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, 1735-1741 [2014-00267]
Download as PDF
<![CDATA[
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Rules and Regulations
solely to the agency’s organization,
procedure, or practice. Accordingly, the
provisions of the Administrative
Procedure Act regarding notice of
proposed rulemaking and opportunity
for public participation are not
applicable.1 The Regulatory Flexibility
Act, therefore, does not apply.2 Because
these rules relate solely to the agency’s
organization, procedure, or practice and
do not substantially affect the rights or
obligations of non-agency parties, they
are not subject to the Small Business
Regulatory Enforcement Fairness Act.3
Finally, these amendments do not
contain any collection of information
requirements as defined by the
Paperwork Reduction Act of 1995, as
amended.4
B. Consideration of Burden on
Competition
80b–11, 7202, and 7211 et seq., unless
otherwise noted.
*
By the Commission.
Elizabeth M. Murphy,
Secretary.
■
[FR Doc. 2014–00219 Filed 1–9–14; 8:45 am]
*
*
*
*
2. In § 200.21 paragraph (a), after the
fourth sentence, that begins with ‘‘In
addition, he or she is responsible’’, add
two new sentences to read as follows:
§ 200.21
Statutory Authority
The amendments to the Commission’s
rules are adopted pursuant to 15 U.S.C.
77o, 77s, 77sss, 78d, 78d–1, 78d–2, 78w,
78ll(d), 78mm, 80a–37, 80b–11, and
7202.
List of Subjects in 17 CFR Part 200
The General counsel.
(a) * * * The General Counsel is
responsible for providing advice to
Commission attorneys on professional
responsibility issues relating to their
official duties. The General Counsel is
further responsible for investigating
allegations of professional misconduct
by Commission staff and, where
appropriate, making referrals to state
professional boards or societies. * * *
*
*
*
*
*
§ 200.21a
Section 23(a)(2) of the Exchange Act
requires the Commission, in making
rules pursuant to any provision of the
Exchange Act, to consider among other
matters the impact any such rule would
have on competition. The Commission
does not believe that the amendments
that the Commission is adopting today
will have any impact on competition.
[Amended]
3. In § 200.21a:
a. In paragraph (a), remove the phrase
‘‘Office of Administrative and Personnel
Management,’’ and add in its place,
‘‘Office of Human Resources, the Office
of Government Ethics,’’;
■ b. In paragraph (b)(1), at the end of the
paragraph, add the phrase ‘‘that relate to
the Commission’s Ethics Program’’
before the period;
■ c. In paragraph (b)(2), at the end of the
paragraph, add the phrase ‘‘, which the
Ethics Counsel shall refer to the General
Counsel’’ before the period;
■ d. Remove paragraph (b)(7);
■ e. Redesignate paragraph (b)(8) as
(b)(7).
■
■
Subpart M—Regulation Concerning
Conduct of Members and Employees
and Former Members and Employees
of the Commission
Administrative practice and
procedure, Authority delegations
(Government agencies), Organization
and functions (Government agencies).
4. The authority citation for Part 200,
Subpart M, continues to read as follows:
■
Text of Amendments
In accordance with the preamble, the
Commission hereby amends Title 17,
Chapter II of the Code of Federal
Regulations as follows:
Authority: 15 U.S.C. 77s, 77sss, 78w, 80a–
37, 80b–11; E.O. 11222, 3 CFR, 1964–1965
Comp., p. 36; 5 CFR 735.104 and 5 CFR 2634;
and 5 CFR 2635, unless otherwise noted.
PART 200—ORGANIZATION;
CONDUCT AND ETHICS; AND
INFORMATION AND REQUESTS
§ 200.735–15
1. The authority citation for part 200,
Subpart A, continues to read, in part, as
follows:
mstockstill on DSK4VPTVN1PROD with RULES
■
Authority: 15 U.S.C. 77o, 77s, 77sss, 78d,
78d–1, 78d–2, 78w, 78ll(d), 78mm, 80a–37,
15
U.S.C. 553(b).
U.S.C. 601–612.
3 5 U.S.C. 804.
4 44 U.S.C. 3501–3520.
25
VerDate Mar<15>2010
16:30 Jan 09, 2014
[Amended]
5. In § 200.735–15:
a. Remove paragraph (b).
b. Redesignate paragraphs (c), (d) (e)
and (f) as paragraphs (b), (c), (d) and (e),
respectively.
■ c. In the first sentence of newly
redesignated paragraph (b), remove the
words ‘‘any Deputy Counselor or’’.
■ d. In newly redesignated paragraph
(c), remove the words ‘‘and Deputy
Counselors’’. Also in newly
redesignated paragraph (c), remove the
words ‘‘they receive’’ and add in their
place ‘‘he or she receives’’ wherever
they appear.
■
■
■
Subpart A—Organization and Program
Management
Dated: January 6, 2014.
Jkt 232001
1735
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
BILLING CODE 8011–01–P
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.
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:
SUMMARY:
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
1 Title III of FDAAA, which includes new section
515A, is also known as the Pediatric Medical
Device Safety and Improvement Act of 2007.
E:\FR\FM\10JAR1.SGM
10JAR1
1736
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Rules and Regulations
mstockstill on DSK4VPTVN1PROD with RULES
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:
• 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
VerDate Mar<15>2010
16:30 Jan 09, 2014
Jkt 232001
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); https://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 § 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
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
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
https://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
E:\FR\FM\10JAR1.SGM
10JAR1
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Rules and Regulations
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.
mstockstill on DSK4VPTVN1PROD with RULES
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 https://
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
VerDate Mar<15>2010
16:30 Jan 09, 2014
Jkt 232001
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’’ (https://
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
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
1737
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
E:\FR\FM\10JAR1.SGM
10JAR1
mstockstill on DSK4VPTVN1PROD with RULES
1738
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Rules and Regulations
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
§ 814.39, it must include readily
available pediatric information as
required by § 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
VerDate Mar<15>2010
16:30 Jan 09, 2014
Jkt 232001
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
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
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
E:\FR\FM\10JAR1.SGM
10JAR1
1739
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Rules and Regulations
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 benefitsadjusted 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.
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
respondents
Activity/21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Pediatric information in an original PMA or PDP—
814.20(b)(13) ....................................................................
Pediatric information in a PMA amendment—814.37(b)(2)
Pediatric information in a PMA supplement—814.39(c)(2)
Pediatric information in an HDE—814.104(b)(6) .................
30
10
693
5
1
1
1
1
30
10
693
5
8
8
2
8
240
80
1,386
40
Total ..............................................................................
........................
........................
738
........................
1,746
mstockstill on DSK4VPTVN1PROD with RULES
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
2 U.S. Bureau of Labor Statistics, 2011 National
Industry-Specific Occupational Employment and
Wage Estimates, SOC 13–1041 (https://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 (https://
www.bls.gov/news.release/ecec.t05.htm).
VerDate Mar<15>2010
16:30 Jan 09, 2014
Jkt 232001
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
E:\FR\FM\10JAR1.SGM
10JAR1
1740
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Rules and Regulations
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:
§ 814.20
§ 814.44
§ 814.3
Definitions.
*
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.
*
*
*
*
*
■ 5. In § 814.37, revise the section
heading and paragraph (b) to read as
follows:
Authority: 21 U.S.C. 351, 352, 353, 360,
360c–360j, 371, 372, 373, 374, 375, 379, 379e,
381.
2. In § 814.1, revise paragraph (a) to
read as follows:
§ 814.39
1. The authority citation for 21 CFR
part 814 continues to read as follows:
■
*
■
§ 814.1
Scope.
(a) This section implements sections
515 and 515A of the act by providing
VerDate Mar<15>2010
16:30 Jan 09, 2014
Jkt 232001
PMA supplements.
*
*
*
*
*
(c) * * *
(2) The supplement must include the
following information:
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
Procedures for review of a PMA.
*
*
*
*
*
(e) * * *
(1) * * *
(ii) The submission of additional
information concerning pediatric uses
required by § 814.20(b)(13);
*
*
*
*
*
■ 8. Amend § 814.100 as follows:
■ a. Redesignate paragraphs (b) through
(e) as paragraphs (d) through (g),
respectively.
■ b. Redesignate paragraph (a) as
paragraph (b), and remove the first
sentence of redesignated paragraph (b);
and
■ c. Add new paragraphs (a) and (c) to
read as follows:
§ 814.100
§ 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 §§ 814.20(b)(13) and
814.39(c)(2).
*
*
*
*
*
■ 6. In § 814.39, redesignate paragraph
(c) as (c)(1) and add paragraph (c)(2) to
read as follows:
PART 814—PREMARKET APPROVAL
OF MEDICAL DEVICES
mstockstill on DSK4VPTVN1PROD with RULES
*
*
*
*
(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.
■ 4. In § 814.20, redesignate paragraph
(b)(13) as paragraph (b)(14) and add new
paragraph (b)(13) to read as follows:
(i) Information concerning pediatric
uses as required under § 814.20(b)(13).
(ii) If information concerning the
device that is the subject of the
supplement was previously submitted
under § 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
§ 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.
*
*
*
*
*
■ 7. In § 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:
procedures for the premarket approval
of medical devices intended for human
use.
*
*
*
*
*
■ 3. In § 814.3, add paragraphs (s) and
(t) to read as follows:
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.
*
*
*
*
*
■ 9. Amend § 814.104 as follows:
■ a. Revise the last sentence of
paragraph (b)(4)(ii);.
■ b. Revise the last sentence of
paragraph (b)(5); and
■ c. Add paragraph (b)(6) to read as
follows:
§ 814.104
Original applications.
*
*
E:\FR\FM\10JAR1.SGM
*
10JAR1
*
*
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Rules and Regulations
(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
§ 814.20(b)(13).
*
*
*
*
*
■ 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:
§ 814.116
HDE.
Procedures for review of an
*
*
*
*
*
(c) * * *
(2) The submission of additional
information concerning pediatric uses of
the device, as required by
§ 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
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2013–1039]
Drawbridge Operation Regulation;
Upper Mississippi River, Sabula, IA
Coast Guard, DHS.
Notice of deviation from
drawbridge regulations.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the Sabula
Railroad Drawbridge across the Upper
Mississippi River, mile 535.0, at Sabula,
Iowa. The deviation is necessary to
allow the bridge owner time to perform
repairs and maintenance that is
essential to the continued safe operation
of the drawbridge. This deviation allows
the bridge to remain in the closed-tonavigation position while a damaged
gear assembly is replaced and structural
steel repairs are completed.
DATES: This deviation is effective from
7 a.m., January 6, 2014 to 7 a.m., March
4, 2014.
mstockstill on DSK4VPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
16:30 Jan 09, 2014
Jkt 232001
The docket for this
deviation, USCG–2013–1039 is available
at https://www.regulations.gov. Type the
docket number in the ‘‘SEARCH’’ box
and click ‘‘SEARCH’’. Click on Open
Docket Folder on the line associated
with this deviation. You may also visit
the Docket Management Facility in
Room W12–140 on the ground floor of
the Department of Transportation West
Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Eric A.
Washburn, Bridge Administrator,
Western Rivers, Coast Guard; telephone
314–269–2378, email Eric.Washburn@
uscg.mil. If you have questions on
viewing the docket, call Cheryl Collins,
Program Manager, Docket Operations,
telephone 202–366–9826.
SUPPLEMENTARY INFORMATION: The
Canadian Pacific Railway requested a
temporary deviation for the Sabula
Railroad Drawbridge, across the Upper
Mississippi River, mile 535.0, at Sabula,
Iowa to remain in the closed-tonavigation position while a damaged
gear assembly is replaced and structural
steel repairs are completed. The closure
period will start at 7 a.m., January 6,
2014 to 7 a.m., March 4, 2014. Work is
scheduled in the winter and when there
is less impact on navigation; instead of
scheduling work in the summer, when
river traffic increases.
Once the gear assembly is removed
and structural steel repairs have
commenced, the swing span will not be
able to open, even for emergencies, until
repairs are complete and gear assembly
is installed.
The Sabula Railroad Drawbridge
currently operates in accordance with
33 CFR 117.5, which states the general
requirement that drawbridges shall open
promptly and fully for the passage of
vessels when a request to open is given
in accordance with the subpart. In order
to facilitate the needed bridge work, the
drawbridge must be kept in the closedto-navigation position.
There are no alternate routes for
vessels transiting this section of the
Upper Mississippi River.
The Sabula Railroad Drawbridge, in
the closed-to-navigation position,
provides a vertical clearance of 18.1 feet
above normal pool. Navigation on the
waterway consists primarily of
commercial tows and recreational
watercraft. This temporary deviation has
been coordinated with the waterway
users. No objections were received.
ADDRESSES:
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
1741
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: December 18, 2013.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2014–00284 Filed 1–9–14; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 412, 413, 414, 419, 424,
482, 485, and 489
[CMS–1599–CN4]
RIN 0938–AR53
Medicare Program; Hospital Inpatient
Prospective Payment Systems for
Acute Care Hospitals and the LongTerm Care Hospital Prospective
Payment System and Fiscal Year 2014
Rates; Quality Reporting Requirements
for Specific Providers; Hospital
Conditions of Participation; Payment
Policies Related to Patient Status;
Corrections
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule; correction.
AGENCY:
This document corrects
technical errors in the correcting
document that appeared in the January
2, 2014 Federal Register entitled
‘‘Medicare Program; Hospital Inpatient
Prospective Payment Systems for Acute
Care Hospitals and the Long-Term Care
Hospital Prospective Payment System
and Fiscal Year 2014 Rates; Quality
Reporting Requirements for Specific
Providers; Hospital Conditions of
Participation; Payment Policies Related
to Patient Status; Corrections.’’
DATES: Effective Date: This correcting
document is effective January 8, 2014.
Applicability Date: This correcting
document is applicable on January 1,
2014.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Tzvi
Hefter, (410) 786–4487.
SUPPLEMENTARY INFORMATION:
I. Background
In the August 19, 2013 Federal
Register (78 FR 50495), we published a
final rule entitled ‘‘Medicare Program;
Hospital Inpatient Prospective Payment
E:\FR\FM\10JAR1.SGM
10JAR1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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);
https://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 https://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 https://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'' (https://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.
---------------------------------------------------------------------------
\2\ U.S. Bureau of Labor Statistics, 2011 National Industry-
Specific Occupational Employment and Wage Estimates, SOC 13-1041
(https://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 (https://www.bls.gov/news.release/ecec.t05.htm).
---------------------------------------------------------------------------
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
