The Inspector General Act of 1978, as amended, created the Offices of Inspectors General as independent and objective units to conduct and supervise audits and investigations relating to Federal programs and operations. The Inspector General Reform Act of 2008, established the Council of the Inspectors General on Integrity and Efficiency (CIGIE) to address integrity, economy, and effectiveness issues that transcend individual Government agencies; and increase the professionalism and effectiveness of personnel by developing policies, standards, and approaches to aid in the establishment of a well-trained and highly skilled workforce in the Offices of Inspectors General. The CIGIE is an interagency council whose executive chair is the Deputy Director for Management, Office of Management and Budget, and is comprised principally of the 73 Inspectors General (IGs).

Under 5 U.S.C. 4314(c)(1)-(5), and in accordance with regulations prescribed by the Office of Personnel Management, each agency is required to establish one or more Senior Executive Service (SES) performance review boards. The purpose of these boards is to review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any recommendations to the appointing authority relative to the performance of the senior executive. The current members of the Council of the Inspectors General on Integrity and Efficiency Performance Review Board, as of October 1, 2011, are as follows:

The business meeting is open to the public. The following business will be conducted: (1) Welcome and roll call; (2) Approval of meeting minutes; (3) Review of approved projects; (4) review of next meeting purpose, location, and date; (5) Receive public comment. Persons who wish to bring related matters to the attention of the Committee may file written statements with the committee staff before or after the meeting. Public input sessions will be provided and individuals who made written requests by September 28, 2011 will have the opportunity to address the committee at these meetings.

Background

On March 29, 1995, the Department published the antidumping duty order on glycine from the PRC. See Antidumping Duty Order: Glycine From the People's Republic of China, 60 FR 16116 (March 29, 1995). On October 1, 2010, the Department initiated the third sunset review of the antidumping duty order on glycine from the PRC pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). See Initiation of Five-Year (“Sunset”) Review, 75 FR 60731 (October 1, 2010).

As a result of this sunset review, the Department determined that revocation of the antidumping duty order on glycine from the PRC would likely lead to continuation or recurrence of dumping and, therefore, notified the USITC of the magnitude of the margins likely to prevail should the order be revoked. See Notice of Final Results of Expedited Sunset Review of the Antidumping Duty Order: Glycine From the People's Republic of China, 76 FR 7150 (February 9, 2011) and accompanying Issues and Decision Memorandum.

On August 30, 2011, the USITC determined, pursuant to section 751(c) of the Act, that revocation of the antidumping duty order on glycine from the PRC would be likely to lead to a continuation or recurrence of material injury to an industry in the United Sates within a reasonably foreseeable time. See Glycine from China, 76 FR 55109 (September 6, 2011), and USITC Publication 4255 (August 2011), titled Glycine from China: Investigation No. 731-TA-718 (Third Review).

The product covered by the order is glycine, which is a free-flowing crystalline material, like salt or sugar. Glycine is produced at varying levels of purity and is used as a sweetener/taste enhancer, a buffering agent, reabsorbable amino acid, chemical intermediate, and a metal complexing agent. This order covers glycine of all purity levels. Glycine is currently classified under subheading 2922.49.4020 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the merchandise under the order is dispositive. 1

As a result of the determinations by the Department and the USITC that revocation of the antidumping duty order on glycine would be likely to lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, the Department hereby orders the continuation of the antidumping duty order on glycine from the PRC.

U.S. Customs and Border Protection will continue to collect antidumping duty cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of the continuation of this order will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act, the Department intends to initiate the next sunset review of this order not later than 30 days prior to the fifth anniversary of the effective date of continuation.

This five-year (sunset) review and this notice are in accordance with section 751(c) of the Act and published pursuant to section 777(i)(1) of the Act.

Background

On September 1, 2010, the Department published in the Federal Register a notice of opportunity to request an administrative review of the antidumping duty order on lined paper from the People's Republic of China (“PRC”), for the period September 1, 2009, through August 31, 2010. See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation: Opportunity To Request Administrative Review, 75 FR 53635 (September 1, 2010). On September 30, 2010, we received a request from petitioner  1 to review the following four companies: Shanghai Lian Li Paper Products Co., Ltd. (“Lian Li”), Hwa Fuh Plastics Co., Ltd./Li Teng Plastics (Shenzhen) Co., Ltd. (“Hwa Fuh/Li Teng”), 2 Leo's Quality Products Co., Ltd./Denmax Plastic Stationery Factory (“Leo/Denmax”); and the Watanabe Group (consisting of Watanabe Paper Products (Shanghai) Co., Ltd. (“Watanabe Shanghai”); Watanabe Paper Products (Linqing) Co., Ltd. (“Watanabe Linqing”); and Hotrock Stationery (Shenzhen) Co., Ltd. (“Hotrock Shenzhen”) (hereafter referred to as “Watanabe” or the “Watanabe Group”). On October 28, 2010, we published in the Federal Register the notice of initiation of this antidumping duty administrative review with respect to Lian Li, Leo/Denmax, and the Watanabe Group. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Request for Revocation in Part, 75 FR 66349 (October 28, 2010) (“ Initiation Notice” ).

On June 13, 2011, we preliminarily rescinded this review with respect to Leo/Denmax, Lian Li, and the Watanabe Group based on evidence on the record indicating that Leo/Denmax, Lian Li, and the Watanabe Group had no shipments of subject merchandise which entered the United States during the period September 1, 2009, through August 31, 2010. See Certain Lined Paper Products From the People's Republic of China; Notice of Preliminary Intent To Rescind the Antidumping Duty Administrative Review, 76 FR 34204 (June 13, 2011) (“ Preliminary Rescission” ). We invited interested parties to submit comments on our Preliminary Rescission. We did not receive any comments on our Preliminary Rescission.

The scope of this order includes certain lined paper products, typically school supplies (for purposes of this scope definition, the actual use of or labeling these products as school supplies or non-school supplies is not a defining characteristic) composed of or including paper that incorporates straight horizontal and/or vertical lines on ten or more paper sheets (there shall be no minimum page requirement for looseleaf filler paper) including but not limited to such products as single- and multi-subject notebooks, composition books, wireless notebooks, looseleaf or glued filler paper, graph paper, and laboratory notebooks, and with the smaller dimension of the paper measuring 6 inches to 15 inches (inclusive) and the larger dimension of the paper measuring 8 3/4 inches to 15 inches (inclusive). Page dimensions are measured size (not advertised, stated, or “tear-out” size), and are measured as they appear in the product ( i.e., stitched and folded pages in a notebook are measured by the size of the page as it appears in the notebook page, not the size of the unfolded paper). However, for measurement purposes, pages with tapered or rounded edges shall be measured at their longest and widest points. Subject lined paper products may be loose, packaged or bound using any binding method (other than case bound through the inclusion of binders board, a spine strip, and cover wrap). Subject merchandise may or may not contain any combination of a front cover, a rear cover, and/or backing of any composition, regardless of the inclusion of images or graphics on the cover, backing, or paper. Subject merchandise is within the scope of this order whether or not the lined paper and/or cover are hole punched, drilled, perforated, and/or reinforced. Subject merchandise may contain accessory or informational items including but not limited to pockets, tabs, dividers, closure devices, index cards, stencils, protractors, writing implements, reference materials such as mathematical tables, or printed items such as sticker sheets or miniature calendars, if such items are physically incorporated, included with, or attached to the product, cover and/or backing thereto. Specifically excluded from the scope of this order are:

• Unlined copy machine paper;

• Writing pads with a backing (including but not limited to products commonly known as “tablets,” “note pads,” “legal pads,” and “quadrille pads”), provided that they do not have a front cover (whether permanent or removable). This exclusion does not apply to such writing pads if they consist of hole-punched or drilled filler paper;

• Three-ring or multiple-ring binders, or notebook organizers incorporating such a ring binder provided that they do not include subject paper;

• Index cards;

• Printed books and other books that are case bound through the inclusion of binders board, a spine strip, and cover wrap;

• Newspapers;

• Pictures and photographs;

• Desk and wall calendars and organizers (including but not limited to such products generally known as “office planners,” “time books,” and “appointment books”);

• Telephone logs;

• Address books;

• Columnar pads & tablets, with or without covers, primarily suited for the recording of written numerical business data;

• Lined business or office forms, including but not limited to: pre-printed business forms, lined invoice pads and paper, mailing and address labels, manifests, and shipping log books;

• Lined continuous computer paper;

• Boxed or packaged writing stationary (including but not limited to products commonly known as “fine business paper,” “parchment paper”, and “letterhead”), whether or not containing a lined header or decorative lines;

• Stenographic pads (“steno pads”), Gregg ruled (“Gregg ruling” consists of a single- or double-margin vertical ruling line down the center of the page. For a six-inch by nine-inch stenographic pad, the ruling would be located approximately three inches from the left of the book.), measuring 6 inches by 9 inches;

Also excluded from the scope of this order are the following trademarked products:

• Fly TM lined paper products: A notebook, notebook organizer, loose or glued note paper, with papers that are printed with infrared reflective inks and readable only by a Fly TM pen-top computer. The product must bear the valid trademark Fly TM (products found to be bearing an invalidly licensed or used trademark are not excluded from the scope).

• Zwipes TM : A notebook or notebook organizer made with a blended polyolefin writing surface as the cover and pocket surfaces of the notebook, suitable for writing using a specially-developed permanent marker and erase system (known as a Zwipes TM pen). This system allows the marker portion to mark the writing surface with a permanent ink. The eraser portion of the marker dispenses a solvent capable of solubilizing the permanent ink allowing the ink to be removed. The product must bear the valid trademark Zwipes TM (products found to be bearing an invalidly licensed or used trademark are not excluded from the scope).

• FiveStar®Advance TM : A notebook or notebook organizer bound by a continuous spiral, or helical, wire and with plastic front and rear covers made of a blended polyolefin plastic material joined by 300 denier polyester, coated on the backside with PVC (poly vinyl chloride) coating, and extending the entire length of the spiral or helical wire. The polyolefin plastic covers are of specific thickness; front cover is 0.019 inches (within normal manufacturing tolerances) and rear cover is 0.028 inches (within normal manufacturing tolerances). Integral with the stitching that attaches the polyester spine covering, is captured both ends of a 1″ wide elastic fabric band. This band is located 2 3/8 ″ from the top of the front plastic cover and provides pen or pencil storage. Both ends of the spiral wire are cut and then bent backwards to overlap with the previous coil but specifically outside the coil diameter but inside the polyester covering. During construction, the polyester covering is sewn to the front and rear covers face to face (outside to outside) so that when the book is closed, the stitching is concealed from the outside. Both free ends (the ends not sewn to the cover and back) are stitched with a turned edge construction. The flexible polyester material forms a covering over the spiral wire to protect it and provide a comfortable grip on the product. The product must bear the valid trademarks FiveStar® Advance TM (products found to be bearing an invalidly licensed or used trademark are not excluded from the scope).

• FiveStar Flex TM : A notebook, a notebook organizer, or binder with plastic polyolefin front and rear covers joined by 300 denier polyester spine cover extending the entire length of the spine and bound by a 3-ring plastic fixture. The polyolefin plastic covers are of a specific thickness; front cover is 0.019 inches (within normal manufacturing tolerances) and rear cover is 0.028 inches (within normal manufacturing tolerances). During construction, the polyester covering is sewn to the front cover face to face (outside to outside) so that when the book is closed, the stitching is concealed from the outside. During construction, the polyester cover is sewn to the back cover with the outside of the polyester spine cover to the inside back cover. Both free ends (the ends not sewn to the cover and back) are stitched with a turned edge construction. Each ring within the fixture is comprised of a flexible strap portion that snaps into a stationary post which forms a closed binding ring. The ring fixture is riveted with six metal rivets and sewn to the back plastic cover and is specifically positioned on the outside back cover. The product must bear the valid trademark FiveStar Flex TM (products found to be bearing an invalidly licensed or used trademark are not excluded from the scope).

Merchandise subject to this order is typically imported under headings 4810.22.5044, 4811.90.9050, 4820.10.2010, 4820.10.2020, 4820.10.2030, 4820.10.2040, 4820.10.2060, and 4820.10.4000 of the Harmonized Tariff Schedule of the United States (“HTSUS”). The HTSUS headings are provided for convenience and customs purposes; however, the written description of the scope of this order is dispositive.

The POR is September 1, 2009, through August 31, 2010.

Because there is no information on the record which indicates that the Watanabe Group, Lian Li, and Leo/Denmax made shipments of subject merchandise which entered the United States during the POR, and because we did not receive any comments on our Preliminary Rescission, in accordance with 19 CFR 351.213(d)(3) and consistent with our practice, we are rescinding this review of the antidumping duty order on certain lined paper products from the PRC for the period of September 1, 2009, through August 31, 2010. The cash deposit rate for the Watanabe Group, Lian Li, and Leo/Denmax will continue to be the rate established in the most recently completed segment of this proceeding.

The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(2). The Department will issue appropriate assessment instructions directly to CBP 15 days after publication of this notice.

This notice serves as a final reminder to importers for whom this review is being rescinded, as of the publication date of this notice, of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of double antidumping duties.

This notice also serves as a reminder to parties subject to administrative protective orders (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

On June 8, 2011, the Department published the preliminary results of administrative review of the antidumping duty order covering light-walled rectangular pipe and tube from Turkey. See Preliminary Results. The respondent subject to this review is Noksel Celik Boru Sanayi A.S., (Noksel). The petitioners in this proceeding are Atlas Tube, Inc. and Searing Industries, Inc. (collectively, Petitioners).

In the Preliminary Results, the Department stated that interested parties were to submit case briefs within 30 days of publication of the Preliminary Results and rebuttal briefs within five days after the due date for filing case briefs. See Preliminary Results, 76 FR at 33204. No interested party submitted briefs. We have made no changes for the final results.

The period of review (POR) is May 1, 2009, through April 30, 2010.

The merchandise subject to this order is certain welded carbon quality light-walled steel pipe and tube, of rectangular (including square) cross section, having a wall thickness of less than 4 mm. The term carbon-quality steel includes both carbon steel and alloy steel which contains only small amounts of alloying elements. Specifically, the term carbon-quality includes products in which none of the elements listed below exceeds the quantity by weight respectively indicated: 1.80 percent of manganese, or 2.25 percent of silicon, or 1.00 percent of copper, or 0.50 percent of aluminum, or 1.25 percent of chromium, or 0.30 percent of cobalt, or 0.40 percent of lead, or 1.25 percent of nickel, or 0.30 percent of tungsten, or 0.10 percent of molybdenum, or 0.10 percent of niobium, or 0.15 percent vanadium, or 0.15 percent of zirconium. The description of carbon-quality is intended to identify carbon-quality products within the scope. The welded carbon-quality rectangular pipe and tube subject to this order is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7306.61.50.00 and 7306.61.70.60. While HTSUS subheadings are provided for convenience and U.S. Customs and Border Protection (CBP) purposes, our written description of the scope of the order is dispositive.

The Department has determined that the following margins exist for the period May 1, 2009, through April 30, 2010:

Pursuant to these final results, the Department has determined, and CBP shall assess, antidumping duties on all appropriate entries. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of these final results. Pursuant to 19 CFR 351.212(b)(1), we calculated importer-specific (or customer-specific) ad valorem duty assessment rates based on the ratio of the total amount of the dumping margins calculated for the examined sales to the total entered value of those same sales. We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review if any importer-specific (or customer-specific) assessment rate calculated in the final results of this review is above de minimis.

The Department clarified its “automatic assessment” regulation on May 6, 2003. See Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003) ( Assessment of Antidumping Duties). This clarification will apply to entries of subject merchandise during the POR produced by Noksel for which Noksel did not know the merchandise was destined for the United States. In such instances, we will instruct CBP to liquidate un-reviewed entries at the 27.04 percent all-others rate from the less than fair value (LTFV) investigation if there is no company-specific rate for an intermediary involved in the transaction. See Notice of Antidumping Duty Order: Light-Walled Rectangular Pipe and Tube From Turkey, 73 FR 31065 (May 30, 2008). See Assessment of Antidumping Duties for a full discussion of this clarification.

Furthermore, the following deposit requirements will be effective upon completion of the final results of this administrative review for all shipments of light-walled rectangular pipe and tube from Turkey entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(c) of the Tariff Act of 1930, as amended (the Act): (1) The cash deposit rate for Noksel will be the rate established in the final results of review; (2) if the exporter is not a firm covered in this review or the LTFV investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (3) if neither the exporter nor the manufacturer is a firm covered in this or any previous review conducted by the Department, the cash deposit rate will be the all-others rate 27.04 percent ad valorem from the LTFV investigation. Id. These deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i) of the Act.

Recruitment for this Mission began at the end of June, and some pending applicants have indicated a need to finalize their schedules and travel arrangements for upcoming holidays and end of fiscal 2011 year financial reports. Rather than wait until after the October 17, 2011 deadline to vet all applicants and make selection decisions, CS is amending the Notice to allow for vetting and selection decisions on a rolling basis beginning September 1, 2011, until the maximum of 20 participants is selected. Although applications will be accepted through October 17th (and after that date if space remains and scheduling constraints permit), interested U.S. renewable energy firms and trade organizations which have not already submitted an application are encouraged to do so as soon as possible.

1. For the reasons stated above, the Timeframe for Recruitment and Applications section of the Notice of the Renewable Energy and Energy Efficiency Executive Business Development Mission, 76 FR, No. 140, July 21, 2011, is amended to read as follows:

Mission recruitment will be conducted in an open and public manner, including publication in the Federal Register , posting on the Commerce Department trade mission calendar ( http://export.gov/trademissions ) and other Internet Web sites, press releases to general and trade media, direct mail, notices by industry trade associations and other multiplier groups, and publicity at industry meetings, symposia, conferences, and trade shows. Recruitment for this mission will conclude no later than October 17, 2011. The U.S. Department of Commerce will review applications and make selection decisions on a rolling basis beginning August 31, 2011. We will inform all applicants of selection decisions on a rolling basis. Applications received after the October 17 deadline will be considered only if space and scheduling constraints permit.

The proposed action evaluated in the April 2009 Final EIS/EIR consisted of the demolition of Buildings B and C and the construction of a new SWFSC building on a property across La Jolla Shores Drive from the existing NOAA facilities. Currently, construction of the SWFSC building at the preferred site is underway. Demolition of Buildings B and C at the existing NOAA property would not occur until construction of the new SWFSC building has been completed.

A Notice of Intent to prepare SEIS was published in the Federal Register on June 30, 2011. Consistent with 40 CFR 1502.9(c)(1)(i), this SEIS focuses on the environmental effects of the proposed changes and feasible alternatives including the no-action alternative, and analyzes the potential effects to affected resources such as: geological conditions, hydraulic processes, construction noise, traffic/pedestrian circulation, air emissions, and protected wildlife. Separately, the University of California—San Diego (UCSD) and UCOP intend to determine what additional CEQA documentation is necessary, such as an Addendum to the Final EIS/EIR, based on the findings of the SEIS and other factors.

NOAA has submitted the Draft SEIS to the U.S. Environmental Protection Agency for review and comment, in conformance with NEPA implementing regulations. Copies of this document have been made available to persons who participated in the Final EIS/EIR scoping process, to other individuals expressing interest, and to local libraries in order to be accessible to the general public. NOAA is accepting comments on the Draft SEIS during a 45-day official comment period beginning September 19, 2011, and ending on October 31, 2011.

On August 27, 2009, an Endangered Species Act (ESA) biological opinion was completed that evaluated the impacts of the continued authorization of the trap component of the spiny lobster commercial sector on ESA-listed species. The opinion prescribed non-discretionary reasonable and prudent measures (RPMs) to help minimize the impacts of takes to ESA-listed species by the trap component of the spiny lobster commercial sector. Specific terms and conditions required to implement the prescribed RPMs included creating new or expanding existing closed areas to protect coral and implementing lobster trap line-marking requirements. A September 2, 2011, memo revised the 5-year phase-in period for the line-marking requirement to 5 years from implementation of the planned final rule or no later than August 6, 2017. The Councils are considering alternatives to meet these requirements.

Actions and alternatives to address these measures were included in Amendment 10 to the Spiny Lobster FMP. However, the Councils felt more time was needed to work with stakeholders in developing management measures. NMFS, in collaboration with the Councils, will develop a SEIS for Amendment 11 to describe and analyze alternatives to address the management needs described above. The alternatives will include a “no action” alternative regarding each action.

In accordance with NOAA's Administrative Order 216-6, Section 5.02(c), Scoping Process, NMFS, in collaboration with the Councils, has identified preliminary environmental issues as a means to initiate discussion for scoping purposes only. These preliminary issues may not represent the full range of issues that eventually will be evaluated in the SEIS.

Copies of an information packet will be available from NMFS (see ADDRESSES ).

After the draft SEIS associated with Amendment 11 is completed, it will be filed with the Environmental Protection Agency (EPA). After filing, the EPA will publish a notice of availability of the draft SEIS for public comment in the Federal Register . The draft SEIS will have a 45-day public comment period. This procedure is pursuant to regulations issued by the Council on Environmental Quality (CEQ) for implementing the procedural provisions of the National Environmental Policy Act (NEPA; 40 CFR parts 1500-1508) and to NOAA's Administrative Order 216-6 regarding NOAA's compliance with NEPA and the CEQ regulations.

NMFS will consider public comments received on the draft SEIS in developing the final SEIS and before adopting final management measures for the amendment. NMFS will submit both the final amendment and the supporting SEIS to the Secretary of Commerce (Secretary) for review as required by the Magnuson-Stevens Fishery Conservation and Management Act.

NMFS will announce, through a notification in the Federal Register , the availability of the final amendment for public review during the Department of Commerce Secretarial review period. During Secretarial review, NMFS will also file the final SEIS with the EPA and the EPA will publish a notice of availability for the final SEIS in the Federal Register . This public comment period is expected to be concurrent with the Secretarial review period and will end prior to final agency action to approve, disapprove, or partially approve the amendment.

NMFS will announce, through a document published in the Federal Register , all public comment periods on the final amendment, its proposed implementing regulations, and the availability of its associated final SEIS. NMFS will consider all public comments received during the Secretarial review period, whether they are on the final amendment, the proposed regulations, or the final SEIS, prior to final agency action.

Under the Magnuson-Stevens Reauthorized Act, the SSC is the body responsible for reviewing the Council's scientific materials. The SEP sub-pane reviews social and economic information and reports its findings to the SSC. The SEP will discuss FMP amendments that are under development and the role of social and economic sciences in the Council process. The SSC will discuss FMP amendments under development, assessments of black sea bass and tilefish, review advancements in ABC control rule development, review planning information for assessments of Spanish mackerel and cobia to be developed in 2013, and discuss the findings of the National SSC workshop.

November 7, 2011, 1 p.m.-5 p.m.

November 8, 2011, 9 a.m.-6 p.m.

November 9, 2011, 9 a.m.-6 p.m.

November 10, 2011, 9 a.m.-3 p.m.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see ADDRESSES ) at least 3 business days prior to the meeting.

Background

Section 101(a)(5)(D) of the Marine Mammal Protect Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ) directs the Secretary of Commerce to authorize, upon request, the incidental, but not intentional, taking of small numbers of marine mammals of a species or population stock, by United States citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

Authorization for the incidental taking of small numbers of marine mammals shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), and will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant). The authorization must set forth the permissible methods of taking, other means of effecting the least practicable adverse impact on the species or stock and its habitat, and requirements pertaining to the mitigation, monitoring and reporting of such takings. NMFS has defined “negligible impact” in 50 CFR 216.103 as “* * * an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the United States can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) of the MMPA establishes a 45-day time limit for NMFS' review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of small numbers of marine mammals. Within 45 days of the close of the public comment period, NMFS must either issue or deny the authorization. NMFS must publish a notice in the Federal Register within 30 days of its determination to issue or deny the authorization.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as:

NMFS received an application on June 17, 2011, from L-DEO for the taking by harassment, of marine mammals, incidental to conducting a marine geophysical survey in the central tropical Pacific Ocean in international waters. L-DEO, with research funding from the U.S. National Science Foundation (NSF), plans to conduct the proposed survey from November 26, 2011, through December 29, 2011. Upon receipt of additional information, NMFS determined the application complete and adequate on August 26, 2011.

L-DEO plans to use one source vessel, the R/V Marcus G. Langseth ( Langseth ) and a seismic airgun array to image the structure of the oceanic lithosphere ( i.e., the Earth's crust and the uppermost mantle) in the Central Pacific using three-dimensional (3-D) seismic reflection techniques. The Langseth will deploy a single hydrophone streamer and approximately 34 short-period Ocean Bottom Seismometers (OBS) to collect geophysical data. After completion of the seismic survey, the Langseth will recover the 34 seismometers and deploy 27 broad-band OBSs and five magneto-telluric instruments on the seafloor. These instruments will remain on the seafloor for 12 months and the scientists will recover these instruments on a subsequent cruise in 2012.

In addition to the proposed operations of the seismic airgun array, L-DEO intends to operate a multibeam echosounder (MBES) and a sub-bottom profiler (SBP) continuously throughout the survey.

Acoustic stimuli ( i.e., increased underwater sound) generated during the operation of the seismic airgun array, may have the potential to cause a short-term behavioral disturbance for marine mammals in the survey area. This is the principal means of marine mammal taking associated with these activities and L-DEO has requested an authorization to take 20 species of marine mammals by Level B harassment. Take is not expected to result from the use of the MBES, the SBP, the OBSs, or the magneto-telluric instruments for reasons discussed in this notice. Also, NMFS does not expect take to result from collision with the Langseth because it is a single vessel moving at a relatively slow speeds during seismic acquisition within the survey, for a relatively short period of time. It is likely that any marine mammal would be able to avoid the vessel.

L-DEO's proposed seismic survey is scheduled to commence on November 26, 2011, and continue for approximately 35 days ending on December 29, 2011. Some minor deviation from these dates is possible, depending on logistics, weather conditions, and the need to repeat some lines if data quality is substandard. Therefore, NMFS proposes to issue an authorization that extends to January 19, 2012.

Within this time period, the Langseth will conduct seismic operations deploying a 36-airgun array, a 6-kilometer (km) hydrophone streamer, and 34 OBSs. The Langseth will depart from Honolulu, Hawai'i on November 26, 2011 and transit to the survey area in the central Pacific Ocean, approximately 1,300 kilometers (km) south of Hawai'i.

Geophysical survey activities will involve 3-D seismic methodologies to define the detailed structure of the oceanic lithosphere and to develop a comprehensive theory on its formation and evolution. To obtain 3-D images of the lithosphere in the survey area, the Langseth will deploy a 36-airgun array as an energy source. The receiving system consists of one 6-km-long hydrophone streamer and approximately 34 OBSs. As the airgun array is towed along the survey lines, the hydrophone streamers will receive the returning acoustic signals and transfer the data to the on-board processing system. The OBSs will receive the returning acoustic signals and record them for internally for later analysis after retrieval from the seafloor.

The proposed study ( e.g., equipment testing, startup, line changes, repeat coverage of any areas, and equipment recovery) will take place in water depths of approximately 5,000 meters (m) (3.1 miles (mi)). The survey will require approximately 11 days (d) to complete approximately 2,120 km (1,317.3 mi) of transect lines. The Langseth will shoot a 600-km long transect line twice; once using the hydrophone streamer as the receiver and once again using the OBSs. Subsequent seismic operations will occur along two semi-circular arcs (180 degrees) centered at the mid-point of the 600-km long transect line with radii of 50 and 150 km, respectively. The Langseth will conduct additional seismic operations in the survey area associated with turns, airgun testing, and repeat coverage of any areas where the initial data quality is sub-standard. Data acquisition will include approximately 264 hours (hr) of airgun operation (11d × 24 hr).

The scientific team for this survey consists of Drs. J.B. Gaherty (L-DEO); D. Lizarralde, J.A. Collins, and R. Evans (Woods Hole Oceanographic Institution); and G. Hirth (Brown University).

The Langseth, owned by NSF, is a seismic research vessel with a propulsion system designed to be as quiet as possible to avoid interference with the seismic signals emanating from the airgun array. The vessel, which has a length of 71.5 m (235 feet (ft)); a beam of 17.0 m (56 ft); a maximum draft of 5.9 m (19 ft); and a gross tonnage of 3,834 pounds, is powered by two 3,550 horsepower (hp) Bergen BRG-6 diesel engines which drive two propellers. Each propeller has four blades and the shaft typically rotates at 750 revolutions per minute. The vessel also has an 800-hp bowthruster, which is not used during seismic acquisition. The Langseth's operation speed during seismic acquisition will be approximately 8.5 km per hr (km/h) (5.3 miles (mi) per hr (mph) or 4.6 knots (kts)) and the cruising speed of the vessel outside of seismic operations is 18.5 km/h (11.5 mph or 10 kts).

When the Langseth is towing the airgun array and the hydrophone streamer, the turning rate of the vessel is limited to five degrees per minute. Thus, the maneuverability of the vessel is limited during operations with the streamer.

The vessel also has an observation tower from which protected species visual observers (PSVO) will watch for marine mammals before and during the proposed airgun operations. When stationed on the observation platform, the PSVO's eye level will be approximately 21.5 m (71 ft) above sea level providing the PSVO an unobstructed view around the entire vessel.

The Langseth will deploy a 36-airgun array, with a total volume of approximately 6,600 cubic inches (in 3 ) at a tow depth of 9 m (29.5 ft). The airguns are a mixture of Bolt 1500LL and Bolt 1900LLX airguns ranging in size from 40 to 360 in 3 , with a firing pressure of 1,900 pounds per square inch. The dominant frequency components range from zero to 188 Hertz (Hz). The array configuration consists of four identical linear or strings, with 10 airguns on each string; the first and last airguns will be spaced 16 m (52 ft) apart. Of the 10 airguns, nine will fire simultaneously while the tenth airgun will serve as a spare and will be turned on in case of failure of one of the other airguns. During the multichannel seismic (MCS) survey, each airgun array will emit a pulse at approximately 22-second (s) intervals which corresponds to a shot interval of approximately 50 m (164 ft). During OBS data acquisition, each airgun array will emit a longer pulse at approximately 300-s intervals which corresponds to a shot interval of approximately 650 m (2,132.5 ft). During firing, the airguns will emit a brief (approximately 0.1 s) pulse of sound; during the intervening periods of operations, the airguns will be silent.

L-DEO will tow each array approximately 100 m (328 ft) behind the vessel and will distribute the array across an area of approximately 24 by 16 m (78.7 by 52.5 ft) behind the Langseth.

This section includes a brief explanation of the sound measurements frequently used in the discussions of acoustic effects in this document. Sound pressure is the sound force per unit area, and is usually measured in micropascals (μPa), where 1 pascal (Pa) is the pressure resulting from a force of one newton exerted over an area of one square meter. Sound pressure level (SPL) is expressed as the ratio of a measured sound pressure and a reference level. The commonly used reference pressure level in underwater acoustics is 1 μPa, and the units for SPLs are dB re: 1 μPa.

SPL is an instantaneous measurement and can be expressed as the peak, the peak-peak (p-p), or the root mean square (rms). Root mean square, which is the square root of the arithmetic average of the squared instantaneous pressure values, is typically used in discussions of the effects of sounds on vertebrates and all references to SPL in this document refer to the root mean square unless otherwise noted. SPL does not take the duration of a sound into account.

Airguns function by venting high-pressure air into the water which creates an air bubble. The pressure signature of an individual airgun consists of a sharp rise and then fall in pressure, followed by several positive and negative pressure excursions caused by the oscillation of the resulting air bubble. The oscillation of the air bubble transmits sounds downward through the seafloor and the amount of sound transmitted in the near horizontal directions is reduced. However, the airgun array also emits sounds that travel horizontally toward non-target areas.

The nominal source levels of the airgun array used by L-DEO on the Langseth is 236 to 265 dB re: 1 μPa (p-p) and the rms value for a given airgun pulse is typically 16 dB re: 1 μPa lower than the peak-to-peak value. However, the difference between rms and peak or peak-to-peak values for a given pulse depends on the frequency content and duration of the pulse, among other factors.

Accordingly, L-DEO has predicted the received sound levels in relation to distance and direction from the 36-airgun array and the single Bolt 1900LL 40-in 3 airgun, which will be used during power downs. A detailed description of L-DEO's modeling for marine seismic source arrays for species mitigation is provided in Appendix A of L-DEO's application. These are the nominal source levels applicable to downward propagation. The effective source levels for horizontal propagation are lower than those for downward propagation because of the directional nature of the sound from the airgun array.

Appendix B of L-DEO's environmental analysis discusses the characteristics of the airgun pulses. NMFS refers the reviewers to the application and environmental analysis documents for additional information.

Tolstoy et al., (2009) reported results for propagation measurements of pulses from the Langseth's 36-airgun, 6,600 in 3 array in shallow-water (approximately 50 m (164 ft)) and deep-water depths (approximately 1,600 m (5,249 ft)) in the Gulf of Mexico in 2007 and 2008. Results of the Gulf of Mexico calibration study (Tolstoy et al., 2009) showed that radii around the airguns for various received levels varied with water depth and with array tow depth.

L-DEO used the results from the Gulf of Mexico study to determine the algorithm for its model that calculates the exclusion zones (EZ) for the 36-airgun array and the single airgun. L-DEO uses these values to designate mitigation zones and to estimate take (described in greater detail in Section VII of L-DEO's application and Section IV of the environmental analysis) for marine mammals.

Comparison of the Tolstoy et al. calibration study with L-DEO's model for the Langseth's 36-airgun array indicated that the model represents the actual received levels, within the first few kilometers, where the predicted exclusions zones are located. However, the model for deep water (greater than 1,000 m; 3,280 ft) overestimated the received sound levels at a given distance but is still valid for defining exclusion zones at various tow depths. Because the tow depth of the array in the calibration study is less shallow (3 m; 9.8 ft) than the tow depth array in the proposed survey (9 m; 29.5 ft), L-DEO used correction factors for estimating the received levels in deep water during the proposed survey. The correction factors used were the ratios of the 160- and 180-dB distances from the modeled results for the 6,600 in 3 airgun array towed at 6 m (19.7 ft) versus 9 m (29.5 ft) from LGL (2008); 1.285 and 1.3381 respectively.

Table 1 summarizes the predicted distances at which sound levels (160- and 180-dB) are expected to be received from the 36-airgun array and a single airgun operating in deep water.

Appendix A of the environmental analysis discusses L-DEO's calculations for the model. NMFS refers the reviewers to the application and environmental analysis documents for additional information.

L-DEO proposes to use the Woods Hole Oceanographic Institution (WHOI) “D2” OBS during the cruise. This type of OBS is approximately one meter in height and has a maximum diameter of 50 centimeters (cm). The anchor (2.5 × 30.5 × 38.1 cm) is made of hot-rolled steel and weighs 23 kilograms (kg). The acoustic release transponder used to communicate with the OBS uses frequencies of 9 to 13 kHz. The source level of the release signal is 190 dB re: 1 μPa.

The Langseth will operate a Kongsberg EM 122 MBES concurrently during airgun operations to map characteristics of the ocean floor. The hull-mounted MBES emits brief pulses of sound (also called a ping) (10.5 to 13 kilohertz (kHz)) in a fan-shaped beam that extends downward and to the sides of the ship. The transmitting beamwidth is one or two degrees (°) fore-aft and 150° athwartship and the maximum source level is 242 dB re: 1 μPa.

For deep-water operations, each ping consists of eight (in water greater than 1,000 m; 3,280 ft) or four (less than 1,000 m; 3,280 ft) successive, fan-shaped transmissions, from two to 15 milliseconds (ms) in duration and each ensonifying a sector that extends 1° fore-aft. Continuous wave pulses increase from two to 15 milliseconds (ms) long in water depths up to 2,600 m (8,530 ft). The MBES uses frequency-modulated chirp pulses up to 100-ms long in water greater than 2,600 m (8,530 ft). The eight successive transmissions span an overall cross-track angular extent of about 150°, with 2-ms gaps between the pulses for successive sectors.

The Langseth will also operate a Knudsen Chirp 3260 SBP concurrently during airgun and MBES operations to provide information about the sedimentary features and bottom topography. The SBP is capable of reaching depths of 10,000 m (6.2 mi). The dominant frequency component of the SBP is 3.5 kHz which is directed downward in a 27° cone by a hull-mounted transducer on the vessel. The nominal power output is 10 kilowatts (kW), but the actual maximum radiated power is three kW or 222 dB re: 1 μPa. The ping duration is up to 64 ms with a pulse interval of one second, but a common mode of operation is to broadcast five pulses at 1-s intervals followed by a 5-s pause.

NMFS expects that acoustic stimuli resulting from the proposed operation of the single airgun or the 36-airgun array has the potential to harass marine mammals, incidental to the conduct of the proposed seismic survey. NMFS expects these disturbances to be temporary and result in a temporary modification in behavior and/or low-level physiological effects (Level B harassment only) of small numbers of certain species of marine mammals. NMFS does not expect that the movement of the Langseth, during the conduct of the seismic survey, has the potential to harass marine mammals because of the relatively slow operation speed of the vessel (4.6 kts; 8.5 km/hr; 5.3 mph) during seismic acquisition.

The survey will encompass the area bounded by 5-10° N, 150-156° W in international waters in the central Pacific Ocean (see Figure 1 in L-DEO's application). Water depth in the survey area is approximately 5,000 m (3.1 mi).

Twenty-six marine mammal species may occur in the proposed survey area, including 19 odontocetes (toothed cetaceans), 6 mysticetes (baleen whales) and one species of pinniped during November through December. Six of these species are listed as endangered under the U.S. Endangered Species Act of 1973 (ESA; 16 U.S.C. 1531 et seq. ), including the humpback ( Megaptera novaeangliae ), sei ( Balaenoptera borealis ), fin ( Balaenoptera physalus ), blue ( Balaenoptera musculus ), and sperm ( Physeter macrocephalus ) whale and the Hawaiian monk seal ( Monachus schauinslandi ).

Hawaiian monk seals have the potential to transit in the vicinity of the proposed seismic survey, although any occurrence would be rare as they are vagrants to the area. Based on available data, L-DEO does not expect to encounter Hawaiian monk seals within the proposed survey area and does not present analysis for these species. Accordingly, NMFS will not consider this pinniped species in greater detail and the proposed IHA will only address requested take authorizations for mysticetes and odontocetes.

The species of marine mammals expected to be most common in the survey area (all delphinids) include the pantropical spotted dolphin ( Stenella attenuata ) and spinner dolphin ( Stenella longirostris ).

Table 2 presents information on the abundance, distribution, and conservation status of the marine mammals that may occur in the proposed survey area November, 2011 through January, 2012.

Refer to Sections III and IV of L-DEO's application for detailed information regarding the abundance and distribution, population status, and life history and behavior of these species and their occurrence in the proposed project area. The application also presents how L-DEO calculated the estimated densities for the marine mammals in the proposed survey area. NMFS has reviewed these data and determined them to be the best available scientific information for the purposes of the proposed IHA.

Acoustic stimuli generated by the operation of the airguns, which introduce sound into the marine environment, may have the potential to cause Level B harassment of marine mammals in the proposed survey area. The effects of sounds from airgun operations might include one or more of the following: Tolerance, masking of natural sounds, behavioral disturbance, temporary or permanent impairment, or non-auditory physical or physiological effects (Richardson et al., 1995; Gordon et al., 2004; Nowacek et al., 2007; Southall et al., 2007).

Permanent hearing impairment, in the unlikely event that it occurred, would constitute injury, but temporary threshold shift (TTS) is not an injury (Southall et al., 2007). Although the possibility cannot be entirely excluded, it is unlikely that the proposed project would result in any cases of temporary or permanent hearing impairment, or any significant non-auditory physical or physiological effects. Based on the available data and studies described here, some behavioral disturbance is expected, but NMFS expects the disturbance to be localized and short-term.

Studies on marine mammals' tolerance to sound in the natural environment are relatively rare. Richardson et al. (1995) defines tolerance as the occurrence of marine mammals in areas where they are exposed to human activities or man-made noise. In many cases, tolerance develops by the animal habituating to the stimulus ( i.e., the gradual waning of responses to a repeated or ongoing stimulus) (Richardson et al., 1995; Thorpe, 1963), but because of ecological or physiological requirements, many marine animals may need to remain in areas where they are exposed to chronic stimuli (Richardson et al., 1995).

Numerous studies have shown that pulsed sounds from airguns are often readily detectable in the water at distances of many kilometers. Malme et al., (1985) studied the responses of humpback whales on their summer feeding grounds in southeast Alaska to seismic pulses from an airgun with a total volume of 100-in 3 . They noted that the whales did not exhibit persistent avoidance when exposed to the airgun and concluded that there was no clear evidence of avoidance, despite the possibility of subtle effects, at received levels up to 172 dB: re 1 μPa.

Weir (2008) observed marine mammal responses to seismic pulses from a 24-airgun array firing a total volume of either 5,085 in 3 or 3,147 in 3 in Angolan waters between August 2004 and May 2005. She recorded a total of 207 sightings of humpback whales (n = 66), sperm whales (n = 124), and Atlantic spotted dolphins (n = 17) and reported that there were no significant differences in encounter rates (sightings/hr) for humpback and sperm whales according to the airgun array's operational status ( i.e., active versus silent).

The term masking refers to the inability of a subject to recognize the occurrence of an acoustic stimulus as a result of the interference of another acoustic stimulus (Clark et al., 2009). Introduced underwater sound may, through masking, reduce the effective communication distance of a marine mammal species if the frequency of the source is close to that used as a signal by the marine mammal, and if the anthropogenic sound is present for a significant fraction of the time (Richardson et al., 1995).

Masking effects of pulsed sounds (even from large arrays of airguns) on marine mammal calls and other natural sounds are expected to be limited. Because of the intermittent nature and low duty cycle of seismic airgun pulses, animals can emit and receive sounds in the relatively quiet intervals between pulses. However, in some situations, reverberation occurs for much or the entire interval between pulses ( e.g., Simard et al., 2005; Clark and Gagnon, 2006) which could mask calls. Some baleen and toothed whales are known to continue calling in the presence of seismic pulses, and their calls can usually be heard between the seismic pulses ( e.g., Richardson et al., 1986; McDonald et al., 1995; Greene et al., 1999; Nieukirk et al., 2004; Smultea et al., 2004; Holst et al., 2005a,b, 2006; and Dunn and Hernandez, 2009). However, Clark and Gagnon (2006) reported that fin whales in the northeast Pacific Ocean went silent for an extended period starting soon after the onset of a seismic survey in the area. Similarly, there has been one report that sperm whales ceased calling when exposed to pulses from a very distant seismic ship (Bowles et al., 1994). However, more recent studies found that they continued calling in the presence of seismic pulses (Madsen et al., 2002; Tyack et al., 2003; Smultea et al., 2004; Holst et al., 2006; and Jochens et al., 2008). Dolphins and porpoises commonly are heard calling while airguns are operating ( e.g., Gordon et al., 2004; Smultea et al., 2004; Holst et al., 2005a, b; and Potter et al., 2007). The sounds important to small odontocetes are predominantly at much higher frequencies than are the dominant components of airgun sounds, thus limiting the potential for masking.

In general, NMFS expects the masking effects of seismic pulses to be minor, given the normally intermittent nature of seismic pulses. Refer to Appendix B (4) of L-DEO's environmental analysis for a more detailed discussion of masking effects on marine mammals.

Disturbance includes a variety of effects, including subtle to conspicuous changes in behavior, movement, and displacement. Reactions to sound, if any, depend on species, state of maturity, experience, current activity, reproductive state, time of day, and many other factors (Richardson et al., 1995; Wartzok et al., 2004; Southall et al., 2007; Weilgart, 2007). If a marine mammal does react briefly to an underwater sound by changing its behavior or moving a small distance, the impacts of the change are unlikely to be significant to the individual, let alone the stock or population. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on individuals and populations could be significant ( e.g., Lusseau and Bejder, 2007; Weilgart, 2007). Given the many uncertainties in predicting the quantity and types of impacts of noise on marine mammals, it is common practice to estimate how many mammals would be present within a particular distance of industrial activities and/or exposed to a particular level of industrial sound. In most cases, this approach likely overestimates the numbers of marine mammals that would be affected in some biologically-important manner.

The sound criteria used to estimate how many marine mammals might be disturbed to some biologically-important degree by a seismic program are based primarily on behavioral observations of a few species. Scientists have conducted detailed studies on humpback, gray, bowhead ( Balaena mysticetus ), and sperm whales. Less detailed data are available for some other species of baleen whales, small toothed whales, and sea otters ( Enhydra lutris ), but for many species there are no data on responses to marine seismic surveys.

Baleen Whales —Baleen whales generally tend to avoid operating airguns, but avoidance radii are quite variable (reviewed in Richardson, et al., 1995). Whales are often reported to show no overt reactions to pulses from large arrays of airguns at distances beyond a few kilometers, even though the airgun pulses remain well above ambient noise levels out to much longer distances. However, as reviewed in Appendix B (5.1) of L-DEO's environmental analysis, baleen whales exposed to strong noise pulses from airguns often react by deviating from their normal migration route and/or interrupting their feeding and moving away. In the cases of migrating gray and bowhead whales, the observed changes in behavior appeared to be of little or no biological consequence to the animals (Richardson et al., 1995). They simply avoided the sound source by displacing their migration route to varying degrees, but within the natural boundaries of the migration corridors.

Studies of gray, bowhead, and humpback whales have shown that seismic pulses with received levels of 160 to 170 dB re: 1 μPa seem to cause obvious avoidance behavior in a substantial fraction of the animals exposed (Malme et al., 1986, 1988; Richardson et al., 1995). In many areas, seismic pulses from large arrays of airguns diminish to those levels at distances ranging from four to 15 km from the source. A substantial proportion of the baleen whales within those distances may show avoidance or other strong behavioral reactions to the airgun array. Subtle behavioral changes sometimes become evident at somewhat lower received levels, and studies summarized in Appendix B (5.1) of L-DEO's environmental analysis have shown that some species of baleen whales, notably bowhead and humpback whales, at times, show strong avoidance at received levels lower than 160-170 dB re: 1 μPa.

McCauley et al. (1998, 2000) studied the responses of humpback whales off western Australia to a full-scale seismic survey with a 16-airgun array (2,678-in 3 ) and to a single airgun (20-in 3 ) with source level of 227 dB re: 1 µPa (p-p) . In the 1998 study, they documented that avoidance reactions began at five to eight km from the array, and that those reactions kept most pods approximately three to four km from the operating seismic boat. In the 2000 study, they noted localized displacement during migration of four to five km by traveling pods and seven to 12 km by more sensitive resting pods of cow-calf pairs. Avoidance distances with respect to the single airgun were smaller but consistent with the results from the full array in terms of the received sound levels. The mean received level for initial avoidance of an approaching airgun was 140 dB re: 1 μPa for humpback pods containing females, and at the mean closest point of approach distance the received level was 143 dB re: 1 μPa. The initial avoidance response generally occurred at distances of five to eight km from the airgun array and two km from the single airgun. However, some individual humpback whales, especially males, approached within distances of 100 to 400 m (328 to 1,312 ft), where the maximum received level was 179 dB re: 1 μPa.

Humpback whales on their summer feeding grounds in southeast Alaska did not exhibit persistent avoidance when exposed to seismic pulses from a 1.64-L (100-in 3 ) airgun (Malme et al., 1985). Some humpbacks seemed “startled” at received levels of 150 to 169 dB re: 1 μPa. Malme et al. (1985) concluded that there was no clear evidence of avoidance, despite the possibility of subtle effects, at received levels up to 172 dB re: 1 μPa.

Studies have suggested that south Atlantic humpback whales wintering off Brazil may be displaced or even strand upon exposure to seismic surveys (Engel et al., 2004). The evidence for this was circumstantial and subject to alternative explanations (IAGC, 2004). Also, the evidence was not consistent with subsequent results from the same area of Brazil (Parente et al., 2006), or with direct studies of humpbacks exposed to seismic surveys in other areas and seasons. After allowance for data from subsequent years, there was no observable direct correlation between strandings and seismic surveys (IWC, 2007:236).

There are no data on reactions of right whales to seismic surveys, but results from the closely-related bowhead whale show that their responsiveness can be quite variable depending on their activity (migrating versus feeding). Bowhead whales migrating west across the Alaskan Beaufort Sea in autumn, in particular, are unusually responsive, with substantial avoidance occurring out to distances of 20 to 30 km from a medium-sized airgun source at received sound levels of around 120 to 130 dB re: 1 μPa (Miller et al., 1999; Richardson et al., 1999; see Appendix B (5) of L-DEO's environmental analysis). However, more recent research on bowhead whales (Miller et al., 2005; Harris et al., 2007) corroborates earlier evidence that, during the summer feeding season, bowheads are not as sensitive to seismic sources. Nonetheless, subtle but statistically significant changes in surfacing-respiration-dive cycles were evident upon statistical analysis (Richardson et al., 1986). In the summer, bowheads typically begin to show avoidance reactions at received levels of about 152 to 178 dB re: 1 μPa (Richardson et al., 1986, 1995; Ljungblad et al., 1988; Miller et al., 2005).

Reactions of migrating and feeding (but not wintering) gray whales to seismic surveys have been studied. Malme et al. (1986, 1988) studied the responses of feeding eastern Pacific gray whales to pulses from a single 100-in 3 airgun off St. Lawrence Island in the northern Bering Sea. They estimated, based on small sample sizes, that 50 percent of feeding gray whales stopped feeding at an average received pressure level of 173 dB re: 1 μPa on an (approximate) rms basis, and that 10 percent of feeding whales interrupted feeding at received levels of 163 dB re: 1 µPa. Those findings were generally consistent with the results of experiments conducted on larger numbers of gray whales that were migrating along the California coast (Malme et al., 1984; Malme and Miles, 1985), and western Pacific gray whales feeding off Sakhalin Island, Russia (Wursig et al., 1999; Gailey et al., 2007; Johnson et al., 2007; Yazvenko et al., 2007a, b), along with data on gray whales off British Columbia (Bain and Williams, 2006).

Various species of Balaenoptera (blue, sei, fin, and minke whales) have occasionally been seen in areas ensonified by airgun pulses (Stone, 2003; MacLean and Haley, 2004; Stone and Tasker, 2006), and calls from blue and fin whales have been localized in areas with airgun operations ( e.g., McDonald et al., 1995; Dunn and Hernandez, 2009). Sightings by observers on seismic vessels off the United Kingdom from 1997 to 2000 suggest that, during times of good sightability, sighting rates for mysticetes (mainly fin and sei whales) were similar when large arrays of airguns were shooting vs. silent (Stone, 2003; Stone and Tasker, 2006). However, these whales tended to exhibit localized avoidance, remaining significantly further (on average) from the airgun array during seismic operations compared with non-seismic periods (Stone and Tasker, 2006). In a study off of Nova Scotia, Moulton and Miller (2005) found little difference in sighting rates (after accounting for water depth) and initial sighting distances of balaenopterid whales when airguns were operating vs. silent. However, there were indications that these whales were more likely to be moving away when seen during airgun operations. Similarly, ship-based monitoring studies of blue, fin, sei and minke whales offshore of Newfoundland (Orphan Basin and Laurentian Sub-basin) found no more than small differences in sighting rates and swim directions during seismic versus non-seismic periods (Moulton et al., 2005, 2006a,b). Data on short-term reactions by cetaceans to impulsive noises are not necessarily indicative of long-term or biologically significant effects. It is not known whether impulsive sounds affect reproductive rate or distribution and habitat use in subsequent days or years. However, gray whales have continued to migrate annually along the west coast of North America with substantial increases in the population over recent years, despite intermittent seismic exploration (and much ship traffic) in that area for decades (Appendix A in Malme et al., 1984; Richardson et al., 1995; Allen and Angliss, 2010). The western Pacific gray whale population did not seem affected by a seismic survey in its feeding ground during a previous year (Johnson et al., 2007). Similarly, bowhead whales have continued to travel to the eastern Beaufort Sea each summer, and their numbers have increased notably, despite seismic exploration in their summer and autumn range for many years (Richardson et al., 1987; Angliss and Allen, 2009).

Toothed Whales —Little systematic information is available about reactions of toothed whales to noise pulses. Few studies similar to the more extensive baleen whale/seismic pulse work summarized above and (in more detail) in Appendix B of L-DEO's environmental analysis have been reported for toothed whales. However, there are recent systematic studies on sperm whales ( e.g., Gordon et al., 2006; Madsen et al., 2006; Winsor and Mate, 2006; Jochens et al., 2008; Miller et al., 2009). There is an increasing amount of information about responses of various odontocetes to seismic surveys based on monitoring studies ( e.g., Stone, 2003; Smultea et al., 2004; Moulton and Miller, 2005; Bain and Williams, 2006; Holst et al., 2006; Stone and Tasker, 2006; Potter et al., 2007; Hauser et al., 2008; Holst and Smultea, 2008; Weir, 2008; Barkaszi et al., 2009; Richardson et al., 2009).

Seismic operators and marine mammal observers on seismic vessels regularly see dolphins and other small toothed whales near operating airgun arrays, but in general there is a tendency for most delphinids to show some avoidance of operating seismic vessels ( e.g., Goold, 1996a,b,c; Calambokidis and Osmek, 1998; Stone, 2003; Moulton and Miller, 2005; Holst et al., 2006; Stone and Tasker, 2006; Weir, 2008; Richardson et al., 2009; see also Barkaszi et al., 2009). Some dolphins seem to be attracted to the seismic vessel and floats, and some ride the bow wave of the seismic vessel even when large arrays of airguns are firing ( e.g., Moulton and Miller, 2005). Nonetheless, small toothed whales more often tend to head away, or to maintain a somewhat greater distance from the vessel, when a large array of airguns is operating than when it is silent ( e.g., Stone and Tasker, 2006; Weir, 2008). In most cases, the avoidance radii for delphinids appear to be small, on the order of one km less, and some individuals show no apparent avoidance. The beluga whale ( Delphinapterus leucas ) is a species that (at least at times) shows long-distance avoidance of seismic vessels. Aerial surveys conducted in the southeastern Beaufort Sea during summer found that sighting rates of beluga whales were significantly lower at distances 10 to 20 km compared with 20 to 30 km from an operating airgun array, and observers on seismic boats in that area rarely see belugas (Miller et al., 2005; Harris et al., 2007).

Captive bottlenose dolphins ( Tursiops truncatus ) and beluga whales exhibited changes in behavior when exposed to strong pulsed sounds similar in duration to those typically used in seismic surveys (Finneran et al., 2000, 2002, 2005). However, the animals tolerated high received levels of sound before exhibiting aversive behaviors.

Results for porpoises depend on species. The limited available data suggest that harbor porpoises ( Phocoena phocoena ) show stronger avoidance of seismic operations than do Dall's porpoises ( Phocoenoides dalli ) (Stone, 2003; MacLean and Koski, 2005; Bain and Williams, 2006; Stone and Tasker, 2006). Dall's porpoises seem relatively tolerant of airgun operations (MacLean and Koski, 2005; Bain and Williams, 2006), although they too have been observed to avoid large arrays of operating airguns (Calambokidis and Osmek, 1998; Bain and Williams, 2006). This apparent difference in responsiveness of these two porpoise species is consistent with their relative responsiveness to boat traffic and some other acoustic sources (Richardson et al., 1995; Southall et al., 2007).

Most studies of sperm whales exposed to airgun sounds indicate that the sperm whale shows considerable tolerance of airgun pulses ( e.g., Stone, 2003; Moulton et al., 2005, 2006a; Stone and Tasker, 2006; Weir, 2008). In most cases the whales do not show strong avoidance, and they continue to call (see Appendix B of L-DEO's environmental analysis for review). However, controlled exposure experiments in the Gulf of Mexico indicate that foraging behavior was altered upon exposure to airgun sound (Jochens et al., 2008; Miller et al., 2009; Tyack, 2009).

There are almost no specific data on the behavioral reactions of beaked whales to seismic surveys. However, some northern bottlenose whales ( Hyperoodon ampullatus ) remained in the general area and continued to produce high-frequency clicks when exposed to sound pulses from distant seismic surveys (Gosselin and Lawson, 2004; Laurinolli and Cochrane, 2005; Simard et al., 2005). Most beaked whales tend to avoid approaching vessels of other types ( e.g., Wursig et al., 1998). They may also dive for an extended period when approached by a vessel ( e.g., Kasuya, 1986), although it is uncertain how much longer such dives may be as compared to dives by undisturbed beaked whales, which also are often quite long (Baird et al., 2006; Tyack et al., 2006). Based on a single observation, Aguilar-Soto et al. (2006) suggested that foraging efficiency of Cuvier's beaked whales ( Ziphius cavirostris ) may be reduced by close approach of vessels. In any event, it is likely that most beaked whales would also show strong avoidance of an approaching seismic vessel, although this has not been documented explicitly.

There are increasing indications that some beaked whales tend to strand when naval exercises involving mid-frequency sonar operation are ongoing nearby ( e.g., Simmonds and Lopez-Jurado, 1991; Frantzis, 1998; NOAA and USN, 2001; Jepson et al., 2003; Hildebrand, 2005; Barlow and Gisiner, 2006; see also the Stranding and Mortality section in this notice). These strandings are apparently a disturbance response, although auditory or other injuries or other physiological effects may also be involved. Whether beaked whales would ever react similarly to seismic surveys is unknown. Seismic survey sounds are quite different from those of the sonar in operation during the above-cited incidents.

Odontocete reactions to large arrays of airguns are variable and, at least for delphinids and Dall's porpoises, seem to be confined to a smaller radius than has been observed for the more responsive of the mysticetes, belugas, and harbor porpoises (See Appendix B of L-DEO's environmental analysis).

Exposure to high intensity sound for a sufficient duration may result in auditory effects such as a noise-induced threshold shift—an increase in the auditory threshold after exposure to noise (Finneran, Carder, Schlundt, and Ridgway, 2005). Factors that influence the amount of threshold shift include the amplitude, duration, frequency content, temporal pattern, and energy distribution of noise exposure. The magnitude of hearing threshold shift normally decreases over time following cessation of the noise exposure. The amount of threshold shift just after exposure is called the initial threshold shift. If the threshold shift eventually returns to zero ( i.e., the threshold returns to the pre-exposure value), it is called temporary threshold shift (TTS) (Southall et al., 2007).

Researchers have studied TTS in certain captive odontocetes and pinnipeds exposed to strong sounds (reviewed in Southall et al., 2007). However, there has been no specific documentation of TTS let alone permanent hearing damage, i.e., permanent threshold shift (PTS), in free-ranging marine mammals exposed to sequences of airgun pulses during realistic field conditions.

Temporary Threshold Shift —TTS is the mildest form of hearing impairment that can occur during exposure to a strong sound (Kryter, 1985). While experiencing TTS, the hearing threshold rises and a sound must be stronger in order to be heard. At least in terrestrial mammals, TTS can last from minutes or hours to (in cases of strong TTS) days. For sound exposures at or somewhat above the TTS threshold, hearing sensitivity in both terrestrial and marine mammals recovers rapidly after exposure to the noise ends. Few data on sound levels and durations necessary to elicit mild TTS have been obtained for marine mammals, and none of the published data concern TTS elicited by exposure to multiple pulses of sound. Available data on TTS in marine mammals are summarized in Southall et al. (2007). Table 1 presents the distances from the Langseth's airguns at which the received energy level (per pulse, flat-weighted) that would be expected to be greater than or equal to 180 dB re: 1 μPa.

To avoid the potential for injury, NMFS (1995, 2000) concluded that cetaceans should not be exposed to pulsed underwater noise at received levels exceeding 180 dB re: 1 μPa. NMFS believes that to avoid the potential for permanent physiological damage (Level A harassment), cetaceans should not be exposed to pulsed underwater noise at received levels exceeding 180 dB re: 1 μPa. The 180-dB level is a shutdown criterion applicable to cetaceans, as specified by NMFS (2000); these levels were used to establish the EZs. NMFS also assumes that cetaceans exposed to levels exceeding 160 dB re: 1 μPa (rms) may experience Level B harassment.

Researchers have derived TTS information for odontocetes from studies on the bottlenose dolphin and beluga. For the one harbor porpoise tested, the received level of airgun sound that elicited onset of TTS was lower (Lucke et al., 2009). If these results from a single animal are representative, it is inappropriate to assume that onset of TTS occurs at similar received levels in all odontocetes ( cf. Southall et al., 2007). Some cetaceans apparently can incur TTS at considerably lower sound exposures than are necessary to elicit TTS in the beluga or bottlenose dolphin.

For baleen whales, there are no data, direct or indirect, on levels or properties of sound that are required to induce TTS. The frequencies to which baleen whales are most sensitive are assumed to be lower than those to which odontocetes are most sensitive, and natural background noise levels at those low frequencies tend to be higher. As a result, auditory thresholds of baleen whales within their frequency band of best hearing are believed to be higher (less sensitive) than are those of odontocetes at their best frequencies (Clark and Ellison, 2004). From this, it is suspected that received levels causing TTS onset may also be higher in baleen whales (Southall et al., 2007). For this proposed study, L-DEO expects no cases of TTS given: (1) The low abundance of baleen whales in the planned study area at the time of the survey; and (2) the strong likelihood that baleen whales would avoid the approaching airguns (or vessel) before being exposed to levels high enough for TTS to occur.

Permanent Threshold Shift —When PTS occurs, there is physical damage to the sound receptors in the ear. In severe cases, there can be total or partial deafness, whereas in other cases, the animal has an impaired ability to hear sounds in specific frequency ranges (Kryter, 1985). There is no specific evidence that exposure to pulses of airgun sound can cause PTS in any marine mammal, even with large arrays of airguns. However, given the possibility that mammals close to an airgun array might incur at least mild TTS, there has been further speculation about the possibility that some individuals occurring very close to airguns might incur PTS ( e.g., Richardson et al., 1995, p. 372 ff; Gedamke et al., 2008). Single or occasional occurrences of mild TTS are not indicative of permanent auditory damage, but repeated or (in some cases) single exposures to a level well above that causing TTS onset might elicit PTS.

Relationships between TTS and PTS thresholds have not been studied in marine mammals, but are assumed to be similar to those in humans and other terrestrial mammals. PTS might occur at a received sound level at least several decibels above that inducing mild TTS if the animal were exposed to strong sound pulses with rapid rise time-see Appendix B (6) of L-DEO's environmental analysis. Based on data from terrestrial mammals, a precautionary assumption is that the PTS threshold for impulse sounds (such as airgun pulses as received close to the source) is at least 6 dB higher than the TTS threshold on a peak-pressure basis, and probably greater than six dB (Southall et al., 2007).

Given the higher level of sound necessary to cause PTS as compared with TTS, it is considerably less likely that PTS would occur. Baleen whales generally avoid the immediate area around operating seismic vessels, as do some other marine mammals.

Stranding and Mortality —Marine mammals close to underwater detonations of high explosives can be killed or severely injured, and the auditory organs are especially susceptible to injury (Ketten et al., 1993; Ketten, 1995). However, explosives are no longer used for marine waters for commercial seismic surveys or (with rare exceptions) for seismic research; they have been replaced entirely by airguns or related non-explosive pulse generators. Airgun pulses are less energetic and have slower rise times, and there is no specific evidence that they can cause serious injury, death, or stranding even in the case of large airgun arrays. However, the association of strandings of beaked whales with naval exercises involving mid-frequency active sonar and, in one case, an L-DEO seismic survey (Malakoff, 2002; Cox et al., 2006), has raised the possibility that beaked whales exposed to strong “pulsed” sounds may be especially susceptible to injury and/or behavioral reactions that can lead to stranding ( e.g., Hildebrand, 2005; Southall et al., 2007). Appendix B (6) of L-DEO's environmental analysis provides additional details.

Specific sound-related processes that lead to strandings and mortality are not well documented, but may include:

(1) Swimming in avoidance of a sound into shallow water;

(2) A change in behavior (such as a change in diving behavior) that might contribute to tissue damage, gas bubble formation, hypoxia, cardiac arrhythmia, hypertensive hemorrhage or other forms of trauma;

(3) A physiological change such as a vestibular response leading to a behavioral change or stress-induced hemorrhagic diathesis, leading in turn to tissue damage; and

(4) Tissue damage directly from sound exposure, such as through acoustically-mediated bubble formation and growth or acoustic resonance of tissues. Some of these mechanisms are unlikely to apply in the case of impulse sounds. However, there are increasing indications that gas-bubble disease (analogous to the bends), induced in supersaturated tissue by a behavioral response to acoustic exposure, could be a pathologic mechanism for the strandings and mortality of some deep-diving cetaceans exposed to sonar. However, the evidence for this remains circumstantial and associated with exposure to naval mid-frequency sonar, not seismic surveys (Cox et al., 2006; Southall et al., 2007).

Seismic pulses and mid-frequency sonar signals are quite different, and some mechanisms by which sonar sounds have been hypothesized to affect beaked whales are unlikely to apply to airgun pulses. Sounds produced by airgun arrays are broadband impulses with most of the energy below one kHz. Typical military mid-frequency sonar emits non-impulse sounds at frequencies of two to 10 kHz, generally with a relatively narrow bandwidth at any one time. A further difference between seismic surveys and naval exercises is that naval exercises can involve sound sources on more than one vessel. Thus, it is not appropriate to assume that there is a direct connection between the effects of military sonar and seismic surveys on marine mammals. However, evidence that sonar signals can, in special circumstances, lead (at least indirectly) to physical damage and mortality ( e.g., Balcomb and Claridge, 2001; NOAA and USN, 2001; Jepson et al., 2003; Fernández et al., 2004, 2005; Hildebrand 2005; Cox et al., 2006) suggests that caution is warranted when dealing with exposure of marine mammals to any high-intensity “pulsed” sound.

There is no conclusive evidence of cetacean strandings or deaths at sea as a result of exposure to seismic surveys, but a few cases of strandings in the general area where a seismic survey was ongoing have led to speculation concerning a possible link between seismic surveys and strandings. Suggestions that there was a link between seismic surveys and strandings of humpback whales in Brazil (Engel et al., 2004) were not well founded (IAGC, 2004; IWC, 2007). In September 2002, there was a stranding of two Cuvier's beaked whales in the Gulf of California, Mexico, when the L DEO vessel R/V Maurice Ewing was operating a 20-airgun (8,490 in 3 ) array in the general area. The link between the stranding and the seismic surveys was inconclusive and not based on any physical evidence (Hogarth, 2002; Yoder, 2002). Nonetheless, the Gulf of California incident plus the beaked whale strandings near naval exercises involving use of mid-frequency sonar suggests a need for caution in conducting seismic surveys in areas occupied by beaked whales until more is known about effects of seismic surveys on those species (Hildebrand, 2005). No injuries of beaked whales are anticipated during the proposed study because of:

(1) The high likelihood that any beaked whales nearby would avoid the approaching vessel before being exposed to high sound levels,

(2) Differences between the sound sources operated by L-DEO and those involved in the naval exercises associated with strandings.

Non-auditory Physiological Effects —Non-auditory physiological effects or injuries that theoretically might occur in marine mammals exposed to strong underwater sound include stress, neurological effects, bubble formation, resonance, and other types of organ or tissue damage (Cox et al., 2006; Southall et al., 2007). Studies examining such effects are limited. However, resonance effects (Gentry, 2002) and direct noise-induced bubble formations (Crum et al., 2005) are implausible in the case of exposure to an impulsive broadband source like an airgun array. If seismic surveys disrupt diving patterns of deep-diving species, this might perhaps result in bubble formation and a form of the bends, as speculated to occur in beaked whales exposed to sonar. However, there is no specific evidence of this upon exposure to airgun pulses.

In general, very little is known about the potential for seismic survey sounds (or other types of strong underwater sounds) to cause non-auditory physical effects in marine mammals. Such effects, if they occur at all, would presumably be limited to short distances and to activities that extend over a prolonged period. The available data do not allow identification of a specific exposure level above which non-auditory effects can be expected (Southall et al., 2007), or any meaningful quantitative predictions of the numbers (if any) of marine mammals that might be affected in those ways. Marine mammals that show behavioral avoidance of seismic vessels, including most baleen whales and some odontocetes, are especially unlikely to incur non-auditory physical effects.

L-DEO will operate the Kongsberg EM 122 MBES from the source vessel during the planned study. Sounds from the MBES are very short pulses, occurring for two to 15 ms once every five to 20 s, depending on water depth. Most of the energy in the sound pulses emitted by this MBES is at frequencies near 12 kHz, and the maximum source level is 242 dB re: 1 μPa. The beam is narrow (1 to 2º) in fore-aft extent and wide (150º) in the cross-track extent. Each ping consists of eight (in water greater than 1,000 m deep) or four (less than 1,000 m deep) successive fan-shaped transmissions (segments) at different cross-track angles. Any given mammal at depth near the trackline would be in the main beam for only one or two of the segments. Also, marine mammals that encounter the Kongsberg EM 122 are unlikely to be subjected to repeated pulses because of the narrow fore-aft width of the beam and will receive only limited amounts of pulse energy because of the short pulses. Animals close to the vessel (where the beam is narrowest) are especially unlikely to be ensonified for more than one 2- to 15-ms pulse (or two pulses if in the overlap area). Similarly, Kremser et al. (2005) noted that the probability of a cetacean swimming through the area of exposure when an MBES emits a pulse is small. The animal would have to pass the transducer at close range and be swimming at speeds similar to the vessel in order to receive the multiple pulses that might result in sufficient exposure to cause TTS.

Navy sonars that have been linked to avoidance reactions and stranding of cetaceans: (1) Generally have longer pulse duration than the Kongsberg EM 122; and (2) are often directed close to horizontally versus more downward for the MBES. The area of possible influence of the MBES is much smaller—a narrow band below the source vessel. Also, the duration of exposure for a given marine mammal can be much longer for naval sonar. During L-DEO's operations, the individual pulses will be very short, and a given mammal would not receive many of the downward-directed pulses as the vessel passes by. Possible effects of an MBES on marine mammals are outlined below.

Masking —Marine mammal communications will not be masked appreciably by the MBES signals given the low duty cycle of the echosounder and the brief period when an individual mammal is likely to be within its beam. Furthermore, in the case of baleen whales, the MBES signals (12 kHz) do not overlap with the predominant frequencies in the calls, which would avoid any significant masking.

Behavioral Responses —Behavioral reactions of free-ranging marine mammals to sonars, echosounders, and other sound sources appear to vary by species and circumstance. Observed reactions have included silencing and dispersal by sperm whales (Watkins et al., 1985), increased vocalizations and no dispersal by pilot whales ( Globicephala melas ) (Rendell and Gordon, 1999), and the previously-mentioned beachings by beaked whales. During exposure to a 21 to 25 kHz “whale-finding” sonar with a source level of 215 dB re: 1 µPa, gray whales reacted by orienting slightly away from the source and being deflected from their course by approximately 200 m (Frankel, 2005). When a 38-kHz echosounder and a 150-kHz acoustic Doppler current profiler were transmitting during studies in the Eastern Tropical Pacific, baleen whales showed no significant responses, while spotted and spinner dolphins were detected slightly more often and beaked whales less often during visual surveys (Gerrodette and Pettis, 2005).

Captive bottlenose dolphins and a beluga whale exhibited changes in behavior when exposed to 1-s tonal signals at frequencies similar to those that will be emitted by the MBES used by LDEO, and to shorter broadband pulsed signals. Behavioral changes typically involved what appeared to be deliberate attempts to avoid the sound exposure (Schlundt et al., 2000; Finneran et al., 2002; Finneran and Schlundt, 2004). The relevance of those data to free-ranging odontocetes is uncertain, and in any case, the test sounds were quite different in duration as compared with those from an MBES.

Hearing Impairment and Other Physical Effects —Given recent stranding events that have been associated with the operation of naval sonar, there is concern that mid-frequency sonar sounds can cause serious impacts to marine mammals (see above). However, the MBES proposed for use by L-DEO is quite different than sonar used for navy operations. Pulse duration of the MBES is very short relative to the naval sonar. Also, at any given location, an individual marine mammal would be in the beam of the MBES for much less time given the generally downward orientation of the beam and its narrow fore-aft beamwidth; navy sonar often uses near-horizontally-directed sound. Those factors would all reduce the sound energy received from the MBES rather drastically relative to that from naval sonar.

Based upon the best available science, NMFS believes that the brief exposure of marine mammals to one pulse, or small numbers of signals, from the MBES is not likely to result in the harassment of marine mammals.

L-DEO will also operate an SBP from the source vessel during the proposed survey. Sounds from the SBP are very short pulses, occurring for one to four ms once every second. Most of the energy in the sound pulses emitted by the SBP is at 3.5 kHz, and the beam is directed downward. The sub-bottom profiler on the Langseth has a maximum source level of 222 dB re: 1 µPa.

Kremser et al. (2005) noted that the probability of a cetacean swimming through the area of exposure when a bottom profiler emits a pulse is small—even for an SBP more powerful than that on the Langseth —if the animal was in the area, it would have to pass the transducer at close range and in order to be subjected to sound levels that could cause TTS.

Masking —Marine mammal communications will not be masked appreciably by the SBP signals given the directionality of the signal and the brief period when an individual mammal is likely to be within its beam. Furthermore, in the case of most baleen whales, the SBP signals do not overlap with the predominant frequencies in the calls, which would avoid significant masking.

Behavioral Responses —Marine mammal behavioral reactions to other pulsed sound sources are discussed above, and responses to the SBP are likely to be similar to those for other pulsed sources if received at the same levels. However, the pulsed signals from the SBP are considerably weaker than those from the MBES. Therefore, behavioral responses are not expected unless marine mammals are very close to the source.

Hearing Impairment and Other Physical Effects —It is unlikely that the SBP produces pulse levels strong enough to cause hearing impairment or other physical injuries even in an animal that is (briefly) in a position near the source. The SBP is usually operated simultaneously with other higher-power acoustic sources. Many marine mammals will move away in response to the approaching higher-power sources or the vessel itself before the mammals would be close enough for there to be any possibility of effects from the less intense sounds from the SBP. Based upon the best available science, NMFS believes that the brief exposure of marine mammals to signals from the SBP is not likely to result in the harassment of marine mammals.

The potential effects to marine mammals described in this section of the document do not take into consideration the proposed monitoring and mitigation measures described later in this document (see the “Proposed Mitigation” and “Proposed Monitoring and Reporting” sections) which, as noted are designed to effect the least practicable adverse impact on affected marine mammal species and stocks.

The proposed seismic survey is not anticipated to have any permanent impact on habitats used by the marine mammals in the proposed survey area, including the food sources they use ( i.e., fish and invertebrates). Additionally, no physical damage to any habitat is anticipated as a result of conducting the proposed seismic survey. While it is anticipated that the specified activity may result in marine mammals avoiding certain areas due to temporary ensonification, this impact to habitat is temporary and reversible and was considered in further detail earlier in this document, as behavioral modification. The main impact associated with the proposed activity will be temporarily elevated noise levels and the associated direct effects on marine mammals, previously discussed in this notice. The next section discusses the potential impacts of anthropogenic sound sources on common marine mammal prey in the proposed survey area ( i.e., fish and invertebrates).

One reason for the adoption of airguns as the standard energy source for marine seismic surveys is that, unlike explosives, they have not been associated with large-scale fish kills. However, existing information on the impacts of seismic surveys on marine fish populations is limited (see Appendix D of L-DEO's environmental analysis). There are three types of potential effects of exposure to seismic surveys: (1) Pathological, (2) physiological, and (3) behavioral. Pathological effects involve lethal and temporary or permanent sub-lethal injury. Physiological effects involve temporary and permanent primary and secondary stress responses, such as changes in levels of enzymes and proteins. Behavioral effects refer to temporary and (if they occur) permanent changes in exhibited behavior ( e.g., startle and avoidance behavior). The three categories are interrelated in complex ways. For example, it is possible that certain physiological and behavioral changes could potentially lead to an ultimate pathological effect on individuals ( i.e., mortality).

The specific received sound levels at which permanent adverse effects to fish potentially could occur are little studied and largely unknown. Furthermore, the available information on the impacts of seismic surveys on marine fish is from studies of individuals or portions of a population; there have been no studies at the population scale. The studies of individual fish have often been on caged fish that were exposed to airgun pulses in situations not representative of an actual seismic survey. Thus, available information provides limited insight on possible real-world effects at the ocean or population scale.

Hastings and Popper (2005), Popper (2009), and Popper and Hastings (2009a,b) provided recent critical reviews of the known effects of sound on fish. The following sections provide a general synopsis of the available information on the effects of exposure to seismic and other anthropogenic sound as relevant to fish. The information comprises results from scientific studies of varying degrees of rigor plus some anecdotal information. Some of the data sources may have serious shortcomings in methods, analysis, interpretation, and reproducibility that must be considered when interpreting their results (see Hastings and Popper, 2005). Potential adverse effects of the program's sound sources on marine fish are then noted.

Pathological Effects —The potential for pathological damage to hearing structures in fish depends on the energy level of the received sound and the physiology and hearing capability of the species in question (see Appendix D L-DEO's environmental analysis). For a given sound to result in hearing loss, the sound must exceed, by some substantial amount, the hearing threshold of the fish for that sound (Popper, 2005). The consequences of temporary or permanent hearing loss in individual fish on a fish population are unknown; however, they likely depend on the number of individuals affected and whether critical behaviors involving sound ( e.g., predator avoidance, prey capture, orientation and navigation, reproduction, etc. ) are adversely affected.

Little is known about the mechanisms and characteristics of damage to fish that may be inflicted by exposure to seismic survey sounds. Few data have been presented in the peer-reviewed scientific literature. As far as we know, there are only two papers with proper experimental methods, controls, and careful pathological investigation implicating sounds produced by actual seismic survey airguns in causing adverse anatomical effects. One such study indicated anatomical damage, and the second indicated TTS in fish hearing. The anatomical case is McCauley et al. (2003), who found that exposure to airgun sound caused observable anatomical damage to the auditory maculae of pink snapper ( Pagrus auratus ). This damage in the ears had not been repaired in fish sacrificed and examined almost two months after exposure. On the other hand, Popper et al. (2005) documented only TTS (as determined by auditory brainstem response) in two of three fish species from the Mackenzie River Delta. This study found that broad whitefish ( Coregonus nasus ) exposed to five airgun shots were not significantly different from those of controls. During both studies, the repetitive exposure to sound was greater than would have occurred during a typical seismic survey. However, the substantial low-frequency energy produced by the airguns [less than 400 Hz in the study by McCauley et al. (2003) and less than approximately 200 Hz in Popper et al. (2005)] likely did not propagate to the fish because the water in the study areas was very shallow (approximately 9 m in the former case and less than two m in the latter). Water depth sets a lower limit on the lowest sound frequency that will propagate (the “cutoff frequency”) at about one-quarter wavelength (Urick, 1983; Rogers and Cox, 1988).

Wardle et al. (2001) suggested that in water, acute injury and death of organisms exposed to seismic energy depends primarily on two features of the sound source: (1) The received peak pressure and (2) the time required for the pressure to rise and decay. Generally, as received pressure increases, the period for the pressure to rise and decay decreases, and the chance of acute pathological effects increases. According to Buchanan et al. (2004), for the types of seismic airguns and arrays involved with the proposed program, the pathological (mortality) zone for fish would be expected to be within a few meters of the seismic source. Numerous other studies provide examples of no fish mortality upon exposure to seismic sources (Falk and Lawrence, 1973; Holliday et al., 1987; La Bella et al., 1996; Santulli et al., 1999; McCauley et al., 2000a,b, 2003; Bjarti, 2002; Thomsen, 2002; Hassel et al., 2003; Popper et al., 2005; Boeger et al., 2006).

Some studies have reported, some equivocally, that mortality of fish, fish eggs, or larvae can occur close to seismic sources (Kostyuchenko, 1973; Dalen and Knutsen, 1986; Booman et al., 1996; Dalen et al., 1996). Some of the reports claimed seismic effects from treatments quite different from actual seismic survey sounds or even reasonable surrogates. However, Payne et al. (2009) reported no statistical differences in mortality/morbidity between control and exposed groups of capelin eggs or monkfish larvae. Saetre and Ona (1996) applied a `worst-case scenario' mathematical model to investigate the effects of seismic energy on fish eggs and larvae. They concluded that mortality rates caused by exposure to seismic surveys are so low, as compared to natural mortality rates, that the impact of seismic surveying on recruitment to a fish stock must be regarded as insignificant.

Physiological Effects —Physiological effects refer to cellular and/or biochemical responses of fish to acoustic stress. Such stress potentially could affect fish populations by increasing mortality or reducing reproductive success. Primary and secondary stress responses of fish after exposure to seismic survey sound appear to be temporary in all studies done to date (Sverdrup et al., 1994; Santulli et al., 1999; McCauley et al., 2000a,b). The periods necessary for the biochemical changes to return to normal are variable and depend on numerous aspects of the biology of the species and of the sound stimulus (see Appendix D of L-DEO's environmental analysis).

Behavioral Effects —Behavioral effects include changes in the distribution, migration, mating, and catchability of fish populations. Studies investigating the possible effects of sound (including seismic survey sound) on fish behavior have been conducted on both uncaged and caged individuals ( e.g., Chapman and Hawkins, 1969; Pearson et al., 1992; Santulli et al., 1999; Wardle et al., 2001; Hassel et al., 2003). Typically, in these studies fish exhibited a sharp startle response at the onset of a sound followed by habituation and a return to normal behavior after the sound ceased.

There is general concern about potential adverse effects of seismic operations on fisheries, namely a potential reduction in the “catchability” of fish involved in fisheries. Although reduced catch rates have been observed in some marine fisheries during seismic testing, in a number of cases the findings are confounded by other sources of disturbance (Dalen and Raknes, 1985; Dalen and Knutsen, 1986; Lokkeborg, 1991; Skalski et al., 1992; Engas et al., 1996). In other airgun experiments, there was no change in catch per unit effort (CPUE) of fish when airgun pulses were emitted, particularly in the immediate vicinity of the seismic survey (Pickett et al., 1994; La Bella et al., 1996). For some species, reductions in catch may have resulted from a change in behavior of the fish, e.g., a change in vertical or horizontal distribution, as reported in Slotte et al. (2004).

In general, any adverse effects on fish behavior or fisheries attributable to seismic testing may depend on the species in question and the nature of the fishery (season, duration, fishing method). They may also depend on the age of the fish, its motivational state, its size, and numerous other factors that are difficult, if not impossible, to quantify at this point, given such limited data on effects of airguns on fish, particularly under realistic at-sea conditions.

The existing body of information on the impacts of seismic survey sound on marine invertebrates is very limited. However, there is some unpublished and very limited evidence of the potential for adverse effects on invertebrates, thereby justifying further discussion and analysis of this issue. The three types of potential effects of exposure to seismic surveys on marine invertebrates are pathological, physiological, and behavioral. Based on the physical structure of their sensory organs, marine invertebrates appear to be specialized to respond to particle displacement components of an impinging sound field and not to the pressure component (Popper et al., 2001; see also Appendix E of L-DEO's environmental analysis).

The only information available on the impacts of seismic surveys on marine invertebrates involves studies of individuals; there have been no studies at the population scale. Thus, available information provides limited insight on possible real-world effects at the regional or ocean scale. The most important aspect of potential impacts concerns how exposure to seismic survey sound ultimately affects invertebrate populations and their viability, including availability to fisheries.

Literature reviews of the effects of seismic and other underwater sound on invertebrates were provided by Moriyasu et al. (2004) and Payne et al. (2008). The following sections provide a synopsis of available information on the effects of exposure to seismic survey sound on species of decapod crustaceans and cephalopods, the two taxonomic groups of invertebrates on which most such studies have been conducted. The available information is from studies with variable degrees of scientific soundness and from anecdotal information. A more detailed review of the literature on the effects of seismic survey sound on invertebrates is provided in Appendix E of L-DEO's environmental analysis.

Pathological Effects —In water, lethal and sub-lethal injury to organisms exposed to seismic survey sound appears to depend on at least two features of the sound source: (1) The received peak pressure; and (2) the time required for the pressure to rise and decay. Generally, as received pressure increases, the period for the pressure to rise and decay decreases, and the chance of acute pathological effects increases. For the type of airgun array planned for the proposed program, the pathological (mortality) zone for crustaceans and cephalopods is expected to be within a few meters of the seismic source, at most; however, very few specific data are available on levels of seismic signals that might damage these animals. This premise is based on the peak pressure and rise/decay time characteristics of seismic airgun arrays currently in use around the world.

Some studies have suggested that seismic survey sound has a limited pathological impact on early developmental stages of crustaceans (Pearson et al., 1994; Christian et al., 2003; DFO, 2004). However, the impacts appear to be either temporary or insignificant compared to what occurs under natural conditions. Controlled field experiments on adult crustaceans (Christian et al., 2003, 2004; DFO, 2004) and adult cephalopods (McCauley et al., 2000a,b) exposed to seismic survey sound have not resulted in any significant pathological impacts on the animals. It has been suggested that exposure to commercial seismic survey activities has injured giant squid (Guerra et al., 2004), but the article provides little evidence to support this claim.

Physiological Effects —Physiological effects refer mainly to biochemical responses by marine invertebrates to acoustic stress. Such stress potentially could affect invertebrate populations by increasing mortality or reducing reproductive success. Primary and secondary stress responses ( i.e., changes in haemolymph levels of enzymes, proteins, etc. ) of crustaceans have been noted several days or months after exposure to seismic survey sounds (Payne et al., 2007). The periods necessary for these biochemical changes to return to normal are variable and depend on numerous aspects of the biology of the species and of the sound stimulus.

Behavioral Effects —There is increasing interest in assessing the possible direct and indirect effects of seismic and other sounds on invertebrate behavior, particularly in relation to the consequences for fisheries. Changes in behavior could potentially affect such aspects as reproductive success, distribution, susceptibility to predation, and catchability by fisheries. Studies investigating the possible behavioral effects of exposure to seismic survey sound on crustaceans and cephalopods have been conducted on both uncaged and caged animals. In some cases, invertebrates exhibited startle responses ( e.g., squid in McCauley et al., 2000a,b). In other cases, no behavioral impacts were noted ( e.g., crustaceans in Christian et al., 2003, 2004; DFO 2004). There have been anecdotal reports of reduced catch rates of shrimp shortly after exposure to seismic surveys; however, other studies have not observed any significant changes in shrimp catch rate (Andriguetto-Filho et al., 2005). Similarly, Parry and Gason (2006) did not find any evidence that lobster catch rates were affected by seismic surveys. Any adverse effects on crustacean and cephalopod behavior or fisheries attributable to seismic survey sound depend on the species in question and the nature of the fishery (season, duration, fishing method).

In order to issue an incidental take authorization (ITA) under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and the availability of such species or stock for taking for certain subsistence uses.

L-DEO has based the mitigation measures described herein, to be implemented for the proposed seismic survey, on the following:

(1) Protocols used during previous L-DEO seismic research cruises as approved by NMFS;

(2) Previous IHA applications and IHAs approved and authorized by NMFS; and

(3) Recommended best practices in Richardson et al. (1995), Pierson et al. (1998), and Weir and Dolman, (2007).

To reduce the potential for disturbance from acoustic stimuli associated with the activities, L-DEO and/or its designees has proposed to implement the following mitigation measures for marine mammals:

(1) Proposed exclusion zones (EZ);

(2) Power-down procedures;

(3) Shutdown procedures; and

(4) Ramp-up procedures.

Proposed Exclusion Zones —L-DEO uses safety radii to designate exclusion zones and to estimate take (described in greater detail in Section IV and Appendix A of L-DEO's environmental analysis) for marine mammals. Table 1 shows the distances at which two sound levels (160- and 180-dB) are expected to be received from the 36-airgun array and a single airgun. The 180-dB level shut-down criterion is applicable to cetaceans, as specified by NMFS (2000); and L-DEO used these levels to establish the EZs. If the protected species visual observer (PSVO) detects marine mammal(s) within or about to enter the appropriate EZ, the Langseth crew will immediately power down the airgun array, or perform a shut down if necessary (see Shut-down Procedures).

Power-down Procedures —A power-down involves decreasing the number of airguns in use such that the radius of the 180-dB zone is decreased to the extent that marine mammals are no longer in or about to enter the EZ. A power down of the airgun array can also occur when the vessel is moving from one seismic line to another. During a power-down for mitigation, L-DEO will operate one airgun. The continued operation of one airgun is intended to alert marine mammals to the presence of the seismic vessel in the area. In contrast, a shut down occurs when the Langseth suspends all airgun activity.

If the PSVO detects a marine mammal outside the EZ, which is likely to enter the EZ, L-DEO will power down the airguns before the animal enters the EZ. Likewise, if a mammal is already within the EZ, when first detected L-DEO will power down the airguns immediately. During a power down of the airgun array, L-DEO will operate the 40-in 3 airgun. If a marine mammal is detected within or near the smaller EZ around that single airgun (Table 1), L-DEO will shut down the airgun (see next section).

Following a power-down, L-DEO will not resume airgun activity until the marine mammal has cleared the safety zone. L-DEO will consider the animal to have cleared the EZ if

• A PSVO has visually observed the animal leave the EZ; or

• A PSVO has not sighted the animal within the EZ for 15 min for small odontocetes, or 30 min for mysticetes and large odontocetes, including sperm, pygmy sperm, dwarf sperm, and beaked whales; or

• The vessel has moved outside the EZ ( e.g., if a marine mammal is sighted close to the vessel and the ship speed is 8.5 km km/h (5.3 mph), it would take the vessel approximately eight minutes to leave the vicinity of the marine mammal.

During airgun operations following a power-down (or shut-down) whose duration has exceeded the time limits specified previously, L-DEO will ramp-up the airgun array gradually (see Shut-down Procedures).

Shut-down Procedures —L-DEO will shut down the operating airgun(s) if a marine mammal is seen within or approaching the EZ for the single airgun. L-DEO will implement a shut-down:

(1) If an animal enters the EZ of the single airgun after L-DEO has initiated a power down, or (2) If an animal is initially seen within the EZ of the single airgun when more than one airgun (typically the full airgun array) is operating.

L-DEO will not resume airgun activity until the marine mammal has cleared the EZ, or until the PSVO is confident that the animal has left the vicinity of the vessel. Criteria for judging that the animal has cleared the EZ will be as described in the preceding section.

Ramp-up Procedures —L-DEO will follow a ramp-up procedure when the airgun subarrays begin operating after a specified period without airgun operations or when a power down has exceeded that period. L-DEO proposes that, for the present cruise, this period would be approximately eight minutes. This period is based on the 180-dB radius for the 36-airgun array towed at a depth of nine m (29.5 ft) in relation to the minimum planned speed of the Langseth while shooting (8.5 km/h; 5.3 mph; 4.6 kts). L-DEO has used similar periods (8-10 min) during previous L-DEO surveys. L-DEO will not resume operations if a marine mammal has not cleared the EZ as described earlier.

Ramp-up will begin with the smallest airgun in the array (40-in 3 ). Airguns will be added in a sequence such that the source level of the array will increase in steps not exceeding six dB per five-minute period over a total duration of approximately 30 min. During ramp-up, the PSVOs will monitor the EZ, and if he/she sights a marine mammal, L-DEO will implement a power down or shut down as though the full airgun array were operational.

If the complete EZ is not visible to the PSVO for at least 30 min prior to the start of operations in either daylight or nighttime, L-DEO will not commence the ramp-up unless at least one airgun (40-in 3 or similar) has been operating during the interruption of seismic survey operations. Given these provisions, it is likely that L-DEO will not ramp up the airgun array from a complete shut-down at night or in thick fog, because the outer part of the EZ for that array will not be visible during those conditions. If one airgun has operated during a power-down period, ramp-up to full power will be permissible at night or in poor visibility, on the assumption that marine mammals will be alerted to the approaching seismic vessel by the sounds from the single airgun and could move away. L-DEO will not initiate a ramp-up of the airguns if a marine mammal is sighted within or near the applicable EZs during the day or close to the vessel at night.

NMFS has carefully evaluated the applicant's proposed mitigation measures and has considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable adverse impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another: (1) The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals; (2) the proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and (3) the practicability of the measure for applicant implementation.

Based on our evaluation of the applicant's proposed measures, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable adverse impacts on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for IHAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the action area.

L-DEO proposes to sponsor marine mammal monitoring during the present project, in order to implement the proposed mitigation measures that require real-time monitoring, and to satisfy the anticipated monitoring requirements of the IHA. L-DEO's proposed Monitoring Plan is described below this section. L-DEO understands that this monitoring plan will be subject to review by NMFS, and that refinements may be required. The monitoring work described here has been planned as a self-contained project independent of any other related monitoring projects that may be occurring simultaneously in the same regions. L-DEO is prepared to discuss coordination of its monitoring program with any related work that might be done by other groups insofar as this is practical and desirable.

L-DEO will position PSVOs aboard the seismic source vessel to watch for marine mammals near the vessel during daytime airgun operations and during any start-ups at night. PSVOs will also watch for marine mammals near the seismic vessel for at least 30 min prior to the start of airgun operations after an extended shut down. PSVOs will conduct observations during daytime periods when the seismic system is not operating for comparison of sighting rates and behavior with and without airgun operations and between acquisition periods.

Based on PSVO observations, the Langseth will power down or shut down the airguns when marine mammals are observed within or about to enter a designated EZ. The EZ is a region in which a possibility exists of adverse effects on animal hearing or other physical effects.

During seismic operations, at least four PSVOs will be based aboard the Langseth. L-DEO will appoint the PSVOs with NMFS' concurrence. During all daytime periods, two PSVOs will be on duty from the observation tower to monitor and PSVOs will be on duty in shifts of duration no longer than four hours. During mealtimes it is sometimes difficult to have two PSVOs on effort, but at least one PSVO will be on watch during bathroom breaks and mealtimes. Use of two simultaneous observers increases the effectiveness of detecting animals near the source vessel.

L-DEO will also instruct other crew to assist in detecting marine mammals and implementing mitigation requirements (if practical). Before the start of the seismic survey, L-DEO will give the crew additional instruction regarding how to accomplish this task.

The Langseth is a suitable platform for marine mammal observations. When stationed on the observation platform, the eye level will be approximately 21.5 m (70.5 ft) above sea level, and the observer will have a good view around the entire vessel. During daytime, the PSVOs will scan the area around the vessel systematically with reticle binoculars ( e.g., 7 x 50 Fujinon), Big-eye binoculars (25 x 150), and with the naked eye. During darkness, night vision devices (NVDs) will be available (ITT F500 Series Generation 3 binocular-image intensifier or equivalent), when required. Laser range-finding binoculars (Leica LRF 1200 laser rangefinder or equivalent) will be available to assist with distance estimation. Those are useful in training observers to estimate distances visually, but are generally not useful in measuring distances to animals directly; that is done primarily with the reticles in the binoculars.

Passive Acoustic Monitoring (PAM) will complement the visual monitoring program, when practicable. Visual monitoring typically is not effective during periods of poor visibility or at night, and even with good visibility, is unable to detect marine mammals when they are below the surface or beyond visual range.

Besides the four PSVOs, an additional Protected Species Acoustic Observer (PSAO) with primary responsibility for PAM will also be aboard the vessel. L-DEO can use acoustical monitoring in addition to visual observations to improve detection, identification, and localization of cetaceans. The acoustic monitoring will serve to alert visual observers (if on duty) when vocalizing cetaceans are detected. It is only useful when marine mammals call, but it can be effective either by day or by night, and does not depend on good visibility. It will be monitored in real time so that the visual observers can be advised when cetaceans are detected. When bearings (primary and mirror-image) to calling cetacean(s) are determined, the bearings will be relayed to the visual observer to help him/her sight the calling animal(s).

The PAM system consists of hardware ( i.e., hydrophones) and software. The “wet end” of the system consists of a towed hydrophone array that is connected to the vessel by a cable. The tow cable is 250 m (820.2 ft) long, and the hydrophones are fitted in the last 10 m (32.8 ft) of cable. A depth gauge is attached to the free end of the cable, and the cable is typically towed at depths less than 20 m (65.6 ft). The array will be deployed from a winch located on the back deck. A deck cable will connect the tow cable to the electronics unit in the main computer lab where the acoustic station, signal conditioning, and processing system will be located. The acoustic signals received by the hydrophones are amplified, digitized, and then processed by the Pamguard software. The system can detect marine mammal vocalizations at frequencies up to 250 kHz.

The PSAO will monitor the towed hydrophones 24 h per day during airgun operations and during most periods when the Langseth is underway while the airguns are not operating. However, PAM may not be possible if damage occurs to both the primary and back-up hydrophone arrays during operations. The primary PAM streamer on the Langseth is a digital hydrophone streamer. Should the digital streamer fail, back-up systems should include an analog spare streamer and a hull-mounted hydrophone. Every effort would be made to have a working PAM system during the cruise. In the unlikely event that all three of these systems were to fail, L-DEO would continue science acquisition with the visual-based observer program. The PAM system is a supplementary enhancement to the visual monitoring program. If weather conditions were to prevent the use of PAM, then conditions would also likely prevent the use of the airgun array.

The PSAO will monitor the acoustic detection system at any one time, by listening to the signals from two channels via headphones and/or speakers and watching the real-time spectrographic display for frequency ranges produced by cetaceans. PSAOs monitoring the acoustical data will be on shift for one to six hours at a time. Besides the PSAO, all PSVOs are expected to rotate through the PAM position, although the most experienced with acoustics will be on PAM duty more frequently.

When a vocalization is detected while visual observations are in progress, the PSAO on duty will contact the visual PSVO immediately, to alert him/her to the presence of cetaceans (if they have not already been seen), and to allow a power down or shut down to be initiated, if required. The information regarding the call will be entered into a database. Data entry will include an acoustic encounter identification number, whether it was linked with a visual sighting, date, time when first and last heard and whenever any additional information was recorded, position and water depth when first detected, bearing if determinable, species or species group ( e.g., unidentified dolphin, sperm whale), types and nature of sounds heard ( e.g., clicks, continuous, sporadic, whistles, creaks, burst pulses, strength of signal, etc. ), and any other notable information. The acoustic detection can also be recorded for further analysis.

PSVOs will record data to estimate the numbers of marine mammals exposed to various received sound levels and to document apparent disturbance reactions or lack thereof. Data will be used to estimate numbers of animals potentially “taken” by harassment (as defined in the MMPA). They will also provide information needed to order a power down or shut down of the airguns when a marine mammal is within or near the EZ.

When a sighting is made, the following information about the sighting will be recorded:

1. Species, group size, age/size/sex categories (if determinable), behavior when first sighted and after initial sighting, heading (if consistent), bearing and distance from seismic vessel, sighting cue, apparent reaction to the airguns or vessel ( e.g., none, avoidance, approach, paralleling, etc. ), and behavioral pace.

2. Time, location, heading, speed, activity of the vessel, sea state, visibility, and sun glare.

The data listed under (2) will also be recorded at the start and end of each observation watch, and during a watch whenever there is a change in one or more of the variables.

All observations and power downs or shut downs will be recorded in a standardized format. Data will be entered into an electronic database. The accuracy of the data entry will be verified by computerized data validity checks as the data are entered and by subsequent manual checking of the database. These procedures will allow initial summaries of data to be prepared during and shortly after the field program, and will facilitate transfer of the data to statistical, graphical, and other programs for further processing and archiving.

Results from the vessel-based observations will provide:

1. The basis for real-time mitigation (airgun power down or shut down).

2. Information needed to estimate the number of marine mammals potentially taken by harassment, which must be reported to NMFS.

3. Data on the occurrence, distribution, and activities of marine mammals and turtles in the area where the seismic study is conducted.

4. Information to compare the distance and distribution of marine mammals and turtles relative to the source vessel at times with and without seismic activity.

5. Data on the behavior and movement patterns of marine mammals seen at times with and without seismic activity.

L-DEO will submit a report to NMFS and NSF within 90 days after the end of the cruise. The report will describe the operations that were conducted and sightings of marine mammals and turtles near the operations. The report will provide full documentation of methods, results, and interpretation pertaining to all monitoring. The 90-day report will summarize the dates and locations of seismic operations, and all marine mammal sightings (dates, times, locations, activities, associated seismic survey activities). The report will also include estimates of the number and nature of exposures that could result in “takes” of marine mammals by harassment or in other ways.

In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by the IHA (if issued), such as an injury (Level A harassment), serious injury or mortality ( e.g., ship-strike, gear interaction, and/or entanglement), L-DEO shall immediately cease the specified activities and immediately report the incident to the Chief of the Permits, Conservation, and Education Division, Office of Protected Resources, NMFS, at 301-427-8401 and/or by e-mail to Michael.Payne@noaa.gov and ITP.Cody@noaa.gov and the Pacific Islands Regional Stranding Coordinator at 808-944-2269 ( David.Schofield@noaa.gov ). The report must include the following information:

• Time, date, and location (latitude/longitude) of the incident;

• Name and type of vessel involved;

• Vessel's speed during and leading up to the incident;

• Description of the incident;

• Status of all sound source use in the 24 hours preceding the incident;

• Water depth;

• Environmental conditions ( e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

• Description of all marine mammal observations in the 24 hours preceding the incident;

• Species identification or description of the animal(s) involved;

• Fate of the animal(s); and

• Photographs or video footage of the animal(s) (if equipment is available).

Activities will not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with L-DEO to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. L-DEO may not resume their activities until notified by NMFS via letter, e-mail, or telephone.

In the event that L-DEO discovers an injured or dead marine mammal, and the lead PSVO determines that the cause of the injury or death is unknown and the death is relatively recent ( i.e., in less than a moderate state of decomposition as described in the next paragraph), L-DEO will immediately report the incident to the Chief of the Permits, Conservation, and Education Division, Office of Protected Resources, NMFS, at 301-427-8401 and/or by e-mail to Michael.Payne@noaa.gov and ITP.Cody@noaa.gov and the Pacific Islands Regional Stranding Coordinator at 808-944-2269 ( David.Schofield@noaa.gov ). The report must include the same information identified in the paragraph above. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with L-DEO to determine whether modifications in the activities are appropriate.

In the event that L-DEO discovers an injured or dead marine mammal, and the lead PSVO determines that the injury or death is not associated with or related to the activities authorized in the IHA ( e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), L-DEO will report the incident to the Chief of the Permits, Conservation, and Education Division, Office of Protected Resources, NMFS, at 301-427-8401 and/or by e-mail to Michael.Payne@noaa.gov and ITP.Cody@noaa.gov and the Pacific Islands Regional Stranding Coordinator at 808-944-2269 ( David.Schofield@noaa.gov ), within 24 hours of the discovery. L-DEO will provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as:

Only take by Level B harassment is anticipated and proposed to be authorized as a result of the proposed marine geophysical survey in the central Pacific Ocean. Acoustic stimuli ( i.e., increased underwater sound) generated during the operation of the seismic airgun array may have the potential to cause marine mammals in the survey area to be exposed to sounds at or greater than 160 decibels (dB) or cause temporary, short-term changes in behavior. There is no evidence that the planned activities could result in injury, serious injury or mortality within the specified geographic area for which L-DEO seeks the IHA. The required mitigation and monitoring measures will minimize any potential risk for injury or mortality.

The following sections describe L-DEO's methods to estimate take by incidental harassment and present the applicant's estimates of the numbers of marine mammals that could be affected during the proposed geophysical survey. The estimates are based on a consideration of the number of marine mammals that could be disturbed appreciably by operations with the 36-airgun array to be used during approximately 2,120 km (1,317.3 mi) of survey lines.

L-DEO assumes that, during simultaneous operations of the airgun array and the other sources, any marine mammals close enough to be affected by the MBES and SBP would already be affected by the airguns. However, whether or not the airguns are operating simultaneously with the other sources, marine mammals are expected to exhibit no more than short-term and inconsequential responses to the MBES and SBP given their characteristics ( e.g., narrow downward-directed beam) and other considerations described previously. Based on the best available science, such reactions are not considered to constitute “taking” (NMFS, 2001). Therefore, L-DEO provides no additional allowance for animals that could be affected by sound sources other than airguns.

Density data on the marine mammal species in the proposed survey area are available from two sources: (1) The NMFS Southwest Fishery Science Center (SWFSC) habitat model that estimates cetacean densities on a finer spatial scale than traditional line-transect analyses by using a continuous function of habitat variables, e.g., sea surface temperature, depth, distance from shore, and prey density (Barlow et al., 2009b); and (2) densities from the offshore stratum of the surveys of Hawaiian waters conducted in August-November 2002 (Barlow, 2006).

For the eastern tropical Pacific Ocean (ETP), the SWFSC based the models on data from 12 SWFSC ship-based cetacean and ecosystem assessment surveys conducted during July-December 1986-2006, extending just into the proposed survey area.

The models have been incorporated into a Web-based Geographic Information System (GIS) developed by Duke University's Department of Defense Strategic Environmental Research and Development Program (SERDP) team in close collaboration with the SWFSC SERDP team (Read et al., 2009). For the cetacean species in the model, we used the GIS to obtain mean densities in the proposed survey area, i.e., in a rectangle bounded by 150 and 156° W and 5 and 10° N.

Table 3 in L-DEO's application shows estimated densities for each cetacean species that could occur in the proposed survey area. They have corrected the densities for both trackline detection probability and availability bias by the authors. Trackline detection probability bias is associated with diminishing sightability with increasing lateral distance from the trackline [ f (0)]. Availability bias refers to the fact that there is less than a 100 percent probability of sighting an animal that is present along the survey trackline [ g (0)].

Because survey effort within the proposed survey area is limited, and densities for some species are from offshore Hawaiian waters, there is some uncertainty about the representativeness of the data and the assumptions used in the calculations below. However, the approach used here is believed to be the best available approach.

L-DEO's estimates of exposures to various sound levels assume that the proposed surveys will be completed. As is typical during offshore ship surveys, inclement weather and equipment malfunctions are likely to cause delays and may limit the number of useful line-kilometers of seismic operations that can be undertaken. L-DEO has included an additional 25% of line transects to account for mission uncertainty and to accommodate turns and lines that may need to be repeated. Furthermore, any marine mammal sightings within or near the designated exclusion zones will result in the power down or shut down of seismic operations as a mitigation measure. Thus, the following estimates of the numbers of marine mammals potentially exposed to sound levels of 160 dB re: 1 μPa are precautionary and probably overestimate the actual numbers of marine mammals that might be involved. These estimates also assume that there will be no weather, equipment, or mitigation delays, which is highly unlikely.

L-DEO estimated the number of different individuals that may be exposed to airgun sounds with received levels greater than or equal to 160 dB re: 1 μPa on one or more occasions by considering the total marine area that would be within the 160-dB radius around the operating airgun array on at least one occasion and the expected density of marine mammals. The number of possible exposures (including repeated exposures of the same individuals) can be estimated by considering the total marine area that would be within the 160-dB radius around the operating airguns, including areas of overlap. In the proposed survey, the seismic lines are parallel and in close proximity; thus individuals could be exposed on two or more occasions. The area including overlap is 1.5 times the area excluding overlap. Thus a marine mammal that stayed in the survey area during the entire survey could be exposed two times, on average. Moreover, it is unlikely that a particular animal would stay in the area during the entire survey.

The number of different individuals potentially exposed to received levels greater than or equal to 160 re: 1 μPa was calculated by multiplying:

(1) The expected species density, times; and

(2) The anticipated area to be ensonified to that level during airgun operations excluding overlap, which is approximately 10,971 square kilometers (km 2 ) (4,235.9 square miles (mi 2 ).

The area expected to be ensonified was determined by entering the planned survey lines into a MapInfo GIS, using the GIS to identify the relevant areas by “drawing” the applicable 160-dB buffer (see Table 1) around each seismic line, and then calculating the total area within the buffers. Areas of overlap were included only once when estimating the number of individuals exposed. Applying this approach, approximately 13,714 km 2 (5,295 mi 2 ) would be within the 160-dB isopleth on one or more occasions during the survey. Because this approach does not allow for turnover in the mammal populations in the study area during the course of the survey, the actual number of individuals exposed could be underestimated. However, the approach assumes that no cetaceans will move away from or toward the trackline as the Langseth approaches in response to increasing sound levels prior to the time the levels reach 160 dB, which will result in overestimates for those species known to avoid seismic vessels.

Table 3 in this notice shows estimates of the number of individual cetaceans that potentially could be exposed to greater than or equal to 160 dB re: 1 μPa during the seismic survey if no animals moved away from the survey vessel. The requested take authorization is shown in the far right column of Table 3. For endangered species, the requested take authorization reflects the mean group size in the ETP (Jackson et al., 2008) for the particular species in cases where the calculated number of individuals exposed was between 0.05 and the mean group size ( i.e., for the blue whale). For non-listed species, the requested take authorization reflects the mean group size in the SWFSC survey area (Barlow et al., 2008) for the particular species in cases where the calculated number of individuals exposed was between one and the mean group size.

The total estimate of the number of individual cetaceans that could be exposed to seismic sounds with received levels greater than or equal to 160 dB re: 1 μPa during the proposed survey is 5,124 (see Table 3 in this notice; Table 4 in L-DEO's application). That total includes: Eight Bryde's whales or 0.6 percent of the regional population; two blue whales (endangered under the ESA) or less than 0.01 percent of the regional population); and 41 sperm whales (also listed as endangered) or 2.97 percent of the regional population could be exposed during the survey. In addition, 110 beaked whales (91 Cuvier's, six Longman's, 14 Longman's beaked whales, and five Mesoplodon spp.) could be exposed during the survey (see Table 3 in this notice; Table 4 in L-DEO's application). Most (94.8 percent) of the cetaceans that could be potentially exposed are delphinids ( e.g., spinner, pantropical spotted, and striped dolphins are estimated to be the most common species in the area) with maximum estimates ranging from five to 2,516 species exposed to levels greater than or equal to 160 dB re: 1 μPa.

Based upon densities estimates for humpback, sei, fin, minke, pygmy sperm, and pygmy killer whales (Barlow et al., 2009; Read et al., 2009) within the action area, L-DEO has not requested take for these species. NMFS preliminarily concurs with this analyses and the proposed authorization will not include authorize take for these species.

L-DEO and NSF will coordinate the planned marine mammal monitoring program associated with the seismic survey in the central Pacific Ocean with other parties that may have interest in the area and/or be conducting marine mammal studies in the same region during the proposed seismic survey.

NMFS has defined “negligible impact” in 50 CFR 216.103 as “* * * an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” In making a negligible impact determination, NMFS considers:

(1) The number of anticipated mortalities;

(2) The number and nature of anticipated injuries;

(3) The number, nature, and intensity, and duration of Level B harassment; and

(4) The context in which the takes occur.

As mentioned previously, NMFS estimates that 20 species of marine mammals could be potentially affected by Level B harassment over the course of the IHA.

For reasons stated previously in this document, no injuries or mortalities are anticipated to occur as a result of L-DEO's proposed seismic survey, and none are proposed to be authorized by NMFS. Additionally, for reasons presented earlier in this document, temporary hearing impairment (and especially permanent hearing impairment) is not anticipated to occur during the proposed specified activity.

Impacts to marine mammals are anticipated to be in the form of Level B behavioral harassment only, due to the brief duration and sporadic nature of the survey. Certain species may have a behavioral reaction ( e.g., increased swim speed, avoidance of the area, etc. ) to the sound emitted during the proposed marine seismic survey. Behavioral modifications, including temporarily vacating the area during the operation of the airgun(s), may be made by these species to avoid the resultant acoustic disturbance. However, alternate areas are available to these species. The location of the survey is not a known feeding ground for these species and it is not used for breeding or nursing.

For reasons stated previously in this document, the specified activities associated with the proposed survey are not likely to cause TTS, PTS or other non-auditory injury, serious injury, or death to affected marine mammals because:

(1) The likelihood that, given sufficient notice through relatively slow ship speed, marine mammals are expected to move away from a noise source that is annoying prior to its becoming potentially injurious;

(2) The fact that cetaceans would have to be closer than 400 m (1,312 ft) in deep water when the 36-airgun array is in use at a 9 m (29.5 ft) tow depth from the vessel to be exposed to levels of sound believed to have even a minimal chance of causing PTS;

(3) The fact that marine mammals would have to be closer than 3,850 m (2.4 mi) in deep water when the full array is in use at a 9 m (29.5 ft) tow depth from the vessel to be exposed to levels of sound (160 dB) believed to have even a minimal chance at causing TTS; and

(4) The likelihood that marine mammal detection ability by trained observers is high at that short distance from the vessel.

Table 3 in this document outlines the number of Level B harassment takes that are anticipated as a result of the proposed activities. No mortality or injury is expected to occur, and due to the nature, degree, and context of behavioral harassment anticipated, the activity is not expected to impact rates of recruitment or survival. The proposed survey would not occur in any areas designated as critical habitat for ESA-listed species. Additionally, as mentioned previously in this document, the proposed seismic survey will not destroy marine mammal habitat.

Of the 26 marine mammal species likely to occur in the proposed survey area, six are listed as endangered under the ESA: The humpback, sei, fin, blue, and sperm whale and the Hawaiian monk seal. These species are also considered depleted under the MMPA. However, no take of endangered humpback, sei, or fin, whales was requested because of the low likelihood of encountering these species during the cruise.

For the 20 species for which take was requested, the requested take numbers are small (each, less than two and one-half percent) relative to the population size. The population estimates for the species that may potentially be taken as a result of L-DEO's proposed seismic survey were presented earlier in this document. For reasons described earlier in this document, the maximum calculated number of individual marine mammals for each species that could potentially be taken by harassment is small relative to the overall population sizes (0.06 percent for Bryde's whales, less than 0.01 percent for the endangered blue whale, 0.17 percent for the endangered sperm whale, and less than 2.5 percent of the other 15 mammal populations or stocks).

Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, NMFS preliminarily finds that L-DEO's planned research activities, will result in the incidental take of small numbers of marine mammals, by Level B harassment only, and that the total taking from the marine geophysical survey will have a negligible impact on the affected species or stocks.

There are no relevant subsistence uses of marine mammals implicated by this action.

Of the species of marine mammals that may occur in the proposed survey area, six are listed as endangered under the ESA, including the humpback, sei, fin, blue, and sperm whales and the Hawaiian monk seal. However, L-DEO is only requested Level B incidental harassment of two species: The humpback and sperm whales. L-DEO did not request take of endangered humpback, sei, or fin, whales because of the low likelihood of encountering these species during the cruise. Under section 7 of the ESA, NSF has initiated formal consultation with the NMFS, Office of Protected Resources, Endangered Species Division, on this proposed seismic survey. NMFS' Office of Protected Resources, Permits, Conservation and Education Division, has initiated formal consultation under section 7 of the ESA with NMFS' Office of Protected Resources, Endangered Species Division, to obtain a Biological Opinion evaluating the effects of issuing the IHA on threatened and endangered marine mammals and, if appropriate, authorizing incidental take. NMFS will conclude formal section 7 consultation prior to making a determination on whether or not to issue the IHA. If the IHA is issued, L-DEO, in addition to the mitigation and monitoring requirements included in the IHA, will be required to comply with the Terms and Conditions of the Incidental Take Statement corresponding to NMFS' Biological Opinion issued to both NSF and NMFS' Office of Protected Resources.

To meet NMFS' National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ) requirements for the issuance of an IHA to L-DEO, NMFS will prepare an Environmental Assessment (EA) titled “Issuance of an Incidental Harassment Authorization to the Lamont-Doherty Earth Observatory to Take Marine Mammals by Harassment Incidental to a Marine Geophysical Survey in the Central Pacific Ocean, November, 2011 through January, 2012.” This EA will incorporate the NSF's Environmental Analysis Pursuant To Executive Order 12114 (NSF, 2010) and an associated report (Report) prepared by LGL Limited Environmental Research Associates (LGL) for NSF, titled, “Environmental Assessment of a Marine Geophysical Survey by the R/V Marcus G. Langseth in the Central Pacific Ocean, November—December 2011,” by reference pursuant to 40 CFR 1502.21 and NOAA Administrative Order (NAO) 216-6 § 5.09(d). Prior to making a final decision on the IHA application, NMFS will make a decision of whether or not to issue a Finding of No Significant Impact (FONSI).

As a result of these preliminary determinations, NMFS proposes to authorize the take of marine mammals incidental to L-DEO's proposed marine seismic survey in the central Pacific Ocean, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.

1. Background. The EIS will assess the impacts associated with dredging approximately 38,137 feet (7.22 miles) of the existing Pascagoula Lower Sound/Bayou Casotte Federal Channel segment to widen the channel 100 feet parallel to the existing channel centerline, to the existing depth of −42 feet mean lower low water, as well as the beneficial use and placement of the dredged material. The proposed project would be developed over approximately the next 2 to 3 years.

The EIS discussed in this notice would support the regulatory process for this specific permit application and Project. The Corps Planning Division is also preparing a separate EIS and Feasibility Study under the Corps Planning Process to evaluate whether there is a Federal interest in modifying the existing federally authorized navigation channel (Federal Navigation Channel) leading to Bayou Casotte ( i.e., Pascagoula channel widening from the Horn Island Pass to the entrance of the Bayou Casotte Harbor) and maintenance of the channel.

The primary Federal involvement in this EIS for the Regulatory Division is an application for a permit to dredge or excavate adjacent to a Federal Navigation Channel in or affecting navigable waters of the United States, and potential impacts on the human environment from such activities, as well as the disposal of material in the littoral disposal area, which could be suitable for beneficial use. Also included in the evaluation is the placement of dredged material within the U.S. Environmental Protection Agency (EPA) designated Pascagoula Ocean Dredged Material Disposal Site (ODMDS) and the designated Littoral Zone Placement Area located east and south of the barrier island. It is anticipated that the excavated area would become part of the Federal Navigation Channel in the future, if the Corps adopts maintenance of the widened area, pending approval of the Corps Planning documents described above. No wetland impacts are known to exist at the proposed dredge disposal site. In accordance with the National Environmental Policy Act (NEPA), the Corps is requiring the preparation of an Environmental Impact Statement (EIS) prior to rendering a final decision on the Port's permit application, based on potentially significant impacts to water quality, cultural resources, endangered or threatened species, or sediment transport. The Corps may ultimately make a determination to approve the permit, approve the permit with conditions, or deny the permit for the above project.

This effort will also support non-federal construction of the project and, in concert with the parallel Planning Division EIS, the potential federal maintenance under the authority of Section 204(b) of the Water Resources Development Act of 1986.

Pursuant to the National Environmental Policy Act of 1969 (as amended), the Corps will serve as Lead Agency for the Preparation of an EIS. The Draft EIS is intended to be sufficient in scope to address both the Federal and the state and local requirements and environmental issues concerning the proposed activities and permit approvals. The National Marine Fisheries Service (NMFS) has expressed interest in acting as a cooperating agency in the preparation of the EIS.

2. Project Purpose and Need. The overall project purpose is to widen the existing Federal Navigation Channel, including excavation, as needed, to reconfigure the site to alleviate the current transit restrictions and increase travel efficiencies for vessel transit, improve safety conditions for vessel operations, improve conditions for port operations, and improve habitat conditions through the beneficial use of dredged material.

3. Issues. There are several potential environmental issues that will be addressed in the EIS. Additional issues may be identified during the scoping process. Issues initially identified as potentially significant include:

a. Impacts to traffic, including marine navigation and ground transportation;

b. Potential impacts to endangered and threatened species;

c. Air quality;

d. Water quality;

e. Socioeconomic effects;

f. Cumulative impacts; and

g. Placement of dredged materials.

4. Alternatives. Alternatives initially being considered for the proposed improvement project include the following:

a. No Project/No Action. .This alternative would not implement any of the elements presented in the project description.

b. Widening 100 feet on the West Side. This alternative is the proposed Project to widen the Federal Channel segment approximately 100 feet parallel to the existing channel centerline, to the existing depth of −42 feet mean lower low water. The width may be increased as necessary to allow adequate transit for navigation in transition zones. The improved channel would be 7.22 miles long and result in excavation of approximately 3.4 to 3.8 million cubic yards of dredged material.

c. Widening of 50 feet on Either Side of the Channel Centerline. This alternative includes a proposal to widen the Federal Channel segment, approximately 50 feet on either side of the existing channel centerline, to the existing depth of −42 feet mean lower low water. The width may be increased as necessary to allow adequate transition for navigation. The improved channel would be similar in length and dredged material quantities to the proposed Project (widening 100 feet on the West Side).

5. Scoping Process. As part of the Corps Planning Division EIS, a public scoping meeting was conducted for the proposed Bayou Casotte and Lower Sound Channels Widening of the Pascagoula Harbor Channel. The meeting was held to receive public comments and assess public concerns regarding the appropriate scope and preparation of the Draft EIS. Participation in the public meeting by Federal, State, and local agencies and other interested organizations and persons was encouraged. This meeting was conducted in English, and was held on Thursday, February 25, 2010 from 5:30 p.m. to 7:30 p.m., located at the Pascagoula Public Library, 3214 Pascagoula Street, Pascagoula, MS 39567.

A comment period was held for the Regulatory Division on the permit application, which was noticed April 15, 2011. The comment period was held from April 15, 2011 to May 16, 2011.

The Corps will be accepting written comments on this Notice of Intent to prepare an EIS, and they will be taken into consideration during development of the document. We encourage any additional comments from interested public, agencies, and local officials. Written and e-mailed comments to the Corps will be received until October 20, 2011. Written comments should be sent to the address below:

U.S. Army Corps of Engineers, Mobile District, Regulatory Division, c/o Philip A. Hegji, 109 St. Joseph Street, Mobile, Alabama 36628-0001, e-mail: Philip.A.Hegji@usace.army.mil.

6. Availability of the Draft EIS. The Corps expects the Draft EIS to be made available to the public in late spring 2012. A public hearing will be held during the public comment period for the Draft EIS.

5 U.S.C. 4314(c)(1) through (5) requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more performance review boards. The PRB shall review and evaluate the initial summary rating of the senior executive's performance, the executive's response, and the higher level official's comments on the initial summary rating. In addition, the PRB will review and recommend executive performance bonuses and pay increases.

The DNFSB is a small, independent Federal agency; therefore, the members of the DNFSB SES Performance Review Board listed in this notice are drawn from the SES ranks of other agencies. The following persons comprise a standing roster to serve as members of the Defense Nuclear Facilities Safety Board SES Performance Review Board:

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and related activities.

Public Participation: The meeting is open to the public. The EM SSAB, Portsmouth, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Joel Bradburne at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Joel Bradburne at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available by writing or calling Joel Bradburne at the address and phone number listed above. Minutes will also be available at the following Web site: http://www.ports-ssab.energy.gov/.

Purpose of Meeting: To conduct an open meeting of the NCC and to provide an update of the current NCC study.

• Welcome and Call to Order by NCC Chair.

• Keynote address by Secretary Steven Chu, Department of Energy.

• Presentation by Phil Ren on the Northeast Asia Coal Exchange Center.

• Presentation by Barry Worthington, President of the U.S. Energy Agency.

• Presentation by Lynn Sprague, National Museum of Forest Service History, on reforestation and reclamation of mine lands.

• Council Business.

• Adjourn.

Public Participation: The meeting is open to the public. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any potential items on the agenda, you should contact Michael J. Ducker, (202) 586-7810 or Michael.Ducker@HQ.DOE.GOV (e-mail). You must make your request for an oral statement at least 5 business days before the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Chairperson of the Committee will conduct the meeting to facilitate the orderly conduct of business. Public comment will follow the 10-minute rule.

Minutes: The NCC will prepare meeting minutes within 45 days of the meeting. The minutes will be posted on the NCC Web site at http://www.nationalcoalcouncil.org/ .

For decades, the U.S. and Mexico have collaborated on efforts to protect the environment and health of border communities. One of the first bi-national efforts was the Border XXI Program, which was initiated in 1996 with a five-year plan for addressing the most challenging environmental and environmentally-related health problems in the region. The formal foundation for these bi-national efforts is the La Paz Agreement ( http://www.epa.gov/usmexicoborder/2002/efpaz.htm ) signed by Presidents De la Madrid and Reagan in 1983. The agreement is implemented through multi-year bi-national programs such as Border XXI, Border 2012 and now the new Border 2020 program. Although most of the Border XXI projects were implemented at the local level, its organizational structure emphasized border-wide coordination and planning. Nine border-wide workgroups—each focused on a particular environmental program, such as air quality or hazardous waste management—coordinated the efforts of various Federal, state, Tribal and local governmental activities in the border area. The existing Border 2012 Program builds upon the successes achieved under Border XXI while also establishing a regionally-focused border plan to facilitate environmental priority setting and planning at the regional and local levels.

Border 2012 is a 10-year, bi-national, results-oriented, environmental program for the U.S.-Mexico border region, which was developed by the EPA, the U.S. Department of Health and Human Services, Secretaría de Medio Ambiente y Recursos Naturales (Mexico's Secretariat of Environment and Natural Resources), Secretaría de Salud (Mexico's Secretariat of Health), the 26 U.S. border Tribes, and the environmental agencies from each of the ten U.S.-Mexico border states. The Border 2012 Program is a multi-year, bi-national planning effort to be implemented under the La Paz Agreement and succeeds Border XXI, a five-year program that ended in 2000. The mission of Border 2012 is “to protect public health and the environment in the U.S.-Mexico border region, consistent with the principles of sustainable development”. Border 2020 will continue to operate under the existing Border 2012 bottom-up approach, which incorporates local decision making within priority setting and project implementation process. Border 2020 will also continue to emphasize concrete measurable results, public participation, transparency and access to environmental information.

New features of the Border 2020 Program are the following: (1) Integration of fundamental principles to be used as we approach and consider complex and critical challenges faced by border communities along the U.S.-Mexico Border ; (2) a focus on improving environmental health through chemical safety; and (3) the use of Action plans that will establish priority and near-term targets that pay attention to the particular needs of a community or geographic area and adapt to unanticipated resource constraints.

Border 2020 will continue to be organized around coordinating bodies. These coordinating bodies include the following: The National Coordinators, six Policy For a, and four Regional (geographically-focused) Workgroups.

Consistent with the requirements of the La Paz Agreement, the National Coordinators will monitor and manage implementation of the Border 2020 Program and ensure cooperation and communication among all coordinating bodies.

Policy Fora concentrate on issues that are border-wide and multi-regional (identified as a priority by two or more regional workgroups), primarily Federal in nature (requiring direct, high-level, and sustained leadership by Federal program partners in the United States and Mexico) and that might require broad policy considerations. Each of the six Policy Fora will have a Federal co-chair from the United States and Mexico, respectively.

Regional Workgroups are multi-media and geographically-focused, and emphasize regional public health and environmental issues. They coordinate activities at the regional level and support the efforts of local Task Forces. Each Regional Workgroup will have one state and one Federal co-chair from each country. Four bi-national workgroups have been established in the following regions:

The Policy Fora and the Regional Workgroups will be broad-based and will include representation from local communities from both sides of the border, including non-governmental or community-based organizations; academic institutions; local, state, and Tribal representatives; and bi-national organizations (such as the Border Environmental Cooperation Commission or the North American Development Bank) with expertise in the given workgroup's subject area.

Except for the National Coordinators, the coordinating bodies may create Task Forces to address specific community-identified concerns and implement site-specific projects. Task Forces will be led by a “team leader” from each country and may be from any sector of government (including Tribal governments), the private sector, academia, or from non-governmental organizations.

Border 2020 establishes the following six environmental goals for the U.S.-Mexico border region:

The coordinating bodies will prepare Highlight reports that describe the accomplishments and successes under the Border 2020 program every three years (2015, 2018). In addition, a comprehensive mid-term (2016) and final progress report (2020) that describe progress on meeting the goals and objectives of the program, including environmental indicators will be made available accordingly. Indicator reports which will measure progress being made toward Border 2020 goals and objectives will be developed during the third and seventh year of the program.

As a companion to the six strategic goals (and associated objectives), which outline the anticipated results we hope to achieve in the next eight years, the following five Fundamental Principles provide the expectation for how we will approach and consider complex and critical challenges faced by border communities along the U.S.-Mexico Border. The fundamental principles will complement and inform the work that we do to achieve the mission and goals of the Border 2020 program. They are identified as follows:

EPA and SEMARNAT are seeking input from border stakeholders and other interested parties about the proposed Border 2020 program. We invite public comments related to all aspects of the proposed Border 2020 plan, and, in particular, we are interested in comments related to: How well will the six long-term strategic goals address the serious environmental and environmentally-related public health challenges in the border region. The draft Border 2020 framework document is available online for viewing at http://www.epa.gov/border 2012. A number of opportunities for the public to comment on the draft document are provided as follows:

Individuals can submit comments directly by filling out the public comment form at: http://www.epa.gov/border2012 .

A number of public meetings will be held in September and October 2011. For meeting locations and times, please check the EPA U.S.-Mexico Border Web site or contact the EPA Office of International and Tribal Affairs. Public comment will be accepted at these meetings.

C. Interested parties can also mail or fax comments to the EPA OITA, Region 9 or Region 6 Border Offices or SEMARNAT at the addresses and/or fax numbers listed below.

D. Interested parties can also e-mail comments to EPA at Border2020.comments@epa.gov or SEMARNAT at frontera2012@semarnat.gob.mx.

EPA will continue to honor its unique trust relationship with U.S. Indian Tribes and enforce its “Policy for the Administration of Environmental Program on Indian Reservations” within the Border 2020 U.S.-Mexico program. EPA recognizes that U.S. Tribal governments are sovereign and are the primary parties for setting standards, making environmental policy decisions, and managing environmental programs on Indian reservations.

Within the Border 2020 Program, EPA will comply with Executive Order 13175 or 13563, Consultation and Coordination with Indian Tribal Governments” and work with Tribes when formulating and implementing policies or taking other actions that have a substantial direct effect on any Indian Tribe.

OMB Control Number: 3060-0627.

Title: Application for AM Broadcast Station License, FCC Form 302-AM.

Form Number: FCC Form 302-AM.

Type of Review: Extension of currently approved collection.

Respondents: Business or other for-profit entities; not for profit institutions.

Number of Respondents and Reponses: 380 respondents; 380 responses.

Estimated Time per Response: 4-20 hours.

Frequency of Response: On occasion reporting requirement.

Total Annual Burden: 2,800 hours.

Total Annual Costs: $16,651,600.

Obligation to Respond: The statutory authority for this collection of information is contained in Sections 154(i), 303 and 308 of the Communications Act of 1934, as amended.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Privacy Impact Assessment(s): No impact(s).

Needs and Uses: Licenses and permittees of AM broadcast stations are required to file FCC Form 302-AM to obtain a new or modified station license, and/or to notify the Commission of certain changes in the licensed facilities of these stations. Additionally, when changes are made to an AM station that alter the resistance of the antenna system, a licensee must initiate a determination of the operating power by the direct method. The results of this are reported to the Commission using the FCC 302-AM.

OMB Control Number: 3060-1122.

Title: Preparation of Annual Reports to Congress for the Collection and Expenditure of Fees or Charges for Enhanced 911 (E911) Services Under the NET 911 Improvement At of 2008.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: State, local or tribal government.

Number of Respondents and Responses: 56 respondents; 56 responses.

Estimated Time Per Response: 50 hours.

Frequency of Response: Annual reporting requirement and recordkeeping requirement.

Obligation to Respond: Voluntary. Statutory authority for this information collection is contained in the New and Emerging Technologies 911 Improvement Act of 2008, Public Law 110-283, 122 Stat. 2620 (2008) (NET 911 Act).

Total Annual Burden: 2,800 hours.

Total Annual Cost: N/A.

Privacy Act Impact Assessment: N/A.

Nature and Extent of Confidentiality: There are no assurances of confidentiality provided to respondents. The Commission's rules address the issue of confidentiality in sections 47 CFR 0.457, 0.459, and 0.461. These rules address access to records that are not routinely available to the public, requests and requirements that materials submitted to the Commission be withheld from public inspection, and requests for inspection of materials not routinely available to the public.

Needs and Uses: The Commission will submit this expiring information collection to the OMB after this comment period to obtain the three year clearance from them. There is no change in the Commission's burden estimates. There are no changes in the reporting and/or recordkeeping requirements.

The purpose of the information collection is to meet the Commission's ongoing statutory obligations under the New and Emerging Technologies 911 Improvement Act of 2008, which requires the Commission to submit an annual report to congress detailing the status in each state of the collection and distribution of such fees or charges, and including findings on the amount of revenues obligated or expended by each state or political subdivision thereof for any purpose other than the purpose for which any such fees or charges are specified.

OMB Control Number: 3060-1151.

Title: Sections 1.1420, 1.1422, and 1.1424, Pole Attachment Access Requirements.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents and Responses: 1,278 respondents; 54,932 responses.

Estimated Time per Response: 1-600 hours.

Frequency of Response: On occasion reporting requirement, recordkeeping requirement and third party disclosure requirement.

Obligation To Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. 224.

Total Annual Burden: 683,169 hours.

Total Annual Cost: N/A.

Privacy Act Impact Assessment: N/A.

Nature and Extent of Confidentiality: No confidentiality regarding recordkeeping or reporting. No known confidentiality between third parties.

Needs and Uses: The Commission is seeking OMB approval for an extension (no change in the reporting, recordkeeping and/or third party disclosure requirements.) There is no change in the Commission's burden estimates. The Commission received emergency OMB approval for this collection on June 21, 2011. This collection is now being submitted to OMB to secure the regular, three-year approval.

The rule sections are needed to implement the statutory mandate that communications companies (attachers) should be able to place facilities on utility poles. The rules set a series of deadlines or “timelines” to govern the process by which permission is sought by attachers and granted by utility pole owners. In practice, attachers must submit detailed applications that cause the utility to survey and perform an engineering analysis on the poles where access is requested.

The post-survey pole preparation work (make-ready) triggers further paperwork burdens. These include the pole owner notifying all known entities with existing attachments and the requesting attacher of the scheduled work. Other notification occurs if the make-ready period is interrupted, and if a pole owner asserts its right to one 15-day extension of time. Pole owners both perform make ready and coordinate with existing attachers over many weeks.

Also, the Order adopted rules intended to make the deadlines largely self-enforcing. Utilities are required to post a list of approved contractors. If a deadline is not met, new attachers may hire a listed, utility-approved contractor to perform pole attachment surveys or preparation in lieu of the utility using its own workers. If an attacher uses a utility-approved contractor, it must notify the utility, and invite the utility to send a representative to oversee the work. This self-enforcing mechanism removes some of the burden from the complaint process, which is often too slow to provide meaningful relief when pole access is denied or unreasonably delayed.

Finally, the Order also broadened the existing enforcement process by permitting incumbent local exchange carriers (LECs) to file complaints alleging that the attachment rates demanded by electric utilities are unreasonable. The Order also encourages incumbent LECs that benefit from lower pole attachment costs to file data at the Commission that demonstrates that the benefits are being passed on to consumers.

The Commission is seeking emergency OMB review by October 17, 2011 for this revised information collection and has requested OMB approval 20 days after the collection is received at OMB. ( Note: The Commission published a regular 60-day notice in the Federal Register on August 23, 2011 (76 FR 52662)). It was later determined that the Commission needed to seek emergency processing of this information collection in order to implement the newly created electronic database in mid-October.

OMB Control Number: 3060-0207.

Title: Emergency Alert System (EAS).

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities; state, local or tribal government; and not-for-profit institutions.

Number of Respondents and Responses: 3,569,028 respondents; 3,569,028 responses.

Estimated Time per Response: .034-20 hours.

Frequency of Response: Reporting requirement, recordkeeping requirement and third party disclosure requirement.

Obligation to Respond: Voluntary. Statutory authority for this information collection is contained in 47 U.S.C. sections 154(i) and 606.

Total Annual Burden: 82,008 hours.

Total Annual Cost: N/A.

Privacy Act Impact Assessment: N/A.

Nature and Extent of Confidentiality: The Commission will treat submissions pursuant to 47 CFR 11.61(a)(3) as confidential.

Needs and Uses: On March 10, 2010, OMB approved the collection of information set forth in the Second FNPRM in EB Docket No. 04-296, FCC 09-10. Specifically, OMB authorized the Commission to require entities require to participate in EAS (EAS participants) to gather and submit the following information on the operation of their EAS equipment during a national test of the EAS: (1) Whether they received the alert message during the designated test; (2) whether they retransmitted the alert; and (3) if they were not able to receive and/or transmit the alert, their “best effort” diagnostic analysis regarding the cause or causes for such failure. OMB also authorized the Commission to require EAS participants to provide it with the date/time of receipt of the Emergency Action Notification (EAN) message by all stations; and the date/time of receipt of the Emergency Action Termination (EAT) message by all stations; a description of their station identification and level of designation (PEP, LP-1, etc); who they were monitoring at the time of the test, and the make and model of the EAS equipment that they utilized.

In the Third Report and Order in EB Docket No. 04-296, FCC 09-10, the Commission adopted the foregoing rule requirements. In addition, the Commission decided that test data will be presumed confidential and disclosure of the test data will be limited to FEMA, NWS and EOP at the federal level. At the state level, test data will be made available only to state government emergency management agencies that have confidential treatment protections at least equal to Freedom of Information Act (FOIA). The process by which these agencies would receive test data will comport with those used to provide access to the Commission's NORS and DIRS data. We seek a shortened comment period on this revision of the pre-approved collection.

In the Third Report and Order, the Commission also indicated that it would establish a voluntary electronic reporting system that EAS test participants may use as part of their participation in the national EAS test. The Commission noted that using this system, EAS test participants could input the same information that they were already required to file manually via a Web-based interface into a confidential database that the Commission would monitor and assess the test. This information would include identifying information such as station call letters, license identification number, geographic coordinates, EAS assignment (LP, NP, etc. ), EAS monitoring assignment, as well as a 24/7 emergency contact for EAS participant. The only difference, other than the electronic nature of the filing, would be the timing of the collection. On the day of the test, EAS test participants would be able to input immediate test results, ( e.g., was the EAN received and did it pass) into a Web-based interface. Test participants would submit the identifying data prior to the test date, and the remaining data called for by our reporting rules ( e.g., the detailed test results) within the 45 day period. The Commission believes that structuring an electronic reporting system in this fashion would allow the participants to populate the database with known information well prior to the test, and thus be able to provide the Commission with actual test data, both close to real-time and within a reasonable period in a minimally burdensome fashion. The Commission also seeks comment on this revision of the pre-approved collection.

OMB Control Number: 3060-0017.

Title: Application for a Low Power TV, TV Translator, or TV Booster Station License.

Form Number: FCC Form 347.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities; State, local or Tribal Government.

Number of Respondents: 300.

Estimated Time per Response: 1.5 hours.

Frequency of Response: On occasion reporting requirement.

Total Annual Burden: 450 hours.

Total Annual Cost: $36,000.

Privacy Impact Assessment(s): No impact(s).

Needs and Uses: The FCC Form 347 is used by licensees/permittees of low power television, TV translator or TV booster stations to apply for a station license. FCC staff uses the data to confirm that the station has been built in the outstanding construction permit. Data from Form 347 is also included in any subsequent license to operate the station.

On December 7, 2010, in document DA-2320, Chairman Julius Genachowski announced the establishment and appointment of members of the VPAAC, following a nominations period that closed on November 1, 2010. All meetings of the VPAAC shall be open to the public. The purpose of the VPAAC is to develop recommendations on closed captioning of Internet programming previously captioned on television; the compatibility between video programming delivered using Internet protocol and devices capable of receiving and displaying such programming in order to facilitate access to captioning, video description and emergency information; video description and accessible emergency information on television programming delivered using Internet protocol or digital broadcast television; accessible user interfaces on video programming devices; and accessible programming guides and menus. Within six (6) months of its first meeting, the VPAAC submitted recommendations concerning the provision of closed captions for Internet-delivered video programming and the ability of video devices to pass through closed captions contained on Internet-based video programming. By April 8, 2012, the VPAAC shall submit recommendations on the remaining issues listed above. At the November 1, 2011 VPAAC meeting, members will continue to develop recommendations to the Commission regarding video description, and the delivery of video description, access to emergency programming, and the interoperability and user interface of the equipment used to deliver video programming.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4) and (e)(11), this document sets forth notice of this proposed new system of records maintained by the FCC. The FCC previously gave complete notice of the two systems of records, FCC/EB-4, “Crisis Management Contacts” and FCC/OMD-11, “Continuity of Operations Plan (COOP),” which it intends to cancel upon approval of FCC/PSHSB-1, “FCC Emergency and Continuity Contacts System (ECCS),” as referenced under this Notice by publication in the Federal Register on April 5, 2006 (71 FR 17234, 17239 and 17254 respectively). This notice is a summary of the more detailed information about the proposed new system of records, which may be viewed at the location given above in the ADDRESSES section. The purposes for adding this new system of records, FCC/PSHSB-1, “FCC Emergency and Continuity Contacts System (ECCS),” are for the FCC's Public Safety and Homeland Security Bureau (PSHSB) to use the records in FCC/PSHSB-1 to allow the FCC to use:

1. The information in the Emergency Contacts database to coordinate crisis response activities, etc. ;

2. The information in the COOP Contacts database to contact FCC employees and contractors regarding COOP matters, etc. ; and

3. An automated telephone and e-mail system to contact its Emergency Contacts and COOP Contacts, etc.

The new system of records will consolidate the two separate internal systems of records that PSHSB currently uses so that all the PII data are now housed in a single PSHSB database for the PSHSB's emergency operations and related activities.

This notice meets the requirement documenting the change to the systems of records that the FCC maintains, and provides the public, OMB, and Congress with an opportunity to comment.

I. Dates

These guidelines supersede the assessment rate adjustment guidelines published by the FDIC on May 15, 2007 (the 2007 Guidelines). 1

On February 7, 2011, the FDIC Board amended its assessment regulations by, among other things, adopting a new methodology for determining assessment rates for large and highly complex institutions (the Amended Assessment Regulations). 2 The Amended Assessment Regulations eliminated risk categories and combined CAMELS ratings and forward-looking financial measures into one of two scorecards, one for highly-complex institutions and another for all other large institutions. 3 Each of the two scorecards produces two scores—a performance score and a loss severity score—that are combined into a total score. 4

Tables 1 and 2 show the scorecards for large and highly complex institutions, respectively.

In most cases, the total score produced by an institution's scorecard should correctly reflect the institution's overall risk relative to other large institutions; however, the FDIC believes it is important that it have the ability to consider idiosyncratic or other relevant risk factors not reflected in the scorecards. The Amended Assessment Regulations, therefore, allow the FDIC to make a limited adjustment to an institution's total score up or down by no more than 15 points (the large bank adjustment). The resulting score is then converted to an initial base assessment rate, which, after application of other possible adjustments, results in the institution's total assessment rate. 5 The total assessment rate is multiplied by the institution's assessment base to calculate the amount of its assessment obligation. Adjustments are made to ensure that the total score produced by an institution's scorecard appropriately reflects the institution's overall risk relative to other large institutions.

The FDIC promulgated regulations allowing for the adjustment of large institutions' quarterly assessment rates in 2006. 6 The FDIC set forth the procedures for these adjustments in guidelines that were published in 2007 (2007 Guidelines). The 2007 Guidelines were designed to ensure that the adjustment process was fair and transparent and that any decision to make an adjustment was well supported. The FDIC has exercised its adjustment authority when warranted since that time.

Following adoption of the Amended Assessment Regulations in February 2011, the FDIC proposed new guidelines that reflect the methodology it now uses to determine assessment rates for large and highly complex institutions. The FDIC sought comment on all aspects of the proposed guidelines. 7 The FDIC received eight comments related to the guidelines, which are described below in the relevant portion of the guidelines.

Request for Comment on Information Collection Proposal

The following information collection, which is being handled under this delegated authority, has received initial Board approval and is hereby published for comment. At the end of the comment period, the proposed information collection, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under OMB delegated authority. Comments are invited on the following:

a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;

b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

c. Ways to enhance the quality, utility, and clarity of the information to be collected; and

d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

e. Estimates of capital or start up costs and costs of operation, maintenance, and purchase of services to provide information.

Report title: Recordkeeping and Disclosure Requirements Associated with Loans Secured by Real Estate Located in Flood Hazard Areas Pursuant to Section 208.25 of Regulation H.

Agency form number: Reg H-2.

OMB control number: 7100-0280.

Frequency: Event-generated.

Reporters: State member banks.

Estimated annual reporting hours: Notice of special flood hazards to borrowers and servicers, 5,768 hours; notice to FEMA of servicer, 5,768 hours; notice to FEMA of change of servicer, 2,884 hours; notice to borrowers of lapsed mandated flood insurance, 1,167 hours; purchase flood insurance on the borrower's behalf, 824 hours; notice to borrowers of lapsed mandated flood insurance due to remapping, 549 hours; purchase flood insurance on the borrower's behalf due to remapping, 824 hours; and retention of standard FEMA form, 14,420 hours.

Estimated average hours per response: Notice of special flood hazards to borrowers and servicers, 5 minutes; notice to FEMA of servicer, 5 minutes; notice to FEMA of change of servicer, 5 minutes; notice to borrowers of lapsed mandated flood insurance, 5 minutes; purchase flood insurance on the borrower's behalf, 15 minutes; notice to borrowers of lapsed mandated flood insurance due to remapping, 5 minutes; purchase flood insurance on the borrower's behalf due to remapping, 15 minutes; and retention of standard FEMA form, 2.5 minutes.

Number of respondents: 824.

General description of report: This information collection is mandatory pursuant to Section 12 of the Flood Disaster Protection Act of 1973, as amended (42 U.S.C. 4012a) and section 1364 of the National Flood Insurance Act of 1968, as amended (42 U.S.C. 4104a). Since the Federal Reserve does not collect any information associated with Reg H-2, confidentiality would not generally be an issue. However, confidentiality issues may arise should the records required by the Reg H-2 requirements come into possession of the Board during an examination of a state member bank, those records would be protected from disclosure by exemption 8 of the Freedom of Information Act. (5 U.S.C. 552(b)(8)).

Abstract: Regulation H requires state member banks to notify a borrower and servicer when loans secured by real estate are determined to be in a special flood hazard area and notify them whether flood insurance is available; notify FEMA of the identity of, and any change of, the servicer of a loan secured by real estate in a special flood hazard area; and retain a completed copy of the Standard Flood Hazard Determination Form used to determine whether property securing a loan is in a special flood hazard area.

Current Action: The Federal Reserve proposes to extend, with revision, the recordkeeping and disclosure requirements of Regulation H for loans secured by improved property in areas having special flood hazards. 1 Although state member banks have been required to comply with Section 208.25 of Regulation H for some time, the current information collection does not include disclosures related to ensuring maintenance of flood insurance over the life of these loans. The Federal Reserve proposes to revise the information collection to account for this statutory requirement.

Under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects.

Both days of this meeting will be devoted to SACHRP discussion of the recent Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 26 Federal Register . The meeting will open October 4 with remarks from SACHRP Chair Dr. Barbara Bierer and OHRP Director Dr. Jerry Menikoff, followed by presentation of joint recommendations on the ANPRM from the Subpart A Subcommittee (SAS) and the Subcommittee on Harmonization (SOH).

SAS is charged with developing recommendations for consideration by SACHRP regarding the application of subpart A of 45 CFR part 46 in the current research environment; this subcommittee was established by SACHRP in October 2006. SOH was established by SACHRP at its July 2009 meeting, and is charged with identifying and prioritizing areas in which regulations and/or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification and/or coordination.

Public Comment will be heard on both days.

Public attendance at the meeting is limited to space available. Individuals who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact persons. Members of the public will have the opportunity to provide comments on both days of the meeting. Public comment will be limited to five minutes per speaker. Any members of the public who wish to have printed materials distributed to SACHRP members for this scheduled meeting should submit materials to the Executive Director, SACHRP, prior to the close of business September 30, 2011.

On June 10, 2010, the President issued Executive Order 13544 to comply with the statutes under Section 4001 of the Patient Protection and Affordable Care Act, Public Law 111-148. This legislation mandated that the Advisory Group was to be established within the Department of Health and Human Services. The charter for the Advisory Group was established by the Secretary of Health and Human Services on June 23, 2010; the charter was filed with the appropriate Congressional committees and Library of Congress on June 24, 2010. The Advisory Group has been established as a non-discretionary Federal advisory committee.

The Advisory Group has been established to provide recommendations and advice to the National Prevention, Health Promotion and Public Health Council (the “Council”). The Advisory Group shall provide assistance to the Council in carrying out its mission.

The Advisory Group membership shall consist of not more than 25 non-Federal members to be appointed by the President. The membership shall include a diverse group of licensed health professionals, including integrative health practitioners who have expertise in (1) worksite health promotion; (2) community services, including community health centers; (3) preventive medicine; (4) health coaching; (5) public health education; (6) geriatrics; and (7) rehabilitation medicine. There are currently 16 members of the Advisory Group appointed by the President. This will be the third meeting of the Advisory Group.

Public attendance at the meeting is limited to the space available. Members of the public who wish to attend must register by 12 p.m. EST September 26, 2011. Individuals should register for public attendance at prevention.council@hhs.gov by providing your full name and affiliation. Individuals who plan to attend the meeting and need special assistance and/or accommodations, i.e., sign language interpretation or other reasonable accommodations, should notify the designated point of contact for the Advisory Group. The public will have the opportunity to provide comments to the Advisory Group on October 3, 2011; public comment will be limited to 3 minutes per speaker. Registration through the designated contact for the public comment session is also required. Any member of the public who wishes to have printed materials distributed to the Advisory Group for this scheduled meeting should submit material to the designed point of contact no later than 12 p.m. EST September 26, 2011.

This System of Records Notice (SORN) addresses a new system which HHS is establishing to support CMS shared savings programs created as a result of the Patient Protection and Affordable Care Act (Pub. L. 111-148), the first of which are the Medicare Shared Savings Program and Pioneer ACO Model (ACO program) described in more detail below.

The recently passed health care reform bill, the Affordable Care Act (PPACA) (Pub. L. 111-148), contains provisions that seek to reward quality care and takes steps toward paying for high quality and efficient care. One of these provisions, Section 3022, amended Title XVIII of the Social Security Act (the Act) (42 U.S.C. 1395 et seq. ) by adding new section 1899 to the Act to establish a shared savings program (SSP) that promotes accountability for a patient population, coordinates items and services under Parts A and B, and encourages investment in infrastructure and redesigned care processes for high quality and efficient service delivery. Specifically:

• Section 1899(a)(1) of the Act requires the Secretary to establish the shared savings program no later than January 1, 2012. Section 1899(a)(1) (A) of the Act further provides that, “groups of providers of services and suppliers meeting criteria specified by the Secretary may work together to manage and coordinate care for Medicare fee-for-service (FFS) beneficiaries through an accountable care organization (ACO).”

• Section 1899(a)(1)(B) of the Act provides that ACOs that meet quality performance standards established by the Secretary are eligible to receive payments for “shared savings.”

The Shared Savings Program is a voluntary program. The statute provides that, to participate in the program, an ACO must “provide the Secretary with such information regarding the ACO professionals participating in the ACO as the Secretary determines necessary to support the assignment of Medicare fee-for-service beneficiaries to an ACO, the implementation of quality and other reporting requirements * * * and the determination of payments for shared savings.” The statute requires an ACO to meet certain eligibility criteria including, but not limited to, having “a formal legal structure that would allow the organization to receive and distribute payments for shared savings,” having “in place a leadership and management structure that includes clinical and administrative systems,” and demonstrating “to the Secretary that it meets patient-centeredness criteria specific by the Secretary.” In addition, the ACO must agree to participate for not less than 3 years, have a formal legal structure including primary care providers sufficient for the care of not less than 5000 beneficiaries, and meet others requirements.

The statute defines an ACO as organization of health care providers that agrees to become accountable for the quality, cost, and overall care of Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to it. The statute states that there are many types of organizational arrangements for eligibility to become an ACO, as determined appropriate by the Secretary.

To qualify for shared savings payments, the ACO must meet specific cost and quality benchmarks. Quality performance standards will be determined by the Secretary and may include measures of clinical processes and outcomes, patient and/or caregiver experience, and utilization measures. An ACO will be eligible to receive a share (a percentage, and any limits, to be determined by the Secretary) of any savings if the actual per capita expenditures of its assigned Medicare beneficiaries are a sufficient percentage below its specified benchmark amount. The benchmark for each ACO will be based on the most recent available three years of per-beneficiary expenditures for Parts A and B services for Medicare FFS beneficiaries assigned to the ACO. The benchmark for each ACO will be adjusted for beneficiary characteristics and other factors as determined by the Secretary, and updated by the projected absolute amount of growth in national per capita expenditures for Parts A and B.

Another provision of the Affordable Care Act (PPACA), Section 3021, amended Title XVIII of the Social Security Act (the Act) (42 U.S.C. 1395 et seq. ) by adding new section 1899 to the Act to establish the Center for Medicare and Medicaid Innovation (Innovation Center). The Innovation Center is tasked with development of the Pioneer ACO Model. Under the Pioneer ACO Model, the Innovation Center will engage up to 30 highly experienced provider organizations in testing alternative payment models that include escalating financial accountability and substantial quality/patient experience standards (“outcomes based arrangements”). CMS intends to pursue payment models that (1) i nclude escalating levels of financial accountability through successive performance periods during the Participation Agreement; (2) provide a transition to Population-Based Payment by the third performance period, and (3) are projected by CMS to generate Medicare savings by the end of the second performance period.

The Privacy Act (5 U.S.C. 552a) governs the means by which the United States Government collects, maintains, and uses personally identifiable information (PII) in a system of records. A “system of records” is a group of any records under the control of a Federal agency from which information about individuals is retrieved by name or other personal identifier. The Privacy Act requires each agency to publish in the Federal Register a system of records notice (SORN) identifying and describing each system of records the agency maintains, including the purposes for which the agency uses PII in the system, the routine uses for which the agency discloses such information outside the agency, and how individual record subjects can exercise their rights under the Privacy Act ( e.g., to determine if the system contains information about them).

The Privacy Act permits an agency to disclose information about an individual (PII) without that individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of PII is known as a “routine use.” HHS/CMS will only release PII from this system as provided in the “Routine Uses” section below. Both identifiable and non-identifiable data may be disclosed under a routine use. HHS/CMS will only disclose the minimum PII necessary to achieve the purpose of the routine use, after determining that:

• The use or disclosure is consistent with the reason that the PII was collected;

• The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form;

• The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect on and/or risk to the privacy of the individual that additional exposure of the record might bring;

• There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s); and

• The data are valid and reliable.

Additionally, HHS/CMS will require the information recipient to:

• Establish administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of the record;

• Remove or destroy at the earliest time all individually-identifiable information; and

• Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352(n)) requires advertisements for prescription drugs to include, among other things, “such information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations.” Under this authority, FDA has issued regulations to require most prescription drug advertisements to provide a “true statement of information in brief summary relating to side effects, contraindications, and effectiveness.” ( § 202.1(e) (1) ( 21 CFR 202.1(e)(1)). To satisfy this requirement, an advertisement that makes claims about a prescription drug must also include a “fair balance” of information about the benefits and risks of the advertised product, in terms of both content and presentation ( §  202.1(e)(5)(ii)). In part, § 202.1(e)(6)(i) states that [a]n advertisement for a prescription drug is false, lacking in fair balance, or otherwise misleading, or otherwise violative of section 502(n) of the act, among other reasons, if it [c]ontains a representation or suggestion, not approved or permitted for use in the labeling, that a drug is better, more effective, useful in a broader range of conditions or patients (as used in § 202.1 ” patients” means humans and in the case of veterinary drugs, other animals) safer, has fewer, or less incidence of, or less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience (as described in paragraphs (e)(4)(ii)( b ) and (e)(4)(ii)( c ) of § 202.1) whether or not such representations are made by comparison with other drugs or treatments, and whether or not such a representation or suggestion is made directly or through use of published or unpublished literature, quotations, or other references.

FDA's current regulations provide a limited exception to the requirement in §  202.1(e)(1), of presenting a true statement of information in brief summary, for “reminder advertisements” (“reminder ads”)—advertisements that draw attention to the name of the product but do not make representations about the product's indication(s) or dosage recommendations ( §  202.1(e)(2)(i)). (Certain drugs are not permitted to qualify for the reminder advertisement exemption.) To meet the terms of this exemption, reminders ads must in general be limited to the proprietary and established name of the product and the established name of each active ingredient in the drug product. Reminder ads may also (optionally) contain information about the product's quantitative ingredients, dosage form, quantity, price, and manufacturer, as well as other written, printed, or graphic matter containing no representation or suggestion relating to the product. Further, reminder ads that are intended to provide consumers with information concerning the price charged for a prescription drug product need not meet the terms of §  202.1(e)(2)(i) in order to be exempt from §  202.1(e)(1) if they meet all of the conditions in § 200.200 ( 21 CFR 200.200). That regulation, in turn, applies to prescription drug reminders ads that are intended solely to provide consumers with information concerning the price charged for a prescription for a particular drug product, and the reminder ad contains no representation or suggestion concerning the drug product's safety, effectiveness, or indications for use ( §  200.200(a)(1) and (b)).

A topic of ongoing interest for consumer product manufacturers and retailers is the use of consumer-oriented sales promotions such as free trial offers, discounts, money-back guarantees, and rebates. Such promotions are widely used in many product categories, including prescription drugs.

Prior research has demonstrated that the type of promotion offered can affect how consumers respond to the promotion (Refs. 1, 2, and 3). Price incentives  1 may act as cues about product quality. For example, a price incentive may not only act as an economic incentive to buy the product, it may also artificially enhance consumers' perceptions of the product's quality (Ref. 4). In the case that consumers can readily test the performance of some products (termed “experience” goods; Ref. 5), this misperception is quickly corrected through the consumer's use of the product. In situations where little information about the product is available or when consumers are unmotivated to seek further information, consumers may use price as a heuristic cue to ascertain the quality of a product. Rao (2005; Ref. 6) has referred to the use of price as a cue to quality as the “price-quality heuristic,” where heuristics are conceptualized as mental shortcuts that minimize cognitive effort to process information and are used when individuals are unable or unwilling to engage in more analytical processing of information (Ref. 7). For example, if length of warranty is strongly believed to be a good predictor of quality, then consumers may perceive a product as higher quality when a long warranty is present than when one is not present (Ref. 8). Thus, price incentives may have the potential to act as an “inference rule” (or heuristic; Refs. 7 and 9) and, when present, they may preempt consumers from thinking carefully about the product information contained in the advertisement ( i.e., fully elaborating on the information). This could result in either favorable or unfavorable beliefs about the product (Refs. 10 and 11). If a price incentive offer acts as a mental heuristic in such a way as to result in an unbalanced or misleading impression of the product's safety or efficacy, however, this would raise concerns for FDA.

Consumers vary in their reactions to price incentive promotions, and researchers and economists have proposed a number of explanations for why some consumers are sensitive to these tactics. Two such traits are “price consciousness” and “belief in the price-quality relationship.” Price consciousness is defined as the degree to which the consumer focuses exclusively on paying low prices. Belief in the price-quality relationship is defined as the degree to which one believes a higher price indicates superior quality (Ref. 12). A broader trait of “value consciousness” has also been used. This trait involves assumptions about the construct of perceived value and its relationship (a ratio) with the constructs of perceived quality and perceived price.

While price incentive promotions have been extensively studied in the context of package goods, information on their effects in direct-to-consumer (DTC) prescription drug ads is limited. One relevant study (Ref. 13) found that a free-trial offer in a DTC ad for a high cholesterol drug resulted in more favorable perceptions of the product and the ad (both rated as good/bad, favorable/unfavorable, and pleasant/unpleasant), and greater intentions to ask about the product. No differences were found in terms of perceived product risk. However, the study did not measure perceptions of product risk and benefit separately, or comprehension of risk and benefit information. Additionally, no attempt was made to control for factors that may predispose individuals toward coupon use nor was the study conducted with the target population (high cholesterol sufferers). We propose to expand on this initial study by measuring perceived product risk and benefit separately, measuring risk and benefit comprehension, investigating a variety of price incentive offers, recruiting a wider range of the target audience from malls and online, and by measuring traits that may predispose individuals to be susceptible to coupon influence.

The current study will examine what effect, if any, the presence of promotional offers in DTC prescription drug ads have on the following: (1) Consumers' perceptions of product risks and benefits, (2) recall of product risks and benefits, and (3) strongly held beliefs that may act as potential moderators.

Design Overview: Study 1: This study will examine types of promotional offers (for example, free trial offer; money off cost; money back guarantee; buy one, get one free; and no offer) in three types of drug advertisements (prescription drug full product, over-the-counter (OTC), and prescription drug reminder). The fictitious test product will treat insomnia and will be modeled on an actual drug used to treat this condition. Participants will be consumers who have insomnia or who self-identify as having met the diagnostic criteria for insomnia. Prescription drug full product advertisements contain information about both benefits and risks, OTC drug advertisements contain benefit information but not risk information, and prescription drug reminder advertisements do not contain either benefit or risk information.

Study 1 will be administered in two modes, online and mall-intercept, in order to assess the effects of mode on study results. Table 1 of this document illustrates the design; the specific promotional offers examined will be determined through pretesting. Offers that demonstrate the most effect on perceptions of product efficacy and risk will be selected for the main study.

Study 1 is experimental in method: participants will be randomly assigned to read one ad version. After reading the ad, participants will answer a series of questions about the drug. We will test how the offer type affects their recall of the benefit and risk information, their perceptions of the benefits and risks of the drug, their perceptions of the incentive, and their behavioral intention to look for more information about the product and try the product. We will also test how mode of administration (online versus mall intercept) affects these variables.

FDA is announcing the availability of a draft guidance for industry entitled “Self-Selection Studies for Nonprescription Drug Products.” This draft guidance is intended to provide recommendations to industry involved in the development of self-selection studies for nonprescription drug products. The draft guidance discusses general concepts to be considered in the design and conduct of a self-selection study. The draft guidance also incorporates advice obtained from the Nonprescription Drugs Advisory Committee at a meeting held on September 25, 2006, which considered issues related to the analysis and interpretation of consumer studies conducted to support the marketing of nonprescription drug products.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on self-selection studies for nonprescription drug products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

I. Background

FDA is announcing the availability of an updated IT plan entitled “PDUFA IV Information Technology Plan.” This plan will meet one of the performance goals agreed to under the 2007 reauthorization of PDUFA IV (Title I of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85)). Under section XIV of the PDUFA Performance Goals, FDA agreed to develop, periodically update, and publish for comment an IT plan for achieving the objectives defined in section XIV, Information Technology Goals, of the PDUFA Performance Goals (see http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm ). This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the process for the review of human drug applications, to achieve the objectives defined in section XIV of the PDUFA Performance Goals. The objectives of the PDUFA IV IT Goals are to move FDA towards the long-term goal of an automated standards-based information technology environment for the exchange, review, and management of information supporting the process for the review of human drug applications throughout the product life cycle.

In the Federal Register of June 30, 2008 (73 FR 36880), FDA issued a notice announcing the availability of an earlier version of the IT plan entitled “Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan” (June 2008 plan). This updated plan revises the June 2008 plan; it communicates the progress and strategic changes for key initiatives that illustrate the accomplishment of near-term objectives and describes FDA's strategy for meeting the long-term goal of a fully electronic submission and review environment. The sections that have been revised are identified in the Revision Index (after the Table of Contents) in the updated plan.

FDA conducts an annual IT assessment to measure performance against the IT plan. The 2010 Annual IT Assessment is available at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm183308.htm.

Persons with access to the Internet may obtain the updated plan at http://www.regulations.gov.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.