[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45109-45110]
[FR Doc No: 2022-16077]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0995]

Ivax Pharmaceuticals, Inc.; Withdrawal of Approval of an
Abbreviated New Drug Application for Chloramphenicol Capsules, 250
Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing the
approval of abbreviated new drug application (ANDA) 062247 for
chloramphenicol capsules, 250 milligrams (mg), held by Ivax
Pharmaceuticals, Inc. (Ivax). Ivax requested withdrawal of this
application and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of July 27, 2022.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: On April 28, 1980, FDA approved ANDA 062247
for chloramphenicol capsules, 250 mg, an antibiotic indicated to treat
only serious infections for which less potentially dangerous drugs are
ineffective or contraindicated. CHLOROMYCETIN (chloramphenicol)
Capsules, 250 mg (ANDA 060591), was the basis of submission for Ivax's
ANDA 062247 for chloramphenicol capsules, 250 mg. In a Federal Register
notice dated July 13, 2012 (77 FR 41412), FDA determined under 21 CFR
314.161 that CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg (ANDA
060591), was withdrawn for safety reasons and that additional
nonclinical and possibly clinical studies of safety and efficacy would
be necessary before CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg,
could be considered for reintroduction to the market. The holders of
approved applications for chloramphenicol capsules, 250 mg, had ceased
marketing of the drug products before July 13, 2012.
    On March 29, 2013, Ivax requested that FDA withdraw approval of
ANDA 062247 for chloramphenicol capsules, 250 mg. On June 17, 2021,
Ivax requested that FDA withdraw approval of ANDA 062247 for
chloramphenicol capsules, 250 mg, specifically under Sec.  314.150(d)
(21 CFR 314.150(d)) and waived its opportunity for a hearing. For the
reasons discussed above, and pursuant to the application holder's
request under 314.150(d), approval of ANDA 062247 for chloramphenicol
capsules, 250 mg, and all amendments and supplements thereto, is
withdrawn under Sec.  314.150(d). Distribution of chloramphenicol
capsules, 250 mg, into interstate commerce without an approved
application is illegal and subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d))).

    Dated: July 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16077 Filed 7-26-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 124 (Friday, June 26, 2020)]
[Rules and Regulations]
[Page 38330]
[FR Doc No: 2020-13903]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 261

Identification and Listing of Hazardous Waste

CFR Correction

0
 In Title 40 of the Code of Federal Regulations, Parts 260 to 265,
revised as of July 1, 2019, in part 261, remove appendix I to part 261
from above subpart I on page 155, and add it in numerical order after
the last section in the part, above appendixes II-III to part 261.

[FR Doc. 2020-13903 Filed 6-25-20; 8:45 am]
BILLING CODE 1301-00-D


[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Notices]
[Page 67307]
[DOCID:fr18de09-124]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Union Pacific Railroad Company

(Docket Number FRA-2009-0109)

    The Union Pacific Railroad (UP) would like to respectfully request
a waiver to the portion of 49 CFR 236.303 requiring portable derails to
be connected to the signal system. Due to the current economic
downturn, UP has found it necessary to use main, siding, and auxiliary
tracks to facilitate the storing of cars. Cars and equipment are being
stored in accordance with 49 CFR 232.103. The railroad also feels that
the placing of portable derails on these tracks will increase the
security of these cars that are being stored for an undetermined length
of time.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0109) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (65 FR 19477) or at
http://www.dot.gov/privacy.html.

     Issued in Washington, DC on December 11, 2009.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E9-30199 Filed 12-17-09; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Proposed Rules]
[Pages 11612-11617]
[FR Doc No: 2013-03647]

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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: Supplemental notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) published a proposed
rule in the Federal Register of April 1, 2010, along with a companion
direct final rule. The proposed rule proposed 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. The Agency received significant adverse
comment and withdrew the direct final rule. The Agency is issuing this
supplemental notice of proposed rulemaking re-proposing the amendments
reflecting comments received.

DATES: Submit either electronic or written comments on the proposed
rule by April 22, 2013. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by March 21, 2013,
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0458 and/or RIN number 0910-AG29, by any of the following methods,
except that comments on information collection issues under the
Paperwork Reduction Act of 1995 must be submitted to the Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB) (see the ``Paperwork Reduction Act of 1995'' section of this
document).

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:
     Mail/Hand delivery/Courier (for paper 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 No. FDA-2009-N-0458 and Regulatory Information Number (RIN)
0910-AG29 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: Sheila Brown, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Avenue, Bldg. 66, Rm. 1651, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. What is the background of this proposed rule?

    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 (21 U.S.C. 360e-1)
of the FD&C Act. 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 will be
essential to completing the annual report that FDA is required to
submit to Congress under section 515A(a)(3), 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 had published a proposed rule, along with a
companion direct final rule (75 FR 16347), with a 75-day comment period
to request input from interested parties (75 FR 16365) 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). One of these
comments stated that by revising Sec.  814.2 as proposed, FDA would
exceed its statutory authority by changing the purpose of the
regulation of medical devices. Furthermore, the comment stated that
since FDA already has the framework to evaluate whether a PMA
application includes all required content, this proposed amendment is
unnecessary. Although FDA disagrees that it does not have the authority
to enact such an amendment, the Agency agrees the amendment is
unnecessary because the objective of ensuring that PMAs include readily
available information concerning pediatric medical devices is subsumed
in proposed Sec.  814.20(b)(13). Per 21 CFR 814.42(e)(2), FDA may
refuse to file any PMA application that does not contain the elements
required by 21 CFR 814.20. Consequently, FDA has concluded that an
amendment to 21 CFR 814.2 is not needed in this proposed rule.
    Another comment challenged FDA's request for information on
potential pediatric uses when implementing section 515A(a)(2) of the
FD&C Act. The comment stated it is inappropriate to use the term
``potential'' in proposed codified Sec. Sec.  814.44, 814.100, 814.104,
and 814.116 because the statute does not require sponsors to speculate
as to possible pediatric uses and possible subpopulations. FDA agrees
with the comment and has revised the regulation by removing any mention
of potential pediatric uses. The proposed regulation now mirrors the
statute more closely and FDA believes this modification will facilitate
compliance.
    Due to the changes made since the April 1, 2010, proposed rule and
in particular, the scope of applications to which this requirement is
to apply (see section II), we are taking this action 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, this document serves to supplement the proposed rule that
issued with the companion direct final rule (75 FR 16365, April 1,
2010).

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). 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; and
     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) of the FD&C Act 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 22d birthday). See
Premarket Assessment of Pediatric Medical Devices (May 14, 2004);
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm.
    For purposes of the requirements proposed in this document, FDA is
proposing to codify 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 22d
birthday) at the time of the diagnosis or treatment.

III. What applications are subject to this proposed rule?

    In accordance with the FD&C Act, the proposed 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 would apply to the following applications
when submitted on or after the effective date of the final rule:
     Any request for a humanitarian device exemption (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; 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 2010 proposed rule. The Agency also wants to
clarify that it does not interpret 30-day notices submitted under 21
CFR 814.39(f) to be PMA supplements for purposes of this proposed rule.
Section 515(d)(6)(A) of the FD&C Act 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 and require the
submission of a ``supplemental application.'' Because of this statutory
distinction, 30-day notices are not considered PMA supplements for
purposes of this proposed rule and,

therefore, are not required to include readily-available pediatric
information.
    Moreover, an applicant submitting a PMA supplement is not required
to resubmit previously submitted information satisfying the pediatric
subpopulation requirements for the device, but may include the
information by referring to the previous application or submission that
contains the information. However, if additional information has become
readily available to the applicant since the previous submission, the
applicant must submit that information as part of the supplement.
    Many premarket approval applications begin with the submission of
one or more PMA modules; see ``Premarket Approval Application Modular
Review--Guidance for Industry and FDA Staff,'' available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089764.htm. Applicants who choose to use the
modular approach should submit the information required by section
515A(a) of the FD&C Act in the final PMA module (i.e., the module that
includes final clinical data, proposed labeling, and the Summary of
Safety and Effectiveness Data).

 IV. What does this proposed rule do?

    This proposed rule would implement section 515A(a) of the FD&C Act
by amending 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 proposed rule would require 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 proposing
to codify a definition of ``readily-available'' and also issue a draft
guidance document 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. The draft
guidance document entitled ``Draft 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'' is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm339162.htm.

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 proposed 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) of
the FD&C Act, 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 515A(a) information in the section listing minor deficiencies. For
additional information concerning ``approvable,'' ``not approvable,''
and ``major deficiency'' letters, see ``FDA and Industry Actions on
Premarket Approval Applications (PMAs): Effect on FDA Review Clock and
Goals,'' available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089733.htm.

V. What is the legal authority for this proposed rule?

    Section 302 of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110-85), amended the FD&C Act by adding, among
other things, a new section 515A (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. Therefore, FDA is publishing this proposed
rule under sections 515A(a) and 701(a) of the FD&C Act (21 U.S.C. 371)
(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 directs FDA to issue a
proposed rule implementing section 515A(a) of the FD&C Act by December
31, 2012, and final rule by December 31, 2013.

VI. What is the environmental impact of this proposed 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.

VII. What is the economic impact of this proposed rule?

    We have examined the impacts of the proposed 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 proposed rule will not be 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 small entities. Because this regulation only requires some
submissions include a small amount of readily available information at
about $80 per submission, the Agency proposes to certify that the 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 $139
million, using the most current (2011) Implicit Price Deflator for the
Gross Domestic Product. We do not expect this proposed 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 (section VII of
this document). 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. As explained in the
Paperwork Reduction analysis, we expect to receive annually 40 PMAs and
5 applications for HDEs. We also expect to receive 693 supplements that
would include the pediatric use information required by section 515A(a)
of the FD&C Act and this proposed rule.
    Based on our experience with similar requirements regarding readily
available information, we estimate it would take 8 hours to gather and
submit information for original applications and amendments to those
applications. Because supplements can incorporate this information by
reference if on a prior submission, we estimate it would 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 (Ref.
1). Adjusting the wage by average private sector benefits of 29.6
percent of total compensation, the benefits-adjusted wage is $45.10
(Ref. 2). At this wage, the estimated cost of submitting an application
with pediatric information is $361 or $16,236 for all supplements. The
estimated cost of submitting pediatric information for a supplement is
$90 or $62,508 for all annual supplements. The estimated cost of this
proposed 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.

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.
    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.
    Burden: FDA estimates the burden of this collection of information
as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section              Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       responses
----------------------------------------------------------------------------------------------------------------
814.20(b)(13)...................              30               1              30               8             240
814.37(b)(2)....................              10               1              10               8              80
814.39(c)(2)....................             693               1             693               2           1,386
814.104(b)(6)...................               5               1               5               8              40
                                 -------------------------------------------------------------------------------
    Totals......................             738  ..............             738  ..............           1,746
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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 proposed rule.
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 515A(a) of the
FD&C Act and this proposed rule. We believe that since the proposed
rule would require 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 proposed rule for
original applications and amendments to those applications.
Furthermore, because supplements may incorporate by reference readily-
available information on pediatric populations if submitted in

a prior submission, FDA estimates the average time to obtain and submit
the information required by this proposed rule in a supplement to be 2
hours. FDA estimates that the total burden created by this proposed
rule is 1,786 hours.
    We based this estimate 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, 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.
    This proposed rule also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR part 814 subpart B have been approved under 0910-0231 and the
collections of information in 21 CFR part 814 subpart H have been
approved under 0910-0332.
    Elsewhere in this issue of the Federal Register, FDA is publishing
a draft guidance that suggests, among other things, that submissions
include an estimate of the number of pediatric patients with diseases
or conditions for which the device can be used, but that are outside
the approved or proposed indication if such uses are described or
acknowledged in acceptable sources of readily available information.

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. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
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 tentatively concludes that the proposed 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 either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. It is only necessary to send one set of comments. Identify
comments 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, and will
be posted to the docket at http://www.regulations.gov.

XI. References

    The following references have been placed on display in the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, and may be seen by interested persons between 9 a.m. and 4
p.m., Monday through Friday. We have verified all the Web site
addresses in the References section, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.
    1. U.S. Bureau of Labor Statistics, 2011 National Industry-Specific
Occupational Employment and Wage Estimates, SOC 13-1041. http://www.bls.gov/oes/current/naics4_339100.htm.
    2. U.S. Bureau of Labor Statistics, Employer Costs for Employee
Compensation, Table 5. Employer costs per hour worked for employee
compensation and costs as a percent of total compensation: Private
industry workers, by major occupational group and bargaining unit
status, June 2012. http://www.bls.gov/news.release/ecec.t05.htm.

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

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 (p) and (q) to read as follows:

Sec.  814.3  Definitions.

* * * * *
    (p) Pediatric patients means 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 22d birthday) at the time of the diagnosis or
treatment.
    (q) 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, the applicant is not
required to resubmit the information, but may include the information
by referring to the 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 (iv) as
paragraphs (e)(1)(iii) through (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 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:
    (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 who are 21 years of
age or younger.
* * * * *
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).
    The revisions and addition 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) 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 (4) as paragraphs
(c)(3) through (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: February 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03647 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 98 (Tuesday, May 21, 2013)]
[Notices]
[Pages 29750-29751]
[FR Doc No: 2013-11989]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP13-898-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Amendment to Neg Rate Agmt (Sequent 34693-15) to be
effective 5/13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5027.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-899-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Amendment to Neg Rate Agmt (Cross Timbers 29061-3) to
be effective 5/13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5055.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-900-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5056.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-901-000.
    Applicants: Big Sandy Pipeline, LLC.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5057.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-902-000.
    Applicants: Bobcat Gas Storage.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5063.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-903-000.
    Applicants: Egan Hub Storage, LLC.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5075.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-904-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5088.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-905-000.
    Applicants: Gulfstream Natural Gas System, L.L.C.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5109.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-906-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5133.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-907-000.
    Applicants: Ozark Gas Transmission, L.L.C.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5136.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-908-000.
    Applicants: Saltville Gas Storage Company L.L.C.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5144.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-909-000.
    Applicants: Southeast Supply Header, LLC.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5147.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-910-000.
    Applicants: Steckman Ridge, LP.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5149.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-911-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: NAESB Copyright Waiver 2 to be effective 6/
13/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5151.
    Comments Due: 5 p.m. ET 5/28/13.

    Docket Numbers: RP13-912-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Non-Conforming--VEPCO Black Start 39275 to be
effective 7/1/2013.
    Filed Date: 5/13/13.
    Accession Number: 20130513-5160.
    Comments Due: 5 p.m. ET 5/28/13.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP13-743-001.
    Applicants: ANR Pipeline Company.
    Description: DTCA 2013 Compliance RP13-743 to be effective 5/1/
2013.
    Filed Date: 5/14/13.
    Accession Number: 20130514-5014.
    Comments Due: 5 p.m. ET 5/28/13.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://

www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information,
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 14, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-11989 Filed 5-20-13; 8:45 am]
BILLING CODE 6717-01-P