Federal Register Vol. 80, No.105,

Title: Business and Industry Guaranteed Loan Program.

OMB Number: 0570-0014.

Expiration Date of Approval: July 31, 2015.

Type of Request: Extension of a currently approved information collection and recordkeeping requirements.

Abstract: The collected information is submitted to the B&I loan official by loan applicants and commercial lenders for use in making program eligibility, financial feasibility determinations, and loan security determinations as required by the Con Act.

Estimate of Burden: Public reporting for this collection of information is estimated to average 3 hours per response.

Respondents: Individuals, rural businesses, for profit businesses, non-profit businesses, Indian tribes, public bodies, and cooperatives.

Estimated Number of Respondents: 40.

Estimated Number of Responses per Respondent: 2.

Estimated Number of Responses: 80.

Estimated Total Annual Burden on Respondents: 600 hours.

Copies of this information collection can be obtained from Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division, at (202) 692-0040.

Comments: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of Business and Cooperative Programs, including whether the information will have practical utility; (b) the accuracy of Business and Cooperative Programs estimate of the burden of the proposed collection of information 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 the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division, U.S. Department of Agriculture, Rural Development, STOP 0742, 1400 Independence Avenue SW., Washington, DC 20250. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The purpose of the meeting is to provide:

(1) Forest Health Working Group Update; and

(2) Governor's Task Force on 2014 Farm Bill; and

(3) 75th Sturgis Motorcycle Rally Planning; and

(4) Black Hills National Forest Social Media Presentation; and

(5) Plan for August Field Trip; and

(6) September Board Elections.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing by June 1, 2015 to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Board may file written statements with the Board's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Scott Jacobson, Black Hills National Forest Supervisor's Office, 1019 North Fifth Street, Custer, South Dakota 57730; by email to [email protected], or via facsimile to 605-673-9208.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

The purpose of the meeting is:

1. The purpose of the meeting is for the Eastern Idaho Resource Advisory Committee members to review and vote on which proposed projects will be recommended for approval by the Designated Federal Officer.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by June 23, 2015 to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Lynn Ballard, Eastern Idaho Resource Advisory Committeee Coordinator, Caribou-Targhee National Forest, 1048 N. 3400 E., Idaho Falls, Idaho 83401; or by email to [email protected], or via facsimile to 1-208-557-5827.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

Background: The Committee was established under the discretionary authority of the Secretary of Commerce and in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2). It provides advice to the Secretary of Commerce on the necessary elements of a comprehensive policy approach to supply chain competitiveness designed to support U.S. export growth and national economic competitiveness, encourage innovation, facilitate the movement of goods, and improve the competitiveness of U.S. supply chains for goods and services in the domestic and global economy; and provides advice to the Secretary on regulatory policies and programs and investment priorities that affect the competitiveness of U.S. supply chains. For more information about the Committee visit: http://trade.gov/td/services/oscpb/supplychain/acscc/.

Matters To Be Considered: Committee members are expected to continue to discuss the major competitiveness-related topics raised at the previous Committee meetings, including trade and competitiveness; freight movement and policy; information technology and data requirements; regulatory issues; finance and infrastructure; and workforce development. The Committee's subcommittees will report on the status of their work regarding these topics. The agenda's may change to accommodate Committee business. The Office of Supply Chain, Professional & Business Services will post the final detailed agenda's on its Web site, http://trade.gov/td/services/oscpb/supplychain/acscc/, at least one week prior to the meeting. The meetings will be open to the public and press on a first-come, first-served basis. Space is limited. The public meetings are physically accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Mr. Richard Boll, at (202) 482-1135 or [email protected] five (5) business days before the meeting.

Interested parties are invited to submit written comments to the Committee at any time before and after the meeting. Parties wishing to submit written comments for consideration by the Committee in advance of this meeting must send them to the Office of Supply Chain, Professional & Business Services, 1401 Constitution Ave. NW., Room 11014, Washington, DC, 20230, or email to [email protected].

For consideration during the meetings, and to ensure transmission to the Committee prior to the meetings, comments must be received no later than 5:00 p.m. EST on June 15, 2015. Comments received after June 15, 2015, will be distributed to the Committee, but may not be considered at the meetings. The minutes of the meetings will be posted on the Committee Web site within 60 days of the meeting.

Background: The Board advises the Secretary of Commerce on matters relating to the U.S. travel and tourism industry.

Public Participation: The call will be open to the public. All guests are required to register in advance by the deadline identified under the DATES caption, and will receive upon registering a copy of the draft letter to be deliberated.

There will be 15 minutes of time allotted for oral comments from members of the public joining the call. To accommodate as many speakers as possible, the item for public comments will be limited to three (3) minutes per person. Individuals wishing to reserve speaking time during the meeting must submit a request at the time of registration along with a brief statement of the general nature of the comments, as well as the name and address of the proposed speaker. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the International Trade Administration may conduct a lottery to determine the speakers. Any member of the public may submit pertinent written comments concerning the Board's affairs at any time before or after the call. Comments may be submitted to Niara Phillips at the contact information indicated above.

To be considered during the call, comments must be received no later than 5:00 p.m. EDT on June 10, 2015, to ensure transmission to the Board prior to the call. Comments received after that deadline will be distributed to the members but may not be considered on the call. A recording will be available within 90 days of the call.

District Export Councils support the mission of US&FCS by facilitating the development of an effective local export assistance network, supporting the expansion of export opportunities for local U.S. companies, serving as a communication link between the business community and US&FCS, and assisting in coordinating the activities of trade assistance partners to leverage available resources. Individuals appointed to a DEC become part of a select corps of trade experts dedicated to providing international trade leadership and guidance to the local business community and assistance to the Department of Commerce on export development issues.

Selection Process: Each DEC has a target membership of 30. Approximately half of the positions are open on each DEC for the four-year term from January 1, 2016, through December 31, 2019. The local USEAC Director receives nominations for membership, and after ensuring that nominees meet the membership criteria outlined below, makes recommendations to the Secretary of Commerce in consultation with the local DEC Executive Committee. After completion of a vetting process, the Secretary selects nominees for appointment to local DECs. DEC members are appointed by and serve at the pleasure of the Secretary of Commerce.

Membership Criteria: Appointment is based upon an individual's international trade leadership in the local community, ability to influence the local environment for exporting, interest in export development, and willingness and ability to devote time to DEC activities. Members include exporters, export service providers and others whose profession supports U.S. export promotion efforts. DEC member appointments are made without regard to political affiliation. DEC membership is open to U.S. citizens and permanent residents of the United States. As representatives of the local exporting community, DEC Members must reside in, or conduct the majority of their work in, the territory that the DEC covers. DEC membership is open to representatives of local and state governments. DEC membership is not open to federal government employees, or individuals representing foreign governments.

An electronic copy of HTC's application and supporting documents, as well as a list of the references cited in this document, may be obtained by visiting the Internet at: www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. In case of problems accessing these documents, please call the contact listed above (see FOR FURTHER INFORMATION CONTACT).

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. 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 U.S. can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) 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 marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny the authorization. Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as “any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

On June 23, 2014 we received a request from HTC for the taking of marine mammals incidental to pile driving and falsework pile extraction associated with the re-development of the Icy Strait Point Cruise Ship Terminal in Hoonah, Alaska. HTC submitted a revised application on September 9, 2014. On February 26, 2015 the applicant submitted an addendum to the application describing modifications to the specified activity. NMFS determined that the application was adequate and complete on February 27, 2015. HTC proposes to conduct in-water work that may incidentally harass marine mammals (i.e., pile driving and falsework removal). In addition, the project would include associated upland improvements, which are not anticipated to have the potential to result in incidental take of marine mammals. This IHA would be valid from June 1 through October 31, 2015. However, all pile driving is expected to be completed by the end of September. October has been included only to cover any contingencies that may arise. Hereafter, use of the generic term “pile driving” may refer to both pile installation and falsework removal unless otherwise noted.

The use of vibratory pile driving is expected to produce underwater sound at levels that have the potential to result in behavioral harassment of marine mammals. Species with the expected potential to be present during the project timeframe include the humpback whale (Megaptera novaeangliae), Steller sea lion (Eumatopius jubatus), harbor seal (Phoca vitulina), Dall's porpoise (Phocoenoides dalli), gray whale (Eschrichtius robustus), harbor porpoise (Phocoena phocoena), killer whale (Orcinus orca), minke whale (Balaenoptera acutorostrata), and Pacific white-sided dolphin (Lagenorhynchus obliquidens).

The project would construct a new cruise ship berth terminal and associated upland improvements at the existing facility in order to streamline cruise ship operations at the site by constructing a permanent cruise ship berth, renovating existing tourist facilities and constructing additional tourist facilities to support cruise ship terminal operations at the site. The existing facility requires the vessel to anchor offshore, and requires passengers to be lightered (ferried in a smaller boat) to shore, which causes a bottleneck in operations. The new terminal has been designed as a floating platform to disembark/embark passengers so that there is a fixed elevation between the dock surface and the ships gangways, and to provide passengers with direct access to shore.

The project will require the installation of 104 steel pipe piles of varying diameters below the MHHW by impact driving, down-hole drilling and vibratory hammer. Piles will be set by vibratory hammer that will cease operation as soon as bedrock is encountered. Vibratory hammer time should be between 10 and 30 minutes per pile. It is estimated that each pile will need to be driven approximately 50 feet to hit bedrock. Piles will then be drilled into bedrock using a down-hole drilling system with an under reaming bit for approximately 15 feet. This process will take an estimated 3 hours. This is a low energy air-powered system that releases decreased acoustic energy compared to impact driving. Proofing or seating of the pile into the drilled socket would occur with either a vibratory or impact hammer depending on the rock encountered and will be selected in the field based on actual sub surface conditions.

In-water work, which is work occurring below the mean higher high water (MHHW) will be limited to pile installation and falsework pile extraction. These activities will be limited to the period between June 1 and October 31, 2015 to avoid the period (15 April to 31 May) when spawning herring are most likely to be present within the project area. HTC expects pile driving will occur on up to 103 days. However, all pile driving is expected to be completed by the end of September. October has been included only to cover any contingencies that may arise. The overall project, including work not anticipated to result in incidental take, was initiated in September 2014 and will run through May 2016.

The existing Icy Strait Point site is located in Hoonah, Alaska. The project site is located at the junction of Icy Strait and Port Frederick, in the Baranof-Chichagof Islands watershed (HUC #19010203). Please see Sheet 1 of Appendix A in the HTC application for details.

We provided a detailed description of the proposed action in our Federal Register notice announcing the proposed authorization (80 FR 14945; March 20, 2015). Please refer to that document; we provide only summary information here. The proposed action would involve construction of a new cruise ship berth terminal and associated upland improvements at the existing facility. The existing facility is served by an approximately 100-foot by 25-foot excursion dock, with an approximately 140-foot walkway connecting to shoreline. There is also an existing 40-foot by 80-foot fishing pier which is connected to the shore by an approximately 120-foot walkway. The new terminal would consist of a floating pontoon, which would be connected to the shore via a new trestle and transfer span. The new terminal would also include two new mooring dolphins, two new breasting dolphins, and three or more new reaction dolphins. Each of these would be interconnected via pile-supported catwalks.

In-water work (work below the MHHW) will be limited to pile installation. Over-water work will include construction and installation of the steel trestle and transfer span, construction of the over-water portions of the mooring, breasting, and reaction dolphins, and construction of the catwalk spans. The floating pontoon will be fabricated in a dry dock and floated into position.

In-water and over-water components of the project would be constructed in areas with water depths ranging between MHHW and approximately -60 feet mean lower low water (MLLW). The majority of the in-water and over-water work including construction of the mooring, breasting, and reaction dolphins; catwalks, a portion of the transfer span and floating pontoon will be completed between approximately -25 feet and -60 feet MLLW. A detailed description of in-water and over-water project components may be found in Table 1 of the HTC Application.

A notice of HTC's proposal to issue an IHA was published in the Federal Register on March 20, 2014 (80 FR 14945). During the 30-day public comment period, both the Marine Mammal Commission and the National Park Service submitted letters. These letters are available on the Internet www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. All comments specific to HTC's application that address the statutory and regulatory requirements or findings NMFS must make to issue an IHA are addressed in this section of the Federal Register notice.

Comment 1: The Commission noted that NMFS did not provide estimated sound source levels and potential takings associated with the down-hole drilling system proposed by HTC. The Commission recommends that NMFS include the down-the-hole drilling system in its incidental harassment authorization and consult with either ME DOT or the associated NMFS analyst regarding the appropriate Level A and B harassment zones, which may have been updated with in-situ measurements and take a consistent approach for activities it proposes to authorize in the future, including the use of down-the-hole drilling systems and down-hole hammers.

Response 1: Down-hole drilling is an uncommon activity that has not usually been included as part of IHA applications or authorizations. The ME DOT project referenced above utilized a down-hole hammer which is a separate and distinct methodology from down-hole drilling. While down‐hole drilling is a common pile installation methodology in cases where piles must be seated in difficult geologic substrates, there is no published literature NMFS is aware of regarding the underwater noise generated during this type of procedure. As part of a 2013 ESA consultation for a proposed Alaska Department of Transportation Kodiak Ferry Dock Reconstruction project (PCTS# AKR-2013-9277), NMFS estimated that underwater noise levels associated with down‐hole drilling would be analogous to use of a hydraulic hammer (hydro‐hammer), and estimated a maximum underwater noise generation of 165 dB (re: 1 μPa at 200 Hz) associated with these devices. However, this analysis did not take into account any additional noise‐attenuating conditions associated with the activity.

The operation of the down‐hole drill at the Icy Strait point project area will occur within the enclosed pile at depths between 5 and 35 feet below the mudline and the pile interior will be filled with air which will further attenuate any underwater noise generation. Based on the best available information, NMFS concludes that down‐hole drilling is not expected to result in underwater noise that would result in Level B harassment of marine mammals and, therefore, need not be included as part of this incidental harassment authorization.

NMFS is aware of in situ studies planned for the future which will include hydroacoustic sound measurement sound associated with down-hole drilling. As this data becomes available it will be consistently incorporated into future authorizations.

Comment 2: The Commission expressed concern that the most pertinent in-situ source level information was not used as part of the exposure analysis. It was noted more recent data from the Washington Department of Transportation (WSDOT) may be applicable to this proposed authorization.

Response 2: NMFS has reviewed the available information and is satisfied that the referenced measurements from the California Department of Transportation (Caltrans) adequately represent the project and site characteristics. The Commission freely acknowledged that the extent of the Level B harassment zone will not likely be affected by use of a greater source level, given that the zone is constrained by surrounding land before reaching its maximum extent. Since the Level B harassment zone would remain unchanged, NMFS does not believe additional analysis is warranted.

Comment 3: The Commission and NPS noted that older data were used to estimate the numbers of marine mammals that would be taken during the proposed activities. However, the Commission and NPS believe that more recent sources of data are available, and these sources should be considered. Further, to provide a more accurate assessment of the numbers of marine mammals that could potentially be harassed in the area, the Commission and NPS recommended that NMFS re-estimate the numbers of takes for humpback whales, Steller sea lions, harbor porpoises, harbor seals, killer whales, and Dall's porpoises.

Response 3: NMFS has reviewed the more recent data and has revised its take estimates for the humpback whale, Steller sea lion, harbor porpoise, killer whale, and Dall's porpoise. See “Estimated Take by Incidental Harassment” section below. NMFS thanks NPS and the Commission for the information and will include the information when evaluating future IHA applications and issuing authorizations.

Comment 4: The Commission noted that the numbers of takes were estimated for a four-month work window with pile driving occurring on only 20 days. However, a modification of the scheduling plan now shows that pile driving may occur on up to 103 days. The Commission expressed concern that, while some of the take estimates may be reasonable for 20 days of pile driving, 103 days of driving would result in vastly underestimated take estimates.

Response 4: The proposed notice of authorization published on March 20, 2015 (80 FR 14945) indicated that in-water down-hole drilling and pile driving would occur on an estimated 20 days during the four month authorization period. It was estimated that there would be a maximum of 100 hours of vibratory drilling time and 10 hours of impact hammer time for a total in-water work time of 110 hours. The applicant modified its schedule, resulting in up to 103 in-water work days. This means that the amount of drilling per day could range from 5.5 hours for 20 days of drilling to 1.07 hours over 103 days. However, the potential exposure time over the course of the project remains unchanged at 110 hours. Note that in this case, potential takes were assessed on the basis of the number of animals reasonably believed to be potentially present in the region during the planned four-month period. So, takes were not assessed on basis of 20 days and, therefore, an expansion to 103 days does not change the calculus.

Comment 5: The Commission wrote that in situations where the estimated takes are less than the mean group size, takes should be increased to a minimum of mean group size. This approach is most pertinent to take estimates for gray whales and pacific white-sided dolphins.

Response 5: NMFS agrees with this assessment and has revised the section containing take estimates accordingly.

Comment 6: The Commission recommends NMFS review recent sightings and group size data for killer whales and Dall's porpoises and increase the number of takes for these two species appropriately.

Response 6: NMFS agrees with the recommendation and has made revisions in the section containing updated take estimates.

Comment 7: In the proposed authorization, NMFS required observers to monitor the Level A and B harassment zones 20 minutes before, during, and 30 minutes after pile driving and removal. It also required that operators implement delay, power-down, or shut-down procedures during pile removal or driving if an animal approaches the Level A harassment zone. The Commission recommends that NMFS require HTC to (1) monitor the harassment zones at least 30 minutes before, during, and 30 minutes after the proposed pile-driving and -removal activities and (2) that after a delay, power down, or shutdown, not resume activities until the marine mammal (a) is observed to have left the Level A harassment zone or (2) has not been seen or otherwise detected within the Level A harassment zone for 15 minutes for small odontocetes and 30 minutes for large and medium-sized whales.

Response 7: NMFS agrees and has incorporated these changes into the section below on Mitigation and Monitoring.

Comment 8: The proposed marine mammal monitoring protocol states: “If waters exceed a sea-state which restricts the observers' ability to make observations within the marine mammal buffer zone (the 100 meter radius) (e.g., excessive wind or fog), impact pile installation will cease until conditions allow the resumption of monitoring.” NPS notes that there is no similar allowance to cease operations if sea conditions/wind/visibility restrict observers' ability to make observations in the Level B harassment zone, and that observers may be unable to document Level B takes accurately if conditions are too poor to see the animal.

Response 8: Level A harassment is not authorized in this case, and is practicably preventable under conditions where the sea-state does not restrict the ability to make observations. Therefore, we cannot allow impact driving to occur when a reasonably observable zone cannot be observed because of conditions. Given the sizable Level B harassment zone, there is no expectation that all Level B harassment would be observable or observed even under favorable sea-state conditions. Furthermore, shutting down operations every time a marine mammal is sighted in the larger Level B harassment zone is likely to significantly extend the length of certain projects, especially those situated in areas that frequently feature inclement weather and extension of a project timeline may expose marine mammals to additional risk of both Level A and Level B harassment.

Comment 9: NPS notes that the Central North Pacific Stock of humpback whales is estimated at 10,103 individuals. This is the best estimate for Hawaii only and should be revised.

Response 9: NMFS has incorporated the correct number (5,833) of humpback whales in the revised section on take estimates. where necessary.

Comment 10: NPS notes that HTC's monitoring plan calls for a third observer who will “monitor from a boat that is conducting a transect along the 2,150 meter limit of the Level B harassment zone,” However, Appendix B, Fig B-3 of the Huna Totem application shows the boat transect covering a much broader area (all the way to the mouth of Excursion Inlet, also including Homeshore and all of Port Frederick). Why will the vessel-based observer monitor this broad area? It extends beyond the project area and may detract from the observer's ability to detect animals within the project area.

Response 10: The Level B harassment zone for impact driving is 2,154 m while the same zone for vibratory driving extends to 21.5 km. Figure B-2 accurately depicts the Level B harassment zone boundary for impact pile driving activities.

Comment 11: NPS states that there is no data source, analysis, or modelling used to reach NMFS' conclusion that the potential for increased vessel interaction or collisions associated with the proposed action are expected to be insignificant.

Response 11: There is little data available that could be used to model vessel interactions and strikes and these statements were provided as background information. The IHA is specifically concerned with only the proposed activity (in-water construction). Discussion of long-term increased potential for strike due to increased cruise ship traffic at the new terminal is outside the scope of analysis here.

There are nine marine mammal species known to occur in the Icy Strait region of SE Alaska during the project's timeframe. These include the humpback whale, Steller sea lion, harbor seal, Dall's porpoise, gray whale, harbor porpoise, killer whale, minke whale, and Pacific white-sided dolphin.

We have reviewed HTC's detailed species descriptions, including life history information, for accuracy and completeness and refer the reader to Section 3 of HTC's application as well as the proposed incidental harassment authorization published in the Federal Register (80 FR 14945) instead of reprinting the information here. Please also refer to NMFS' Web site (www.nmfs.noaa.gov/pr/species/mammals) for generalized species accounts which provide information regarding the biology and behavior of the marine resources that occur in SE Alaska. We provided additional information for the potentially affected stocks, including details of stock-wide status, trends, and threats, in our Federal Register notice of proposed authorization (80 FR 14945, March 20, 2015). Note that the estimated population of humpback whales has been updated from 10,103 to 5,833 to reflect more recent stock assessment report data.

Table 1 lists the twelve marine mammal stocks that could occur in the vicinity of Icy Strait Point during the project timeframe and summarizes key information regarding stock status and abundance. Taxonomically, we follow Committee on Taxonomy (2014). Please see NMFS' Stock Assessment Reports (SAR), available at www.nmfs.noaa.gov/pr/sars, for more detailed accounts of these stocks' status and abundance.

The Federal Register notice of proposed authorization (80 FR 14945, March 20, 2015), incorporated here by reference, provides a general background on sound relevant to the specified activity as well as a detailed description of marine mammal hearing and of the potential effects of these construction activities on marine mammals.

We described potential impacts to marine mammal habitat in detail in our Federal Register notice of proposed authorization (80 FR 14945, March 20, 2015). In summary, the project activities would not modify existing marine mammal habitat. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range; but, because of the short duration of the activities and the relatively small area of the habitat that may be affected, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences for individual marine mammals or their populations

In order to issue an IHA 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 impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking” for certain subsistence uses.

Measurements from similar pile driving events were coupled with practical spreading loss to estimate zones of influence (ZOI; see “Estimated Take by Incidental Harassment”). ZOIs are often used to establish a mitigation zone around each pile (when deemed practicable) to prevent Level A harassment to marine mammals, and also provide estimates of the areas within which Level B harassment might occur. ZOIs may vary between different diameter piles and types of installation methods. In addition to the measures described later in this section, HTC will employ the following standard mitigation measures:

(a) Conduct briefings between construction supervisors and crews, marine mammal monitoring team, and HTC staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

(b) For in-water heavy machinery work other than pile driving (using, e.g., standard barges, tug boats, barge-mounted excavators, or clamshell equipment used to place or remove material), if a marine mammal comes within 10 m, operations shall cease and vessels shall reduce speed to the minimum level required to maintain steerage and safe working conditions. This type of work could include the following activities: (1) Movement of the barge to the pile location or (2) positioning of the pile on the substrate via a crane (i.e., stabbing the pile).

The following measures apply to HTC's mitigation through shutdown and disturbance zones:

Shutdown Zone—For all pile driving activities, HTC will establish a shutdown zone. Shutdown zones are intended to contain the area in which SPLs equal or exceed the 180/190 dB rms acoustic injury criteria, with the purpose being to define an area within which shutdown of activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area), thus preventing injury of marine mammals. For vibratory driving, HTC's activities are not expected to produce sound at or above the 180 dB rms injury criterion (see “Estimated Take by Incidental Harassment”). As described above, HTC would, however, implement a minimum shutdown zone of 10 m radius for all marine mammals around all vibratory pile driving and removal activity and 100 m radius around impact pile driving activity. These precautionary measures are intended to further reduce the unlikely possibility of injury from direct physical interaction with construction operations.

Disturbance Zone—Disturbance zones are the areas in which SPLs equal or exceed 120 dB rms (for continuous sound) for pile driving installation and removal. Disturbance zones provide utility for monitoring conducted for mitigation purposes (i.e., shutdown zone monitoring) by establishing monitoring protocols for areas adjacent to the shutdown zones. Monitoring of disturbance zones enables observers to be aware of and communicate the presence of marine mammals in the project area but outside the shutdown zone and thus prepare for potential shutdowns of activity. However, the primary purpose of disturbance zone monitoring is for documenting incidents of Level B harassment; disturbance zone monitoring is discussed in greater detail later (see “Monitoring and Reporting”). Nominal radial distances for disturbance zones are shown in Table 2. Given the size of the disturbance zone for vibratory pile driving, it is impossible to guarantee that all animals would be observed or to make comprehensive observations of fine-scale behavioral reactions to sound. We discuss monitoring objectives and protocols in greater depth in “Monitoring and Reporting.”

In order to document observed incidents of harassment, monitors record all marine mammal observations, regardless of location. The observer's location, as well as the location of the pile being driven, is known from a GPS. The location of the animal is estimated as a distance from the observer, which is then compared to the location from the pile and the estimated ZOIs for relevant activities (i.e., pile installation and removal). This information may then be used to extrapolate observed takes to reach an approximate understanding of actual total takes.

Time Restrictions—Work would occur only during daylight hours, when visual monitoring of marine mammals can be conducted. In addition, all in-water construction will be limited to the period between June 1 and October 31, 2015. However, all pile driving is expected to be completed by the end of September. October has only been included to cover any contingencies that may arise.

Soft Start—The use of a soft start procedure is believed to provide additional protection to marine mammals by warning or providing a chance to leave the area prior to the hammer operating at full capacity, and typically involves a requirement to initiate sound from the hammer at reduced energy followed by a waiting period. This procedure is repeated two additional times. It is difficult to specify the reduction in energy for any given hammer because of variation across drivers and, for impact hammers, the actual number of strikes at reduced energy will vary because operating the hammer at less than full power results in “bouncing” of the hammer as it strikes the pile, resulting in multiple “strikes.” The project will utilize soft start techniques for both impact and vibratory pile driving. We require HTC to initiate sound from vibratory hammers for fifteen seconds at reduced energy followed by a thirty-second waiting period, with the procedure repeated two additional times. For impact driving, we require an initial set of three strikes from the impact hammer at reduced energy, followed by a thirty-second waiting period, then two subsequent three strike sets. Soft start will be required at the beginning of each day's pile driving work and at any time following a cessation of pile driving of 20 minutes or longer (specific to either vibratory or impact driving).

Monitoring Protocols—Monitoring would be conducted before, during, and after pile driving and removal activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven. Observations made outside the shutdown zone will not result in shutdown; that pile segment would be completed without cessation, unless the animal approaches or enters the shutdown zone, at which point all pile driving activities would be halted. Monitoring will take place from thirty minutes prior to initiation through thirty minutes post-completion of pile driving activities. Pile driving activities include the time to remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than thirty minutes. Please see the Marine Mammal Monitoring Plan (available at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm), developed by HTC with our approval, for full details of the monitoring protocols.

The following additional measures apply to visual monitoring:

(1) Monitoring will be conducted by qualified observers, who will be placed at the best vantage point(s) practicable to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. Qualified observers are trained biologists, with the following minimum qualifications:

(a) Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;

(b) Advanced education in biological science or related field (undergraduate degree or higher required);

(c) Experience and ability to conduct field observations and collect data according to assigned protocols (this may include academic experience);

(d) Experience or training in the field identification of marine mammals, including the identification of behaviors;

(e) Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;

(f) Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates and times when in-water construction activities were suspended to avoid potential incidental injury from construction sound of marine mammals observed within a defined shutdown zone; and marine mammal behavior; and

(g) Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.

(2) Prior to the start of pile driving activity, the shutdown zone will be monitored for 30 minutes to ensure that it is clear of marine mammals. Pile driving will only commence once observers have declared the shutdown zone clear of marine mammals; animals will be allowed to remain in the shutdown zone (i.e., must leave of their own volition) and their behavior will be monitored and documented. The shutdown zone may only be declared clear, and pile driving started, when the entire shutdown zone is visible (i.e., when not obscured by dark, rain, fog, etc.). In addition, if such conditions should arise during impact pile driving that is already underway, the activity would be halted.

If a marine mammal approaches or enters the shutdown zone during the course of pile driving operations, activity will be halted and delayed until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or 15 minutes have passed for small odontocetes and pinnipeds and 30 minutes have passed for large and medium-sized whales without re-detection of the animal. Monitoring will be conducted throughout the time required to drive a pile.

(3) The area within the Level B harassment threshold for impact driving (shown in Figure B-2 of Appendix B of the revised marine mammal monitoring plan) will be monitored by the field monitor stationed either on the pile driving rig or in the vicinity, and by a second qualified field monitor stationed on or in the vicinity of Halibut Island near the 2,154 meter limit of the Level B harassment zone for impact driving. A third qualified observer will also monitor from a boat that is conducting a transect along the 21,500 meter limit of the Level B harassment zone for vibratory driving. Marine mammal presence within this Level B harassment zone, if any, will be monitored, but impact pile driving activity will not be stopped if marine mammals are found to be present. Any marine mammal documented within the Level B harassment zone during impact driving would constitute a Level B take (harassment), and will be recorded and reported as such.

We have carefully evaluated the HTC's proposed mitigation measures and considered their effectiveness in past implementation to determine whether they are likely to effect the least practicable 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.

Any mitigation measure(s) we prescribe should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

(1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

(2) A reduction in the number (total number or number at biologically important time or location) of individual marine mammals exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only).

(3) A reduction in the number (total number or number at biologically important time or location) of times any individual marine mammal would be exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only).

(4) A reduction in the intensity of exposure to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing the severity of behavioral harassment only).

(5) Avoidance or minimization of adverse effects to marine mammal habitat, paying particular attention to the prey base, blockage or limitation of passage to or from biologically important areas, permanent destruction of habitat, or temporary disturbance of habitat during a biologically important time.

(6) For monitoring directly related to mitigation, an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

Based on our evaluation of HTC's proposed measures, including information from monitoring of implementation of mitigation measures very similar to those described here under previous IHAs from other marine construction projects, we have determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an IHA 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 incidental take authorizations 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 proposed action area.

Any monitoring requirement we prescribe should improve our understanding of one or more of the following:

(1) An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;

(2) An increase in our understanding of how many marine mammals are likely to be exposed to levels of pile driving that we associate with specific adverse effects, such as behavioral harassment, TTS, or PTS;

(3) An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:

Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);

Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);

Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;

(4) An increased knowledge of the affected species; and

(5) An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.

HTC submitted a marine mammal monitoring plan as part of the IHA application for this project, which can be found on the Internet at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. The plan may be modified or supplemented based on comments or new information received from the public during the public comment period.

• Three individuals meeting the minimum qualifications identified in Appendix B of the monitoring plan submitted by HTC will monitor the Level A and B harassment zones during impact pile driving, and the Level B harassment zone during vibratory pile driving.

• During impact pile driving, the area within 100 meters of pile driving activity will be monitored and maintained as marine mammal buffer area in which pile installation will not commence or will be suspended temporarily if any marine mammals are observed within or approaching the area of potential disturbance. This area will be monitored by one qualified field monitor stationed either on the pile driving rig or in the immediate vicinity.

• The area within the Level B harassment threshold for impact driving (shown in Figure B-2 of Appendix B of the revised marine mammal monitoring plan) will be monitored by the field monitor stationed either on the pile driving rig or in the vicinity, and by a second qualified field monitor stationed on or in the vicinity of Halibut Island near the 2,150 meter limit of the Level B harassment zone. A third qualified observer will also monitor from a boat that is conducting a transect along the 2,154 meter limit of the Level B harassment zone. Marine mammal presence within this Level B harassment zone, if any, will be monitored, but impact pile driving activity will not be stopped if marine mammals are found to be present. Any marine mammal documented within the Level B harassment zone during impact driving would constitute a Level B take (harassment), and will be recorded and reported as such.

• During vibratory pile driving, the area within 10 meters of pile driving activity will be monitored and maintained as a marine mammal buffer area in which pile installation will not commence or will be suspended temporarily if any marine mammals are observed within or approaching the area of potential disturbance. The Level B harassment area will be monitored by three qualified observers (Figure B-3). One individual will be stationed either on the pile driving rig or in the immediate vicinity, a second individual will be stationed on either Halibut Island or a location in the vicinity, and a third observer will be located on a vessel that is conducting meander transects throughout the Level B harassment zone. The monitoring staff will record any presence of marine mammals by species, will document any behavioral responses noted, and record Level B takes when sightings overlap with pile installation activities.

• The individuals will scan the waters within each monitoring zone activity using binoculars (Vector 10X42 or equivalent), spotting scopes (Swarovski 20-60 zoom or equivalent), and visual observation.

• The area within which the Level A harassment thresholds could be exceeded (the 100 meter radius) will be maintained as a marine mammal exclusion zone, in which impact pile driving will be shut down immediately if any marine mammal is observed with the area.

• The area within which the Level B harassment thresholds could be exceeded during impact pile driving (Figure B-2) and vibratory pile driving (Figure B-3) will also be monitored for the presence of marine mammals during all impact and vibratory pile driving. Marine mammal presence within these zones, if any, will be monitored but pile driving activity will not be stopped if marine mammals were found to be present. Any marine mammal documented within the Level B harassment zone will constitute a Level B take, and will be recorded and used to document the number of take incidents.

• If waters exceed a sea-state which restricts the observers' ability to make observations within the marine mammal buffer zone (the 100 meter radius) (e.g. excessive wind or fog), impact pile installation will cease until conditions allow the resumption of monitoring.

• The waters will be scanned for 30 minutes before, during, and 30 minutes after any and all pile driving and removal activities.

• If marine mammals enter or are observed within the designated marine mammal buffer zone (the 100m radius) during or 30 minutes prior to pile driving, the monitors will notify the on-site construction manager to not begin until the animal has moved outside the designated radius.

• If a marine mammal approaches the Level A harassment zone, HTC must implement delay, power-down, or shut-down procedures during pile driving and removal. After a delay, power down, or shutdown, pile driving and removal activities will not resume until the marine mammal (a) is observed to have left the Level A harassment zone or (b) has not been seen or otherwise detected within the Level A harassment zone for 15 minutes for small odontocetes and pinnipeds and 30 minutes for large and medium-sized whales.

• The waters will continue to be scanned for at least 30 minutes after pile driving has completed each day, and after each stoppage of 30 minutes or greater.

We require that observers use approved data forms. Among other pieces of information, HTC will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, HTC will attempt to distinguish between the number of individual animals taken and the number of incidents of take. We require that, at a minimum, the following information be collected on the sighting forms:

• Date and time that monitored activity begins or ends;

• Construction activities occurring during each observation period;

• Weather parameters (e.g., percent cover, visibility);

• Water conditions (e.g., sea state, tide state);

• Species, numbers, and, if possible, sex and age class of marine mammals;

• Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;

• Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;

• Locations of all marine mammal observations; and

• Other human activity in the area.

HTC would provide NMFS with a draft monitoring report within 90 days of the conclusion of the proposed construction work. This report will detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. If no comments are received from NMFS within 30 days, the draft final report will constitute the final report. If comments are received, a final report must be submitted within 30 days after receipt of comments.

Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: “. . . any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

All anticipated takes would be by Level B harassment resulting from impact and vibratory pile driving/removal and involving temporary changes in behavior. Injurious or lethal takes are not expected due to the expected source levels and sound source characteristics associated with the activity, and the planned mitigation and monitoring measures are expected to further minimize the possibility of such take.

If a marine mammal responds to a stimulus by changing its behavior (e.g., through relatively minor changes in locomotion direction/speed or vocalization behavior), the response may or may not constitute taking at the individual level, and is unlikely to affect the stock or the species as a whole. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on animals or on the stock or species could potentially be significant (e.g., Lusseau and Bejder, 2007; Weilgart, 2007). Given the many uncertainties in predicting the quantity and types of impacts of sound on marine mammals, it is common practice to estimate how many animals are likely to be present within a particular distance of a given activity, or exposed to a particular level of sound.

This practice potentially overestimates the numbers of marine mammals taken because it is often difficult to distinguish between the individuals harassed and incidences of harassment. In particular, for stationary activities, it is more likely that some smaller number of individuals may accrue a number of incidences of harassment per individual than for each incidence to accrue to a new individual, especially if those individuals display some degree of residency or site fidelity and the impetus to use the site (e.g., because of foraging opportunities) is stronger than the deterrence presented by the harassing activity.

HTC has requested authorization for the incidental taking of small numbers of humpback whale, Steller sea lion, harbor seal, Dall's porpoise, gray whale, harbor porpoise, killer whale (Orcinus orca), minke whale, and Pacific white-sided dolphin near Icy Strait Point that may result from vibratory and impact pile driving during construction activities associated with the re-development of the cruise ship terminal described previously in this document.

In order to estimate the potential incidents of take that may occur incidental to the specified activity, we must first estimate the extent of the sound field that may be produced by the activity and then consider in combination with information about marine mammal density or abundance in the project area. We first provide information on applicable sound thresholds for determining effects to marine mammals before describing the information used in estimating the sound fields, the available marine mammal density or abundance information, and the method of estimating potential incidences of take. We provided detailed information on applicable sound thresholds for determining effects to marine mammals as well as describing the information used in estimating the sound fields, the available marine mammal density or abundance information, and the method of estimating potential incidences of take, in our Federal Register notice of proposed authorization (80 FR 14945; March 20, 2015). Due to more recent population and abundance estimates pointed out by the Commission and NPS, some of the take estimates have been revised and are described below (see also “Comments and Responses” above).

According to the Caltrans (2012) compendium, there is an average sound pressure level of 195 dB rms for impact driving of 60-in pile and 170 dB rms reported for 72-in steel pipe pile vibratory driving. Based on the formula listed above, it has been determined that the 190 dB rms Level A harassment (injury) threshold for underwater noise for pinniped species could be exceeded at a distance of up to approximately 22 meters during impact pile driving activities, and the 180 dB rms Level A harassment (injury) threshold for cetacean species could be exceeded at a distance of up to approximately 100 meters during impact pile driving activities. Additionally, the 160 dB rms Level B harassment (behavioral disruption) threshold for impulsive source underwater noise for pinniped and cetacean species could be exceeded at a distance of up to approximately 2,150 meters during impact pile driving and the 120 dB Level B harassment threshold could be exceeded at 21,544 meters during vibratory driving as is shown in Table 2.

Note that the actual area ensonified by pile driving activities is significantly constrained by local topography relative to the threshold radius depicted in Table 2. This is represented in in the monitoring plan submitted by HTC in Appendix B, Figure B-1.

The estimated takes for several species has been revised after receiving comments from the Commission and NPS and these revisions are described below.

Humpback whale—There are no density estimates of humpback whales available in the action area. The best available information on the distribution of these marine mammals in the study area is data obtained from a National Park Service humpback whale study. Neilson et al. (2014) documented a total of 237 individual humpback whales (including 10 mother-calf pairs) in Glacier Bay and adjacent waters of Icy Strait in the 2013 peak survey period between June and August. This is the highest yearly count of individual humpback whales since the survey began in 1985. Of these 237 whales, 148 were documented as remaining in the vicinity for a period greater than 20 days. One year later in the Icy Strait sub-area of the 2014 NPS survey, 202 humpback whales were counted. Because whales move freely back and forth between Glacier Bay and Icy Strait, NMFS used the higher total survey count of 237 whales from 2013, or an average of almost 79 whales per month, to estimate exposure. Given that the period of active pile driving will be up to four months (June through September), a worst-case estimate would predict that up to 316 (79*4) Level B takes of humpback whale could occur as a result of the proposed action. This estimate is likely conservative given that action area for this project is smaller than the overall survey area and smaller than the portion of the survey conducted in Icy Strait.

Steller sea lion—Womble et al. (2009) conducted mean monthly counted of Steller sea lions at multiple haulout sites in Southeast Alaska between 2001 and 2004. The haulout site nearest to Hoonah was Rocky Island which featured monthly averages of 2 sea lions or less for June, July and August while 174 were sighted in September. Barlow et al. (in press) reported number of sightings, numbers of individuals, and sightings per unit effort data from opportunistic marine mammal surveys conducted in Glacier Bay and Icy Strait between 2005 and 2014. Steller sea lions were observed at relatively high densities around Point Adolphus and other locations in Icy Strait and in various places inside Glacier Bay. The highest count of observed individuals was 395 sea lions between June and August of 2008, which equates to 132 sightings per month. Since the authorization period is four months, this estimate would mean that up to 528 (132*4) individual Level B takes of Steller sea lions could occur as a result of pile driving activities. This figure is within the range of findings published in the 2009 study by Womble et al.

Harbor seal—A recent study by Barlow et al. (in press) of Glacier Bay and Icy Strait determined that an average of 26 sightings occurred each month between June and August of 2014. This would result in an estimated 104 takes during the July through August authorization period. While the harbor seal population has notably declined in the Glacier Bay area between 1992 and 2009 (Womble et al. 2013, 2010), these seals are not uncommon in the Icy Strait and Port Frederick area. As such, there exists the possibility of numerous repeated takes of the same animal. Therefore, NMFS believes that the original conservative estimate of 480 harbor seal takes is more realistic for this species.

Dall's porpoise—The Barlow et al. (in press) study documented 9 individual Dall's porpoises in Glacier Bay across three months in 2007, for an average of 3 sightings per month. Based on this data, a worst-case estimate would mean that up to 12 (3*4) individual Level B takes of Dall's porpoise could occur as a result of pile driving activities. However, Dahlheim et al. (2008) recorded 346 sightings of Dall's porpoise in Southeast Alaska during the summer (June/July) of 2007, resulting in an average of 173 observations per month. Over a four-month activity period (4*173) this would result in an estimated 692 takes during the authorization period. Dahlheim et al. (2008) also reported that high concentrations of this porpoise were encountered in Icy Strait. Given the broader geographic focus of Barlow et al. (in press) and the high concentrations of Dall's porpoise reported in the Icy Strait area by Dahlheim et al. (2008), NMFS believes that an estimate of 692 takes of Dall's porpoise is based on the best available information and is appropriate for this authorization.

Gray whale—Gray whales are not common in Icy Strait during the summer months. The Barlow et al. (in press) study documented only 3 whales, each occurring in a different year, over the course of the ten year study period. The Commission suggested NMFS increase allowed take to reflect the mean group size. Gray whales usually occur in groups of 1 to 3. NMFS will conservatively assume that during every month of the activity period a single group of 3 whales may occur in the Level B harassment zone (3*4), which would result in a conservative estimate of 12 gray whale takes during the Authorization.

Harbor porpoise—Harbor porpoises are known to occur regularly in the Icy Strait area. Dahlheim (2015) indicated that 332 resident harbor porpoises occur in the Icy Strait area, and are known to use the Port Frederick area as part of their core range. The population has been declining across Southeast Alaska since the early 1990's (Dahlheim et al. 2012). During a 2014 survey Barlow et al. (in press) observed 462 harbor porpoises in the Glacier Bay and Icy Strait area during a three-month summer survey period. This was the highest number observed during the 10 year study, with an average of 154 porpoise per month. Given that harbor porpoise are known to frequent this area, NMFS has revised its take estimates. NMFS will assume that all 322 resident harbor porpoises will occur in the Level B harassment area each month (322*4) resulting in 1,288 takes.

Killer whale—Killer whales occur commonly in the waters of the action area, and could include members of several designated stocks that may occur in the vicinity of the proposed project area. Whales are known to use the Icy Strait corridor to enter and exit inland waters and are observed in every month of the year, with certain pods being observed inside Port Frederick passing directly in front of Hoonah (Dahlheim 2015).

NMFS examined only summer and fall (no spring) results from a line-transect survey by Dalheim et al. (2008) and determined the maximum number of combined resident and transient killer whales. During a single two-month survey period (September/October) of 1992, 173 resident whales were observed, or an average of 87 per month. The greatest number of transient sightings occurred in 1993 with 32 sightings over two months for an average of 16 sightings per month. Combining maximum resident and transient whales sighting per month (87+16) results in a monthly average of 103 and a total take estimate of (103*4) 412 killer whales over the 4 month activity period. Mean group size for resident killer whales in summer was greatest in 2004 at 45. For transients the mean group average also peaked during the same year at 15. Recent information provided by Dahlheim (2015) indicated that group sizes for specific resident killer whale pods found in the Icy Strait area ranged from 42 to 79. Using the best information available, NMFS has estimated take at 412 killer whales which allows for Level B take of several large pods of killer whales during the authorization period and also account for multiple repeated counts of pods.

Minke whale—The original take estimate provided in the Federal Register (80 FR 14945) requesting public comments remains unchanged as no comments were received regarding Minke whales.

Pacific white-sided dolphin—Dalheim et al. 2008 did not observe Pacific white-sided dolphins during the summer season during the final years (2006, 2007) of a survey run in the years 1991 through 2007. These dolphins were observed intermittently during the years 1992 and 1993 when there were 39 and 122 sightings, respectively. However, members of this species have not been observed in Frederick Strait since the early 1990's. The Commission recommended utilizing a mean group size when estimating take for this species if it is anticipated to be encountered in low numbers. The mean group size ranged from 19.5 (1992) to 152.5(1996). As part of a conservative approach, NMFS will authorize Level B take of 153 white-sided dolphins.

Negligible impact is “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” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of Level B harassment takes, alone, is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, migration, etc.), as well as the number and nature of estimated Level A harassment takes, the number of estimated mortalities, effects on habitat, and the status of the species.

To avoid repetition, the discussion of our analyses applies to all the species listed in Table 3, given that the anticipated effects of this pile driving project on marine mammals are expected to be relatively similar in nature. There is no information about the size, status, or structure of any species or stock that would lead to a different analysis for this activity, else species-specific factors would be identified and analyzed.

Pile driving activities associated with the cruise ship terminal re-development, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the specified activities may result in take, in the form of Level B harassment (behavioral disturbance) only, from underwater sounds generated from pile driving. Potential takes could occur if individuals of these species are present in the ensonified zone when pile driving is happening.

No injury, serious injury, or mortality is anticipated given the nature of the activity and measures designed to minimize the possibility of injury to marine mammals. The potential for these outcomes is minimized through the construction method and the implementation of the planned mitigation measures. Specifically, vibratory hammers will be the primary method of installation, though impact driving may be used for brief, irregular periods. Vibratory driving does not have significant potential to cause injury to marine mammals due to the relatively low source levels produced (site-specific acoustic monitoring data show no source level measurements above 180 dB rms) and the lack of potentially injurious source characteristics. Impact pile driving produces short, sharp pulses with higher peak levels and much sharper rise time to reach those peaks. When impact driving is necessary, required measures (implementation of shutdown zones) significantly reduce any possibility of injury. Given sufficient “notice” through use of soft start (for impact driving), marine mammals are expected to move away from a sound source that is annoying prior to its becoming potentially injurious. The likelihood that marine mammal detection ability by trained observers is high under the environmental conditions described for Icy Strait Point further enables the implementation of shutdowns to avoid injury, serious injury, or mortality.

HTC's proposed activities are localized and of short duration. The entire project area is limited to the Icy Strait cruise ship terminal area and its immediate surroundings. The project will require the installation of a total of approximately 104 steel pipe piles of varying diameters below the MHHW. Piles that will be used include 24-inch, 30-inch, 42-inch, and 60-inch steel pipe piles. Total impact hammer time would not exceed 5 minutes per pile for 104 piles resulting in less than 10 hours of driving time. Total vibratory hammer time would not exceed 5 hours on any one given day over the course of an estimated 103 driving days, nor would it exceed more than 100 hours over a four-month period. These localized and short-term noise exposures may cause brief startle reactions or short-term behavioral modification by the animals. These reactions and behavioral changes are expected to subside quickly when the exposures cease. Moreover, the proposed mitigation and monitoring measures are expected to reduce potential exposures and behavioral modifications even further. Additionally, no important feeding and/or reproductive areas for marine mammals are known to be near the proposed action area. Therefore, the take resulting from the proposed HTC re-development of the Icy Strait Point Cruise Ship Terminal is not reasonably expected to and is not reasonably likely to adversely affect the marine mammal species or stocks through effects on annual rates of recruitment or survival.

The project also is not expected to have significant adverse effects on affected marine mammals' habitat, as analyzed in detail in the “Anticipated Effects on Marine Mammal Habitat” section. The project activities would not modify existing marine mammal habitat. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range; but, because of the short duration of the activities and the relatively small area of the habitat that may be affected, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.

Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature as well as monitoring from other similar activities, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (e.g., Thorson and Reyff, 2006; HDR, 2012; Lerma, 2014). Most likely, individuals will simply move away from the sound source and be temporarily displaced from the areas of pile driving, although even this reaction has been observed primarily only in association with impact pile driving. In response to vibratory driving, pinnipeds (which may become somewhat habituated to human activity in industrial or urban waterways) have been observed to orient towards and sometimes move towards the sound. The pile driving activities analyzed here are similar to, or less impactful than, numerous construction activities conducted in other similar locations, which have taken place with no reported injuries or mortality to marine mammals, and no known long-term adverse consequences from behavioral harassment. Repeated exposures of individuals to levels of sound that may cause Level B harassment are unlikely to result in hearing impairment or to significantly disrupt foraging behavior. Thus, even repeated Level B harassment of some small subset of the overall stock is unlikely to result in any significant realized decrease in fitness for the affected individuals, and thus would not result in any adverse impact to the stock as a whole. Level B harassment will be reduced to the level of least practicable impact through use of mitigation measures described herein and, if sound produced by project activities is sufficiently disturbing, animals are likely to simply avoid the project area while the activity is occurring.

In summary, this negligible impact analysis is founded on the following factors: (1) The possibility of injury, serious injury, or mortality may reasonably be considered discountable; (2) the anticipated incidents of Level B harassment consist of, at worst, temporary modifications in behavior; (3) the absence of any significant habitat within the project area, including rookeries, significant haul-outs, or known areas or features of special significance for foraging or reproduction; (4) the presumed efficacy of the proposed mitigation measures in reducing the effects of the specified activity to the level of least practicable impact. In combination, we believe that these factors, as well as the available body of evidence from other similar activities, demonstrate that the potential effects of the specified activity will have only short-term effects on individuals. The specified activity is not expected to impact rates of recruitment or survival and will therefore not result in population-level impacts.

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 proposed monitoring and mitigation measures, NMFS finds that the total marine mammal take from HTC's re-development of the Icy Strait Point Cruise Ship Terminal will have a negligible impact on the affected marine mammal species or stocks.

Table 3 demonstrates the number of animals that could be exposed to received noise levels that could cause Level B behavioral harassment for the proposed work associated with the re-development of the Icy Strait Point Cruise Ship Terminal in Hoonah, Alaska. The analyses provided represents between <0.01% to 14.4% of the stocks of humpback whale, Steller sea lion, harbor seal, Dall's porpoise, gray whale, harbor porpoise, minke whale, and Pacific white-sided dolphin that could be affected by Level B behavioral harassment. NMFS therefore concludes that small numbers of these stocks will be taken relative to the total populations of the affected species or stocks.

As explained previously, we are proposing to authorize 412 takes (Level B harassment only) of killer whales from three stocks of killer whales that are known to occur in the Icy Strait area: (1) Alaska resident stock with an estimated population of 2,347; (2) Gulf of Alaska, Aleutian Islands, and Bering Sea transient stock with an estimated population of 587; and (3) West Coast transient stock with an estimated population of 354. Given that all three stocks occur in the Icy Strait Area, the 412 proposed takes will most likely be apportioned among the three stocks. As described in the estimated take section, based on sightings data, NMFS expects approximately 348 takes (87 per month * 4 months) of the resident stock to occur and 64 (16 per month * 4 months) of the two transient stocks to occur. These numbers are small relative to the population sizes of the resident and transient stocks. Furthermore, NMFS notes that the number of takes proposed to be authorized represents the estimated incidents of take, not the number of individuals taken. More likely, fewer individuals would be taken, but a subset would be taken more than one time during the duration of the Authorization.

Specific resident pods are frequently encountered throughout Icy Strait according to Dalheim (2015). These would be the AG pod numbering a minimum of 42 whales and the AF pod with a minimum count of 79 whales. Whales from these two pods have been seen in the area every month of the year and the Icy Strait corridor is a major route for them both entering and exiting inland waters. The AG pod, specifically, has been observed on numerous occasions inside Port Frederick, passing directly off shore of Hoonah. As such, many of the anticipated takes are likely to be repeated takes of the same animals from AG and AF pods. However, even in a worst-case scenario in which all 412 takes came from the resident stock, the number of takes would still be small compared to the population size (approximately 17.6%).

As stated above, the anticipated number of takes attributable to the transient stocks (64) is small compared to the population sizes of both the West coast transient stock and the Gulf of Alaska, Aleutian Islands, and Bering Sea transient stock. Further, NMFS also believes that small numbers of the West Coast transient stock would be taken based on the limited region of exposure in comparison with the known distribution of the transient stock. The West Coast transient stock ranges from Southeast Alaska to California while the proposed project activity would be stationary. As described in the Description of Marine Mammals in the Area of the Specified Activity section in our Federal Register notice announcing the proposed authorization (80 FR 14945; March 20, 2015), a notable percentage of West Coast transient whales have never been observed in Southeast Alaska. Only 155 West Coast transient killer whales have been identified as occurring in Southeast Alaska according to Dahlheim and White (2010). The same study identified three pods of transients, equivalent to 19 animals, that remained almost exclusively in the southern part of Southeast Alaska (i.e. Clarence Strait and Sumner Strait). This information indicates that only a small subset of the entire West Coast Transient stock would be at risk for take in the Icy Strait area because a sizable portion of the stock has either not been observed in Southeast Alaska or consistently remains far south of Icy Strait. Similarly, only a very small number of Gulf of Alaska, Aleutian Islands, and Bering Sea transient killer whales have been observed in Southeast Alaska with sightings being an uncommon occurrence (Dalheim 2015). Whales from this stock occur mainly from Prince William Sound through the Aleutian Islands and Bering Sea and are spread across a vast area.

In summary, NMFS concludes that small numbers of each of the three stocks of killer whales known to occur in the Icy Strait region will be taken relative to the population sizes of the affected stocks. This conclusion is based on the small likelihood that all of the incidents of take would come from only one stock; the reduced percentage of transient stocks of killer whales likely to be found in the Icy Strait area due to the wide geographic distribution of these two stocks; and the likelihood of repeated exposures of both transient and resident whales, especially among the two resident pods identified as commonly frequenting the waters near the action area.

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, which are expected to reduce the number of marine mammals potentially affected by the proposed action, NMFS finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.

There are no subsistence uses of marine mammals in the proposed project area; and, thus, no subsistence uses impacted by this action. The nearest locations where subsistence hunting may occur are at Eagle Point, located approximately 10 miles distant from the Icy Strait Cruise Terminal project site and at Flynn Cove, located approximately 7.5 miles from the project site. Peak subsistence hunting months are March, May, and October and the pile driving is slated to occur in the June to September timeframe. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

There are two marine mammal species that are listed as endangered under the ESA with confirmed or possible occurrence in the study area: humpback whale and Steller sea lion (Western DPS). NMFS' Permits and Conservation Division initiated consultation with NMFS' Protected Resources Division under section 7 of the ESA on the issuance of an IHA to HTC under section 101(a)(5)(D) of the MMPA for this activity. NMFS' Protected Resources Division concluded that the proposed action is likely to adversely affect, but not likely to jeopardize these species.

NMFS has prepared an Environmental Assessment (EA) in accordance with the National Environmental Policy Act (NEPA) which considered comments submitted in response to this notice as part of that process. The EA and Finding of No Significant Impact (FONSI) are posted at http://www.nmfs.noaa.gov/pr/permits/incidental/construction.htm.

As a result of these determinations, we have issued an IHA to HTC for conducting the described activities at Icy Strait Point, Alaska, from June 1, 2015 through October 31, 2015 provided the previously described mitigation, monitoring, and reporting requirements are incorporated.

This request is for an extension of a currently approved information collection. National Marine Fisheries Service (NMFS) has issued regulations under authority of the Western and Central Pacific Fisheries Convention Implementation Act (WCPFCIA; 16 U.S.C. 6901 et seq.) to carry out the obligations of the United States under the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Commission). The regulations include requirements for the owners and operators of U.S. vessels to: (1) Complete and submit a Pacific Transshipment Declaration form for each transshipment that takes place in the Convention Area of highly migratory species caught in the Convention Area, (2) submit notice to the WCPFC Executive Director containing specific information at least 36 hours prior to each transshipment on the high seas in the Convention Area, (3) in the event that a vessel anticipates a transshipment where an observer is required, provide notice to NMFS at least 72 hours before leaving port of the need for an observer, (4) submit a notice to the WCPFC Executive Director containing specific information six hours prior to entry or exit of the Eastern High Seas Special Management Area, (5) complete and submit a U.S. Purse Seine Discard form within 48 hours after any discard, and (6) submit a FAD Report within 24 hours at the end of each day that the vessel is on a fishing trip in the Convention Area.

The information collected from these requirements is used by NOAA and the Commission to help ensure compliance with domestic laws and the Commission's conservation and management measures, and are necessary in order for the United States to satisfy its obligations under the Convention.

Respondents must submit some of the information by mail or in person via paper forms, and must submit other information electronically by fax or email.

OMB Control Number: 0648-0649.

Form Number(s): None.

Type of Review: Regular submission (extension of a currently approved information collection).

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 211.

Estimated Time per Response: Transshipment Report: 60 minutes; Notice for Transshipment: 15 minutes; Pre-trip Notification for Observer Placement: 1 minute; Notice of Entry or Exit for Eastern SMA: 15 minutes; Purse Seine Discard Report: 30 minutes; Daily FAD Report: 10 minutes.

Estimated Total Annual Burden Hours: 2,260.

Estimated Total Annual Cost to Public: $11,116 in recordkeeping/reporting costs.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments are also requested on possible modifications to both the Pacific Transshipment Declaration form and the U.S. Purse Seine Discard form in order to enhance the convenience and usability of the forms. Recent versions of both forms can be found in the WCPFC Transshipping, Bunkering, Reporting and Purse Seine Discard Compliance Guide at http://www.fpir.noaa.gov/Library/IFD/BA85-compliance-guide-IRC.pdf.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three step process including: (1) Data Workshop; (2) Assessment Process utilizing workshops and webinars; and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, the Atlantic and Gulf States Marine Fisheries Commissions and NOAA Fisheries Southeast Regional Office and Southeast Fisheries Science Center. Participants include: Data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.

SEDAR also coordinates procedural workshops which provide an opportunity for focused discussion and deliberation on topics that arise in multiple assessments. They are structured to develop best practices for addressing common issues across assessments. The seventh procedural workshop will develop best practice recommendations for SEDAR Data Workshops.

Workshop objectives include developing an inventory of common or recurring data and analysis issues from SEDAR Data Workshops; documenting how the identified data and analysis issues were addressed in the past and identifying potential additional methods to address these issues; developing and selecting best practice procedures and approaches for addressing these issues in future, including procedures and approaches to follow when deviating from best practice recommendations; and identifying a process to address future revision and evaluation of workshop recommendations, considering all unaddressed data and analysis issues.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SEDAR office (see ADDRESSES) at least 10 business days prior to the meeting.

PBA's Statutory Authority and Function: The President's Board of Advisors on Historically Black Colleges and Universities (the Board) is established by E.O. 13532 (February 26, 2010) and subsequently continued by E.O. 13652, which was signed by the President on September 30, 2013. The Board is governed by the provisions of the Federal Advisory Committee Act (FACA), (Pub. L. 92-463; as amended, 5 U.S.C.A., Appendix 2) which sets forth standards for the formation and use of advisory committees. The purpose of the Board is to advise the President and the Secretary of Education (Secretary) on all matters pertaining to strengthening the educational capacity of Historically Black Colleges and Universities (HBCUs).

The Board shall advise the President and the Secretary in the following areas: (i) improving the identity, visibility, and distinctive capabilities and overall competitiveness of HBCUs; (ii) engaging the philanthropic, business, government, military, homeland-security, and education communities in a national dialogue regarding new HBCU programs and initiatives; (iii) improving the ability of HBCUs to remain fiscally secure institutions that can assist the nation in reaching its goal of having the highest proportion of college graduates by 2020; (iv) elevating the public awareness of HBCUs; and (v) encouraging public-private investments in HBCUs.

Meeting Agenda: In addition to its review of activities prior to June 23, 2015, the meeting agenda will include Chairman William R. Harvey's report on HBCU issues and concerns; Executive Director, George Cooper will provide an update on current priorities of the White House Initiative on HBCUs to include the 2015 HBCU Week Conference and an update on the 2013 Report to the President on the Results of the Participation of Historically Black Colleges and Universities in Federal Programs; David Johns, Executive Director of the White House Initiative on Educational Excellence for African Americans will discuss the joint meeting requirement for the President's Advisory Commission on Educational Excellence for African Americans and the Board; and Chairman Harvey will lead a conversation regarding the re-focus of Board subcommittees.

Below is a list of agencies, invited to provide updates on fiscal year 2015 activities and outreach during the June 23, 2015 meeting:

Submission of requests to make an oral comment: There are two methods the public may use to make an oral comment at the June 23, 2015 meeting.

Method One: Submit a request by email to the [email protected] mailbox. Please do not send material directly to PBA members. Requests must be received by June 17, 2015. Include in the subject line of the email request “Oral Comment Request: (organization name).” The email must include the name(s), title, organization/affiliation, mailing address, email address, telephone number, of the person(s) requesting to speak, and a brief summary (not to exceed one page) of the principal points to be made during the oral presentation. All individuals submitting an advance request in accordance with this notice will be afforded an opportunity to speak for three minutes.

Method Two: Register at the meeting location on June 23, 2015, to make an oral comment during the PBA's deliberations concerning Historically Black Colleges and Universities. The requestor must provide his or her name, title, organization/affiliation, mailing address, email address, and telephone number. Individuals will be selected on a first-come, first-served basis. If selected, each commenter will have an opportunity to speak for three minutes.

All oral comments made will become part of the official record of the Board. Similarly, written materials distributed during oral presentations will become part of the official record of the meeting.

Submission of written public comments: The Board invites written comments to be read during the Public Comment segment of the agenda. Comments must be received by June 17, 2015, in the [email protected] mailbox, include in the subject line “Written Comments: Public Comment”. The email must include the name(s), title, organization/affiliation, mailing address, email address, and telephone number, of the person(s) making the comment. Comments should be submitted as a Microsoft Word document or in a medium compatible with Microsoft Word (not a PDF file) that is attached to an electronic mail message (email) or provided in the body of an email message. Please do not send material directly to the PBA members.

Access to Records of the Meeting: The Department will post the official report of the meeting on the PBA Web site 90 days after the meeting. Pursuant to the Federal Advisory committee Act (FACA), the public may also inspect the materials at 400 Maryland Avenue SW., Washington, DC, by emailing [email protected] or by calling (202) 453-5634 to schedule an appointment.

Reasonable Accommodations: The meeting site is accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting (e.g., interpreting service, assistive listening device, or materials in an alternate format), notify the contact person listed in this notice at least one week before the meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

Electronic Access to this Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: School Survey on Crime and Safety (SSOCS) 2016 and 2018.

OMB Control Number: 1850-0761.

Type of Review: A reinstatement of a previously approved information collection.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 3,919.

Total Estimated Number of Annual Burden Hours: 1,795.

Abstract: The School Survey on Crime and Safety (SSOCS) is a nationally representative survey of elementary and secondary school principals that serves as the primary source of school-level data on crime and safety in public schools. SSOCS is the only recurring federal survey collecting detailed information on the incidence, frequency, seriousness, and nature of violence affecting students and school personnel from the school's perspective. Data are also collected on frequency and types of disciplinary actions taken for select offenses; perceptions of other disciplinary problems, such as bullying, verbal abuse and disorder in the classroom; the presence and role of school security staff; parent and community involvement; staff training; mental health services available to students; and, school policies and programs concerning crime and safety. Prior administrations of SSOCS were conducted in 2000, 2004, 2006, 2008, and 2010. This request is to conduct the 2016 and 2018 administrations of SSOCS.

General Information: The meeting is open to the public. Any member of the public interested in receiving a draft agenda, attending the meeting, or making a presentation at the meeting may contact Tim Benner, the Designated Federal Officer, via any of the contact methods listed in the FOR FURTHER INFORMATION CONTACT section above. In general, each individual making an oral presentation will be limited to a total of three minutes. For security purposes, all attendees must provide their names to the Designated Federal Officer or register online at https://sites.google.com/site/epaboardofscientificcounselors/bosc-committees/air-climate-and-energy by June 11, 2015, and must go through a metal detector, sign in with the security desk, and show government-issued photo identification to enter the building. Attendees are encouraged to arrive at least 15 minutes prior to the start of the meeting to allow sufficient time for security screening. Proposed agenda items for the meeting include, but are not limited to, the following: Overview of materials provided to the subcommittee; Overview of ORD; Overview of ORD's Air, Climate, and Energy Research Program; Poster session; and Subcommittee discussion.

Information on Services for Individuals with Disabilities: For information on access or services for individuals with disabilities, please contact Tim Benner at (202) 564-6769 or [email protected]. To request accommodation of a disability, please contact Tim Benner, preferably at least ten days prior to the meeting, to give the EPA as much time as possible to process your request.

I. General Information A. Does this action apply to me?

This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that may apply to this action. Although others may be affected, this action applies directly to the submitter of the PMNs addressed in this action.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

This document provides receipt and status reports, which cover the period from April 1, 2015 to April 29, 2015, and consists of the PMNs and TMEs both pending and/or expired, and the NOCs to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period.

Section 5 of TSCA requires that EPA periodical publish in the Federal Register receipt and status reports, which cover the following EPA activities required by provisions of TSCA section 5.

EPA classifies a chemical substance as either an “existing” chemical or a “new” chemical. Any chemical substance that is not on EPA's TSCA Inventory is classified as a “new chemical,” while those that are on the TSCA Inventory are classified as an “existing chemical.” For more information about the TSCA Inventory go to: http://www.epa.gov/opptintr/newchems/pubs/inventory.htm. Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by TSCA section 5 to provide EPA with a PMN, before initiating the activity. Section 5(h)(1) of TSCA authorizes EPA to allow persons, upon application, to manufacture (includes import) or process a new chemical substance, or a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a), for “test marketing” purposes, which is referred to as a test marketing exemption, or TME. For more information about the requirements applicable to a new chemical go to: http://www.epa.gov/oppt/newchems.

Under TSCA sections 5(d)(2) and 5(d)(3), EPA is required to publish in the Federal Register a notice of receipt of a PMN or an application for a TME and to publish in the Federal Register periodic status reports on the new chemicals under review and the receipt of NOCs to manufacture those chemicals.

In Table I. of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the PMNs received by EPA during this period: The EPA case number assigned to the PMN, the date the PMN was received by EPA, the projected end date for EPA's review of the PMN, the submitting manufacturer/importer, the potential uses identified by the manufacturer/importer in the PMN, and the chemical identity.

In Table II. of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the NOCs received by EPA during this period: The EPA case number assigned to the NOC, the date the NOC was received by EPA, the projected end date for EPA's review of the NOC, and chemical identity.

If you are interested in information that is not included in these tables, you may contact EPA as described in Unit III. to access additional non-CBI information that may be available.

On May 27, 2015, the Federal Maritime Commission instituted an Order of Investigation and Hearing entitled John T. Barbour t/d/b/a Barbour Auto Group; Barbour Auto Sales; Barbour Shipping; and Barbour Shipping and Transportation Inc.—Possible Violations of Sections 8 and 19 of the Shipping Act. Acting pursuant to Section 11 of the Shipping Act, 46 U.S.C. 41302, that investigation is instituted to determine:

(1) Whether John T. Barbour, t/d/b/a Barbour Auto Group, Barbour Auto Sales, Barbour Shipping, and Barbour Shipping and Transportation Inc. violated sections 8 and 19 of the Shipping Act, 46 U.S.C. 40501, 40901, and 40902, by acting as a NVOCC without a license, filing evidence of financial security, or keeping open for public inspection a tariff containing its rates, charges, rules and practices; (2) in the event violations of the Shipping Act are found, whether civil penalties should be assessed against Barbour, and in what amount; and (3) whether appropriate cease and desist orders should be entered.

The Order may be viewed in its entirety at http://www.fmc.gov/15-03.

The National Human Trafficking Victim Assistance Program (NHTVAP) provides funding for comprehensive case management services to victims of trafficking and certain family members on a per capita basis. The NHTVAP grantees help clients gain access to housing, employability services, mental health screening and therapy, medical care, and some legal services. During FY 2015, a grantee, U.S. Committee for Refugees and Immigrants (USCRI), served more clients than it had planned for in its budget for the year. Without the additional funding, USCRI would have to make significant cuts in services to current clients and limit the enrollment of new clients. Also, without additional funding USCRI would not have sufficient programmatic support for the increase in client enrollments. With the supplemental funding, USCRI will be able to ensure that all of the clients' essential needs will be met.

On March 06, 2015, the Agency submitted a proposed collection of information entitled “Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0435. The approval expires on May 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

I. Funding Opportunity Description RFA-FD-15-011 93.103 A. Background

This FOA is soliciting an application from the Graduate School USA to support and extend the education programs of the Education Team in the Office of Analytics and Outreach. As part of its mission to promote and protect public health, the Education Team is tasked to implement targeted education programs that reach school-aged children using FDA-approved food safety and nutrition messages. This cooperative agreement requires the grantee to provide 37 teachers for one school year to extend CFSAN's reach into additional U.S. schools. The selected grantee must train and ensure that these 37 teachers will use the FDA curriculum Science and Our Food Supply (SOFS), which has been approved by FDA scientists. The grantee shall also guarantee that these teachers will use CFSAN's educational materials and, in turn, support and promote food safety and nutrition on a national scale.

This cooperative agreement will support the commitment of 37 middle and high school teachers to implement the FDA-National Science Teachers Association (NSTA) supplementary food science curriculum SOFS, and includes one week of targeted training with this curriculum as the basis of instruction. It also includes a 1-day Enhancement Training session at the December NSTA Regional Conference. SOFS content is linked to specific national science education standards to help teachers integrate this content into their existing classroom materials. The course covers the latest research on food safety, food microbiology, epidemiology, and nutrition from FDA experts and scientists. These 37 teachers must conduct a train-the-teacher session for other science teachers in their area of the country on how to successfully use SOFS in their classrooms. To date, 620 teachers have completed the week-long program, reaching approximately 13,000 teachers and more than 7 million students across the country. Teachers in this program have represented all 50 states, the District of Columbia, the U.S. Virgin Islands, Guam, and Puerto Rico.

In recent years, CFSAN has added other training and online resources through the NSTA Learning Center, as well as FDA and Graduate School Web sites. The grantee shall assume the responsibilities of arranging print and electronic program advertisements to science teachers through science teacher journals, Web-based formats, and listservs (where appropriate). The grantee shall act as a National Training Coordinator for the year-round SOFS content delivery by teachers. In addition, the grantee shall oversee and coordinate exhibiting at one regional NSTA conference in the fall of 2015 and one national NSTA conference in spring 2016. The goal of this cooperative agreement is to provide continued support for this program, which requires around-the-calendar attention to cover the various stages of teacher primary training, in-school SOFS curriculum implementation, secondary training, and train-the-teacher programs, as well as to distribute food science education materials to teachers to promote student education in food safety and nutrition.

Specific objectives of this support are to:

• Provide 37 teachers from diverse U.S. schools a weeklong course in food science in the Washington, DC metropolitan area;

• distribute approved food science curricula and other materials for the train-the-teacher session and exhibit at the national NSTA and regional NSTA conferences; and

• facilitate, identify, and prioritize technical assistance and development needs, develop strategic and project plans, and allocate resources to coordinate FDA training program components for U.S. teachers actively incorporating FDA's food safety and nutrition curriculum in their classrooms, as specified in the various training components of this proposed cooperative agreement.

The following organization is eligible to apply: Graduate School USA.

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

FDA/CFSAN intends to fund up to $452,700.00 for fiscal year 2015 in support of this grant program. Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full announcement located at http://www.grants.gov. Search by Funding Opportunity Number: RFA-FD-15-011. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) For all electronically submitted applications, the following steps are required.

Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps, submit electronic applications to: http://www.grants.gov.

In the Federal Register of April 29, 2015, in FR Doc. 2015-09884, on page 23798, the following correction is made:

1. On page 23798, in the first column, in the headings section of the document, “[Docket No. FDA-2014-D-0090]” is corrected to read “[Docket No. FDA-2015-N-1805]”.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection approval request is for FDA guidance on the process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that cannot be resolved at the division level. The guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented. The guidance provides information on how the Agency will interpret and apply provisions of the existing regulations regarding internal Agency review of decisions (§ 10.75 (21 CFR 10.75)) and dispute resolution during the investigational new drug (IND) process (§ 312.48 (21 CFR 312.48)) and the new drug application/abbreviated new drug application (NDA/ANDA) process (§ 314.103 (21 CFR 314.103)). In addition, the guidance provides information on how the Agency will interpret and apply the specific Prescription Drug User Fee Act (PDUFA) goals for major dispute resolution associated with the development and review of PDUFA products.

Existing regulations, which appear primarily in parts 10, 312, and 314 (21 CFR parts 10, 312, and 314), establish procedures for the resolution of scientific and procedural disputes between interested persons and the Agency, CDER, and CBER. All Agency decisions on such matters are based on information in the administrative file (§ 10.75(d)). In general, the information in an administrative file is collected under existing regulations in part 312 (OMB control number 0910-0014), part 314 (OMB control number 0910-0001), and part 601 (21 CFR part 601) (OMB control number 0910-0338), which specify the information that manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of drugs and biological products. This information is usually submitted as part of an IND, NDA, or biologics license application (BLA), or as a supplement to an approved application. While FDA already possesses in the administrative file the information that would form the basis of a decision on a matter in dispute resolution, the submission of particular information regarding the request itself and the data and information relied on by the requestor in the appeal would facilitate timely resolution of the dispute. The guidance describes the following collection of information not expressly specified under existing regulations: The submission of the request for dispute resolution as an amendment to the application for the underlying product, including the submission of supporting information with the request for dispute resolution.

Agency regulations (§§ 312.23(a)(11) and (d), 314.50, 314.94, and 601.2) state that information provided to the Agency as part of an IND, NDA, ANDA, or BLA is to be submitted in triplicate and with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs, ANDAs, and BLAs. Both forms have valid OMB control numbers as follows: FDA Form 1571—OMB control number 0910-0014, and FDA Form 356h—OMB control number 0910-0338.

In the guidance document, CDER and CBER ask that a request for formal dispute resolution be submitted as an amendment to the application for the underlying product and that it be submitted to the Agency in triplicate with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The Agency recommends that a request be submitted as an amendment in this manner for two reasons: To ensure that each request is kept in the administrative file with the entire underlying application and to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the Agency's tracking databases enables the appropriate Agency official to monitor progress on the resolution of the dispute and to ensure that appropriate steps will be taken in a timely manner.

CDER and CBER have determined and the guidance recommends that the following information should be submitted to the appropriate center with each request for dispute resolution so that the Center may quickly and efficiently respond to the request: (1) A brief but comprehensive statement of each issue to be resolved, including a description of the issue, the nature of the issue (i.e., scientific, procedural, or both), possible solutions based on information in the administrative file, whether informal dispute resolution was sought prior to the formal appeal, whether advisory committee review is sought, and the expected outcome; (2) a statement identifying the review division/office that issued the original decision on the matter and, if applicable, the last Agency official that attempted to formally resolve the matter; (3) a list of documents in the administrative file, or additional copies of such documents, that are deemed necessary for resolution of the issue(s); and (4) a statement that the previous supervisory level has already had the opportunity to review all of the material relied on for dispute resolution. The information that the Agency suggests submitting with a formal request for dispute resolution consists of: (1) Statements describing the issue from the perspective of the person with a dispute, (2) brief statements describing the history of the matter, and (3) the documents previously submitted to FDA under an OMB approved collection of information.

Based on FDA's experience with dispute resolution, the Agency expects that most persons seeking formal dispute resolution will have gathered the materials listed previously when identifying the existence of a dispute with the Agency. Consequently, FDA anticipates that the collection of information attributed solely to the guidance will be minimal.

Description of Respondents: A sponsor, applicant, or manufacturer of a drug or biological product regulated by the Agency under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act who requests formal resolution of a scientific or procedural dispute.

Burden Estimate: Provided in this document is an estimate of the annual reporting burden for requests for dispute resolution. Based on data collected from review divisions and offices within CDER and CBER, FDA estimates that approximately eight sponsors and applicants (respondents) submit requests for formal dispute resolution to CDER annually and approximately one respondent submits requests for formal dispute resolution to CBER annually. The total annual responses are the total number of requests submitted to CDER and CBER in 1 year, including requests for dispute resolution that a single respondent submits more than one time. FDA estimates that CDER receives approximately 31 requests annually and CBER receives approximately 1 request annually. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for formal dispute resolution in accordance with this guidance, including the time it takes to gather and copy brief statements describing the issue from the perspective of the person with the dispute, brief statements describing the history of the matter, and supporting information that has already been submitted to the Agency. Based on experience, FDA estimates that approximately 8 hours on average would be needed per response. Therefore, FDA estimates that 8 hours will be spent per year by respondents requesting formal dispute resolution under the guidance.

Under the PRA, (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

On July 9, 2012, the Generic Drug User Fee Act (GDUFA) (Pub. L. 112-144, Title 111) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug manufacturers pay user fees to finance critical and measurable program enhancements. The user fees required by GDUFA are as follows: A one-time fee for original abbreviated new drug applications (ANDAs) pending on October 1, 2012 (also known as backlog applications); fees for type II active pharmaceutical ingredient (API) and final dosage form (FDF) facilities; fees for new ANDAs and prior approval supplements (PASs); and a one-time fee for drug master files (DMFs).

The purpose of this notice is to solicit feedback on the collection of information in an electronic form used to calculate and pay generic drug user fees. Proposed Form FDA 3794, the Generic Drug User Fee Cover Sheet, requests the minimum necessary information to determine if a person has satisfied all relevant user fee obligations. The proposed form is modeled on other FDA user fee cover sheets, including Form FDA 3397, the Prescription Drug User Fee Act Cover Sheet. The information collected would be used by FDA to initiate the administrative screening of generic drug submissions and DMFs, support the inspection of generic drug facilities, and otherwise support the generic drug program. A copy of the proposed form will be available in the docket for this notice.

Respondents to this proposed collection of information would be potential or actual generic application holders and/or related manufacturers (manufacturers of FDF and/or APIs). Companies with multiple applications will submit a cover sheet for each application and facility. Based on FDA's database of application holders and related manufacturers, we estimate that approximately 460 companies would submit a total of 3,544 cover sheets annually to pay for application and facility user fees. FDA estimates that the 3,544 annual cover sheet responses would break down as follows: 1,439 facilities fees, 942 ANDAs, 502 PASs, and 661 Type II API DMFs. The estimated hours per response are based on FDA's past experience with other submissions and range from approximately 0.1 to 0.5 hours. The hours per response are estimated at the upper end of the range to be conservative.

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

This notice amends part B of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (HHS), Administration for Community Living, as last amended at 79 FR 62142-62152, dated October 16, 2014, as follows:

I. Delete Part B, “The Administration for Community Living”; in its entirety and replace with the following:

B.00 Mission. The Administration for Community Living's (ACL) mission is to maximize the independence, well-being, and health of older adults, people with disabilities across the lifespan, and their families and caregivers. ACL provides national leadership and direction to plan, manage, develop, and raise awareness of comprehensive and coordinated systems of long-term services and supports that enable older Americans and individuals with disabilities, including intellectual, developmental, physical, and other disabilities, to maintain their health and independence in their homes and communities. ACL programs support strong state, tribal, and local community networks designed to respond to the needs of persons with disabilities, older Americans, and their families through advocacy, research, systems change and capacity building to ensure access to needed community services, individualized supports, and other forms of assistance that promote self-determination, independence, productivity, and integration and inclusion in all facets of community life.

ACL advises the Secretary, departmental components and other federal departments and agencies on the development and implementation of policies to improve access to community living services and supports and enhance opportunities for persons with disabilities and older Americans, while retaining discrete policy and programmatic operations that respond to the unique needs of these populations. ACL's visibility within the Department of Health and Human Services and with other federal agencies helps ensure that federal policies and programs allow all individuals across the lifespan to live with respect and dignity as full members of their communities.

B.10 Organization. ACL is an operating division of the Department of Health and Human Services. ACL is headed by an Administrator, who reports directly to the Secretary. The Administrator is also the Assistant Secretary for Aging. In addition to the Administrator, the ACL consists of the Principal Deputy Administrator who also reports to the Secretary, serving as the senior disability policy advisor to the Secretary; and staff and program offices. ACL is organized as follows:

B.20 Functions. ACL is the principal agency in the department designated to lead aging and disability programs. More specifically, the provisions of the Older Americans Act (OAA) of 1965 are carried out by its subcomponent, the Administration on Aging; the provisions of the Developmental Disabilities Assistance and Bill of Rights Act (DD Act) of 2000 and Title VII of the Rehabilitation Act of 1973 are carried out by its subcomponent, the Administration on Disabilities; and the provisions of Title II of the Rehabilitation Act of 1973 are carried out by its subcomponent, the Nation lInstitute on Disability, Independent Living, and Rehabilitation Research. ACL also administers programs authorized under Title III and Title XXIX of the Public Health Service Act (PHSA), section 262 and 292 of the Help America Vote Act (HAVA), section 119 of the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008, section 6021(d) of the Deficit Reduction Act (DRA) of 2005, section 4360 of the Omnibus Budget Reconciliation Act (OBRA) of 1990, the Elder Justice Act (EJA) of 2010 (Subtitle B of Title XX of the Social Security Act), and the Assistive Technology Act of 1998. In addition, ACL provides continuing support for the administration of the President's Committee for People with Intellectual Disabilities pursuant to E.O. 13652.

Specifically, ACL develops, recommends and issues regulations, policies, procedures, standards and guidelines to provide direction for the programs it administers. Approves or disapproves plans and funding applications for national programs providing community-based long-term services and supports. Administers programs for training, research, demonstration, evaluation and information dissemination. Administers programs related to advocacy, systems change and capacity building. Administers national centers for service development and provides technical assistance to states, tribal organizations, local communities and service providers. Serves as the lead federal agency for adult protective services.

Assists the Secretary in all matters pertaining to opportunities and challenges of persons with disabilities, older Americans, and Americans of all ages about their current and potential future need for information and access to long-term services and supports. Advocates for the needs of these constituencies in program planning and policy development within the department and in other federal agencies. Advises the Secretary, departmental components and other federal organizations on the characteristics, circumstances and needs of these populations and develops policies, plans and programs designed to promote their welfare.

The functions of the organizational units of ACL are described in detail in the succeeding chapters.

A. Office of the Administrator (BA):

BA.00 Mission. The Office of the Administrator provides executive direction, leadership, and guidance for ACL programs, and serves as the focal point for the development, coordination and administration of those programs nationwide. The office advises the Secretary on issues affecting seniors and persons with disabilities.

BA.10 Organization. The Office of the Administrator is headed by the Administrator, who reports directly to the Secretary. The Office of the Administrator includes the Principal Deputy Administrator, who also serves as the senior advisor to the Secretary on HHS activities relating to disabilities, and the following components:

BA.20 Functions.

1. Immediate Office of the Administrator (BAA). The Immediate Office of the Administrator provides executive supervision to the major components of ACL. The Administrator and Principal Deputy both serve as members of the Secretary's senior leadership team, ensuring that federal policies and programs support the goal of enabling all individuals to live with respect and dignity as fully participating members of their communities.

Specifically, the Immediate Office of the Administrator sets national policies, establishes national priorities, ensures policy consistency, and directs plans and programs conducted by ACL. Advises the Secretary, HHS operating divisions, and other federal agencies on the characteristics, circumstances, and needs of persons with disabilities, older Americans, and their families and on policies, plans and programs designed to promote their welfare.

Coordinates the development of legislative proposals, testimony, background statements, and other policy documents in activities related to legislation. In coordination with the HHS Office of the Assistant Secretary for Legislation, analyzes proposed and enacted legislation related directly or indirectly to older people and persons with disabilities, including legislation directly affecting ACL programs.

In collaboration with other federal agencies, develops and implements interagency agreements to advance the concerns and interests of persons with disabilities, older adults, and families of such individuals. Provides liaison to federal advisory committees. Works with national organizations, professional societies, and academic organizations to identify mutual interests and plan voluntary and funded approaches to enhance opportunities for community living.

Receives, assesses, and controls incoming correspondence and makes assignments to the appropriate ACL component(s) for response and action; provides assistance and advice to ACL staff on the development of responses to correspondence; and tracks development of periodic reports and facilitates departmental clearance. Maintains official copies of all policy and information issuances, ensuring adherence to ethics requirements as well as requirements for records management and disposition and the Freedom of Information Act.

2. Office of External Affairs (BAB). The Office of External Affairs (OEA) supports the Immediate Office of the Administrator in the effective communication of ACL policies, goals, and objectives. Develops and executes strategy for interaction with the news media. Initiates media outreach activities; responds to all media inquiries concerning ACL programs and related issues; develops communications products such as news releases, feature articles and opinion-editorial pieces on ACL programs, initiatives, and issues affecting ACL stakeholders

Manages preparation and clearance of speeches and official statements on ACL programs. Coordinates ACL's participation in conferences and other events intended to educate and inform ACL stakeholders about ACL programs and federal initiatives that affect older Americans and people with disabilities.

Develops and implements public education activities to support program objectives. Develops and distributes communications products such as brochures, fact sheets, and conference exhibits about issues affecting older people and people with disabilities and programs that support them.

Coordinates with other federal agencies, regional offices and partners in the aging and disability networks to develop and implement communications campaigns that advance mutual goals. Coordinates ceremonies and celebrations. Manages the content of ACL Web sites and social media platforms. Implements the National Clearinghouse for Long-Term Care Information authorized under section 6021(d) of the DRA of 2005.

3. Office of Regional Operations (BAC). The Office of Regional Operations includes a coordinating central office liaison and Regional Support Centers around the country. ACL has five Regional Administrators (RA), who each oversee two regions.

The Regional Support Centers (BAC1-BAC10) serve as the focal point for the administration and coordination of Older Americans Act programs within their designated HHS regions, and coordinate with ACL program offices as needed on other ACL programs that support state and local efforts to improve community living for older adults and persons with disabilities (for example, Regional Support Center staff serve as liaisons between State Offices on Aging and other ACL divisions). Represent the Administrator within the region, providing information for, and helping to advance the development of, national programs serving older adults and persons with disabilities. Serve as advocate for ACL stakeholders to other federal agencies in their geographic jurisdictions; advise, consult and cooperate with each federal agency proposing or administering programs or services that affect ACL stakeholders; coordinate and assist public (including federal, state, tribal and local agencies) and private organization in the planning and development of comprehensive and coordinated services; and conduct education of officials and the broader community to ensure understanding of the need for community-based services and supports for older adults and people with disabilities.

Monitor, assist and evaluate state agencies and tribal organizations administering programs supported under the OAA and other authorizing legislation as directed. Participate in the review of state plans and recommend approval or disapproval. Participate in the review of applications for tribal programs and recommend approval or disapproval. Review grantee financial and program reports and provide technical assistance on fiscal operations. Oversee disaster assistance and reimbursement activities pursuant to section 310 of the OAA.

Advise the Administrator on problems and progress of programs; evaluate the effectiveness of programs and services in the regions and recommend changes that would improve program operations and enhance effectiveness; and provide guidance to agencies and grantees in applications of policy to specific operational issues requiring resolution. Facilitate interagency cooperation at the federal, regional, state and tribal levels to enhance resources and assistance available to older adults and persons with disabilities. Disseminate and provide technical assistance regarding program guidelines and developments to state agencies, tribal organizations, and local community service providers.

B. Administration on Aging (BB):

BB.00 Mission. The Administration on Aging (AoA) carries out programs operated under the OAA, section 398 and Title III of the PHSA, and the EJA (Subtitle B of Title XX of the Social Security Act), including, but not limited to, those concerning the Elder Justice Coordinating Council and Adult Protective Services. The Administration on Aging helps elderly individuals maintain their dignity and independence in their homes and communities through comprehensive, coordinated, and cost-effective systems of long-term services and supports and livable communities across the United States.

BB.10 Organization. The Administration on Aging is headed by the Assistant Secretary for Aging, who is also the ACL Administrator. The Deputy Assistant Secretary for Aging supports the Assistant Secretary in overseeing the Administration on Aging. The Administration on Aging includes the following components:

BF.20 Functions.

1. Office of the Assistant Secretary for Aging (BBA). The Office of the Assistant Secretary for Aging advises and supports the Administrator, the Secretary, and other elements of the department in serving as the visible and effective advocate for older people within the federal government. Provides leadership and expertise on program development, advocacy and initiatives affecting seniors and their caregivers. Plans and directs grant programs designed to provide planning, coordination and services to older Americans as authorized under the OAA and other legislation. Actively partners with other ACL subcomponents to develop coordinated programs and policies that jointly address the common needs of older adults and people with disabilities.

Performs functions under Title II of the OAA related to consultation with other federal agencies and the provision of information about aging services, programs and policies in order to enhance coordination and delivery. Supports the Administrator in implementing section 203(1) of the OAA by advising and coordinating with the head of each department and agency and instrumentality of the federal government proposing or administering programs or services substantially related to the objectives of the OAA. Oversees the consultation process by which agency heads must consult with AoA before establishing programs or services related to the OAA. Plans and implements the process for the collaboration with AoA and all federal agencies executing programs and services related to the OAA.

Consults with and provides technical assistance to and education for State and Area Agencies on Aging, tribal grantees and local community service providers in the development of plans, goals, and system development activities. Ensures that statutory requirements, regulations, policies, and instructions are implemented for mandatory grant programs under Titles III, VI and VII of the OAA, and for the discretionary grant programs under Title II and Title IV of the OAA, as well as section 398 and Title III of the PHSA and the EJA.

Provides oversight and leadership, technical assistance, and guidance to Regional Support Centers, states, Area Agencies on Aging and community service providers. Provides technical guidance to the Regional Support Centers as they implement the national programs of the OAA and ensures that clear and consistent guidance is given on program and policy directives. Issues substantive operating procedures to guide central office and regional staff in the conduct of their programmatic responsibilities.

At all levels, from national to the local service delivery level, develops methods and collaborations to articulate the problems and concerns of the elderly to organizations beyond the traditional network of agencies and works with these organizations to be more sensitive and responsive to age-related needs and issues. In coordination with the Office of External Affairs, develops strategies for increasing public awareness of the needs of older Americans and their families, and programs designed to address them.

2. Office of Supportive and Caregiver Services (BBB). The Office of Supportive and Caregiver Services serves as the focal point for the operation, administration, and assessment of the programs authorized under Titles III-B and III-E of the OAA and section 398 of the PHSA, as well as activities under Titles II and IV of the OAA that are designed to provide information and referral services to seniors and caregivers, and to support technical assistance, outreach, and information dissemination that are culturally and linguistically appropriate in order to meet the needs of diverse populations of older individuals. In addition, the Office performs the functions under Title II of the OAA related to consultation with other federal agencies and the provision of information about supportive and caregiver services in order to enhance service coordination and delivery.

Implements Titles III-B and III-E of the OAA through the development of regulations, policies and guidance governing the development and enhancement by State and Area Agencies on Aging of comprehensive and coordinated systems of home- and community-based supportive and caregiver services. This includes implementing and enhancing systems for home- and community-based supportive services, the operation of multi-purpose senior centers, and caregiver support and assistance services.

In coordination with the Office of Nutrition and Health Promotion Programs, provides guidance regarding state plan processing and approval, the process and criteria for approval of states' Intrastate Funding Formulas for the allocation and targeting of resources within states, and implementation of the Interstate Funding Formula for distribution of Title III-B and III-E funds among states. Through the analysis of state plans, evaluation findings and other relevant material, identifies potential program and management issues and develops recommendations on possible solutions.

Fosters, oversees, and ensures accountability for the implementation of programs by states and Area Agencies on Aging through guidance and direction to regional staff regarding program reviews and system development and enhancements. Designs and provides training and technical assistance for program compliance, effectiveness, and enhancement. Provides technical and subject matter expertise targeted at enhancing the capabilities of State and Area Agencies on Aging and local communities to improve service delivery to older people.

Directs and assesses the development of state-administered home- and community-based long-term care systems providing supportive services for the elderly and caregivers. Initiates and encourages expansion of the capacities of home- and community-based supportive and caregiver services.

Implements programs under section 398 of the PHSA, as well as activities under Titles II and IV of the OAA, through the development of demonstrations designed to test the efficacy of new and innovative models in improving the delivery and effectiveness of community-based supportive services for seniors and caregivers. Plans and develops discretionary grant program announcements. Evaluates demonstration grant and contract proposals and recommends approval/disapproval. Monitors progress, gives technical guidance, and evaluates program performance.

Promotes the coordination of innovation and demonstration activities with other national, field and local programs related to aging. Develops standards and identifies successful service and systems development strategies and best practice models for use by the aging network. Provides technical assistance to aging network partners in utilizing the findings from program demonstrations to inform policy and program development and enhance service delivery and coordination at the federal, state and local level.

3. Office of Nutrition and Health Promotion Programs (BBC). The Office of Nutrition and Health Promotion Programs serves as the focal point for the operation, administration, and assessment of the programs authorized under Titles III-C and III-D of the OAA and Title III of the PHSA, as well as activities under Titles II and IV of the OAA designed to promote healthy behaviors and improved health status for older people. In addition, the office performs the functions under Title II of the OAA related to consultation with other federal agencies and the provision of information about nutrition and preventive health services in order to enhance service coordination and delivery.

Implements Titles III-C and III-D of the OAA through the development of regulations, policies and guidance governing the development and enhancement by State and Area Agencies on Aging of comprehensive and coordinated systems of home- and community-based nutrition and preventive health services. Carries out the functions of the designated Nutrition Officer, who coordinates nutritional services under the OAA, develops the regulations and guidelines, and provides technical assistance regarding nutrition to State and Area Agencies on Aging, nutrition service providers, and other organizations. Serves as the liaison to the Department of Agriculture and other federal agencies and organizations related to nutrition policy and program issues.

In coordination with ACL's Office of Supportive and Caregiver Services, provides guidance regarding state plan processing and approval, the process and criteria for approval of states' Intrastate Funding Formulas for the allocation and targeting of resources within states, and implementation of the Interstate Funding Formula for distribution of Title III-C and III-D funds among states. Through the analysis of state plans, evaluation findings and other relevant material, identifies potential program and management issues and develops recommendations on possible solutions.

Fosters, oversees, and ensures accountability for the implementation of programs by states and Area Agencies on Aging through guidance and direction to regional staff regarding program reviews and system development and enhancements. Designs and provides training and technical assistance for program compliance, effectiveness, and enhancement. Provides technical and subject matter expertise targeted at enhancing the capabilities of State and Area Agencies on Aging and local communities to improve service delivery to older people.

Directs and assesses the development of State-administered home- and community-based long-term care systems providing nutrition and preventive health services for the elderly and caregivers. Initiates and encourages expansion of the capacities of home- and community-based nutrition and preventive health services to deliver comprehensive services to the elderly.

Implements programs under Title III of the PHSA, as well as other activities under Titles II and IV of the OAA, through the development of demonstrations designed to test the efficacy of new and innovative models in improving the delivery and effectiveness of community-based nutrition, health promotion, and evidenced-based disease prevention. Prepares the planning documents for and develops discretionary grant program announcements. Evaluates demonstration grant and contract proposals; and recommends approval/disapproval. Monitors progress, gives technical guidance to, and evaluates the performance of grantees and contractors.

Promotes the coordination of innovation and demonstration activities with other national, field and local programs related to aging. Develops standards and identifies successful service and systems development strategies and best practice models for use by the aging network. Provides technical assistance to aging network partners in utilizing the findings from program demonstrations to inform policy and program development and enhance service delivery and coordination at the federal, state and local level.

4. Office of Elder Justice and Adult Protective Services (BBD). The Office of Elder Justice and Adult Protective Services serves as the focal point for the operation, administration, and assessment of the elder abuse prevention, legal assistance development, and pension counseling programs under Titles II and VII of the OAA, and for Adult Protective Services and related activities carried out under the Elder Justice Act. The office also coordinates with the Office of the National Long-Term Care Ombudsman which oversees the Long-Term Care Ombudsman Program and the National Ombudsman Resource Center.

Reviews state plans to determine eligibility for funding under the OAA and recommends approval or disapproval. Implements Title VII in the field, in coordination with the National Long-Term Care Ombudsman, through the provision to Regional Support Centers of guidance and information, and the development and interpretation of Title VII program regulations and policy. Ensures the implementation of guidance and instructions concerning prevention of elder abuse, elder justice and legal assistance development programs. Provides guidance and leadership in the development of the pension counseling program and effective models for nationwide replication.

Fosters, coordinates, and ensures accountability for the implementation of Title VII by states through guidance and direction to regional staff regarding program reviews, and program and system development and enhancements. Designs and provides training and technical assistance for program compliance, effectiveness, and enhancement. Develops program plans and instructions for Regional Support Centers and State and Area Agencies on Aging to improve the Title VII protection and representational programs funded under the OAA.

Implements demonstration activities under Titles II and IV of the OAA and the EJA designed to test the efficacy of new and innovative models in improving the delivery and effectiveness of elder rights activities. Prepares the planning documents for and develops discretionary grant program announcements. Evaluates demonstration grant and contract proposals and recommends approval/disapproval. Monitors progress, gives technical guidance, and evaluates program performance.

Promotes the coordination of innovation and demonstration activities with other national, field and local programs related to aging. Develops standards and identifies successful service and systems development strategies and best practice models for use by the aging network. Provides technical assistance to aging network partners in utilizing the findings from program demonstrations to inform policy and program development and enhance service delivery and coordination at the federal, state and local level.

Provides federal leadership for the development and implementation of comprehensive Adult Protective Services systems in order to provide a coordinated and seamless response for helping adult victims of abuse and to prevent abuse before it happens. Develops national Adult Protective Services data systems and standards, and provides technical assistance to states on using and interfacing with the system. Develops model Adult Protective Services program standards that help states improve the quality and consistency of programs. Advances a coordinated federal research strategy to fill the gaps in knowledge and develop evidence-based interventions to prevent, identify and report, and respond to elder abuse, neglect and exploitation. Provides support for the Elder Justice Coordinating Council.

5. Office for American Indian, Alaskan Native, and Native Hawaiian Programs (BBE). The Office for American Indian, Alaskan Native, and Native Hawaiian Programs serves as advocate within the Department of Health and Human Services and with other departments and agencies of the federal government regarding all federal policies affecting older individuals who are Native Americans. Works with state, local and tribal governments providing leadership and coordination of activities, services and policies affecting American Indians, Alaskan Natives and Native Hawaiian elders. Promotes linkages among national Indian organizations, national aging organizations, and national provider organizations with the goal of enhancing the interests of and services to Native American elders. Recommends policies and priorities with respect to the development and operation of programs and activities relating to individuals who are older Native Americans. The office coordinates activities among other federal departments and agencies to ensure a continuum of improved services through memoranda of agreements or through other appropriate means of coordination.

Evaluates outreach under Title III and Title VI of the OAA and recommends necessary action to improve service delivery, outreach, and coordination between Title III and Title VI services. Encourages and assists with the provision of information to older Native Americans to ensure a continuum of services. Develops research plans, conducts and arranges for research in the field of Native American aging; collects, analyzes, and disseminates information related to problems experienced by older Native Americans, including information on health status of older individuals who are Native Americans, elder abuse, in-home care, and problems unique to Native Americans. Develops, implements, and oversees the uniform data collection procedures for tribal and Native Hawaiian Organizations and implements and oversees the consultation requirements of Title II as they apply to Native American issues.

Serves as the AoA focal point for the administration of the programs authorized under Title VI and the Native American Organization provisions of Title VII-B of the OAA, including administering grants, cooperative agreements and contracts. Coordinates with the Regional Support Centers to provide program guidance, policy direction, training, technical assistance, and monitoring of Title VI grantees. Oversees the development and operation of Resource Centers on Native American Elders under Title IV of the OAA, which gather information, perform research, provide for dissemination of results, and provide technical assistance and training to those who provide services to Native American elders. Arranges for and manages ongoing training and technical assistance for Title VI grantees. Coordinates additional training and technical assistance related to diversity and national minority aging organizations and coalitions with other projects managed by other components of the agency.

6. Office of Long-Term Care Ombudsman Programs (BBF). The Office of the Long-Term Care Ombudsman Programs carries out the functions established in section 201(d)(1) of the OAA, serving as the advocate for older Americans in the development and implementation of federal policies and laws that may affect the health, safety, welfare, or rights of residents of long-term care facilities.

Reviews federal legislation, regulations, and policies regarding long-term care ombudsman programs and makes recommendations to the Assistant Secretary for Aging. Coordinates the activities of ACL with other federal, state and local entities relating to long-term care ombudsman programs; prepares an annual report to Congress on the effectiveness of services provided by state long-term care ombudsman programs; and establishes standards for the training of state long-term care ombudsman staff.

Coordinates with the Office of Elder Justice and Adult Protective Services on the administration of the Long-Term Care Ombudsman Program and the National Ombudsman Resource Center to ensure alignment with agency initiatives related to elder rights and adult protective services. Makes recommendations to the Administrator regarding the operation of the National Ombudsman Resource Center, and the review and approval of the provisions in state plans submitted under section 307(a) of the OAA that relate to state long-term care ombudsman programs.

C. Administration on Disabilities (BC):

BC.00 Mission. The Administration on Disabilities (AoD) advises the Secretary, through the Administrator and Principal Deputy Administrator for Community Living, on matters relating to services and supports for individuals with disabilities and their families, and serves as a focal point in the department to support and encourage the provision of quality services and supports, and implementation of program and policy that benefit people with disabilities and their families. The AoD supports states and communities in increasing the independence, productivity and community inclusion of individuals with disabilities; empowers individuals with disabilities to maximize opportunities for competitive integrated employment, economic self-sufficiency, independence and integration into society; promotes consumer control and self-advocacy; and ensures that the rights of individuals with disabilities are protected. Carries out programs operated under the DD Act, Title VII of the Rehabilitation Act, section 262 and 292 of the HAVA, section 5 of the Assistive Technology Act of 1998, and Title III of the PHSA.

BC.10 Organization. The Administration on Disabilities is headed by a Commissioner, who reports directly to the ACL Administrator, and a Deputy Commissioner who also serves as Director of Independent Living. In this dual role, the Deputy Commissioner/Director of Independent Living serves as a member of the ACL Administrator's senior leadership team and reports directly to the ACL Administrator in carrying out the functions of the Director of Independent Living consistent with Section 701A of the Rehabilitation Act, as amended. The AoD includes the following components:

BC.20 Functions.

1. Office of the Commissioner on Disabilities (BCA). The Office of the Commissioner on Disabilities (OCD) provides executive leadership and management strategies for all components of the Administration on Disabilities. The Commissioner and Deputy Commissioner/Director of Independent Living advise the ACL Administrator on issues related to services and supports, civil rights and other matters affecting individuals with disabilities and their families. Plans, coordinates and controls AoD policy, planning and management activities which include the development of legislative proposals, regulations and policy issuances for AoD.

Provides executive direction to AoD's components and establishes goals and objectives for AoD programs. Assists states, through the design and implementation of state plans for independent living, developmental disabilities, and protection and advocacy programs, in making optimal use of federal, state, and local resources that maximize the independence, productivity, economic self-sufficiency and community inclusion and integration of individuals with disabilities and their families.

In concert with other components of ACL as well as other public, private, and volunteer sector partners, develops and implements research, demonstration and evaluation strategies for discretionary funding of activities designed to improve and enrich the lives of individuals with disabilities. Serves as a resource in the development of policies and programs to reduce or eliminate barriers experienced by individuals with disabilities through the identification of promising practices and dissemination of information. Supports and encourages programs or services and manages initiatives, involving the private and voluntary sectors that benefit individuals with disabilities and their families.

Initiates, executes and supports the development of interagency, intergovernmental and public-private sector agreements, committees, task forces, commissions or joint-funding efforts as appropriate. Actively partners with other ACL subcomponents to develop coordinated programs and policies that jointly address the common needs of older adults and people with disabilities. In coordination with the Office of External Affairs, develops strategies for increasing public awareness of the needs of individuals with disabilities, their families, and programs designed to address them.

2. Administration on Intellectual and Developmental Disabilities (BCB). The Administration on Intellectual and Developmental Disabilities (AIDD) is responsible for the coordination, oversight, management and evaluation of programs authorized by the DD Act and activities authorized under section 5 of the AT Act and section 262 and 292 of the HAVA. AIDD includes two program offices, the Office of Program Support (OPS) and the Office of Innovation (OI).

OPS (BCB1) is responsible for the coordination, oversight, management and evaluation of the State Councils on Developmental Disabilities, the Developmental Disabilities Protection and Advocacy Systems, and the University Centers for Excellence in Developmental Disabilities grant programs as authorized by the DD Act. OPS is responsible for the development of procedures and performance standards that ensure compliance with the DD Act and that improve the outcomes of the programs in increasing the independence, productivity and community inclusion of persons with developmental disabilities. OPS conducts routine and special analyses of state plans of State Councils on Developmental Disabilities, statements of goals and objectives of state Protection and Advocacy systems, and five-year plans of the University Centers for Excellence in Developmental Disabilities, to ensure consistent application of AIDD program goals and objectives. Provides program development services, develops and initiates guidelines, policy issuances and actions with team participation by other components of AoD, ACL, HHS and other government agencies to fulfill the mission and goals of the DD Act, as amended.

OPS also administers Protection and Advocacy programs under section 292 of the HAVA and section 5 of the AT Act that help to ensure full participation in the electoral process for individuals with disabilities and to assist individuals with disabilities in the acquisition, utilization, or affordability of AT services or devices. Administers a training and technical assistance grant program under the HAVA that provides technical assistance to Protection and Advocacy systems in their mission to promote the full participation in the electoral process for individuals with the full range of disabilities, including registering to vote, casting vote, and accessing polling places.

OI (BCB2) is responsible for the coordination, oversight, management and evaluation of the Projects of National Significance program, including the Family Support and the Direct Support Workers grant programs as authorized by the DD Act. OI ensures the dissemination of grantee results, including project results and information produced by AD grantees, in coordination with the Independent Living Administration and the Office of the Commissioner on Disabilities. Manages cross-cutting research, demonstration and evaluation initiatives consistent with the purposes of the DD Act, with other components of ACL, HHS and other government agencies to promote and integrate the grant programs into cross-agency and cross-disability efforts. Coordinates information sharing and other activities related to national program trends and studies, reviews and analyzes other federal programs providing services applicable to persons with developmental disabilities for the purpose of integrating and coordinating program efforts. OI also oversees activities under section 262 of the HAVA that support state efforts to improve accessibility for individuals with the full range of disabilities to polling places and voting facilities.

OI also provides general staff support for the President's Committee for People with Intellectual Disabilities (BCB2A) as established by E.O. Coordinates all meetings, provides advice and assistance in the areas of intellectual disabilities as requested by the President or the Secretary, and prepares and issues an annual report concerning intellectual disabilities and additional reports or recommendations as appropriate.

3. Independent Living Administration (BCC). Established by section 701A of the Rehabilitation Act, the Independent Living Administration (ILA) aims to maximize the leadership, empowerment, independence, and productivity of individuals with disabilities while promoting the independent living philosophy of consumer control, self-help and self-advocacy, development of peer relationships and peer role models, and equal access for individuals with significant disabilities to all aspects of society. Administers grants to support independent living programs that offer financial assistance to provide expanded and improved independent living services. Develops and supports statewide networks of centers for independent living and improves working relationships among state independent living rehabilitation programs, centers for independent living, statewide Independent Living Councils (SILCs), Rehabilitation Act programs outside of Title VII, and other relevant federal and non-federal programs. Also funds grants for consumer-controlled, community-based, cross-disability, nonresidential, private nonprofit agencies that are designed and operated within a local community by individuals with disabilities and provide an array of independent living services, such as community planning and decision making; school-based peer counseling, transition services, role modeling, and skills training. Manages other grants, contracts or cooperative agreements to provide training and technical assistance with respect to planning, developing, conducting, administering, and evaluating centers for independent living. Ensure compliance with the Rehabilitation Act, which establishes a set of standards and assurances that centers for independent living must meet and requires development and publication of indicators of minimum compliance with the standards.

In addition, participates in the development and dissemination of policy guidance, regulations, and program guidance related to Independent Living Programs. In collaboration with the Center for Policy and Evaluation, develops program performance measures, which are used to evaluate and monitor grantees. Provides program development services, develops and initiates guidelines, policy issuances and actions with team participation by other components of ACL, HHS and other government agencies to fulfill the purpose and goals of Title VII of the Rehabilitation Act, as amended. Also carries out activities under Title III of the PHSA that promote the health and well-being of people living with paralysis and limb loss. Supports their families and caregivers by providing comprehensive information and referral services that assist individuals to remain at home and in the community.

D. Center for Integrated Programs (BD):

BD.00 Mission. The Center for Integrated Programs (CIP) serves as the locus within ACL for the administration of programs and initiatives that serve both older adults and persons with disabilities, including consumer access and protection programs. Also manages programs and initiatives that promote the use of self-directed and person-centered service models and advance the development of health and long-term care services and support systems that are responsive to the needs and preferences of older adults, persons with disabilities, caregivers, and families. The CIP carries out programs authorized under Titles II and IV of the OAA, Title XXIX of the PHSA, section 119 of the MIPPA, section 4360 of the OBRA of 1990, and section 4 of the AT Act that focus on helping states make their health care and long-term service and support systems more person-centered, improve access to health care and assistive technology services, and promote the values of self-determination, full participation in community, integration and independence. CIP also implements initiatives at the national, state and local level to strengthen the capacity of ACL's network of state and community-based organizations to play a meaningful role in the transformation of our nation's health and long-term service and support systems.

BD.10 Organization. The Center for Integrated Programs is headed by a Deputy Administrator, who reports directly to the ACL Administrator. The CIP includes the following components:

BD.20 Functions.

1. Office of the Deputy Administrator for Integrated Programs (BDA). The Office of the Deputy Administrator for Integrated Programs supports the ACL Administrator and the Principal Deputy Administrator in advancing programmatic and systemic changes to make state health and long-term services and supports systems more person-centered and responsive to the needs and preferences of older Americans, people with disabilities, their families, and caregivers. Works with other ACL components, federal partners and key external stakeholder groups to engage the multiple state agencies involved in long-term services and supports in developing high performing, consumer-oriented, and responsive systems of care for all populations.

Provides leadership and strategic direction to guide the administration of ACL programs that assist consumers in understanding their health care and long-term services and supports options, improve access to services including assistive technologies, and prevent fraud and abuse. Consults with, provides technical assistance to, and supports the education of states and local community service providers in the development of plans, goals, and system development activities. Supports the coordination of programs within HHS and with federal, state, community and private-sector partners.

Works closely with AoA, AoD, and other ACL components to facilitate the coordination across ACL of multiple consumer protection and family support programs and various systems change and network capacity initiatives to fully optimize the potential synergies of these investments across ACL. Uses data and learnings from the programs administered by CIP to inform the work of other ACL components and ACL's policy priorities and provides guidance to the Regional Support Centers to ensure clear and consistent direction to the states on relevant program implementation issues.

2. Office of Healthcare Information and Counseling (BDB). The Office of Healthcare Information and Counseling oversees the operation and administration of the State Health Insurance Assistance Program, authorized under the section 4360 of the OBRA of 1990, and the Senior Medicare Patrol Program, authorized under Title IV of the OAA, that help Medicare and Medicaid beneficiaries as well as coming-of-agers navigate the complexities of health and long-term care systems and educate them on how to prevent fraud, waste, and abuse. The office also manages related activities funded under section 119 of the MIPPA that focus on outreach to help beneficiaries understand and apply for their Medicare benefits including the Low Income Subsidy program (LIS), Medicare Savings Program (MSP), and Medicare Prescription Drug Coverage (Part D).

Coordinates, implements, monitors, and promotes efforts to provide consumer information and education designed to increase access to, and detect, prevent and report error, fraud and abuse in, the Medicare and Medicaid programs. Works with the ACL Regional Support Centers to provide in-depth expertise, information, leadership and technical assistance to assist the State Health Insurance Assistance Program and Senior Medicare Patrol networks, and serves as a reliable clearinghouse of information for older persons, people with disabilities, and their families and caregivers.

Develops funding opportunities and monitors grants to ensure all necessary activities are completed. Manages the full spectrum of contract requirements including identifying contractual needs, developing statements of work and necessary planning documents, and ensuring that contractors are completing assigned tasks. Ensures that grantees and their volunteers have the necessary information and training to carry out program functions. Develops and refines the performance management systems and provides specialized guidance and technical assistance to help grantees improve their performance. Coordinates with the Centers for Medicare & Medicaid Services and other national partnerships to advance program objectives.

3. Office of Integrated Care Innovations (BDC). The Office of Integrated Care Innovations oversees a variety of initiatives to ensure that the interests and needs of older adults and people with disabilities, as well as the state and local organizations that serve these populations, are adequately reflected in the transformations occurring in our nation's health and long-term services and support systems as those systems shift toward the use of managed care, Health Information Technology (IT), and other models and approaches to better integrate the delivery of health and long-term services and supports as well as to make those systems more person-centered. These initiatives involve partnerships with other federal agencies and external stakeholders at the national, state, and local level and the management and execution of technical assistance activities, including the identification and dissemination of best practices and program models.

Leads ACL's Business Acumen work to help community-based organizations that serve older adults and persons with disabilities to build their business capacity and align their service capabilities in order to work effectively with integrated healthcare entities (e.g., accountable care organizations, health plans, managed care organizations, hospitals, health systems, etc.) to provide community-based long-term services and supports and/or evidence-based preventive health programs and services. Works with other ACL components to coordinate the various business acumen and related activities across ACL, and oversees the provision of the business acumen technical assistance that is delivered through a variety of methods and techniques to state level and community-based aging and disability agencies and organizations. Develops partnerships with external stakeholders at the national, state and local level in both the public and private sectors, including private foundations, to enhance and complement ACL's work in this area.

Works with the HHS Office of the National Coordinator for Health Information Technology, CMS, and other internal and external stakeholders on Health IT initiatives that have a potential impact on older adults and persons with disabilities and the state and local agencies and organizations that serve these populations to ensure that the needs and interests of these populations and organizations are reflected in the Health IT initiatives that are shaping the future of our nation's health and long-term services and support systems.

Administers, in partnership with the Centers for Medicare and Medicaid Services, the Duals Demonstration Ombudsman Technical Assistance Program which supports grantees serving beneficiaries of state demonstrations to integrate care for Medicare-Medicaid enrollees associated with the CMS Financial Alignment Initiative. Ensures that grantees and their volunteers have the necessary information and training to carry out program functions. Coordinates with CMS and the state grantees in developing and refining performance management systems and provides specialized guidance and technical assistance to help grantees improve their performance. Analyzes program reports, including consumer feedback and complaints, and makes recommendations to CMS for improving the Ombudsman Program and the Financial Alignment Initiative.

OICI works with CPE and other ACL components to track policy and program trends and emerging issues related to integrated care to inform ACL's ongoing program and policy development work as the transformations in health and long-term services and supports continue to evolve.

4. Office of Consumer Access and Self-Determination (BDD). The Office of Consumer Access and Self-Determination (OCASD) plans and directs the implementation of programs designed to enhance consumer access to long-term services and supports, including integrated systems of services and person-centered programs and systems at the state and local level that support community living. Supports state and community efforts to improve the provision of assistive technology for individuals with disabilities of all ages through comprehensive, statewide programs that are consumer responsive. Serves as the focal point for the administration of the Lifespan Respite Care Program authorized under Title XXIX of the PHSA, Aging and Disability Resource Center program authorized under Title II of the OAA, the Veterans-Directed Home and Community-Based Services program, the Assistive Technology state programs authorized under section 4 of the AT Act, and other activities as deemed appropriate.

Provides leadership and a central strategic focus for ACL's efforts to work with states and communities to develop single entry point/no wrong door systems of access to long-term services and supports for seniors, persons with disabilities, and their families and caregivers, in coordination with CMS and other Federal agencies. Promotes initiatives to expand access to services and the development of more responsive service systems, including person-centered planning and self-directed service models. Implements partnerships with external stakeholder organizations to enhance access to integrated systems of services that support both older Americans and persons of all ages with disabilities. Coordinates with the Department of Veterans Affairs on the development and implementation of their long term services and support programs, including the Veteran-Directed Home and Community-Based Services program and caregiver support programs. Provides technical assistance and support services to programs funded under the AT Act to make assistive technology devices and services more available and accessible to individuals with disabilities and their families. Works with NIDILRR and other ACL components to facilitate and accelerate the translation of relevant research findings into practice nationwide. Supports the development and maintenance of a database of technical assistance resources, best practices and model programs for use by federal, state and local agencies and organizations involved in advancing system changes that make long-term services and support systems more person-centered and more responsive to the needs and preferences of older adults and persons with disabilities.

Develops funding opportunities and monitors grants to ensure all necessary activities are completed. Manages the full spectrum of contract requirements including identifying contractual needs, developing statements of work and necessary planning documents, and ensuring that contractors are completing assigned tasks. Ensures that grantees have the necessary information and training to carry out program functions. Develops and refines performance management systems and provides specialized guidance and technical assistance to help grantees improve their performance.

E. Center for Management and Budget (BE):

BE.00 Mission. The Center for Management and Budget advises the Administrator on the budget, financial, grants, information resources, procurement, administrative and human resources management activities of ACL.

BE.10 Organization. The Center for Management and Budget is headed by a Deputy Administrator, who reports directly to the Administrator. The Center for Management and Budget includes the following components:

BE.20 Functions.

1. Office of the Deputy Administrator for Management and Budget (BEA). The Office of the Deputy Administrator for Management and Budget directs and coordinates all administrative and resource management activities for ACL. The Deputy Administrator for Management and Budget serves as the Executive Officer and Chief Financial Officer and is the principal advisor and counselor to the ACL Administrator on all aspects of the internal administration of ACL.

Serves as the ACL liaison with the Office of the Assistant Secretary for Administration (ASA), the Office of the Assistant Secretary for Financial Resources (ASFR), the Office of the General Counsel (OGC), the Office of Inspector General (OIG), and the Office of Management and Budget (OMB) for all budget and administrative management issues. Develops, administers, and coordinates financial, operational, and budgetary policies, processes, and controls necessary to administer ACL programs and financial resources; directs the processes that support the administration of discretionary and mandatory grants activities; oversees the utilization of information resources, information technology systems and telecommunications; provides leadership for human capital development; and coordinates ACL's internal control activities.

Coordinates with other components to carry out reviews of program activities and management practices required under the Chief Financial Officers Act, the Federal Managers Financial Integrity Act, the Improper Payments Information Act, the Federal Information Security Management Act, and other legislation. Monitors legislation related to administrative management and provides analysis of the impact on ACL programs and resources. Conducts annual reviews and assessments of internal controls required under the Federal Managers Financial Integrity Act and ensures compliance with the Government Accountability Office (GAO) and OMB standards. Plans, organizes and conducts studies of organizational structures, functional statements, job structures, staffing patterns, and management and administrative information systems; and identifies and resolves problems of organization and administrative management. Prepares and maintains organizational and functional statements and delegations and designations of authority for ACL.

2. Office of Budget and Finance (BEB). The Office of Budget and Finance supports the Deputy Administrator for Management and Budget in fulfilling ACL's Chief Financial Officer responsibilities. The Director serves as the Deputy Chief Financial Officer, Budget Officer, and Senior Travel Official and oversees and coordinates ACL's budget formulation, budget execution, and financial management activities. Serves as the primary liaison with the Program Support Center's Division of Financial Management Services, which provides accounting, audit, and financial management services to ACL.

In coordination with the program offices, formulates and presents budget estimates; executes apportionment documents; and plans, directs, and coordinates financial and budgetary programs of ACL. Provides guidance to program offices in preparing budgets, justifications, and other supporting budgetary materials. Solicits, obtains and consolidates information and data from other offices, and prepares budget documents on behalf of the Administrator for presentation to the department, OMB, and Congress.

Analyzes the budget as approved by Congress and apportioned by OMB, obtains input from program offices and recommends for the ACL Administrator's approval a financial plan for its execution. Makes allowances to ACL offices within the guidelines of the approved financial plan. Develops and maintains an overall system of budgetary controls to ensure observance of established ceilings on both program—including all mandatory and discretionary grant accounts—and salaries and expense funds; maintains administrative control of funds against allotments and allowances; certifies funds availability for all accounts; and coordinates the management of interagency agreement activities. Prepares requests for apportionment of appropriated funds; and prepares spending plans and status-of-funds reports for the ACL Administrator.

Develops financial operating procedures and manuals; coordinates financial audits; and provides analysis on financial issues. Ensures that internal controls are in place for administrative and programmatic activities that provide reasonable assurance of the effectiveness and efficiency of operations and compliance with applicable laws and regulations. Serves as the liaison with the Office of the Secretary and OMB on all budgetary and financial matters.

Coordinates all travel management activities. Provides technical assistance and oversight on the use of government travel systems; manages employee participation in the Travel Charge Card program, and coordinates the provision of Travel Management Center services.

3. Office of Administration and Personnel (BEC). The Office of Administration and Personnel (OAP) provides support to ACL in the areas of human capital development, personnel, facilities, acquisitions, and other administrative services. The OAP Director serves as the Chief Human Capital Officer and provides leadership for the strategic planning and operational management of human capital resources. OAP serves as the primary liaison to the Program Support Center's Division of Acquisition Management Services, which provides procurement services to ACL; and the Washington Human Resources Center, which provides personnel support services.

Develops and implements human capital strategies and strategic workforce plans; directs the development and creation of strategies to attract diverse talent and develop a highly skilled workforce; and provides leadership in the development of plans for achieving short- and long-range human capital goals. Provides leadership and guidance to meet the human resource management needs and coordinates internal and external resources to provide staff with personnel services including position management, performance management, employee recognition, staffing, recruitment, employee and labor relations, employee assistance, payroll liaison, staff development and training, and special hiring and placement programs.

Provides oversight and direction to meet the administrative needs of ACL components. Prepares, coordinates and disseminates information, policy and procedural guidance on human resource and administrative management issues on an agency-wide basis. Serves as liaison with the Program Support Center's Division of Real Property Management Services and the General Services Administration (GSA) to plan, develop and coordinate space and facilities services. Serves as the lead for coordination and liaison with departmental, GSA, Federal Protective Service, and other federal agencies for planning and executing the agency's environmental health, safety and physical security programs. Provides coordination and direction for continuity-of-operations activities.

Assists other ACL components in securing contractor assistance by advising on appropriate acquisition vehicles, developing statements of work and independent cost estimates, and managing the technical aspects of contracts. Coordinates with the Office of Information Resources Management to develop and implement procurement strategies for information technology support services and review all information technology acquisition documentation for compliance with applicable laws and regulations. Monitors the use of credit cards for small purchases and establishes and manages contracts and/or blanket purchase agreements for administrative support and facilities management services.

4. Office of Grants Management (BED). The Office of Grants Management (OGM) serves as ACL's focal point for the management, leadership and administration of grants, and cooperative agreements. The OGM Director serves as the Chief Grants Management Officer and provides national policy oversight and development for grants management and administration matters. The office ensures that all grant awards conform to applicable statutory, regulatory, and administrative policy requirements, both before and following award. Maintains liaison and coordination with appropriate ACL and HHS organizations to ensure consistency between discretionary and mandatory grant award activities, including the Program Support Center's Division of Payment Management Services, which provides payment system services for grants.

Ensures that the administrative, business and financial management aspects of grants administration are carried out and grantee performance is monitored. Performs cost analysis/budget analysis for all discretionary grant award documents and negotiates grant budgets, executing all awards. Advises management and program officials in developing, implementing and evaluating program plans, strategies, regulations, announcements, guidelines and procedures. Only the Office of Grants Management has the authority to obligate the government to the expenditure of funds for grants and cooperative agreements. Serves as liaison with other departmental offices for grants policy and administration.

Issues grant awards pursuant to requirements established in authorizing legislation and makes adjustments to previously issued mandatory grant awards. In coordination with other ACL subcomponents, reviews and assesses grant award procedures; directs and/or coordinates management initiatives to improve grant programs in financial areas; develops proposals for improving the efficiency in awarding grants and coordinating financial operations among grant programs; establishes priorities and develops procedures for grantee financial monitoring; and reviews fiscal activities at the field level for all grant programs.

For grant activities, develops financial management standards and provides guidance on and interpretation of applicable federal regulations. Based on grants management policies and procedures approved by the department, reprograms grant funds as required under authoring legislation. Following consultation with ACL staff with grant administration responsibilities, and with the approval of the ACL Administrator, develops instructions and procedures for the administration of the business aspects of all grants.

Provides training, technical assistance, overall guidance, monitoring and assistance to ACL staff in all areas of administrative and financial management of grants. Has primary responsibility for developing grants management policy issuances, and ensuring consistent policy interpretation within ACL concerning grants management. Serves as the liaison to the General Accounting Office and the HHS Office of the Inspector General on grant matters. Assists before the HHS Appeals Board at grant hearings in response to disallowances and other financial claims. Responds to departmental and OIG audit reviews, ensuring proper analysis and resolution of audit findings by Regional Support Centers for final action by the Administrator. Coordinates receipt and processing of all grants and related materials.

5. Office of Information Resources Management (BEE). The Office of Information Resources Management (OIRM) oversees and coordinates the provision of information technology services for ACL. The OIRM Director serves as the Chief Information Officer and Privacy Officer and prepares, coordinates and disseminates information, policies, standards, guidelines, and procedures on information technology management issues. OIRM serves as the primary liaison to the HHS Office of Information Technology Infrastructure Operations, which provides for the management, maintenance and operation of ACL's information technology systems infrastructure, including the LAN, personal computers, software, hosting, and support services.

Manages the development of ACL custom applications and systems; in close collaboration with the Office of External Affairs, manages ACL Web sites; oversees training and technical assistance for all systems, hardware and software; and coordinates the preparation of manuals and policy issuances required to meet the instructional and informational needs of users of the systems. Directs and coordinates ACL's systems security and privacy responsibilities, including protection, security and integrity of data; and is responsible for establishing and maintaining a secure Internet and intranet presence. Coordinates mandated OMB approvals required for data collection activities under the Paperwork Reduction Act of 1980, as amended. Represents ACL on the department's Chief Information Officer's Council and other departmental information technology policy and planning boards, teams, and workgroups.

In coordination with the Office of Administration and Personnel, develops and implements procurement strategies for information technology support services. Reviews all information technology acquisition documentation for compliance with applicable laws and regulations and defines the specifications for procurement of all hardware and software. Identifies opportunities to share information technology services through intergovernmental, interdepartmental and interagency agreements.

Serves as liaison with the Office of the Secretary, GSA, and outside vendors to plan, develop and coordinate guidelines and activities for telecommunications services. Provides telecommunications planning and management, including procurement, installation, and maintenance of telecommunications equipment and services such as telephones, cellular phone service, cable TV service, and audio and video conferencing equipment and services.

F. Center for Policy and Evaluation (BF):

BF.00 Mission. The Center for Policy and Evaluation (CPE) advises and supports the ACL Administrator and the Principal Deputy Administrator in developing effective federal policies to address the needs of older individuals and individuals with disabilities. The CPE collects and analyzes data on populations and services, develops strategic goals and objectives, evaluates the effectiveness of programs, and plans and coordinates the development of policies designed to overcome barriers that prevent older Americans and persons with disabilities from fully participating and contributing in an inclusive, integrated community life.

BF.10 Organization. The Center for Policy and Evaluation is headed by a Director, who reports directly to the Administrator. The Center for Policy and Evaluation includes the following components:

BF.20 Functions.

1. Office of the Director for Policy and Evaluation (BFA). The Office of the Director for Policy and Evaluation advises the Administrator and the Principal Deputy Administrator on matters relating to implementation and coordination of policies, regulations, and special initiatives within the department and with other federal agencies focused on disability and aging. Serves as a focal point within ACL and the department for the analysis of, and development of recommendations related to, disability and aging issues, including policies, regulations, and special initiatives. Supports the coordination of policies within HHS and with federal, state, community and private sector partners.

Leads the agency's strategic planning, policy analysis, and program evaluation functions, including the formulation of short- and long-term strategies for advancing ACL policy and program priorities. Coordinates the development and implementation of the agency's strategic plan that establishes long and short-range goals, objectives, strategies and action plans for advancing the agency's policy and program agenda. Reviews and coordinates all policy and program development documents, regulations and activities to ensure consistency with ACL's strategic plan; and adjusts goals and strategies as appropriate. Coordinates the identification and analysis of emerging policy issues and trends and appropriate federal responses. Formulates an agency-wide policy and program development strategy consistent with the priorities established by the Administrator and the Principal Deputy Administrator.

Plans and directs the evaluation of ACL programs designed to provide planning, coordination and services to older Americans and people with disabilities. Coordinates work of CPE with the work of National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR). The Director serves as the Performance Improvement Officer and is the primary liaison with the Office of the Assistant Secretary for Planning and Evaluation, the Office of the Assistant Secretary for Financial Resources, and the Office of Management and Budget for program performance and evaluation activities.

2. Office of Policy Analysis and Development (BFB). The Office of Policy Analysis and Development analyzes trends in demographics, service needs, public policies and program development, and translates those trends into new policies and initiatives in long-term services and supports and health care that assist people with disabilities and older individuals to remain in their own homes and communities.

Directs intergovernmental activities as they relate to the agency's policy and program development agenda, and develops and maintains effective relationships with other governmental departments and agencies. Plans, negotiates, facilitates and updates memoranda of understanding with other departments and agencies to promote agreements and cooperative relationships. Maintains information on, and pursues collaborative opportunities with, other federal agencies, non-profit organizations and private corporations that have the potential to contribute to the agency's policy and program development priorities.

Provides technical, program and policy development input on legislative activities and the annual budget. Participates in departmental and inter-departmental activities that concern health and long-term care; reviews and comments on departmental regulations and policies regarding health programs, institutional and non-institutional long-term care services, and programs and services designed to enhance community living.

Conducts short-term policy research, policy reviews and environmental scans, and carries out periodic reviews of needs and resources in the fields of aging and disability, and undertakes qualitative and quantitative analyses to develop policy options and recommendations for the Administrator and the Principal Deputy Administrator. Develops policy reports based on the needs and circumstances of older people, their family members and the aging population. Develops and coordinates initiatives with other federal agencies, national aging organizations, national disability organizations, and universities to fill gaps in information in the field of aging and disability.

3. Office of Performance and Evaluation (BFC). The Office of Performance and Evaluation (OPE), in collaboration with the respective ACL program offices, implements, oversees and manages ACL's program performance responsibilities, data collection systems, and program evaluation activities. Develops plans and priorities for evaluation of ACL service delivery programs, with subject matter input from appropriate units. Manages contracts for mandated evaluation projects and performs intramural evaluation studies. Prepares reports of the results of service delivery program and impact evaluations conducted by and for ACL, with technical input from other ACL units. Provides technical guidance on evaluation activities conducted as part of ACL's discretionary grants for service delivery programs.

Implements the requirements of the Government Performance and Results Act of 1993 (GPRA) and the GPRA Modernization Act of 2010. Interprets ACL goals, priorities, and strategies for consistency with ACL long-range GPRA goals and strategies, and adjusts GPRA goals and strategies accordingly. Provides guidance and technical assistance to ACL organizational units in developing operational plans, particularly in developing measurable objectives and indicators reflecting program and organizational performance. Prepares annual GPRA plans and reports and coordinates with the Office of Budget and Finance on the development of the ACL performance budget.

Coordinates ACL activities related to the collection, analysis, and dissemination of national and program data on older individuals and individuals with disabilities. Develops and manages data requirements; designs the criteria for collecting, analyzing and disseminating program performance data; and prepares the data for reporting to Congress and the public. Designs, implements and provides guidance and technical assistance to funding recipients on data collection and analysis. Works with the Office of Information Resources Management to coordinate mandated Office of Management and Budget approvals required under the Paperwork Reduction Act of 1980, as amended.

Compiles, publishes, and disseminates information on demographic data and data from other federal agencies on the health, social and economic status of older persons and persons with disabilities. Performs routine and special statistical analyses of data for ACL offices, other federal and non-federal organizations, and the general public.

G. National Institute on Disability, Independent Living, and Rehabilitation Research (BG):

BG.00 Mission. The National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) administers research programs authorized under sections 202 and 204 of the Rehabilitation Act of 1973,

NIDILRR supports the generation of new knowledge and promotes the effective use of this knowledge to (1) improve the abilities of individuals with disabilities to participate in community activities of their choice and (2) enhance society's capacity to provide opportunities and accommodations for these individuals. NIDILRR fulfills its mission through research, development, and dissemination and related activities designed to contribute to community living and participation, employment, and health and function of individuals of all ages with all types and degrees of disability, including low-incidence disability.

BG.10 Organization. NIDILRR is headed by a Director, who reports directly to the Administrator, and serves as a member of the Administrator's senior leadership team. NIDILRR includes the following components:

BG.20 Functions.

1. Office of the Director of Disability, Independent Living, and Rehabilitation Research (BGA). The Office of the Director of Disability, Independent Living and Rehabilitation Research (ODDILRR) provides executive leadership and management strategies for all components of NIDILRR. The Office of the Director, which includes a Deputy Director, manages all internal and external activities of the NIDILRR, including the research, dissemination, and public information programs, research evaluation, and provides direction and guidance to NIDILLR's scientific peer review. ODDILRR prepares and issues an annual report and coordinates with the Office of External Affairs and other agency components to ensure that the results of research are disseminated to, and utilized by service providers, people with disabilities and their families, and the general public.

Responsible for the coordination and management of research and research capacity building programs. Promotes the widespread dissemination of research results and other new knowledge both nationally and internationally to individuals with disabilities, families, service providers, researchers, and others through appropriate and accessible media, training, and technical assistance. Sponsors research that can be used to promote the use of appropriate assistive technology and the development of coordinated systems of technology services. Provides general staff support for the Disability, Independent Living, and Rehabilitation Research Advisory Council. Coordinates all meetings, provides advice and assistance, and prepares and issues reports or recommendations as appropriate. Chairs and supports the Interagency Committee on Disability Research (ICDR), authorized by section 203 of the Rehabilitation Act, and promotes the coordination of disability independent living, and research throughout the federal Government. The ICDR is responsible for identifying, assessing, and seeking to coordinate and promote cooperation among all federal program activities, projects, and plans with respect to the conduct of research related to rehabilitation of individuals with disabilities; facilitating the compilation of information about the status of disability, independent living and rehabilitation research sponsored by federal agencies. Coordinates its activities with other federal agencies and participates in joint-funding of rehabilitation research and related activities, in collaboration with the ICDR. Prepares and submits to Congress a long-range plan for rehabilitation research and provides necessary data and information required by the National Council on Disability. The ICDR is also responsible for preparing a comprehensive government-wide strategic plan for disability, independent living and rehabilitation research and ensuring accountability for achievement of measurable goals, objectives and timetables.

2. Office of Research Sciences (BGB). The Office of Research Sciences is responsible for national and international programs of research, training, and knowledge translation. Develops and manages a comprehensive program of grants, cooperative agreements, and contracts that address all of NIDILRR's research, capacity building, and knowledge translation activities. Sponsors research on, and development of programs and interventions involving technological systems, techniques and devices to overcome environmental barriers, and enable persons with disabilities to maximize community living and participation, employment, and their health and functional abilities. Responsible for providing research-based knowledge to industry to facilitate development, marketing, and distribution of aids and devices that can be used by people with disabilities. Determines criteria and standards and sets priorities for all NIDILRR research, training, and evaluation activities in the areas of community living and participation, employment, and health and function.

Plans, develops, implements, and manages a comprehensive national and international program of research, training, and knowledge translation in specific program areas. Identifies trends and needs and recommends research and development priorities to the leadership of NIDILRR. Manages a comprehensive scientific peer review of all grant applications and conducts pre-award site visits, as required by statute. Recommends new and continuation awards, as well as award terminations. Performs program oversight and monitoring of the progress of grants and contracts. Collaborates with ACL senior leaders, the Center for Policy and Evaluation, and the Center for Management and Budget in developing and publishing regulatory documents, including annual announcements of priorities and grant application packages.

Enhances the public understanding of the barriers to and facilitators of optimal outcomes for individuals with disabilities through the dissemination of research findings and other data. Other data include statistical data on disability status and outcomes, as evidenced by the annual publication of the Annual Compendium of Disability Statistics, distributed widely each year. Coordinates with the Office of External Affairs as well as ACL subcomponents to plan, develop, and administer knowledge translation, research utilization, public information, public education, and publications which address NIDILRR research activities and findings; and manages a comprehensive program to disseminate NIDILRR research findings through accessible media to a range of target audiences. Provides research-based information from grantees to the Interagency Committee on Disability Research, the National Council on Disability, and other agencies and private organizations serving individuals with disabilities. Sponsors studies to determine innovative techniques and systems for the dissemination and utilization of rehabilitation research findings.

3. Office of Research Evaluation and Administration (BGC). The Office of Research Evaluation and Administration (OREA) supports the administration of NIDILRR's grants and contracts portfolio. OREA also coordinates NIDILRR's program evaluation activities and collaborates with ORS in program planning and priority setting.

Coordinates with the Office of Research Sciences staff in the preparation of all contract packages, development of requirements and performance work statements. Conducts routine contract management activities to include completion of administrative and fiscal tasks required throughout the contract lifecycle. Maintains and monitors annual grant forecasts and schedules, and provides grants administration support for NIDILRR including packaging grant announcements and application kits.

Makes recommendations to the Director/NIDILRR regarding allocation of NIDILRR program funds for current and future budget years. Coordinate and collaborates with Office of Research Sciences program staff in the preparation of the annual spending plan and facilitate the implementation of the plan to ensure compliance with established departmental guidance. Provides administrative support in the monitoring of grants and cooperative agreements, and facilitates the administrative execution of interagency agreements.

Administers NIDILRR evaluation activities to improve the effectiveness of NIDILRR's research activities. This includes collaboration with NIDILRR's senior management to define and facilitate the conduct of analyses of program and budget data as well as focused, special program evaluation activities. In its evaluation function, it coordinates with CPE to prepare planning and evaluation documents required by ACL, HHS, OMB and Congress.

II. Delegations of Authority: All delegations and re-delegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further re-delegations.

III. Funds, Personnel and Equipment: Transfer of organizations and functions affected by this reorganization shall be accompanied in each instance by direct and support funds, positions, personnel, records, equipment, supplies and other resources.

On September 18, 2014, the President issued Executive Order 13676 on Combating Antibiotic-Resistant Bacteria (https://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria) and the Antimicrobial Resistance Challenge was called for in the accompanying White House Fact Sheet https://www.whitehouse.gov/the-press-office/2014/09/18/fact-sheet-obama-administration-takes-actions-combat-antibiotic-resistan). The development and use of rapid, point-of-care, and innovative diagnostic tests for identification and characterization of resistant bacteria was a goal identified in the National Strategy for Combating Antibiotic-Resistant Bacteria released in September 2014 (https://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf) and addressed in the National Action Plan for Combating Antibiotic-Resistant Bacteria released in March 2015 (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf).

In conformance to the above documents, the NIH and BARDA are sponsoring a prize competition, and the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are contributing technical and regulatory expertise to develop the award evaluation process.

The aim of the prize competition is to incentivize the development of one or more in vitro diagnostic tests that would be of significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria. For example, such a diagnostic test could be used by health care providers to identify bacterial infections in patients to help guide their decisions about the necessity of prescribing antibiotics, and if so, which antibiotics may be effective—thus promoting antibiotic stewardship. Another important diagnostic use could be to facilitate clinical trials for new antibacterial products by allowing for the enrichment of patient populations with specific infections, thus advancing the development of new antibacterial agents. The prize-winning diagnostic(s) must exhibit a set of predefined technical criteria and performance characteristics based on the intended use(s).

When exercising prize authority under the America COMPETES Act, agencies are to “consult widely both within and outside the federal Government” when developing prize competitions. As such, HHS is seeking input from the medical, public health, and scientific communities; the pharmaceutical and medical diagnostic sectors; patients and other advocacy groups; and the public at-large in order to receive broad input on the type(s) of diagnostic(s) that may be developed in an appropriate time frame to be of significant utility in combating the development and spread of antibiotic resistant bacteria.

At this time, HHS is seeking comments on the topics identified below as they pertain to a rapid, point-of-care diagnostic test(s) that could be developed in an appropriate time frame to be of significant clinical and public health utility in combating the development and spread of antibiotic resistant bacteria. A prioritized list of 18 bacteria of highest concern can be found in Table 3 of the National Action Plan (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf). The comment period will be open for 45 days from the publication of this request for information (RFI). Input received during this 45-day comment period and during the subsequent public consultation will be used by HHS to develop the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered. The design of the Challenge will take into account previous guidance obtained in the aforementioned National Strategy and National Action Plan to combat antibiotic resistant bacteria. Comments can be submitted to the discussion board for this Challenge accessible on https://www.challenge.gov.

This web-based discussion board also provides an open forum for discussion of this prize competition. The online community is open to the public and will allow for a broad and interactive discussion of the topics covered by this RFI. This platform will allow users to submit ideas about a desired diagnostic test and to comment on the ideas that have been submitted by others.

Comments may include, but are not limited to, the following topic areas:

1. Purpose. The purpose(s) or function(s) a rapid, point-of-care in vitro diagnostic test that would be of significant utility to the clinical and public health communities in combating antibiotic resistance. Comments may reflect considerations about in vitro diagnostic tests that distinguish between bacterial and viral infections, or that identify specific bacterial pathogens and/or their drug susceptibility in patients.

2. Characterizing drug susceptibility. The development of an effective in vitro diagnostic test that can identify whether bacterial pathogens are resistant and/or sensitive to certain clinically relevant antibiotics, and thus would be of significant utility in combating antibiotic resistance. Examples may be provided.

3. Sample matrix. The development of an effective in vitro diagnostic test that identifies pathogens by testing human samples (e.g., blood, urine, sputum, tissue fluid, multiple or other sample specimens). Comments may include what type or types of samples would be most relevant in identifying pathogens and/or antibiotic susceptibility.

4. Speed. The development of an effective in vitro diagnostic test that rapidly produces results. Comments may reflect considerations about what would be the maximum acceptable time-to-result for an in vitro diagnostic test to be of significant utility (i.e., from the time that a sample is collected from a patient to the time that the result is available to the healthcare provider).

5. Setting. The settings or venues in which the proposed point-of-care in vitro diagnostic test may be most needed for combating antibiotic resistance.

6. Ease-of-use. The development of an effective in vitro diagnostic test that is easy to use. Recognizing that diagnostics often require specialized equipment for sample storage, processing and/or analysis, comments also may include considerations about how such specialized equipment may affect an in vitro diagnostic test's ease of use or otherwise limit its utility. Comments also may include considerations about the nature and extent of training that would be necessary to operate and obtain results from the proposed in vitro diagnostic test.

7. Diagnostic performance. The performance characteristics (e.g., sensitivity, specificity, positive predictive value, and negative predictive value) required of the proposed in vitro diagnostic test in order for it to have significant utility in combatting antibiotic resistance.

8. Tradeoffs. Any inherent tradeoffs associated with the performance characteristics/parameters described in connection with your previous comments and priority of the characteristics/parameters, if applicable.

9. Cost. The development of an effective in vitro diagnostic test that is not cost prohibitive for its intended purpose. Cost and cost considerations may include what price or price range would be desirable to support the widespread adoption of an in vitro diagnostic test that will be effective in combating antibiotic resistant bacteria.

10. Other characteristics. Additional characteristics of the proposed in vitro diagnostic test that would be of significant value.

11. Key technologies. The specific technologies or disciplines, current or nascent, which would lend themselves to the development of a successful in vitro diagnostic test including, for example, what special considerations, advantages, and disadvantages may be associated with each technology/discipline. Comments on what timeframe would be considered reasonable for the development and licensure of a successful in vitro diagnostic test are also welcome.

12. Interest. Major factors that may influence a person's decision to compete in the prize competition described in this information request.

13. Use. Identification of who is likely to purchase and/or use the type of in vitro diagnostic tests being targeted by this prize competition and how or where such a purchaser or user is most likely to use the in vitro diagnostic test. Examples may be provided (e.g., patient/self-diagnosis, guiding prescriptive decisions, etc.).

14. Barriers. Major barriers that may impede development of the proposed in vitro diagnostic test (e.g., technical or research driven; financial or regulatory; infrastructure or resource based). Comments may reflect considerations about what potential solutions, if any, may be available to overcome such barriers and the level of difficulty associated with implementing any such solution in the U.S. and/or globally.