
[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Rules and Regulations]               
[Page 16347-16351]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01ap10-13]                         

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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; Direct Final Rule

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Direct final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is 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. Elsewhere in this issue of the 
Federal Register, we are publishing a companion proposed rule under 
FDA's usual procedure for notice and comment to provide a procedural 
framework to finalize the rule in the event we receive significant 
adverse comment and withdraw this direct final rule.

DATES:  This rule is effective August 16, 2010. Submit electronic or 
written comments on the direct final rule by June 15, 2010. Submit 
electronic or written comments on the information collection 
requirements by June 1, 2010. If we receive no significant adverse 
comments within the specified comment period, we intend to publish a 
document confirming the effective date of the final rule in the Federal 
Register within 30 days after the comment period on this direct final 
rule ends. If we receive any timely significant adverse comment, we 
will withdraw this final rule in part or in whole by publication of a 
document in the Federal Register within 30 days after the comment 
period ends.

ADDRESSES:  You may submit comments, identified by Docket No. FDA-2009-
N-0458, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number and regulatory information number (RIN) for this 
rulemaking. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Robert Gatling, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 1640, Silver Spring, MD 20993, 301-796-
6560.

SUPPLEMENTARY INFORMATION:

I. What Is the Background of This Rule?

    On September 27, 2007, the Food and Drug Administration Amendments 
Act of 2007 (FDAAA)\1\ (Public Law 110-85) amended the Federal Food, 
Drug, and Cosmetic Act (the act) by adding, among other things, a new 
section 515A of the act (21 U.S.C. 360e-1). Section 515A(a) of the act 
requires persons 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. This rule amends FDA's regulations to 
implement the requirements of section 515A(a) of the 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.
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    Section 515A(c) of the 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 act (21 U.S.C. 
360j(m)(6)(E)(ii)). Section 520(m)(6)(E)(ii) of the act defines the 
term ``pediatric subpopulation'' to mean one of the following 
populations:
     Neonates;
     Infants;
     Children; or
     Adolescents.
    We have previously issued guidance recommending the age range for 
each of the populations included in the term ``pediatric 
subpopulation.'' See Premarket Assessment of Pediatric Medical Devices 
(May 14, 2004); (http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm).
    The term ``pediatric patient'' is defined, for purposes of section 
520(m)(6)(E)(i) of the act as patients who are 21 years of age or 
younger at the time of the diagnosis or treatment. Because no other 
definition of ``pediatric patient'' is included in the Pediatric 
Medical Device Safety and Improvement Act of 2007, and because the 
definition in section 520(m)(6)(E)(i) of the act is consistent with the 
definition of pediatric subpopulations in section 520(m)(6)(E)(ii), FDA 
has concluded that the term ``pediatric patient'' in section 515A of 
the act refers to patients who are 21 years of age or younger at the 
time of the diagnosis or treatment.
    The information submitted under section 515A(a) of the act will 
help FDA track the following information that it is required to report 
annually to Congress, in accordance with section 515A(a)(3) of the act:
     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;
     The number of approved devices labeled for use in 
pediatric patients;
     The number of approved pediatric devices that were 
exempted from a review fee under section 738(a)(2)(B)(v) of the act (21 
U.S.C. 379j(a)(2)(B)(v)); and
     The review time for each such device.

[[Page 16348]]

II. What Applications Are Subject to This Rule?

    In accordance with the act, these requirements 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 act;
     Any premarket approval application (PMA) or supplement to 
a PMA submitted under section 515 of the act; and
     Any product development protocol (PDP) submitted under 
section 515 of the act.
    If the applicant of a supplement to a PMA has previously submitted 
information satisfying these requirements, the applicant may 
incorporate that information by reference 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 PMAs 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 act in the final PMA module (i.e., 
the module that includes final clinical data, proposed labeling, and 
the summary of safety and effectiveness).

III. What Does This Direct Final Rule Do?

    This direct final rule implements new section 515A(a) of the act by 
amending 21 CFR Part 814, 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.

A. What Information Must Be Provided?

    This 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.

B. What Are the Consequences of Not Submitting ``Readily Available'' 
Information?

    If you do not submit the information required by section 515A(a) of 
the act, FDA may not approve your application until you provide the 
required information. We intend to contact you during the normal course 
of our review to inform you that your submission lacks the information 
required by section 515A(a) of the act and by this rule, and to ask you 
to amend your application to provide the required information. If your 
application has no other deficiencies and otherwise meets applicable 
statutory and regulatory requirements for approval, but still lacks 
information required by section 515A(a) of the act, we intend to send 
you an ``approvable'' letter informing you that we will approve your 
application after you provide the information required by section 
515A(a). If your application has other deficiencies or does not meet 
all applicable statutory and regulatory requirements for approval, we 
intend to send you a ``not approvable'' letter or a ``major 
deficiency'' letter describing what information or data you need to 
provide before FDA can approve your application; the ``not approvable'' 
or ``major deficiency'' letter may cite the absence of 515A(a) 
information in the section listing minor deficiencies. For additional 
information concerning the interactive process we will use during our 
review, see Guidance for Industry and FDA Staff: Interactive Review for 
Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, 
Original BLAs, and BLA Supplements, available at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
ucm089402.htm. 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.

IV. What Are the Procedures for Issuing a Direct Final Rule?

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
announced the availability of the guidance document entitled ``Guidance 
for FDA and Industry: Direct Final Rule Procedures'' that described 
when and how we will employ direct final rulemaking. We believe that 
this rule is appropriate for direct final rulemaking because it is 
intended to make noncontroversial amendments and minor corrections to 
existing regulations. We anticipate no significant adverse comment.
    Consistent with FDA's procedures on direct final rulemaking, we are 
publishing elsewhere in this issue of the Federal Register a companion 
proposed rule that is identical in substance to this direct final rule. 
The companion proposed rule provides a procedural framework within 
which the rule may be finalized in the event the direct final rule is 
withdrawn because of any significant adverse comment. The comment 
period for this direct final rule runs concurrently with the comment 
period of the companion proposed rule. Any comments received in 
response to the companion proposed rule will also be considered as 
comments regarding this direct final rule.
    If we receive any significant adverse comment, we intend to 
withdraw this final rule before its effective date by publishing a 
notice in the Federal Register within 30 days after the comment period 
ends. A significant adverse comment is defined as a comment that 
explains why the rule would be inappropriate, including challenges to 
the rule's underlying premise or approach, or would be ineffective or 
unacceptable without change. In determining whether an adverse comment 
is significant and warrants withdrawing a direct final rulemaking, we 
will consider whether the comment raises an issue serious enough to 
warrant a substantive response in a notice-and-comment process in 
accordance with section 553 of the Administrative Procedure Act (APA) 
(5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside 
the scope of the rule will not be considered a significant adverse 
comment, unless the comment states why the rule would be ineffective 
without the additional change. In addition, if a significant adverse 
comment applies to part of a rule and that part can be severed from the 
remainder of the rule, we may adopt as final those parts of the rule 
that are not the subject of a significant adverse comment.
    If we withdraw the direct final rule, all comments received will be 
considered under the companion proposed rule in developing a final rule 
under the usual notice-and-comment procedures under the APA (5 U.S.C. 
552a et seq.). If we receive no significant adverse comment during the 
specified comment period, we intend to publish a confirmation document 
in the Federal Register within 30 days after the comment period ends.

[[Page 16349]]

V. What Is the Legal Authority for This Rule?

    This rule, if finalized, would amend Sec. Sec.  814.1, 814.2, 
814.20, 814.37, 814.39, 814.44, 814.100, 814.104, and 814.116. FDA's 
legal authority to modify 814.1, 814.2, 814.20, 814.37, 814.39, 814.44, 
814.100, 814.104 and 814.116 arises from the same authority under which 
FDA initially issued these regulations, the device and general 
administrative provisions of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321, 331, 351, 352, 360e, 360e-1, 360j, and 371).

VI. What Is the Environmental Impact of This Rule?

    FDA has determined under 21 CFR 25.30(h) and 25.34(a) 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.

VII. What Is the Economic Impact of This Rule?

    We have examined the impacts of this rule under Executive Order 
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs 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). We believe that this 
direct final rule is not a significant regulatory action as defined by 
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this regulation only requires that some 
submissions include a small amount of readily available information, 
creating little additional burden, the agency certifies that the direct 
final rule will 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 $133 million, using the most current (2008) Implicit 
Price Deflator for the Gross Domestic Product. We do not expect this 
final 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 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. We have also limited 
the rule to exclude supplements that do not involve a new intended use; 
if a supplement does not involve a new intended use, we do not expect 
the applicant will have new information pertinent to the requirement of 
section 515A(a) of the act and this rule, and the limitation avoids the 
needless submission of duplicate information to FDA. 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.

VIII. How Does the Paperwork Reduction Act of 1995 Apply to This Rule?

    This direct 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 below 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. FDA invites comments on: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection techniques, when 
appropriate, and other forms of information technology.
    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 FDAAA 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; the number of approved devices labeled for 
use in pediatric patients; the number of approved pediatric devices 
that were exempted from a review fee under section 738(a)(2)(B)(v) of 
the act; and the review time for each such device.
    Description of Respondents: These requirements apply to applicants 
who submit the following applications when submitted on or after the 
effective date of this rule:
     Any request for an HDE submitted under section 520(m) of 
the act;
     Any PMA submitted under section 515 of the act;
     Any PDP submitted under section 515 of the act; and
     Any supplement to an HDE, PMA, or PDP that proposes a new 
intended use, whether for an adult population or a pediatric 
population.
    Burden: FDA estimates the burden of this collection of information 
as follows:

[[Page 16350]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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814.20(b)(3)(i)                                                        25                     1                 25                  4                100
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814.37(b)(2)                                                           10                     1                 10                  4                 40
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814.39(h)                                                              10                     1                 10                  4                 40
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814.104(b)(6)                                                           5                     1                  5                  4                 20
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Totals                                                                                                                                               200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    All that is required is to access, organize, and submit information 
that is readily available, using any approach that meets the 
requirements of section 515A(a) of the act and this rule. FDA expects 
to receive approximately 40 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 2007 
through FY 2008. 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 10 supplements that describe a new 
indication for use and will include the pediatric use information 
required by 515A(a) of the act and this rule. We believe that because 
the rule requires that the applicant organize and submit only readily 
available information or a description of the methodology employed to 
determine whether information required is readily available, no more 
than 4 hours will be required to comply with section 515A(a) of the act 
and this rule. FDA estimates that the total burden created by this rule 
is 200 hours.
    We based this estimate on our experience with similar information 
collection requirements and on consultations with the Interagency 
Pediatric Devices Working Group which includes the Agency for 
Healthcare Research and Quality, FDA, National Institutes of Health, 
members of the Pediatric Advisory Committee, researchers, healthcare 
practitioners, medical device trade associations, and medical device 
manufacturers.
    As provided in 5 CFR 1320.5(c)(1), collections of information in a 
direct final rule are subject to the procedures set forth in 5 CFR 
1320.10. Interested persons and organizations may submit comments on 
the information collection requirements of this direct final rule (see 
DATES), to the Division of Dockets Management (see ADDRESSES).
    At the close of the 60-day comment period, FDA will review the 
comments received, revise the information collection provisions as 
necessary, and submit these provisions to OMB for review. FDA will 
publish a notice in the Federal Register when the information 
collection provisions are submitted to OMB, and an opportunity for 
public comment to OMB will be provided at that time. Prior to the 
effective date of the direct final rule, FDA will publish a notice in 
the Federal Register of OMB's decision to approve, modify, or 
disapprove the information collection provisions. 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.

IX. What Are the Federalism Impacts of This Rule?

    FDA has analyzed this direct final rule in accordance with the 
principles set forth in Executive Order 13132. We have 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, we have 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.

X. How Do You Submit Comments on This Rule?

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this direct 
final rule. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

List of Subjects in 21 CFR Part 814

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

0
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. Revise Sec.  814.2 to read as follows:


Sec.  814.2   Purpose.

    The purpose of this part is to establish an efficient and thorough 
device review process--
    (a) To facilitate the approval of PMAs for devices that have been 
shown to be safe and effective and that otherwise meet the statutory 
criteria for approval;
    (b) To ensure the disapproval of PMAs that have not been shown to 
be safe and effective or that do not otherwise meet the statutory 
criteria for approval; and

[[Page 16351]]

    (c) To ensure PMAs include readily available information concerning 
actual and potential pediatric uses of medical devices.

0
4. In Sec.  814.20, revise paragraph (b)(3)(i) to read as follows:


Sec.  814.20   Application.

* * * * *
    (b) * * *
    (3) * * *
    (i) Indications for use. (A) A general description of the disease 
or condition the device will diagnose, treat, prevent, cure, or 
mitigate, including a description of the patient population for which 
the device is intended.
    (B) Information concerning uses in pediatric patients who are 21 
years of age or younger: The application must include the following 
information, if readily available:
    (1) 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
    (2) 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.  
814.20(b)(3)(i).
* * * * *

0
6. In Sec.  814.39, add paragraph (h) to read as follows:


Sec.  814.39   PMA supplements.

* * * * *
    (h) The application must include the following information, if 
readily available:
    (1) 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
    (2) The number of affected pediatric patients who are 21 years of 
age or younger.
    (3) If information concerning the device that is the subject of the 
supplement was previously submitted under Sec.  814.20(b)(3)(i), that 
information may be incorporated by reference to the application or 
submission that contains the information. However, if additional 
information required under Sec.  814.20(b)(3)(i) 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 potential 
pediatric uses required by Sec.  814.20(b)(3)(i) that is readily 
available to the applicant;
* * * * *

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 newly 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 actual and potential pediatric 
uses of medical devices.
* * * * *

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.

* * * * *
    (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) Readily available information concerning actual and potential 
pediatric uses of the device, as required by Sec.  814.20(b)(3)(i).
* * * * *

0
10. In Sec.  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 potential 
pediatric uses required by Sec.  814.20(b)(3)(i) that is readily 
available to the applicant;
* * * * *

    Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7193 Filed 3-31-10; 8:45 am]
BILLING CODE 4160-01-S

