agency for Healthcare Research and Quality, FDA, National 
Institutes of Health, members of the Pediatric Advisory Committee, 
researchers, health care practitioners, medical device trade 
associations, and medical device manufacturers.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section

[[Page 1740]]

3507(d) of the Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.
    This final rule also refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
part 814, subpart B have been approved under OMB control number 0910-
0231 and the collections of information in part 814, subpart H have 
been approved under OMB control number 0910-0332.

X. What are the federalism impacts of this final rule?

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
814 is amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
1. The authority citation for 21 CFR part 814 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 
373, 374, 375, 379, 379e, 381.

0
2. In Sec.  814.1, revise paragraph (a) to read as follows:

Sec.  814.1  Scope.

    (a) This section implements sections 515 and 515A of the act by 
providing procedures for the premarket approval of medical devices 
intended for human use.
* * * * *

0
3. In Sec.  814.3, add paragraphs (s) and (t) to read as follows:

Sec.  814.3  Definitions.

* * * * *
    (s) Pediatric patients means patients who are 21 years of age or 
younger (that is, from birth through the twenty-first year of life, up 
to but not including the twenty-second birthday) at the time of the 
diagnosis or treatment.
    (t) Readily available means available in the public domain through 
commonly used public resources for conducting biomedical, regulatory, 
and medical product research.

0
4. In Sec.  814.20, redesignate paragraph (b)(13) as paragraph (b)(14) 
and add new paragraph (b)(13) to read as follows:

Sec.  814.20  Application.

* * * * *
    (b) * * *
    (13) Information concerning uses in pediatric patients. The 
application must include the following information, if readily 
available:
    (i) A description of any pediatric subpopulations (neonates, 
infants, children, adolescents) that suffer from the disease or 
condition that the device is intended to treat, diagnose, or cure; and
    (ii) The number of affected pediatric patients.
* * * * *

0
5. In Sec.  814.37, revise the section heading and paragraph (b) to 
read as follows:

Sec.  814.37  PMA amendments and resubmitted PMAs.

* * * * *
    (b)(1) FDA may request the applicant to amend a PMA or PMA 
supplement with any information regarding the device that is necessary 
for FDA or the appropriate advisory committee to complete the review of 
the PMA or PMA supplement.
    (2) FDA may request the applicant to amend a PMA or PMA supplement 
with information concerning pediatric uses as required under Sec. Sec.  
814.20(b)(13) and 814.39(c)(2).
* * * * *

0
6. In Sec.  814.39, redesignate paragraph (c) as (c)(1) and add 
paragraph (c)(2) to read as follows:

Sec.  814.39  PMA supplements.

* * * * *
    (c) * * *
    (2) The supplement must include the following information:
    (i) Information concerning pediatric uses as required under Sec.  
814.20(b)(13).
    (ii) If information concerning the device that is the subject of 
the supplement was previously submitted under Sec.  814.20(b)(13) or 
under this section in a previous supplement, that information may be 
included by referencing a previous application or submission that 
contains the information. However, if additional information required 
under Sec.  814.20(b)(13) has become readily available to the applicant 
since the previous submission, the applicant must submit that 
information as part of the supplement.
* * * * *

0
7. In Sec.  814.44, redesignate paragraphs (e)(1)(ii) through 
(e)(1)(iv) as paragraphs (e)(1)(iii) through (e)(1)(v), respectively, 
and add new paragraph (e)(1)(ii) to read as follows:

Sec.  814.44  Procedures for review of a PMA.

* * * * *
    (e) * * *
    (1) * * *
    (ii) The submission of additional information concerning pediatric 
uses required by Sec.  814.20(b)(13);
* * * * *

0
8. Amend Sec.  814.100 as follows:
0
a. Redesignate paragraphs (b) through (e) as paragraphs (d) through 
(g), respectively.
0
b. Redesignate paragraph (a) as paragraph (b), and remove the first 
sentence of redesignated paragraph (b); and
0
c. Add new paragraphs (a) and (c) to read as follows:

Sec.  814.100  Purpose and scope.

    (a) This subpart H implements sections 515A and 520(m) of the act.
* * * * *
    (c) Section 515A of the act is intended to ensure the submission of 
readily available information concerning:
    (1) Any pediatric subpopulations (neonates, infants, children, 
adolescents) that suffer from the disease or condition that the device 
is intended to treat, diagnose, or cure; and
    (2) The number of affected pediatric patients.
* * * * *

0
9. Amend Sec.  814.104 as follows:
0
a. Revise the last sentence of paragraph (b)(4)(ii);.
0
b. Revise the last sentence of paragraph (b)(5); and
0
c. Add paragraph (b)(6) to read as follows:

Sec.  814.104  Original applications.

* * * * *

[[Page 1741]]

    (b) * * *
    (4) * * *
    (ii) * * * The effectiveness of this device for this use has not 
been demonstrated;
    (5) * * * If the amount charged is $250 or less, the requirement 
for a report by an independent certified public accountant or an 
attestation by a responsible individual of the organization is waived; 
and
    (6) Information concerning pediatric uses of the device, as 
required by Sec.  814.20(b)(13).
* * * * *

0
10. In 814.116, redesignate paragraphs (c)(2) through (c)(4) as 
paragraphs (c)(3) through (c)(5), respectively, and add new paragraph 
(c)(2) to read as follows:

Sec.  814.116  Procedures for review of an HDE.

* * * * *
    (c) * * *
    (2) The submission of additional information concerning pediatric 
uses of the device, as required by Sec.  814.20(b)(13);
* * * * *

    Dated: January 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00267 Filed 1-9-14; 8:45 am]
BILLING CODE 4160-01-P