[Federal Register Volume 80, Number 40 (Monday, March 2, 2015)]
[Rules and Regulations]
[Pages 11128-11131]
[FR Doc No: 2015-04280]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2014-0152]
RIN 1625-AA00, 1625-AA87

Safety and Security Zones, Jacksonville Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard has modified several aspects of the safety and
security zones within the Sector Jacksonville Captain of the Port Zone.
This action was necessary to consolidate, clarify, and otherwise modify
safety and security zone regulations to eliminate unnecessary
regulations and better meet the safety and security needs of the Ports
of Jacksonville, Fernandina, and Canaveral. This action modifies
existing safety and security zones; establishes safety zones governing
port regulation in the event of natural and other disasters; and
removes unnecessary or superfluous safety and security zones.

DATES: This rule is effective April 1, 2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2014-0152. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Allan Storm, Sector Jacksonville Office of
Waterways Management, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Cheryl Collins, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
COTP Captain of the Port
GRT Gross Register Ton

A. Regulatory History and Information

    On June 17, 2014, we published a Notice of Proposed Rulemaking
(NPRM) entitled Safety and Security Zones: Jacksonville Captain of the
Port Zone in the Federal Register (79 FR 34674).
    In 1994, the USCG published a safety zone around firework barges
between the Hart and Acosta Bridges within the Port of Jacksonville. As
of 2008, there are 22 special local regulations listed under 33 CFR
100.701 which establish a 500 yard regulated area around various barges
for firework display events. This regulation revises the current
regulations to add safety zone regulations during natural and other
disasters. It also implements safety zones for all fire work displays
in the Jacksonville Captain of the Port Zone.

B. Basis and Purpose

    The legal basis for this rule is the Coast Guard's authority to
establish regulated navigation areas and limited access areas: 33
U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Department of Homeland Security
Delegation No. 0170.1.
    The purpose of these regulations is to ensure the safety of life on
navigable waters of the United States through the addition of
regulations applicable during disasters and firework displays within
the Jacksonville Captain of the Port Zone.

C. Discussion of Comments, Changes and the Final Rule

    Public meetings were held on June 23, 2014 in Jacksonville and June
25, 2014 in Port Canaveral. No comments were received during the
meetings or the NPRM comment period.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. This regulation is not a
significant regulatory action because most of the regulations already
exist in some form such as special local regulations for firework
displays. The regulations that are being added are not expected to have
a significant regulatory action due to the infrequency of use for the
safety zones around firework barges. The removal of the safety and
security zone for Blount Island would have no effect as the Restricted
Area set in place by the Army Corps of Engineers will remain in effect.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended,

requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received zero comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities.
    For the reasons discussed in the Regulatory Planning and Review
section above, this rule will not have a significant economic impact on
a substantial number of small entities.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves disestablishing of a safety and
security zone, addition of port regulations that would be otherwise
published as a Temporary Final Rule, and addition of safety zones to
include all firework barge displays within the Jacksonville Captain of
the Port Zone. This rule is categorically excluded from further review
under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

0
2. Revise Sec.  165.720 to read as follows:

Sec.  165.720  Safety Zone; Natural and Other Disasters in Ports of
Jacksonville, Fernandina, and Canaveral, Florida.

    (a) Regulated Areas. The following areas are established as safety
zones during the specified conditions:
    (1) Fernandina, FL. All waters within the Cumberland Sound and
Amelia River encompassed within the following locations: starting at
the demarcation line drawn across the seaward extremity of the St.
Marys River Entrance Jetties; thence following the shoreline north to
Stafford Island; thence north to Point 1 in position 30[deg]50'00'' N.,
81[deg]29'10'' W.; thence west to Point 2 in position 30[deg]50'00''
N., 81[deg]30'47'' W.; thence southwest to Kings Bay in position
30[deg]48'42'' N., 81[deg]31'27'' W.; thence south following the
shoreline south to point 3 in position 30[deg]40'30'' N.,
81[deg]28'38'' W.; thence southwest to R ``18'' at Point 4
30[deg]39'57'' N., 81[deg]29'04'' W.; thence southeast to Point 5
30[deg]39'48'' N., 81[deg]28'57'' W.; thence following the shoreline
northeast back to origin.
    (2) Jacksonville, FL. All waters within the Port of Jacksonville,
FL encompassed within the following locations: starting at the
demarcation line drawn across the seaward extremity of the St. Johns
River Entrance Jetties, thence following the northern riverbank west to
the Sister's Creek Bridge, thence following the riverbank west to the
Interstate 95 Trout River Bridge, thence following the riverbank south
to the Henry H. Buckman Bridge, thence following the eastern riverbank
back to origin.
    (3) Canaveral, FL. All waters within the Canaveral Barge Canal in
Port Canaveral, FL encompassed within the following locations: starting
at the demarcation line drawn across the seaward extremity of the Port
Canaveral Entrance Channel Jetties, thence following the northern
shoreline west to the SR401 Bridge, thence following the southern
shoreline back to origin.
    (4) All coordinates are North American Datum 1983.
    (b) Definition. (1) The term ``designated representative'' means
Coast Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Jacksonville in the enforcement of the regulated
area.
    (2) Hurricane Port Condition YANKEE. Set when weather advisories
indicate that sustained Gale Force winds from a tropical or hurricane
force storm are predicted to make landfall at the port within 24 hours.
    (3) Hurricane Port Condition ZULU. Set when weather advisories
indicate that sustained Gale Force winds from a Tropical or hurricane
force storm are predicted to make landfall at the port within 12 hours.
    (c) Regulations. (1) Hurricane Port Condition YANKEE. All
commercial, oceangoing vessels and barges over 500 GRT as measured
under Title 46 United States Code Section 14502 or an alternate tonnage
established as 6,000 gross tonnage as measured under 46 U.S.C. 14302
(GT ITC) are prohibited from entering in any of the regulated areas
designated as being in Port Condition YANKEE within the COTP Zone
Jacksonville. Oceangoing commercial vessel traffic outbound will be
authorized to transit through the regulated areas until Port Condition
ZULU. Additionally, in the Port of Canaveral, no vessel, regardless of
size or service, will be allowed to transit through the Port Canaveral
Barge Canal upon the setting of Port Condition YANKEE.
    (2) Hurricane Port Condition ZULU. All commercial, oceangoing
vessels and barges over 500 GRT as measured under Title 46 United
States Code Section 14502 or an alternate tonnage established as 6,000
gross tonnage as measured under 46 U.S.C. 14302 (GT ITC) are prohibited
from transiting or remaining in any of the regulated areas designated
as being in Port Condition ZULU within COTP Zone Jacksonville. All
ship-to-shore cargo operations must cease 6 hours prior to setting Port
Condition Zulu.
    (3) Emergency Regulation for Other Disasters. Any natural or other
disasters that are to affect the Jacksonville COTP Zone will result in
the prohibition of commercial vessel traffic over 500 GRT as measured
under Title 46 United States Code Section 14502 or an alternate tonnage
established as 6,000 gross tonnage as measured under 46 U.S.C. 14302
(GT ITC) transiting or remaining in any of the regulated areas
predicted to be effected as designated by the COTP Jacksonville.
    (4) Persons and vessels desiring to enter, transit through, anchor
in, or remain in the regulated area may contact the Captain of the Port
Jacksonville via telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to request authorization.
If authorization to enter, transit through, anchor in, or remain in the
regulated area is granted by the Captain of the Port Jacksonville or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Jacksonville or a designated representative.
    (5) Coast Guard Sector Jacksonville will attempt to notify the
maritime community of periods during which these safety zones will be
in effect via Broadcast Notice to Mariners or by on-scene designated
representatives.

0
3. Add Sec.  165.723 to read as follows:

Sec.  165.723  Safety Zone; Firework Displays in Captain of the Port
Zone Jacksonville, Florida.

    (a) Regulated Area. The following area is established as a safety
zone during the specified conditions: All waters within the
Jacksonville COTP Zone within a 500 yard radius of a firework barge or
barges during the storage, preparation, and launching of fireworks.
    (1) The Coast Guard realizes that some large scale events, such as
those with many participants or spectators, or those that could
severely restrict navigation or pose a significant hazard, may still
require separate special local regulations or safety zones that address
the specific peculiarities of the event. In those situations, the Coast
Guard will create special local regulations or safety zones
specifically for the event, and those regulations will supersede the
regulations in this rule.
    (2) All coordinates are North American Datum 1983.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Jacksonville in the enforcement of the regulated
area.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area unless authorized by the Coast Guard Captain of the Port
Jacksonville or a designated representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain in the regulated area may contact the Captain of the Port
Jacksonville via telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to request authorization.
If authorization to enter, transit through, anchor in, or remain in the
regulated area is granted by the Captain of the Port Jacksonville or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Jacksonville or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area via

Broadcast Notice to Mariners or by on-scene designated representatives.
    (4) This regulation does not apply to authorized law enforcement
agencies operating within the regulated area.

    Dated: February 19, 2015.
T.G. Allan, Jr.,
Captain, U.S. Coast Guard, Captain of the Port Jacksonville.
[FR Doc. 2015-04280 Filed 2-27-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Page 5092]
[FR Doc No: 2018-02243]

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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: RP11-1711-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Report Filing: 2017 Cash Out Filing.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5075.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP13-886-003.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Compliance filing Petition to Amend Stipulation and
Agreement under RP13-886.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5286.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP17-197-008.
    Applicants: Dominion Energy Cove Point LNG, LP.
    Description: Compliance filing DECP--RP17-197 Settlement
Compliance--Appendix D to be effective 3/1/2018.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5076.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-365-000.
    Applicants: Nautilus Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Nautilus Section-Based
Baseline Tariff to be effective 3/15/2018.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5063.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-366-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Bay State
Releases eff 2-1-2018 to be effective 2/1/2018.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5067.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-367-000.
    Applicants: Kinder Morgan Illinois Pipeline LLC.
    Description: Penalty Revenue Crediting Report of Kinder Morgan
Illinois Pipeline LLC.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5068.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-368-000.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: Compliance filing Cameron Access Rate Implementation
Compliance CP15-109 to be effective 3/1/2018.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5070.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-369-000.
    Applicants: Sea Robin Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Revise Quality Provisions to
be effective 3/1/2018.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5071.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-370-000.
    Applicants: Kinder Morgan Illinois Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Removal of Negotiated Rate
Agreement to be effective 3/1/2018.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5087.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-371-000.
    Applicants: Kinder Morgan Louisiana Pipeline LLC.
    Description: Penalty Revenue Crediting Report of Kinder Morgan
Louisiana Pipeline LLC.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5137.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-372-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Transportation Service
Agreement Update Filing (City of Mesa) to be effective 3/1/2018.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5252.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-373-000.
    Applicants: Wyoming Interstate Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Fuel and L&U Update to be
effective 3/1/2018.
    Filed Date: 1/29/18.
    Accession Number: 20180129-5253.
    Comments Due: 5 p.m. ET 2/12/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings 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: January 30, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-02243 Filed 2-2-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Notices]
[Page 79534]
[FR Doc No: 2013-31133]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71178; File No. SR-CBOE-2013-107]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Designation of a Longer Period for Commission
Action on Proposed Rule Change To Amend Its Rules Regarding Option
Orders That Include a Stock Component

December 23, 2013.
    On October 31, 2013, the Chicago Board Options Exchange,
Incorporated (the ``Exchange'' or ``CBOE'') filed with the Securities
and Exchange Commission (the ``Commission''), pursuant to Section
19(b)(1) of the Securities Exchange Act of 1934 (the ``Act'') \1\ and
Rule 19b-4 thereunder,\2\ a proposed rule change to amend CBOE's rules
regarding option orders that include a stock component. The proposed
rule change was published for comment in the Federal Register on
November 19, 2013.\3\ The Commission received two comment letters
regarding the proposed rule change.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 70857 (November 13,
2013), 78 FR 69487.
    \4\ See letters to Elizabeth M. Murphy, Secretary, Commission,
from Manisha Kimmel, Executive Director, Financial Information
Forum, dated December 10, 2013; and Ellen Greene, Vice President,
Securities Industry and Financial Markets Association, dated
December 16, 2013.
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    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is January 3, 2014. The Commission is
extending this 45-day time period.
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    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider this proposed rule change and the comment
letters that have been submitted in connection with this proposed rule
change.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\6\ designates February 17, 2014, as the date by which the
Commission should either approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change (File No. SR-CBOE-2013-107).
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    \6\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(31).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-31133 Filed 12-27-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 22, 2005 (Volume 70, Number 224)]
[Notices]
[Page 70602-70603]
[DOCID:fr22no05-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER06-1-000]

Leaning Juniper Wind Power, LLC; Notice of Issuance of Order

November 10, 2005.
    Leaning Juniper Wind Power, LLC (Leaning Juniper) filed an
application for market-based rate authority, with an accompanying rate
schedule. The proposed rate schedule provides for the sales of energy,
capacity and ancillary services at market-based rates. Leaning Juniper
also requested waiver of various Commission regulations. In particular,
Leaning Juniper requested that the Commission grant blanket approval
under 18 CFR Part 34 of all future issuances of securities and
assumptions of liability by Leaning Juniper.
    On November 4, 2005, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--South, granted the request
for blanket approval under Part

34. The Director's order also stated that the Commission would publish
a separate notice in the Federal Register establishing a period of time
for the filing of protests. Accordingly, any person desiring to be
heard or to protest the blanket approval of issuances of securities or
assumptions of liability by Leaning Juniper should file a motion to
intervene or protest with the Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426, in accordance with Rules 211
and 214 of the Commission's Rules of Practice and Procedure. 18 CFR
385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is December 5, 2005.
    Absent a request to be heard in opposition by the deadline above,
Leaning Juniper is authorized to issue securities and assume
obligations or liabilities as a guarantor, indorser, surety, or
otherwise in respect of any security of another person; provided that
such issuance or assumption is for some lawful object within the
corporate purposes of Leaning Juniper, compatible with the public
interest, and is reasonably necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approval of Leaning Juniper's issuances of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6421 Filed 11-21-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Rules and Regulations]
[Pages 1735-1741]
[FR Doc No: 2014-00267]

=======================================================================
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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: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
amending the regulations on premarket approval of medical devices to
include requirements relating to the submission of information on
pediatric subpopulations that suffer from the disease or condition that
a device is intended to treat, diagnose, or cure.

DATES: This rule is effective April 10, 2014.

FOR FURTHER INFORMATION CONTACT: Sheila Brown, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1651, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration Amendments Act of 2007 (FDAAA) \1\
(Pub. L. 110-85) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) by among other things, adding section 515A of the FD&C Act
(21 U.S.C. 360e-1). Section 515A(a) of the FD&C Act requires persons
who submit certain medical device applications to include, if readily
available, a description of any pediatric subpopulations that suffer
from the disease or condition that the device is intended to treat,
diagnose, or cure, and the number of affected pediatric patients. The
information submitted under section 515A(a) of the FD&C Act

will be essential to completing the annual report that FDA is required
to submit to Congress under section 515A(a)(3) of the FD&C Act,
including:
---------------------------------------------------------------------------

    \1\ Title III of FDAAA, which includes new section 515A, is also
known as the Pediatric Medical Device Safety and Improvement Act of
2007.
---------------------------------------------------------------------------

     The number of approved devices for which there is a
pediatric subpopulation that suffers from the disease or condition that
the device is intended to treat, diagnose, or cure; and
     The review time for each such device application.
    On April 1, 2010, FDA published a proposed rule, along with a
companion direct final rule, with a 75-day comment period to request
input from interested parties (75 FR 16365, April 1, 2010) as a step
towards implementing section 515A(a) of the FD&C Act. A few months
later, FDA withdrew the direct final rule because we received
significant adverse comment (75 FR 41986, July 20, 2010.)
    Due to the changes made since the April 1, 2010, proposed rule,
particularly changes to the scope of applications to which this
requirement applies (see section II), a supplemental notice of proposed
rulemaking was issued on February 19, 2013 (78 FR 11612 at 11616), to
allow for public comment on the re-drafted proposed rule. In addition
to providing FDA's revised proposal for implementing section 515A(a) of
the FD&C Act, that document served to supplement the proposed rule that
issued with the companion direct final rule (75 FR 16365, April 1,
2010). FDA received four additional comments on the supplemental notice
of proposed rulemaking that were considered when developing this final
rule.

II. How are pediatric patients and pediatric subpopulations defined?

    Section 515A(c) of the FD&C Act states that, for the purposes of
that section, the term ``pediatric subpopulation'' has the meaning
given the term in section 520(m)(6)(E)(ii) of the FD&C Act (21 U.S.C.
360j(m)(6)(E)(ii)). Section 520(m)(6)(E)(ii) of the FD&C Act defines
the term ``pediatric subpopulation'' to mean one of the following
populations:
     Neonates;
     Infants;
     Children; or
     Adolescents.
    Section 515A additionally requires that the descriptions of
pediatric subpopulations include the number of affected ``pediatric
patients.'' Section 515A does not define the term ``pediatric
patients.'' The term ``pediatric patients'', however, is defined for
purposes of section 520(m)(6)(E)(i) of the FD&C Act (relating to
humanitarian device exemptions for pediatric patients) as patients who
are 21 years of age or younger at the time of the diagnosis or
treatment. The definition for ``pediatric patients'' in section
520(m)(6)(E)(i) is consistent with the definition of ``pediatric
subpopulations'' in section 520(m)(6)(E)(ii).
    These definitions of pediatric subpopulation and pediatric patient
are reflected in FDA's previously issued 2004 guidance on pediatric
medical devices, which recommended the age range for each of the
populations included in the term ``pediatric subpopulation.'' Those age
ranges span from birth to 21 years of age (that is, from birth through
the 21st year of life, up to but not including the 22nd birthday). See
``Premarket Assessment of Pediatric Medical Devices'' (May 14, 2004);
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm.
    For purposes of the requirements in this final rule, FDA is
codifying a definition of the term ``pediatric patients'' as patients
who are 21 years of age or younger (that is, from birth through the
21st year of life, up to but not including the 22nd birthday) at the
time of the diagnosis or treatment.

III. What applications are subject to this final rule?

    In accordance with the FD&C Act, the requirements to include, if
readily available, a description of any pediatric subpopulations that
suffer from the disease or condition that the device is intended to
treat, diagnose, or cure, and the number of affected pediatric patients
apply to the following applications when submitted on or after the
effective date of this rule:
     Any request for a humanitarian device exemption (HDE)
submitted under section 520(m) of the FD&C Act;
     Any premarket approval application (PMA) or supplement to
a PMA submitted under section 515 of the FD&C Act; and
     Any product development protocol (PDP) submitted under
section 515 of the FD&C Act.
    FDA concludes that section 515A applies to all submission types
listed in the statute--PMA, HDE, PDP, and all PMA supplements--not just
the subset of PMA supplements that propose a new indication for use, as
was proposed in the April 1, 2010, proposed rule. The Agency also wants
to clarify that it does not interpret 30-day notices submitted under
Sec.  814.39(f) (21 CFR 814.39(f)) to be PMA supplements for purposes
of this final rule. Section 515(d)(6)(A) of the FD&C Act (21 U.S.C.
360e(d)(6)(A)) distinguishes between modifications to manufacturing
procedures or methods of manufacture that affect the safety and
effectiveness of a device subject to an approved PMA, which require the
submission of a written notice, and other changes that affect safety
and effectiveness that require the submission of a ``supplemental
application.'' Because of this statutory distinction, 30-day notices
are not considered PMA supplements for purposes of this final rule and,
therefore, are not required to include readily available pediatric
information.
    Moreover, an applicant submitting a PMA supplement that previously
submitted information satisfying the pediatric subpopulation
requirements for the device may include that information by referencing
the previous application rather than resubmitting the same information.
However, if additional information has become readily available to the
applicant since the previous submission, the applicant must submit that
information as part of the supplement.
    Many premarket approval applications begin with the submission of
one or more PMA modules; see ``Premarket Approval Application Modular
Review--Guidance for Industry and FDA Staff,'' available at 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 final rule do?

    This final rule implements section 515A(a) of the FD&C Act by
amending part 814 (21 CFR part 814), Premarket Approval of Medical
Devices, to include requirements relating to the submission of readily
available information on pediatric subpopulations that suffer from the
disease or condition that a device is intended to treat, diagnose, or
cure.

A. What information must the applicant provide?

    This final rule requires each applicant who submits an HDE, PMA,
supplement to a PMA, or PDP to include, if ``readily available,'' a
description of any pediatric subpopulations that suffer from the
disease or condition that the device is intended to treat, diagnose, or
cure, and the number of affected pediatric patients. FDA is codifying a
definition of ``readily available'' and

will be issuing a guidance document entitled ``Guidance for Industry
and Food and Drug Administration Staff: Providing Information About
Pediatric Uses of Medical Devices Under Section 515A of the Federal
Food, Drug, and Cosmetic Act'' to explain the Agency's current thinking
on the meaning of ``readily available information'' and how to comply
with the requirements set forth in section 515A of the FD&C Act.

B. What are the consequences of not submitting ``Readily Available''
information?

    If the applicant does not submit the information required by
section 515A(a) of the FD&C Act, FDA may not approve the application
until the applicant provides the required information. The Agency
intends to contact the applicant during the normal course of our review
to inform the applicant that the submission lacks the information
required by section 515A(a) of the FD&C Act and by this final rule, and
to ask the applicant to amend the application to provide the required
information. If the application has no other deficiencies and otherwise
meets applicable statutory and regulatory requirements for approval,
but still lacks information required by section 515A(a), the Agency
intends to send the applicant an ``approvable'' letter informing them
that FDA will approve the application after the applicant provides the
information required by section 515A(a). If the application has other
deficiencies or does not meet all applicable statutory and regulatory
requirements for approval, the Agency intends to send the applicant a
``not approvable'' letter or a ``major deficiency'' letter describing
what information or data the applicant needs to provide before FDA can
approve the application; the ``not approvable'' or ``major deficiency''
letter may cite the absence of section 515A(a) information in the
section listing minor deficiencies. For additional information
concerning ``approvable,'' ``not approvable,'' and ``major deficiency''
letters, see ``FDA and Industry Actions on Premarket Approval
Applications (PMAs): Effect on FDA Review Clock and Goals,'' available
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089733.htm.

V. How has FDA addressed comments received on the proposed rule?

    A number of comments recommended using age 18 as the upper boundary
for the definition of ``pediatric patients'' instead of age 21 for
reasons such as attainment of skeletal maturity by age 18 and how the
phrase is understood in certain professional communities. After
considering this suggestion, FDA has opted to keep age 21 as the
definitional upper boundary ``pediatric patients.'' FDA oversees a wide
array of medical devices and combination products including various
medical devices that are used in pediatric populations. With this in
mind, and as part of initiatives designed to help FDA achieve the
intent of several pediatric provisions added to the FD&C Act by the
Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250,
116 Stat. 1588 (2002)), CDRH established the definition of the
pediatric population in the 2004 Guidance ``Premarket Assessment of
Pediatric Medical Devices'' (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm). Beyond
setting the upper age limit, the Guidance document further defines the
pediatric population as comprising the following subpopulations:
Neonate, infant, child, and adolescent. The definition mirrors that
used by the American Academy of Pediatrics and takes into consideration
the different pediatric subpopulations that make up the pediatric
population. This definition ensures that the term ``pediatric'' applies
to populations who may be mature skeletally or according to other
measures, but who remain developmentally immature in certain anatomical
or physiological systems.
    This definition reflects the scientific evidence that children are
not merely young adults, but that there are unique host characteristics
across the various pediatric subpopulations that should be considered
before using medical devices in the pediatric population or
subpopulation. FDA recognizes that not all 18- to 21-year-olds are
identical: Different rates of pubertal development may be encountered;
different disease processes may cause delayed maturation, or
conversely, accelerated maturation (e.g. precocious puberty). Moreover,
Congress also used age 21 as the upper boundary for a pediatric
population when it enacted FDAAA (section 303(a)(3)).
    One comment stated that FDA should not have removed the proposed
requirement on ``potential pediatric uses'' in the supplemental notice
of proposed rulemaking because providing readily available information
on potential pediatric uses is easily achievable and would pose no
serious burden to applicants. FDA declines to accept the recommendation
in the comment because section 515A of the FD&C Act does not require
sponsors to speculate as to possible pediatric uses and possible
subpopulations. However, if such information were readily available and
provided in a premarket submission, FDA would find the information
useful in support of advancing pediatric device development. Therefore,
in the forthcoming guidance document, ``Guidance for Industry and Food
and Drug Administration: Providing Information About Pediatric Uses of
Medical Devices Under Section 515A of the Federal Food, Drug, and
Cosmetic Act,'' FDA invites applicants to include pediatric use
information for uses of the device outside the approved or proposed
indication if such uses are described or acknowledged in acceptable
sources of readily available information.
    One comment proposed that FDA require applicants to state whether
each new PMA supplement relates to a new device and that PMA applicants
provide the number of new devices approved under the PMA during the
preceding year in the PMA annual report. The comment also requested
that, in order to ease the administrative burden on FDA and applicants,
PMA supplements filed subsequent to the initial submission of pediatric
population information update this information only if there is new
information readily available that results in a change in the
identification of pediatric subpopulations that suffer from the disease
or condition that the device is intended to treat, diagnose, or cure,
or the number of affected pediatric patients. FDA appreciates the
suggested additions to the rule, but declines to include a requirement
that applicants state whether each supplement relates to a new device
because each applicant could interpret the types of changes that could
be considered a ``new device'' differently. To better ensure
consistency for reporting purposes, FDA's internal tracking system will
be used for the collection and compilation of data regarding the number
of devices approved each year. FDA also declines to require applicants
to provide information in their PMA annual report regarding the number
of new devices approved under the PMA in the prior year because, while
FDA must provide a report to Congress once per year, PMA annual reports
can be due at different times throughout the calendar year as the
report is due on the anniversary of the initial PMA approval. Since the
PMA annual reports would each address different time periods for the
prior year, this information would not enable FDA to compile the data
needed for the report to Congress.
    One comment disputed FDA's estimate of the amount of time it will

take to fulfill the requirements instated by this rule for original HDE
and PMA applications. The comment states that reading just a single
article in the medical literature to obtain a thorough understanding of
a specific situation can take 1 to 2 hours and therefore the estimate
that 8 hours are needed for an applicant to fulfill the requirement is
unreasonably low. FDA disagrees that 8 hours is insufficient to fulfill
the requirements implemented by this final rule because applicants are
not expected to make an assessment of whether the information is
clinically appropriate or would support a particular indication;
rather, when reviewing sources, applicants are only required to
identify any pediatric subpopulations that suffer from the disease or
condition that the device is intended to treat, diagnose, or cure, as
well as the number of affected pediatric patients. Please see the
forthcoming guidance document, ``Guidance for Industry and Food and
Drug Administration: Providing Information About Pediatric Uses of
Medical Devices Under Section 515A of the Federal Food, Drug, and
Cosmetic Act'' for more information on how to comply with this
requirement.
    Some comments took the position that by implementing the rule, FDA,
in effect, would be promoting the off-label use of devices. FDA
disagrees with this comment. The rule does not ask applicants to
perform any clinical studies or to use or promote the device outside
its approved indications for use; rather, the rule requires the
submission of information already in existence on any pediatric
subpopulations that suffer from the disease or condition that the
device is intended to treat, diagnose, or cure.
    One comment stated that if FDA were to request an applicant to
submit a PMA supplement for a PMA that was approved prior to the
effective date of FDAAA solely to provide readily available pediatric
information, then this would be retroactive application of law. FDA
does not intend to require any applicant to submit a PMA supplement
solely to provide readily available pediatric information. However, if
an applicant is submitting a PMA supplement for any of the reasons in
Sec.  814.39, it must include readily available pediatric information
as required by Sec.  814.39(c)(2).
    One comment stated that the rule should provide an exemption from
the requirement of submitting readily available pediatric information
in instances where the device does not and will never have pediatric
uses, as well as instances where the device is specifically indicated
for use in pediatric patients. FDA declines to incorporate this comment
because an exemption for devices that do not and are thought not to
ever have pediatric uses undermines the intent of the rule. It is not
possible to determine whether a device will have pediatric uses in the
future as modifications to the device (e.g., design or size) and
advances in medicine could change whether a device could be used in a
pediatric population. Furthermore, an exemption for devices intended
specifically for use in pediatric subpopulations would undermine the
intent of the rule because there could be other pediatric
subpopulations not included in the proposed or approved indications for
use that suffer from the disease or condition that the device is
intended to treat, diagnose, or cure. If there are no pediatric uses of
the device at the time of the PMA or PMA supplement submission, FDA
merely expects applicants to state such in the application.

VI. What is the legal authority for this final rule?

    Section 302 of FDAAA amended the FD&C Act by adding, among other
things, a new section 515A. Section 515A(a) of the FD&C Act requires
persons who submit certain medical device applications to include, if
readily available, a description of any pediatric subpopulations that
suffer from the disease or condition that the device is intended to
treat, diagnose, or cure, and the number of affected pediatric
patients. Therefore, FDA is issuing this final rule under section
515A(a), and section 701(a) of the FD&C Act (21 U.S.C. 371(a)) (which
provides FDA the authority to issue regulations for the efficient
enforcement of the FD&C Act). The Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144, section 620(b)) directs FDA to
issue a final rule implementing section 515A(a) of the FD&C Act by
December 31, 2013.

VII. What is the environmental impact of this final rule?

    FDA has determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. What is the economic impact of this final rule?

    We have examined the impacts of this final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on a substantial number of small entities. Because this regulation only
requires some submissions include a small amount of readily available
information at about $90 per submission, the Agency certifies that the
final rule does not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
rule to result in any 1-year expenditure that would meet or exceed this
amount.
    We believe that the only costs to industry are those that we
account for in our Paperwork Reduction Act analysis, which immediately
follows this section. The final rule does not require additional
clinical research or other costly efforts, and simply requires the
applicant to briefly summarize readily available information that will
have been reviewed by the applicant during the course of its
development of the device and preparation of its application to FDA. As
explained in the Paperwork Reduction Act analysis, we expect to receive
annually 40 PMAs and 5 applications for HDE. We also expect to receive
693 supplements that include the pediatric use information required by
section 515A(a) of the FD&C Act and this final rule.
    Based on our experience with similar requirements regarding readily
available information, we estimate it will take 8

hours to gather and submit information for original applications and
amendments to those applications. Because supplements can include this
information by referencing a previous submission, we estimate it will
take only 2 hours to obtain and submit the required information on
pediatric populations.
    The estimated time burden for all 45 annual applications is 360
hours. For the 693 supplements, the time burden is an estimated 1,386
hours for a total of 1,746 hours. The 2011 median wage for a compliance
officer in the medical device manufacturing industry is $31.75.\2\
Adjusting the wage by average private sector benefits of 29.6 percent
of total compensation, the benefits-adjusted wage is $45.10.\3\ At this
wage, the estimated cost of submitting an application with pediatric
information is $361 or $16,236 for all applications. The estimated cost
of submitting pediatric information for a supplement is $90 or $62,508
for all supplements. The estimated cost of this final rule is $78,744.
---------------------------------------------------------------------------

    \2\ U.S. Bureau of Labor Statistics, 2011 National Industry-
Specific Occupational Employment and Wage Estimates, SOC 13-1041
(http://www.bls.gov/oes/current/naics4_339100.htm).
    \3\ U.S. Bureau of Labor Statistics, Employer Costs for Employee
Compensation, Table 5. Employer costs per hour worked for employee
compensation and costs as a percent of total compensation: Private
industry workers, by major occupational group and bargaining unit
status, June 2012 (http://www.bls.gov/news.release/ecec.t05.htm).
---------------------------------------------------------------------------

    We expect FDA's additional costs will be inconsequential, as the
information required here will be filed and managed as an integral part
of each submission, using existing filing, storage, and data management
systems and processes.

IX. How does the Paperwork Reduction Act of 1995 apply to this final
rule?

    This final rule contains information collection requirements that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown in the following paragraphs with an
estimate of the annual reporting burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
    Title: Medical Devices; Pediatric Uses of Devices; Requirement for
Submission of Information on Pediatric Subpopulations That Suffer From
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or
Cure.
    Description: Section 515A(a) of the Food and Drug Administration
Amendments Act of 2007 requires applicants who submit certain medical
device applications to include readily available information providing
a description of any pediatric subpopulations that suffer from the
disease or condition that the device is intended to treat, diagnose, or
cure, and the number of affected pediatric patients. The information
submitted will allow FDA to track the number of approved devices for
which there is a pediatric subpopulation that suffers from the disease
or condition that the device is intended to treat, diagnose, or cure
and the review time for each such device application.
    Description of Respondents: These requirements apply to applicants
who submit the following applications on or after the effective date of
this rule:
     Any request for an HDE submitted under section 520(m) of
the FD&C Act;
     Any PMA or supplement to a PMA submitted under section 515
of the FD&C Act;
     Any PDP submitted under section 515 of the FD&C Act.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Pediatric information in an                   30               1              30               8             240
 original PMA or PDP--
 814.20(b)(13)..................
Pediatric information in a PMA                10               1              10               8              80
 amendment--814.37(b)(2)........
Pediatric information in a PMA               693               1             693               2           1,386
 supplement--814.39(c)(2).......
Pediatric information in an HDE--              5               1               5               8              40
 814.104(b)(6)..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............             738  ..............           1,746
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA expects to receive approximately 45 original PMA/PDP/HDE
applications each year, 5 of which FDA expects to be HDEs. This
estimate is based on the actual average of FDA's receipt of new PMA
applications in FY 2010-2011. The Agency estimates that 10 of those 40
original PMA submissions will fail to provide the required pediatric
use information and their sponsors will therefore be required to submit
PMA amendments. The Agency also expects to receive 693 supplements that
will include the pediatric use information required by section 515A(a)
of the FD&C Act and this final rule.
    All that is required is to gather, organize, and submit information
that is readily available, using any approach that meets the
requirements of section 515A(a) of the FD&C Act and this final rule. We
believe that because the final rule requires that the applicant
organize and submit only readily available information, no more than 8
hours will be required to comply with section 515A(a) of the FD&C Act
and this final rule for original applications and amendments to those
applications. Furthermore, because supplements may include readily
available information on pediatric populations by referencing a
previous submission, FDA estimates the average time to obtain and
submit the information required by this final rule in a supplement to
be 2 hours. FDA estimates that the total burden created by this final
rule is 1,746 hours.
    We estimate the ``Average Burden per Response'' based on our
experience with similar information collection requirements and on
consultations with the Interagency Pediatric Devices Working Group that
includes the Agency for Healthcare Research and Quality, FDA, National
Institutes of Health, members of the Pediatric Advisory Committee,
researchers, health care practitioners, medical device trade
associations, and medical device manufacturers.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section

3507(d) of the Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
    This final rule also refers to previously approved collections of
information found in FDA regulations. The collections of information in
part 814, subpart B have been approved under OMB control number 0910-
0231 and the collections of information in part 814, subpart H have
been approved under OMB control number 0910-0332.

X. What are the federalism impacts of this final rule?

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 814

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

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
814 is amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
1. The authority citation for 21 CFR part 814 continues to read as
follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.

0
2. In Sec.  814.1, revise paragraph (a) to read as follows:

Sec.  814.1  Scope.

    (a) This section implements sections 515 and 515A of the act by
providing procedures for the premarket approval of medical devices
intended for human use.
* * * * *

0
3. In Sec.  814.3, add paragraphs (s) and (t) to read as follows:

Sec.  814.3  Definitions.

* * * * *
    (s) Pediatric patients means patients who are 21 years of age or
younger (that is, from birth through the twenty-first year of life, up
to but not including the twenty-second birthday) at the time of the
diagnosis or treatment.
    (t) Readily available means available in the public domain through
commonly used public resources for conducting biomedical, regulatory,
and medical product research.

0
4. In Sec.  814.20, redesignate paragraph (b)(13) as paragraph (b)(14)
and add new paragraph (b)(13) to read as follows:

Sec.  814.20  Application.

* * * * *
    (b) * * *
    (13) Information concerning uses in pediatric patients. The
application must include the following information, if readily
available:
    (i) A description of any pediatric subpopulations (neonates,
infants, children, adolescents) that suffer from the disease or
condition that the device is intended to treat, diagnose, or cure; and
    (ii) The number of affected pediatric patients.
* * * * *

0
5. In Sec.  814.37, revise the section heading and paragraph (b) to
read as follows:

Sec.  814.37  PMA amendments and resubmitted PMAs.

* * * * *
    (b)(1) FDA may request the applicant to amend a PMA or PMA
supplement with any information regarding the device that is necessary
for FDA or the appropriate advisory committee to complete the review of
the PMA or PMA supplement.
    (2) FDA may request the applicant to amend a PMA or PMA supplement
with information concerning pediatric uses as required under Sec. Sec.
814.20(b)(13) and 814.39(c)(2).
* * * * *

0
6. In Sec.  814.39, redesignate paragraph (c) as (c)(1) and add
paragraph (c)(2) to read as follows:

Sec.  814.39  PMA supplements.

* * * * *
    (c) * * *
    (2) The supplement must include the following information:
    (i) Information concerning pediatric uses as required under Sec.
814.20(b)(13).
    (ii) If information concerning the device that is the subject of
the supplement was previously submitted under Sec.  814.20(b)(13) or
under this section in a previous supplement, that information may be
included by referencing a previous application or submission that
contains the information. However, if additional information required
under Sec.  814.20(b)(13) has become readily available to the applicant
since the previous submission, the applicant must submit that
information as part of the supplement.
* * * * *

0
7. In Sec.  814.44, redesignate paragraphs (e)(1)(ii) through
(e)(1)(iv) as paragraphs (e)(1)(iii) through (e)(1)(v), respectively,
and add new paragraph (e)(1)(ii) to read as follows:

Sec.  814.44  Procedures for review of a PMA.

* * * * *
    (e) * * *
    (1) * * *
    (ii) The submission of additional information concerning pediatric
uses required by Sec.  814.20(b)(13);
* * * * *

0
8. Amend Sec.  814.100 as follows:
0
a. Redesignate paragraphs (b) through (e) as paragraphs (d) through
(g), respectively.
0
b. Redesignate paragraph (a) as paragraph (b), and remove the first
sentence of redesignated paragraph (b); and
0
c. Add new paragraphs (a) and (c) to read as follows:

Sec.  814.100  Purpose and scope.

    (a) This subpart H implements sections 515A and 520(m) of the act.
* * * * *
    (c) Section 515A of the act is intended to ensure the submission of
readily available information concerning:
    (1) Any pediatric subpopulations (neonates, infants, children,
adolescents) that suffer from the disease or condition that the device
is intended to treat, diagnose, or cure; and
    (2) The number of affected pediatric patients.
* * * * *

0
9. Amend Sec.  814.104 as follows:
0
a. Revise the last sentence of paragraph (b)(4)(ii);.
0
b. Revise the last sentence of paragraph (b)(5); and
0
c. Add paragraph (b)(6) to read as follows:

Sec.  814.104  Original applications.

* * * * *

    (b) * * *
    (4) * * *
    (ii) * * * The effectiveness of this device for this use has not
been demonstrated;
    (5) * * * If the amount charged is $250 or less, the requirement
for a report by an independent certified public accountant or an
attestation by a responsible individual of the organization is waived;
and
    (6) Information concerning pediatric uses of the device, as
required by Sec.  814.20(b)(13).
* * * * *

0
10. In 814.116, redesignate paragraphs (c)(2) through (c)(4) as
paragraphs (c)(3) through (c)(5), respectively, and add new paragraph
(c)(2) to read as follows:

Sec.  814.116  Procedures for review of an HDE.

* * * * *
    (c) * * *
    (2) The submission of additional information concerning pediatric
uses of the device, as required by Sec.  814.20(b)(13);
* * * * *

    Dated: January 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00267 Filed 1-9-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Rules and Regulations]
[Pages 9412-9413]
[FR Doc No: 2014-03582]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 800

[Docket No. FDA-1977-N-0222]

Administrative Detention; Corrections

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendment.

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

SUMMARY: The Food and Drug Administration (FDA) published a document in
the Federal Register on Friday, March 9, 1979 (44 FR 13239). The
document established administrative detention procedures for devices
intended for human use believed to be adulterated or misbranded. The
document was published with a citation in the first column on page
13240 that subsequently was changed by the Nutrition Labeling and
Education Act Amendments of 1993. In addition, the document was
published with one typographical error in the first column on page
13241. This document corrects these errors.

DATES: This correction is effective February 19, 2014.

FOR FURTHER INFORMATION CONTACT: Jan B. Welch, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3412,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is correcting a final rule that appeared
in the Federal Register on Friday, March 9, 1979 (44 FR 13239). The
final rule established administrative detention procedures for devices
intended for human use believed to be adulterated or misbranded. The
document was published with a citation to section 201(y) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(y)) (the FD&C Act) in the
first column on page 13240 (Sec.  800.55(g)(1) (21 CFR 800.55(g)(1))
that subsequently was changed to section 201(x) of the FD&C Act by
section 3(b) of the Nutrition Labeling and Education Act Amendments of
1993 (Pub. L. 103-80). In addition, the document was published with one
typographical error in the first column on page 13241 (Sec.
800.55(k)(1)) in which the word ``is'' should have been the word
``in''. This document updates the statutory reference in Sec.
800.55(g)(1) and corrects the typographical error in Sec.
800.55(k)(1).
    Publication of this rule constitutes final action under the
Administrative Procedure Act (5 U.S.C. 553). This amendment to the
regulations provides only a technical change and corrects a
nonsubstantive error. FDA therefore, for good cause, finds under 5
U.S.C. 553(b)(3)(B) that notice and public comment are unnecessary, and
under 5 U.S.C. 553(d)(3) that the rule can become effective upon
publication.
    FDA has determined under 21 CFR 25.30(i) that this final rule is of
a type that, as a class, 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.
    This final rule contains information collection provisions 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
collections of information in Sec.  800.55 have been approved under OMB
control number 0910-0114, which expires April 30, 2016.

List of Subjects in 21 CFR Part 800

    Administrative practice and procedure; Medical devices; Ophthalmic
goods and services; Packaging and containers; 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
800 is amended as follows:

PART 800--GENERAL

0
1. The authority citation for 21 CFR Part 800 continues to read as
follows:

    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k,
361, 362, 371.

0
2. In Sec.  800.55, revise paragraph (g)(1) and the first sentence of
paragraph (k) to read as follows:

Sec.  800.55  Administrative detention.

* * * * *
    (g) Appeal of a detention order. (1) A person who would be entitled
to claim

the devices, if seized, may appeal a detention order. Any appeal shall
be submitted in writing to the FDA District Director in whose district
the devices are located within 5 working days of receipt of a detention
order. If the appeal includes a request for an informal hearing, as
defined in section 201(x) of the act, the appellant shall request
either that a hearing be held within 5 working days after the appeal is
filed or that the hearing be held at a later date, which shall not be
later than 20 calendar days after receipt of a detention order.
* * * * *
    (k) Recordkeeping requirements. (1) After issuance of a detention
order under paragraph (d) of this section, the owner, operator, or
agent in charge of any factory, warehouse, other establishment, or
consulting laboratory where detained devices are manufactured,
processed, packed, or held shall have, or establish, and maintain
adequate records relating to how the detained devices may have become
adulterated or misbranded, records on any distribution of the devices
before and after the detention period, records on the correlation of
any in-process detained devices that are put in final form under
paragraph (h) of this section to the completed devices, records of any
changes in, or processing of, the devices permitted under the detention
order, and records of any other movement under paragraph (h) of this
section. * * *
* * * * *

    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03582 Filed 2-18-14; 8:45 am]
BILLING CODE 4160-01-P