Document ID: FDA-2009-N-0458-0001
Agency: fda
Document Type: Proposed Rule
Title: Medical Devices; Pediatric Uses of Devices: Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease, etc.
Posted Date: 2010-04-01T04:00Z

[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Proposed Rules]               
[Page 16365-16370]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01ap10-23]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

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

 
Medical Devices; Pediatric Uses of Devices; Requirement for 
Submission of Information on Pediatric Subpopulations That Suffer From 
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or 
Cure

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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SUMMARY:  The Food and Drug Administration (FDA) is proposing to amend 
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 direct final rule. This

[[Page 16366]]

proposed rule will provide a procedural framework to finalize the rule 
in the event we receive significant adverse comment and withdraw the 
direct final rule.

DATES:  Submit electronic or written comments on the proposed rule by 
June 15, 2010. Submit electronic or written comments on the information 
collection requirements by June 1, 2010.

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. Why Is This Companion Proposed Rule Being Issued?

    This proposed rule is a companion to a direct final rule regarding 
the submission of information on pediatric subpopulations that suffer 
from a disease or condition that a device is intended to treat, 
diagnose, or cure. The direct final rule is published in the final 
rules section of this issue of the Federal Register. The direct final 
rule and this companion proposed rule are substantively identical. This 
companion proposed rule provides the procedural framework to finalize 
the rule in the event that the direct final rule receives any 
significant adverse comment and is withdrawn. We are publishing the 
direct final rule because we believe the rule is noncontroversial, and 
we do not anticipate receiving any significant adverse comments. If no 
significant adverse comment is received in response to the direct final 
rule, no further action will be taken relating to this proposed rule. 
Instead, we will publish a notice within 30 days after the comment 
period ends confirming when the direct final rule will go into effect.
    If we receive any significant adverse comment regarding the direct 
final rule we will withdraw the direct final rule within 30 days after 
the comment period ends and proceed to respond to all of the comments 
under this companion proposed rule using our usual notice-and-comment 
rulemaking procedures under the Administrative Procedure Act (APA) (5 
U.S.C. 552a et seq.). The comment period for this companion proposed 
rule runs concurrently with the direct final rule's comment period. Any 
comments received under this companion proposed rule will be considered 
as comments regarding the direct final rule and vice versa. We will not 
provide additional opportunity for comment.
    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 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.
    In the Federal Register of November 21, 1997 (62 FR 62466), you can 
find additional information about FDA's direct final rulemaking 
procedures in our guidance document entitled ``Guidance for FDA and 
Industry: Direct Final Rule Procedures.'' This guidance document is 
available at http://www.fda.gov/RegulatoryInformation/Guidances/
ucm125166.htm.

II. What Is the Background of This Proposed 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 proposed 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.
---------------------------------------------------------------------------

    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

[[Page 16367]]

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.

III. What Applications Are Subject to This Proposed Rule?

    In accordance with the act, these requirements apply to the 
following applications when submitted on or after the effective date of 
this proposed 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).

IV. What Does This Proposed Rule Do?

    This proposed rule would implement 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 proposed 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 proposed 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.

V. What Is the Legal Authority for This Proposed Rule?

    This proposed 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 Sec. Sec.  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 Proposed 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 Proposed Rule?

    We have examined the impacts of this proposed 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 
proposed 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 
proposed rule will not have a significant

[[Page 16368]]

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 
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 proposed 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 proposed 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 
Proposed Rule?

    This proposed 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:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.20(b)(3)(i)                                                        25                     1                 25                  4                100
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.37(b)(2)                                                           10                     1                 10                  4                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.39(h)                                                              10                     1                 10                  4                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.104(b)(6)                                                           5                     1                  5                  4                 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals                                                                                                                                               200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

[[Page 16369]]

readily available information, 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.
    In compliance with the provisions of the Paperwork Reduction Act of 
1995 (44 U.S.C. 3507(d)), the agency has submitted the information 
collection provisions of this proposed rule to OMB for review. As 
provided in 5 CFR 1320.5(c)(1), collections of information in a 
proposed 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 proposed 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 Proposed Rule?

    FDA has analyzed this proposed 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 proposed 
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.
    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 proposed to be amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

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

[[Page 16370]]

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.
    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;
* * * * *
    8. Amend Sec.  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:

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.
* * * * *
    9. Amend Sec.  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:

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).
* * * * *
    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. 2010-7192 Filed 3-31-10; 8:45 am]
BILLING CODE 4160-01-S