[Federal Register: March 28, 2007 (Volume 72, Number 59)]
[Notices]
[Page 14546-14548]
[DOCID:fr28mr07-57]

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ENVIRONMENTAL PROTECTION AGENCY

[AMS-FRL-8292-8]

California State Nonroad Engine and Vehicle Pollution Control
Standards; Authorization of Marine Outboard, Personal Watercraft and
Tier One Inboard/Sterndrive Engine Standards, Notice of Decision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Decision for Authorization of California Marine
Outboard, Personal Watercraft and Tier One Inboard/Sterndrive Engine
Emission Standards.

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SUMMARY: EPA today, pursuant to section 209(e) of the Clean Air Act
(Act), 42 U.S.C. 7543(e), is granting California its requests for
authorization of its Marine Spark-Ignition Engines regulations for
outboard and personal watercraft engines in their entirety, and for the
first tier of regulations affecting inboard and sterndrive engines. EPA
is deferring an authorization decision on the second tier of inboard
and sterndrive standards pending the completion of testing currently
underway to evaluate the technological feasibility of both the
California inboard and sterndrive standards and Federal inboard and
sterndrive standards which are expected to be proposed regulations in
2007.

ADDRESSES: The Agency's Decision Document, containing an explanation of
the Assistant Administrator's decision, as well as all documents relied
upon in making that decision, including those submitted to EPA by
California, are available for public inspection in EPA Air and
Radiation Docket and Information Center (Air Docket). Materials
relevant to this decision are contained in Docket OAR-2004-0403 at the
following location: EPA Air Docket, Room 3334, 1301 Constitution Avenue
NW., Washington, DC 20460. The EPA Docket Center Public Reading Room is
open from 8 a.m. to 5:30 p.m. Monday through Friday, except on
government holidays. The Air Docket telephone number is<PHONE_NUMBER>,
and the facsimile number is<PHONE_NUMBER>. You may be charged a
reasonable fee for photocopying docket materials, as provided in 40 CFR
part 2.

FOR FURTHER INFORMATION CONTACT: Robert M. Doyle, Attorney-Advisor,
Office of Transportation and Air Quality, (6403J), U.S. Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460
(U.S. mail), 1310 L Street, NW., Washington, DC 20005 (courier mail).
Telephone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, E-Mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Obtaining Electronic Copies of Documents

    EPA makes available an electronic copy of this Notice on the Office
of Transportation and Air Quality (OTAQ) homepage (http://www.epa.gov/OTAQ
). Users can find this document by accessing the OTAQ homepage and

looking at the path entitled ``Federal Register Notices''. This service
is free of charge, except any cost you already incur for Internet
connectivity. Users can also get the official Federal Register version
of the Notice on the day of publication on the primary Web site:
(http://www.epa.gov/docs/fedrgstr/EPA-AIR/) Please note that due to

differences between the software used to develop the documents and the
software into which the documents may be downloaded, changes in format,
page length, etc., may occur.
    Additionally, an electronic version of the public docket is
available through the Federal government's electronic public docket and
comment system. You may access EPA dockets at http://www.regulations.gov After opening the http://www.regulations.gov. Web

site, select ``Environmental Protection Agency'' from the pull-down
Agency list, then scroll to Docket ID EPA-HQ-OAR-2004-0403 to view
documents in the record of this Marine Authorization Request docket.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute.

II. Background

(A) Nonroad Authorizations

    Section 209(e)(1) of the Act addresses the permanent preemption of
any State, or political subdivision thereof, from adopting or
attempting to enforce any standard or other requirement relating to the
control of emissions for certain new nonroad engines or vehicles.\1\
Section 209(e)(2) of the Act allows the Administrator to grant
California authorization to enforce state standards for new nonroad
engines or vehicles which are not listed under section 209(e)(1),
subject to certain restrictions. On July 20, 1994, EPA promulgated a
regulation that sets forth, among other things, the criteria, as found
in section 209(e)(2), by which EPA must consider any California
authorization requests for new nonroad engines or vehicle emission
standards (section 209(e) rules).\2\
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    \1\ Section 209(e)(1) of the Act provides:
    No State or any political subdivision thereof shall adopt or
attempt to enforce any standard or other requirement relating to the
control of emissions from either of the following new nonroad
engines or nonroad vehicles subject to regulation under this Act--
    (A) New engines which are used in construction equipment or
vehicles or used in farm equipment or vehicles and which are smaller
than 175 horsepower.
    (B) New locomotives or new engines used in locomotives.
Subsection (b) shall not apply for purposes of this paragraph.
    \2\ See 59 FR 36969 (July 20, 1994), and regulations set forth
therein, 40 CFR part 85, Subpart Q, Sec. Sec.  85.1601-85.1606.
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    Section 209(e)(2) requires the Administrator, after notice and
opportunity for public hearing, to authorize California to enforce
standards and other requirements relating to emissions control of new
engines not listed under section 209(e)(1).\3\ The section 209(e) rule
and its codified regulations \4\ formally set forth the criteria,
located in section 209(e)(2) of the Act, by which EPA must grant
California authorization to enforce its new nonroad emission standards:
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    \3\ As discussed above, states are permanently preempted from
adopting or enforcing standards relating to the control of emissions
from new engines listed in section 209(e)(1).
    \4\ See 40 CFR part 85, Subpart Q, Sec.  85.1605.
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    40 CFR part 85, Subpart Q, Sec.  85.1605 provides:

    (a) The Administrator shall grant the authorization if
California determines that its standards will be, in the aggregate,
at least as protective of public health and welfare as applicable
Federal standards.
    (b) The authorization shall not be granted if the Administrator
finds that:
    (1) The determination of California is arbitrary and capricious;
    (2) California does not need such California standards to meet
compelling and extraordinary conditions; or
    (3) California standards and accompanying enforcement procedures
are not consistent with section 209.

    As stated in the preamble to the section 209(e) rule, EPA has
interpreted the requirement that EPA cannot find ``California standards
and accompanying enforcement procedures are not consistent with section
209'' to mean that California standards and

accompanying enforcement procedures must be consistent with section
209(a), section 209(e)(1), and section 209(b)(1)(C), as EPA has
interpreted that subsection in the context of motor vehicle waivers.\5\
In order to be consistent with section 209(a), California's nonroad
standards and enforcement procedures must not apply to new motor
vehicles or new motor vehicle engines. Secondly, California's nonroad
standards and enforcement procedures must be consistent with section
209(e)(1), which identifies the categories permanently preempted from
state regulation.\6\ California's nonroad standards and enforcement
procedures would be considered inconsistent with section 209 if they
applied to the categories of engines or vehicles identified and
preempted from State regulation in section 209(e)(1).
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    \5\ See 59 FR 36969, 36983 (July 20, 1994).
    \6\ Section 209(e)(1) of the Act has been implemented, See 40
CFR part 85, Subpart Q Sec. Sec.  85.1602, 85.1603.
    Sec.  85.1603 provides in applicable part:
    (a) For equipment that is used in applications in addition to
farming or construction activities, if the equipment is primarily
used as farm and/or construction equipment or vehicles, as defined
in this subpart, it is considered farm or construction equipment or
vehicles. (b) States are preempted from adopting or enforcing
standards or other requirements relating to the control of emissions
from new engines smaller than 175 horsepower, that are primarily
used in farm or construction equipment or vehicles, as defined in
this subpart.
    Sec.  85.1602 provides definitions of terms used in Sec.
85.1603 and states in applicable part:
    Construction equipment or vehicle means any internal combustion
engine-powered machine primarily used in construction and located on
commercial construction sites.
    Farm Equipment or Vehicle means any internal combustion engine-
powered machine primarily used in the commercial production and/or
commercial harvesting of food, fiber, wood, or commercial organic
products or for the processing of such products for further use on
the farm.
    primarily used means used 51 percent or more.
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    Finally, because California's nonroad standards and enforcement
procedures must be consistent with section 209(b)(1)(C), EPA will
review nonroad authorization requests under the same ``consistency''
criteria that are applied to motor vehicle waiver requests. Under
section 209(b)(1)(C), the Administrator shall not grant California a
motor vehicle waiver if he finds that California ``standards and
accompanying enforcement procedures are not consistent with section
202(a)'' of the Act. Previous decisions granting waivers of Federal
preemption for motor vehicles have stated that State standards are
inconsistent with section 202(a) if there is inadequate lead time to
permit the development of the necessary technology giving appropriate
consideration to the cost of compliance within that time period or if
the Federal and State test procedures impose inconsistent certification
requirements.\7\
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    \7\ To be consistent, the California certification procedures
need not be identical to the Federal certification procedures.
California procedures would be inconsistent, however, if
manufacturers would be unable to meet both the state and the Federal
requirement with the same test vehicle in the course of the same
test. See, e.g., 43 FR 32182 (July 25, 1978).
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    With regard to enforcement procedures accompanying standards, EPA
must grant the requested authorization unless it finds that these
procedures may cause the California standards, in the aggregate, to be
less protective of public health and welfare than the applicable
Federal standards promulgated pursuant to section 213(a), or unless the
Federal and California certification test procedures are
inconsistent.\8\
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    \8\ See, e.g., Motor and Equipment Manufacturers Association,
Inc. v. EPA, 627 F.2d 1095, 1111-14 (D.C. Cir. 1979), cert. denied,
446 U.S. 952 (1980) (MEMA I); 43 FR 25729 (June 14, 1978).
    While inconsistency with section 202(a) includes technological
feasibility, lead time, and cost, these aspects are typically
relevant only with regard to standards. The aspect of consistency
with 202(a) which is of primary applicability to enforcement
procedures (especially test procedures) is test procedure
consistency.
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    Once California has received an authorization for its standards and
enforcement procedures for a certain group or class of nonroad
equipment engines or vehicles, it may adopt other conditions precedent
to the initial retail sale, titling or registration of these engines or
vehicles without the necessity of receiving an additional
authorization.\9\
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    \9\ See 43 FR 36679, 36680 (August 18, 1978).
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    If California acts to amend a previously authorized standard or
accompanying enforcement procedure, the amendment may be considered
within the scope of a previously granted authorization provided that it
does not undermine California's determination that its standards in the
aggregate are as protective of public health and welfare as applicable
Federal standards, does not affect the consistency with section 209 of
the Act, and raises no new issues affecting EPA's previous
authorization determination.\10\
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    \10\ Decision Document for California Nonroad Engine Regulations
Amendments, Dockets A-2000-05 to 08, entry V-B, p. 28.
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(B) Summary of Background Requests

    The California Air Resources Board (CARB) submitted to EPA three
separate but related requests to authorize various marine spark
ignition engine regulations. EPA examined all three submissions
together in our review of the requests to enforce CARB's marine SI
engine emissions regulation program. These requests are summarized in
order below.
    (1) By letter dated April 4, 2000, CARB requested EPA authorization
to enforce California's marine SI regulations affecting outboard (OB)
marine engines. The CARB regulations set emission standards for these
marine engines commencing with model year 2001 for both certification
and in-use standards. The first tier of the CARB regulations basically
adopted the standards equivalent to the EPA 2006 marine SI engines.
CARB also adopted a second tier of outboard engine regulations,
commencing in model year 2004 requiring emissions at levels
approximately 80% of the EPA 2006 standards, and a third tier,
commencing in 2008, requiring emissions at levels approximately 35% of
the EPA 2006 standard. Manufacturers are permitted to meet the
standards directly or on a corporate average basis, where some engine
families may emit more than the emission standard if they are offset by
engines which emit sufficiently less than the standard. To accompany
the new standards, CARB also adopted regulations requiring manufacturer
production line testing (along with CARB authority to conduct Selective
Enforcement Audits), manufacturer demonstration of in-use compliance,
emission warranties, permanent emission certification labels for
covered engines, and special ``hang tags'' for consumer/environmental
awareness of clean technology engines.\11\
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    \11\ At the time this request was presented to EPA, the
California Office of Administrative Law had not approved the section
of the regulations dealing with these hang tags because of problems
it found with the applicability date of the hang tag requirement.
These problems were resolved and the hang tag requirement was
included as part of the CARB June 5, 2002 request described below.
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    (2) By letter dated June 5, 2002, CARB extended the earlier
authorization request to include regulations for marine SI engines in
personal watercraft (PWC) \12\ for model year 2002 and beyond. The PWCs
are subject to the same emission standards and requirements as the
marine outboard SI engines discussed above. The CARB marine regulations
had included both outboards and PWCs from the outset, but PWCs had not
been included in the original CARB request because of technical issues
raised by PWC manufacturers related to compliance with the CARB
standards for model year 2001. The June 5, 2002 CARB request stated
that those issues had been

resolved, so CARB submitted this extension. In addition, CARB submitted
for authorization the marine engine consumer hang tag regulations
because the earlier model year applicability issue had been resolved.
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    \12\ Personal watercraft are small watercraft on which the rider
sits or stands during operation, such as jet skis and wave runners.
CARB Staff Report, October 23, 1998, at p. 9, Docket OAR-2004-0403.
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    (3) By letter dated March 2, 2004, CARB extended the earlier
requests by requesting authorization to enforce California's marine SI
regulations affecting inboard and sterndrive (IB/SD) engines for model
years 2003 and beyond.\13\ The first tier of regulations, for model
year 2003 through 2008, sets a cap reflecting average emission levels
of 16.0 grams per kilowatt hour (g/kW-hr) HC plus NOX which
manufacturers can meet directly by engine family or by corporate
average. The second tier of standards sets a level of 5.0 g/kW-hr HC
plus NOX and will phase in beginning with 45% of
manufacturers' sales in 2007, 75% in 2008 and 100% in 2009 and beyond.
For 2007 and 2008, all engines subject to the standard must comply
directly with the standard, with no option for sales weighted-
averaging. Besides these new standards, other regulations establish
requirements for certification, emission test procedures, emissions
warranty, and emission certification labels and consumer/environmental
awareness hang tag labels. In addition, the IB/SD regulations require
on-board diagnostics for these engines. Finally, as part of the IB/SD
rulemaking, CARB adopted some minor amendments to the OB and PWC
regulations to clarify some definitions and labeling requirements made
necessary by the adoption of the regulations for IB/SD marine engines.
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    \13\ Inboard engines include a propeller shaft that penetrates
the hull of the marine vessel, while the engine and the remainder of
the drive unit are internal to the hull of the marine watercraft. In
sterndrive engines, the drive unit is external to the hull of the
marine watercraft, while the engine is internal to the hull of the
marine watercraft. CARB Staff Report, June 8, 2002, at p. 4, Docket
OAR-2004-0403.
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    As required by the Act, EPA offered the opportunity for a public
hearing and requested public comments on these new standards by
publication of a Federal Register notice to such effect on January 12,
2005.\14\ EPA received a request for a hearing from the National Marine
Manufacturers Association,\15\ and a hearing was held on February 28,
2005.\16\ In addition, EPA received post-hearing written comments for
the Docket of this proceeding from the U.S. Coast Guard, the
Manufacturers of Emissions Controls Association, the National Marine
Manufacturers Association, several marine engine manufacturers, Senator
Herb Kohl (D-WI), and Senator James Inhofe (R-OK), and a supplemental
submission from CARB responding to matters raised at the public
hearing.\17\ Accordingly, EPA has made this authorization decision
based on the information submitted by CARB in its requests, and the
information presented to the Agency at the public hearing and in the
comments received after the hearing.
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    \14\ 70 FR 2151 (January 12, 2005).
    \15\ See Letter from John McKnight, National Marine
Manufacturers Association, to Robert M. Doyle, USEPA, dated January
27, 2005, Docket Entry 2004-0403-0030.
    \16\ Written Statements presented at this hearing and the
hearing transcript appear in the Docket as Docket Entries 2004-0403-
0031 through 2004-0403-0036.
    \17\ These comments appear in the Docket as Docket Entries 2004-
0403-0037 through 2004-0403-0047.
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(C) Authorization Decision

    After review of the information submitted by CARB and other parties
to the record of this Docket, EPA finds that no party has presented
information to the Agency which would demonstrate that California did
not meet the burden of satisfying the statutory criteria of section
209(e). For this reason, EPA is granting authorization for the CARB
Marine Spark-Ignition Engines regulations for OB and PWC engines in
their entirety. With respect to the regulations affecting IB/SD
engines, EPA grants authorization for CARB to enforce the first tier of
these regulations for model year 2003 through 2008, which set a cap
reflecting average emission levels of 16.0 grams per kilowatt hour (g/
kW-hr) HC plus NOX which manufacturers can meet directly by
engine family or by corporate average. EPA is deferring an
authorization decision on the second tier of standards which set a
level of 5.0 g/kW-hr HC plus NOX and will phase in beginning
with 45% of manufacturers' sales in 2007, 75% in 2008 and 100% in 2009
and beyond. There is testing currently underway, performed as a joint
program by CARB, EPA, the U.S. Coast Guard and the industry, to
evaluate the technological feasibility of both the CARB IB/SD standards
and Federal IB/SD standards which are expected to be proposed
regulations in 2007. At the conclusion of this testing, EPA will issue
its authorization decision for the second tier (i.e., for 2007 and
beyond) CARB IB/SD standards.
    My decision will affect not only persons in California but also the
manufacturers outside the State who must comply with California's
requirements in order to produce nonroad engines and vehicles for sale
in California. For this reason, I hereby determine and find that this
is a final action of national applicability.
    Under section 307(b)(1) of the Act, judicial review of this final
action may be sought only in the United States Court of Appeals for the
District of Columbia Circuit. Petitions for review must be filed by May
29, 2007. Under section 307(b)(2) of the Act, judicial review of this
final action may not be obtained in subsequent enforcement proceedings.
    As with past authorization decisions, this action is not a rule as
defined by Executive Order 12866. Therefore, it is exempt from review
by the Office of Management and Budget as required for rules and
regulations by Executive Order 12866.
    In addition, this action is not a rule as defined in the Regulatory
Flexibility Act, 5 U.S.C. 601(2). Therefore, EPA has not prepared a
supporting regulatory flexibility analysis addressing the impact of
this action on small business entities.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, does not
apply because this action is not a rule, for purposes of 5 U.S.C.
804(3).
    Finally, the Administrator has delegated the authority to make
determinations regarding authorizations under section 209(e) of the Act
to the Assistant Administrator for Air and Radiation.

    Dated: March 22, 2007.
William L. Wehrum,
Acting Assistant Administrator for Air and Radiation.
[FR Doc. E7-5665 Filed 3-27-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Rules and Regulations]
[Pages 2615-2616]
[FR Doc No: 2013-00525]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1245; Directorate Identifier 2012-NE-41-AD;
Amendment 39-17279; AD 2012-24-09]
RIN 2120-AA64

Airworthiness Directives; Lycoming Engines and Continental
Motors, Inc. Reciprocating Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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SUMMARY: The FAA is correcting an airworthiness directive (AD) that
published in the Federal Register. That AD applies to Lycoming Engines
TSIO-540-AK1A, and Continental Motors, Inc. TSIO-360-MB, TSIO-360-SB,
and TSIO-360-RB reciprocating engines, with certain Hartzell Engine
Technologies (HET) turbochargers, model TA0411, part number 466642-
0001;<PHONE_NUMBER>;<PHONE_NUMBER>;<PHONE_NUMBER>;<PHONE_NUMBER>; or 466642-
9006, or with certain HET model TA0411 turbochargers overhauled or
repaired since August 29, 2012. The Summary paragraph and the
Applicability paragraph list an incorrect engine model for Lycoming
Engines. This document corrects those errors. In all other respects,
the original document remains the same.

DATES: This final rule is effective January 14, 2013. The effective
date for AD 2012-24-09 (77 FR 72203, December 5, 2012) remains December
20, 2012.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Christopher Richards, Aerospace
Engineer, Chicago Aircraft Certification Office, FAA, 2300 E. Devon
Ave., Des Plaines, IL 60018; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Airworthiness Directive 2012-24-09,
Amendment 39-17279 (77 FR 72203, December 5, 2012), currently requires
removing the affected turbochargers from service before further flight.
    As published, the Summary paragraph and the Applicability paragraph
are incorrect.
    No other part of the preamble or regulatory information has been
changed; therefore, only the changed portion of the final rule is being
published in the Federal Register.
    The effective date of this AD remains December 20, 2012.

Correction of Non-Regulatory Text

    In the Federal Register of December 5, 2012, AD 2012-24-09;
Amendment 39-17279 is corrected as follows:
    On page 72203, in the second column, on line 3 of the Summary,
change Lycoming Engines TSIO-540-AK1A to ``Lycoming Engines TIO-540-
AK1A.''

Correction of Regulatory Text

Sec.  39.13  [Corrected]

0
In the Federal Register of December 5, 2012, on page 72204, in the
third column, the first sentence of paragraph (c) of AD 2012-24-09 is
corrected to read as follows:
* * * * *
    (c) This AD applies to Lycoming Engines TIO-540-AK1A, and
Continental Motors, Inc. TSIO-360-MB, TSIO-360-SB, and TSIO-360-RB
reciprocating engines with any of the following turbochargers
installed:
* * * * *

    Issued in Burlington, Massachusetts, on January 7, 2013.
Colleen M. D'Alessandro,
Assistant Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2013-00525 Filed 1-11-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Pages 4921-4923]
[FR Doc No: 2016-01684]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0380]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Product Jurisdiction: Assignment of Agency Component
for Review of Premarket Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information
including each proposed extension of an existing collection of
information and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the procedure by which an
applicant may obtain an assignment or designation determination for
combination products.

DATES: Submit either electronic or written comments on the collection
of information by March 28, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your

comment will be made public, you are solely responsible for ensuring
that your comment does not include any confidential information that
you or a third party may not wish to be posted, such as medical
information, your or anyone else's Social Security number, or
confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2009-N-0380 for ``Product Jurisdiction: Assignment of Agency
Component for Review of Premarket Applications.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (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 of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Product Jurisdiction: Assignment of Agency Component for Review of
Premarket Applications 21 CFR Part 3 (OMB Control Number 0910-0523)--
Extension
    This regulation relates to Agency management and organization and
has two purposes. The first is to implement section 503(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by
the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and amended by
the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-
250), by specifying how FDA will determine the organizational component
within FDA assigned to have primary jurisdiction for the premarket
review and regulation of products that are comprised of any combination
of: (1) A drug and a device; (2) a device and a biological product; (3)
a biological product and a drug; or (4) a drug, a device, and a
biological product. The second purpose of this regulation is to enhance
the efficiency of Agency management and operations by providing
procedures for classifying and determining which Agency component is
designated to have primary jurisdiction for any drug, device, or
biological product where such jurisdiction is unclear or in dispute.
    The regulation establishes a procedure by which an applicant may
obtain an assignment or designation determination. The regulation
requires that the request include the identity of the applicant, a
comprehensive description of the product and its proposed use, and the
applicant's recommendation as to which Agency component should have
primary jurisdiction, with an accompanying statement of reasons. The
information submitted would be used by FDA as the basis for making the
assignment or designation decision. Most information required by the
regulation is already required for premarket applications affecting
drugs, devices, biological products, and combination products. The
respondents will be businesses or other for-profit organizations.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Numberr of
                            21 CFR Part                                 Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
3                                                                                84                1               84               24            2,016
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    These burden estimates are based on the number of applications FDA
received over the past fiscal year.

    Dated: January 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01684 Filed 1-27-16; 8:45 am]
 BILLING CODE 4164-01-P