Federal Register Vol. 82, No.202,

The Lacey Act (16 U.S.C. 3371 et seq.), first enacted in 1900 and significantly amended in 1981, is the United States' oldest wildlife protection statute. The Act combats trafficking in illegally taken wildlife, fish, and plants. The Food, Conservation, and Energy Act of 2008, effective May 22, 2008, amended the Lacey Act by expanding its protections to a broader range of plants and plant products (Section 8204, Prevention of Illegal Logging Practices). As amended, the Lacey Act now makes it unlawful to, among other things, import, export, transport, sell, receive, acquire, or purchase in interstate or foreign commerce any plant, with some limited exceptions, taken, possessed, transported, or sold in violation of any Federal, State, tribal, or foreign law that protects plants or that regulates the theft of plants; the taking of plants from a park, forest reserve, or other officially protected area; the taking of plants from an officially designated area; or the taking of plants without, or contrary to, required authorization.

In addition, Section 3 of the Lacey Act, as amended, makes it unlawful, beginning December 15, 2008, to import plants and plant products without an import declaration. The declaration must contain, among other things, the scientific name of the plant, value of the importation, quantity of the plant, and the name of the country in which the plant was harvested. Currently, enforcement of the declaration requirement is being phased in, as described in five notices published in the Federal Register.1

Commenters on these notices asked that we consider establishing a program through which importers could submit periodic blanket declarations instead of submitting declarations with each shipment. The commenters noted that such declarations would reduce the paperwork burden on affected entities, reduce costs, and could, in addition, improve the quality and usefulness of the information collected. Some commenters provided detailed descriptions of possible blanket declaration programs.

In response to these comments, the Animal and Plant Health Inspection Service (APHIS) began a pilot blanket declaration program on May 1, 2009 for participants in U.S. Customs and Border Protection's (CBP's) expedited border release programs, Automated Line Release (ALR) or Border Release Advance Screening and Selectivity (BRASS) in CBP's Automated Commercial System (ACS). This pilot program tested the feasibility of collecting the required information through the use of a monthly “blanket” declaration, with subsequent reconciliation reports. Blanket declarations could be used to declare routine and/or repeat shipments. The pilot program for the Lacey Act blanket declaration was open only to those entities participating in ALR or BRASS. Eligible importers who wished to participate in the pilot were required to send a letter to APHIS specifically requesting participation in the program. Eighty-two individual companies registered a total of 119 participants with the pilot program. We note that by January 2017, only eight companies were still participating in the program.

Executive Order 13659 required CBP to create a “single window” for trade to file entries through its Automated Commercial Environment (ACE). As a result, the ACS was discontinued and entries are no longer filed in that system.

Due to the development of the ACE system, and a diminishing number of participants, APHIS has decided to end the pilot program on April 18, 2018. CBP's BRASS program will continue to operate as it did prior to the creation of the pilot program, and participants in the blanket declaration pilot program will not lose their line release status in the expedited border release programs. When the program ends, importers whose products are subject to the Lacey Act declaration requirement and clear under the BRASS program are advised to file the required declaration information along with their CBP entry summary documentation.

APHIS will continue to provide the latest information regarding the Lacey Act on our Web site, http://www.aphis.usda.gov/plant_health/lacey_act/. The Web site currently contains the full text of the Lacey Act, as amended; a slideshow covering background and context, requirements, commodities and products covered, information on prohibitions, the current status of implementation of the declaration requirement of the Lacey Act, and frequently asked questions. The Web site will be updated as new materials become available. We encourage persons interested in receiving timely updates on APHIS' Lacey Act efforts to register for our stakeholder registry at https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new/ and select “Lacey Act Declaration” as a topic of interest.

Certain 2017 hurricanes caused widespread destruction in Puerto Rico, including to dairy operations. Dairy operations in Puerto Rico suffered intense damage in late September, 2017. Puerto Rico and its residents continue to suffer severe hardships related to the availability of electricity, fuel, and water, among other things. As a result of the 2017 hurricanes, dairy operations in Puerto Rico face the possibility of financial and other, actual losses to their dairy operation due to amount of and availability of feed for their animals and lack of electricity to run their dairy operations until recovery operations are able to stabilize conditions on Puerto Rico. There are an estimated 94,000 dairy cows, heifers, and other livestock, such as bulls necessary for a dairy operation as part of Puerto Rico's 277 dairy operations. Dairy feed and fuel are both available on Puerto Rico; however, there are various challenges to dairy operations, including actual feed surcharges and the potential for additional surcharges, increasing the cost of feed to the dairy operations, and the recent preference of vendors subsequent to the hurricanes to be paid only in cash or certified check instead of their usual policy, prior to the hurricanes, to allow dairy operations to pay for feed with credit.

The Commodity Credit Corporation Charter (CCC) Act (15 U.S.C. 714c(b)) includes authority for CCC to use its general powers to make available materials and facilities required in connection with the production and marketing of agricultural commodities (other than tobacco). The procurement of feed and fuel for the dairy sector in Puerto Rico is required in connection with the production and marketing of dairy in Puerto Rico.

DAP-PR is being implemented as a NOFA, as opposed to a regulation, because it is one-time assistance to help Puerto Rico dairy operations purchase feed in connection with the production and marketing of dairy. FSA has designed DAP-PR as a simplified, stream-lined method to provide assistance as quickly as possible to dairy operations in Puerto Rico given the extent of the disaster and the resulting need for feed assistance.

FSA will administer DAP-PR on behalf of the Commodity Credit Corporation (CCC), using CCC funds.

DAP-PR is anticipated to provide an estimated $12 million to provide vouchers to dairy operations in Puerto Rico for acquiring feed from feed dealers in Puerto Rico. Each licensed dairy operation can apply to receive a voucher to acquire one-month supply of feed for 100 percent of the feed cost, as calculated by FSA. The value of the voucher does not guarantee a given quantity of feed. The feed may last less or more than 30 days, depending upon the feeding requirements of each dairy operation and how much feed is acquired.

FSA will prepare one voucher for the value of the required feed needs for each eligible dairy operation on Puerto Rico, as determined by FSA. The operation may elect to use the whole value of the voucher at one time, or may elect to use a portion of the voucher, up to 4 times, not to exceed the value of the voucher. The value of the voucher expires 45 days from the date approved by FSA. If any value remains on the voucher after it expires, that value may not be used by the dairy operation.

FSA, on behalf of CCC, through the vouchers themselves, will enter into agreements with Puerto Rican feed dealers to accept the vouchers from dairy operations. FSA will reimburse the dealers for the feed acquired via the vouchers. The voucher can only be used to acquire feed from the vendors and for no other purpose, including paying down any existing debt owed by a dairy operation or individual or producer affiliated with that dairy operation to a vendor.

Each dairy operation in Puerto Rico is licensed by the Department of Agriculture of Puerto Rico; as a result, FSA has received certain information from the Puerto Rican Department of Agriculture about each dairy, including, the name, address, contact information, and number of head of cattle. The information was compiled as of August 2017. An application, on a form determined by FSA, will include the number of dairy head as reported to FSA by the Puerto Rican Department of Agriculture, and should only reflect the number of live, eligible dairy cows at the time of application. If the number of cattle on the application is correct, the dairy operation will certify as such on the application. If the number of head has changed due to animal deaths or sales, the dairy operation must correct the number and certify to the change on the application. The dairy operation may apply for the Livestock Indemnity Program (LIP) If any cattle have died due to a LIP eligible cause of loss and all other LIP eligibility conditions and LIP payment limitations are met. The application period begins October 20, 2017. DAP-PR applications must be received by FSA by December 1, 2017.

The result of an approved feed application will be a one-time maximum eligible amount for feed to be acquired by the eligible dairy operation, consistent with the terms specified in this NOFA. The acquisition of the total amount of feed determined under the DAP-PR for the 30 days can be spread among up to 4 feed acquisitions under the one voucher. As the dairy operation acquires feed from the vendor(s), FSA employees will deduct the value of the feed acquired, not to exceed the calculated eligible maximum. The vouchers can only be used to acquire feedstuff for the cattle on that dairy operation to consume, acquired from the feed vendor(s) and cannot be used for any other purpose. All applications are subject to the approval by FSA on behalf of CCC; FSA will not approve ineligible applications.

The maximum value of the voucher will be determined based on (1) $101 per adult cow, bull, and heifers over 2 years old times the number of head in each of those categories in the dairy operation and (2) $34 per heifers under 2 years old and young bulls and calves times the number of head in each of those categories in the dairy operation. The total will be the value of the voucher for the dairy operation.

If funds remain available under the DAP-PR, and if the Secretary of Agriculture determines that additional assistance can be provided, the acquisition of feed supply for days greater than a one-month supply may be made available under DAP-PR. In addition, at the sole discretion of the Secretary of Agriculture, DAP-PR may be made available for the purchase of fuel for generators.

In the event that any application for a DAP-PR voucher resulted from erroneous information or a miscalculation, the amount will be recalculated and the participant must refund any excess to FSA with interest to be calculated from the date of the disbursement to the participant. If for whatever reason FSA determines that the applicant misrepresented either the number of cows, or if the DAP-PR voucher would exceed the participant's voucher based upon the correct number of cows, the application will be disapproved and the full DAP-PR voucher for that dairy and participant will be required to be refunded to FSA with interest from date of disbursement.

The liability of anyone for any penalty or sanction resulting from a DAP-PR application, or for any refund to FSA or related charge is in addition to any other liability of such person under any civil or criminal fraud statute or any other provision of law including, but not limited to: 18 U.S.C. 286, 287, 371, 641, 651, 1001, and 1014; 15 U.S.C. 714; and 31 U.S.C. 3729.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), OMB approved an emergency information collection request on DAP-PR so FSA can begin the application period upon publication of this NOFA.

Because this is a one-time provision of commodities and the impacts of DAP-PR occur outside of any impacts resulting from the existing dairy operations (consistent with 7 CFR 799.31(b)(6)(iii)), there are no measureable individual or cumulative impacts to the human environment, as defined by the National Environmental Policy Act and, as such, no Environmental Assessment nor Environmental Impact Statement will be prepared. Consistent with the emergency nature of this action, this NOFA serves as documentation of the programmatic environmental compliance for this federal action.

I. Abstract

The U.S. Census Bureau plans to request an extension of the current Office of Management and Budget (OMB) clearance of the Manufacturers' Shipments, Inventories and Orders (M3) survey. The M3 survey requests data monthly from domestic manufacturers on form M-3 (SD). Data requested are shipments, new orders, unfilled orders, total inventory, materials and supplies, work-in-process, and finished goods.

The M3 survey is designed to measure current industrial activity and to provide an indication of future production commitments. The value of shipments measures the value of goods delivered during the month by domestic manufacturers. Estimates of new orders serve as an indicator of future production commitments and represent the current sales value of new orders received during the month, net of cancellations. Substantial accumulation or depletion of unfilled orders measures excess or deficient demand for manufactured products. The level of inventories, especially in relation to shipments, is frequently used to monitor the business cycle, by calculating the inventories to sales ratio. In general, a low ratio indicates strong shipments. A high ratio indicates weaker shipments or accumulation of inventories in stock.

We do not plan any changes to the M-3 (SD) form.

Respondents may submit data on form M-3 (SD) via mail, or via the Internet. We send emails and make telephone calls to respondents to remind them to report on time.

OMB Control Number: 0607-0008.

Form Number(s): M-3 (SD).

Type of Review: Regular submission.

Affected Public: Businesses, large and small, or other for profit.

Estimated Number of Respondents: 5,000.

Estimated Time per Response: 20 minutes.

Estimated Total Annual Burden Hours: 20,000.

Estimated Total Annual Cost to Public: $0.

Respondent's Obligation: Voluntary.

Legal Authority: Title 13 U.S.C. Sections 131, 182, and 193.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

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

In accordance with 5 U.S.C. 4314(c)(4), the Department of Commerce (DOC), announces the appointment of those individuals who have been selected to serve as members of the Departmental Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) members and (2) making recommendations to the appointing authority on other performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards. The appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.

The name, position title, and type of appointment of each member of the Performance Review Board are set forth below:

In accordance with 5 U.S.C. 4314(c)(4), the Office of the Secretary, Department of Commerce (DOC), announces the appointment of those individuals who have been selected to serve as members of the Office of the Secretary Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) and (SL) members and (2) making recommendations to the appointing authority on other performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards. The appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.

Dates: The name, position title, and type of appointment of each member of the Performance Review Board are set forth below:

In accordance with 5 U.S.C. 4314(c)(4), the EDA, NTIA and BIS, Department of Commerce (DOC), announce the appointment of those individuals who have been selected to serve as members of EDA, NTIA and BIS's Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) and Senior Level (SL) members and (2) making recommendations to the appointing authority on other Performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards for SES and SL members. The Appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.

Dates: The name, position title, and type of appointment of each member of the Performance Review Board are set forth below:

On April 3, 2017, the Department published in the Federal Register a notice of “Opportunity to Request Administrative Review” of the antidumping duty order on non-malleable cast iron pipe fittings from the PRC for the above POR.1 On May 1, 2017, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b), the Department received timely requests from Tianjin Port Free Trade Zone Star Pipe International Trade Co., Ltd. (Tianjin Star) and Dalian Reliable Industrial Co., Ltd. (Dalian Reliable) to conduct an administrative review.2

Pursuant to these requests and in accordance with 19 CFR 351.221(c)(1)(i), on June 7, 2017, the Department published a notice of initiation of an administrative review of the antidumping duty order on non-malleable cast iron pipe fittings from the PRC.3 This administrative review covers Tianjin Star and Dalian Reliable during the period April 1, 2016, through March 31, 2017. On July 6, 2017, Tianjin Star and Dalian Reliable withdrew their requests for an administrative review.4

Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review if the party that requested the review withdraws its request within 90 days of the publication date of the notice of initiation of the requested review. Tianjin Star and Dalian Reliable withdrew their requests before the 90-day deadline, and no other party requested an administrative review of the antidumping duty order. Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding this administrative review in its entirety.

The Department will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of non-malleable cast iron pipe fittings from the PRC. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions to CBP 15 days after the date of publication of this notice in the Federal Register.

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

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

This notice is published in accordance with section 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).

In accordance with 5 U.S.C. 4314(c)(4), the International Trade Administration (ITA), Department of Commerce (DOC), announces the appointment of those individuals who have been selected to serve as members of the ITA Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) members and (2) making recommendations to the appointing authority on other Performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards for SES. The Appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.

Dates: The name, position title, and type of appointment of each member of the Performance Review Board are set forth below:

On May 1, 2017, the Department published in the Federal Register a notice of “Opportunity to Request Administrative Review” of the antidumping duty order on polyethylene terephthalate resin from Canada for the above POR.1 On May 31, 2017, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b), the Department received a timely request from Compagnie Selenis Canada (Selenis) to conduct an administrative review.2

Pursuant to this request and in accordance with 19 CFR 351.221(c)(1)(i), on July 6, 2017, the Department published a notice of initiation of an administrative review of the antidumping duty order on polyethylene terephthalate resin from Canada.3 This administrative review covers Selenis during the period October 15, 2015, through April 30, 2017. On August 24, 2017, Selenis withdrew its request for an administrative review.4

Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review if the party that requested the review withdraws its request within 90 days of the publication date of the notice of initiation of the requested review. Selenis withdrew its review request before the 90-day deadline, and no other party requested an administrative review of the antidumping duty order. Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding this administrative review in its entirety.

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

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

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

This notice is published in accordance with section 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).

The Department's regulations provide that the Secretary will publish in the Federal Register a list of scope rulings on a quarterly basis.1 Our most recent notification of scope rulings was published on June 2, 2017.2 This current notice covers all scope rulings and anticircumvention determinations made by Enforcement and Compliance between July 1, 2016, and September 30, 2016, inclusive. Subsequent lists will follow after the close of each calendar quarter.

Interested parties are invited to comment on the completeness of this list of completed scope inquiries. Any comments should be submitted to the Deputy Assistant Secretary for AD/CVD Operations, Enforcement and Compliance, International Trade Administration, 1401 Constitution Avenue NW., APO/Dockets Unit, Room 18022, Washington, DC 20230.

This notice is published in accordance with 19 CFR 351.225(o).

Background

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (Secretary) 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 geographic region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, 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.

The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

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).

The National Defense Authorization Act for Fiscal Year 2004 (Pub. L. 108-136) removed the “small numbers” and “specified geographical region” limitations indicated above and amended the definition of “harassment” as it applies to a “military readiness activity” to read as follows (Section 3(18)(B) of the MMPA): (i) Any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild (Level A Harassment); or (ii) Any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, including, but not limited to, migration, surfacing, nursing, breeding, feeding, or sheltering, to a point where such behavioral patterns are abandoned or significantly altered (Level B Harassment).

On October 12, 2017, NMFS received an adequate and complete application from the Navy requesting authorization for take of marine mammals, by Level A and B harassment, incidental to training, testing, and routine military operations (all categorized as military readiness activities) from the use of sonar and other transducers, in-water detonations, airguns, and pile driving. In addition, the Navy is requesting authorization of three takes of large whales by serious injury or mortality resulting from vessel strikes. The requested regulations would be valid for five years, from 2018 through 2023.

This will be the third time NMFS has promulgated incidental take regulations pursuant to the MMPA relating to similar military readiness activities in HSTT, following those effective from January 5, 2009, through January 5, 2014, (74 FR 1456; January 12, 2009) and from December 24, 2013, through December 24, 2018 (78 FR 78106; December 24, 2013).

The HSTT Study Area includes areas in the north-central Pacific Ocean, from Southern California west to Hawaii and the International Date Line, and including the Hawaii and Southern California (SOCAL) Range Complexes, as well as the Silver Strand Training Complex and overlaps a portion of the Point Mugu Sea Range. The Hawaii Range Complex encompasses ocean areas around the Hawaiian Islands, extending from 16 degrees north latitude to 43 degrees north latitude and from 150 degrees west longitude to the International Date Line. The SOCAL Range Complex is located approximately between Dana Point and San Diego, California, and extends southwest into the Pacific Ocean and also includes a small portion of the Point Mugu Sea Range. The Silver Strand Training Complex is an integrated set of training areas located on and adjacent to the Silver Strand, a narrow, sandy isthmus separating the San Diego Bay from the Pacific Ocean. Please refer to Figure 1-1 of the application for a map of the HSTT Study Area, Figures 2-1 to 2-4 for the Hawaii Operating Area (where the majority of training and testing activities occur within the Hawaii Range Complex), Figures 2-5 to 2-7 for the SOCAL Range Complex, and Figure 2-8 for the Silver Strand Training Complex. The following types of training and testing, which are classified as military readiness activities pursuant to section 315(f) of Public Law 101-314 (16 U.S.C. 703), are included in the specified activity described in the Navy's application: amphibious warfare (in-water detonations), anti-submarine warfare (sonar and other transducers, in-water detonations), surface warfare (in-water detonations), mine warfare (sonar and other transducers, in-water detonations), and other (sonar and other transducers, pile driving, air guns).

The Navy's application includes proposed mitigation measures for marine mammals that would be implemented during training and testing activities in the HSTT Study Area. Proposed procedural mitigation measures generally include: (1) The use of one or more trained lookouts to diligently observe for specific biological resources within a mitigation zone, (2) requirements for lookouts to immediately communicate sightings of specific biological resources to the appropriate watch station for information dissemination, and (3) requirements for the watch station to implement mitigation (e.g., halt an activity) until certain recommencement conditions have been met. Mitigation measures are also proposed for specific mitigation areas and consist of a variety of measures in those areas including, but not limited to: Conducting a limited number of major training exercises per year, not planning or avoiding planning major training exercises, minimizing or not conducting active sonar, conducting a limited amount of hull-mounted mid-frequency active sonar per year, and not expending explosive or non-explosive ordnance.

The Navy also proposes to undertake monitoring and reporting efforts to track compliance with incidental take authorizations and to help investigate the effectiveness of implemented mitigation measures in the HSTT Study Area. This can include Adaptive Management, the Integrated Comprehensive Monitoring Program, the Strategic Planning Process, and Annual Monitoring and Exercise and Testing Reports. As an example, under the Integrated Comprehensive Monitoring Program, the monitoring relating to the effects of Navy training and testing activities on protected marine species are designed to increase the understanding of the likely occurrence of marine mammals in the vicinity of the action (i.e., presence, abundance, distribution, and density of species) and to increase the understanding of the nature, scope, or context of the likely exposure of marine mammals to any of the potential stressors associated with the action.

Interested persons may submit information, suggestions, and comments concerning the Navy's request (see ADDRESSES). NMFS will consider all information, suggestions, and comments related to the request during the development of proposed regulations governing the incidental taking of marine mammals by the Navy, if appropriate.

Seabirds congregate around trawlers to feed on offal putting them at risk of colliding with cables (trawl warps and data cables) that run aft of trawlers. Cable strikes are a known source of seabird mortality, particularly on at-sea factory trawlers (referred to as catcher/processors). Research projects observing seabird cable strikes have been conducted in the Alaska catcher/processor fleet targeting pollock in the Bering Sea and in the West Coast at-sea hake fishery. Data from both studies indicate that estimated mortalities for cable strikes are greater than observed mortalities collected as part of typical observer duties. To address this issue, NMFS will host a 1.5-day workshop on gear modification strategies for reducing seabird cable strike mortality in West Coast trawl (hake) fisheries. The goal is to develop mitigation strategies that reduce cable strikes and could be used by both West Coast hake and Alaska pollock trawlers. This collaborative workshop will bring together the at-sea processing industry, engineers, biologists and fisheries managers to develop innovative, practical gear-modifications for reducing seabird cable strike mortality.

This workshop will be physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Vanessa Tuttle, 206-860-3479, at least 10 working days prior to the meeting date.

All visitors to the NOAA Western Regional Center's facility should bring one of the following forms of identification:

Visitors who are foreign nationals (defined as a person who is not a citizen or national of the United States) will require additional security clearance to access the NMFS Northwest Fisheries Science Center. Foreign national visitors should contact Vanessa Tuttle, 206-860-3479, at least 10 working days prior to the meeting date to initiate the security clearance process.

This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

If the Committee approves the proposed addition, the entities of the Federal Government identified in this notice will be required to procure the service listed below from the nonprofit agency employing persons who are blind or have other severe disabilities.

The following service is proposed for addition to the Procurement List for production by the nonprofit agency listed:

The following product and service are proposed for deletion from the Procurement List:

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

Purpose of the Meeting: The Advisory Committee on Arlington National Cemetery is an independent Federal advisory committee chartered to provide the Secretary of the Army independent advice and recommendations on Arlington National Cemetery, including, but not limited to, cemetery administration, the erection of memorials at the cemetery, and master planning for the cemetery. The Secretary of the Army may act on the Committee's advice and recommendations.

Agenda: The Committee will receive an engineering update on the status of the Millennium Project and the Tomb of Remembrance; results of a survey to measure family satisfaction with ANC; a presentation interagency cooperation concerning cemetery standards and measures and Contracting Officer Representative training; and an update concerning the national dialogue and public survey in response to Public Law 114-158.

Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis. The Arlington National Cemetery conference room is readily accessible to and usable by persons with disabilities. For additional information about public access procedures, contact Mr. Timothy Keating, the subcommittee's Alternate Designated Federal Officer, at the email address or telephone number listed in the FOR FURTHER INFORMATION CONTACT section.

Written Comments and Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act, the public or interested organizations may submit written comments or statements to the Committee, in response to the stated agenda of the open meeting or in regard to the Committee's mission in general. Written comments or statements should be submitted to Mr. Timothy Keating, the Alternate Designated Federal Officer, via electronic mail, the preferred mode of submission, at the address listed in the FOR FURTHER INFORMATION CONTACT section. Each page of the comment or statement must include the author's name, title or affiliation, address, and daytime phone number. Written comments or statements being submitted in response to the agenda set forth in this notice must be received by the Designated Federal Officer at least seven business days prior to the meeting to be considered by the Committee. The Designated Federal Officer will review all timely submitted written comments or statements with the Committee Chairperson, and ensure the comments are provided to all members of the Committee before the meeting. Written comments or statements received after this date may not be provided to the Committee until its next meeting. Pursuant to 41 CFR 102-3.140d, the Committee is not obligated to allow a member of the public to speak or otherwise address the Committee during the meeting. Members of the public will be permitted to make verbal comments during the Committee meeting only at the time and in the manner described below. If a member of the public is interested in making a verbal comment at the open meeting, that individual must submit a request, with a brief statement of the subject matter to be addressed by the comment, at least three (3) business days in advance to the Committee's Designated Federal Official, via electronic mail, the preferred mode of submission, at the addresses listed in the FOR FURTHER INFORMATION CONTACT section. The Designated Federal Official will log each request, in the order received, and in consultation with the Committee Chair determine whether the subject matter of each comment is relevant to the Committee's mission and/or the topics to be addressed in this public meeting. A 15-minute period near the end of meeting may be available for public comments. Members of the public who have requested to make a comment and whose comments have been deemed relevant under the process described above, will be allotted no more than three (3) minutes during this period, and will be invited to speak in the order in which their requests were received by the Designated Federal Official.

These subcommittee meetings are being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Sunshine in the Government Act of 1976 (U.S.C. 552b, as amended) and 41 Code of the Federal Regulations (CFR 102-3.150).

Purpose of the Meetings: The Advisory Committee on Arlington National Cemetery is an independent Federal advisory committee chartered to provide the Secretary of the Army independent advice and recommendations on Arlington National Cemetery, including, but not limited to, cemetery administration, the erection of memorials at the cemetery, and master planning for the cemetery. The Secretary of the Army may act on the committee's advice and recommendations. The primary purpose of the Honor subcommittee is to accomplish an independent assessment of methods to address the long-term future of the Army national cemeteries, including how best to extend the active burials and what ANC should focus on once all available space is used.

The primary purpose of the Remember & Explore Subcommittee is to recommend methods to maintain the Tomb of the Unknown Soldier Monument, including the cracks in the large marble sarcophagus, the adjacent marble slabs, and the potential replacement marble stone for the sarcophagus already gifted to the Army; accomplish an independent assessment of requests to place commemorative monuments; and identify means to capture and convey ANC's history, including Section 60 gravesite mementos, and improve the quality of visitors' experiences now and for generations to come.

Agenda: The Honor subcommittee will receive an update concerning the national dialogue and public survey in response to Public Law 114-158; an update to the renovation plans for the ANC Administrative building; and a presentation regarding timelines involved with Full Military Honor Funerals at ANC. The Remember and Explore subcommittee will receive a presentation on how “Smart City” technology developments might be used to enhance the visitor experience at ANC; an update to the horticultural plan supporting the iconic image of ANC; and a briefing on the status of all commemorative monuments within and proposed for erection at the cemetery.

Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis. The ANC Welcome Center Conference room is readily accessible to and usable by persons with disabilities. For additional information about public access procedures, contact Mr. Timothy Keating, the Alternate Designated Federal Officer, at the email address or telephone number listed in the FOR FURTHER INFORMATION CONTACT section.

Written Comments and Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act, the public or interested organizations may submit written comments or statements to the subcommittee, in response to the stated agenda of the open meeting or in regard to the subcommittee's mission in general. Written comments or statements should be submitted to Mr. Timothy Keating, the subcommittee's Alternate Designated Federal Officer, via electronic mail, the preferred mode of submission, at the address listed in the FOR FURTHER INFORMATION CONTACT section. Each page of the comment or statement must include the author's name, title or affiliation, address, and daytime phone number. Written comments or statements being submitted in response to the agenda set forth in this notice must be received by the Designated Federal Officer at least seven business days prior to the meeting to be considered by the subcommittee. The Designated Federal Officer will review all timely submitted written comments or statements with the respective subcommittee Chairperson, and ensure the comments are provided to all members of the subcommittee before the meeting. Written comments or statements received after this date may not be provided to the subcommittee until its next meeting. Pursuant to 41 CFR 102-3.140d, the subcommittee is not obligated to allow the public to speak or otherwise address the subcommittee during the meeting. However, interested persons may submit a written statement or a request to speak for consideration by the subcommittee. After reviewing any written statements or requests submitted, the subcommittee Chairperson and the Designated Federal Officer may choose to invite certain submitters to present their comments verbally during the open portion of this meeting or at a future meeting. The Designated Federal Officer in consultation with the subcommittee Chairperson, may allot a specific amount of time for submitters to present their comments verbally.

DoD has concluded RDP MOUs with 27 “qualifying” countries at the level of the Secretary of Defense and his counterpart. The purpose of a RDP MOU is to promote rationalization, standardization, and interoperability of conventional defense equipment with allies and other friendly governments. These MOUs provide a framework for ongoing communication regarding market access and procurement matters that enhance effective defense cooperation.

RDP MOUs generally include language by which the Parties agree that their defense procurements will be conducted in accordance with certain implementing procedures. These procedures relate to—

• Publication of notices of proposed purchases;

• The content and availability of solicitations for proposed purchases;

• Notification to each unsuccessful offeror;

• Feedback, upon request, to unsuccessful offerors concerning the reasons they were not allowed to participate in a procurement or were not awarded a contract; and

• Provision for the hearing and review of complaints arising in connection with any phase of the procurement process to ensure that, to the extent possible, complaints are equitably and expeditiously resolved.

Based on the MOU, each country affords the other country certain benefits on a reciprocal basis consistent with national laws and regulations. The benefits that the United States accords to the products of qualifying countries include—

• Offers of qualifying country end products are evaluated without applying the price differentials otherwise required by the Buy American statute and the Balance of Payments Program;

• The chemical warfare protective clothing restrictions in 10 U.S.C. 2533a and the specialty metals restriction in 10 U.S.C. 2533b(a)(1) do not apply to products manufactured in a qualifying country; and

• Customs, taxes, and duties are waived for qualifying country end products and components of defense procurements.

Both countries have been listed as “qualifying countries” in the definition of “qualifying country” at Defense Federal Acquisition Regulation Supplement 225.003(10), and offers of products of the UK and Finland, or that contain components from these countries, would continue to be afforded the benefits available to all qualifying countries. This also means that U.S. products would be exempt from any analogous “Buy National” laws or policies applicable to procurements by the Ministry of Defence of each country.

While DoD is evaluating laws and regulations in this area, DoD would benefit from U.S. industry's experience in participating in public defense procurements issued by these countries. DoD is, therefore, asking U.S. firms that have participated or attempted to participate in procurements by or on behalf of the UK's Ministry of Defence or Finland's Ministry of Defence to let us know if the procurements were conducted with transparency, integrity, fairness, and due process in accordance with published procedures, and if not, the nature of the problems encountered.

DoD is also interested in comments relating to the degree of reciprocity that exists between the United States and the UK Finland when it comes to the openness of defense procurements to offers of products from either country.

This information collection request contains: (1) OMB No. 1910-1800; (2) Information Collection Request Title: Security; (3) Type of Review: renewal/revision; (4) Purpose: The collections are used by DOE to exercise management oversight and control over its contractors that provide goods and services for DOE organizations and activities in accordance with the terms of their contracts and the applicable statutory, regulatory, and mission support requirements of the Department. Information collected is for (1) Foreign Ownership, Control or Influence data from bidders on DOE contracts requiring personnel security clearances; and (2) individuals in the process of applying for a security clearance/access authorization or who already holds one. The collections are: DOE Form 5631.18, Security Acknowledgement; DOE F 5631.20, Request for Visitor Access Approval; DOE Form 5631.29, Security Termination Statement; DOE F 5631.34, Data Report on Spouse/Cohabitant; DOE Form 5631.5, The Conduct of Personnel Security Interviews; DOE Form 5639.3 Report of Security Incident/Infraction; DOE F 471.1, Security Incident Notification Report; DOE Form 472.3 Foreign Citizenship Acknowledgement; DOE Form 473.2, Security Badge Request; DOE Form 473.3, U.S. Department of Energy Clearance Access Request; Influence (e-FOCI) System as required by DOE Order 470.4B, Safeguards and Security Program, Section 2; and the Foreign Access Central Tracking System (FACTS); (5) Estimated Number of Respondents: 86,893; (6) Annual Estimated Number of Total Responses: 86,893; (7) Annual Estimated Number of Burden Hours: 11,296; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: 0.

Statutory Authority: Section 641 of the Department of Energy Organization Act, codified at 42 U.S.C. 7251, and the following additional authorities:

DOE F 5631.34, Data Report on Spouse/Cohabitant: Section 145(b) of the Atomic Energy Act of 1954, as amended, codified at 42 U.S.C. 2165; Executive Order 12968 (August 2, 1995); Executive Order 10865 (February 20, 1960); Executive Order 10450 (April 27, 1953); DOE O 472.2 (July 21, 2011).

Security Incident Notification Report and Report of Preliminary Security Incident/Infraction (DOE F 471.1 and DOE F 5639.3): Executive Order 13526 (December 29, 2009); 32 CFR part 2001; DOE O 470.4B (July 21, 2011).

DOE F 5631.20, Request for Visitor Access Approval: Section 145(b) of the Atomic Energy Act of 1954, as amended, codified at 42 U.S.C. 2165.

DOE Form 5631.18, Security Acknowledgement: Section 145(b) of the Atomic Energy Act of 1954, as amended, codified at 42 U.S.C. 2165; Executive Order 13526 (December 29, 2009); Executive Order 10865 (Feb. 20, 1960); Executive Order 10450 (April 27, 1953); DOE O 5631.2C (February 17, 1994).

DOE Form 5631.29, Security Termination Statement: Section 145(b) of the Atomic Energy Act of 1954, as amended, codified at 42 U.S.C. 2165; Executive Order 13526 (December 29, 2009); Executive Order 10865 (Feb. 20, 1960); Executive Order 10450 (Apr. 27, 1953); 32 CFR part 2001; DOE O 472.2 (July 21, 2011).

DOE Form 5631.5, The Conduct of Personnel Security Interviews: 10 CFR part 710; Executive Order 12968 (Aug. 2, 1995); Executive Order 10450 (April 27, 1953); DOE Order 472.2 (July 21, 2011).

DOE F 471.1, Security Incident Notification Report; DOE Form 472.3 Foreign Citizenship Acknowledgement; and DOE Form 473.2, Security Badge Request; the Atomic Energy Act of 1954, as amended, and by Executive Orders 13764, 10865, and 13526.

Electronic Foreign Ownership, Control or Influence (e-FOCI) System: Executive Order 12829 (January 6, 1993); DOE O 470.4B (July 21, 2011).

Foreign Access Central Tracking System (FACTS): Presidential Decision Directive 61 (February 1999); DOE O 142.3A (October 14, 2010).

The proposed information collection activity provides a means to collect qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations. This feedback also provides an early warning of issues with service, or focuses attention on areas where communication, training or changes in operations might improve the accuracy of data reported on survey instruments or the delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.

This information collection request contains:

(1) OMB Control No.: 1905-0210;

(2) Information Collection Request Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery;

(3) Type of Request: Renewal with changes;

(4) Purpose: The solicitation of feedback will target areas such as: Timeliness, understanding of questions and terminology used in survey instruments, perceptions on data confidentiality and security, appropriateness and relevancy of information, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the agency's services will be unavailable.

The agency will only submit a collection for approval under this generic clearance if it meets the following conditions: The collections are voluntary; The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government; The collections are non-controversial and do not raise issues of concern to other Federal agencies; Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future; Personally identifiable information (PII) is collected only to the extent necessary for initially contacting respondents and is not retained; Information gathered is intended to be used only internally for general service improvement, the design, modification, and evaluation of survey instruments, modes of data collection, and program management purposes. It is not intended for release outside of the agency (if released, the agency must indicate the qualitative nature of the information); Information gathered will not be used for the purpose of substantially informing influential policy decisions; and the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study. The information gathered will only generate qualitative type of information. Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

(5) Annual Estimated Number of Respondents: 80,600.

(6) Annual Estimated Number of Responses: 80,600.

(7) Annual Estimated Number of Burden Hours: 8,450.

Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. All written comments will be available for public inspection at www.Regulations.gov. Comments submitted in response to this notice may be made available to the public through relevant Web sites. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment; your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

This information collection request contains:

(1) OMB No.: 1905-0209;

(2) Information Collection Request Title: Densified Biomass Fuel Report;

(3) Type of Request: Renewal, with Changes;

(4) Purpose: Form EIA-63C Densified Biomass Fuel Report is part of EIA's comprehensive energy data program. The survey collects information on the manufacture, shipment, exports, energy characteristics, and sales of pellet fuels and other densified biomass fuel products data from facilities that manufacture densified biomass fuel products, primarily pellet fuels, for energy applications. The data collected is a primary source of information for the nation's growing production of biomass products for heating and electric power generation, for both domestic use and export markets.

(4a) Proposed Changes to Information Collection: To reduce reporting burden, EIA proposes to eliminate the following seven questions: Part 2 Question 2.2 “What is the operational month” Part 2 Question 2.4 “What is the total installed horsepower of the pellet extrusion machinery at this facility”; Part 2. Question 2.5 “If the pellet extrusion machinery was not fully utilized during the month, choose the applicable explanation” and all of explanation selection choices”; Part 2. Question 2.6 “What is the planned maximum annual production capacity at this facility”; Part 2. Question 2.7 “What is the planned total installed horsepower of the pellet extrusion machinery at this facility”; Part 3. Question 3.2 “In the reporting period, did the mill utilize any portion of the above feedstock for uses other than transformation into densified biomass products, such as to operate the mill, produce electricity (combined heat and power) or other beneficial use of energy produced (such as heating/cooling)”; Part 4. Question 4.2, Delete the column for reporting “Export Port.” Respondents will continue to report on all other data elements in section 4.2. EIA is proposing to delete these data elements based on consultations with respondents during the collection cycle. The questions that EIA proposes to delete were questions that respondents stated were either confusing or difficult to answer, or are questions that EIA receives too few responses to allow publication because of the data confidentiality rules that EIA applies to the aggregate statistical estimates. EIA is also proposing to change the due date for annual respondents (small biomass fuel manufacturers having a capacity of less than 10,000 tons per year or planned facilities) from February 1 to June 1 to coincide with the industry's off-season and ease their burden during their busiest time of the year. Respondents that need to file annually will only need to report limited data in Parts 1 and 2 of the form.

(5) Annual Estimated Number of Respondents: 105;

(6) Annual Estimated Number of Total Responses: 1095;

(7) Annual Estimated Number of Burden Hours: 1,516;

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: The cost of the burden hours is estimated to be $111,699 (1,516 burden hours times $73.66 per hour). EIA estimates that there are no additional costs to respondents associated with the survey other than the costs associated with the burden hours.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

This information collection request contains:

(1) OMB No.: 1905-0208;

(2) Information Collection Request Title: Quarterly Electricity Imports and Exports Report;

(3) Type of Request: Renewal;

(4) Purpose: Form EIA-111 collects U.S. electricity import and export data. The data are used to generate accurate estimates of the flow of electricity into and out of the United States. The import and export data are reported by U.S. purchasers, sellers, and transmitters of wholesale electricity, including persons authorized to export electric power from the United States to foreign countries, persons authorized by Presidential Permit to construct, operate, maintain, or connect electric power transmission lines that cross the U.S. international border, and U.S. Balancing Authorities that are interconnected with foreign Balancing Authorities. Such entities report monthly flows of electricity received or delivered across the border, the cost associated with the transactions, and actual and implemented interchange.

(5) Annual Estimated Number of Respondents: 176;

(6) Annual Estimated Number of Total Responses: 704;

(7) Annual Estimated Number of Burden Hours: 1056;

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: The cost of the burden hours is estimated to be $77,785 (1,056 burden hours times $73.66 per hour). EIA estimates that there are no additional costs to respondents associated with the survey other than the costs associated with the burden hours.

This information collection requirement pertains to information that an offeror must submit in response to the requirements of the provisions and clauses in FAR 52.225 that relate to the following:

* The Buy American statute (41 U.S.C. chapter 83 and E.O. 10582).

* The Trade Agreements Act (19 U.S.C. 2501-2515), including the World Trade Organization Government Procurement Agreement and various free trade agreements.

* The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) (Recovery Act).

* Subchapters VIII and X of Chapter 98 of the Harmonized Tariff Schedule of the United States (19 U.S.C. 1202).

a. 52.225-2, Buy American Certificate, as prescribed in FAR 25.1101(a)(2), requires the offeror to identify in its proposal supplies that do not meet the definition of domestic end product. The Buy American statute does not apply to acquisitions of commercial information technology.

b. 52.225-4, Buy American—Free Trade Agreements—Israeli Trade Act Certificate, as prescribed in FAR 25.1101(b)(2)(i), requires separate listing of foreign products that are eligible under a trade agreement, and listing of all other foreign end products.

c. 52.225-6, Trade Agreements Certificate, as prescribed in FAR 25.1101(c)(2), requires the offeror to certify that all end products are either U.S.-made or designated country end products, except as listed in paragraph (b) of the provision. Offerors are not allowed to provide other than a U.S.-made or designated country end product, unless the requirement is waived.

d. Construction provisions and clauses:

The listed provisions and clauses, as prescribed in FAR 25.1102(a) through (e), provide that an offeror/contractor requesting to use foreign construction material due to unreasonable cost of domestic construction material shall provide adequate information to permit evaluation of the request.

e. 52.225-8, Duty-Free Entry (formerly OMB clearance 9000-0022), as prescribed in FAR 25.1101(e), requires the contractor to notify the contracting officer when it purchases foreign supplies, in order to determine whether the supplies should be duty-free. In addition, all shipping documents and containers must specify certain information to assure the duty-free entry of the supplies.

1. Buy American and Trade Agreements—Supplies:

FAR Clause 52.225-2, Buy American Certificate, requires the offeror to identify in its proposal supplies for use in the United States that do not meet the definition of domestic end product. The Buy American statute does not apply to acquisitions of commercial information technology.

Respondents: 3,306.

Responses per Respondent: 5.

Total Responses: 16,530.

Hours per Response: .25.

Total Burden Hours: 4,133.

FAR Clause 52.225-4, Buy American-Free Trade Agreements—Israeli Trade Act Certificate, requires separate listing of foreign products that are eligible under a trade agreement, and listing of all other foreign end products.

Respondents: 1,977.

Responses per Respondent: 5.

Total Responses: 9,885.

Hours per Response: .25.

Total Burden Hours: 2,471.

FAR Clause 52.225-6, Trade Agreements Certificate, requires the offeror to certify that all end products are either U.S.-made or designated country end products, except as listed in paragraph (b) of the provision. Offerors are not allowed to provide other than a U.S.-made or designated country end product, unless the requirement is waived.

Respondents: 397.

Responses per Respondent: 2.

Total Responses: 794.

Hours per Response: .25.

Total Burden Hours: 199.

2. Buy American and Trade Agreements—Construction provisions and clauses provide that an offeror/contractor requesting to use foreign construction material due to unreasonable cost of domestic construction material shall provide adequate information to permit evaluation of the request.

Respondents: 853.

Responses per Respondent: 2.3.

Total Responses: 1,990.

Hours per Response: 5.

Total Burden Hours: 10,045.

3. Duty-Free Entry. The clause at FAR 52.225-8, Duty-Free Entry (formerly OMB clearance 9000-0022), is included in solicitations and contracts for supplies that may be imported into the United States and for which duty-free entry may be obtained in accordance with FAR 25.903(a), if the value of the acquisition (1) exceeds the simplified acquisition threshold; or (2) does not exceed the simplified acquisition threshold, but the savings from waiving the duty is anticipated to be more than the administrative cost of waiving the duty. The contracting officer analyzes the information submitted by the contractor to determine whether or not supplies should enter the country duty-free.

Respondents: 1,330.

Responses per Respondent: 10.

Total Responses: 13,300.

Hours per Response: 0.5.

Total Burden Hours: 6,650.

4. Summary

Respondents: 7,863.

Responses per Respondent: 5.4.

Total Responses: 42,499.

Hours per Response: .5.

Total Burden Hours: 23,497.

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755.

Please cite OMB Control No. 9000-0024, Buy American, Trade Agreements, and Duty-Free Entry in all correspondence.

Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

5. Assess information collection costs.

Respiratory Protective Devices—42 CFR part 84—Regulation—(0920-0109)—Revision—National Institute for Occupational Safety and Health (NIOSH), of the Centers for Disease Control and Prevention (CDC).

The regulatory authority for the National Institute for Occupational Safety and Health (NIOSH) certification program for respiratory protective devices is found in the Mine Safety and Health Amendments Act of 1977 (30 U.S.C. 577a, 651 et seq., and 657(g)) and the Occupational Safety and Health Act of 1970 (30 U.S.C. 3, 5, 7, 811, 842(h), 844). These regulations have, as their basis, the performance tests and criteria for approval of respirators used by millions of American construction workers, miners, painters, asbestos removal workers, fabric mill workers, and fire fighters.

Regulations of the Environmental Protection Agency (EPA) and the Nuclear Regulatory Commission (NRC) also require the use of NIOSH-approved respirators. These regulations also establish methods for respirator manufacturers to submit respirators for testing under the regulation and have them certified as NIOSH-approved if they meet the criteria given in the above regulation. This data collection was formerly named Respiratory Protective Devices 30 CFR part 11, but in 1995, the respirator standard was moved to 42 CFR part 84.

In accordance with 42 CFR part 84, NIOSH performs the following activities: (1) Issues certificates of approval for respirators which have met specified construction, performance, and protection requirements; (2) establishes procedures and requirements to be met in filing applications for approval; (3) specifies minimum requirements and methods to be employed by NIOSH and by applicants in conducting inspections, examinations, and tests to determine effectiveness of respirators; (4) establishes a schedule of fees to be charged applicants for testing and certification, and (5) establishes approval labeling requirements. To establish the scope and intent of request, NIOSH collects information from those who request services under 42 CFR part 84.

Information collected from requests for respirator approval functions includes contact information and information about factors likely to affect respirator performance and use. Such information includes, but is not necessarily limited to, respirator design, manufacturing methods and materials, quality assurance plans and procedures, and user instruction and draft labels, as specified in the regulation.

The main instrument for data collection for respirator approval functions is the Standard Application for the Approval of Respirators (SAF), currently Version 9.

Respirator manufacturers are the respondents (estimated to average 73 each year over the years 2017-2020). Upon submission of the SAF, NIOSH evaluates their applications for approval. Respirator manufacturers submit applications according to their business needs, which depends upon market conditions, technical advances, and other factors that are not easy to forecast. The best estimate for the annual number of respondents is the number from the most recent year for which data exists, 73 in 2016, an increase from 63 in 2014. Those 73 applicants submitted 542 applications in 2016, providing the current best estimate. A $200 fee is required for each application. Respondents requesting respirator approval or certain extensions of approval are required to submit additional fees for necessary testing and evaluation as specified in 42 CFR parts 84.20-22, 84.66, 84.258 and 84.1102. In 2016, $2,662,329.00 was accepted.

Applicants are required to provide test data that shows that the manufacturer is capable of ensuring that the respirator is capable of meeting the specified requirements in 42 CFR part 84. The requirement for submitted test data is likely to be satisfied by standard testing performed by the manufacturer, and is not required to follow the relevant NIOSH Standard Test Procedures. As additional testing is not required, providing proof that an adequate test has been performed is limited to providing existing paperwork.

Also, 42 CFR part 84 approvals offer corroboration that approved respirators are produced to certain quality standards. Although 42 CFR part 84 Subpart E prescribes certain quality standards, it is not expected that requiring approved quality standards will impose an additional cost burden over similarly effective quality standards that are not approved under 42 CFR part 84.

Manufacturers with current approvals are subject to site audits by the Institute or its agents. Audits may occur periodically, typically every second year, or because of a reported issue. NIOSH scheduled Sixty-three site audits from 92 respirator approval holders for the 2016 fiscal year.

There is an average fee of $8,833 for each audit to align with fee collection provisions of the Independent Offices Appropriations Act of 1952 (31 U.S.C. 9701), and OMB Circular A-25 Revised.

In addition to this Notice, 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 or update of an existing collection of information, before submitting the collection to OMB for approval. In compliance with this requirement, ACF published a notice in the Federal Register on June 30, 2017 and invited comment on: (1) Whether the proposed collection of information is necessary for the proper performance of ACF's functions, including whether the information will have practical utility; (2) the accuracy of ACF'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 for the existing AFCARS reporting that is required by States and Tribes.

ACF received 71 comment letters to the first notice. No substantive comments were received regarding the existing AFCARS data collection in 45 CFR 1355.40 under OMB Number 0970-0457. Instead, commenters provided feedback on the new AFCARS data collection under 45 CFR 1355.41-.47 to be implemented October 1, 2019. Commenters addressed support for the collection of information under the Indian Child Welfare Act and other areas covered by the new requirements. ACF received no comment on the specific burden hours for the existing AFCARS requirements undergoing renewal.

AFCARS is mandated by 42 U.S.C. 679. The regulation at 45 CFR 1355.40 and the appendices to 45 CFR 1355 set forth the requirements of section 479 of the Social Security Act for the collection of uniform, reliable information on children who are under the responsibility of the State or Tribal title IV-B/IV-E agency for placement, care, and adoption. The AFCARS requirements under 45 CFR 1355.40 have been in effect since October 1, 1993 for States. In 2009, section 479B(b) of the Act was enacted authorizing direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The data collected informs State/Tribal/Federal policy decisions, program management, and responses to Congressional and Departmental inquiries.

Respondents: Title IV-E State and Tribal Child Welfare Agencies.

Additional Information: Copies of the regulation containing the data elements may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected].

OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families.

I. Background

In the Federal Register of August 25, 2016 (81 FR 58519), FDA published the notice of availability for a draft guidance entitled “Current Good Manufacturing Practice Requirements for Food for Animals,” giving interested persons until November 23, 2016, to comment on the draft guidance. FDA received comments on the draft guidance and those comments were considered as the guidance was finalized. Changes made include additional explanation and examples and the inclusion of a part 507 (21 CFR part 507) Current Good Manufacturing Practice (CGMP) Self-Assessment Tool in Appendix B to assist facilities in reviewing the implementation of CGMP requirements at their facility. Information regarding human food by-products for use as food for animals was removed; this information is contained in draft GFI #239, entitled “Human Food By-Products for Use as Animal Food” (81 FR 58521, August 25, 2016). In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated August 2016.

This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on current good manufacturing practice requirements for food for animals. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 507 have been approved under OMB control number 0910-0789.

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.

I. Background

In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products,” which explained the process that would be used to make product-specific guidances available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

As described in that guidance, FDA adopted this process to develop and disseminate product-specific guidances and to provide a meaningful opportunity for the public to consider and comment on the guidances. This notice announces the availability of draft product-specific guidances for generic salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder.

FDA initially approved new drug application (NDA) 020692 for SEREVENT DISKUS (salmeterol xinafoate inhalation powder) in September 1997. We are now issuing a draft guidance for industry on, among other things, BE recommendations for generic salmeterol xinafoate inhalation powder (“Draft Guidance on Salmeterol Xinafoate”).

FDA initially approved NDA 021433 for FLOVENT HFA (fluticasone propionate inhalation aerosol) in May 2004 and NDA 020833 for FLOVENT DISKUS 100 (fluticasone propionate inhalation powder) in September 2000. We are now also issuing two draft guidances for industry on, among other things, BE recommendations for generic fluticasone propionate inhalation aerosol and fluticasone propionate inhalation powder (both entitled “Draft Guidance on Fluticasone Propionate”).

In December 2009, GlaxoSmithKline (GSK), manufacturer of the reference listed drugs SEREVENT DISKUS, FLOVENT HFA, and FLOVENT DISKUS 100, submitted a citizen petition requesting that FDA withhold approval of any ANDA or 505(b)(2) application for generic oral inhalation products containing salmeterol xinafoate and/or fluticasone propionate unless certain conditions were satisfied, including conditions related to demonstrating BE (Docket No. FDA-2009-P-0597). FDA is reviewing the issues raised in the petition. FDA will consider any comments on guidances entitled, “Draft Guidance on Salmeterol Xinafoate” or “Draft Guidance on Fluticasone Propionate,” before responding to GSK's citizen petition.

The draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the design of BE studies to support ANDAs for salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. These guidances are not subject to Executive Order 12866.

Persons with access to the internet may obtain the draft guidances at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products,” which explained the process that would be used to make product-specific guidances available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

As described in that guidance, FDA adopted this process to develop and disseminate product-specific guidances and to provide a meaningful opportunity for the public to consider and comment on the guidances. This notice announces the availability of a draft product-specific guidance for generic tiotropium bromide inhalation powder.

FDA initially approved new drug application 21395 for SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) in January 2004. We are now issuing draft guidance for industry on, among other things, BE recommendations for generic tiotropium bromide inhalation powder (“Draft Guidance on Tiotropium Bromide”).

In October 2012, Boehringer Ingelheim, manufacturer of the reference listed drug SPIRIVA HANDIHALER, submitted a citizen petition requesting, among other things, that FDA adopt and apply certain requirements that ensure the safety and efficacy of any proposed generic and follow-on versions of SPIRIVA HANDIHALER under section 505(j) and (b)(2), respectively, of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j) and (b)(2)) (Docket No. FDA-2012-P-1072). FDA is reviewing the issues raised in the petition, and will consider any comments on the draft guidance entitled “Draft Guidance on Tiotropium Bromide” before responding to Boehringer's citizen petition.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on, among other things, the design of BE studies to support ANDAs for tiotropium bromide inhalation powder. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

I. Background

In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA's Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the Federal Register on July 14, 2017 (82 FR 32556). This notice announces draft product-specific guidances, either new or revised, that are posted on FDA's Web site.

FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients:

FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients:

For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.

These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

Persons with access to the internet may obtain the draft guidances at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

On May 14, 2015, FDA announced in the Federal Register (80 FR 27690) its adoption of LOINC for lab test results. FDA supports LOINC-coded laboratory test results because: (1) LOINC is widely used among clinical laboratories; (2) LOINC-coded lab data make the information easier to understand and analyze; and (3) the currently supported exchange standard for laboratory test results in clinical trials, the Study Data Tabulation Model (available at http://www.cdisc.org/sdtm), already supports the exchange of LOINC codes (available at https://loinc.org/). FDA's decision to adopt LOINC for lab test results is part of a larger FDA effort to align the use of data standards for clinical research with ongoing nationwide health information technology initiatives. The FDA Data Standards Catalog was updated to indicate FDA support for LOINC and a requirement date of March 15, 2018, for NDAs, ANDAs, and BLAs, and March 15, 2019, for certain INDs (see https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm). FDA has determined, in response to industry comments and internal review, that it is appropriate to extend the date required to submit LOINC codes. LOINC codes will be required in NDAs, ANDAs, and BLAs for studies that start after March 15, 2020 (March 15, 2021, for certain INDs). Although use of LOINC codes are not required at this time, FDA continues to support and encourages the use of LOINC codes for clinical laboratory test results used in investigational study data.

I. Background

We are announcing the availability of a draft guidance for industry entitled “Application of the “Solely Engaged” Exemptions in Parts 117 and 507.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This guidance concerns two regulations that we have established in Title 21 of the Code of Federal Regulations as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353). These two regulations are part 117 (published in the Federal Register on September 17, 2015, 80 FR 55908 and part 507 (published in the Federal Register on September 17, 2015, 80 FR 56170). This guidance is intended to help establishments and facilities subject to part 117 or part 507 determine whether they are “solely engaged” in certain activities. Establishments and facilities “solely engaged” in certain activities are exempt from some or all requirements in parts 117 or 507.

Parts 117 and 507 contain exemptions specific to establishments and facilities “solely engaged” in certain activities. The relevant exemptions can be categorized as follows: (1) Exemption from human food current good manufacturing practice (CGMP) requirements, (2) exemption from human food preventive controls requirements, (3) exemption from animal food CGMP requirements, and (4) exemption from animal food preventive controls requirements.

This draft guidance, when finalized, will clarify that if all of the activities performed by an establishment are exempt under one or more CGMP exemptions, then the establishment is not subject to the part 117 and/or part 507 CGMPs, as applicable. If all the activities performed by a facility are exempt under one or more preventive controls exemptions, then the facility is not subject to the part 117 and/or part 507 preventive controls requirements, as applicable. If all the activities performed by a facility are exempt under one or more CGMP exemptions and one or more preventive controls exemptions, then the facility is not subject to the CGMP or preventive controls requirements in part 117 and/or part 507, as applicable.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ucm153033.htm (whichever is applicable) or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

Public Participation and Request for Comments

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2017-0105], and must be received by November 20, 2017.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0002.

This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (82 FR 35979, August 2, 2017) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collections.

Title: Applications for Vessel Inspection, Waiver, and Continuous Synopsis Record.

OMB Control Number: 1625-0002.

Summary: The collection of information requires the owner, operator, agent, or master of a vessel to apply in writing to the Coast Guard before the commencement of an inspection for certification, when a waiver is desired from the requirements of navigation and vessel inspection, or to request a Continuous Synopsis Record.

Need: Title 46 U.S. Code 3306 authorizes the Coast Guard to establish regulations to protect life, property, and the environment. The reporting requirements are part of the Coast Guard's Marine Safety Program.

Forms: CG-2633, Application for Waiver and Waiver Order; CG-3752, Application for Inspection of U.S. Vessel; CG-3752A, Application for Inspection of U.S. Vessel (New Construction); CG-6039, Application for Continuous Synopsis Record.

Respondents: Vessel owner, operator, agent, master or interested U.S. Government agency.

Frequency: On occasion, annually, or on a 5-year cycle.

Hour Burden Estimate: The estimated burden has decreased from 1,172 hours to 741 hours per year due to a decrease in the estimated annual number of respondents.

Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.

Public Participation and Request for Comments

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2017-0126], and must be received by November 20, 2017.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0082.

This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (82 FR 34960, July 27, 2017) required by 44 U.S.C. 3506(c)(2). We received two comments from a commenter to the 60-day Notice. The first comment was about the navigation charts and publications requirements for small towing vessels that operate on inland waters. The commenter stated that the requirements for these vessels should not be the same as the requirements for vessels on other voyages. We agree. 33 CFR 164.72 prescribes fewer publication carriage requirements for vessels engaged in towing exclusively on Western Rivers than for those that operate elsewhere (towing or otherwise). Furthermore, the Coast Guard has allowed electronic carriage of some publications further reducing burden (see Navigation and Vessel Inspection Circular 01-16).

The second comment was about the Muster List and Emergency Instructions requirements. The commenter stated that we should take into account various levels of risk, and not apply the rules to all towing vessels. Again, we agree. The Muster List and Emergency Instructions requirements in 33 CFR 199.80 do not apply to towing vessels inspected under 46 CFR Subchapter M. These requirements apply to towing vessels inspected under 46 CFR Subchapter I on international voyages. The comments result in no changes to the Collection.

Title: Navigation Safety Information and Emergency Instructions for Certain Towing Vessels.

OMB Control Number: 1625-0082.

Summary: Navigation safety regulations in 33 CFR part 164 help assure that the mariner piloting a towing vessel has adequate equipment, charts, maps, and other publications. For inspected towing vessels, under 46 CFR 199.80 a muster list and emergency instructions provide effective plans and references for crew to follow in an emergency situation.

Need: The purpose of the regulations is to improve the safety of towing vessels and the crews that operate them.

Forms: None.

Respondents: Owners, operators and masters of vessels.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has increased from 345,620 hours to 369,980 hours a year due to an increase in the estimated annual number of respondents.

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2017-0009], and must be received by December 19, 2017.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

Title: U.S. Coast Guard Non-appropriated Fund Employment Application.

OMB Control Number: 1625-0120.

Summary: The USCG Non-Appropriated Fund Employment Application form is used to collect applicant qualification information associated with vacancy announcements. The form allows individuals to apply for employment opportunities with the Coast Guard Non-appropriated Fund (NAF) workforce and fills the gap created by the cancellation of the optional Application for Federal Employment, form OF-612, OMB No. 3206-0219.

Need: The U.S. Coast Guard rates applicants under the authority of Title 5 of U.S. Code, Sections 1104, 2103, 3301 and 3320. The Optional Application for Federal Employment, Form OF-612, was cancelled and the information is now collected in USA Jobs. The NAF personnel system does not utilize USA Jobs because of the high cost and high turnover rate and thus relied heavily on form OF-612 for applicants.

Forms: CG-1227B, Non-Appropriated Fund Employment Application.

Respondents: Public applying for positions with the USCG Non-appropriated fund workforce.

Frequency: Per vacancy announcements.

Hour Burden Estimate: The estimated burden has decreased from 8,400 hours to 3,837 hours a year due to a decrease in the estimated annual number of respondents.

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek reinstatement of the Collection. We will consider all comments and material received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2017-0879], and must be received by December 19, 2017.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

Title: Waste Management Plans, Refuse Discharge Logs, Letters of Instruction for Certain Persons-in-Charge (PIC) and Great Lakes Dry Cargo Residue Recordkeeping.

OMB Control Number: 1625-0072.

Summary: This information is needed to ensure that: (1) Certain U.S. oceangoing vessels develop and maintain a waste management plan; (2) certain U.S. oceangoing vessels maintain refuse discharge records; (3) certain individuals that act as person-in-charge of the transfer of fuel receive a letter of instruction, for prevention of pollution; and (4) certain Great Lakes vessels comply with dry cargo residue requirements.

Need: This collection of information is needed as part of the Coast Guard's pollution prevention compliance program.

Forms: None.

Respondents: Owners, operators, masters, and persons-in-charge of vessels.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has increased from 65,696 hours to 116,095 hours a year due to an estimated increase in the annual number of respondents.

Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.

CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

Title: Declaration for Free Entry of Returned American Products.

OMB Number: 1651-0011.

Form Number: CBP Form 3311.

Action: CBP proposes to extend the expiration date of this information collection with no change to the burden hours or to the information collected on Form 3311.

Type of Review: Extension (with no change).

Abstract: CBP Form 3311, Declaration for Free Entry of Returned American Products, is used by importers and their agents when duty-free entry is claimed for a shipment of returned American products under the Harmonized Tariff Schedules of the United States. This form serves as a declaration that the goods are American made and that they have not been advanced in value or improved in condition while abroad; were not previously entered under a temporary importation under bond provision; and that drawback was never claimed and/or paid. CBP Form 3311 is authorized by 19 CFR 10.1, 10.66, 10.67, 12.41, 123.4, and 143.23 and is accessible at: http://www.cbp.gov/newsroom/publications/forms?title=3311&=Apply.

Affected Public: Businesses.

Estimated Number of Respondents: 12,000.

Estimated Number of Responses per Respondent: 35.

Estimated Number of Total Annual Responses: 420,000.

Estimated Time per Response: 6 minutes.

Estimated Total Annual Burden Hours: 42,000.

CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

Title: Application for Identification Card.

OMB Number: 1651-0008.

Form Number: CBP Form 3078.

Action: CBP proposes to extend the expiration date of this information collection with no change to the estimated burden hours or to CBP Form 3078.

Type of Review: Extension (without change).

Abstract: CBP Form 3078, Application for Identification Card, is filled out in order to obtain an Identification Card which is used to gain access to CBP security areas. This form collects biographical information and is usually completed by licensed Cartmen or Lightermen whose duties require receiving, transporting, or otherwise handling imported merchandise which has not been released from CBP custody. This form is submitted to the local CBP office at the port of entry that the respondent will be requesting access to the Federal Inspection Section. Form 3078 is authorized by 19 U.S.C. 66, 1551, 1555, 1565, 1624, 1641; and 19 CFR 112.42, 118, 122.182, and 146.6. This form is accessible at: http://www.cbp.gov/sites/default/files/documents/CBP%20Form%203078.pdf.

Affected Public: Businesses.

Estimated Number of Respondents: 150,000.

Estimated Number of Total Annual Responses: 150,000.

Estimated Time per Response: 17 minutes.

Estimated Total Annual Burden Hours: 42,450.

The notice of a major disaster declaration for the State of Florida is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of September 10, 2017.