43353 Federal Register / Vol. 68, No. 140 / Tuesday, July 22, 2003 / Notices the Commission, on or before the specified deadline date for the particular application, a competing development application, or a notice of intent to file such an application. Submission of a timely notice of intent allows an interested person to file the competing development application no later than 120 days after the specified deadline date for the particular application. Applications for preliminary permits will not be accepted in response to this notice. o. Notice of Intent: A notice of intent must specify the exact name, business address, and telephone number of the prospective applicant, and must include an unequivocal statement of intent to submit, if such an application may be filed, either a preliminary permit application or a development application ( specify which type of application). A notice of intent must be served on the applicant( s) named in this public notice. p. Protests or Motions to Intervene: Anyone may submit a protest or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In determining the appropriate action to take, the Commission will consider all protests filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any protests or motions to intervene must be received on or before the specified deadline date for the particular application. q. All filings must ( 1) bear in all capital letters the title `` PROTEST'', `` MOTION TO INTERVENE'', `` NOTICE OF INTENT TO FILE COMPETING APPLICATION,'' `` COMPETING APPLICATION,'' `` COMMENTS,'' `` REPLY COMMENTS,'' `` RECOMMENDATIONS,'' `` TERMS AND CONDITIONS,'' or `` PRESCRIPTIONS;'' ( 2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; ( 3) furnish the name, address, and telephone number of the person protesting or intervening; and ( 4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34( b). Agencies may obtain copies of the application directly from the applicant. Any of these documents must be filed by providing an original and eight copies to: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. An additional copy must be sent to Director, Division of Hydropower Administration and Compliance, Office of Energy Projects, Federal Energy Regulatory Commission, at the above address. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34( b) and 385.2010.

Magalie R. Salas, Secretary. [ FR Doc. 03   18662 Filed 7   21   03; 8: 45 am]

BILLING CODE 6717   01   P ENVIRONMENTAL PROTECTION AGENCY [ OW   2003   0014; FRL   7534   3]

Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Surveys To Determine the Effectiveness of No Discharge Zones ( NDZ) for Vessel Sewage and Marine Sanitation Devices, EPA ICR Number 2107.01 AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that an Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval. This is a request for a new collection. This ICR describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before August 21, 2003. ADDRESSES: Submit your comments, referencing docket ID number OW   2003   0014, to ( 1) EPA at: online using EDOCKET ( our preferred method), by email to OW Docket@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Water Docket, EPA West, 4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: James Woodley, Oceans and Coastal Protection Division, Office of Water, Environmental Protection Agency, 4504T, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 566   1287; fax number: ( 202) 566   1546; e mail address: woodley. james@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On March 27, 2003, ( 68 FR 14975), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received 20 sets of comments and addressed them in a separate document entitled, `` Response to Comments on the March 27, 2003 Proposed Information Collection Request: Surveys to Determine the Effectiveness of No Discharge Zones for Vessel Sewage and Marine Sanitation Devices.'' A copy of this document can be viewed or obtained from the public docket. Information pertaining to accessing the materials in the docket is explained below. None of the comments suggested that EPA not conduct the proposed surveys. The comments were from States, a U. S. Territory, non governmental organizations, trade associations, a marine sanitation device ( MSD) manufacturer, a laboratory, and private citizens. The vast majority of the comments provided information regarding the potential questions that the surveys should ask. Some provided information regarding the perception of the effectiveness of the current nodischarge zones ( NDZs) and MSDs, and additional comments provided recommendations on how EPA should modify the current Vessel Sewage Discharge Program. Lastly, some of the respondents offered their assistance in this effort. EPA has established a public docket for this ICR under Docket ID No. OW   2003   0014, which is available for public viewing at the Water Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for the Water Docket is ( 202) 566   2426. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public VerDate Jan< 31> 2003 19: 58 Jul 21, 2003 Jkt 200001 PO 00000 Frm 00011 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 22JYN1. SGM 22JYN1 43354 Federal Register / Vol. 68, No. 140 / Tuesday, July 22, 2003 / Notices docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information ( CBI), or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. Title: Surveys to Determine the Effectiveness of No Discharge Zones for Vessel Sewage and Marine Sanitation Devices. Abstract: This ICR is for a series of surveys to be conducted to determine the effectiveness of NDZs for vessel sewage and MSDs in removing harmful pollutants from the waste stream of the device. This ICR requests approval to collect information from boat owners and operators, marina owners and operators, and State and local government officials regarding the effectiveness of NDZs. It also requests approval to collect information regarding the effectiveness of MSDs in removing harmful pollutants from the waste stream of the device. This information will be gathered from MSD manufacturers and U. S. Coast Guard accepted independent laboratories. A survey will be developed for boat owners and operators to address the boater's experience with using pumpout or dump facilities in NDZs. The survey will collect general information regarding the respondent's boating activity and will seek information on whether the pump out or dump facilities were working. It will address whether the boater would use the facilities if they were available, and how often the boaters actually use the facilities. It will also seek information on the boater's knowledge about NDZs. Respondents will be selected from North Atlantic States, Mid Atlantic States, South Atlantic States, California, and the Great Lakes that contain NDZs. Approximately 1,400 respondents from the geographical regions will be selected for response. EPA predicts that completed surveys from about 1,200 boat owners and operators will be received. The information collection will be voluntary and will not include CBI. A survey will be developed for marina owners and operators located in a particular NDZ to seek general information on the pump out and dump facilities operations, to address the downtime of these facilities, and their use by boaters. It will seek information regarding the marina owner/ operator's knowledge of NDZs. Respondents will be selected from North Atlantic States, Mid Atlantic States, South Atlantic States, California, and the Great Lakes that contain NDZs. Approximately 100 marina owners or operators from the geographical regions will be selected for response. EPA predicts that completed surveys from about 75 marina owners and operators will be received. The information collection will be voluntary and will not include CBI. A survey will also be developed for State and local government officials to determine if the designation of NDZs has been effective in addressing water quality issues of the particular water body, if boaters were in compliance with NDZ requirements, and the roles and responsibilities associated with the NDZ. Respondents will be selected from North Atlantic States, Mid Atlantic States, South Atlantic States, California, and the Great Lakes that contain NDZs. Approximately 80 respondents from the geographical regions will be selected for response. EPA predicts that about 54 State and local government officials will complete the survey. The information collection will be voluntary and will not include CBI. The information collected from these surveys will be used to assess the overall effectiveness of NDZs for vessel sewage established under Clean Water Act section 312( f)( 3) to help determine if modifications to the program are needed. An additional survey will be developed to review current MSD technology. The information on MSDs that will be requested includes effluent constituents and their concentrations; bacteria eradication processes and suspended solids removal; cost; and installation. This information will be used to help determine the effectiveness of current MSD technologies and will be used to collect information to assist EPA in promulgating regulations implementing Title XIV: Certain Alaskan Cruise Ship Operations. Approximately 60 MSD manufacturers and 8 U. S. Coast Guard accepted independent laboratories will be selected for response. EPA predicts that about 30 MSD manufacturers and 7 U. S. Coast Guard accepted independent laboratories will complete the survey. Responding to the collection of information will be voluntary. Information collected from these entities that may be CBI and is covered by a CBI claim will be treated in accordance with the procedures set forth in 40 CFR part 2, subpart B. EPA estimates that the respondent total burden and cost associated with this ICR is 474 hours, reflecting $ 13,053. The Agency burden and cost is estimated at 6,672 hours, reflecting $ 282,642. 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. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and record keeping burden for this collection of information is estimated to average 21 minutes per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Boat owners and operators, Marina owners and operations, State and local government officials, Marine Sanitation Device manufacturers, U. S. Coast Guard accepted independent laboratories. Estimated Number of Respondents: 1,366. Frequency of Response: one time collection. Estimated Total Annual Hour Burden: 474.

VerDate Jan< 31> 2003 19: 58 Jul 21, 2003 Jkt 200001 PO 00000 Frm 00012 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 22JYN1. SGM 22JYN1 43355 Federal Register / Vol. 68, No. 140 / Tuesday, July 22, 2003 / Notices Estimated Total Annual Cost: $ 13,053, includes $ 0 annualized capital or O& M costs.

Dated: July 2, 2003. Doreen Sterling, Acting Director, Collection Strategies Division. [ FR Doc. 03   18613 Filed 7   21   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ FRL   7534   4]

State of Wisconsin Prohibition on Marine Discharges of Vessel Sewage Into Waters of Lake Superior; Receipt of Petition and Tentative Determination AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of tentative determination.

SUMMARY: Today's notice announces that, by letter dated June 24, 2003, the United States Environmental Protection Agency has tentatively determined that there is a reasonable availability of adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels on the waters of Lake Superior under the jurisdiction of the State of Wisconsin. DATES: Comments and views regarding this petition and EPA's tentative determination may be filed on or before August 21, 2003. FOR FURTHER INFORMATION CONTACT: Irvin J. Dzikowski, United States Environmental Protection Agency, Region 5, Water Division WN   16J, 77 West Jackson Boulevard, Chicago, Illinois 60604, ( 312) 886   6100. SUPPLEMENTARY INFORMATION: A petition to the Regional Administrator, EPA, dated February 28, 2003, was received from the Secretary, State of Wisconsin Department of Natural Resources, requesting a determination pursuant to section 312( f)( 3) of the Clean Water Act ( CWA), 33 U. S. C. 1322( f)( 3) and 40 CFR 140.4( a) that there is a reasonable availability of adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels on the waters of Lake Superior under the jurisdiction of the State of Wisconsin. There are 13 waterfront facilities that operate sanitary waste pumpout facilities and or dump stations in the proposed Wisconsin Waters Lake Superior No Discharge Area. In addition to the sanitary waste pumpout facilities, numerous shoreline restroom facilities are available at public boat launches, docks and parks. Commercial vessels use the facilities at the Port of Duluth Superior. On May 18, 2003, the State supplemented its petition with a `` Greater Protection and Enhancement Certification.'' Once the EPA determines that adequate facilities are available, the State of Wisconsin has the authority pursuant to section 312( f)( 3) and 40 CFR 140.4( a), to completely prohibit the discharge from all vessels of any sewage, whether treated or not, into the waters of Lake Superior under its jurisdiction. The EPA hereby makes a tentative affirmative determination that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available in the Lake Superior area under the jurisdiction of the State of Wisconsin. A final determination on this matter will be made by the Regional Administrator following the 30 day period for public comment.

Dated: June 24, 2003. Thomas V. Skinner, Regional Administrator, Region 5. [ FR Doc. 03   18614 Filed 7   21   03; 8: 45 am]

BILLING CODE 6560   50   P FEDERAL COMMUNICATIONS COMMISSION Notice of Public Information Collection( s) Being Submitted to OMB for Review and Approval July 8, 2003. SUMMARY: The Federal Communications Commissions ( FCC), as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104   13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act ( PRA) that does not display a valid control number. Comments are requested concerning ( a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; ( b) the accuracy of the Commission's burden estimate; ( c) ways to enhance the quality, utility, and clarity of the information collected; and ( d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. DATES: Written comments should be submitted on or before August 21, 2003. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible. ADDRESSES: Direct all comments to Les Smith, Federal Communications Commission, Room 1   A804, 445 12th Street, SW., Washington, DC 20554 or via the Internet to Leslie. Smith@ fcc. gov. FOR FURTHER INFORMATION CONTACT: For additional information or copies of the information collections contact Les Smith at ( 202) 418   0217 or via the Internet at Leslie. Smith@ fcc. gov. SUPPLEMENTARY INFORMATION: OMB Control Number: 3060   XXXX. Title: Remedial Measures for Failure to Construct Digital Television Stations ( DTV Policy Statement). Form Number: N/ A. Type of Review: New collection. Respondents: Business and other forprofit entities; not for profit institutions; and individuals or households. Number of Respondents: 400. Estimated Time per Response: 0.5 to 1.0 hours. Frequency of Response: On occasion reporting requirements. Total Annual Burden: 210 hours. Total Annual Costs: $ 76,000. Needs and Uses: On April 16, 2003, the FCC released a Report and Order and Memorandum Opinion and Order on Reconsideration, In the Matter of Remedial Steps for Failure to Comply with Digital Television Construction Schedule, MM Docket No. 02   113, FCC 03   77, (`` R& O''), in which the Commission has adopted a series of remedial measures for stations that fail to construct their digital television ( DTV) facilities in a timely fashion and fail to justify an extension of their DTV construction deadline. Stations will be subject to periodic reporting requirements. Under the first step, the Commission will deny the request for an unqualified extension and admonish the station for its failure to comply with its DTV construction obligation. The station must submit a report within thirty days outlining the steps it intends to take to complete construction and the approximate date that it expects to reach each of these construction milestones. Sixty days after its initial report, the station must submit a report detailing its progress on meeting its proposed construction milestones and justifying any delays it has encountered. Under the second step in the approach, if the VerDate Jan< 31> 2003 19: 58 Jul 21, 2003 Jkt 200001 PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 22JYN1. SGM 22JYN1


[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Rules and Regulations]
[Pages 69388-69390]
[FR Doc No: 2012-28051]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2012-0518]
RIN 1625-AA00

Safety Zone; Water Main Crossing; Choctawhatchee Bay; Santa Rosa
Beach, FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard has established a temporary safety zone for a
portion of the Gulf Intracoastal Waterway in Choctawhatchee Bay, Santa
Rosa Beach, FL. This action is necessary for the protection of persons
and vessels, on navigable waters, during the construction of a
subaqueous water main. Entry into or transiting in this zone will be
prohibited to all vessels, mariners, and persons unless specifically
authorized by the Captain of the Port Mobile or a designated
representative.

DATES: This rule is effective in the CFR on November 19, 2012 through
November 30, 2012. This rule is effective with actual notice for
purposes of enforcement on October 12, 2012. This rule will remain in
effect through November 30, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2012-0518. 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
temporary rule, call or email LT Lenell J. Carson, Sector Mobile,
Waterways Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, 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
GICW Gulf Intracoastal Waterway
COTP Captain of the Port
LLNR Light List Number
TFR Temporary Final Rule

A. Regulatory History and Information

    The Coast Guard published a NPRM in the Federal Register on July
10, 2012 (77 FR 40541), providing proper notice and opportunity to
comment on this rule. No comments were received nor were there any
requests for a public meeting. The Coast Guard also published a TFR in
the Federal Register on September 14, 2012 (77 FR 56772).
    The Coast Guard is making this rule effective less than 30 days
after publication in the Federal Register pursuant to authority the
Administrative Procedure Act (APA) (5 U.S.C. 533(d)). This provision
authorizes an agency to make a rule effective less than 30 days after
publication in the Federal Register when the agency for good cause
finds that those procedures are ``impracticable, unnecessary, or
contrary to the public interest.'' Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making this rule effective less
than 30 days after publication in the Federal Register. This action is
necessary for the protection of persons and vessels, on navigable
waters, during the construction of a subaqueous water main that begun
in June 2012. It would be contrary to public interest to delay the
effective date of the rule.

B. Basis and Purpose

    A 36'' subaqueous water main is being constructed across the
Choctawhatchee Bay to improve water system delivery. The water main
will cross the GICW, a federally maintained navigable channel.
Construction of the water main and the required use of turbidity silt
curtains pose significant safety hazards to both vessels and mariners
operating in or near the GICW. The COTP Mobile is establishing a
temporary safety zone for a portion of GICW in Choctawhatchee Bay,
Santa Rosa Beach, FL. This temporary safety zone is deemed necessary to
protect persons and vessels during construction of the water main
across the GICW. The legal basis and authorities for this rule are
found in 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, and 160.5; Public Law 107-295,
116 Stat. 2064; and Department of Homeland Security Delegation No.
0170.1, which collectively authorize the Coast Guard to propose,
establish, and define regulatory safety zones.
    The COTP anticipates some impact on vessel traffic due to this
regulation. However, the temporary safety zone is deemed necessary for
the protection of life and property within the COTP Mobile zone.

C. Discussion of Comments, Changes and the Temporary Final Rule

    The regulatory text for this rule has been amended reflecting an
updated effective period and anticipated closure times for the safety
zone. The original effective date of September 14, 2012 to October 14,
2012 has been amended to read; October 12, 2012 to November 30, 2012.
This amendment is necessary to reflect changes in the project's
timeline due to delays caused by severe tropical weather.
    The Coast Guard has established a temporary safety zone for a
portion of the GICW in Choctawhatchee Bay from the Highway 331 fixed
bridge west to the Red Nun Buoy ``26'' (LLNR 31510), to include the
entire width of the channel. This rule will protect the safety of life
and property in this area. Entry into or transiting in this zone will
be prohibited to all vessels, mariners, and persons unless specifically
authorized by the COTP Mobile or a designated

representative. The COTP may be contacted by telephone at (251) 441-
5976.
    This rule will be effective and enforceable with actual notice from
October 12, 2012 to November 30, 2012. The COTP Mobile anticipates that
this rule will be enforced for approximately three (3) days, to include
a complete Twenty-Four (24) hour closure of the GICW. The COTP Mobile
or a designated representative will inform the public through Broadcast
Notices to Mariners of the specific enforcement periods throughout the
water main construction project as well as any changes in the safety
zone.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes or 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.
    The temporary safety zone listed in this rule will only restrict
vessel traffic from entering or transiting a small portion of the GICW.
The effect of this regulation will not be significant for several
reasons: (1) The COTP Mobile will issue maritime advisories widely
available to users of the waterway; (2) this rule will only affect
vessel traffic that are subject to transiting the GICW due to draft
restrictions; and (3) the impacts on routine navigation are expected to
be minimal. Notifications to the marine community will be made through
Local Notices to Mariners and Broadcast Notices to Mariners. These
notifications will allow the public to plan operations around the
affected area.

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 Coast Guard
received 0 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. This rule will affect the following entities, some of
which may be small entities: The owners or operators of vessels
intending to transit the affected portion of the GICW during
construction of the water main. This safety zone would not have a
significant economic impact on a substantial number of small entities
for the following reasons. This safety zone is limited in size, is of
short duration and shallow draft vessel traffic may pass safely around
the temporary safety zone.

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,
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 have
determined that it 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 would not result
in such expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule would 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 From Environmental Health Risks

    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 would 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 rule 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 made a
preliminary determination that this action is one of a category of
actions which do not individually or cumulatively have a significant
effect on the human environment. This rule involves a temporary safety
zone for a portion of the GICW in Choctawhatchee Bay, Santa Rosa Beach,
FL, for the safety of the public and is not expected to result in any
significant adverse environmental impact as described in NEPA. 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.

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. Add Sec.  165.T08-0518 to read as follows:

Sec.  165.T08-0518  Safety Zone; Water Main Crossing; Choctawhatchee
Bay; Santa Rosa Beach, FL.

    (a) Location. The following area is a temporary safety zone: A
portion of the Gulf Intracoastal Waterway in Choctawhatchee Bay from
the Highway 331 fixed bridge west to the Red Nun Buoy ``26'' (LLNR
31510), to include the entire width of the channel.
    (b) Effective dates. This rule is effective from October 12, 2012
to November 30, 2012.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Mobile or a designated
representative.
    (2) Persons or vessels not restricted to navigation in the Gulf
Intracoastal Waterway by draft and that can safely do so, may pass
around the zone while maintaining a safe distance and transiting at
slowest safe navigational speed.
    (d) Informational broadcasts. The Captain of the Port or a
designated representative will inform the public through broadcast
notices to mariners of the enforcement period for the safety zone as
well as any changes in the planned schedule.

    Dated: October 12, 2012.
D.J. Rose,
Captain, U.S. Coast Guard, Captain of the Port Mobile.
[FR Doc. 2012-28051 Filed 11-16-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Pages 10506-10507]
[FR Doc No: 2012-4067]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0004; FRL-9338-7]

Access to Confidential Business Information by Syracuse Research
Corporation, Inc., and Its Identified Subcontractor, BeakerTree
Corporation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has authorized its contractor, Syracuse Research
Corporation (SRC), Inc., of North Syracuse, NY, and its identified
subcontractor BeakerTree Corporation to access information which has
been submitted to EPA under sections 4, 5, 6, and 8 of the Toxic
Substances Control Act (TSCA). Some of the information may be claimed
or determined to be Confidential Business Information (CBI).

DATES: Access to the confidential data will occur no sooner than
February 29, 2012.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Pamela Moseley, Information
Management Division (7407M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this notice apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to all who manufacture, process, or distribute
industrial chemicals. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2003-0004. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT
Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at
Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., Washington, DC.
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number of the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. Docket visitors
are required to show photographic identification, pass through a metal
detector, and sign the EPA visitor log. All visitor bags are processed
through an X-ray machine and subject to search. Visitors will be
provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.

II. What action is the agency taking?

    Under EPA contract number EP-W-12-003, contractor SRC, Inc., of
4225 Running Ridge Road, North Syracuse, NY; and BeakerTree Corporation
of 13402 Birch Bark Court, Fairfax, VA, will assist the Office of
Pollution Prevention and Toxics (OPPT) by performing chemistry
evaluation of new and existing chemicals including the chemistry
aspects of their manufacture, processing, use, potential new uses, and
pollution prevention. They will also assist in examining documents for
information on chemical structures, manufacture, physical/chemical
properties, production volume and other pertinent data used in the
assessment of the potential effects of chemicals. In accordance with 40
CFR 2.306(j), EPA has determined that under EPA contract number EP-W-
12-003, SRC and BeakerTree will require access to CBI submitted to EPA
under sections 4, 5, 6, and 8 of TSCA to perform successfully the
duties specified under the contract. SRC and BeakerTree personnel will
be given access to information submitted to EPA under sections 4, 5, 6,
and 8 of TSCA. Some of the information may be claimed or determined to
be CBI.
    EPA is issuing this notice to inform all submitters of information
under sections 4, 5, 6, and 8 of TSCA that EPA

may provide SRC and BeakerTree access to these CBI materials on a need-
to-know basis only. All access to TSCA CBI under this contract will
take place at EPA Headquarters and SRC's site located in 2451 Crystal
Drive, Suite 475, Arlington, VA, site, in accordance with EPA's TSCA
CBI Protection Manual.
    Access to TSCA data, including CBI, will continue until January 12,
2017. If the contract is extended, this access will also continue for
the duration of the extended contract without further notice.
    SRC and BeakerTree personnel will be required to sign nondisclosure
agreements and will be briefed on appropriate security procedures
before they are permitted access to TSCA CBI.

List of Subjects

    Environmental protection, Confidential business information.

    Dated: February 15, 2012.
Mario Caraballo,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2012-4067 Filed 2-21-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Rules and Regulations]
[Pages 2354-2357]
[FR Doc No: 2018-00479]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0324; Product Identifier 2017-CE-004-AD; Amendment
39-19157; AD 2018-02-04]
RIN 2120-AA64

Airworthiness Directives; Aerospace Welding Minneapolis, Inc.,
Mufflers

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Aerospace Welding Minneapolis, Inc. mufflers, part numbers A1754001-23
and A1754001-25, installed on airplanes. This AD was prompted by
occurrences of cracks or broken welds in the connecting weld of the
muffler body to muffler cuff that may allow carbon monoxide exhaust
fumes into the cockpit heating system. This AD requires an inspection
of the muffler for leaking to identify cracks and replacement of the
muffler. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective February 21, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 21,
2018.

ADDRESSES: For service information identified in this final rule,
contact Aerospace Welding Minneapolis, Inc. (AWI) 1045 Gemini Road,
Eagan, Minnesota 55121; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
internet: www.awi-ami.com. You may view this service information at the
FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0324.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0324; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is Docket Operations, 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: Mark Grace, Aerospace Engineer, FAA,
Chicago ACO Branch, 2300 East Devon Avenue, Des Plaines, IL 60018-4696;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Aerospace Welding
Minneapolis, Inc. (AWI) mufflers, part numbers A1754001-23 and
A1754001-25, installed on airplanes. The NPRM published in the Federal
Register on April 18, 2017 (82 FR 18265). The NPRM was prompted by
reports of broken or cracked welds in the connecting weld of the
muffler body to muffler cuff. There have been 54 occurrences identified
by maintenance and 2 occurrences identified by the carbon monoxide (CO)
gas monitor warning system. The NPRM proposed to require an inspection
of the muffler for leaking to identify cracks and replacement of the
muffler. We are issuing this AD to correct the unsafe condition on
these products.

Comments

    We gave the public the opportunity to participate in developing
this final rule. The following presents the comments received on the
NPRM and the FAA's response to each comment.

Request To Expand the Applicability

    An anonymous commenter requested we expand the applicability of the
AD to include additional part number mufflers produced by the same
manufacturer as the mufflers affected by this AD. The commenter thinks
the additional part number mufflers may share some of the same
materials, processes, and methods of assembly as the mufflers affected
by this AD.
    We do not agree with this comment. We addressed this concern during
the investigation of the unsafe condition. We found that the unsafe
condition is related to a design change and was applicable to one
manufacturing lot. The unsafe condition applies to only the part
numbers and serial numbers affected by this AD.
    We have not changed this AD based on this comment.

Request To Prohibit the Installation of the Affected Muffler on Cessna
172R and 172S Airplanes

    An anonymous commenter pointed out that that all 10 SDRs address
the Models 172R and 172S airplanes. This commenter also asks how many
of the 56 parts were installed on Cessna Models C172R and C172S
airplanes. The commenter explains that (AWI) mufflers, part numbers
A1754001-23 and A1754001-25, lack the reinforced ends and high
temperature corrosion resistant material specified in FAR Part
23.1125(a)(1). The material substitution

makes it less resistant to high temperature and corrosion than the
original type-certificated product. Based on the comments, the FAA
infers that the commenter wants the AD to prohibit the installation of
the affected parts, regardless of serial number, specifically on the
Cessna Models 172R and 172S airplanes.
    We do not agree with the implication that the installation
prohibition should apply to all produced parts or only apply to the
Cessna Model 172R and 172S airplanes. The unsafe condition resulted
from a design change with a limited serial number effectivity and that
is approved for installation on other models. We don't know how many
parts are installed or could be installed in the future on the Cessna
Models C172R and C172S airplanes. The current applicability captures
all the potentially unsafe parts in the field. Concerns about material
substitutions complying with 14 CFR 23.1125(a)(1) goes beyond the scope
of this AD.
    We have not changed this AD based on this comment.

Request We Add an Exhaust Systems Inspection

    An anonymous commenter requested we issue an AD similar to a
Transport Canada AD which requires an ongoing periodic pressure testing
of the exhaust systems to help identify and reduce the risk of CO
entering the cabin area.
    We do not agree with this comment. This AD addresses the identified
unsafe condition on the affected mufflers by requiring removal of the
affected mufflers from airplanes. A more general pressure testing of
exhaust systems is beyond the scope of this AD.
    We have not changed this AD based on this comment.

Request To Make Spot Weld Procedures More Rigid

    An anonymous commenter requested we require parts manufacturer
approval (PMA) spot weld procedures to be more rigid. The commenter
stated that manually operated spot welding machines do not consistently
control pressure, time, or frequency as required by weld schedules
because the human operator controls those factors. It is almost
impossible to meet the weld code without a computer aided machine.
    We do not agree with this comment. Regulating how spot welds are
done goes beyond the scope of this AD. This AD addresses the identified
unsafe condition on the affected mufflers by requiring removal of the
affected mufflers from airplanes.
    We have not changed this AD based on this comment.

Request We Prohibit the Use of Less Heat Resistant Material

    An anonymous commenter requested we not allow the substitution of
less heat resistant material for higher heat resistant material. There
are a number of FAA-approved PMA articles in existence certified by
Identicality or Test and Computation where less heat resistant
materials have been substituted. In many cases these PMA articles are
used as terminating action to ADs and undermine the basis of the AD.
    We do not agree with this comment. An applicant for a PMA must
demonstrate compliance with the applicable regulations before the PMA
is granted. This AD addresses the unsafe condition on the affected
mufflers by requiring removal of the affected mufflers from airplanes.
Changing the PMA process goes beyond the scope of this AD.
    We have not changed this AD based on this comment.

Request We Make Related Documents Available

    David McGhee requested we ensure documents related to the AD are
readily available. Although requested several times by telephone and
email, the commenter was unable to obtain a copy of related service
information. This made review and comment on the proposed AD difficult.
    We agree with this comment. Related documents should be available
for a timely review of the AD. The NPRM incorrectly cited the related
AWI service bulletin as AWI Mandatory Service Bulletin No. 16063001,
dated June 30, 2015. The correct citation should read AWI Mandatory
Service Bulletin No. 15063001, dated June 30, 2015. We confirmed the
availability of the related service bulletin with the document provider
and confirmed the commenter received a copy prior to the close of the
comment period.
    We changed this AD to use the correct citation based on this
comment.

Request a Change to the Cost of Compliance

    David McGhee requested we add the cost to determine if the affected
muffler is installed on the airplane to the estimated cost of the AD.
The related service information estimated it would take 1 hour of labor
to inspect the airplane to determine if the affected muffler is
installed.
    We do not agree with this comment. The estimated cost of the AD
applies specifically to addressing and correcting the unsafe condition.
The FAA process for determining the cost of compliance does not include
the initial determination of applicability. Also, for many airplanes, a
review of the maintenance records will identify if the affected muffler
is installed.
    We have not changed this AD based on this comment.

Request We Allow the Use of Other Service Information for Muffler
Replacement

    David McGhee requested we revise the AD to allow the use of other
service information for installing a replacement muffler. Operators may
choose to install an FAA-approved muffler from a source other than AWI.
The service information proposed in the NPRM may not be appropriate for
mufflers produced by a different manufacturer.
    We agree with this comment. If an operator installs an FAA-approved
muffler other than the AWI muffler, the installation instructions from
that manufacturer should be used.
    We have revised the language in this AD to allow the use of the
manufacturer's installation instructions for the specific muffler that
is being installed.

Request We Revise the Subject Heading

    Thomas Nelson requested we revise the subject heading of the AD
because it is not part of the company's name and implies the AD applies
to all mufflers made by this company.
    We partially agree with this comment. We agree the subject header
could more clearly define the specific mufflers this AD applies to;
however, we disagree with revising the subject header. The subject
header is intended as a general header and is not intended to include
details that address the specifics of applicability. The Office of the
Federal Register develops the guidelines for the format and structure
of rulemaking documents for all federal agencies to follow.
    We have not changed this AD based on this comment.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule with the changes described previously and minor
editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and

     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    We reviewed AWI Cessna 172 (Lycoming) Muffler Removal and
Installation, Revision 01, January 17, 2017. The service information
describes procedures for removing and replacing the affected mufflers.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Other Related Service Information

    We reviewed AWI Mandatory Service Bulletin No. 15063001, dated June
30, 2015. The service bulletin describes how to identify the
installation of an affected muffler.

Costs of Compliance

    We estimate that this AD affects 171 mufflers installed on
airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost              Parts cost          product        operators
----------------------------------------------------------------------------------------------------------------
Inspection of muffler............  1 work-hour x $85 per     Not applicable.....             $85         $14,535
                                    hour = $85.
Replacement of the muffler.......  4 work-hours x $85 per    $350...............             690         117,990
                                    hour = $340.
----------------------------------------------------------------------------------------------------------------

    This AD affects 171 mufflers with PMA; however, only 9 mufflers
remain in service.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to small airplanes, gliders,
balloons, airships, domestic business jet transport airplanes, and
associated appliances to the Director of the Policy and Innovation
Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-02-04 Aerospace Welding Minneapolis, Inc.: Amendment 39-19157;
Docket No. FAA-2017-0324; Product Identifier 2017-CE-004-AD.

(a) Effective Date

    This AD is effective February 21, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Aerospace Welding Minneapolis, Inc. (AWI)
mufflers listed in figure 1 of paragraph (c) of this AD that are
installed on but not limited to the airplanes listed in figure 2 of
paragraph (c) of this AD.

    Note 1 to paragraph (c) of this AD: You may use AWI Mandatory
Service Bulletin No. 15063001, dated June 30, 2015, to identify if
an affected muffler is installed on the airplane.

         Figure 1 of Paragraph (c) of This AD--Affected Mufflers
------------------------------------------------------------------------
         Muffler part No.                   Muffler serial Nos.
------------------------------------------------------------------------
A1754001-23......................  33553 through 33557; 34721 through
                                    34728; 35322 through 35329; 35670;
                                    38481 through 38485; 38584 through
                                    38586; and 38723 through 38727.
A1754001-25......................  32795 through 32800; 33558 through
                                    33569; 33779 through 33790; 34636
                                    through 34653; 34968 through 34984;
                                    35159 through 35176; 37903 through
                                    37906; 38174 through 38193; 38502
                                    through 38506; 38566 through 38575;
                                    and 38817 through 38836.
------------------------------------------------------------------------

        Figure 2 of Paragraph (c) of This AD--Affected Airplanes
------------------------------------------------------------------------
                                        Textron Aviation Inc. (type
         Muffler part No.          certificate previously held by Cessna
                                        Aircraft Company) airplanes
------------------------------------------------------------------------
A1754001-23......................  Model 172 Serial numbers (S/Ns)
                                    17259224 and up; Model 172R S/Ns
                                    80001 and up; and Model 172S S/Ns
                                    8001 and up.
A1754001-25......................  Model 172 S/Ns 17256513 and up; Model
                                    172R S/Ns 80001 and up; 172S S/N
                                    8001 and up; and Model 177 S/N
                                    1770001 and up.
------------------------------------------------------------------------

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 7820, Exhaust Noise Suppressor.

(e) Unsafe Condition

    This AD was prompted by occurrences of cracks or broken welds in
the connecting weld of the muffler body to muffler cuff that may
allow carbon monoxide (CO) exhaust fumes into the cockpit heating
system. We are issuing this AD to prevent cracks in the connecting
weld of the muffler body to muffler cuff that may allow CO fumes to
enter the cockpit heating system and possibly inhibit the pilot's
ability to maintain control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspection of the Muffler

    (1) Within 5 hours time-in-service after February 21, 2018 (the
effective date of this AD), inspect the affected muffler following
the instructions listed in paragraphs (g)(1)(i) through (iii).
    (i) Using a vacuum cleaner with the hose attached to the blowing
side of the vacuum (with the filter installed), attach the vacuum to
the airplane tailpipe and seal securely.
    (ii) The vacuum will pressurize the system sufficiently for a
soap solution to be brushed or applied from a spray bottle to the
surface of the exhaust system.
    (iii) Inspect for evidence of breaches (leakage) in the system
from cracks.
    (2) In lieu of doing the inspection required in paragraph (g)(1)
of this AD, within 5 hours after February 21, 2018 (the effective
date of this AD), you may remove the affected muffler following AWI
Cessna 172 (Lycoming) Muffler Removal and Installation, Revision 01,
January 17, 2017, and replace the affected muffler with an FAA-
approved part that is not a muffler listed in figure 1 of paragraph
(c) of this AD following the manufacturer's instructions.
    (3) If replacement specified in paragraph (g)(2) of this AD is
done instead of the inspection required in paragraph (g)(1) of this
AD, then paragraph (h)(3) of this AD is the only additional
requirement of this AD.

(h) Replacement of the Muffler

    (1) If evidence of breaches (leakage) is found during the
inspection required in paragraph (g) of this AD, before further
flight, remove the affected muffler following AWI Cessna 172
(Lycoming) Muffler Removal and Installation, Revision 01, January
17, 2017, and replace the affected muffler with an FAA-approved part
that is not a muffler listed in figure 1 of paragraph (c) of this AD
following the manufacturer's instructions.
    (2) If no evidence of breaches (leakage) is found during the
inspection required in paragraph (g) of this AD, within the next 100
hours TIS after February 21, 2018 (the effective date of this AD) or
at the next annual inspection after February 21, 2018 (the effective
date of this AD), whichever occurs later, remove and replace the
affected muffler with an FAA-approved part that is not a muffler
listed in figure 1 of paragraph (c) of this AD as described in
(h)(1).
    (3) After February 21, 2018 (the effective date of this AD), do
not install on any airplane an affected muffler listed in figure 1
of paragraph (c) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Chicago ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the ACO Branch, send it to the attention of the person
identified in paragraph (j)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    For more information about this AD, contact Mark Grace,
Aerospace Engineer, FAA, Chicago ACO Branch, 2300 East Devon Avenue,
Des Plaines, IL 60018-4696; telephone:<PHONE_NUMBER>; fax: (847)
294-7834; email: [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) AWI Cessna 172 (Lycoming) Muffler Removal and Installation,
Revision 01, January 17, 2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Aerospace Welding Minneapolis, Inc. (AWI) 1045 Gemini Road, Eagan,
Minnesota 55121; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
internet: www.awi-ami.com.
    (4) You may view this service information at FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on January 8, 2018.
Melvin Johnson,
Deputy Director, Policy and Innovation Division, Aircraft Certification
Service.
[FR Doc. 2018-00479 Filed 1-16-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 27 (Thursday, February 9, 2012)]
[Notices]
[Page 6814]
[FR Doc No: 2012-3053]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4029-DR; Docket ID FEMA-2012-0002]

Texas; Amendment No. 13 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Texas (FEMA-4029-DR), dated September 9, 2011, and
related determinations.

DATES: Effective Date: February 1, 2012.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Texas is hereby amended to include the following areas
among those areas determined to have been adversely affected by the
event declared a major disaster by the President in his declaration of
September 9, 2011.

    Bosque County for Public Assistance, including direct federal
assistance. Caldwell, Fayette, and Grimes Counties for emergency
protective measures (Category B), including direct federal
assistance, under the Public Assistance program (already designated
for Individual Assistance).
    Bowie, Camp, Crockett, Foard, Franklin, Grayson, Hardin, Hunt,
Jefferson, Kendall, La Salle, Lee, Limestone, Matagorda, McCulloch,
Newton, Orange, Pecos, Polk, Red River, Reeves, Roberts, San
Augustine, Shelby, Titus, and Tyler Counties for emergency
protective measures (Category B), including direct federal
assistance, under the Public Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-3053 Filed 2-8-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: June 1, 2010 (Volume 75, Number 104)]
[Rules and Regulations]
[Page 30290-30292]
[DOCID:fr01jn10-11]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1156; Directorate Identifier 2009-NE-38-AD;
Amendment 39-16309; AD 2010-11-04]
RIN 2120-AA64

Airworthiness Directives; Teledyne Continental Motors (TCM) 240,
346, 360, 470, 520, and 550 Series and Rolls-Royce Motors, Ltd. (R-RM)
IO-240-A Reciprocating Engines

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is superseding an existing emergency airworthiness
directive (AD) 2009-24-52 that was sent previously to all known U.S.
owners and operators of TCM 240, 360, 470, 520, and 550 series
reciprocating engines. That AD requires before further flight,
replacing certain part number (P/N) hydraulic lifters. This AD results
from TCM reporting another occurrence of rapid wear on the face of
hydraulic lifters, P/Ns 657913, 657915, and 657916, and from the need
to expand the applicability of this AD to include the TCM 346 series
reciprocating engines and the R-RM IO-240-A reciprocating engines. We
are issuing this AD to prevent excessive hydraulic lifter wear, which
can result in loss of engine power and loss of control of the airplane.

DATES: This AD becomes effective June 16, 2010. The Director of the
Federal Register approved the incorporation by reference of certain
publications listed in the regulations as of June 16, 2010.
    We must receive any comments on this AD by August 2, 2010.

ADDRESSES: Use one of the following addresses to comment on this AD.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.

     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Contact Teledyne Continental Motors, Inc., P.O. Box 90, Mobile, AL
36601; telephone<PHONE_NUMBER>, or go to: http://tcmlink.com/
servicebulletins.cfm, for the service information identified in this
AD.

FOR FURTHER INFORMATION CONTACT: Anthony Holton, Aerospace Engineer,
Atlanta Certification Office, FAA, Small Airplane Directorate, 1701
Columbia Avenue, College Park, GA 30337; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On November 18, 2009, we issued emergency AD
2009-24-52, that applies to TCM 240, 360, 470, 520, and 550 series
reciprocating engines. That AD requires determining if hydraulic
lifters, P/Ns 657913, 657915, and 657916, are installed, and replacing
those lifters before further flight. That AD resulted from TCM
reporting three occurrences of rapid wear on the face of hydraulic
lifters, P/Ns 657913, 657915, and 657916, at five, six, and 38-hours
time-in-service (TIS), and from the need to add the TCM 550 series
reciprocating engines to the applicability.

Actions Since AD 2009-24-52 was Issued

    Since that AD was issued, we have received a report of excessive
wear at one-hour TIS. We also determined that we need to expand the
applicability of the AD to include the TCM 346 series engines and the
R-RM IO-240-A reciprocating engines.

Relevant Service Information

    We have reviewed and approved the technical contents of TCM
Mandatory Service Bulletin (MSB) No. MSB09-8A, dated December 4, 2009,
that describes procedures for inspecting and removing certain TCM
engine hydraulic lifters.

FAA's Determination and Requirements of This AD

    The unsafe condition described previously is likely to exist or
develop on other TCM 240, 346, 360, 470, 520, and 550 series and R-RM
IO-240-A reciprocating engines of the same type design. We are issuing
this AD to prevent excessive hydraulic lifter wear, which can result in
loss of engine power and loss of control of the airplane. This AD
requires replacing before further flight, hydraulic lifters, P/Ns
657913, 657915, and 657916. You must use the service information
described previously to perform the actions required by this AD.

FAA's Determination of the Effective Date

    Since an unsafe condition exists that requires the immediate
adoption of this AD, we have found that notice and opportunity for
public comment before issuing this AD are impracticable, and that good
cause exists for making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send us any written relevant data,
views, or arguments regarding this AD. Send your comments to an address
listed under ADDRESSES. Include ``AD Docket No. FAA-2009-1156;
Directorate Identifier 2009-NE-38-AD'' in the subject line of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify it.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of the
Web site, anyone can find and read the comments in any of our dockets,
including, if provided, the name of the individual who sent the comment
(or signed the comment on behalf of an association, business, labor
union, etc.). You may review the DOT's complete Privacy Act Statement
in the Federal Register published on April 11, 2000 (65 FR 19477-78).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
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 street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is the same as
the Mail address provided in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
subtitle VII, part A, subpart III, section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a summary of the costs to comply with this AD and
placed it in the AD Docket. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Under the authority delegated to me by the Administrator, the Federal
Aviation Administration amends part 39 of the Federal Aviation
Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2010-11-04 Teledyne Continental Motors (Formerly Continental and
Rolls-Royce Motors, Ltd.): Amendment 39-16309. Docket No. FAA-2009-
1156; Directorate Identifier 2009-NE-38-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective June 16,
2010.

Affected ADs

    (b) This AD supersedes AD 2009-24-52.

Applicability

    (c) This AD applies to all Teledyne Continental Motors (TCM)
240, 346, 360, 470, 520, and 550 series and Rolls-Royce Motors, Ltd.
(R-RM) IO-240-A reciprocating engines with hydraulic lifters, part
numbers (P/Ns) 657913, 657915, or 657916, installed. These engines
are installed on, but not limited to, general aviation airplanes.

Unsafe Condition

    (d) This AD results from TCM reporting another occurrence of
rapid wear on the face of hydraulic lifters, P/Ns 657913, 657915,
and 657916, and from the need to expand the applicability of this AD
to include the TCM 346 series engines and the R-RM IO-240-A
reciprocating engines. We are issuing this AD to prevent excessive
hydraulic lifter wear, which can result in loss of engine power and
loss of control of the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed before further flight after the effective date of this
AD, unless the actions have already been done.

Excluded Engines

    (f) If your engine was manufactured or rebuilt before June 19,
2009, and you have not had any hydraulic lifters replaced after June
19, 2009, no action is required.

Determining P/N of Lifters

    (g) If your engine was manufactured or rebuilt on or after June
19, 2009, or if any of your hydraulic lifters were replaced on or
after June 19, 2009, and you can't determine the P/N of your
hydraulic lifters from the engine records:
    (1) Use the list of engine serial numbers in Section A of TCM
Mandatory Service Bulletin (MSB) No. MSB09-8A, dated December 4,
2009.
    (2) Inspect the hydraulic lifters in each cylinder for P/Ns
657913, 657915, and 657916. Use TCM MSB No. MSB09-8A, dated December
4, 2009, Section I. Action Required, paragraphs 1. through 3. to
determine the P/N of the lifters.

Replacing the Lifters

    (h) If your engine has any affected hydraulic lifters, replace
the hydraulic lifters using TCM MSB No. MSB09-8A, dated December 4,
2009, Step 2, paragraphs 2.a.1) through 2.b.4).

Installation Prohibition

    (i) After the effective date of this AD, do not install any
hydraulic lifters, P/Ns 657913, 657915, or 657916, into any TCM 240,
346, 360, 470, 520, or 550 series or R-RM IO-240-A reciprocating
engine.

Alternative Methods of Compliance

    (j) The Manager, Atlanta Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Special Flight Permits

    (k) We will not approve any special flight permits.

Related Information

    (l) Contact Anthony Holton, Aerospace Engineer, Atlanta
Certification Office, FAA, Small Airplane Directorate, 1701 Columbia
Avenue, College Park, GA 30337; e-mail<EMAIL_ADDRESS>
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>, for more information
about this AD.

Material Incorporated by Reference

    (m) You must use Teledyne Continental Motors Mandatory Service
Bulletin No. MSB09-8A, dated December 4, 2009, to perform the
actions required by this AD. The Director of the Federal Register
approved the incorporation by reference of this service bulletin in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You can get a
copy from Teledyne Continental Motors, Inc., P.O. Box 90, Mobile, AL
36601; telephone<PHONE_NUMBER>, or go to: http://tcmlink.com/
servicebulletins.cfm. You may review copies at the FAA, New England
Region, 12 New England Executive Park, Burlington, MA; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.

    Issued in Burlington, Massachusetts, on May 12, 2010.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2010-12177 Filed 5-28-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61645-61646]
[FR Doc No: 2018-26035]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-3305]

Determination of Regulatory Review Period for Purposes of Patent
Extension; PROVAYBLUE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for PROVAYBLUE and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
human drug product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by January
29, 2019. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by May 29, 2019. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2016-E-3305 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; PROVAYBLUE.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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 Sec.  10.20 (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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, PROVAYBLUE
(methylene blue) indicated for the treatment of pediatric and adult
patients with acquired methemoglobinemia. Subsequent to this approval,
the USPTO received a patent term restoration application for PROVAYBLUE
(U.S. Patent No. 8,765,942) from Provepharm S.A.S. and the USPTO
requested FDA's assistance in determining the patent's eligibility for
patent term restoration. In a letter dated February 6, 2018, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of PROVAYBLUE
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
PROVAYBLUE is 415 days. Of this time, 232 days occurred during the
testing phase of the regulatory review period, while 183 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
February 20, 2015. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was February
20, 2015.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: October 9,
2015. FDA has verified the applicant's claim that the new drug
application (NDA) for PROVAYBLUE (NDA 204630) was initially submitted
on October 9, 2015.
    3. The date the application was approved: April 8, 2016. FDA has
verified the applicant's claim that NDA 204630 was approved on April 8,
2016.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 298 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26035 Filed 11-29-18; 8:45 am]
 BILLING CODE 4164-01-P