Federal Register Vol. 82, No.98,

Revision and Clarification

On December 22, 2016, USDA published a NOFA for OCCSP (81 FR 93884-93887). That NOFA announced that the purpose of OCCSP is to provide cost share assistance to producers and handlers of agricultural products in obtaining certification under the National Organic Program (NOP) established under the Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501-6524) and the regulations in 7 CFR part 205. FSA administers OCCSP.

In the December NOFA, USDA announced that beginning in FY 2017, transitional certification and State organic program fees would be eligible for cost share reimbursement, and that for OCCSP purposes, they would be considered two additional, separate scopes. As stated in the NOFA, transitional certification is an optional certification offered by some certifiers for producers and handlers who are in the process of transitioning land to organic production.

Upon review of OCCSP authority, FSA determined that it had erroneously announced the availability of cost-share for transitional certification, because no transitional certification programs are currently established under OFPA. Accordingly, this notice clarifies that cost-share assistance will not be available for transitional certification.

Consistent with this clarification, this NOFA provides revised information about eligible scopes for the OCCSP, allowable and unallowable costs, eligibility requirements for producers and handlers, documentation to be provided in a producer or handler's application package, provisions for grant agreements with State agencies, and the definition of “certified operation.”

In addition, this NOFA provides the corrected date when the producer and applications were made available, which changed from the date announced in the December NOFA of March 20, 2017, to the actual start date of March 27, 2017, once the forms were approved for use.

The purpose of OCCSP is to provide cost share assistance to producers and handlers of agricultural products in obtaining certification under NOP established under the Organic Foods Production Act of 1990 (7 U.S.C. 6501-6524) and the regulations in 7 CFR part 205. The Agricultural Marketing Service (AMS) implemented OCCSP and has been running OCCSP through agreements with State agencies since FY 2008. USDA transferred authority to administer OCCSP from AMS to FSA beginning with FY 2017.

FSA accepted applications from States interested in overseeing reimbursements to their producers and handlers. In addition, all producers and handlers will have access to OCCSP through their local FSA offices. In States where State agencies provide cost share funds, producers and handlers can choose between the State agencies or the local FSA office. In addition to expanding to FSA local offices for FY 2017, OCCSP will now cover costs related to State organic program fees.

In order for a State agency to receive new fund allocations for FY 2017, it must establish a new agreement with FSA to administer OCCSP. FY 2017 agreements will include provisions allowing a State agency to request an extension of that new FY 2017 agreement to provide additional funds and allow the State agency to continue to administer OCCSP for FY 2018. FSA has not yet determined whether an additional application period will be announced for FY 2018 for State agencies that choose not to participate in FY 2017; State agencies that would like to administer OCCSP for FY 2018 are encouraged to establish an agreement for FY 2017 to ensure that they will be able to continue to participate. FSA does not anticipate substantive changes to the agreement process with the participating States. Agreements will continue to allow subgrants to other entities.

Certified operations will be subject to the same eligibility criteria and calculation of cost share payments regardless of whether they apply for OCCSP through an FSA local office or a participating State agency. Certified operations may only receive OCCSP payment for the same scope for the same year from one source: Either the State agency or FSA. FSA will coordinate with participating State agencies to ensure there are no duplicate payments. If a duplicate payment is inadvertently made, then FSA will inform the participant and require that funds be returned to CCC.

Funding for OCCSP is provided through two authorizations: National Organic Certification Cost Share Program (National OCCSP) funds and Agricultural Management Assistance (AMA) funds. Section 10004 of the Agricultural Act of 2014 (the 2014 Farm Bill, Pub. L. 113-79) amended section 10606(d) of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 6523(d)), authorizing $11.5 million from CCC to be used for National OCCSP funds for each of FYs 2014 through 2018, to remain available until expended. National OCCSP funds will be used for cost share payments to certified operations in the 50 United States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the U.S. Virgin Islands, and the Commonwealth of the Northern Mariana Islands.

The USDA organic regulations recognize four separate categories, or “scopes,” that must be individually inspected for organic certification: Crops, livestock, wild crops, and handling (that is, processing). A single operation may be certified under multiple scopes. For example, a certified organic vegetable farm that also has certified organic chickens and produces certified organic jams would be required to be certified for three scopes: Crops, livestock, and handling. Beginning in FY 2017, State organic program fees will also be eligible for cost share reimbursement and for OCCSP purposes will be considered an additional separate scope. State organic program fees may be required by States that have established a State organic program according to 7 CFR 205.620-205.622, and are in addition to the costs of organic certification under the four scopes of USDA organic certification.

National OCCSP funds can be used to provide cost share for all four scopes of USDA organic certification (that is, crops, wild crops, livestock, and handling) and the additional scope of State organic program fees.

In addition to the National OCCSP funds, Section 1609 of the 2014 Farm Bill made a minor technical correction to the AMA authorizing language codified at 7 U.S.C. 1524, but did not change the amount authorized, which is $1 million. The availability of the AMA funds for OCCSP is contingent upon appropriations; the AMA funds are available for FY 2017. AMA funds may be used only for cost share payments for organic certification for the three scopes of crops, wild crops, and livestock, and are specifically targeted to the following 16 States:

• Connecticut,

• Delaware,

• Hawaii,

• Maryland,

• Massachusetts,

• Maine,

• Nevada,

• New Hampshire,

• New Jersey,

• New York,

• Pennsylvania,

• Rhode Island,

• Utah,

• Vermont,

• West Virginia, and

• Wyoming.

Sequestration will apply to the total amount of funding available for OCCSP for FYs 2017 and 2018, if required by law.

As required by law (7 U.S.C. 6523(b)), the cost share payments cannot exceed 75 percent of eligible costs incurred, up to a maximum of $750 for each producer or handler. FSA will calculate 75 percent of the allowable costs incurred by an eligible operation, not to exceed a maximum of $750 per certification scope. Cost share assistance will be provided for allowable costs paid by the eligible operation during the same FY for which the OCCSP payment is being requested. Cost share assistance will be provided on a first come, first served basis, until all available funds are obligated for each FY. Applications received after all funds are obligated will not be paid. Allowable costs include:

• Application fees;

• Inspection fees, including travel costs and per diem for organic inspectors;

• USDA organic certification costs, including fees necessary to access international markets with which AMS has equivalency agreements or arrangements;

• State organic program fees;

• User fees or sale assessments; and

• Postage.

Unallowable costs include:

• Inspections due to violations of USDA organic regulations or violations of State organic program requirements;

• Costs related to non-USDA organic certifications;

• Costs associated with or incidental to transitional certification;

• Costs related to any other labeling program;

• Materials, supplies, and equipment;

• Late fees;

• Membership fees; and

• Consultant fees.

To be eligible for OCCSP payments, a producer or handler must both:

• Possess USDA organic certification at the time of application; and

• Have paid fees or expenses related to its initial certification or renewal of its certification from a certifying agent.

Operations with suspended, revoked, or withdrawn certifications at the time of application are ineligible for cost share reimbursement. OCCSP is open to producers and handlers in the 50 United States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the U.S. Virgin Islands, and the Commonwealth of the Northern Mariana Islands.

State agencies must have an agreement in place to participate in OCCSP. State agencies with funds remaining from an agreement from a previous FY may continue to administer OCCSP with those funds under the terms of their existing agreement. In the previous NOFA, State agencies were notified that they must complete an Application for Federal Assistance (Standard Form 424), and enter into a grant agreement with FSA to receive new fund allocations to provide cost share assistance for FY 2017. FSA accepted applications from State agencies between January 3, 2017, and February 17, 2017. Pending fund availability, applications received after February 17, 2017, may be considered.

State agencies that have submitted applications for FY 2017 do not need to resubmit their applications. All grant agreements between FSA and State agencies for FY 2017 will include revised terms and conditions consistent with the clarification in this NOFA that cost-share assistance will not be made available for transitional certification.

Agreements for FY 2017 will include provisions to allow modification of the agreement to also cover a period of performance for FY 2018. At this time, FSA has not determined whether an additional application period will be announced for FY 2018 for State agencies that do not establish an agreement to administer OCCSP for FY 2017.

Certified operations may apply for OCCSP payments through FSA local offices or through a State agency (or authorized subgrantee) if their State has established an agreement to administer OCCSP. For a producer or handler to apply for OCCSP through FSA, each applicant must submit a complete application, either in person or by mail, to any FSA county office. Additional options for producers or handlers to submit their application may be available at https://www.fsa.usda.gov/programs-and-services/occsp. A complete application includes the following documentation:

• Form CCC-884—Organic Certification Cost Share Program, available online at https://www.fsa.usda.gov/programs-and-services/occsp or at any FSA county office;

• Proof of USDA organic certification;

• Itemized invoice showing expenses paid to a third-party certifying agency for certification services during the FY in which the application is submitted; and

• An AD-2047, if not previously provided.

Producers or handlers may be required to provide additional documentation to FSA if necessary to verify eligibility or issue payment.

FSA's application period began on March 27, 2017, for FY 2017 and will begin on October 1, 2017, for FY 2018. Both application periods end on October 31 of their respective years, or when there is no more available funding, whichever comes first.

Participating State agencies will establish their own application process and deadlines for producers and handlers, as specified in their grant agreements, and eligible operations must submit an application package according to the instructions provided by the State agency. A list of participating States will be available at https://www.fsa.usda.gov/programs-and-services/occsp after their agreements with FSA to administer OCCSP are finalized.

For this NOFA, new or revised definitions include the following:

“State agency” means the agency, commission, or department of a State government, the District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the U.S. Virgin Islands, or the Commonwealth of the Northern Marian Islands, authorized by the State to administer OCCSP.

“USDA organic certification” means a determination made by a certifying agent that a production or handling operation is in compliance with Organic Foods Production Act of 1990 (7 U.S.C. 6501-6522) and the regulations in 7 CFR part 205, which is documented by a certificate of organic operation.

The following definitions from the regulations of 7 CFR 205.2 also apply to this NOFA: “certified operation,” “certifying agent,” “crop,” “handler,” “inspection,” “inspector,” “labeling,” “livestock,” “organic,” “organic production,” “processing,” “producer,” “State certifying agent,” “State organic program,” and “wild crop.”

Twice a year, each participating State agency must provide FSA with a Federal Financial Report (form SF-425) along with a spreadsheet of Operations Reimbursed, listing the producers and handlers receiving cost share payments within the reporting period. The semi-annual reports are due to FSA on May 30 and November 30 of each year. Once a year, each participating State agency will need to provide FSA with a narrative report to describe program activities and any sub-recipients. The annual reports are due to FSA on November 30 of each year.

Persons and legal entities who file an application with FSA have the right to an administrative review of any FSA adverse decision with respect to the application under the appeals procedures at 7 CFR parts 780 and 11. FSA program requirements and determinations that are not in response to, or result from, an individual disputable set of facts in an individual participant's application for assistance are not matters that can be appealed.

A producer or handler may file an application with an FSA county office after the OCCSP application deadline, and in such case the application will be considered a request to waive the deadline. The Deputy Administrator has the discretion and authority to consider the case and waive or modify application deadlines and other requirements or program provisions not specified in law, in cases where the Deputy Administrator determines it is equitable to do so and where the Deputy Administrator finds that the lateness or failure to meet such other requirements or program provisions do not adversely affect the operation of OCCSP. Although applicants have a right to a decision on whether they filed applications by the deadline or not, applicants have no right to a decision in response to a request to waive or modify deadlines or program provisions. The Deputy Administrator's refusal to exercise discretion to consider the request will not be considered an adverse decision and is, by itself, not appealable.

Any person or legal entity who applies to a State agency is subject to review rights afforded by the State agency.

Participating State agencies that are dissatisfied with any FSA decision relative to a State agency agreement may seek review for programs governed by Federal contracting laws and regulations.

The regulations governing offsets and withholdings in 7 CFR part 1403 apply to OCCSP payments. Any participant entitled to an OCCSP payment may assign such payment(s) in accordance with the regulations in 7 CFR part 1404.

Awards to State agencies will be subject to 2 CFR part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

The information collection request for OCCSP have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. The OMB control number for the approval is 0560-0289. There were no public comments submitted for the information collection request.

The title and number of the Federal assistance program in the Catalog of Federal Domestic Assistance to which this NOFA applies is 10.171, Organic Certification Cost share Program (OCCSP).

The environmental impacts of this NOFA have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347), the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and the FSA regulations for compliance with NEPA (7 CFR part 799). As previously stated, since FY 2008 USDA implemented OCCSP through AMS via agreements with State agencies. To make OCCSP more accessible by using FSA county offices as a sign-up option for applicants, USDA shifted jurisdiction of OCCSP from AMS to FSA. FSA is now administering and coordinating OCCSP through agreements with interested States, and also now provides cost share payments directly to eligible producers and handlers for eligible expenses. The general scope of OCCSP, as implemented previously by AMS, is unchanged.

The purpose of OCCSP is to provide cost share assistance to producers and handlers of agricultural products in obtaining USDA organic certification. FSA's jurisdiction over OCCSP and the minor, discretionary changes to OCCSP (that is, two options for payment receipt: From a State, or from FSA) are administrative in nature. The discretionary aspects of OCCSP (for example, program eligibility, calculation of cost share payments, etc.) were effectively designed by AMS and are not proposed to be substantively changed. As such, the Categorical Exclusions in 7 CFR part 799.31 apply, specifically 7 CFR 799.31(b)(6)(iii) (that is, financial assistance to supplement income). No Extraordinary Circumstances (7 CFR 799.33) exist. As such, FSA has determined that this NOFA does not constitute a major Federal action that would significantly affect the quality of the human environment, individually or cumulatively. Therefore, FSA will not prepare an environmental assessment or environmental impact statement for this regulatory action.

The Rural Housing Service (RHS), an agency within the USDA Rural Development mission area herein referred to as the Agency, published a final rule with comment in the Federal Register on January 14, 2016 implementing Section 6006 of the Agriculture Act of 2014 (Pub. L. 113-79) which provides authority to make Community Facilities Technical Assistance and Training (TAT) Grants. The Final Rule became effective on March 14, 2016 and is found at 7 CFR 3570 subpart F. A correction amendment was published in the Federal Register on May 6, 2016. The purpose of this Notice is to solicit applications for the FY 2017 TAT Grant Program.

The paperwork burden has been cleared by the Office of Management and Budget (OMB) under OMB Control Number 0575-0198.

All recipients under this Notice are subject to the requirements of 7 CFR part 1970. However, awards for technical assistance and training under this Notice are classified as a Categorical Exclusion according to 7 CFR 1970.53(b), and usually do not require any additional documentation. The Agency will review each grant application to determine its compliance with 7 CFR part 1970. The applicant may be asked to provide additional information or documentation to assist the Agency with this determination.

Federal Agency: Rural Housing Service.

Funding Opportunity Title: Community Facilities Technical Assistance and Training Grant.

Announcement Type: Notice of Solicitation of Applications (NOSA).

Catalog of Federal Domestic Assistance Number: 10.766.

Dates: To apply for funds, the Agency must receive the application by 5:00 p.m. Eastern Daylight Time on July 24, 2017. Electronic applications must be submitted via grants.gov by Midnight Eastern time on July 24, 2017. The Agency will not consider any application received after this deadline.

Availability of Notice: This Notice is available through the USDA Rural Development site at: https://www.rd.usda.gov/newsroom/notices-solicitation-applications-nosas.

Congress authorized the Community Facilities Technical Assistance and Training Grant program in Title VI, Section 6006 of the Agricultural Act of 2014 (Pub. L. 113-79). Program regulations can be found at 7 CFR part 3570, subpart F, which are incorporated by reference in this Notice. The purpose of this Notice is to seek applications from entities that will provide technical assistance and/or training with respect to essential community facilities programs. It is the intent of this program to assist entities in rural areas in accessing funding under the Rural Housing Service's Community Facilities Programs in accordance with 7 CFR part 3570, subpart F. Funding priority will be made to private, nonprofit or public organizations that have experience in providing technical assistance and training to rural entities.

Type of Awards: Grants will be made to eligible entities who will then provide technical assistance and/or training to eligible ultimate recipients.

Fiscal Year Funds: FY 2017 Technical Assistance Training (TAT) Grant funds.

Available Funds: This Notice is being issued prior to enactment of a full year appropriation act for Fiscal Year (FY) 2017. Once funding for TAT has been appropriated, the Agency will publish the program funding level on the Rural Development Web site (https://www.rd.usda.gov/programs-services/community-facilities-technical-assistance-and-training-grant).

Award Amounts: Grants will be made in amounts based upon the availability of grant funds but no grant award will exceed $150,000. The Agency reserves the right to reduce funding amounts based on the Agency's determination of available funding or other Agency funding priorities.

Award Dates: Awards will be made on or before September 15, 2017.

Both the applicant and the use of funds must meet eligibility requirements. The applicant eligibility requirements can be found at 7 CFR 3570.262. Eligible project purposes can be found at 7 CFR 3570.263. Ineligible project purposes can be found at 7 CFR 3570.264. Sections 743, 744, 745, and 746 of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113) apply. Any corporation (i) that has been convicted of a felony criminal violation under any Federal law within the past 24 months or (ii) that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, is not eligible for financial assistance provided with funds, unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government. In addition, none of the funds appropriated or otherwise made available by this or any other Act may be available for a contract, grant, or cooperative agreement with an entity that requires employees or contractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or contractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information. Additionally, no funds appropriated in this or any other Act may be used to implement or enforce the agreements in Standard Forms 312 and 4414 of the Government or any other nondisclosure policy, form, or agreement if such policy, form, or agreement does not contain the following provisions: “These provisions are consistent with and do not supersede, conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classified information, (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety, or (4) any other whistleblower protection.”

The requirements for submitting an application can be found at 7 CFR 3570.267. All Applicants can access application materials at http://www.grants.gov. Applications must be received by the Agency by the due date listed in the DATES section of this Notice. Applications received after that due date will not be considered for funding. Paper copies of the applications will be submitted to the State Office in which the applicant is headquartered. Electronic submissions should be submitted at http://www.grants.gov. A listing of the Rural Development State Offices may be found at https://www.rd.usda.gov/files/CF_State_Office_Contacts.pdf. For applicants whose headquarters are in the District of Columbia, they will submit their application to the National Office in care of Shirley Stevenson, 1400 Independence Ave. SW., STOP 0787, Room 0175-S, Washington, DC 20250. Both paper and electronic applications must be received by the Agency by the deadlines stated in the DATES section of this Notice. The use of a courier and package tracking for paper applications is strongly encouraged.

Application information for electronic submissions may be found at http://www.grants.gov.

Applications will not be accepted via FAX or electronic email.

Applications will be processed and scored in accordance with 7 CFR 3570.273. Those applications receiving the highest points using the scoring factors found at 7 CFR 3570.273 will be selected for funding.

Once the successful applicants are announced, the State Office will be responsible for obligating the grant funds, executing all obligation documents, and the grant agreement, as provided by the agency.

1. Federal Award Notice. Within the limit of funds available for such purpose, the awarding official of the Agency shall make grants in ranked order to eligible applicants under the procedures set forth in this Notice and the grant regulation 7 CFR 3570 subpart F.

Successful applicants will receive a letter in the mail containing instructions on requirements necessary to proceed with execution and performance of the award. This letter is not an authorization to begin performance. In addition, selected applicants will be requested to verify that components of the application have not changed at the time of selection and on the award date, if requested by the Agency.

The award is not approved until all information has been verified, and the awarding official of the Agency has signed Form RD 1940-1, “Request for Obligation of Funds” and the grant agreement.

Unsuccessful and ineligible applicants will receive written notification of their review and appeal rights.

2. Administrative and National Policy Requirements. Grantees will be required to do the following:

(a) Execute a Grant Agreement.

(b) Execute Form RD 1940-1.

(c) Use Form SF 270, “Request for Advance or Reimbursement” to request reimbursement. Provide receipts for expenditures, timesheets, and any other documentation to support the request for reimbursement.

(d) Provide financial status and project performance reports as set forth at 7 CFR 3570.276.

(e) Maintain a financial management system that is acceptable to the Agency.

(f) Ensure that records are maintained to document all activities and expenditures utilizing CF TAT grant funds and any matching funds, if applicable. Receipts for expenditures will be included in this documentation.

(g) Provide audits or financial information as set forth in 7 CFR 3570.277.

(h) Complete Form 400-4—Assurance Agreement. Each prospective recipient must sign Form RD 400-4, Assurance Agreement, which assures USDA that the recipient is in compliance with Title VI of the Civil Rights Act of 1964, 7 CFR part 15 and other Agency regulations. It also assures that no person will be discriminated against based on race, color or national origin, in regard to any program or activity for which the re-lender receives Federal financial assistance. Finally, it assures that nondiscrimination statements are in the recipient's advertisements and brochures.

(i) Collect and maintain data provided by ultimate recipients on race, sex, and national origin and ensure Ultimate Recipients collect and maintain this data. Race and ethnicity data will be collected in accordance with OMB Federal Register notice, “Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity,” (62 FR 58782), October 30, 1997. Sex data will be collected in accordance with Title IX of the Education Amendments of 1972. These items should not be submitted with the application but should be available upon request by the Agency.

(j) Provide a final performance report as set forth at 7 CFR 3570.276(a)(7).

(k) Identify and report any association or relationship with Rural Development employees.

(l) The applicant and the ultimate recipient must comply with Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act of 1973, Age Discrimination Act of 1975, Executive Order 12250, Executive Order 13166 Limited English Proficiency (LEP), and 7 CFR part 1901, subpart E. The grantee must comply with policies, guidance, and requirements as described in the following applicable Code of Federal Regulations and any successor regulations:

(1) 2 CFR parts 200 and 400 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).

(2) 2 CFR parts 417 and 180 (Government-wide Debarment and Suspension (Nonprocurement)).

(m) Form AD-3031, “Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants” must be signed by corporate applicants who receive an award under this Notice.

3. Reporting. Reporting requirements for this grant as set forth at 7 CFR 3570.276.

Contact the Rural Development state office in the state where the applicant's headquarters is located. A list of Rural Development State Offices can be found at: https://www.rd.usda.gov/files/CF_State_Office_Contacts.pdf. For Applicants located in Washington, DC, please contact Shirley Stevenson at (202) 205-9685 or via email at [email protected].

In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at http://www.ascr.usda.gov/complaint_filing_cust.html and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by:

(1) By mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250-9410;

(2) Fax: (202) 690-7442; or

(3) Email: [email protected].

Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-312-3051, conference ID: 3424504. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at [email protected]. Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311.

Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Arkansas Advisory Committee link (http://www.facadatabase.gov/committee/meetings.aspx?cid=236). Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.

Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-877-874-1588 and conference call 4862480. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-877-874-1588 and conference call 4862480.

Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected]. Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=253; click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Eastern Regional Office at the above phone numbers, email or street address.

Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-452-4004, conference ID: 8153251. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at [email protected]. Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311.

Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Louisiana Advisory Committee link (https://database.faca.gov/committee/committee.aspx?cid=251&aid=17). Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.

On April 26, 2017 (82 FR 19205), the Bureau of Industry and Security (BIS) published the Notice Request for Public Comments and Public Hearing on Section 232 National Security Investigation of Imports of Steel. The April 26 notice specified that on April 19, 2017, the Secretary of Commerce (“Secretary”) initiated an investigation under section 232 of the Trade Expansion Act of 1962, as amended (19 U.S.C. 1862), to determine the effects on the national security of imports of steel. (See the April 26 notice for additional details on the investigation and the request for public comments.)

The April 26 notice also announced that the Department of Commerce will hold a public hearing on the investigation. The hearing will be held on May 24, 2017 at the U.S. Department of Commerce auditorium, 1401 Constitution Avenue NW., Washington, DC 20230. The hearing will begin at 10:00 a.m. local time and conclude at 1:00 p.m. local time. The hearing will assist the Department in determining whether imports of steel threaten to impair the national security and in recommending remedies, if such a threat is found to exist.

The April 26 notice included the following information: (a) Procedures for requesting participation in the hearing, including procedures for submitting comments; (b) conduct of the hearing; and (c) special accommodations for the hearing. (See the April 26 notice for additional details on these aspects of the public hearing.)

Today's notice provides additional details on the procedures for attending the hearing and for viewing the hearing, via webcast.

Registration: Individuals and entities who wish to attend the public hearing are required to pre-register for the meeting on-line at www.bis.doc.gov/232SteelHearing (preferred) or by emailing [email protected]. Anyone wishing to attend this public hearing must register by 5:00 p.m. (EST), Tuesday, May 23, 2017.

Webcast: The public hearing will be available live via webcast. Please visit: www.bis.doc.gov/232SteelHearing.

Visitor Access Requirement: For participants attending in person, please note that federal agencies can only accept a state-issued driver's license or identification card for access to federal facilities if such license or identification card is issued by a state that is compliant with the REAL ID Act of 2005 (Pub. L. 109-13), or by a state that has an extension for REAL ID compliance. The main entrance of the Department of Commerce is on 14th Street NW. between Pennsylvania Avenue and Constitution Avenue, across from the Ronald Reagan Building. Upon entering the building, please go through security and check in at the guard's desk. BIS staff will meet and escort visitors to the auditorium.

Non U.S. Citizens Please Note: All foreign national visitors who do not have permanent resident status and who wish to register for the above meeting must fax a copy of their passport to (202) 482-5361. Please also bring a copy of your passport on the day of the hearing to serve as identification. Failure to provide this information prior to arrival will result, at a minimum, in significant delays in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12. Please visit www.bis.doc.gov/232SteelHearing to register and for more details regarding this requirement.

Background

On April 6, 2017, the Department published the Preliminary Results. 1 We invited interested parties to comment on the Preliminary Results, 2 but received no comments. The Department conducted this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act).

The merchandise subject to this antidumping duty order is polyethylene retail carrier bags (PRCBs), which also may be referred to as t-shirt sacks, merchandise bags, grocery bags, or checkout bags. The subject merchandise is defined as non-sealable sacks and bags with handles (including drawstrings), without zippers or integral extruded closures, with or without gussets, with or without printing, of polyethylene film having a thickness no greater than 0.035 inch (0.889 mm) and no less than 0.00035 inch (0.00889 mm), and with no length or width shorter than 6 inches (15.24 cm) or longer than 40 inches (101.6 cm). The depth of the bag may be shorter than 6 inches (15.24 cm) but not longer than 40 inches (101.6 cm).

PRCBs are typically provided without any consumer packaging and free of charge by retail establishments, e.g., grocery, drug, convenience, department, specialty retail, discount stores, and restaurants to their customers to package and carry their purchased products. The scope of this antidumping duty order excludes (1) PRCBs that are not printed with logos or store names and that are closeable with drawstrings made of polyethylene film and (2) PRCBs that are packed in consumer packaging with printing that refers to specific end-uses other than packaging and carrying merchandise from retail establishments, e.g., garbage bags, lawn bags, trash-can liners.

Imports of merchandise included within the scope of this antidumping duty order are currently classifiable under statistical category 3923.21.0085 of the Harmonized Tariff Schedule of the United States (HTSUS). This subheading may also cover products that are outside the scope of this antidumping duty order. Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of this antidumping duty order is dispositive.

As noted above, the Department received no comments from interested parties concerning the Preliminary Results on the record of this segment of the proceeding. As there are no changes from, or comments on, the Preliminary Results, the Department finds that there is no reason to modify its analysis. Thus, we continue to find that Euro SME had no reviewable transactions during the POR.3 Accordingly, no decision memorandum accompanies this Federal Register notice. For further details of the issues addressed in this proceeding, see the Preliminary Results. 4

The Department determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise, where applicable, in accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b). For entries of subject merchandise during the POR for which SME did not know its merchandise was destined for the United States, we will instruct CBP to liquidate un-reviewed entries at the all-others rate if there is no rate for the intermediate company involved in the transaction.5 The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of this review.

The following cash deposit requirements will be effective for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of this notice of final results of the administrative review, as provided by section 751(a)(2)(C) of the Act: (1) For Euro SME, which claimed no shipments, the cash deposit rate will remain unchanged from the rate assigned to Euro SME in the most recently completed review of the company; (2) for previously investigated or reviewed companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is a firm not covered in this review, a prior review, or the less-than-fair-value investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters is 2.40 percent. These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

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

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

Background

On April 10, 2017, based on a timely request for review on behalf of the Ad Hoc Shrimp Trade Action Committee (the petitioner) 1 and the American Shrimp Processors Association (Domestic Processors),2 the Department published in the Federal Register a notice of initiation of an administrative review of the antidumping duty order on shrimp from the PRC covering the period February 1, 2016, through January 31, 2017.3 The review covers 84 companies. On May 2, 2017, and May 9, 2017, the petitioner and Domestic Processors withdrew their requests for an administrative review on all companies listed in the Initiation Notice. 4 No other party requested a review of these companies or any other exporters of subject merchandise.

Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the publication of the notice of initiation of the requested review. In this case, the petitioner and Domestic Processors timely withdrew their request by the 90-day deadline, and no other party requested an administrative review of the antidumping duty order. As a result, pursuant to 19 CFR 351.213(d)(1), we are rescinding the administrative review of the antidumping order on shrimp from the PRC for the period February 1, 2016, through January 31, 2017, in its entirety.

The Department will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. Because the Department is rescinding this administrative review in its entirety, the entries to which this administrative review pertained shall be assessed antidumping duties at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions to CBP 15 days after the publication of this notice in the Federal Register, if appropriate.

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

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

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

Public comment: Written comments may be directed to Gregg Waugh, Executive Director, South Atlantic Fishery Management Council (see Council address) or electronically via the Council's Web site at http://safmc.net/meetings-documents/june-2017-meeting-details/. The public comment form is open for use when the briefing book is posted to the Web site on the Friday, two weeks prior to the Council meeting (5/26/17). Comments received by close of business the Monday before the meeting (6/5/17) will be compiled, posted to the Web site as part of the meeting materials, and included in the administrative record; please use the Council's online form available from the Web site. For written comments received after the Monday before the meeting (after 6/5/17), individuals submitting a comment must use the Council's online form available from the Web site. Comments will automatically be posted to the Web site and available for Council consideration. Comments received prior to noon on Thursday, June 15, 2017 will be a part of the meeting administrative record. The items of discussion in the individual meeting agendas are as follows:

1. The Committee will review applications for appointments to the SSC and provide recommendations.

1. The Committee will review applicants to the Citizen Science Advisory Panel Pool and provide recommendations.

2. The Committee will discuss the current structure and function of the Cobia Sub-panel of the Mackerel Cobia Advisory Panel, discuss options for an open Cobia Sub-panel seat, and discuss a petition sent to Council members concerning a Cobia Sub-panel member.

3. The Committee will discuss the proposed process for future appointments to the Citizen Science Advisory Panel (AP) Pool and SEDAR AP Pool and provide recommendations.

SEDAR Committee (Partially Closed Session), Monday, June 12, 2017, 10:30 a.m. until 12 p.m.

1. The Committee will provide recommendations for appointment to upcoming SEDAR assessments.

1. The Committee will receive an update on SEDAR projects including the status of on-going projects, schedule for the vermilion snapper stock assessment and Terms of Reference, and take action as necessary.

2. The Committee will also discuss the stock assessment process and schedule with a report from the SEDAR Steering Committee, an update on plans for a joint meeting of the South Atlantic Council and Gulf of Mexico Councils SSCs, and an SSC report relative to future priorities and research track. The Committee will provide recommendations as appropriate.

3. The Committee will receive an overview of NOAA Fisheries' Stock Assessment Improvement Plan (SAIP) Updates, review SSC comments and provide recommendations as appropriate.

1. The Committee will receive an update on the status of catches versus annual catch limits (ACLs) for spiny lobster, review Spiny Lobster Regulatory Amendment 4 addressing management parameters including Acceptable Biological Catch (ABC) and ACLs, and the use of traps to recreationally harvest spiny lobster. The Committee will provide recommendations for approving the amendment for submission to the Secretary of Commerce for review.

2. The Committee will also receive updates on measures to align federal regulations with Florida Fish and Wildlife Commission regulations for spiny lobster.

1. The Committee will review a white paper on HMS general category permit holders' compliance with U.S. Coast Guard commercial vessel safety requirements and receive an overview of shark feeding activities. The Committee will take action as appropriate.

Council staff will provide an introduction to the problem of focusing on discard mortality rates used in stock assessments and the number of fish estimated to be discarded dead. The Council will then receive presentations on best fishing practices being used to reduce discard mortality including the use of descending devices, venting tools, and outreach efforts.

1. The Committee will discuss and recommend an appointment for the Council's 2016 Law Enforcement Officer of the Year Award.

1. The Committee will receive a report from the Law Enforcement Advisory Panel, and discuss the utility of operator cards and enforcement of offloading and closure timing for the commercial sector.

2. The Committee will discuss how non-reporting could result in suspension of a permit per the Magnuson-Stevens Conservation and Management Act and also discuss agenda items for its next meeting. The Committee will provide guidance to staff.

1. The Committee will receive a report from the Habitat Protection and Ecosystem-Based Management Advisory Panel.

2. The Committee will review and approve the Council's Essential Fish Habitat Policy Statement on Artificial Reefs and the core Fishery Ecosystem Plan II sections.

3. The Committee will discuss the Habitat and Ecosystem Tools and Model Development, receive a presentation on International Sargassum Conservation, and an update on Council actions pertaining to habitat and provide recommendations as appropriate.

1. The Committee will receive updates from NOAA Fisheries on commercial catches versus quota for dolphin and wahoo, receive a report from the Dolphin Wahoo Advisory Panel, from the SSC and provide guidance to staff.

1. The Committee will receive updates from NOAA Fisheries on commercial catches versus quotas for species under ACLs and the status of amendments under formal Secretarial review.

2. The Committee will receive a report from the Snapper Grouper Advisory Panel and an update on the Southeast Reef Fish Survey (SERFS).

3. The Committee will receive an overview of Vision Blueprint Regulatory Amendment 26 addressing recreational management actions and alternatives and Vision Blueprint Regulatory Amendment 27 addressing commercial management actions and alternatives, as identified in the 2016-2020 Vision Blueprint for the Snapper Grouper Fishery. The Committee will modify the documents as necessary, provide guidance to staff and is scheduled to approve the amendments for public hearings.

4. The Committee will receive a report from NOAA Fisheries' Southeast Fisheries Science Center on 2016 red snapper landings and discard estimates and the status of the 2017 red snapper season for federal waters in the South Atlantic. The Committee will also receive a report from the SSC and an update on the joint Council and Snook & Gamefish Foundation reporting app project.

5. The Committee will receive an overview of management options in Amendment 43 to the Snapper Grouper Fishery Management Plan addressing red snapper management and recreational reporting requirements, discuss, and provide direction to staff.

6. The Committee will review a white paper on limiting entry for Federal For-Hire (Charter) Permits, discuss and provide direction to staff.

7. The Committee will receive an update on the status of the Snapper Grouper Socio-economic Characterization/Portfolio analysis for the snapper grouper fishery.

8. The Committee will receive a presentation from NOAA Fisheries on the stock assessment for red grouper, review SSC comments and provide guidance as appropriate.

9. The Committee will receive a report from the SSC relative to golden tilefish, receive an update on the SEDAR Steering Committee actions, review a background document on golden tilefish management and provide recommendations regarding the develop of an interim rule and any other guidance.

10. The Committee will receive an update on the Acceptable Biological Catch (ABC) Control Rule, receive a report from the SSC relative to the ABC Control Rule, and provide guidance to staff.

11. The Committee will receive an update on the review of the Wreckfish Individual Transferable Quota (ITQ) program, discuss background and timing, and provide guidance to staff.

Public comment will be accepted on items on the Council agenda. Comment will be accepted first on items before the Council for Secretarial review and public hearings: Formal Review—Spiny Lobster Regulatory Amendment 4 and Public Hearings—Visioning Regulatory Amendment 26 (recreational) and Visioning Regulatory Amendment 27 (commercial). The Council Chair, based on the number of individuals wishing to comment, will determine the amount of time provided to each commenter.

1. The Committee will make recommendations for appointments to the Citizen Science Action Teams.

1. The Committee will receive an update on the Citizen Science Program and Terms of Reference, review and take action as necessary.

1. The Committee will receive status updates from NOAA Fisheries on commercial catches versus quotas for species under ACLs and amendments currently under Secretarial review.

2. The Committee will receive a meeting report from the Mackerel Cobia Advisory Panel and Cobia Sub-Panel, discuss emergency action for Atlantic cobia, receive an update on the status of the Atlantic States Marine Fisheries Commission's Interstate Cobia Plan, state reports on Atlantic cobia for 2017, discuss these items and take action as appropriate.

3. The Committee will consider a Framework to adjust Atlantic King Mackerel Trip Limits, discuss using a common unit for tracking Coastal Migratory Pelagic species, and take action as necessary.

1. The Committee will receive reports and updates on the following: For-Hire Electronic Reporting Amendment, Bycatch Amendment, the Joint Council and Atlantic Coastal Cooperative Statistics Program (ACCSP) For-Hire Electronic Reporting Pilot Project, the draft Headboat Annual Report, and the South Atlantic Research Plan. The Committee will review and take action as necessary.

1. The Committee will receive a report on the May 2017 Council Coordinating Committee meeting and provide guidance as necessary.

2. The Committee will receive an overview of the Calendar Year 2017 Budget and approve; and review, modify, and approve the Council Follow-up and Work Priorities.

3. The Committee will discuss standards and procedures for participating in Council webinar meetings, review of Exempted Fishing Permits, and document timing for meeting briefing book materials, public comment at advisory panel meetings, and the SSC liaison and role of Council members at SSC meetings. The Committee will provide guidance and take action as appropriate.

4. The Committee will discuss options for an advisory panel/workgroup for the System Management Plan for the Council's managed areas and take action as necessary.

5. The Committee will receive an overview of the Marine Recreational Information Program (MRIP) 5-Year Strategic Plan and provide guidance as necessary.

The Full Council will convene beginning on Thursday afternoon with a Call to Order, announcements and introductions, presentations, and approval of the March 2017 meeting minutes.

The Council will receive a Legal Briefing on Litigation from NOAA General Counsel (if needed) during Closed Session. The Council will receive a report from the Executive Director. The Council will also receive reports from NOAA Fisheries on the status of commercial and recreational catches versus ACLs for species not covered during an earlier committee meeting, Protected Resources updates, and the status of Bycatch Collection Programs. The Council will review any Exempted Fishing Permits received by NOAA Fisheries, receive a report on the Workshop to Improve Survival of Released Fish and take action as necessary.

The Council will receive a report from the Spiny Lobster Committee, approve/disapprove Spiny Lobster Regulatory Amendment 4 for Secretarial review, consider other Committee recommendations, and take action as appropriate.

The Council will receive a report from the Snapper Grouper Committee and approve/disapprove Visioning Amendment 26 (recreational) and Visioning Amendment 27 (commercial) for public hearings.

The Council will continue to receive committee reports from the Mackerel Cobia, Dolphin Wahoo, Law Enforcement, Advisory Panel Selection, SSC Selection, SEDAR, Data Collection, Habitat and Ecosystem-Based Management, HMS, Citizen Science, and Executive Finance Committees, review recommendations, and take action as appropriate.

The Council will receive agency and liaison reports; and discuss other business and upcoming meetings.

Documents regarding these issues are available from the Council office (see ADDRESSES).

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 Council's intent to take final action to address the emergency.

These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see ADDRESSES) 3 days prior to the meeting.

Note: The times and sequence specified in this agenda are subject to change.

Availability

An electronic copy of the COU'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: http://www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. In case of problems accessing these documents, please call the contact listed under 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.

An 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.”

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 March 22, 2016, we received a request from the COU for authorization to take marine mammals incidental to pile driving and pile removal associated with construction activities that would expand the existing UMC Dock in Dutch Harbor in the City of Unalaska, on Amaknak Island, Alaska. The COU submitted a revised version of the request on July 30, 2016, which was deemed adequate and complete. In August 2016, NMFS released its Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (the Guidance, available at http://www.nmfs.noaa.gov/pr/acoustics/guidelines.htm) which provides technical guidance for assessing the effects of anthropogenic sound on the hearing of marine mammal species under the jurisdiction of NMFS. The Guidance establishes new thresholds for predicting auditory injury, which equates to Level A harassment under the MMPA. The COU was able to update relevant portions of their application to incorporate re-calculated Level A harassment zones for vibratory and impact pile driving activities based on the updated acoustic thresholds described in the Guidance. The results of those calculations (i.e., revised distances to Level A harassment thresholds) were provided to NMFS by the COU in September 2016 and were included in the proposed IHA. NMFS published a notice in the Federal Register making preliminary determinations and proposing to issue an IHA on November 10, 2016 (81 FR 78969). The notice initiated a 30-day comment period.

The COU proposes to demolish portions of the existing UMC dock and install a new dock between April 2017 and November 2017. The use of both vibratory and impact pile driving during pile removal and installation 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 all or a portion of the in-water work window include Steller sea lion (Eumetopias jubatus), harbor seal (Phoca vitulina), humpback whale (Megaptera novaeangliae), and killer whale (Orcinus orca).

To account for potential unexpected delay in project time frame, the IHA issued to COU covers the period from April 28, 2017, to April 27, 2018, based on impact analysis.

In order to meet the increasing needs of the international shipping industry and increase vessel berthing capacity, a substantial upgrade of aging UMC facilities is necessary. The proposed project will replace the existing pile supported docks located at UMC Dock Positions III and IV with a modern high-capacity sheet pile bulkhead dock that extends from the existing bulkhead dock at Position V to the U.S. Coast Guard (USCG) Dock.

COU port operations saw numerous factory trawler offloads occurring at Dock Positions III and IV in 2013. These operations require more length at the face of the dock and greater uplands area than is available with the current infrastructure. The existing pile-supported docks are aging structures in shallower water that no longer meet the needs of the Port and require increasing levels of maintenance and monitoring costs. Both docks are also severely constrained by the limited uplands area available for offloading and loading operations.

Dock Position III is a timber pile-supported dock with approximately 160 feet of dock face that was constructed in the 1960's by the U.S. Army Corps of Engineers (USACE). This dock has been used for the Alaska Marine Highway System, vessel moorage, and factory trawler offloads. However, use of this structure is severely limited due to the low load-carrying capacity of the dock. The bullrails, deck surface, and bollards have deteriorated with age and the entire structure is in need of replacement or extensive renovations.

Dock Position IV is a steel-pile-supported, concrete deck structure with an approximate length of 200 feet that was constructed in the 1980s by the State of Alaska. Similar to Dock Position III, use of this dock is limited due to the low load capacity of the structure. Erosion has damaged an abutment underneath the dock, which is very difficult to repair and has the potential for further damage to adjacent portions of the dock.

The dock face of Dock Positions III and IV does not align with the larger sections of the UMC facility, significantly limiting overall usable moorage space. The proposed project aligns the new dock structures with the adjacent facilities, eliminates two angle breaks, provides substantially more usable moorage, and provides much deeper water at the dock face. The sheet pile dock will encompass the area between Dock Position V and the adjacent USCG Dock, providing maximum use of the available berthing area and upland storage space. The new dock alignment will allow larger, deeper vessels as well as simultaneous use of the other UMC facilities.

In-water and over-water construction of Phase 1 (all sheet pile installation, all in-water pipe pile installation, most upland pipe pile installation, and fill placement) is planned to occur between approximately April 1, 2017 and November 1, 2017. Phase 2 is planned to occur between approximately May 1, 2018 and October 1, 2018. Some of the upland pipe pile for utilities may be driven in upland fill away from the dock face during Phase 2. The COU proposes to use the following general construction sequence, subject to adjustment by the construction contractor's means and methods:

Construction Phase 1 (2017):

• Mobilization of equipment and demolition of the existing dock Positions III and IV and removal of any existing riprap/obstructions (April-May 2017).

• Development of the quarry for materials.

• Installation (and later removal) of temporary support piles for contractor's template structures and barge support.

• Installation of the new sheet pile bulkhead dock. This includes driving sheet piles, placing fill within the cell to grade, and compaction of fill.

• Installation of fender and platform support piles in the water adjacent to the dock and miscellaneous support piles within the completed sheet pile cells.

• Installation of pre-assembled fender systems (energy absorbers, sleeve piles, steel framing, and fender panels).

• Installation of the crane support piles.

• Installation of temporary utilities and gravel surface to provide functional dock capability for the 2017/2018 season.

Construction Phase 2 (2018):

• Installation of concrete grade beam for crane rails, utility vaults, and dock surfacing.

• Installation of electrical, sewer, fuel, water, and storm drainage utilities.

Pile removal and pile driving is expected to occur between April 1 and November 1, 2017. In the summer months (April-September), 12-hour workdays in extended daylight will likely be used. In winter months (October-March), shorter 8-hour to 10-hour workdays in available daylight will likely be achievable. Work windows may be extended or shortened if or when electrical lighting is used. The daily construction window for pile driving or removal will begin no sooner than 30 minutes after sunrise to allow for initial marine mammal monitoring to take place, and will end 30 minutes before sunset to allow for pre-activity monitoring. It is assumed that sound associated with the pile driving and removal activities will be put into the water approximately 50 percent of the total estimated project duration of 245 days (2,940 hours for 12-hour workdays). The remaining 50 percent of the project duration will be spent on activities that provide distinct periods without noise from pile driving or drilling such as installing templates and braces, moving equipment, threading sheet piles, pulling piles (without vibration), etc. During this time, a much smaller area will be monitored to ensure that animals are not injured by equipment or materials.

The UMC Dock is located in Dutch Harbor in the City of Unalaska, on Amaknak Island, Alaska (see Figure 5 of the application). Dutch Harbor is separated from the adjacent Iliuliuk Bay by a spit. The dock is located in Section 35, Township 72 South, Range 118 West, of the Seward Meridian. Tidelands in this vicinity are owned by the COU. Some of the adjacent uplands are owned by the COU and some are leased by the COU from Ounalashka Corporation. Adjacent infrastructure includes Ballyhoo Road and the Latitude 54 Building in which the COU Department of Ports and Harbors offices and facilities are currently housed. Neighboring docks include the USCG Dock and the existing UMC OCSP dock positions. Other marine facilities within Dutch Harbor include Delta Western Fuel, the Resolve-Magone Dock, North Pacific Fuel, the Kloosterboer Dock, and the COU's Light Cargo Dock and Spit Dock facilities, as shown in Figure 5 of the application. APL Limited is located within Iliuliuk Bay, and the entrance channel to Iliuliuk Harbor is south of Dutch Harbor.

The COU proposes to install an OPEN CELL SHEET PILETM (OCSP) dock at UMC Dock Position III and IV, replacing the existing pile-supported structure and providing a smooth transition between the UMC facility and the USCG dock. The OCSP dock will be constructed of PS31 flat sheet piles (web thickness of 0.5 inches and width between interlocks of 19.69 inches). In order to replace the existing timber pile-supported dock, the dock construction would include installation of the following:

• Approximately forty (40) 30-inch diameter steel fender and transition platform support piles;

• Approximately thirty (30) 30-inch diameter miscellaneous steel support piles

• Approximately one hundred fifty (150) 30-inch diameter steel crane rail support piles (approximately 25 of which are above the high tide line (HTL));

• Approximately one hundred fifty (150) 18-inch steel piles (H or round) used for temporary support of the sheet pile during construction (to be removed prior to completion);

• Approximately 1,800 PS31 flat sheet piles (approximately 100 of which are above the high tide line (HTL)); and

• Placement of approximately 110,000 cubic yards of clean fill.

The anticipated project quantities are shown in Table 1.

Concurrent with the dock construction, a material source will be developed in the hillside adjacent to Dock Position VII. The quarry will provide material for dock fill and other future projects, and the cleared area will be used for COU port offices and associated parking after the quarry is completed. The quarry will be developed through blasting benches in the rock face, with each bench being approximately 25 feet high, with the total height being approximately 125 feet. Quarry materials will be transported the short distance to the adjacent project site using heavy equipment.

The existing structure will be demolished by removing the concrete deck, steel superstructure, and attached appurtenances and structures and then extracting the existing steel support piles with a vibratory hammer. Sheet pile will also be installed with a vibratory hammer. Pile driving may occur from shore or from a stationary barge platform, depending on the Contractor's selected methods. After cells are completely enclosed, they will be incrementally filled with clean material using bulldozers and wheel loaders. Fill will be placed primarily from shore, but some may be placed from the barge if needed. Fill will be compacted using vibratory compaction methods, described below. After all the sheet piles are installed and the cells are filled and compacted, fender piles, crane rail piles, mooring cleats, concrete surfacing, and other appurtenances will be installed.

As described, the project requires the removal and installation of various types and sizes of piles with the use of a vibratory hammer and impact hammer. These activities have the potential to result in Level B harassment (behavioral disruption) only, as a monitoring plan will be implemented to reduce the potential for exposure to Level A harassment (harassment resulting in injury). The rest of the in-water components of the project are provided here for completeness. Note that many of the support piles will be installed to an elevation below MHW or HTL; however, they will be installed within the enclosed fill of the sheet pile dock rather than in the water.

Utilities will be installed during Phase II, and include addition/extension of water, sewer, fuel, electrical, and storm drain. Authorization to construct the sewer and storm drain extension, as well as a letter of non-objection for the storm drain, will be obtained from the State of Alaska Department of Environmental Conservation (ADEC).

A detailed description of the proposed project is provided in the Federal Register notice for the proposed IHA (81 FR 78969; November 10, 2016). Since that time, no changes have been made to the planned project activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specific activity.

A notice of NMFS's proposal to issue an IHA to the City was published in the Federal Register on November 10, 2016 (81 FR 78969). That notice described, in detail, the COU's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. During the 30-day public comment period, NMFS received comments from the Marine Mammal Commission (Commission). Specific comments and responses are provided below. Comments are also posted at http://www.nmfs.noaa.gov/pr/permits/incidental/.

Comment 1: The Commission recommends that NMFS (1) compile all in-situ source level pile-driving and pile-removal measurements from past and future projects in a central database, (2) require each action proponent to specify the sediment composition, water depth (in terms of hydrophone placement and bathymetry), duration over which the pressure was averaged for SPLrms metrics, and median values in all future hydroacoustic monitoring reports, (3) ensure consistency regarding integration timeframes used for SPLrms measurements (e.g., 1-second averages, maximum over 10 seconds, or maximum over 30 seconds) in all future hydroacoustic monitoring reports, (4) require each action proponent to use median proxy source levels from all relevant sources when in-situ data are unavailable, and (5) require each action proponent to use the upper 90th percentile rather than the best-fit regression to inform the range to effects in all future hydroacoustic monitoring reports.

Response: NMFS understands the importance of taking a consistent approach when disseminating data for impact analyses, and is currently working on a guidance on in-water pile driving assessment, which will be supplemented by a compilation of in-situ source levels from pile driving and pile removal measurements from the past. The guidance will also include language that requires future sound source verifications (SSVs) to include information on sediment composition and water depth. Many of the standardized practices for SSVs such as hydrophone depth and integration time for impact and vibratory sound sources are provided in NMFS 2012 pile driving guidance. NMFS will refer applicants to this guidance in the future, and will also refer to these documents in the guidance that is being developed.

While NMFS is striving to achieve consistency in marine mammal impact analyses, including developing standard and acceptable methodologies and metrics for measuring and quantifying underwater noise sources, considerations are also given to action proponents with limited resources. In the case of data treatment whether percentile or regression to be used would depend on how measurements are conducted and how many data points an action proponent collected. For example, if an SSV is conducted using a shipboard hydrophone that collected acoustic data at various distances from the source, the amount of data at each location may be limited, not necessarily allowing us to perform a statistical treatment to obtain the percentile. Therefore, NMFS accepts a single data point at the received distance, or a distance derived using best-fit regression from a set of data that is available.

Comment 2: The Commission recommends that NMFS require each action proponent to (1) use a consistent source level reduction factor when sound attenuation devices would be used during impact pile driving and in-situ data are unavailable and (2) conduct bubble curtain testing (for air pressure and flow prior to impact hammer use) and place the bubble curtain device on the substrate in all relevant incidental take authorizations.

Response: The effectiveness of noise attenuation devices often depends on oceanographic conditions such as currents and tides, thus should be evaluated in a case by case fashion. For example, for pile driving activities being conducted in Puget Sound where local currents are strong, NMFS worked with the action proponent and recommend 0 dB reduction when calculating ensonified zones, while in other locations it has been shown in the past that an attenuation of 10 dB or more can be achieved. Regarding the second point from the Commission's comment, NMFS believes that the requirement for bubble curtain testing and design should also be considered in a case by case situation, as some of the action proponents may have limited resources to conduct such test or design a bubble curtain device that meets certain specifications.

In this case, no noise reduction is included in the calculation because the project proponent is not required to implement bubble curtain.

Comment 3: The Commission recommends that NMFS require each action proponent to implement a 100- rather than 50-msec pulse duration consistently when using NMFS's user spreadsheet and SPLrms-based source levels to determine ranges to the various Level A harassment SELcum thresholds for impact pile driving.

Response: NMFS agrees with the Commission and will require each action proponent to implement a 100-msec pulse duration when using NMFS's optional spreadsheet and SPLrms-based source level to determine ranges to Level A harassment zones. Consequently, 100-msec is the pulse duration we used for calculating Level A ensonified zones.

Comment 4: The Commission recommends that NMFS specify whether source levels based on SPLrms or SELs-s are more appropriate for action proponents to use when both are available and require each action proponent to use that metric consistently to determine the ranges to the various Level A harassment SELcum thresholds.

Response: NMFS considers SELs-s provides a more accurate metric to calculate Level A harassment SELcum when using NMFS optional spread. Therefore, NMFS recommended action proponents to use that metric when both SPLrms and SELs-s are available. In the case of issuance an IHA to COU, SELs-s metric was used.

Marine waters near Unalaska Island support many species of marine mammals, including pinnipeds and cetaceans; however, the number of species regularly occurring within Dutch Harbor, including near the project location is limited due to the high volume of vessel traffic in and around the harbor. Due to this, Steller sea lion, harbor seal, humpback whale, and killer whale are the only species within NMFS jurisdiction that are being included in the COA's IHA request. Sightings of other marine mammals within Dutch Harbor are extremely rare, and therefore, no further descriptions of the other marine mammals were included in the COA's application or in the notice of proposed authorization.

We have reviewed COA's species descriptions—which summarize available information regarding status and trends, distribution and habitat preferences, behavior and life history, and auditory capabilities of the potentially affected species—for accuracy and completeness and refer the reader to Sections 3 and 4 of the application. Please also refer to NMFS' Web site (www.nmfs.noaa.gov/pr/species/mammals/) for generalized species accounts.

Table 2 lists the marine mammal species with the potential for occurrence in the vicinity of the project during the project timeframe and summarizes key information regarding stock status and abundance. A detailed description of the species likely to be affected by the project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed IHA (81 FR 78969; November 10, 2016). Since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' Web site (www.nmfs.noaa.gov/pr/species/mammals/) for generalized species accounts.

The effects of underwater noise from construction activities for the project have the potential to result in behavioral harassment of marine mammals in the vicinity of the action area. The Federal Register notice for the proposed IHA (81 FR 78969; November 10, 2016) included a discussion of the effects of anthropogenic noise on marine mammals, therefore that information is not repeated here. Please refer to the Federal Register notice for that information.

The proposed activities at Dutch Harbor would not result in permanent impacts to habitats used directly by marine mammals, such as haul-out sites, but may have potential short-term impacts to food sources such as forage fish and salmonids. There are no rookeries or haulout sites within the modeled zone of influence for impact or vibratory pile driving associated with the project, or ocean bottom structure of significant biological importance to marine mammals that may be present in the waters in the vicinity of the project area. The project location receives heavy use by vessel moorage and factory trawler offloads, and experiences frequent vessel traffic because of these activities, thus the area is already relatively industrialized and not a pristine habitat for marine mammals. As such, the main impact associated with the proposed activity would be temporarily elevated sound levels and the associated direct effects on marine mammals, as discussed previously in this document. The most likely impact to marine mammal habitat occurs from pile driving effects on likely marine mammal prey (i.e., fish) near the project location, and minor impacts to the immediate substrate during installation and removal of piles during the dock construction project.

The potential effects on marine mammal habitat are discussed in detail in the Federal Register notice for the proposed IHA (81 FR 78969; November 10, 2016), therefore that information is not repeated here; please refer to that Federal Register notice for that information.

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.

The COU's calculation of the Level A harassment zones utilized the methods presented in Appendix D of NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (the Guidance, available at http://www.nmfs.noaa.gov/pr/acoustics/guidelines.htm), and the accompanying User Spreadsheet.1 The Guidance provides updated PTS onset thresholds using the cumulative SEL (SELcum) metric, which incorporates marine mammal auditory weighting functions, to identify the received levels, or acoustic thresholds, at which individual marine mammals are predicted to experience changes in their hearing sensitivity for acute, incidental exposure to all underwater anthropogenic sound sources. The Guidance (Appendix D) and its companion User Spreadsheet provide alternative methodology for incorporating these more complex thresholds and associated weighting functions.

The User Spreadsheet accounts for effective hearing ranges using Weighting Factor Adjustments (WFAs), and the COU's application uses the recommended values for vibratory and impact driving therein. NMFS' new acoustic thresholds use dual metrics of SELcum and peak sound level (PK) for impulsive sounds (e.g., impact pile driving) and SELcum for non-impulsive sounds (e.g., vibratory pile driving) (Table 3). The COU used proxy source level measurements taken from similar pile driving events (as described in “Estimated Take by Incidental Harassment”), and using the User Spreadsheet, applied the updated PTS onset thresholds for impulsive PK and SELcum in the new acoustic guidance to determine distance to the isopleths for PTS onset for impact pile driving. For vibratory pile driving, the COU used the User Spreadsheet to determine isopleth estimates for PTS onset using the cumulative sound exposure level metric (LE) (http://www.nmfs.noaa.gov/pr/acoustics/guidelines.htm). In determining the cumulative sound exposure levels, the Guidance considers the duration of the activity, the sound exposure level produced by the source during one working day, and the effective hearing range of the receiving species. In the case of the duel metric acoustic thresholds (Lpk and LE) for impulsive sound, the larger of the two isopleths for calculating PTS onset is used. These values were then used to develop mitigation measures for proposed pile driving activities. The exclusion zone effectively represents the mitigation zone that would be established around each pile to prevent Level A harassment (PTS onset) to marine mammals (Table 4), while the zones of influence (ZOI) provide estimates of the areas within which Level B harassment might occur for impact/vibratory pile driving and quarry blasting (Table 5).

As discussed below, some of the proxy source levels, and the resulting PTS isopleth and harassment zone calculations, have been modified since the FR notice for the proposed IHA was published.

The following measures would apply to the COU's mitigation through the exclusion zone and zone of influence:

Exclusion Zone—For all pile driving activities, the COU will establish an exclusion zone intended to contain the area in which Level A harassment thresholds are exceeded. The purpose of the exclusion zone is to define an area within which shutdown of construction activity would occur upon sighting of a marine mammal within that area (or in anticipation of an animal entering the defined area), thus preventing potential injury of marine mammals. Calculated distances to the updated PTS onset acoustic thresholds are shown in Table 4. Some of these distances have changed since the publication of the FR notice for the proposed IHA, as NMFS has incorporated more appropriate proxy source levels (see Underwater Sound) for some of the pile sizes based on Caltrans 2014 and 2015, as well as source levels used for recent Navy pile driving construction IHAs (79 FR 43429; 81 FR 66628; Navy, 2014). The greatest calculated distance to the Level A harassment threshold during impact pile driving, assuming a targeted maximum of 5 piles driven per day, is 397.6 m for low-frequency cetaceans (humpback whale). For mid-frequency cetaceans (killer whale), phocid pinnipeds (harbor seal), and otariid pinnipeds (Steller sea lion), the distances are 14.1 m, 212.8 m, and 15.5 m, respectively (Table 4). Calculated distances to the PTS onset threshold during vibratory pile driving range from a maximum of 14.7 m for low-frequency cetaceans to 0.6 m for otariids—depending on the specific type of piles/sheets that are installed or removed (Table 4).

The established shutdown zones corresponding to the Level A harassment zones for each activity are shown in Table 4 and are as follows:

• For all vibratory pile driving activities except vibratory installation of 30″ steel pile, a 10-m radius shutdown zone will be employed for all species observed. For vibratory installation of 30″ steel pile a 15-m radius shutdown zone will be employed.

• During impact pile driving, a shutdown zone will be determined by the number of piles to be driven that day as follows: If a maximum of five piles are to be driven that day, shutdown during the first driven pile will occur if a marine mammal enters the `5-pile' radius. After the first pile is driven, if no marine mammals have been observed within the `5-pile' radius, the `4-pile' radius will become the shutdown radius. This pattern will continue unless an animal is observed within the most recent shutdown radius, at which time that shutdown radius will remain in effect for the rest of the workday. Shutdown radii for each species, depending on number of piles driven, are as follows:

○ 5-pile radius: Humpback whale, 400 m; killer whale, 15 m; harbor seal, 215 m; Steller sea lion, 15 m.

○ 4-pile radius: Humpback whale, 340 m; killer whale, 15 m; harbor seal, 185 m; Steller sea lion, 15 m.

○ 3-pile radius: Humpback whale, 280 m; killer whale, 10 m; harbor seal, 150 m; Steller sea lion, 10 m.

○ 2-pile radius: Humpback whale, 215 m; killer whale, 10 m; harbor seal, 115 m; Steller sea lion, 10 m.

○ 1-pile radius: Humpback whale, 135 m; killer whale, 10 m; harbor seal, 75 m; Steller sea lion, 10 m.

A shutdown will occur prior to a marine mammal entering a shutdown zone appropriate for that species and the concurrent work activity. Activity will cease until the observer is confident that the animal is clear of the shutdown zone: The animal will be considered clear if:

• It has been observed leaving the shutdown zone; or

• It has not been seen in the shutdown zone for 30 minutes for cetaceans and 15 minutes for pinnipeds.

If shutdown lasts for more than 30 minutes, pre-activity monitoring (see below) must recommence.

If the exclusion zone is obscured by fog or poor lighting conditions, pile driving will not be initiated until the exclusion zone is clearly visible. Should such conditions arise while impact driving is underway, the activity would be halted.

Level B Harassment Zone (Zone of Influence)—The zone of influence (ZOI) refers to the area(s) in which SPLs equal or exceed NMFS' current Level B harassment thresholds (160 and 120 dB rms for pulsed and non-pulsed continuous sound, respectively). ZOIs provide utility for monitoring that is conducted for mitigation purposes (i.e., exclusion zone monitoring) by establishing monitoring protocols for areas adjacent to the exclusion zone. Monitoring of the ZOI enables observers to be aware of, and communicate about, the presence of marine mammals within the project area but outside the exclusion zone and thus prepare for potential shutdowns of activity should those marine mammals approach the exclusion zone. However, the primary purpose of ZOI monitoring is to allow documentation of incidents of Level B harassment; ZOI monitoring is discussed in greater detail later (see “Monitoring and Reporting”). The modeled radial distances for ZOIs for impact and vibratory pile driving and removal (not taking into account landmasses which are expected to limit the actual ZOI radii) are shown in Table 6.

In order to document observed incidents of harassment, monitors will record all marine mammals observed within the ZOI. Modeling was performed to estimate the ZOI for impact pile driving (the areas in which SPLs are expected to equal or exceed 160 dB rms during impact driving) and for vibratory pile driving (the areas in which SPLs are expected to equal or exceed 120 dB rms during vibratory driving and removal). Results of this modeling showed the ZOI for impact driving would extend to a radius of 1,000 m from the pile being driven and the ZOI for vibratory pile driving would extend to a maximum radius of 11,659 m from the pile being driven. However, due to the geography of the project area, landmasses surround Dutch Harbor and Iliuliuk Bay are expected to limit the propagation of sound from construction activities such that the actual distances to the ZOI extent for vibratory pile driving will be substantially smaller than those described above. Modeling results of the ensonified areas, taking into account the attenuation provided by landmasses, suggest the actual ZOI will extend to a maximum distance of 3,300 m for vibratory driving. Due to this adjusted ZOI, and due to the monitoring locations chosen by the COU (see the Monitoring Plan in Appendix E of the application for details), we expect that monitors will be able to observe the entire modeled ZOI for both impact and vibratory pile driving, and thus we expect data collected on incidents of Level B harassment to be relatively accurate. The modeled areas of the ZOIs for impact and vibratory driving, taking into account the attenuation provided by landmasses in attenuating sound from the construction project, are shown in Appendix B of the application. The actual Level B harassment/monitoring zones for impact pile driving (1,000 m) and vibratory pile driving (3,300 m) are shown in Table 6. Some of these distances have changes since the publication of the FR notice for the proposed IHA, as NMFS has incorporated more appropriate proxy source levels (see Underwater Sound) for some of the pile sizes based on Caltrans 2014 and 2015, as well as proxy source levels used for recent Navy pile driving construction IHAs (79 FR 43429; 81 FR 66628; Navy, 2014).

Qualified observers will be on site before, during, and after all pile-driving activities. The Level A and Level B harassment zones for underwater noise will be monitored before, during, and after all in-water construction activity. The observers will be authorized to shut down activity if pinnipeds or cetaceans are observed approaching or within the shutdown zone of any construction activities.

Observers will follow observer protocols, meet training requirements, fill out data forms and report findings in accordance with protocols reviewed and approved by NMFS. A detailed Marine Mammal Monitoring Plan is found in Appendix E of the application.

If marine mammals are observed approaching or within the shutdown zone, shutdown procedures will be implemented to prevent unauthorized exposure. If marine mammals are observed within the monitoring zone (ZOI), the sighting will be documented as a potential Level B take and the animal behaviors shall be documented. If the number of marine mammals exposed to Level B harassment approaches the number of takes allowed by the IHA, the COU will notify NMFS and seek further consultation. If any marine mammal species are encountered that are not authorized by the IHA and are likely to be exposed to sound pressure levels greater than or equal to the Level B harassment thresholds, then the COU will shut down in-water activity to avoid take of those species.

Prior to the start of daily in-water construction activity, or whenever a break in pile driving of 30 minutes or longer occurs, the observer will observe the shutdown and monitoring zones for a period of 30 minutes. The shutdown zone will be cleared when a marine mammal has not been observed within zone for that 30-minute period. If a marine mammal is observed within the shutdown zone, a soft-start (described below) cannot proceed until the marine mammal has left the zone or has not been observed for 15 minutes (for pinnipeds) and 30 minutes (for cetaceans). If the Level B harassment zone has been observed for 30 minutes and non-permitted species are not present within the zone, soft start procedures can commence and work can continue even if visibility becomes impaired within the Level B zone. If the Level B zone is not visible while work continues, exposures will be recorded at the estimated exposure rate for each permitted species. If work ceases for more than 30 minutes, the pre-activity monitoring of both zones must recommence

The use of a “soft-start” procedure is believed to provide additional protection to marine mammals by providing a warning and an opportunity to leave the area prior to the hammer operating at full capacity. Soft start procedures will be used prior to pile removal, pile installation, and in-water fill placement to allow marine mammals to leave the area prior to exposure to maximum noise levels. For vibratory hammers, the soft start technique will initiate noise from the hammer for short periods at a reduced energy level, followed by a brief waiting period and repeating the procedure two additional times. For impact hammers, the soft start technique will initiate several strikes at a reduced energy level, followed by a brief waiting period. This procedure would also be repeated two additional times. Equipment used for fill placement will be idled near the waterside edge of the fill area for 15 minutes prior to performing in-water fill placement.

During in-water or over-water construction activities having the potential to affect marine mammals, but not involving a pile driver, a shutdown zone of 10 m will be monitored to ensure that marine mammals are not endangered by physical interaction with construction equipment. These activities could include, but are not limited to, the positioning of the pile on the substrate via a crane (“stabbing” the pile) or the removal of the pile from the water column/substrate via a crane (“deadpull”), or the slinging of construction materials via crane.

Sound attenuation devices (e.g., air bubble curtains, pile caps, or other attenuating device) shall be used during all impact pile driving operations. Sound levels can be greatly reduced during impact pile driving using sound attenuation devices. The exact reduction of noise level by a noise attenuator varies, and depends on many factors such as water depth, current flow, and in the case of an air bubble curtain, bubble density and bubble diameter, etc. Caltrans (2015) and Navy (2014) provide information on the general effectiveness of various air bubble curtain systems in attenuating underwater sound. In low current situations, 5 to 15 dB of noise reduction has been achieved (Caltrans, 2015). Data are more limited on the effectiveness of pile caps in reducing the sound generated by the pile during impact pile driving.

To minimize impacts from vessels interactions with marine mammals, the crews aboard project vessels will follow NMFS's marine mammal viewing guidelines and regulations as practicable. (https://alaskafisheries.noaa.gov/protectedresources/mmv/guide.htm).

We have carefully evaluated the COU's proposed mitigation measures and considered their likely effectiveness relative to implementation of similar mitigation measures in previously issued IHAs to determine whether they are likely to affect 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.

Based on our evaluation of the COU's proposed measures, we have determined that the mitigation measures provide the means of affecting the least practicable impact on marine mammal species or stocks and their habitat.

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 accomplish one or more of the following general goals:

1. An increase in the probability of detecting marine mammals, both within defined zones of effect (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 stimuli that we associate with specific adverse effects, such as behavioral harassment or hearing threshold shifts;

3. An increase in our understanding of how marine mammals respond to stimuli expected to result in incidental take and how anticipated adverse effects on individuals may impact the population, stock, or species (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 pertinent information, e.g., received level, distance from source);

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

• 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; or

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

The COU submitted a Marine Mammal Monitoring Plan as part of their IHA application (Appendix E of the application; also available online at: http://www.nmfs.noaa.gov/pr/permits/incidental/). The COU's proposed Marine Mammal Monitoring Plan was created with input from NMFS and was based on similar plans that have been successfully implemented by other action proponents under previous IHAs for pile driving projects.

The COU will collect sighting data and will record behavioral responses to construction activities for marine mammal species observed in the project location during the period of activity. All marine mammal observers (MMOs) will be trained in marine mammal identification and behaviors and are required to have no other construction-related tasks while conducting monitoring. The COU will monitor the exclusion zone (shutdown zone) and Level B harassment zone before, during, and after pile driving, with observers located at the best practicable vantage points (See Figure 3 in the Marine Mammal Monitoring Plan for the observer locations planned for use during construction). Based on our requirements, the Marine Mammal Monitoring Plan would implement the following procedures for pile driving:

• During observation periods, observers will continuously scan the area for marine mammals using binoculars and the naked eye. Observers will work shifts of a maximum of four consecutive hours followed by an observer rotation or a 1-hour break and will work no more than 12 hours in any 24-hour period.

• Observers will collect data including, but not limited to, environmental conditions (e.g., sea state, precipitation, glare, etc.), marine mammal sightings (e.g., species, numbers, location, behavior, responses to construction activity, etc.), construction activity at the time of sighting, and number of marine mammal exposures. Observers will conduct observations, meet training requirements, fill out data forms, and report findings in accordance with this IHA.

• During all observation periods, observers will use binoculars and the naked eye to search continuously for marine mammals.

• If the exclusion zone is obscured by fog or poor lighting conditions, pile driving will not be initiated until the exclusion zone is clearly visible. Should such conditions arise while impact driving is underway, the activity would be halted.

• Observers will implement mitigation measures including monitoring of the shutdown and monitoring zones, clearing of the zones, and shutdown procedures.

• Observers will be in continuous contact with the construction personnel via two-way radio. A cellular phone will be used as back-up communications and for safety purposes.

• Individuals implementing the monitoring protocol will assess its effectiveness using an adaptive approach. MMOs will use their best professional judgment throughout implementation and seek improvements to these methods when deemed appropriate. Any modifications to protocol will be coordinated between NMFS and the COU.

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

• Date and time that permitted construction activity begins or ends;

• Weather parameters (e.g. percent cloud cover, percent glare, visibility) and Beaufort sea state;

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

• Construction activities occurring during each sighting;

• Marine mammal behavior patterns observed, including bearing and direction of travel;

• Specific focus should be paid to behavioral reactions just prior to, or during, soft-start and shutdown procedures;

• Location of marine mammal, distance from observer to the marine mammal, and distance from pile driving activities to marine mammals;

• Record of whether an observation required the implementation of mitigation measures, including shutdown procedures and the duration of each shutdown; and

• Other human activity in the area. Record the hull numbers of fishing vessels if possible.

The companion User Spreadsheet provided with NMFS' new acoustic guidance uses multiple conservative assumption which may result in unrealistically large isopleths associated with PTS onset. The COU may elect to verify the values used for source levels and sound attenuation in the various exclusion radii calculations. This would be achieved using the techniques and equipment for sound source verification discussed in Appendix A of the application. Sound levels would be measured at the earliest possibility during pile driving at 10, 100, 300, and 500 meters from the sound source. For the purpose of recalculating the observation and hazard radii, measured source levels (at 10 m) would be substituted for the assumed source levels for piles of the same size and method of installation as the measured pile. The distant values would be plotted and a logarithmic line of best fit used to determine the site specific attenuation rate (geometric loss coefficient) experienced at the project site. If the measured geometric loss coefficient is higher than the typically-used value of 15, the observation and hazard radii for all pile driving activities will be revised by applying the site specific measured values to the practical spreading loss equation. The site specific radii would be used for the remaining duration of construction. The COU may elect not to exercise this option, if the cost of shutdown during impact pile driving is not anticipated to warrant additional measurements.

The COU must obtain approval from NMFS of any new exclusion zone before it may be implemented.

A draft report will be submitted within 90 calendar days of the completion of the activity. The report will include information on marine mammal observations pre-activity, during-activity, and post-activity during pile driving days, and will provide descriptions of any behavioral responses to construction activities by marine mammals and a complete description of any mitigation shutdowns and results of those actions, as well as an estimate of total take based on the number of marine mammals observed during the course of construction. A final report must be submitted within 30 days following resolution of comments from NMFS on the draft report. The report shall include at a minimum:

• General data:

○ Date and time of activity.

○ Water conditions (e.g., sea-state).

○ Weather conditions (e.g., percent cover, percent glare, visibility).

• Specific pile driving data:

○ Description of the pile driving activity being conducted (pile locations, pile size and type), and times (onset and completion) when pile driving occurs.

○ The construction contractor and/or marine mammal monitoring staff will coordinate to ensure that pile driving times and strike counts are accurately recorded. The duration of soft start procedures should be noted as separate from the full power driving duration.

○ Detailed description of the sound attenuation system utilized, including the design.

○ Description of in-water construction activity not involving pile driving (location, type of activity, onset and completion times).

• Pre-activity observational survey-specific data:

○ Date and time survey is initiated and terminated.

○ Description of any observable marine mammals and their behavior in the immediate area during monitoring.

○ Times when pile driving or other in-water construction is delayed due to presence of marine mammals within shutdown zones.

• During-activity observational survey-specific data:

○ Description of any observable marine mammal behavior within monitoring zones or in the immediate area surrounding the monitoring zones, including the following:

Distance from animal to pile driving sound source.

Reason why/why not shutdown implemented.

If a shutdown was implemented, behavioral reactions noted and if they occurred before or after implementation of the shutdown.

If a shutdown was implemented, the distance from animal to sound source at the time of the shutdown.

Behavioral reactions noted during soft starts and if they occurred before or after implementation of the soft start.

Distance to the animal from the sound source during soft start.

• Post-activity observational survey-specific data:

○ Results, which include the detections and behavioral reactions of marine mammals, the species and numbers observed, sighting rates and distances,

○ Refined exposure estimate based on the number of marine mammals observed. This may be reported as a rate of take (number of marine mammals per hour or per day), or using some other appropriate metric.

In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner not authorized by the IHA, such as a Level A harassment, or a take of a marine mammal species other than those authorized, the COU would immediately cease the specified activities and immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and the Alaska Stranding Coordinator.

The report would include the following information:

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

• Description of the incident;

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

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

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

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

• Fate of the animal(s); and

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

Activities would not resume until NMFS is able to review the circumstances of the prohibited take. NMFS would work with the COU to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. The COU would not be able to resume their activities until notified by NMFS via letter, email, or telephone.

In the event that the COU discovers an injured or dead marine mammal, and determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition), the COU would immediately report the incident to Jolie Harrison ([email protected]), Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and Mandy Migura ([email protected]), Alaska Stranding Coordinator. The report would include the same information identified in the paragraph above. Construction related activities would be able to continue while NMFS reviews the circumstances of the incident. NMFS would work with the COU to determine whether modifications in the activities are appropriate.

In the event that the COU discovers an injured or dead marine mammal, and determines that the injury or death is not associated with or related to the activities authorized in the IHA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), the COU would report the incident to Jolie Harrison ([email protected]), Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and Mandy Migura ([email protected]), Alaska Stranding Coordinator, within 24 hours of the discovery. The COU would provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. The COU can continue its operations under such a case.

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 vibratory and impact pile driving and involving temporary changes in behavior. Based on the best available information, the proposed activities—vibratory and impact pile driving—would not result in serious injuries or mortalities to marine mammals even in the absence of the planned mitigation and monitoring measures. Additionally, the mitigation and monitoring measures are expected to minimize the potential for injury, such that take by Level A harassment is considered discountable.

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, as it is often difficult to distinguish between the individual animals 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.

The COU has requested authorization for the incidental taking of small numbers of Steller sea lions, harbor seals, humpback whales, and killer whales that may result from pile driving activities associated with the UMC dock construction project 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 incorporate 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 use sound exposure thresholds to determine when an activity that produces sound might result in impacts to a marine mammal such that a “take” by harassment might occur. As discussed above, NMFS has recently revised PTS (and temporary threshold shift) onset acoustic thresholds for impulsive and non-impulsive sound as part of its new acoustic guidance (refer to Table 3 for those thresholds). The Guidance does not address Level B harassment, nor airborne noise harassment; therefore, COU uses the current NMFS acoustic exposure criteria to determine exposure to airborne and underwater noise sound pressure levels for Level B harassment (Table 5).

Public comment periods will be provided in the agenda. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business.

Although other non-emergency issues not on the agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Actions will be restricted to those issues specifically listed 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 Council's intent to take final action to address the emergency.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.

The Defense Science Board was unable to provide public notification concerning its meeting on May 22 through 23, 2017, of the Defense Science Board 2017 Summer Study Task Force on Countering Anti-access Systems with Longer Range and Standoff Capabilities, as required by 41 CFR 102-3.150(a). Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.

Purpose of the Meeting: The mission of the DSB is to provide independent advice and recommendations on matters relating to the Department of Defense's (DoD) scientific and technical enterprise. The objective of the Long Range Effects 2017 Summer Study Task Force is to explore new defense systems and technologies that will enable cost effective power projection that relies on the use of longer stand-off distances than current capabilities. System components may be deployed on manned or unmanned platforms with a range of potential autonomous capabilities. Use of cost reducing technology and advanced production practices from defense and commercial industry may be a major part of the strategy for deploying adequate numbers of weapons.

Agenda: This two-day session will focus on industry perspectives regarding potential future capabilities and architectures for DoD implementation. Day One briefings will include opening remarks and expectations for the two-day session from Dr. David Whelan and Mr. Mark Russell, task force co-chairs; a briefing on Raytheon perspectives regarding potential future capabilities and architectures for the DoD from Mr. William Kiczuk, The Raytheon Company; a briefing on Aerojet Rocketdyne perspectives regarding potential future capabilities and architectures for the DoD from Mr. Tyler Evans, Aerojet Rocketdyne; a briefing on Boeing perspectives regarding potential future capabilities and architectures for the DoD from Mr. Kevin Bowcutt, Mr. Brian Tillotson, and Mr. David Bujold, The Boeing Company; and a briefing on Northrop Grumman perspectives regarding potential future capabilities and architectures for the DoD from Mr. Patrick Antkowiak, Northrop Grumman Corporation. Day Two activities will include a briefing on Lockheed Martin perspectives regarding potential future capabilities and architectures for the DoD by Mr. Richard Lewis, Lockheed Martin Corporation. The remainder of Day Two activities will be the Long Range Effects 2017 Summer Study Task Force's four-panel break-out sessions: Architecture; Intelligence, Surveillance, and Reconnaissance; Basing, Delivery, and Weapons; and Command, Control, Communications, and Cyber. These panels will meet simultaneously to discuss topics to analyze in support of the study. Day Two will close with discussion of the four panels' work.

Meeting Accessibility: In accordance with section 10(d) of the FACA and 41 CFR 102-3.155, the DoD has determined that the Long Range Effects 2017 Summer Study Task Force meeting will be closed to the public. Specifically, the Under Secretary of Defense (Acquisition, Technology, and Logistics), in consultation with the DoD Office of General Counsel, has determined in writing that the meeting will be closed to the public because matters covered by 5 U.S.C. 552b(c)(1) will be considered. The determination is based on the consideration that it is expected that discussions throughout will involve classified matters of national security concern. Such classified material is so intertwined with the unclassified material that it cannot reasonably be segregated into separate discussions without defeating the effectiveness and meaning of the overall meetings. To permit the meeting to be open to the public would preclude discussion of such matters and would greatly diminish the ultimate utility of the DSB's findings and recommendations to the Secretary of Defense and to the Under Secretary of Defense for Acquisition, Technology, and Logistics.

Written Statements: In accordance with section 10(a)(3) of the FACA and 41 CFR 102-3.105(j) and 102-3.140, interested persons may submit a written statement for consideration by the Long Range Effects 2017 Summer Study Task Force members at any time regarding its mission or in response to the stated agenda of a planned meeting. Individuals submitting a written statement must submit their statement to the DSB's DFO—Ms. Karen D.H. Saunders, Executive Director, Defense Science Board, 3140 Defense Pentagon, Room 3B888A, Washington, DC 20301, via email at [email protected] or via phone at (703) 571-0079 at any point; however, if a written statement is not received at least 3 calendar days prior to the meeting, which is the subject of this notice, then it may not be provided to or considered by the Long Range Effects 2017 Summer Study Task Force until the next meeting of this task force. The DFO will review all submissions with the Long Range Effects 2017 Summer Study Task Force Co-Chairs and ensure they are provided to Long Range Effects 2017 Summer Study Task Force members prior to the end of the two-day meeting on May 23, 2017.

This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.

Purpose of the Meeting: The purpose of the meeting is to obtain, review, and evaluate information related to strategies, policies, and practices designed to improve and enhance the capabilities, efficiency, and effectiveness of the Reserve Components.

Agenda: The RFPB will hold a meeting from 9:10 a.m. to 4:00 p.m. The portion of the meeting from 9:10 a.m. to 1:30 p.m. will be closed to the public and will consist of remarks to the RFPB from following invited speakers: The Chief, National Guard Bureau will discuss the guidance and readiness goals for the National Guard and the future role of the Army and Air Guard as part of the Total Force; the Assistant Deputy Chief of Staff for Operations, Headquarters U.S. Air Force will discuss the readiness priorities of the Air Force, the Air Force Reserve Commission initiatives, and the Air Force challenges to balance force structure, readiness and modernization while supporting operations across the globe in a fiscally constrained environment and its effects on the Reserve Components; the Deputy Chief of Naval Operations for Operations, Plans, and Strategy will discuss the key readiness priorities for the Navy and the “Operational Reserve” challenges in this period of fiscal uncertainty and increasingly challenging security environment; the Deputy Commandant Plans, Policies, and Operations, Headquarters Marine Corps will discuss the readiness challenges for the Marine Corps and the future role of the Reserve Components as part of the Total Force in this period of fiscal uncertainty and increasingly challenging security environment; and the Deputy Director Operations, Readiness, and Mobilization, Headquarters, Department of the Army will discuss the Army readiness posture, the Report of the National Commission on the Future of the Army initiatives, and plans to adapt the Total Army to meet future challenges in this period of fiscal uncertainty and increasingly challenging security environment. The portion of the meeting from 1:35 p.m. to 4:00 p.m. will be open to the public and will consist of the following briefings: The Deputy Director of the Air National Guard will discuss the Air Guard goals, readiness objectives, and challenges for the “Operational Reserve” as part of the Total Force; the Chair of the Subcommittee on Supporting and Sustaining Reserve Component Personnel will discuss the subcommittee's review of the Department of Defense's Duty Status reform proposals, the Joint Professional Military Education II Qualifications program issues, and the Reserve Joint Travel Regulation issues, as well as the proposed recommendation reports to the Secretary of Defense; the Chair of the Subcommittee on Ensuring a Ready, Capable, Available, and Sustainable Operational Reserve will discuss the subcommittee's proposed RFPB recommendation report to the Secretary of Defense from the review of the 10 U.S.C. 12304b Mobilization Authority disparity issues with Reservist's benefits and entitlements for involuntary recalls.

Meeting Accessibility: Pursuant to section 10(a)(1) of the FACA and 41 CFR 102-3.140 through 102-3.165, and subject to the availability of space, the meeting is open to the public from 1:35 p.m. to 4:00 p.m. Seating is on a first-come, first-served basis. All members of the public who wish to attend the public meeting must contact Mr. Alex Sabol, the Designated Federal Officer, not later than 12:00 p.m. on Tuesday, June 6, 2017, as listed in the FOR FURTHER INFORMATION CONTACT section to make arrangements for a Pentagon escort, if necessary. Public attendees requiring escort should arrive at the Pentagon Metro Entrance with sufficient time to complete security screening no later than 1:00 p.m. on June 7. To complete the security screening, please be prepared to present two forms of identification. One must be a picture identification card. In accordance with section 10(d) of the FACA, 5 U.S.C. 552b(c), and 41 CFR 102-3.155, the DoD has determined that the portion of this meeting scheduled to occur from 9:10 a.m. to 1:30 p.m. will be closed to the public. Specifically, the Under Secretary of Defense (Personnel and Readiness), in coordination with the Department of Defense FACA Attorney, has determined in writing that this portion of the meeting will be closed to the public because it is likely to disclose classified matters covered by 5 U.S.C. 552b(c)(1).

Written Statements: Pursuant to section 10(a)(3) of the FACA and 41 CFR 102-3.105(j) and 102-3.140, interested persons may submit written statements to the RFPB about its approved agenda or at any time on the RFPB's mission. Written statements should be submitted to the RFPB's Designated Federal Officer at the address, email, or facsimile number listed in the FOR FURTHER INFORMATION CONTACT section. If statements pertain to a specific topic being discussed at the planned meeting, then these statements must be submitted no later than five (5) business days prior to the meeting in question. Written statements received after this date may not be provided to or considered by the RFPB until its next meeting. The Designated Federal Officer will review all timely submitted written statements and provide copies to all the RFPB members before the meeting that is the subject of this notice. Please note that since the RFPB operates under the provisions of the FACA, all submitted comments and public presentations will be treated as public documents and will be made available for public inspection, including, but not limited to, being posted on the RFPB's Web site.

The Biomass Research and Development Act of 2000 (Biomass Act) [Pub. L. 106-224] requires cooperation and coordination in biomass research and development (R&D) between the U.S. Department of Agriculture (USDA) and U.S. Department of Energy (DOE). The Biomass Act was repealed in June 2008 by section 9008 of the Food, Conservation and Energy Act of 2008 (FCEA) [Pub. L. 110-246, 122 Stat. 1651, enacted June 18, 2008, H.R. 6124]. The Biomass Act was re-authorized in the Agricultural Act of 2014.

FCEA section 9008(d) established the Biomass Research and Development Technical Advisory Committee and lays forth its meetings, coordination, duties, terms, and membership types. Committee members are paid travel and per diem for each meeting. The Committee must meet quarterly and should not duplicate the efforts of other Federal advisory committees. Meetings are typically two days in duration. At least three meetings are held in the Washington DC area, with the fourth meeting possibly held at a site to be determined each year. The Committee advises DOE and USDA points of contact with respect to the Biomass R&D Initiative (Initiative) and priority technical biomass R&D needs and makes written recommendations to the Biomass R&D Board (Board). Those recommendations regard whether: (A) Initiative funds are distributed and used consistent with Initiative objectives; (B) solicitations are open and competitive with awards made annually; (C) objectives and evaluation criteria of the solicitations are clear; and (D) the points of contact are funding proposals selected on the basis of merit, and determined by an independent panel of qualified peers.

The committee members may serve two, three-year terms and committee membership must include: (A) An individual affiliated with the biofuels industry; (B) an individual affiliated with the biobased industrial and commercial products industry; (C) an individual affiliated with an institution of higher education that has expertise in biofuels and biobased products; (D) 2 prominent engineers or scientists from government (non-federal) or academia that have expertise in biofuels and biobased products; (E) an individual affiliated with a commodity trade association; (F) 2 individuals affiliated with environmental or conservation organizations; (G) an individual associated with state government who has expertise in biofuels and biobased products; (H) an individual with expertise in energy and environmental analysis; (I) an individual with expertise in the economics of biofuels and biobased products; (J) an individual with expertise in agricultural economics; (K) an individual with expertise in plant biology and biomass feedstock development; (L) an individual with expertise in agronomy, crop science, or soil science; and (M) at the option of the points of contact, other members (REF: FCEA 2008 section 9008(d)(2)(A)). All nominees will be carefully reviewed for their expertise, leadership, and relevance to an expertise. Appointments will be made for three-year terms as dictated by the legislation.

Nominations this year are needed for the following categories in order to address the Committee's needs: (E) An individual affiliated with a commodity trade association; (F) individuals affiliated with environmental or conservation organizations; and (I) an individual with expertise in the economics of biofuels and biobased products. Nominations for other categories will also be accepted. Nomination categories C, D, H, I, J, K, L, and M are considered special Government employees and require submittal of an annual financial disclosure form. In addition to the required categories, other areas of expertise of interest to the Committee are individuals with expertise in process engineering related to biorefineries, or biobased coproducts that enable fuel production.

Nominations are solicited from organizations, associations, societies, councils, federations, groups, universities, and companies that represent a wide variety of biomass research and development interests throughout the country. In your nomination letter, please indicate the specific membership category of interest. Each nominee must submit their resume and biography along with any letters of support by the deadline above. If you were nominated in previous years but were not appointed to the committee and would still like to be considered, please submit your nomination package again in response to this notice with all required materials. All nominees will be vetted before selection.

Nominations are open to all individuals without regard to race, color, religion, sex, national origin, age, mental or physical handicap, marital status, or sexual orientation. To ensure that recommendations of the Technical Advisory Committee take into account the needs of the diverse groups served by DOE, membership shall include (to the extent practicable), all racial and ethnic groups, women and men, and persons with disabilities. Please note that registered lobbyists serving in an “individual capacity,” individuals already serving another Federal Advisory Committee, and Federal employees are ineligible for nomination.

Appointments to the Biomass Research and Development Technical Advisory Committee will be made by the Secretary of Energy and the Secretary of Agriculture.

Purpose of Meeting: To develop advice and guidance that promotes research and development leading to the production of biobased fuels and biobased products.

Tentative Agenda: Agenda will include the following:

Public Participation: In keeping with procedures, members of the public are welcome to observe the business of the Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, you must contact Dr. Mark Elless at; Email: [email protected] and Roy Tiley at (410) 997-7778 ext. 220; Email: [email protected] at least 5 business days prior to the meeting. Members of the public will be heard in the order in which they sign up at the beginning of the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Co-chairs of the Committee will make every effort to hear the views of all interested parties. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. The Co-chairs will conduct the meeting to facilitate the orderly conduct of business.

Minutes: The summary of the meeting will be available for public review and copying at http://biomassboard.gov/committee/meetings.html.

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

Tentative Agenda:

• Welcome and Announcements.

• Comments from the Deputy Designated Federal Officer (DDFO).

• Comments from the DOE, Tennessee Department of Environment and Conservation and Environmental Protection Agency Liaisons.

• Public Comment Period.

• Presentation by DOE EM SSAB DFO: Federal Advisory Committee Act.

• Motions/Approval of May 10, 2017 Meeting Minutes.

• Status of Outstanding Recommendations.

• Alternate DDFO Report.

• Committee Reports.

• Adjourn.

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

Minutes: Minutes will be available by writing or calling Melyssa P. Noe at the address and phone number listed above. Minutes will also be available at the following Web site: https://energy.gov/orem/services/community-engagement/oak-ridge-site-specific-advisory-board/oak-ridge-site-specific-0.

The CASAC was established pursuant to the Clean Air Act (CAA) Amendments of 1977, codified at 42 U.S.C. 7409(d)(2), to review air quality criteria and National Ambient Air Quality Standards (NAAQS) and recommend any new NAAQS and revisions of existing criteria and NAAQS as may be appropriate. The CASAC is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. Section 109(d)(1) of the CAA requires that the Agency periodically review and revise, as appropriate, the air quality criteria and the NAAQS for the six “criteria” air pollutants, including sulfur oxides. EPA is currently reviewing the primary (health-based) NAAQS for sulfur dioxide (SO2), as an indicator for health effects caused by the presence of sulfur oxides in the ambient air. Pursuant to FACA and EPA policy, notice is hereby given that the Chartered CASAC and the CASAC Sulfur Oxides Panel will hold a public teleconference to discuss the draft CASAC review of the EPA's Integrated Science Assessment for Sulfur Oxides—Health Criteria (Second External Review Draft—December 2016). The CASAC Sulfur Oxides Panel and CASAC will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies.

Technical Contacts: Any technical questions concerning the Integrated Science Assessment for Sulfur Oxides—Health Criteria (Second External Review Draft—December 2016) should be directed to Dr. Tom Long ([email protected]), EPA Office of Research and Development.

Availability of Meeting Materials: Prior to the meeting, the review documents, agenda and other materials will be available on the CASAC Web page at http://www.epa.gov/casac/.

Procedures for Providing Public Input: Public comment for consideration by EPA's federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office.

Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Members of the public can submit relevant comments on the topic of this advisory activity, including the charge to the panel and the EPA review documents, and/or the group conducting the activity, for the CASAC to consider as it develops advice for EPA. Input from the public to the CASAC will have the most impact if it provides specific scientific or technical information or analysis for CASAC panels to consider, or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should follow the instructions below to submit comments.

Oral Statements: In general, individuals or groups requesting an oral presentation on a public teleconference will be limited to three minutes. Each person making an oral statement should consider providing written comments as well as their oral statement so that the points presented orally can be expanded upon in writing. Interested parties should contact Mr. Aaron Yeow, DFO, in writing (preferably via email) at the contact information noted above by June 13, 2017, to be placed on the list of public speakers.

Written Statements: Written statements will be accepted throughout the advisory process; however, for timely consideration by CASAC members, statements should be supplied to the DFO (preferably via email) at the contact information noted above by June 13, 2017. It is the SAB Staff Office general policy to post written comments on the Web page for the advisory meeting or teleconference. Submitters are requested to provide an unsigned version of each document because the SAB Staff Office does not publish documents with signatures on its Web sites. Members of the public should be aware that their personal contact information, if included in any written comments, may be posted to the CASAC Web site. Copyrighted material will not be posted without explicit permission of the copyright holder.

Accessibility: For information on access or services for individuals with disabilities, please contact Mr. Aaron Yeow at (202) 564-2050 or [email protected]. To request accommodation of a disability, please contact Mr. Yeow preferably at least ten days prior to each meeting to give EPA as much time as possible to process your request.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control Number: 3060-0997.

Title: Section 52.15(k), Numbering Utilization and Compliance Audit.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Businesses or other for-profit.

Number of Respondents and Responses: 10 respondents; 10 responses.

Estimated Time per Response: 33 hours.

Frequency of Response: Third party disclosure requirement.

Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. Section 251.

Total Annual Burden: 330 hours.

Total Annual Cost: No cost.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: Commission employees and the independent auditor are prohibited by 47 U.S.C. 220(f) from divulging any fact or information that may come to their knowledge in the course of performing the audit, except as directed by the Commission or a court.

Needs and Uses: The audit program, consisting of audit procedures and guidelines, is developed to conduct random audits. The random audits are conducted on the carriers that use numbering resources in order to verify the accuracy of numbering data reported on FCC Form 502, and to monitor compliance with FCC rules, orders and applicable industry guidelines. Failure of the audited carriers to respond to the audits can result in penalties. Based on the final audit report, evidence of potential violations may result in enforcement action.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control Number: 3060-1113.

Title: Commercial Mobile Alert System (CMAS).

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents and Responses: 1,253 respondents; 1,253 responses.

Estimated Time per Response: 30 minutes (.5 hours).

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

Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. 151, 154(i), 154(j), 154(o), 218, 219, 230, 256, 302(a), 303(f), 303(g), 303(r), 403, 621(b)(3), and 621(d).

Total Annual Burden: 28,193 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No Impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality.

Needs and Uses: This collection will be submitted as an extension after this 60 day comment period to the Office of Management and Budget (OMB) in order to obtain OMB approval.

On August 7, 2008, the FCC released a Third Report and Order in PS Docket No. 07-287, FCC 08-184 (CMAS Third R&O), the CMAS Third R&O implements provisions of the Warning, Alert and Response Network (“WARN”) Act, including inter alia, a requirement that within 30 days of release of the CMAS Third R&O, each Commercial Mobile Service (CMS) provider must file an election with the Commission indicating whether or not it intends to transmit emergency alerts as part of the Commercial Mobile Alert System (CMAS). The CMAS Third R&O noted that this filing requirement was subject to OMB review and approval. The Commission received “pre-approval” from the OMB on February 4, 2008. The Commission began accepting CMAS election filings on or before September 8, 2008.

All CMS providers are required to submit a CMAS election, including those that were not licensed at the time of the initial filing deadline with the FCC. In addition, any CMS provider choosing to withdraw its election must notify the Commission at least sixty (60) days prior to the withdrawal of its election. The information collected will be the CMS provider's contact information and its election, i.e., a “yes” or “no”, on whether it intends to provide commercial mobile service alerts.

The Commission will use the information collected to meet its statutory requirement under the WARN Act to accept licensees' election filings and to establish an effective CMAS that will provide the public with effective mobile alerts in a manner that imposes minimal regulatory burdens on affected entities.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control Number: 3060-0819.

Title: Lifeline and Link Up Reform and Modernization, Telecommunications Carriers Eligible for Universal Service Support, Connect America Fund.

Form Numbers: FCC Form 555, FCC Form 481, FCC Form 497.

Type of Review: Revision of a currently approved collection.

Respondents: Individuals or households and business or other for-profit.

Number of Respondents and Responses: 20,535,330 respondents; 23,328,463 responses.

Estimated Time per Response: .0167 hours-250 hours.

Frequency of Response: Annual, biennial, monthly, daily and on occasion reporting requirements and third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in sections 1, 4(i), 5, 201, 205, 214, 219, 220, 254, 303(r), and 403 of the Communications Act of 1934, as amended, and section 706 of the Communications Act of 1996, as amended; 47 U.S.C. 151, 154(i), 155, 201, 205, 214, 219, 220, 254, 303(r), 403, and 1302.

Total Annual Burden: 12,148,151 hours.

Total Annual Cost: $937,500.

Privacy Act Impact Assessment: Yes. The Commission completed a Privacy Impact Assessment (PIA) for some of the information collection requirements contained in this collection. The PIA was published in the Federal Register at 78 FR 73535 on December 6, 2013. The PIA may be reviewed at: http://www.fcc.gov/omd/privacyact/Privacy_Impact_Assessment.html.

Nature and Extent of Confidentiality: Some of the requirements contained in this information collection affect individuals or households, and thus, there are impacts under the Privacy Act. The FCC's system of records notice (SORN) associated with this collection is FCC/WCB-1, “Lifeline Program.” The Commission will use the information contained in FCC/WCB-1 to cover the personally identifiable information (PII) that is required as part of the Lifeline Program (“Lifeline”). As required by the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Commission published FCC/WCB-1 “Lifeline Program” in the Federal Register on December 6, 2013 (78 FR 73535).

Also, respondents may request materials or information submitted to the Commission or to the Universal Service Administrative Company (USAC or Administrator) be withheld from public inspection under 47 CFR 0.459 of the FCC's rules. We note that USAC must preserve the confidentiality of all data obtained from respondents; must not use the data except for purposes of administering the universal service programs; and must not disclose data in company-specific form unless directed to do so by the Commission.

Needs and Uses: The Commission will submit this information collection after this comment period to obtain approval from the Office of Management and Budget (OMB) of proposed revisions to this information collection.

On April 27, 2016, the Commission released an order reforming its low-income universal service support mechanisms. Lifeline and Link Up Reform and Modernization; Telecommunications Carriers Eligible for Universal Service Support; Connect America Fund, WC Docket Nos. 11-42, 09-197, 10-90, Third Further Notice of Proposed Rulemaking, Order on Reconsideration, and Further Report and Order, (Lifeline Third Reform Order). In the Lifeline Third Reform Order, the Commission adopted the National Verifier to make eligibility determinations and perform other functions necessary to enroll subscribers into the Lifeline program. This revised information collection addresses changes associated with transition to the National Verifier. In addition, the Commission seeks to update the number of respondents for certain requirements contained in this information collection, thus increasing the total burden hours for some requirements and decreasing the total burden hours for other requirements. Finally, the Commission seeks to revise the FCC Form 555 to reflect the transition to the National Verifier.

As part of its continuing effort to reduce paperwork burdens, and as required by the PRA, 44 U.S.C. 3501-3520, the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control No.: 3060-1039.

Title: Nationwide Programmatic Agreement Regarding the Section 106 National Historic Preservation Act—Review Process, WT Docket No. 03-128.

Form No.: FCC Form 620 and 621, TCNS E-filing.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities; not-for-profit institutions; State, Local or Tribal Government.

Number of Respondents and Responses: 70,152 respondents and 70,152 responses.

Estimated Time per Response: 1-5 hours.

Frequency of Response: Recordkeeping requirement; on occasion reporting requirement; third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in sections 1, 4(i), 303(q), 303(r), 309(a), 309(j) and 319 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 303(q), 303(r), 309(a), 309(j) and 319, sections 101(d)(6) and 106 of the National Historic Preservation Act (NHPA) of 1966, 16 U.S.C. 470a(d)(6) and 470f, and section 800.14(b) of the rules of the Advisory Council on Historic Preservation, 36 CFR 800.14(b).

Total Annual Burden: 97,929 hours.

Annual Cost Burden: $13,087,425.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: In general there is no need for confidentiality. On a case by case basis, the Commission may be required to withhold from disclosure certain information about the location, character, or ownership of a historic property, including traditional religious sites.

Needs and Uses: FCC staff, State Historic Preservation Officers (SHPO), Tribal Historic Preservation Officers (THPO) and the Advisory Council of Historic Preservation (ACHP) use the data to take such action as may be necessary to ascertain whether a proposed action may affect sites of cultural significance to tribal nations and historic properties that are listed or eligible for listing on the National Register as directed by section 106 of the National Historic Preservation Act (NHPA) and the Commission's rules.

FCC Form 620, New Tower (NT) Submission Packet is to be completed by or on behalf of applicants to construct new antenna support structures by or for the use of licensees of the FCC. The form is to be submitted to the State Historic Preservation Office (“SHPO”) or to the Tribal Historic Preservation Office (“THPO”), as appropriate, and the Commission before any construction or other installation activities on the site begins. Failure to provide the form and complete the review process under section 106 of the NHPA prior to beginning construction may violate section 110(k) of the NHPA and the Commission's rules.

FCC Form 621, Collocation (CO) Submission Packet is to be completed by or on behalf of applicants who wish to collocate an antenna or antennas on an existing communications tower or non-tower structure by or for the use of licensees of the FCC. The form is to be submitted to the State historic Preservation Office (“SHPO”) or to the Tribal Historic Preservation Office (“THPO”), as appropriate, and the Commission before any construction or other installation activities on the site begins. Failure to provide the form and complete the review process under section 106 of the NHPA prior to beginning construction or other installation activities may violate section 110(k) of the NHPA and the Commission's rules.

The Tower Construction Notification System (TCNS) is used by or on behalf of Applicants proposing to construct new antenna support structures, and some collocations, to ensure that Tribal Nations have the requisite opportunity to participate in review prior to construction. To facilitate this coordination, Tribal Nations have designated areas of geographic preference, and they receive automated notifications based on the site coordinates provided in the filing. Applicants complete TCNS before filing a 620 or 621 and all the relevant data is pre-populated on the 620 and 621 when the forms are filed electronically.

Federal Communications Commission. Marlene H. Dortch, [FR Doc. 2017-10436 Filed 5-22-17; 8:45 am] BILLING CODE 6712-01-P FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10244—Granite Community Bank, NA., Granite Bay, California

Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Granite Community Bank, NA., Granite Bay, California (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Granite Community Bank, NA. on May 28, 2010. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.

No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

On February 9, 2017, (82 FR 10004), the FDIC requested comment for 60 days on a proposal to renew the information collections described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these collections, and again invites comment on this renewal.

Proposal to renew the following currently approved collections of information:

1. Title: Interagency Notice of Change in Control.

OMB Number: 3064-0019.

Form Number: FDIC 6822/01.

Affected Public: Insured state nonmember banks and state savings associations.

Burden Estimate:

General Description of Collection: The Interagency Notice of Change in Control is submitted by any person proposing to acquire ownership control of an insured state nonmember bank. The information is used by the FDIC to determine whether the competence, experience, or integrity of any acquiring person indicates it would not be in the interest of the depositors of the bank, or in the public interest, to permit such persons to control the bank.

There is no change in the method or substance of the collection. The overall burden remains the same. In particular, the number of respondents and the hours per response remain the same.

2. Title: Foreign Banking and Investment by Insured State Nonmember Banks.

OMB Number: 3064-0061.

Form Number: Summary of Deposits.

Affected Public: All FDIC-insured institutions, including insured U.S. branches of foreign banks.

Burden Estimate:

General Description of Collection: The Summary of Deposits (SOD) is the annual survey of branch office deposits as of June 30 for all FDIC-insured institutions, including insured U.S. branches of foreign banks. All FDIC‐insured institutions that operate a main office and one or more branch locations (including limited service drive‐thru locations) as of June 30 each year are required to file the SOD Survey. Insured branches of foreign banks are also required to file. All data collected on the SOD submission are available to the public. The survey data provides a basis for measuring the competitive impact of bank mergers and has additional use in research on banking.

There is no change in the method or substance of the collection. The overall reduction in burden hours is a result of economic fluctuation. In particular, the number of respondents has decreased while the hours per response remain the same.

3. Title: Procedures for Monitoring Bank Secrecy Act Compliance.

OMB Number: 3064-0087.

Form Number: None.

Affected Public: Insured State Nonmember Banks and Savings Associations.

Burden Estimate:

General Description of Collection: Respondents must establish and maintain procedures designed to monitor and ensure their compliance with the requirements of the Bank Secrecy Act and the implementing regulations promulgated by the Department of Treasury at 31 CFR part 103. Respondents must also provide training for appropriate personnel.

There is no change in the method or substance of the collection. The overall reduction in burden hours is a result of economic fluctuation. In particular, the number of respondents has decreased while the hours per response remain the same.

4. Title: Forms Relating to Processing Deposit Insurance Claims.

OMB Number: 3064-0143.

Form Number: 7200/04—Declaration for Government Deposit; 7200/05—Declaration for Revocable Trust; 7200/06—Declaration of Independent Activity; 7200/07—Declaration of Independent Activity for Unincorporated Association; 7200/08—Declaration for Joint Ownership Deposit; 7200/09—Declaration for Testamentary Deposit; 7200/10—Declaration for Defined Contribution Plan; 7200/11—Declaration for IRA/KEOGH Deposit; 7200/12—Declaration for Defined Benefit Plan; 7200/13—Declaration of Custodian Deposit; 7200/14—Declaration or Health and Welfare Plan; 7200/15—Declaration for Plan and Trust; 7200/18—Declaration for Irrevocable Trust; 7200/24—Claimant Verification; 7200/26—Depositor Interview Form.

Affected Public: Any person who has a deposit account relationship with an insured depository institution that has failed and from whom more information is needed to complete the deposit insurance determination.

Burden Estimate:

General Description of Collection: The collection involves forms used by the FDIC to obtain information from depositors and deposit brokers necessary to supplement the records of failed insured depository institutions to make determinations regarding deposit insurance coverage. The information provided enables the FDIC to identify the actual owners of an account, each owner's interest in the account, and the right and capacity in which the deposit is insured.

There is no change in the method or substance of the collection. The overall reduction in burden hours is a result of economic fluctuation. In particular, the number of respondents has decreased while the hours per response remain the same.

Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collections, 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 collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

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.

Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers, and distributors (sponsors) who advertise prescription human and animal drugs, including biological products for humans, disclose in advertisements certain information about the advertised product's uses and risks. For prescription drugs and biologics, section 502(n) of the FD&C Act requires advertisements to contain “* * * a true statement * * *” of certain information including “* * * information in brief summary relating to side effects, contraindications, and effectiveness * * *” as required by regulations issued by FDA. FDA's prescription drug advertising regulations at § 202.1 (21 CFR 202.1) describe requirements and standards for print and broadcast advertisements. Section 202.1 applies to advertisements published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems. Print advertisements must include a brief summary of each of the risk concepts from the product's approved package labeling (§ 202.1(e)(1)). Advertisements that are broadcast through media such as television, radio, or telephone communications systems must disclose the major risks from the product's package labeling in either the audio or audio and visual parts of the presentation (§ 202.1(e)(1)); this disclosure is known as the “major statement.” If a broadcast advertisement omits the major statement, or if the major statement minimizes the risks associated with the use of the drug, the advertisement could render the drug misbranded in violation of section 502(n) of the FD&C Act, section 201(n) of the FD&C Act (21 U.S.C. 321(n)), and FDA's implementing regulations at § 202.1(e).

Advertisements subject to the requirements at § 202.1 are subject to the PRA because these advertisements disclose information to the public. In addition, § 202.1(e)(6) and (j) include provisions that are subject to OMB approval under the PRA.

Section 202.1(e)(6) permits a person who would be adversely affected by the enforcement of a provision of § 202.1(e)(6) to request a waiver from FDA for that provision. The waiver request must set forth clearly and concisely the petitioner's interest in the advertisement, the specific provision of § 202.1(e)(6) from which a waiver is sought, a complete copy of the advertisement, and a showing that the advertisement is not false, lacking in fair balance, misleading, or otherwise violative of section 502(n) of the FD&C Act.

Section 202.1(j), which sets forth requirements for the dissemination of advertisements subject to the standards in § 202.1(e), contains the following information collection that is subject to the PRA:

Under § 202.1(j)(1), a sponsor must submit advertisements to FDA for prior approval before dissemination if: (1) The sponsor or FDA has received information that has not been widely publicized in medical literature that the use of the drug may cause fatalities or serious damage; (2) FDA has notified the sponsor that the information must be part of the advertisements for the drug; and (3) the sponsor has failed to present to FDA a program for assuring that such information will be publicized promptly and adequately to the medical profession in subsequent advertisements, or if such a program has been presented to FDA but is not being followed by the sponsor.

Under § 202.1(j)(1)(iii), a sponsor must provide to FDA a program for assuring that significant new adverse information about the drug that becomes known (i.e., use of drug may cause fatalities or serious damage) will be publicized promptly and adequately to the medical profession in any subsequent advertisements.

Under § 202.1(j)(4), a sponsor may voluntarily submit advertisements to FDA for comment prior to publication.

Under § 202.1, advertisements for human and animal prescription drug and biological products must comply with the standards described in that section.

Under § 202.1(j)(1), if information that the use of a prescription drug may cause fatalities or serious damage has not been widely publicized in the medical literature, a sponsor must include such information in the advertisements for that drug.

We estimate the burden of this collection of information as follows:

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.

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the Fair Packaging and Labeling Act (the FPLA) require that cosmetic manufacturers, packers, and distributors disclose information about themselves or their products on the labels or labeling of their products. Sections 201, 301, 502, 601, 602, 603, 701, and 704 of the FD&C Act (21 U.S.C. 321, 352, 361, 362, 363, 371, and 374) and sections 4 and 5 of the FPLA (15 U.S.C. 1453 and 1454) provide authority to FDA to regulate the labeling of cosmetic products. Failure to comply with the requirements for cosmetic labeling may render a cosmetic adulterated under section 601 of the FD&C Act or misbranded under section 602 of the FD&C Act.

FDA's cosmetic labeling regulations are published in part 701 (21 CFR part 701). Four of the cosmetic labeling regulations have information collection provisions. Section 701.3 requires the label of a cosmetic product to bear a declaration of the ingredients in descending order of predominance. Section 701.11 requires the principal display panel of a cosmetic product to bear a statement of the identity of the product. Section 701.12 requires the label of a cosmetic product to specify the name and place of business of the manufacturer, packer, or distributor. Section 701.13 requires the label of a cosmetic product to declare the net quantity of contents of the product.

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

The hour burden is the additional or incremental time that establishments need to design and print labeling that includes the following required elements: A declaration of ingredients in decreasing order of predominance, a statement of the identity of the product, a specification of the name and place of business of the establishment, and a declaration of the net quantity of contents. These requirements increase the time establishments need to design labels because they increase the number of label elements that establishments must take into account when designing labels. These requirements do not generate any recurring burden per label because establishments must already print and affix labels to cosmetic products as part of normal business practices.

The estimated annual third party disclosure is based on data available to the Agency, our knowledge of and experience with cosmetic labeling, and our communications with industry. We estimate there are 1,518 cosmetic product establishments in the United States. We calculate label design costs based on stock keeping units (SKUs) because each SKU has a unique product label. Based on data available to the Agency and on communications with industry, we estimate that cosmetic establishments will offer 94,800 SKUs for retail sale in 2017. This corresponds to an average of 62 SKUs per establishment.

One of the four provisions that we discuss in this information collection, § 701.3, applies only to cosmetic products offered for retail sale. However, the other three provisions, §§ 701.11, 701.12, and 701.13, apply to all cosmetic products, including non-retail professional-use-only products. We estimate that including professional-use-only cosmetic products increases the total number of SKUs by 15 percent to 109,020. This corresponds to an average of 72 SKUs per establishment.

Finally, based on the Agency's experience with other products, we estimate that cosmetic establishments may redesign up to one-third of SKUs per year. Therefore, we estimate that the number of disclosures per respondent will be 21 (31,878 SKUs) for § 701.3 and 24 each (36,432 SKUs) for §§ 701.11, 701.12, and 701.13.

We estimate that each of the required label elements may add approximately 1 hour to the label design process. We base this estimate on the hour burdens the Agency has previously estimated for food, drug, and medical device labeling and on the Agency's knowledge of cosmetic labeling. Therefore, we estimate that the total hour burden on members of the public for this information collection is 141,174 hours per year.

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.

The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use issued, on November 15, 2012, the ICH harmonized tripartite guideline entitled “Periodic Benefit-Risk Evaluation Report (PBRER) E2C(R2)” (the PBRER guideline) (available at http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html). The PBRER guideline is intended to promote a consistent approach to periodic post-marketing safety reporting among the ICH regions and to enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities. The PBRER is intended to provide a common standard for periodic reporting on approved drugs or biologics among the ICH regions.

FDA currently has OMB approval for the required submission of periodic adverse drug experience reports (PADER) for drugs subject to a new drug application (NDA) or an abbreviated new drug application (ANDA) (§  314.80(c)(2) (21 CFR 314.80(c)(2)) (OMB control number 0910-0230), and for the required submission of periodic adverse experience reports (PAER) for drugs subject to a biologics license application (BLA) (§  600.80(c)(2) (21 CFR 600.80(c)(2)) (OMB control number 0910-0308).

There is considerable overlap in the information required under §§  314.80(c)(2) and 600.80(c)(2) and the information requested in a periodic safety report using the ICH E2C(R2) PBRER format. Applicants subject to periodic safety reporting requirements under FDA regulations could choose to continue to submit the reports as specified in those regulations, and would be permitted to submit reports in the PBRER format and submit reports as specified in FDA regulations with an approved waiver. Companies who submit periodic reports on the same drug to multiple regulators, including not only the United States, but, also the European Union, Japan, and regulators in other countries who have elected to adopt the ICH standards, may find it in their interest to prepare a single PBRER, rather than preparing multiple types of reports for multiple regulators. As a result, FDA, in the Federal Register of November 29, 2016 (81 FR 85976), announced the availability of the guidance for industry entitled “Providing Post-marketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)” to indicate its willingness to accept post-market periodic safety reports using the ICH PBRER format in lieu of the specific reports described in FDA regulations.

Because FDA regulations in §§  314.80(c)(2) and 600.80(c)(2) include specific requirements for periodic safety reports, in order for an applicant to submit an alternative report, such as the PBRER, for a given product, FDA must grant a waiver. Existing regulations permit applicants to request waivers of any post-marketing safety reporting requirement, and the information collections associated with such waiver requests generally are approved under existing control numbers. (See §  314.90(a), waivers for drugs subject to NDAs and ANDAs, approved under OMB control number 0910-0001, and §  600.90(a), waivers for products subject to BLAs, approved under OMB control number 0910-0308.) The November 29, 2016, guidance both explains conditions under which applicants that have previously received waivers to submit reporting information in the format of the previous ICH guidance would be permitted to apply those existing waivers to the submission of PBRERs, and also advises how applicants that have not previously obtained a waiver may submit waiver requests to submit the PBRER.

There are information collections proposed in the November 29, 2016, guidance that are related to waivers specifically to enable the submission of PBRERs, and these information collections are not already addressed under the approved control numbers covering waiver submissions and periodic safety reports generally. FDA has previously granted waiver requests, submitted under §§  314.90(a) and 600.90(a), that allow applicants to prepare and submit reports using the periodic safety update report (PSUR) format described in FDA's 1996 and 2004 ICH E2C guidance. In accordance with the recommendations of the November 29, 2016, guidance, if an applicant already has a PSUR waiver in place for a given approved application, FDA will consider the existing PSUR waiver to allow the applicant to submit a PBRER instead of a PSUR because the PBRER replaces the PSUR for post-marketing periodic safety reporting for that application. The applicant would not need to submit a new waiver request unless the applicant wishes to change the frequency of reporting. FDA will consider requests to be waived of the quarterly reporting requirement but will not waive applicants of the annual reporting requirement.

If an applicant submits a PBRER in place of the PSUR and uses a different data lock point, the applicant should submit overlapping reports or submit a one-time PADER/PAER in order to cover the gap in reporting intervals. The applicant should submit notification to the application(s), indicating the change in data lock point and should include a description of the measures taken to ensure that there are no resulting gaps in reporting.

If an applicant submits a PBRER in place of the PSUR and uses a different reporting frequency for the PBRER than was used for the PSUR, the continued validity of the waiver will be conditioned on the submission of a PADER/PAER as needed to fulfill the reporting frequency requirement under FDA regulations. The applicant should submit a notification to the application(s), describing this change and the measures taken to ensure that the periodicity requirements are being met.

FDA expects approximately 187 waiver requests and notifications to include the additional information described previously in this document for using a different data lock point and/or for using a different reporting frequency when submitting a PBRER. FDA expects approximately 55 applicants to make these submissions, and we estimate that the time for submitting the additional information described previously would be on average approximately 1 hour for each waiver request or notification.

If an applicant does not have a PSUR waiver in place for an approved application, the applicant may submit a waiver request under §  314.90(a) or §  600.90(a) to submit a PBRER instead of the PADER/PAER. The applicant should submit a request to FDA for each approved application for which a waiver is requested, and a single waiver request letter can include multiple applications. Waiver requests should be submitted to each of the application(s) in the request, and may be submitted electronically or by mail as described in the November 29, 2016, guidance. Each PBRER waiver request should include the following information:

• The product name(s) and application number(s);

• a brief description of the justification for the request;

• the U.S. approval date for the product(s) and current reporting interval used;

• the reporting interval of the last PADER/PAER submitted for the product(s); and

• the data lock point that will be used for each PBRER. If a data lock point other than one aligned to the U.S. approval date is proposed, the applicant should describe how he/she will ensure that there are no gaps in reporting intervals (e.g., by submitting overlapping reports; submitting a one-time PADER/PAER to cover the gap period; or, if the gap is less than 2 months, extending the reporting interval of the final PADER/PAER to close the gap).

• The frequency for submitting the PBRER, as described in section IV.C of the April 8, 2013, draft guidance.

• The email address and telephone number for the individual who can provide additional information regarding the waiver request.

As explained earlier, existing regulations at § 314.90(a) or 600.90(a) permit applicants to request waivers of any post-marketing safety reporting requirement, and the information collections associated with such waiver requests generally are approved under OMB control numbers 0910-0001 and 0910-0308. FDA believes that the information submitted under numbers 1-4 and number 7 in the list in the previous paragraph is information that is typical of any waiver request regarding post-marketing safety reporting and is accounted for in the existing approved collections of information for waiver requests and reports. Concerning numbers 5 and 6, FDA expects approximately 67 waiver requests to include the additional information for using a different data lock point and/or for using a different reporting frequency when submitting a PBRER. FDA expects approximately 29 applicants to make these submissions, and we estimate that the time for submitting the additional information described in the previous paragraph would be on average approximately 2 hours for each waiver request.

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

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.

The guidance provides recommendations for applicants planning to request waivers or reductions in prescription drug user fees assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g and 21 U.S.C. 379h) (the FD&C Act). The guidance describes the types of waivers and reductions permitted under the prescription drug user fee provisions of the FD&C Act, and the procedures for submitting requests for waivers or reductions. It also includes recommendations for submitting information for requests for reconsideration of denials of waiver or reduction requests, and for requests for appeals. The guidance also provides clarification on related issues such as user fee exemptions for orphan drugs.

Based on Agency records, we estimate that the total annual number of waiver requests submitted for all of these categories will be 150, submitted by 115 different applicants. We estimate that the average burden hours for preparation of a submission will total 16 hours. Because FDA may request additional information from the applicant during the review period, we have also included in this estimate time to prepare any additional information. We have included in the burden estimate the preparation and submission of application fee waivers for small businesses, because small businesses requesting a waiver must submit documentation to FDA on the number of their employees and must include the information that the application is the first human drug application, within the meaning of the FD&C Act, to be submitted to the Agency for approval.

Previously, after receipt of a small business waiver request, FDA would request a small business size determination from the Small Business Administration (SBA). Waiver applicants would submit their supporting documentation directly to SBA for evaluation and after completing their review, SBA provided FDA with a determination whether a waiver applicant qualified as a small business for purposes of evaluating user fee waivers. The burden for submission of this information to SBA is approved under OMB control number 3245-0101. Beginning fiscal year 2015, the SBA declined to conduct further size determinations for evaluation of small business user fee waivers and as a result, a processing change at FDA occurred. The new FDA process requires waiver applicants to submit documentation directly to FDA. In addition, fewer supporting documents than previously requested by SBA are required. As a result, we estimate that the 4 burden hours per small business waiver previously attributed to SBA and approved under OMB control number 3245-0101, should now be attributed to FDA because SBA is no longer conducting size determinations for FDA. Also, because FDA is asking that applicants submit fewer supporting documents, we estimate that these burden hours should be reduced to 2 hours instead of 4 hours. We understand that SBA plans to submit a revised burden estimate to OMB control number 3245-0101 to account for this redistribution.

The reconsideration and appeal requests are not addressed in the FD&C Act, but are discussed in the guidance. We estimate that we will receive seven requests for reconsideration annually, and that the total average burden hours for a reconsideration request will be 24 hours. In addition, we estimate that we will receive one request annually for an appeal of a user fee waiver determination, and that the time needed to prepare an appeal would be approximately 12 hours We have included in this estimate both the time needed to prepare the request for appeal to the Chief Scientist, User Fee Appeals Officer, Office of the Commissioner, and the time needed to create and send a copy of the request for an appeal to the Director, Division of User Fee Management, Office of Management at the Center for Drug Evaluation and Research.

The burden for completing and submitting Form FDA 3397 (Prescription Drug User Fee Coversheet) is not included in this analysis as the burden is included under OMB control number 0910-0297. The collection of information associated with submission of a new drug application or biologics license application are approved under OMB control numbers 0910-0001 and 0910-0338, respectively.