Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq. ), the regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.”

The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.

APHIS has received a petition (APHIS Petition Number 19-099-01p) from Westhoff Vertriebsgesellschaft mbH (Westhoff), seeking a determination of nonregulated status of petunias containing the A1 gene of maize (A1-DFR Petunias), which have been genetically engineered to add a new color (orange) and brilliance. The Westhoff petition states that the plant with the new flower color is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.

As described in the petition, the orange-colored A1-DFR Petunias were initially developed at the Max Plank Institute for Plant Breeding Research and this genetic modification was later unknowingly transferred into other petunia genetic background and released as commercial varieties. Westhoff is seeking a determination of nonregulated status for a few GE varieties of petunias containing DFR gene in the United States.

Data were gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine if the new variety poses a plant pest risk.

Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the Federal Register providing 60 days for public comment for petitions for a determination of nonregulated status. On March 6, 2012, we published in the Federal Register (77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice  1 describing our process for soliciting public comment when considering petitions for determinations of nonregulated status for GE organisms. In that notice we indicated that APHIS would accept written comments regarding a petition once APHIS deemed it complete.

In accordance with § 340.6(d) of the regulations and our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review and comment, and copies are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested in receiving comments regarding potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. We are particularly interested in receiving comments regarding biological, cultural, or ecological issues, and we encourage the submission of scientific data, studies, or research to support your comments.

After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. Any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of comments will be considered in the development of our decision-making documents. As part of our decision-making process regarding a GE organism's regulatory status, APHIS prepares a plant pest risk assessment to assess its plant pest risk and the appropriate environmental documentation—either an environmental assessment (EA) or an environmental impact statement (EIS)—in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will follow our published process for soliciting public comment (see footnote 1) and publish a separate notice in the Federal Register announcing the availability of APHIS' EA and plant pest risk assessment.

Should APHIS determine that an EIS is necessary, APHIS will complete the NEPA EIS process in accordance with Council on Environmental Quality regulations (40 CFR part 1500-1508) and APHIS' NEPA implementing regulations (7 CFR part 372).

Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq. ), the regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.”

The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.

APHIS has received a petition (APHIS Petition Number 19-101-01p) from Pioneer Hi-Bred International, Inc. (Pioneer) seeking a determination of nonregulated status of a maize event designated as DP202216, which has been genetically engineered for enhanced grain yield potential and glufosinate-ammonium resistance. The Pioneer petition states that this maize is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.

As described in the petition, DP202216 maize was generated using Agrobacterium -mediated transformation with plasmid PHP40099 containing the zmm28 and mo-pat gene cassettes. Both the introduced and native zmm28 genes encode the ZMM28 protein, and the increased and extended expression of the ZMM28 protein results in plants with enhanced grain yield potential. DP202216 maize also contains the phosphinothricin acetyltransferase (PAT) protein, which confers resistance to the herbicidal active ingredient glufosinate-ammonium at current labeled rates. DP202216 maize has been field tested in the continental United States and Puerto Rico over 9 years in more than 100 separate plantings as authorized under APHIS permits and notifications.

Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the likelihood of persistence in the environment after completion of the tests. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine if the new variety poses a plant pest risk.

Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the Federal Register providing 60 days for public comment for petitions for a determination of nonregulated status. On March 6, 2012, we published in the Federal Register (77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice  1 describing our process for soliciting public comment when considering petitions for determinations of nonregulated status for GE organisms. In that notice we indicated that APHIS would accept written comments regarding a petition once APHIS deemed it complete.

In accordance with § 340.6(d) of the regulations and our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review and comment, and copies are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested in receiving comments regarding potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. We are particularly interested in receiving comments regarding biological, cultural, or ecological issues, and we encourage the submission of scientific data, studies, or research to support your comments.

After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. Any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of comments will be considered in the development of our decisionmaking documents. As part of our decisionmaking process regarding a GE organism's regulatory status, APHIS prepares a plant pest risk assessment to assess its plant pest risk and the appropriate environmental documentation—either an environmental assessment (EA) or an environmental impact statement (EIS)—in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will follow our published process for soliciting public comment (see footnote 1) and publish a separate notice in the Federal Register announcing the availability of APHIS' EA and plant pest risk assessment.

Should APHIS determine that an EIS is necessary, APHIS will complete the NEPA EIS process in accordance with Council on Environmental Quality regulations (40 CFR part 1500-1508) and APHIS' NEPA implementing regulations (7 CFR part 372).

Title: Permit to Transport Undenatured Inedible Meat Products.

OMB Control Number: 0583-XXXX.

Type of Request: Request for a new information collection.

Abstract: FSIS has been delegated the authority to exercise the functions of the Secretary (7 CFR 2.18, 2.53) as specified in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq. ). This statute mandates that FSIS protect the public by verifying that meat products are safe, wholesome, unadulterated, and properly labeled and packaged.

FSIS is requesting approval for a new information collection for permits to transport domestic undenatured inedible meat products. This is a new information collection with an estimated burden of 87 hours.

Under the regulations at 9 CFR 325.11(e), official establishments are to apply in writing to their District Office to obtain a permit for the transport of undenatured inedible meat products in commerce. The application is to indicate the name and address of the applicant, a description of the type of business operations, and the purpose of making such application.

FSIS has made the following estimates based upon an information collection assessment:

Estimate of burden: FSIS estimates that it will take respondents an average of 34.8 minutes per response.

Respondents: Official establishments.

Estimated total number of respondents: 150.

Estimated annual number of responses per respondent: 1.

Estimated Total Annual Burden on Respondents: 87 hours.

Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, South Building, Washington, DC 20250-3700; (202) 720-5627.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of FSIS's functions, including whether the information will have practical utility; (b) the accuracy of FSIS's estimate of the burden of the proposed collection of information, including the validity of the method 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, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, DC 20253.

Responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: http://www.fsis.usda.gov/federal-register.

FSIS will also announce and provide a link to this Federal Register publication through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS can provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

Send your completed complaint form or letter to USDA by mail, fax, or email: Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410; Fax: (202) 690-7442; Email: program.intake@usda.gov .

Persons with disabilities who require alternative means for communication (braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

The purpose of the meeting is to:

1. Review RAC funding, roles, responsibilities, and operating guidelines,

2. Allow public input on project proposals,

3. Allow time for project proposal presentations,

4. Discuss, recommend, and approve new Title II projects, and

5. Discuss possible future meetings and next steps.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by Friday, August 2, 2019, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Ariel Chomey, RAC Coordinator, 13308 West Highway 160, Del Norte, Colorado 81132; by email to ariel.chomey@usda.gov, or via facsimile at 719-657-6035.

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

List of Petitions Received by EDA for Certification of Eligibility To Apply for Trade Adjustment Assistance [7/9/2019 through 7/18/2019] Firm name Firm address Date accepted for

Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended.

Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.

Background

On May 1, 2019, the Department of Commerce (Commerce) published the Final Affirmative Countervailing Duty Determination on glycine from the People's Republic of China (China). 1 On June 21, 2019, in accordance with section 706(a) of the Tariff Act of 1930, as amended (the Act), Commerce published the Countervailing Duty Orders on glycine from China. 2 In both the Final Affirmative Countervailing Duty Determination and the Countervailing Duty Orders, Commerce made a typographical error with respect to the spelling of the company name of Simagchem Corp., a mandatory respondent subject to the countervailing duty investigation on glycine from China. Specifically, Commerce misspelled the company name as “Sigmachem Corp” in the subsidy rate tables of both the Final Affirmative Countervailing Duty Determination and the Countervailing Duty Orders. The correct spelling of the company name is “Simagchem Corp.” As a result, we hereby correct the Final Affirmative Countervailing Duty Determination and the Countervailing Duty Orders.

Commerce has corrected the spelling of the company name of Simagchem Corp. in the subsidy rate tables of the Final Affirmative Countervailing Duty Determination and the Countervailing Duty Order. The estimated subsidy rates remain unchanged. The corrected subsidy rate table is as follows:

This correction to the Final Affirmative Countervailing Duty Determination and the Countervailing Duty Orders is issued and published in accordance with sections 777(i)(1) and 706(a) of the Act.

HAB and hypoxic events are some of the most scientifically complex and economically damaging coastal issues challenging our ability to safeguard the health of our nation's coastal ecosystems. Almost every state now experiences some kind of HAB event, and the number of hypoxic water bodies in the United States has increased over the last century. Recent economic analyses show effects costing hundreds of millions of dollars. Even just one major HAB or hypoxia event can incur tens of millions of dollars to local coastal economies, indicating that the nationwide economic impacts are likely much larger.

In 1998, Congress recognized the severity of these threats and passed the Harmful Algal Bloom and Hypoxia Research and Control Act (HABHRCA 1998; Pub. L. 105-383). The Harmful Algal Bloom and Hypoxia Research and Control Amendments Act of 2004 (HABHRCA 2004, Pub. L. 108-456) and 2014 (HABHRCA 2014, Pub. L. 113-124) reaffirmed and expanded the mandate for NOAA to advance the scientific understanding and ability to detect, monitor, assess, and predict HAB and hypoxia events. Congress most recently reauthorized and amended HABHRCA through the National Integrated Drought Information System Reauthorization Act of 2018 (Pub. L. 115-423). Section 9 of this Act, cited as the Harmful Algal Bloom and Hypoxia Research and Control Amendments Act of 2017, provides NOAA and the U.S. Environmental Protection Agency with independent authority to make a determination of “HABs and hypoxia events of national significance.” Following such a determination, federal officials may “make sums available to the affected State or local government for the purposes of assessing and mitigating the detrimental environmental, economic, subsistence use, and public health effects of the event of national significance.” Funds would be subject to the availability of appropriations. This notice focuses only on the authority granted to NOAA and provides interested parties with an opportunity to provide information early in the policy development process for determining HAB and hypoxia events of national significance in marine or coastal waters.

Factors to be considered in making a determination include the toxicity of the HAB, severity of hypoxia, potential for spread, economic impact, relative size in relation to the past five occurrences, and the geographic scope. NOAA is accepting comments to inform the development of guidance for assessing these considerations and whether additional factors should be considered. The determination process optimally will include quantitative and qualitative means of assessment. In particular, NOAA is interested in the following topics:

• The approach that NOAA should use to quantify and qualify the factors identified in the reauthorization of HABHRCA to determine an event of national significance.

○ How NOAA should define and weigh the following statutory parameters:

Toxicity of the HAB and severity of hypoxia;

Economic impact;

Relative size in relation to the past five occurrences of HAB or hypoxia events; that occur on a recurrent or annual basis;

Geographic scope, including the potential to spread and affect either a single jurisdiction or multiple municipalities, states, or countries.

○ Based on the statutory parameters above, how should NOAA define significant detrimental environmental, economic, subsistence use, and public health effects and what thresholds should be considered in making a determination.

○ Whether NOAA should consider developing additional criteria, and, if so, how NOAA should quantify or qualify these additional criteria. For example:

How NOAA should define an hypoxia event, and whether hypoxia should be defined relative to a set value or specific to an organism, a place, or time;

Whether NOAA should consider inclusion of the duration of an event;

Whether NOAA should consider the level of public concern and, if so, how to measure that.

• For the parameters described above, the information that a state should provide when requesting a determination and/or funds.

• For the purposes of a determination, and possible assessments and/or mitigation funds, how NOAA should define (A) the start and end of an event; and (B) the geographic extent of the event. Relative to these definitions, whether and how NOAA should establish the point at which states can/may make a funding request for assessment and mitigation assistance.

• For an event that has affected more than one state or shows the potential to do so in the case of an on-going event, whether NOAA should:

○ Make a single determination for an event applicable to all states affected at the time of a determination and any future states affected by the event via geographic expansion, movement, or intensification of the event, or;

○ limit determinations to the area requested by a State based on the then-current location and geographic extent of the event. This alternative could result in multiple state-by-state determinations for a single event.

• How to define subsistence use.

• The definition of the 50% federal/state match, and what contributions may be considered.

To ensure clarity, NOAA requests separate comments for HAB and hypoxia events as it is likely that the factors for each will be considered differently. For more details and background, please refer to this site: https://coastalscience.noaa.gov/ .

Introduction

In accordance with OPA NRDA regulations in the Code of Federal Regulations (CFR) at 15 CFR part 990, NEPA (42 U.S.C. 4321 et seq. ), the Consent Decree, and the Final PDARP/PEIS, the Federal and State natural resource trustee agencies (Trustees) have prepared a Draft Restoration Plan 2/Environmental Assessment: Fish, Sea Turtles, Marine Mammals, and Mesophotic and Deep Benthic Communities. The Draft RP/EA analyzes 23 alternatives and proposes 18 preferred alternatives for the following restoration types: Fish and Water Column Invertebrates, Sea Turtles, Marine Mammals, and Mesophotic and Deep Benthic Communities:

• Reduction of Post-Release Mortality from Barotrauma in Gulf of Mexico Reef Fish Recreational Fisheries—Preferred, $30,011,000.

• Better Bycatch Reduction Devices for the Gulf of Mexico Commercial Shrimp Trawl Fishery—Preferred, $17,171,000.

• Communication Networks and Mapping Tools to Reduce Bycatch—Phase 1—Preferred, $4,416,000.

• Restoring for Bluefin Tuna via Fishing Depth Optimization—Preferred, $6,175,000.

• Reduce the Impacts of Ghost Fishing by Removing Derelict Fishing Gear from Marine and Estuarine Habitats—Not Preferred, $6,128,000.

• Gulf of Mexico Sea Turtle Atlas—Preferred, $5,700,000.

• Identifying Methods to Reduce Sea Turtle Bycatch in the Reef Fish Bottom Longline Fishery—Preferred, $290,000.

• Developing a Gulf-wide Comprehensive Plan for In-Water Sea Turtle Data Collection—Preferred, $655,000.

• Developing Methods to Observe Sea Turtle Interactions in the Gulf of Mexico Menhaden Purse Seine Fishery—Preferred, $3,000,000.

• Reducing Juvenile Sea Turtle Bycatch Through Development of Reduced Bar Spacing in Turtle Excluder Devices—Preferred, $2,153,000.

• Long-term Nesting Beach Habitat Protection for Sea Turtles—Preferred, $7,000,000.

• Reducing Sea Turtle Entanglement from Recreational Fishing Debris—Not Preferred, $1,113,600.

• Reducing Sea Turtle Bycatch at Recreational Fishing Sites—Not Preferred, $1,329,000.

• Reducing Impacts to Cetaceans During Disasters by Improving Response Activities—Preferred, $4,287,000.

• Compilation of Environmental, Threats, and Animal data for Cetacean Population Health Analyses—Preferred, $5,808,500.

• Reduce Impacts of Anthropogenic Noise on Cetaceans—Preferred, $8,992,200.

• Reduce and Mitigate Vessel Strike Mortality of Cetaceans—Preferred, $3,834,000.

• Assessment of Northern Gulf of Mexico Shelf Small Cetacean Health, Habitat. Use, and Movement Patterns—Not Preferred, $4,620,000.

• Mapping, Ground-Truthing, and Predictive Habitat Modeling—Preferred, $35,909,000.

• Habitat Assessment and Evaluation—Preferred, $52,639,000.

• Coral Propagation Technique Development—Preferred, $16,951,000.

• Active Management and Protection—Preferred, $20,689,000.

• Habitat Characterization at Known High Priority Sites—Not Preferred, $21,500,000.

The Open Ocean TIG also analyzes a No Action alternative. One or more alternatives may be selected for implementation by the Open Ocean TIG in the Final RP/EA or in future restoration plans.

For additional background information, see our original Federal Register notice, with which we opened the comment period (May 15, 2019; 84 FR 21753). That comment period was extended on July 1 and formally closed on July 15, 2019 (July 1, 2019; 84 FR 31306). Due to extenuating weather conditions associated with the recent Hurricane Barry, this notice reopens that comment period through August 2, 2019.

The Open Ocean TIG seeks public review and comment on the Draft RP/EA (see ADDRESSES above). Before including your address, telephone number, email address, or other personal identifying information in your comment, please be aware that your entire comment, including your personal identifying information, will become part of the public record. Comments submitted previously in response to the two Federal Register notices, including any comments submitted after July 15, 2019 and before issuance of this notice do not need to be resubmitted.

The authority of this action is the Oil Pollution Act of 1990 (33 U.S.C. 2701 et seq. ) and its implementing Oil Pollution Act Natural Resource Damage Assessment regulations found at 15 CFR part 990 and the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ).

Title; Associated Form; and OMB Number: DoD's Defense Industrial Base (DIB) Cybersecurity (CS) Program Point of Contact (POC) Information; OMB Control Number 0704-0490.

Needs and Uses: The information collection requirement is necessary to execute the voluntary Defense Industrial Base (DIB) Cybersecurity (CS) program. DoD will collect business points of contact (POC) information from all DIB CS program participants on a one-time basis, with updates as necessary, to facilitate communications and the sharing of share unclassified and classified cyber threat information.

Affected Public: Business or other for-profit and not-for-profit institutions.

Annual Burden Hours: 312.

Number of Respondents: 935.

Responses per Respondent: 1.

Annual Responses: 935.

Average Burden per Response: 20 minutes.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Department of Defense Security Agreement; DD Form 441, DD Form 441-1, OMB Control Number 0704-0194.

Needs and Uses: This information collection requirement is necessary for inspecting and monitoring the contractors, licensees, and grantees who require or will require access to, or who store or will store classified information; and for determining the eligibility for access to classified information of contractors, licensees, and grantees and their respective employees.

Affected Public: Individuals or households.

Annual Burden Hours: 869.63.

Number of Respondents: 4,021.

Responses per Respondent: 1.

Annual Responses: 4,021.

Average Burden per Response: 24 minutes.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Request for Armed Forces Participation in Public Events (Non-Aviation), DD Form 2536 and Request for Military Aerial Support, DD Form 2535; OMB Control Number 0704-0290.

Needs and Uses: This information collection requirement is necessary to evaluate the eligibility of events to receive Armed Forces community relations support and to determine whether requested military assets are available.

Affected Public: State, local, or tribal governments; Federal agencies or employees; for-profit and non-profit institutions; and individuals or households.

Annual Burden Hours: 17,850.

Number of Respondents: 51,000.

Responses per Respondent: 1.

Annual Responses: 51,000 minutes.

Average Burden per Response: 21 minutes.

Frequency: On Occasion.

This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 19-24 with attached Policy Justification and Sensitivity of Technology.

(i) Prospective Purchaser: The Government of Germany through the NATO Support and Procurement Agency (NSPA) acting as its Agent

(ii) Total Estimated Value:

(iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

Major Defense Equipment (MDE):

Non-MDE:

(iv) Military Department: Navy

(v) Prior Related Cases, if any: GY-P-GLC, GY-P-GLO, GY-P-GPN, GY-P-ALB

(vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

(vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: See Annex Attached

(viii) Date Report Delivered to Congress: June 28, 2019

*As defined in Section 47(6) of the Arms Export Control Act.

The Government of Germany has requested to buy, through the NATO Support and Procurement Agency (NSPA) acting as its Agent, up to ninety-one (91) AGM-88E Advanced Anti-Radiation Guided Missile (AARGM) Tactical Missiles, and up to eight (8) AGM-88E AARGM Captive Air Training Missiles (CATM). Also included are up to six (6) telemetry/flight termination systems, Flight Data Recorders (FDR), U.S. Government and contractor engineering, technical and logistics support services and miscellaneous support equipment, and other related elements of logistical and program support. The total estimated cost is $122.86 million.

This proposed sale will support the foreign policy and national security of the United States by helping to improve the security of a NATO ally, which is an important force for political and economic stability in Europe. It is vital to the U.S. national interests that Germany develops and maintains a strong and ready self-defense capability.

The AGM-88E AARGM is an upgrade to the older generation AGM-88B High-Speed Anti-Radiation Missile (HARM), which Germany first purchased in 1988. The AGM-88E AARGMs in this case will be manufactured using a mixture of new components and older sections from Germany's existing stock of AGM-88Bs provided as Government Furnished Equipment (GFE). Germany will have no difficulty absorbing this equipment and support into its armed forces.

The proposed sale of this equipment and support will not alter the basic military balance in the region.

Germany has requested that the NSPA act as its agent for the FMS procurement and case management to support the AARGM program. The principal U.S. contractor will be NGIS, Ridgecrest, CA. The integration efforts will be via a Direct Commercial Sale (DCS), initiated by the Luftwaffe, between the Tornado Management Agency (NETMA) and the AARGM Original Equipment Manufacturer, Northrop Grumman Innovation Systems, formerly known as Orbital ATK (OA). There are no known offset agreements associated with this potential sale.

Implementation of this proposed sale will require five U.S. government personnel and three contractor representatives to travel to Germany to provide Program Management Reviews. Two visits are planned per year over the next five years.

There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

(vii) Sensitivity of Technology:

1. The AGM-88E Advanced Anti-Radiation Guided Missile (AARGM) AGM-88E weapon system is an air-to-ground missile intended to suppress or destroy land or sea-based radar emitters associated with enemy air defenses and provides tactical air forces with a lethal countermeasure to enemy radar directed, surface-to-air missiles, and air defense artillery weapons systems. Destruction or suppression of enemy radars denies the enemy the use of air defense systems, thereby improving the survivability of our tactical aircraft. It uses a multimode seeker that incorporates global positioning system/inertial measurement unit (GPS/IMU) midcourse guidance, a radio frequency (RF) radiation homing receiver, an active millimeter. When assembled, the AGM-88E AARGM is classified SECRET. The AARGM Guidance Section (seeker hardware) and Control Section with the Target Detector is classified CONFIDENTIAL.

2. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.

3. A determination has been made that the Government of Germany can provide substantially the same degree of protection for the technology being released as the U.S. Government. This sale supports the U.S. foreign policy and national security objectives as outlined in the Policy Justification.

4. All defense articles and services listed in this transmittal have been authorized for release and export to Germany.

According to the Synthetic Turf Council, there are currently 12,000 to 13,000 synthetic turf fields in the United States, with 1,200 to 1,500 new installations each year. Fields often use recycled tire rubber as infill material, sometimes mixed with sand. Fields are at municipal and county parks; schools, colleges, and universities; professional sports stadiums and practice fields; and military installations. It is estimated that millions of people use or work at these fields each year.

Parents, athletes, schools, and communities have raised concerns about potential health effects. To help address these concerns, the Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry (CDC/ATSDR) and the U.S. Environmental Protection Agency (EPA), in collaboration with the Consumer Product Safety Commission (CPSC), launched a multi-agency research effort in February 2016.

This multi-agency research effort, known as the Federal Research Action Plan (FRAP) on Recycled Tire Crumb Used on Playing Fields and Playground. The specific FRAP research covered in this report is focused on assessing potential human exposure, which includes conducting research activities to characterize the chemicals associated with recycled tire crumb rubber and to identify the ways in which people may be exposed to those chemicals based on their activities on synthetic turf fields. Also, the research includes characterizing emissions and bioaccessibility to differentiate what is present in the recycled tire crumb rubber from what people may actually be exposed to from recycled tire crumb rubber.

This research was designed to evaluate exposure. Results from this study can be used by others to inform potential risk. Prior to the FRAP being initiated, most studies examining these potential risks have been considered inconclusive or otherwise incomplete. Based upon available literature, this research effort represents the largest tire crumb rubber study conducted in the United States. The information and results from the effort will fill specific data gaps about the potential for human exposure to chemical constituents associated with recycled tire crumb rubber used in synthetic turf fields. The research is not intended to be a risk assessment.

The FRAP includes: (1) A Literature Review/Gap Analysis; (2) Tire Crumb Characterization research; (3) Exposure Characterization research; and (4) A Playground Study. A status report was previously released describing activities of the FRAP as of December 2016 (EPA/600/R-16/364, available at: https://www.epa.gov/tirecrumb). The status report included a summary of stakeholder outreach, an overview of the tire crumb rubber manufacturing industry, progress on the research activities, and the final peer-reviewed literature review/gaps analysis (LRGA) white paper.

This Synthetic Turf Field Tire Crumb Rubber Research Under the Federal Research Action Plan Final Report: Part 1—Tire Crumb Rubber Characterization summarizes the findings from the Tire Crumb Characterization research effort. While the research under the FRAP is not a risk assessment, the results of the research described in this and future reports will advance the understanding of exposure to inform the risk assessment process. The Part 1 report currently being posted has been through external peer review. A summary of these comments is included in Appendix V. A response-to-peer review comments document will be released along with Part 2.

More information is available at https://www.epa.gov/tirecrumb concerning the timeline of the report. Feedback about the study and report can be sent to recycledtirecrumb@epa.gov. Information collected as part of the Exposure Characterization research under the FRAP (Part 2) will be released at a later date. Part 2 will include information from a biomonitoring study initiated by CDC/ATSDR to investigate potential exposure to constituents in tire crumb rubber infill. The timeline and information about Part 2 will be posted to the agency's website as it becomes available. CPSC is also conducting the work on playgrounds and results from that effort will be reported separately.

The proposed Settlement Agreement allows the Owners to make a cash payment: (1) To EPA and the State to resolve alleged civil CERCLA liability; and (2) to DOI and the State to resolve alleged natural resource damage liability. The proposed Settlement Agreement also facilitates the sale of the Property within the Site to Purchaser as a CERCLA Bona Fide Prospective Purchaser and provides for the performance of Work by Purchaser at the Property and for the payment of certain response costs incurred by the United States at or in connection with the Property. The Owners and Purchaser consent to and will not contest the authority of the United States to enter into the Agreement or to implement or enforce its terms. The Owners and Purchaser recognize that the Agreement has been negotiated in good faith and that the Agreement is entered into without the admission or adjudication of any issue of fact or law.

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.

Evaluation of the DP18-1801 Healthy Schools Program—New—Division of Population Health (DPH) National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

The Centers for Disease Control and Prevention's (CDC) School Health Branch (SHB) requests a three-year OMB approval to conduct a new information collection entitled DP18-1801 Healthy Schools (DP18-1801) Program Evaluation. The DP18-1801 Healthy Schools Program builds upon previous CDC efforts designed to enhance the capacity of state education agencies (SEAs) to adopt and implement evidence-based policies, practices, and programs that support health among the nation's youth. The purpose of the DP18-1801 Healthy Schools Program is to: (1) Increase the number of students who consume nutritious food and beverages ( i.e., those aligned with the Dietary Guidelines for Americans ); (2) increase the number of students who participate in daily physical education and physical activity; and (3) increase the number of students who can effectively manage their chronic health conditions. The evaluation approach is a multisite, embedded case study design, consisting of both process and outcome components, focusing on three 1801 state grantees and a subset of their targeted LEAs and schools. The process component will assess implementation of strategies and activities at the state, local, and school levels and their integration across levels; fidelity of implementation; implementation facilitators and barriers; and contributions of national and state level TA towards program achievements. Three primary data collection methods will be used: (1) Key informant interviews (KII) conducted during in-person site visits or by phone, (2) Web-based surveys, and (3) review of secondary data sources.

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.

Monitoring and reporting for the Overdose Data to Action Cooperative Agreement—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

This new request for a data collection effort is to collect information from grantees funded under the Overdose Data to Action. OMB approval is requested for three years for this new collection. Drug overdose deaths in the United States increased by 18% per year from 2014 to 2016. Opioid overdose deaths have increased fivefold from 1999 to 2016 and in 2017, there were more than 47,000 deaths attributed to opioids. The purpose of the Overdose Data to Action funding opportunity is to support funded grantees in getting high quality, complete, and timely data on opioid prescribing and overdoses, and to use those data to inform prevention and response efforts. There are two required components of this award, a surveillance component, and a prevention component. The intent is to ensure that funded grantees are well equipped to do rigorous work under both components.

The information collected will provide crucial data to CDC for program monitoring and budget tracking, to improve timely CDC-recipient communications, and to inform technical assistance and guidance documents produced by CDC to support program implementation among funded grantees. It will also provide CDC with the capacity to respond in a timely manner to requests for information about the program from the Department of Health and Human Services (HHS), the White House, Congress, and other sources.

Data collection will include 100% of the funded grantee population, with no sampling. The data will be analyzed using descriptive, summary statistics, and qualitative summary. CDC requests approval for 1,320 annualized burden hours. There are no costs to the respondents other than their time.

Section 3011 of the 21st Century Cures Act (Pub. L. 114-255) added a new section 507 to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357). Section 3011(b)(3)(A) requires FDA to collaborate with biomedical research consortia and other interested parties to “establish a taxonomy for the classification of biomarkers (and related scientific concepts) for use in drug development.” FDA is meeting this legislative requirement through updates to the BEST Resource on the National Library of Medicine website, available at https://www.ncbi.nlm.nih.gov/books/NBK326791/, is FDA's response to this legislative requirement. In Spring 2015, the FDA-NIH (National Institutes of Health) Joint Leadership Council identified the harmonization of terms used in translational science and medical product development as a priority need, with a focus on terms related to study endpoints and biomarkers (see https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm614359.htm ). Working together with the goals of improving communication, aligning expectations, and improving scientific understanding, the two agencies developed the BEST Resource. The current phase of BEST comprises a glossary that clarifies use of important terms in the context of biomarkers and related scientific concepts and describes some of the hierarchical relationships, connections, and dependencies among the terms it contains. For example, the BEST glossary aims to capture distinctions between biomarkers and clinical assessments and to describe their distinct roles in biomedical research, clinical practice, and medical product development. FDA refers the public to the following web page for additional background information as well as a link to the BEST glossary of terms: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm614359.htm. FDA has previously discussed taxonomy for biomarkers used in drug development at its public meeting on Drug Development Tool Process on December 11, 2018, and invited comment on the BEST taxonomy in guidance published on December 12, 2018, on the evidentiary framework for biomarker qualification.

To help FDA determine the utility of the BEST glossary of terms, develop future iterations, and identify best methods for conveying this information, FDA is soliciting public comments on the BEST glossary that can be found on the following web page: https://www.ncbi.nlm.nih.gov/books/NBK338448/?report=reader. The BEST glossary is meant to be a resource that will be periodically updated with additional terms and clarifying information. Specifically, FDA welcomes comments concerning: (1) The utility of the BEST glossary; (2) specific proposed edits, including additions and removal of terms, with a rationale supporting these proposed edits; (3) the best approach for developing future iterations of the glossary; and (4) questions pertaining to the BEST glossary that you would like FDA to address in future communications. As the glossary is refined, the goal is to elaborate on these terms, so they will remain relevant, thus fostering consistent usage. Ultimately, FDA hopes that the BEST glossary will help to accelerate development and refinement of medical products, which will lead to improvements in health outcomes. The Agency will consider comments submitted to the docket as it revises the BEST glossary of terms.

I. Background

Section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387k) addresses the marketing and distribution of modified risk tobacco products (MRTPs). MRTPs are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Section 911(a) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any MRTP unless an order issued by FDA pursuant to section 911(g) of the FD&C Act is effective with respect to such product.

Section 911(d) of the FD&C Act describes the information that must be included in a MRTPA, which must be filed and evaluated by FDA before an applicant can receive an order from FDA. FDA is required by section 911(e) of the FD&C Act to make a MRTPA available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying the application. The determination of whether an order is appropriate under section 911 of the FD&C Act is based on the scientific information submitted by the applicant as well as the scientific evidence and other information that is made available to the Agency, including through public comments.

Section 911(g) of the FD&C Act describes the demonstrations applicants must make to obtain an order from FDA under either section 911(g)(1) or (g)(2). The applicant, 22nd Century Group, Inc., is seeking an order under section 911(g)(2) of the FD&C Act.

FDA may issue an order under section 911(g)(2) of the FD&C Act with respect to a tobacco product that does not satisfy the section 911(g)(1) standard. A person seeking an order under section 911(g)(2) of the FD&C Act must show that:

• Such an order would be appropriate to promote the public health;

• any aspect of the label, labeling, and advertising for the product that would cause the product to be an MRTP is limited to an explicit or implicit representation that the tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke;

• scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards for obtaining an order under section 911(g)(1);

• the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies;

• the magnitude of overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;

• the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users;

• testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product is or has been demonstrated to be less harmful or presents or has been demonstrated to present less of a risk of disease than one or more other commercially marketed tobacco products; and

• issuance of an order with respect to the application is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

Section 911(g)(4) of the FD&C Act describes factors that FDA must take into account in evaluating whether a tobacco product satisfies the requirements in section 911(g)(2).

FDA is issuing this notice to inform the public that the MRTPAs for the following products submitted by 22nd Century Group, Inc. have been filed and are being made available for public comment:

FDA will post the application documents, including any amendments, to its website for the MRTPAs (see section II) for public comment on a rolling basis as they are redacted in accordance with applicable laws. In this document, FDA is announcing the availability of the first batch of application documents for public comment. FDA intends to establish a closing date for the comment period that is both at least 180 days after the date of this notice and at least 30 days after the final documents from the applications are made available for public comment. FDA will announce the closing date at least 30 days in advance. FDA believes that this comment period is appropriate given the volume and complexity of the applications being posted.

FDA will notify the public about the availability of additional application documents and the comment period closing date via the Agency's web page for the MRTPAs (see section II) and by other means of public communication, such as by email to individuals who have signed up to receive email alerts. FDA does not intend to issue additional notices in the Federal Register regarding the availability of additional application documents, including amendments, or the comment period for these MRTPAs. To receive email alerts, visit FDA's email subscription service management website ( https://updates.fda.gov/subscriptionmanagement ), provide an email address, scroll down to the “Tobacco” heading, select “Modified Risk Tobacco Product Application Update,” and click “Submit.” To encourage public participation consistent with section 911(e) of the FD&C Act, FDA is making the redacted MRTPAs that are the subject of this notice available electronically (see section II).

Persons with access to the internet may obtain the documents at https://www.fda.gov/tobacco-products/advertising-and-promotion/22nd-century-group-inc-modified-risk-tobacco-product-mrtp-applications.

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

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) (Pub. L. 100-578) in 1988 to establish quality standards for all laboratory testing. The purpose was to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test took place. CLIA requires that clinical laboratories obtain a certificate from the Secretary of Health and Human Services (the Secretary), before accepting materials derived from the human body for laboratory tests (42 U.S.C. 263a(b)). Laboratories that perform only tests that are “simple” and that have an “insignificant risk of an erroneous result” may obtain a certificate of waiver (42 U.S.C. 263a(d)(2)). The Secretary has delegated to FDA the authority to determine whether particular tests (waived tests) are “simple” and have “an insignificant risk of an erroneous result” under CLIA (69 FR 22849).

On January 30, 2008, FDA published a guidance document entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices—Guidance for Industry and FDA Staff” ( https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079632.htm ). This guidance describes recommendations for device manufacturers submitting to FDA an application for determination that a cleared or approved device meets this CLIA standard (CLIA waiver application). The guidance recommends that CLIA waiver applications include a description of the features of the device that make it “simple”; a report describing a hazard analysis that identifies potential sources of error, including a summary of the design and results of flex studies and conclusions drawn from the flex studies; a description of fail-safe and failure alert mechanisms and a description of the studies validating these mechanisms; a description of clinical tests that demonstrate the accuracy of the test in the hands of intended operators; and statistical analyses of clinical study results.

In the Federal Register of March 26, 2019 (84 FR 11307), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Section 107 of FSMA (Pub. L. 111-353) added section 743 to the FD&C Act (21 U.S.C. 379j-31) to provide FDA with the authority to assess and collect fees from, in part: (1) The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspection-related costs; (2) the responsible party for a domestic facility and an importer who does not comply with a recall order, to cover food  1 recall activities associated with such order; and (3) each importer subject to a reinspection to cover reinspection-related costs (sections 743(a)(1)(A), (B), and (D) of the FD&C Act). Section 743 of the FD&C Act directs FDA to establish fees for each of these activities based on an estimate of 100 percent of the costs of each activity for each year (sections 743(b)(2)(A)(i), (ii), and (iv)), and these fees must be made available solely to pay for the costs of each activity for which the fee was incurred (section 743(b)(3)). These fees are effective on October 1, 2019, and will remain in effect through September 30, 2020. Section 743(b)(2)(B)(iii) of the FD&C Act directs FDA to develop a proposed set of guidelines in consideration of the burden of fee amounts on small businesses. As a first step in developing these guidelines, FDA invited public comment on the potential impact of the fees authorized by section 743 of the FD&C Act on small businesses (76 FR 45818, August 1, 2011). The comment period for this request ended November 30, 2011. As stated in FDA's September 2011 “Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act,” ( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-implementation-fee-provisions-section-107-fda-food-safety-modernization-act ), because FDA recognizes that for small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, FDA intends to consider reducing certain fees for those firms. FDA does not intend to issue invoices for reinspection or recall order fees until FDA publishes a guidance document outlining the process through which firms may request a reduction in fees.

In addition, FDA is in the process of considering various issues associated with the assessment and collection of importer reinspection fees. The fee rates set forth in this notice will be used to determine any importer reinspection fees assessed in FY 2020.

FDA is required to estimate 100 percent of its costs for each activity in order to establish fee rates for FY 2020. In each year, the costs of salary (or personnel compensation) and benefits for FDA employees account for between 50 and 60 percent of the funds available to, and used by, FDA. Almost all of the remaining funds (operating funds) available to FDA are used to support FDA employees for paying rent, travel, utility, information technology (IT), and other operating costs.

Full-time Equivalent (FTE) reflects the total number of regular straight-time hours—not including overtime or holiday hours—worked by employees, divided by the number of compensable hours applicable to each fiscal year. Annual leave, sick leave, compensatory time off and other approved leave categories are considered “hours worked” for purposes of defining FTE employment.

In general, the starting point for estimating the full cost per direct work hour is to estimate the cost of an FTE or paid staff year. Calculating an Agency-wide total cost per FTE requires three primary cost elements: Payroll, non-payroll, and rent.

We have used an average of past year cost elements to predict the FY 2020 cost. The FY 2020 FDA-wide average cost for payroll (salaries and benefits) is $160,885; non-payroll—including equipment, supplies, IT, general and administrative overhead—is $92,828; and rent, including cost allocation analysis and adjustments for other rent and rent-related costs, is $24,888 per paid staff year, excluding travel costs.

Summing the average cost of an FTE for payroll, non-payroll, and rent, brings the FY 2020 average fully supported cost to $278,602 per FTE, excluding travel costs. FDA will use this base unit fee in determining the hourly fee rate for reinspection and recall order fees for FY 2020 prior to including domestic or foreign travel costs as applicable for the activity.

To calculate an hourly rate, FDA must divide the FY 2020 average fully supported cost of $278,602 per FTE by the average number of supported direct FDA work hours in FY 2018—the last FY for which data are available. See table 1.

Dividing the average fully supported FTE cost in FY 2020 ($278,602) by the total number of supported direct work hours available for assignment in FY 2018 (1,160) results in an average fully supported cost of $240 (rounded to the nearest dollar), excluding inspection travel costs, per supported direct work hour in FY 2020.

To adjust the hourly rate for FY 2020, FDA must estimate the cost of inflation in each year for FY 2019 and FY 2020. FDA uses the method prescribed for estimating inflationary costs under the Prescription Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1) (21 U.S.C. 379h(c)(1))), the statutory method for inflation adjustment in the FD&C Act that FDA has used consistently. FDA previously determined the FY 2019 inflation rate to be 1.7708 percent; this rate was published in the FY 2019 PDUFA user fee rates notice in the Federal Register (August 1, 2018, 83 FR 37504). Utilizing the method set forth in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation rate of 1.7708 percent for 2019 and 2.3964 percent for 2020 and FDA intends to use these inflation rates to make inflation adjustments for FY 2020 for several of its user fee programs; the derivation of this rate will be published in the Federal Register in the FY 2020 notice for the PDUFA user fee rates.

The average fully supported cost per supported direct FDA work hour, excluding travel costs, of $240 already takes into account inflation as the calculation above is based on FY 2020 predicted costs. FDA will use this base unit fee in determining the hourly fee rate for reinspection and recall order fees for FY 2020 prior to including domestic or foreign travel costs as applicable for the activity. In FY 2018, FDA's Office of Regulatory Affairs (ORA) spent a total of $6,027,291 for domestic regulatory inspection travel costs and General Services Administration Vehicle costs related to FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) field activities programs. The total ORA domestic travel costs spent is then divided by the 9,976 CFSAN and CVM domestic inspections, which averages a total of $604 per inspection. These inspections average 35.44 hours per inspection. Dividing $604 per inspection by 35.44 hours per inspection results in a total and an additional cost of $17 (rounded to the nearest dollar) per hour spent for domestic inspection travel costs in FY 2018. To adjust for the $17 per hour additional domestic cost inflation increases for FY 2019 and FY 2020, FDA must multiply the FY 2019 PDUFA inflation rate adjustor (1.017708) times the FY 2020 PDUFA inflation rate adjustor (1.023964) times the $17 additional domestic cost which results in an estimated cost of $18 (rounded to the nearest dollar) per paid hour in addition to $240 for a total of $258 per paid hour ($240 plus $18) for each direct hour of work requiring domestic inspection travel. FDA will use these rates in charging fees in FY 2020 when domestic travel is required.

In FY 2018, ORA spent a total of $3,229,335 on 455 foreign inspection trips related to FDA's CFSAN and CVM field activities programs, which averaged a total of $7,097 per foreign inspection trip. These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing $7,097 per trip by 120 hours per trip results in a total and an additional cost of $59 (rounded to the nearest dollar) per paid hour spent for foreign inspection travel costs in FY 2018. To adjust $59 for inflationary increases in FY 2019 and FY 2020, FDA must multiply it by the same inflation factors mentioned previously in this document (1.017708 and 1.023964), which results in an estimated cost of $61 (rounded to the nearest dollar) per paid hour in addition to $240 for a total of $301 per paid hour ($240 plus $61) for each direct hour of work requiring foreign inspection travel. FDA will use these rates in charging fees in FY 2020 when foreign travel is required.

The fee will be assessed for a reinspection conducted under section 704 of the FD&C Act (21 U.S.C. 374) to determine whether corrective actions have been implemented and are effective and compliance has been achieved to the Secretary of Health and Human Services' (the Secretary) (and, by delegation, FDA's) satisfaction at a facility that manufactures, processes, packs, or holds food for consumption necessitated as a result of a previous inspection (also conducted under section 704) of this facility, which had a final classification of Official Action Indicated (OAI) conducted by or on behalf of FDA, when FDA determined the non-compliance was materially related to food safety requirements of the FD&C Act. FDA considers such non-compliance to include non-compliance with a statutory or regulatory requirement under section 402 of the FD&C Act (21 U.S.C. 342) and section 403(w) of the FD&C Act (21 U.S.C. 343(w)). However, FDA does not consider non-compliance that is materially related to a food safety requirement to include circumstances where the non-compliance is of a technical nature and not food safety related ( e.g., failure to comply with a food standard or incorrect font size on a food label). Determining when non-compliance, other than under sections 402 and 403(w) of the FD&C Act, is materially related to a food safety requirement of the FD&C Act may depend on the facts of a particular situation. FDA intends to issue guidance to provide additional information about the circumstances under which FDA would consider non-compliance to be materially related to a food safety requirement of the FD&C Act.

Under section 743(a)(1)(A) of the FD&C Act, FDA is directed to assess and collect fees from “the responsible party for each domestic facility (as defined in section 415(b) (21 U.S.C. 350d(b))) and the United States agent for each foreign facility subject to a reinspection” to cover reinspection-related costs.

Section 743(a)(2)(A)(i) of the FD&C Act defines the term “reinspection” with respect to domestic facilities as “1 or more inspections conducted under section 704 subsequent to an inspection conducted under such provision which identified non-compliance materially related to a food safety requirement of th[e] Act, specifically to determine whether compliance has been achieved to the Secretary's satisfaction.”

The FD&C Act does not contain a definition of “reinspection” specific to foreign facilities. In order to give meaning to the language in section 743(a)(1)(A) of the FD&C Act to collect fees from the U.S. agent of a foreign facility subject to a reinspection, the Agency is using the following definition of “reinspection” for purposes of assessing and collecting fees under section 743(a)(1)(A), with respect to a foreign facility, “1 or more inspections conducted by officers or employees duly designated by the Secretary subsequent to such an inspection which identified non-compliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved to the Secretary's (and, by delegation, FDA's) satisfaction.”

This definition allows FDA to fulfill the mandate to assess and collect fees from the U.S. agent of a foreign facility in the event that an inspection reveals non-compliance materially related to a food safety requirement of the FD&C Act, causing one or more subsequent inspections to determine whether compliance has been achieved to the Secretary's (and, by delegation, FDA's) satisfaction. By requiring the initial inspection to be conducted by officers or employees duly designated by the Secretary, the definition ensures that a foreign facility would be subject to fees only in the event that FDA, or an entity designated to act on its behalf, has made the requisite identification at an initial inspection of non-compliance materially related to a food safety requirement of the FD&C Act. The definition of “reinspection-related costs” in section 743(a)(2)(B) of the FD&C Act relates to both a domestic facility reinspection and a foreign facility reinspection, as described in section 743(a)(1)(A).

The FD&C Act states that this fee is to be paid by the responsible party for each domestic facility (as defined in section 415(b) of the FD&C Act) and by the U.S. agent for each foreign facility (section 743(a)(1)(A) of the FD&C Act). This is the party to whom FDA will send the invoice for any fees that are assessed under this section.

The fee is based on the number of direct hours spent on such reinspections, including time spent conducting the physical surveillance and/or compliance reinspection at the facility, or whatever components of such an inspection are deemed necessary, making preparations and arrangements for the reinspection, traveling to and from the facility, preparing any reports, analyzing any samples or examining any labels if required, and performing other activities as part of the OAI reinspection until the facility is again determined to be in compliance. The direct hours spent on each such reinspection will be billed at the appropriate hourly rate shown in table 2 of this document.

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated with such order performed by the Secretary (and by delegation, FDA) (section 743(a)(1)(B) of the FD&C Act). Non-compliance may include the following: (1) Not initiating a recall as ordered by FDA; (2) not conducting the recall in the manner specified by FDA in the recall order; or (3) not providing FDA with requested information regarding the recall, as ordered by FDA.

Section 743(a)(1)(B) of the FD&C Act states that the fee is to be paid by the responsible party for a domestic facility (as defined in section 415(b) of the FD&C Act) and an importer who does not comply with a recall order under section 423 or under section 412(f) of the FD&C Act. In other words, the party paying the fee would be the party that received the recall order.

The fee is based on the number of direct hours spent on taking action in response to the firm's failure to comply with a recall order. Types of activities could include conducting recall audit checks, reviewing periodic status reports, analyzing the status reports and the results of the audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition. The direct hours spent on each such recall will be billed at the appropriate hourly rate shown in table 2 of this document.

An invoice will be sent to the responsible party for paying the fee after FDA completes the work on which the invoice is based. Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration. Detailed payment information will be included with the invoice when it is issued.

Under section 743(e)(2) of the FD&C Act, any fee that is not paid within 30 days after it is due shall be treated as a claim of the U.S. Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code.

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

Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(e)(2)) provides for the exportation of an unapproved device under certain circumstances if the exportation is not contrary to the public health and safety and it has the approval of the foreign country to which it is intended for export. Requesters communicate (either directly or through a business associate in the foreign country) with a representative of the foreign government to which they seek exportation, and written authorization must be obtained from the appropriate office within the foreign government approving the importation of the medical device. An alternative to obtaining written authorization from the foreign government is to accept a notarized certification from a responsible company official in the United States that the product is not in conflict with the foreign country's laws. This certification must include a statement acknowledging that the responsible company official making the certification is subject to the provisions of 18 U.S.C. 1001. This statutory provision makes it a criminal offense to knowingly and willingly make a false or fraudulent statement, or make or use a false document, in any manner within the jurisdiction of a department or Agency of the United States. The respondents to this collection of information are companies that seek to export medical devices. FDA's estimate of the reporting burden is based on the experience of FDA's medical device program personnel.

In the Federal Register of March 11, 2019 (84 FR 8727), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

We have adjusted our burden estimate by decreasing the number of respondents by 5, which has resulted in a corresponding decrease of 15 hours to the currently approved hour burden and $1,250 to the total operating and maintenance costs. This adjustment is based on a decrease in the number of submissions we received over the last few years.

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

The Tobacco Control Act, enacted on June 22, 2009, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and provided FDA with the authority to regulate tobacco products (Pub. L. 111-31; 123 Stat. 1776). Specifically, section 101(b) of the Tobacco Control Act amended the FD&C Act by adding chapter IX (21 U.S.C. 387 through 387u), which provides FDA with tools to regulate tobacco products. Section 901 of the FD&C Act (21 U.S.C. 387a) states that Chapter IX—Tobacco Products applies to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary of Health and Human Services by regulation deems to be subject to this chapter.

The FD&C Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. On May 10, 2016 (81 FR 28973) FDA issued a final rule to deem products meeting the statutory definition of “tobacco product” to be subject to the FD&C Act. This final rule extended FDA's “tobacco product” authorities under Chapter IX to all tobacco products that meet the statutory definition of “tobacco product” in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)).

Section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1)) defines a “new tobacco product” as a tobacco product that was not commercially marketed in the United States on February 15, 2007, or a modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery, or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007. An order under section 910(c)(1)(A)(i) of the FD&C Act is required prior to marketing a new tobacco product. This requirement applies unless the product has been shown to be substantially equivalent to a valid predicate product or is exempt from substantial equivalence.

Section 910(b) of the FD&C Act states that a premarket tobacco application (PMTA) shall contain full reports of all investigations of health risks; a full statement of all components, ingredients, additives, and properties, and of the principle or principles of operation of such tobacco product; a full description of methods of manufacturing and processing (which includes a listing of all manufacturing, packaging, and control sites for the product); an explanation of how the product complies with applicable tobacco product standards; samples of the product and its components; and labeling.

FDA also encourages persons who would like to study their new tobacco product to meet with the Office of Science in the Center for Tobacco Products (CTP) to discuss their investigational plan. The request for a meeting should be sent in writing to the Director of CTP's Office of Science and should include adequate information for FDA to assess the potential utility of the meeting and to identify FDA staff necessary to discuss agenda items.

When the deeming final rule published, FDA revised the following information collections that added deemed products to these collections: Tobacco Product Establishment Registration and Submission of Certain Health Information (OMB control number 0910-0650); Tobacco Health Document Submission (OMB control number 0910-0654); Exemptions from Substantial Equivalence Requirements (OMB control number 0910-0684); Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product (OMB control number 0910-0673); Electronic Importer's Entry Notice (OMB control number 0910-0046); Exports: Notification and Recordkeeping Requirements (OMB control number 0910-0482); and Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 (OMB control number 0910-0775).

In the Federal Register of April 22, 2019 (84 FR 16673), FDA published a 60-day notice requesting public comment on the extension of collection of information “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act.” FDA received one comment that was Paperwork Reduction Act (PRA) related.

The commenter noted that they would like to see the associated collections that the deeming rule revised. FDA appreciates the comment addressing the associated deemed product information collections. FDA notes that in the PRA section of the deeming final rule (81 FR 28973 at 29076) all the revised OMB information collection control numbers and their revised burdens were all listed. Per the comment, we have added a listing of all the collections the final rule revised.

The commenter also notes that the burdens associated with deemed products are not all included in this notice even though the notice “appears intended to present a comprehensive set of burden estimates and analyses for information collection activities associated with . . . the Deeming Rule.” FDA notes that this notice is not intended to cover all information collection reviews associated with the deeming rule. Instead, this notice only covers the information collections that did not already have an approved collection prior to the deeming final rule. For the collections that existed prior to the deeming final rule, FDA added the new associated deeming-related burdens to these previously approved OMB control numbers. We also note that some of the estimates from the PRA section of the deeming rule may have changed since the final rule published. If any estimates have changed, these changes have been published in the Federal Register through the process associated with renewing PRA collections.

The comment also mentions the omission of the burden associated with the submission of harmful and potentially harmful constituents (HPHC) listings. FDA notes that we have not yet sought OMB approval of the burden associated with listing and reporting HPHCs for deemed products. On March 8, 2019, FDA revised the “Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule” guidance ( https://www.fda.gov/media/105346/download ) and the related Small Entity Compliance Guide entitled “FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements” ( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-deems-certain-tobacco-products-subject-fda-authority-sales-and-distribution-restrictions-and ). This revision extends the HPHCs reporting compliance date to a date that is 6 months after the publication date of a final guidance regarding HPHC reporting under section 904(a)(3) of the FD&C Act (21 U.S.C. 287d(a)(3)) and 9 months after that publication date for small tobacco product manufacturers. For products entering the market after the publication date of the final guidance, manufacturers must submit their HPHC report 90 days prior to marketing the products under section 904(a)(3).

In the preamble to the final deeming rule, FDA indicated that it intends to issue guidance regarding HPHC reporting (and later a testing and reporting regulation under section 915 of the FD&C Act (21 U.S.C. 387o)) with enough time for manufacturers to report, given the original 3-year compliance period. At this time, FDA has not published a final HPHC reporting guidance and as a result, we are providing a revised compliance date based on when a final HPHC reporting guidance is issued.

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

FDA estimates that it will take each respondent approximately 1,500 hours to prepare a PMTA seeking an order from FDA allowing the marketing of a new tobacco product. FDA also estimates that it would on average take an additional 213 hours to prepare an environmental assessment in accordance with the requirements of 21 CFR 25.40, for a total of 1,713 hours per PMTA application. This average represents a wide range of hours that will be required for these applications under different circumstances, with a small number requiring more hours ( e.g., as many as 5,000 hours for early applications that involve complex products and for which the company has no experience conducting studies or preparing analysis of public health impacts, or for which reliance on master files is not possible) as well as many requiring fewer hours ( e.g., as few as 50 hours for applications for products that are very similar to other new products). A PMTA may require one or more types of studies including chemical analysis, nonclinical studies, and clinical studies. FDA also estimates the number of PMTAs that FDA expects to receive annually will be 750 (642 ENDS Liquids and 108 ENDS Delivery Systems).

For tobacco products already on the market at the time of the final rule, much of the information required to support a PMTA may be obtained from previously published research on similar products. Therefore, FDA expects that a large portion of applications may be reviewed with no or minimal new nonclinical or clinical studies being conducted to support an application. In contrast, nonclinical and clinical studies may be required for market authorization of a new product for which there is limited understanding of its potential impact on the public health. The range of hours involved to compile these two types of applications would be quite variable.

FDA anticipates that the 200 potential respondents to this collection may need to meet with CTP's Office of Science to discuss their investigational plans. To request this meeting, applicants should compile and submit information to FDA for meeting approval. FDA estimates that it will take approximately 4 hours to compile this information, for a total of 800 hours additional burden.

Therefore, the total annual burden for submitting PMTA applications is estimated to be 1,285,550 hours. FDA's estimates are based on the corresponding information collection estimates and an assumption that manufacturers would submit applications for the premarket review of tobacco products.

In § 1143.3(c) (21 CFR 1143.3(c)) an exemption is provided to the manufacturer of a product that otherwise would be required to include the warning statement in § 1143.3(a)(1) on its packages and in its advertisements, i.e., “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” This warning is required to appear on at least 30 percent of the two principal display panels of the package and on at least 20 percent of the area of the advertisement.

To obtain an exemption from this requirement, a manufacturer is required to certify to FDA that its product does not contain nicotine and that the manufacturer has data to support that assertion. For any product that obtains this exemption, § 1143.3(c) requires that the product bear the statement: “This product is made from tobacco.” The parties that package and label such products will share responsibility for ensuring that this alternative statement is included on product packages and in advertisements.

The estimated average burden per response is based on currently approved information collection estimates. The estimated hours listed in the burden table for certification submissions reflect the time needed to test the product for nicotine and to prepare and submit the self-certification request. FDA expects that these types of certifications will be rare and estimates that the Agency will receive on average five submissions per year.

FDA concludes that the labeling statements in §§ 1143.3(a)(1) and 1143.5(a)(1) and the alternative statement in § 1143.3(c) ( i.e., “This product is made from tobacco”) are not subject to review by OMB because they do not constitute a “collection of information” under the PRA (44 U.S.C. 3501-3520). Rather, these labeling statements are a “public disclosure” of information originally supplied by the Federal government to the recipient for the purpose of “disclosure to the public” (5 CFR 1320.3(c)(2)).

The requirement for submission of warning plans for cigar products, and the specific requirements relating to the random display and distribution of required warning statements on cigar packaging and quarterly rotation of required warning statements in alternating sequence on cigar product advertising, appear in § 1143.5(c).

The six warnings for cigars (five specifically for cigars and the one addictiveness warning) are required to be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of cigar sold in product packaging and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a warning plan submitted to and approved by FDA. For advertisements, the warning statements must be rotated quarterly in alternating sequence in each advertisement for each brand of cigar in accordance with a warning plan submitted to and approved by FDA.

FDA published a final guidance in August 2018 ( https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM534739.pdf ) to assist manufacturers, importers, distributors, and retailers of cigars with the submission of warning plans. FDA will work with the submitters to ensure that the plans submitted meet the established criteria for approval under 21 CFR part 1143.

The warning statements on cigar packaging must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of cigar sold and are required to be randomly distributed in all areas of the United States in which the product is marketed in accordance with a warning plan submitted by the responsible cigar manufacturer, importer, distributor, or retailer to and approved by FDA.

FDA also requires that the required warning statements be rotated quarterly in alternating sequence in each advertisement for each brand of cigar, regardless of whether the cigar is sold in product packaging. This rotation of warning statements in cigar advertisements also must be done in accordance with a warning plan submitted by the responsible cigar manufacturer, importer, distributor, or retailer to and approved by FDA.

The burden estimates are based on FDA's experience with cigar warning plans, smokeless warning plans associated information collection (OMB control number 0910-0671), as well as warning plans for cigarettes submitted to the Federal Trade Commission prior to the implementation of the Tobacco Control Act on June 22, 2009.

We estimate 10 entities will submit warning plans, and it will take an average of 120 hours per respondent to prepare and submit a warning plan for packaging and advertising for a total of 1,200 hours.

Generally, FDA considers a “small-scale tobacco product manufacturer” to be a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5,000,000 or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with such manufacturer. To help make FDA's individual enforcement decisions more efficient, a manufacturer may voluntarily submit information regarding employment and revenues. FDA does not believe many manufacturers who fit the criteria of a small-scale tobacco product manufacturer would submit the voluntary information.

FDA estimates that there are approximately 75 small-scale manufacturers who will voluntarily submit information. FDA believes it will take respondents 2 hours to voluntarily submit information regarding employment and revenues for a total of 150 hours.

The total estimated burden for this information collection is 1,286,950 reporting hours, and 1,040 annual responses. Our estimated burden for the information collection reflects an overall decrease of 39,050 hours and a corresponding decrease of 315 responses. We attribute this adjustment to updated information in the number of submissions we received over the last few years.

Notice of this meeting is in compliance with the Federal Advisory Committee Act, (Title 5 U.S.C. Appendix). The National Offshore Safety Advisory Committee provides advice and recommendations to the Department of Homeland Security on matters relating to activities directly involved with or in support of the exploration of offshore mineral and energy resources insofar as they relate to matters within Coast Guard jurisdiction.

The National Offshore Safety Advisory Committee's Use of Offshore Supply Vessels and Other Non-Purpose Built Vessels for Restoration/Recovery Activities Subcommittee will meet on September 10, 2019 from 1:00 p.m. to 4:00 p.m. (Central Time) to review, discuss and formulate recommendations to be presented to the full Committee during the September 11, 2019 public meeting.

The National Offshore Safety Advisory Committee will hold a public meeting on September 11, 2019 from 8 a.m. to 6 p.m. (Central Time) to review and discuss the progress of, and any reports and recommendations received from the above listed subcommittee from their deliberations. The Committee will then use this information and consider public comments in discussing and formulating recommendations to the United States Coast Guard. Public comments or questions will be taken at the discretion of the Designated Federal Officer during the discussion and recommendation portions of the meeting and during the public comment period, see Agenda item (5). A complete agenda for the September 11, 2019 full Committee meeting is as follows:

(1) Welcoming remarks.

(2) General administration and acceptance of minutes from the March 20, 2019 National Offshore Safety Advisory Committee public meeting.

(3) Current business—Presentation and discussion of progress from the Use of Offshore Supply Vessels and Other Non-Purpose Built Vessels for Restoration/Recovery Activities Subcommittee.

(4) New Business—

(a) Status of National Offshore Safety Advisory Committee Recommendations to the U.S. Coast Guard.

(b) Presentation and discussion on future trends anticipated by classification societies.

(c) Presentation on Industry views of the new Well Control Rule.

(d) International Association of Drilling Contractors Presentation on trade association views of the new Well Control Rule.

(e) Bureau of Safety and Environmental Enforcement—Regulator view of the new Well Control Rule.

(f) Maritime Administration Update.

(5) Public comment period.

A copy of all meeting documentation will be available at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/nosac/meetings no later than August 27, 2019. Alternatively, you may contact Commander Myles Greenway or Mr. Patrick Clark as noted in the FOR FURTHER INFORMATION CONTACT section above.

Public comments or questions will be taken throughout the meeting as the Committee discusses the issues and prior to deliberations and voting. There will also be a public comment period at the end of the meeting. Speakers are requested to limit their comments to 3 minutes. Please note that the public comment period may end before the period allotted, following the last call for comments. Contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section above to register as a speaker.

The 15-member Council advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in Southeast Oregon. The members provide diverse perspectives in commodity, conservation, and general interests.

The meeting will include review and discussion of potential formal comments regarding the Southeastern Oregon Resource Management Plan Amendment Draft Environmental Impact Statement as part of the public participation process.

A final agenda will be posted online at https://www.blm.gov/get-involved/resource-advisory-council/near-you/oregon-washington/southeast-oregon-rac at least 1 week prior to the teleconference.

All meetings are open to the public in their entirety and a public comment period is scheduled for 10:15 a.m. to 10:45 a.m. The public may address the RAC during the public comment period or submit a written statement no later than August 16, 2019. Written comments should be sent to the BLM Public Affairs Officer at the address listed in the FOR FURTHER INFORMATION CONTACT section of this Notice. All comments received will be provided to the Southeast Oregon RAC prior to the meeting. Before including your address, phone number, email address, or other personal identifying information in your comments, please be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The Board has been established by authority of the Secretary of the Interior (Secretary) under 54 U.S.C. 100906, and is regulated by the Federal Advisory Committee Act.

The Board will convene its business meeting at 9:30 a.m. and adjourn at 5:15 p.m. During the morning session, the Board will be addressed by Secretary of the Interior David Bernhardt, and other senior Department of the Interior and National Park Service leaders. During the afternoon session, the Board will be briefed by National Park Service officials on the organization, programs, and priorities of the National Park Service; and the Board will attend to housekeeping matters, including the election of the chair and vice chair, and establishment of committees under the Board. There will also be a public comment period. The final agenda will be posted to the Board's website prior to the meeting at https://www.nps.gov/advisoryboard.htm.

The meeting is open to the public, but preregistration is required due to security requirements in the building and limited seating. Any individual who wishes to attend the meeting should register via email at Joshua Winchell itmd_joshuawinchell@nps.gov, or telephone (202) 513-7053. Interested persons may choose to make a public comment at the meeting during the designated time for this purpose. Members of the public may also choose to submit written comments by mailing them to Joshua Winchell, Staff Director, National Park System Advisory Board, Office of Policy, National Park Service, 1849 C Street NW, MS 2659, Washington, DC 20240, or via email at itmd_joshuawinchell@nps.gov. Individuals who plan to attend and need special assistance, such as sign language interpretation, should contact the NPS as provided above.

Public Disclosure of Comments: Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The Commission instituted this investigation under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on October 11, 2017, based on a complaint filed on September 5, 2017, by Intellectual Ventures II LLC of Bellevue, Washington (“IV”). 82 FR 47250 (Oct. 11, 2017). The complaint alleges a violation of section 337 by reason of infringement of certain claims of U.S. Patent Nos. 7,683,509 (“the '509 patent”); 7,928,348 (“the '348 patent”); 7,154,200 (“the '200 patent”); 7,067,944 (“the '944 patent”); and 7,067,952 (“the '952 patent”). The notice of investigation names as respondents Aisin Seiki Co., Ltd. of Aichi, Japan; Aisin Holdings of America, Inc. of Seymour, Indiana; Aisin Technical Center of America, Inc. of Northville, Michigan; and Aisin World Corporation of America of Northville, Michigan (collectively, “Aisin” or “Aisin Seiki”); Bayerische Motoren Werke AG of Munich, Germany, BMW of North America, LLC of Woodcliff Lake, New Jersey and BMW Manufacturing Co., LLC of Greer, South Carolina (collectively, “BMW”); Denso Corporation of Aichi, Japan and Denso International America, Inc. of Southfield, Michigan (“collectively, DENSO”); Honda Motor Co., Ltd. of Tokyo, Japan; Honda North America, Inc., of Torrance, California; American Honda Motor Co., Inc. of Torrance, California; Honda of America Mfg., Inc. of Marysville, Ohio; Honda Manufacturing of Alabama, LLC of Lincoln, Alabama; and Honda R&D Americas, Inc. of Torrance, California (collectively, “Honda”); Mitsuba Corporation of Gunma, Japan and American Mitsuba Corporation of Mount Pleasant, Michigan (collectively, “Mitsuba”); Nidec Corporation of Kyoto, Japan and Nidec Automotive Motor Americas, LLC of Auburn Hills, Michigan (collectively, “Nidec”); and Toyota Motor Corporation of Aichi Prefecture, Japan; Toyota Motor North America, Inc. of New York, New York; Toyota Motor Sales, U.S.A., Inc. of Torrance, California; Toyota Motor Engineering & Manufacturing North America, Inc. of Erlanger, Kentucky; Toyota Motor Manufacturing, Indiana, Inc. of Princeton, Indiana; and Toyota Motor Manufacturing, Kentucky, Inc. of Georgetown, Kentucky (collectively, “Toyota”). The Office of Unfair Import Investigations (“OUII”) was also named a party in this investigation.

The Commission previously terminated the investigation in part with respect to respondents BMW, DENSO, Mitsuba, and Nidec, as well as the '200, '944, and '952 patents. Notice (Apr. 18, 2018) (determining not to review Order No. 22 (Mar. 16, 2018)); Notice (May 4, 2018) (determining not to review Order No. 29 (Apr. 10, 2018)); Notice (May 4, 2018) (determining not to review Order No. 31 (Apr. 16, 2018)); Notice (May 11, 2018) (determining not to review Order No. 33 (Apr. 23, 2018)); Notice (June 19, 2018) (determining not to review Order No. 39 (May 21, 2018)); Notice (Aug. 15, 2018) (determining not to review Order No. 46 (July 19, 2018)); Notice (Aug. 15, 2018) (determining not to review Order No. 47 (July 24, 2018)); Notice (Aug. 27, 2018) (determining not to review Order No. 48 (Aug. 13, 2018)). Thus, the remaining respondents in this investigation are Aisin, Honda, and Toyota (collectively, “Respondents”), and the remaining asserted patents are the '509 and '348 patents (collectively, the “asserted patents”).

On November 13, 2018, the presiding administrative law judge (“ALJ”) issued a final initial determination (“ID”), finding no violation of section 337 with respect to the '509 and '348 patents. Specifically, the ID finds that the accused products infringe claims 14 and 15 of the '509 patent, but do not infringe claims 24-27 of the '348 patent. With respect to both patents, the ID finds that IV has not satisfied the domestic industry requirement of section 337(a)(2) & (a)(3), nor have Respondents established that any asserted claim is invalid for obviousness.

On November 27, 2018, the ALJ issued a Recommended Determination (“RD”) on remedy, the public interest, and bonding, recommending, should the Commission find a violation: (1) The issuance of a limited exclusion order directed to certain infringing thermoplastic-encapsulated electric motors, components thereof, and products and vehicles containing same; (2) the issuance of cease and desist orders against Aisin and Toyota; and (3) imposition of a bond of zero percent for infringing products that are imported during the period of Presidential review.

Also, on November 27, 2018, IV filed a petition for review, and Respondents filed a contingent petition for review, each challenging various findings in the final ID. On December 6, 2018, IV, Respondents, and OUII filed responses to the petitions for review.

On December 14, 2018, Respondents filed a notice that, on December 12, 2018, the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office issued four final written decisions finding that every claim asserted against Respondents in this investigation is unpatentable on invalidity grounds.

On January 7, 2019, the Alliance of Automobile Manufacturers and the Association of Global Automakers filed a joint public-interest submission.

On February 19, 2019, the Commission determined to review the ID in its entirety, and solicited further briefing from the parties on certain issues, and briefing from the parties and the public on remedy, the public interest and bonding. On March 1, 2019, the parties filed opening briefs, and on March 8, 2019, the parties filed reply briefs.

Having examined the record of this investigation, including the final ID and the parties' submissions, the Commission has determined that IV has failed to satisfy the domestic industry requirement of section 337(a)(2) & (a)(3), 19 U.S.C. 1337(a)(2) & (a)(3). Accordingly, the Commission has determined to terminate the investigation with a finding of no violation of section 337. The Commission, therefore, does not reach and takes no position on the other issues raised in the parties' petitions for Commission review.

The reasons for the Commission's determination are set forth more fully in the Commission's opinion.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

The Commission instituted this investigation on June 24, 2016, based on an amended complaint, as supplemented, filed by Laerdal Medical Corp. of Wappingers Falls, New York, and Laerdal Medical AS of Stavanger, Norway (together, “Laerdal”). 81 FR 41349-50. The investigation was instituted to determine whether there is a violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain carbon spine board, cervical collar, CPR masks, various medical training manikin devices, trademarks, copyrights of product catalogues and product inserts, and components thereof by reason of infringement of one or more of U.S. Patent No. 6,090,058 (“the '058 patent”), U.S. Trademark Registration No. 3,476,656 (“the '656 trademark”), U.S. Copyright Registration Nos. VA 1-879-023 and VA 1-879-026, or by reason of trade dress misappropriation and infringement. Id. at 41349. The Commission's notice of investigation named as respondents Shanghai Evenk International Trading Co., Ltd., Shanghai Honglian Medical Instrument Development Co., Ltd., and Shanghai Jolly Medical Education Co., Ltd., all of Shanghai, China; Zhangjiagang Xiehe Medical Apparatus & Instruments Co., Ltd., Zhangjiagang New Fellow Med Co., Ltd., Jiangsu Yongxin Medical Equipment Co., Ltd., and Jiangsu Yongxin Medical-Use Facilities Making, Co., Ltd, all of Zhangjiagang City, China; Jiangyin Everise Medical Devices Co., Ltd., of Jiangyin City, China; Medsource International Co., Ltd. and Medsource Factory, Inc. of PuDong, China; and Basic Medical Supply, LLC of Richmond, Texas (collectively, “Respondents”). Id. at 41350. The Office of Unfair Import Investigations was also named as a party. Id.

On November 21, 2016, the ALJ issued an initial determination finding all of the Respondents in default for failing to respond to the complaint and notice of investigation, Order No. 6 (Nov. 21, 2016). The Commission declined to review that determination, Notice (Dec. 20, 2016). The Commission determined to issue an LEO and a CDO with respect to the '058 patent and the '656 trademark, but declined to issue any relief with respect to Laerdal's trade dress or copyright claims. Comm'n Op. (Jun. 14, 2017). The Commission found that, even when the facts in Laerdal's complaint were taken as true, Laerdal's trade dress allegations were inadequate because Laerdal failed to specify its trade dresses, failed to show that its trade dress was nonfunctional, and failed to allege an adequate injury. Id. at 8-11. The Commission also found that Laerdal's copyright allegations were legally erroneous. Id. at 5-8.

Laerdal appealed the Commission's denial of trade dress relief. On December 7, 2018, the Federal Circuit held that the Commission erred by refusing to issue trade dress relief based on the allegations in the amended complaint, and remanded the proceeding to the Commission for a determination on the proper trade dress remedy and the public interest. Laerdal Med. Corp. v. Int'l Trade Comm'n, 910 F.3d 1207, 1210, 1216 (Fed. Cir. 2018). The Court's mandate issued on January 29, 2019.

On March 26, 2019, the Commission ordered Laerdal and OUII to: (1) Define each trade dress at issue; (2) explain what remedy is appropriate for each trade dress; (3) explain the effect of each remedy on the public interest; and (4) provide proposed remedial orders. Order (Mar. 26, 2019). Laerdal and OUII each provided responses on April 15, 2019, and reply submissions on April 29, 2019. On April 30, 2019, Laerdal provided corrected versions of its proposed LEO and CDO. The submissions agreed that the appropriate remedy is the entry of an LEO against Respondents and the entry of a CDO against Basic Medical Supply, LLC (“Basic Medical”), that the public interest factors do not weigh against granting these remedial orders, and that bonding should be set at 100 percent of the entered value of the infringing products.

The Commission has determined that the appropriate form of relief in this investigation is: (a) An LEO against Respondents prohibiting the unlicensed entry of products that infringe Laerdal's trade dresses; and (b) an order that Basic Medical cease and desist from importing, selling, offering for sale, marketing, advertising, distributing, offering for sale, transferring (except for exportation), or soliciting U.S. agents or distributors of imported cervical collars that infringe Laerdal's trade dresses. The Commission has further determined that the public interest factors enumerated in section 337(g)(1) (19 U.S.C. 1337(g)(1)) do not preclude the issuance of the LEO and CDO. Finally, the Commission has determined that the bond for importation during the period of Presidential review shall be in the amount of 100 percent of the entered value of the imported subject articles of the respondents. The investigation is terminated.

The Commission's orders and opinion were delivered to the President and the United States Trade Representative on the day of their issuance.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

The Commission instituted this investigation on April 10, 2019, based on a complaint filed by Heraeus Medical LLC of Yardley, Pennsylvania, and Heraeus Medical GmbH of Wehrheim, Germany (collectively, “Heraeus”). 84 FR 14394-95 (Apr. 10, 2019). The complaint alleges a violation of section 337 by reason of misappropriation of trade secrets, the threat or effect of which is to destroy or substantially injure a domestic industry in the United States or to prevent the establishment of such an industry. The complaint named as respondents Zimmer Biomet Holdings, Inc. of Warsaw, Indiana; Biomet, Inc. of Warsaw, Indiana; Zimmer Orthopaedic Surgical Products, Inc. of Dover, Ohio; Zimmer Surgical, Inc. of Dover, Ohio; Biomet France S.A.R.L. of Valence, France; Biomet Deutschland GmbH of Berlin, Germany; Zimmer Biomet Deutschland GmbH of Freiburg im Breisgau, Germany; Biomet Europe B.V. of Dordrecht, Netherlands; Biomet Global Supply Chain Center B.V. of Dordrecht, Netherlands; Zimmer Biomet Nederland B.V. of Dordrecht, Netherlands; Biomet Orthopedics, LLC of Warsaw, Indiana; and Biomet Orthopaedics Switzerland GmbH of Dietikon, Switzerland. The Commission's Office of Unfair Import Investigations (“OUII”) was named as a party. Subsequently, the investigation was terminated as to respondents Zimmer Orthopaedic Surgical Products, Inc. and Biomet Europe B.V. Order No. 10 (May 23, 2019), unreviewed Notice (June 14, 2019).

On June 17, 2019, complainants Heraeus moved for leave to amend the first amended complaint and notice of investigation to add three entities as respondents: Zimmer US, Inc. of Warsaw, Indiana; Zimmer, GmbH of Winterthur, Switzerland; and Biomet Manufacturing, LLC of Warsaw, Indiana. On June 21, 2019, respondents Zimmer Biomet Holdings, Inc.; Biomet, Inc.; Zimmer Surgical, Inc.; Biomet France S.A.R.L.; Biomet Deutschland GmbH; Zimmer Biomet Deutschland GmbH; Biomet Global Supply Chain Center B.V.; Zimmer Biomet Nederland B.V.; Biomet Orthopedics, LLC; and Biomet Orthopaedics Switzerland GmbH (collectively, “Biomet”) filed a response not opposing the motion to add the three entities. On June 25, 2019, OUII also filed a response supporting the motion.

On June 26, 2019, the ALJ issued the subject ID Commission Rule 210.14(b)(1) (19 CFR 210.14(b)(1)), granting the motion. The ALJ found that respondents' motion complies with the Commission's rules. ID at 2. The ALJ also found that there is no dispute over Heraeus's claim that it did not know nor should have known of the three entities' roles in the sale for importation, importation, and/or sale after importation of the accused products in this investigation prior to Biomet's discovery responses. Id. at 2-3. The ALJ found that such a circumstance constitutes the requisite good cause. Id. at 3. The ALJ further found that the certificate of service appended to Heraeus's motion indicates the three entities were served with the motion in accordance with Commission Rule 210.14(b) (19 CFR 210.14(b)). Id. (citing Mot. Mem. at 12.) The ALJ also found no prejudice to the public interest or to the rights of the parties to the investigation would result from granting the motion. Id. No party petitioned for review of the ID.

The Commission has determined not to review the subject ID.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in Part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

(1) Type of Information Collection: New Information Collection Instrument.

(2) Title of the Form/Collection: Developing and Validating Self-Guided Wellness and Stress Management Tools for Law Enforcement Agencies.

(3) The agency form number 1103-****. U.S. Department of Justice Office of Community Oriented Policing Services.

(4) Affected public who will be asked or required to respond as well as a brief abstract:

Primary: Law Enforcement Agencies and community partners.

Abstract: The study proposes an innovative and methodologically sophisticated research design to address the critical issue of law enforcement officer health and wellness.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: The estimate of the data collection tasks for respondents assigned to four groups for a total of 1,550 respondents and anticipated at 45 minutes per respondent.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated time burden is 893 hours.

If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, Room 3E, Room 405A, Washington, DC 20530.

DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the Office of Management and Budget (OMB) for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.

The National Agricultural Workers Survey (NAWS) is an employment-based, annual survey of the demographic, employment, and health characteristics of hired crop workers, including those who employers hire indirectly through labor contractors. The survey began in 1988. Each year the NAWS contractor interviews between 1,500 and 3,500 crop workers. The contractor interviews crop workers three times per year to account for the seasonality of agricultural employment. ETA uses NAWS data to estimate each state's share of crop workers who are eligible for employment and training services through ETA's National Farmworker Jobs Program. Other Federal agencies similarly use the survey's data to estimate the number and characteristics of crop workers and their dependents who qualify to participate in or receive services from various migrant and seasonal farmworker programs. The United States Department of Agriculture routinely uses NAWS data, along with other data, to estimate changes in agricultural productivity. ETA is seeking approval to continue the NAWS, without change. The Wagner-Peyser Act, as amended (29 U.S.C. 49f (d) and 49 l -2(a)) authorizes this information collection.

This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6.

Interested parties are encouraged to provide comments to the contact shown in the ADDRESSES section. To receive consideration, you must provide written comments, which DOL will summarize and include in the request for OMB approval of the final ICR. In order to help ensure appropriate consideration, comments should mention OMB Control No. 1205-0453.

Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.

DOL is particularly interested in comments that:

• 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;

• 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;

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

• 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).

Agency: DOL-ETA.

Type of Review: Extension without Changes.

Title of Collection: National Agricultural Workers Survey.

Form: Primary Questionnaire.

OMB Control Number: 1205-0453.

Affected Public: Individuals, Farms.

Estimated Number of Respondents: 6,090.

Frequency: Annual.

Total Estimated Annual Responses: 6,090.

Estimated Average Time per Response: 45 minutes.

Estimated Total Annual Burden Hours: 1,615 hours.

Total Estimated Annual Other Cost Burden: $0.

The NRTL Program recognizes organizations that provide product-safety testing and certification services to manufacturers. These organizations perform testing and certification for purposes of the program, to U.S. consensus-based product-safety test standards. The products covered by the NRTL Program consist of those items for which OSHA safety standards require “certification” by a NRTL. The requirements affect electrical products and 38 other types of products. OSHA does not develop or issue these test standards, but generally relies on standards development organizations (SDOs), which develop and maintain the standards using a method that provides input and consideration of views of industry groups, experts, users, consumers, governmental authorities and others having broad experience in the safety field involved.

Periodically, OSHA will add new test standards to the NRTL list of appropriate test standards following an evaluation of the test standard document. To qualify as an appropriate test standard, the agency evaluates the document to (1) verify it represents a product category for which OSHA requires certification by a NRTL, (2) verify the document represents an end product and not a component, and (3) verify the document defines safety test specifications (not installation or operational performance specifications). OSHA becomes aware of new test standards through various avenues. For example, OSHA may become aware of new test standards by: (1) Monitoring notifications issued by certain SDOs; (2) reviewing applications by NRTLs or applicants seeking recognition to include a new test standard in their scopes of recognition; and (3) obtaining notification from manufacturers, manufacturing organizations, government agencies, or other parties that a new test standard may be appropriate to add to the list of appropriate standards. OSHA may determine to include a new test standard in the list, for example, if the test standard is for a particular type of product that another test standard also covers, addresses a type of product that no standard previously covered, or is otherwise new to the NRTL Program.

In a March 14, 2019, Federal Register notice (84 FR 9384, referred to in this notice as “Proposed Modification,” and available at www.regulations.gov under Docket ID OSHA-2013-0012-0019), OSHA proposed adding one standard to the NRTL Program List of Appropriate Test Standards. OSHA received one comment on this proposed action (available at www.regulations.gov under Docket IDs OSHA-2013-0012-0022). OSHA fully considered this comment and determined that no action was necessary.

In this notice, OSHA announces the final decision to add one new test standard, to the NRTL Program List of Appropriate Test Standards, as described in Table 1:

OSHA will add this test standard to the “Appropriate Test Standards” web page on OSHA's website. Access to this web page is available at http://www.osha.gov/dts/otpca/nrtl/index.html.

Loren Sweatt, Acting Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice. Accordingly, the agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2)), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.

I. Background

The Department of Labor, as part of a continuing effort to reduce paperwork and respondent ( i.e., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)).

This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information collection burden is accurate. The Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651 et seq. ) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the extent possible unnecessary duplication of efforts in obtaining information (29 U.S.C. 657).

The collection of information contained in the Walking and Working Surfaces Standard for General Industry is necessary to protect workers from slip, trip, and fall hazards; increases compliance flexibility for employers; incorporates advances in industry best practices, national consensus standards, and technology since OSHA adopted the standard in 1971; and provides greater consistency between subpart D and construction standards. The following describes the information collection requirements in subpart D.

Paragraph 1910.23(b)(10) requires that the employer ensure that any ladder with structural or other defects be immediately tagged with “Dangerous: Do Not Use” or with similar language in accordance with § 1910.145 and removed from service until “repaired . . . or replaced.” The information will alert employers and workers that the ladder is not safe and must not be used.

Paragraph 1910.27(b)(1)(i) requires that before any rope descent system is used, the building owner inform the employer in writing that the building owner has identified, tested, certified, and maintained each anchorage so it is capable of supporting at least 5,000 pounds (268 kg), in any direction for each employee attached. The information must be based on an annual inspection by a qualified person and certification of each anchorage by a qualified person, as necessary, and at least every 10 years. The information will assure employers and workers that the building owner has inspected, tested and certified the anchorage, which the employer may not own or have any control over, as safe to use. Paragraph 1910.27(b)(1)(ii) requires that the employer ensure that no employee uses any anchorage before the employer has obtained written information from the building owner indicating that each anchorage meets the requirements of § 1910.27(b)(1)(i). The employer must keep the information for the duration of the job. The information will assure employers and workers that the anchorage, which the employer may not own or have any control over, is safe to use.

Paragraph 1910.28(b)(1)(ii) that requires when the employer can demonstrate that it is not feasible or creates a greater hazard to use guardrail, safety net, or personal fall protection systems on residential roofs, the employer must develop and implement a fall protection plan that meets the requirements of 29 CFR 1926.502(k) and training that meets the requirements of 29 CFR 1926.503(a) and (c).

OSHA has a particular interest in comments on the following issues:

• Whether the proposed information collection requirements are necessary for the proper performance of the agency's functions, including whether the information is useful;

• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;

• The quality, utility, and clarity of the information collected; and

• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.

OSHA is requesting that OMB extend approval of the information collection requirements contained in the Walking and Working Surfaces Standard for General Industry (29 CFR part 1910, subpart D). OSHA is requesting an adjustment decrease in the burden hours from 498,803 hours to 498,640 hours, a difference of 163 hours. The decrease is due to the change in the methodology of the calculations. The agency will summarize the comments submitted in response to this notice and will include this summary in the request to OMB.

Type of Review: Extension of a currently approved collection.

Title: Walking and Working Surfaces for General Industry (29 CFR 1910, subpart D).

OMB Control Number: 1218-0199.

Affected Public: Business or other for-profits; Federal Government; State, Local, or Tribal Government.

Number of Respondents: 487,500.

Frequency of Response: On occasion.

Average Time per Response: Various.

Estimated Total Burden Hours: 498,640 hours.

Estimated Cost (Operation and Maintenance): $54,697,500.

You may submit comments in response to this document as follows: (1) Electronically at http://www.regulations.gov, which is the Federal eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All comments, attachments, and other material must identify the agency name and the OSHA docket number for the ICR (Docket No. OSHA-2013-0002). You may supplement electronic submissions by uploading document files electronically. If you wish to mail additional materials in reference to an electronic or facsimile submission, you must submit them to the OSHA Docket Office (see the section of this notice titled ADDRESSES ). The additional materials must clearly identify your electronic comments by your name, date, and the docket number so the agency can attach them to your comments.

Because of security procedures, the use of regular mail may cause a significant delay in the receipt of comments. For information about security procedures concerning the delivery of materials by hand, express delivery, messenger, or courier service, please contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627).

Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about submitting personal information such as social security numbers and dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information ( e.g., copyrighted material) is not publicly available to read or download through this website. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Information on using the http://www.regulations.gov website to submit comments and access the docket is available at the website's “User Tips” link. Contact the OSHA Docket Office for information about materials not available through the website, and for assistance in using the internet to locate docket submissions.

Loren Sweatt, Acting Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506 et seq. ) and Secretary of Labor's Order No. 1-2012 (77 FR 3912).

The Institute of Museum and Library Services is the primary source of federal support for the nation's libraries and museums. We advance, support, and empower America's museums, libraries, and related organizations through grant making, research, and policy development. Our vision is a nation where museums and libraries work together to transform the lives of individuals and communities. To learn more, visit www.imls.gov.

Current Actions: The Museums for Digital Learning (MDL) is a project funded by the Institute of Museum and Library Services (IMLS) that seeks to identify and test new ways that digitized museum collections can be made available in the form of engaging digital educational resources via a pilot digital platform to educators around the country seeking to engage their students with all subjects. This two-year project is being led by the Indianapolis Museum of Art at Newfields in collaboration with two museum content partners—The Field Museum and History Colorado and a team of K-12 educators. Once the pilot suite of online products has been created by the project team, they will be tested in the classrooms of the ten educational partners. Testing and validation of the content contribution approach and standard templates to the pilot platform will be conducted with a cohort of up to ten additional museums of various sizes and disciplines.

This project aligns with IMLS's strategic goal and priorities of building the digital capacity of the sector. MDL will catalyze and empower museums to come together and create a national model with a shared vision to thoughtfully assess some of the critical gaps in the current platforms and digital access/use models, and then leverage the power of a shared digital platform to provide easy-to-access, interdisciplinary, and dynamic content from museums in digital format for educators and students.

The project will benefit the national education sector by providing a model for museums to collaborate as a sector with educators and engaging them not just as users of museum content and services, but as co-creators and co-facilitators of student learning; a suite of curriculum enhancing and student-centric digital collections-based educational resources; and an opportunity to pilot-test and improve the resources from the formative evaluation to better meet the needs of the nation's learners.

The product and process evaluation of the MDL project will be completed by a third party evaluator with experience in evaluating digital education platforms produced by the cultural heritage community. The process evaluation aspect will assess the overall planning and implementation of the collaborative model of MDL between the partner museums and the educators, as well as the effectiveness of the training and ease of content contribution of the ten additional museums. Much of the front-end and user experience design of the MDL platform will be formed through the collaboration and co-creation process between the cooperator, lead museum content partners, and the team of educators. The product evaluation will assess the ease of access and educational value of the collections-based digital education products for educators and students.

This action is to create the overall evaluation plan, survey and data collection instruments and instructions for the various evaluation techniques to be used at different points in the development and implementation of the MDL pilot initiative for the next two years.

Agency: Institute of Museum and Library Services.

Title: Museums for Digital Learning Project Evaluation.

OMB Number: 3137-TBD.

Frequency: Once.

Affected Public: Museum staff, teachers.

Number of Respondents: 100.

Estimated Average Burden per Response: 45 minutes.

Estimated Total Annual Burden: 65 hours.

Total Annualized capital/startup costs: N/A.

Total Annual costs: $1,755.

Section 4062(e) of the Employee Retirement Income Security Act of 1974 (ERISA) imposes reporting obligations in the event of a “substantial cessation of operations.” A substantial cessation of operations occurs when a permanent cessation at a facility causes a separation from employment of more than 15 percent of all “eligible employees.” “Eligible employees” are employees eligible to participate in any of the facility's employer's employee pension benefit plans. Following a substantial cessation of operations, the facility's employer is treated, with respect to its single employer pension plans covered by title IV of ERISA that are covering participants at the facility, as if the employer were a withdrawing substantial employer under a multiple-employer plan. Under section 4063(a) of ERISA, the Pension Benefit Guaranty Corporation (PBGC) must receive notice of the substantial cessation of operations and a request to determine the employer's resulting liability.

To fulfill such resulting liability, the employer may elect, under section 4062(e)(4)(A), to make additional contributions annually for seven years to plans covering participants at the facility where the substantial cessation of operations took place. Under sections 4062(e)(4)(E)(i)(I), (II), (III), (IV), and (V) respectively, an employer that is making the election for annual additional contributions must give notice to PBGC of: (1) Its decision to make the election, (2) its payment of an annual additional contribution, (3) its failure to pay an annual additional contribution, (4) its receipt of a funding waiver from the Internal Revenue Service (“IRS”), and (5) the ending of its obligation to make annual additional contributions.

PBGC is proposing a new form series that would be used to fulfill these reporting obligations. An employer or a plan administrator would file Form 4062(e)-01 to notify PBGC of the occurrence of a substantial cessation of operations and request a determination of the employer's liability. An employer would file Form 4062(e)-02 to notify PBGC that it made the election to pay annual additional contributions to a plan. An employer would file Form 4062(e)-03 to notify PBGC that it paid an annual additional contribution, received a funding waiver from the IRS, or is no longer obligated to pay annual additional contributions. Finally, an employer would file Form 4062(e)-04 to notify PBGC that it failed to pay an annual additional contribution to the plan.

PBGC needs the requested information in the forms and notification (1) to determine an employer's liability to a plan following a substantial cessation of operations and (2) to ensure that an employer that made the election of annual additional contributions is fulfilling its payment obligations.

On May 15, 2019, PBGC published in the Federal Register (at 84 FR 21840) a notice informing the public of its intent to request an approval of the new form series. PBGC did not receive any comments about this collection of information.

PBGC is requesting that OMB approve the collection of information for three years. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

PBGC estimates that 70 forms (10 Forms 4062(e)-01, 10 Forms 4062(e)-02, 49 Forms 4062(e)-03, and one Form 4062(e)-04) would be submitted each year. PBGC estimates that these forms would be completed by a combination of plan office staff and outside professionals (attorneys and actuaries). PBGC estimates a total annual hour burden of 315 hours (based on plan office time). The estimated dollar equivalent of this hour burden, based on an assumed hourly rate of $75 for administrative, clerical, and supervisory time is $23,625. PBGC estimates a total annual cost burden of $92,750 (based on 265 professional hours assuming an average hourly rate of $350).

Table of Contents I. Introduction II. Docketed Proceeding(s) I. Introduction

The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.

Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.

The public portions of the Postal Service's request(s) can be accessed via the Commission's website ( http://www.prc.gov ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3007.301. 1

The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.

1. Docket No(s).: MC2019-169 and CP2019-191; Filing Title: USPS Request to Add First-Class Package Service Contract 100 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: July 19, 2019; Filing Authority: 39 U.S.C. 3642, 39 CFR 3020.30 et seq., and 39 CFR 3015.5; Public Representative: Kenneth R. Moeller; Comments Due: July 29, 2019.

2. Docket No(s).: MC2019-170 and CP2019-192; Filing Title: USPS Request to Add Priority Mail Contract 539 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: July 19, 2019; Filing Authority: 39 U.S.C. 3642, 39 CFR 3020.30 et seq., and 39 CFR 3015.5; Public Representative: Kenneth R. Moeller; Comments Due: July 29, 2019.

This Notice will be published in the Federal Register .

Additional information is contained in the Board's decision served on July 22, 2019, which is available at www.stb.gov.

Together, the Caribbean Basin Economic Recovery Act (CBERA), as amended by the Caribbean Basin Trade Partnership Act (CBTPA) (19 U.S.C. 2701 et seq. ), are commonly referred to as the Caribbean Basin Initiative, or CBI. Section 212(f)(1) of CBERA (19 U.S.C. 2702(f)(1)) requires the U.S. Trade Representative to report on the performance of each CBERA or CBTPA beneficiary country. Barbados, Belize, Curacao, Guyana, Haiti, Jamaica, Saint Lucia, and Trinidad and Tobago receive benefits under both CBERA and CBTPA. Antigua and Barbuda, Aruba, the Bahamas, British Virgin Islands, Dominica, Grenada, Montserrat, Saint Kitts and Nevis, and Saint Vincent and the Grenadines currently receive benefits only under CBERA. For the purposes of this report, the term “beneficiary country” includes both the independent countries and dependent territories receiving benefits under CBTPA and/or CBERA.

As described in more detail below, the TPSC seeks comments on any aspect of the CBI program's operation, including the performance of CBERA and CBTPA beneficiary countries under the criteria described in sections 212(b) (19 U.S.C. 2702(b)), 212(c) (19 U.S.C. 2702(c)), and 213(b)(5)(B) (19 U.S.C. 2703(b)(5)(B)) of the CBERA, as amended. You can access the criteria at: http://www.gpo.gov/fdsys/pkg/USCODE-2011-title19/html/USCODE-2011-title19-chap15.htm . The report also will examine the CBI's effect on the volume and composition of trade and investment between the United States and the CBI beneficiary countries and on advancing U.S. trade policy goals. You can access the most recent CBI report at: https://ustr.gov/sites/default/files/gsp/2017%20CBI%20Report.pdf .

The TPSC seeks comments on any aspect of the CBI program's operation, including the performance of CBERA and CBTPA beneficiary countries using the following criteria:

Under section 212(b) (19 U.S.C. 2702(b)), unless the President determines that it is in the national economic or security interest of the United States, the President may not designate as a CBI beneficiary country any country that:

1. Is a Communist country.

2. Has expropriated, nationalized, or otherwise seized control of property owned by a U.S. citizen or by a corporation which is 50 percent or more owned by a U.S. citizen, unless the President determines that the country is taking steps to resolve the U.S. citizen's claim.

3. Fails to act in good faith in recognizing as binding or in enforcing arbitral awards in favor of U.S. citizens or corporations owned by U.S. citizens.

4. Affords preferential treatment to the products of a developed country other than the United States that has, or is likely to have, a significant adverse effect on U.S. commerce, unless the President has received satisfactory assurances that the country will eliminate the preferential treatment or acts to assure that there will be no significant adverse effect.

5. Allows a government-owned entity in such country to engage in the broadcast of copyrighted material, including films or television material, belonging to United States copyright owners without their express consent.

6. Is not a signatory to a treaty, convention, protocol, or other agreement regarding the extradition of U.S. citizens.

7. Has not or is not taking steps to afford internationally recognized worker rights, as defined in section 507(4) of the Trade Act of 1974, as amended (19 U.S.C. 2467(4)), to workers in the country (including any designated zone in that country).

Under section 212(c) (19 U.S.C. 2702(c)), the President has to consider the following factors in determining whether to designate any country as a CBI beneficiary country:

1. An expression of a country's desire to be so designated.

2. The economic conditions and living standards in a country.

3. The extent to which a country has assured the United States that it will provide equitable and reasonable access to the markets and basic commodity resources of the country.

4. The degree to which the country follows the international trade rules of the World Trade Organization (WTO).

5. The degree to which a country uses export subsidies or imposes export performance requirements or local content requirements that distort international trade.

6. The degree to which the trade policies of a country as they relate to other beneficiary countries are contributing to the revitalization of the region.

7. The degree to which a country is undertaking self-help measures to promote its own economic development.

8. Whether or not a country has taken or is taking steps to afford to workers in that country (including any designated zone in that country) internationally recognized worker rights.

9. The extent to which a country provides adequate and effective legal means for foreign nationals to secure, exercise, and enforce exclusive intellectual property rights.

10. The extent to which a country prohibits its nationals from broadcasting U.S. copyrighted materials, including film and television material, without their express consent.

11. The extent to which a country cooperates with the United States in the administration of CBI preferences.

Under section 213(b)(5)(B) (19 U.S.C. 2703(b)(5)(B)), in considering the eligibility of the CBI countries and dependent territories that have expressed an interest in receiving the enhanced preferences of the CBTPA, the President must take into account the existing eligibility criteria of the CBERA, as well as several additional revised criteria elaborated in the CBTPA. These additional criteria are:

1. Whether the beneficiary country has demonstrated a commitment to undertake its obligations under the World Trade Organization (WTO) on or ahead of schedule and participate in negotiations toward the completion of the Free Trade Area of the Americas (FTAA) or another free trade agreement.

2. The extent to which the country provides protection of intellectual property rights consistent with or greater than the protection afforded under the Agreement on Trade-Related Aspects of Intellectual Property Rights.

3. The extent to which the country provides internationally recognized worker rights, including: The right of association; the right to organize and bargain collectively; a prohibition on the use of any form of forced or compulsory labor; a minimum age for the employment of children; and acceptable conditions of work with respect to minimum wages, hours of work, and occupational safety and health.

4. Whether the country has implemented its commitments to eliminate the worst forms of child labor, as defined in section 507(6) of the Trade Act of 1974, as amended (19 U.S.C. 2467(6)).

5. The extent to which the country has met U.S. counter-narcotics certification criteria under the Foreign Assistance Act of 1961.

6. The extent to which the country has taken steps to become a party to and implements the Inter-American Convention Against Corruption.

7. The extent to which the country applies transparent, nondiscriminatory, and competitive procedures in government procurement, and contributes to efforts in international fora to develop and implement international rules on transparency in government procurement.

The TPSC must receive your comments by the August 30, 2019 deadline. You must make all submissions in English via http://www.regulations.gov, using Docket Number USTR-2019-0007. USTR will not accept hand-delivered submissions.

To make a submission using http://www.regulations.gov, enter the appropriate docket number in the “search for” field on the home page and click “search.” The site will provide a search-results page listing all documents associated with this docket. Find a reference to this notice by selecting “notice” under “document type” in the “filter results by” section on the left side of the screen and click on the link entitled “comment now.” You must identify on the first page of the submission the subject matter of the comment as the “CBI Report to Congress.” The regulations.gov website offers the option of providing comments by filling in a “type comment” field or by attaching a document using the “upload file(s)” field. The TPSC prefers that you provide submissions in an attached document and note “see attached” in the “type comment” field on the online submission form.

The TPSC prefers submissions in Microsoft Word (.doc) or Adobe Acrobat (.pdf) format. If the submission is in another file format, please indicate the name of the software application in the “Type Comment” field. File names should reflect the name of the person or entity submitting the comments. Please do not attach separate cover letters to electronic submissions; rather, include any information that might appear in a cover letter in the comments themselves. Similarly, to the extent possible, please include any exhibits, annexes, or other attachments in the same file as the comment itself, rather than submitting them as separate files. Submissions should not exceed 30 single-spaced, standard letter-size pages in 12-point type, including attachments.

You will receive a tracking number upon completion of the submission procedure at http://www.regulations.gov . The tracking number is confirmation that regulations.gov received the submission. Keep the confirmation for your records. The TPSC is not able to provide technical assistance for the website. The TPSC may not consider documents you do not submit in accordance with these instructions. If you are unable to provide submissions as requested, please contact Magaly Garcia, Director for Bolivia, Ecuador, and the Caribbean, at magaly.a.garcia@ustr.eop.gov, to arrange for an alternative method of transmission.

If you ask the TPSC to treat information you submitted as business confidential information (BCI), you must certify that the information is business confidential and you would not customarily release it to the public. You must clearly designate BCI by marking the submission “BUSINESS CONFIDENTIAL” at the top and bottom of the cover page and each succeeding page, and indicating, via brackets, the specific information that is BCI. Additionally, you must include “Business Confidential” in the “type comment” field. For any submission containing BCI, you must separately submit a non-confidential version, i.e., not as part of the same submission with the confidential version, indicating where BCI has been redacted. The TPSC will post the non-confidential version in the docket and it will be open to public inspection.

The TPSC will post comments in the docket for public inspection, except business confidential information. You can view comments on the www.regulations.gov website by entering the relevant docket number in the search field on the home page. You can find general information about the Office of the United States Trade Representative on its website: http://www.ustr.gov .

Title: FHWA Environmental Excellence Awards.

Background: In 1995 FHWA established the biennial Environmental Excellence Awards to recognize partners, projects, and processes that use FHWA funding sources to go beyond environmental compliance and achieve environmental excellence. The Environmental Excellence Awards also recognize partners, projects, and processes that exemplify innovation and commitment to the human environment, and organization and process innovation. Awardees must make an outstanding contribution that goes beyond traditional transportation projects and that encourages environmental stewardship and partnerships to achieve a truly multi-faceted, environmentally sensitive transportation solution.

Award: Anyone can nominate a project, process, person or group that has used FHWA funding sources to make an outstanding contribution to transportation and the environment. The nominator is responsible for submitting an application via the FHWA Environmental Excellence Awards website that gives a summary of the outstanding accomplishments of the entry. The collected information will be used by FHWA to evaluate the project, showcase environmental excellence, and enhance the public's knowledge of environmental stewardship in the planning and project development process. Nominations will be reviewed by a panel of judges from varying backgrounds. It is anticipated that awards will be given every 2 years. The winners are presented plaques at an awards ceremony.

Respondents: Anyone who has used FHWA funding sources in the 50 States, U.S. territories, and the District of Columbia.

Frequency: The information will be collected biennially.

Estimated Average Burden per Response: 8 hours per respondent per application.

Estimated Total Annual Burden Hours: It is expected that the respondents will complete approximately 150 applications for an estimated total of 1200 annual burden hours.

Public Comments Invited: You are asked to comment on any aspect of this information collection, including: (1) Whether the proposed collection is necessary for the FHWA's performance; (2) the accuracy of the estimated burdens; (3) ways for the FHWA to enhance the quality, usefulness, and clarity of the collected information; and (4) ways that the burden could be minimized, including the use of electronic technology, without reducing the quality of the collected information. The agency will summarize and/or include your comments in the request for OMB's clearance of this information collection.

As described by the applicant the intended service of the vessel BETTINA VITA is:

The complete application is available for review identified in the DOT docket as MARAD-2019-0115 at http://www.regulations.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the vessel name, state the commenter's interest in the waiver application, and address the waiver criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.

Please submit your comments, including the attachments, following the instructions provided under the above heading entitled ADDRESSES . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.

Go to the docket online at http://www.regulations.gov, keyword search MARAD-2019-0115 or visit the Docket Management Facility (see ADDRESSES for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.

Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.

If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to www.regulations.gov, as described in the system of records notice, DOT/ALL-14 FDMS, accessible through www.dot.gov/privacy. To facilitate comment tracking and response, we encourage commenters to provide their name, or the name of their organization; however, submission of names is completely optional. Whether or not commenters identify themselves, all timely comments will be fully considered. If you wish to provide comments containing proprietary or confidential information, please contact the agency for alternate submission instructions.

As described by the applicant the intended service of the vessel DELPHINE is:

Please submit your comments, including the attachments, following the instructions provided under the above heading entitled ADDRESSES . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.

Go to the docket online at http://www.regulations.gov., keyword search MARAD-2019-0117 or visit the Docket Management Facility (see ADDRESSES for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.

Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.

If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to www.regulations.gov, as described in the system of records notice, DOT/ALL-14 FDMS, accessible through www.dot.gov/privacy. To facilitate comment tracking and response, we encourage commenters to provide their name, or the name of their organization; however, submission of names is completely optional. Whether or not commenters identify themselves, all timely comments will be fully considered. If you wish to provide comments containing proprietary or confidential information, please contact the agency for alternate submission instructions.

As described by the applicant the intended service of the vessel PELAGIC 1 is:

The complete application is available for review identified in the DOT docket as MARAD-2019-0120 at http://www.regulations.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the vessel name, state the commenter's interest in the waiver application, and address the waiver criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.

Please submit your comments, including the attachments, following the instructions provided under the above heading entitled ADDRESSES . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.

Go to the docket online at http://www.regulations.gov, keyword search MARAD-2019-0120 or visit the Docket Management Facility (see ADDRESSES for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.

Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.

If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to www.regulations.gov, as described in the system of records notice, DOT/ALL-14 FDMS, accessible through www.dot.gov/privacy. To facilitate comment tracking and response, we encourage commenters to provide their name, or the name of their organization; however, submission of names is completely optional. Whether or not commenters identify themselves, all timely comments will be fully considered. If you wish to provide comments containing proprietary or confidential information, please contact the agency for alternate submission instructions.

As described by the applicant the intended service of the vessel KATHRYN JEAN is:

Please submit your comments, including the attachments, following the instructions provided under the above heading entitled ADDRESSES . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.

Go to the docket online at http://www.regulations.gov, keyword search MARAD-2019-0119 or visit the Docket Management Facility (see ADDRESSES for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.

Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.

If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to www.regulations.gov, as described in the system of records notice, DOT/ALL-14 FDMS, accessible through www.dot.gov/privacy. To facilitate comment tracking and response, we encourage commenters to provide their name, or the name of their organization; however, submission of names is completely optional. Whether or not commenters identify themselves, all timely comments will be fully considered. If you wish to provide comments containing proprietary or confidential information, please contact the agency for alternate submission instructions.

As described by the applicant the intended service of the vessel FOOTLOOSE is:

Please submit your comments, including the attachments, following the instructions provided under the above heading entitled ADDRESSES . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.

Go to the docket online at http://www.regulations.gov, keyword search MARAD-2019-0116 or visit the Docket Management Facility (see ADDRESSES for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.

Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.

If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to www.regulations.gov, as described in the system of records notice, DOT/ALL-14 FDMS, accessible through www.dot.gov/privacy. To facilitate comment tracking and response, we encourage commenters to provide their name, or the name of their organization; however, submission of names is completely optional. Whether or not commenters identify themselves, all timely comments will be fully considered. If you wish to provide comments containing proprietary or confidential information, please contact the agency for alternate submission instructions.

Under the Paperwork Reduction Act of 1995, before an agency submits a proposed collection of information to OMB for approval, it must first publish a document in the Federal Register providing a 60-day comment period and otherwise consult with members of the public and affected agencies concerning each proposed collection of information. The OMB has promulgated regulations describing what must be included in such a document. Under OMB's regulation at 5 CFR 1320.8(d), an agency must ask for public comment on the following: (i) 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; (ii) 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; (iii) how to enhance the quality, utility, and clarity of the information to be collected; (iv) how to minimize the burden of the collection of information on those who are to respond, including 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.

In compliance with these requirements, NHTSA asks for public comments on the following proposed collection of information:

Title of Collection: State Notification to Consumers of Motor Vehicle Recall Status.

OMB Control Number: None.

Type of Request: New information collection request.

Type of Review: Regular.

Form Number: OMB SF 424, OMB SF 424A, and OMB SF 424B.

Requested Expiration Date of Approval: 3 years from date of approval.

Abstract: NHTSA is responsible for reducing deaths, injuries and economic losses resulting from motor vehicle crashes. This is accomplished by setting and enforcing safety performance standards for motor vehicles and motor vehicle equipment, and through grants to state and local governments to enable them to conduct effective local highway safety programs. NHTSA investigates safety defects in motor vehicles; sets and enforces fuel economy standards; helps states and local communities reduce the threat of impaired drivers; promotes the use of safety belts, child safety seats and air bags; investigates odometer fraud; establishes and enforces vehicle anti-theft regulations; and provides consumer information on motor vehicle safety issues.

The National Traffic and Motor Vehicle Safety Act, 49 U.S.C. 30101, et. seq., as amended (the Safety Act), requires a motor vehicle manufacturer to notify the owners and purchasers of its vehicles of a safety-related defect, or that the vehicle does not comply with an applicable Federal motor vehicle safety standard. 1 A vehicle manufacturer must provide notice of a recall, in a manner prescribed through regulation by NHTSA, to each person registered under State law as the owner and whose name and address are reasonably ascertainable by the manufacturer through State records or other available sources or, if a registered owner is not notified through State registration information, to the most recent purchaser known to the manufacturer. 2

In order to identify owners of vehicles subject to a safety-related recall and provide notification to them, a motor vehicle manufacturer typically contracts with a third party that obtains vehicle registration data for the affected vehicles from State motor vehicle administrations. The motor vehicle manufacturer then notifies owners and purchasers by U.S. Mail about the safety recall and, among other things, about how to obtain a remedy to fix the defect or noncompliance. 3 To obtain a remedy, the consumer must then present the recalled motor vehicle to an authorized dealer for the dealer to remedy the defect or noncompliance. 49 U.S.C. 30120.

Recall completion rates can and do vary widely depending on a variety of factors such as the age and type of vehicle, as well as owners' perception of relative risk. 4 Considering this wide range, regardless of completion averages, the fact remains that there are at any time tens of millions of vehicles on the road with unremedied safety defects or noncompliances, each one creating a safety risk. NHTSA and the motor vehicle industry have sought to improve notice of safety-related defects to owners and to develop ways to increase the rate at which owners complete the remedy identified in the notice.

In 2016, in accordance with Section 24105 of the Fixing America's Surface Transportation (FAST) Act, Public Law 114-94, NHTSA announced a pilot program to evaluate the feasibility and effectiveness of a State process to inform consumers of open motor vehicle recalls at the time of motor vehicle registration. The grant was conditioned upon a State having the capability to use a vehicle identification number (VIN) to identify whether the specific vehicle was subject to an open safety recall. In 2017, NHTSA awarded the Maryland Motor Vehicle Administration a grant to provide vehicle owners and lessees notice of open safety related recalls on their vehicles. Maryland began notifying vehicle owners and lessees in the Spring of 2018.

Since the start of the Maryland notification program, several States have expressed an interest in partnering with NHTSA to provide similar recall notification to consumers in their states. While the Maryland Pilot Program offers a promising effort to increase consumer awareness to repair open safety recalls (and an opportunity to measure the effectiveness of such notification), additional notification by State DMVs would increase consumer awareness of open safety recalls and increase the repair rate of recalled vehicles. NHTSA believes such efforts will ultimately reduce the risk of a crash or injury due to a safety defect. Under its existing authority provided in the Safety Act, NHTSA is offering this opportunity to further develop this State to consumer notification to increase awareness of open recalls.

NHTSA encourages applicants to be creative and innovative when developing a proposal (application) for this grant. NHTSA is interested in proposals that provide vehicle owners and lessees with frequent notifications at touchpoints between the State and the vehicle. For example, NHTSA is interested in proposals that may offer options at the time of vehicle registration and other unique notification methods (or even follow-up notification). One potential option is to have notification at the time of registration and at motor vehicle emissions and/or safety inspection stations. A State is free to propose a process to make use of the functionality that may exist through its inspection stations or other intersection between the State and the consumer's vehicle. NHTSA does not want to discourage innovative approaches, provided they satisfy the program requirements of notification at the intersection of a vehicle owner or lessee and the State.

NHTSA is also interested in proposals that provide an analysis of recall completion data on an ongoing basis to assist in program evaluation, or assessment of owners' attitudes toward a particular recall notification protocol. In particular, NHTSA is interested in ways for a State to identify the motor vehicles that were remedied following notification of an open recall by the State. NHTSA looks forward to reviewing resourceful approaches that will motivate owners to remedy open recalls.

While this funding opportunity will be made available to all states, NHTSA anticipates an estimated twenty (20) state applications. NHTSA will require these applications not exceed 25 pages (not including resumes or appendices). NHTSA will also require OMB Standard Form (SF) 424 (including 424 “Application for Federal Assistance,” 424A “Budget Information for Non-Construction Programs,” and 424B “Assurances for Non-Construction Programs”), with the required information filled in and certified assurances signed. NHTSA estimates the burden for completing these applications at 3,200 hours total (160 hours × 20 state applicants = 3,200 hours) to allow each applicant thirty (30) days to conduct the necessary research, design their program, and complete the application package.

Affected Public: State vehicle registration authorities.

Estimated Number of Respondents: 20.

Frequency: One-time.

Number of Responses: 20.

Estimated Total Annual Burden Hours: 3,200.

Estimated Total Annual Burden Cost: None.

Public Comments Invited: You are asked to comment on any aspect of this information collection, including (a) whether the proposed collection of information is necessary for the Department's performance, including whether the information will have practical utility; (b) the accuracy of the Department's estimated burden; (c) ways for the Department to enhance the quality, utility and clarity of the information collection; and (d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.

A comment to OMB is most effective if OMB receives it within 30 days of publication.

Notice is hereby given under 41 CFR 102-3.65, pursuant to the Federal Advisory Committee Act (5 U.S.C. Appendix), that the FACI has been renewed for an additional two years beginning June 13, 2019. The purpose of the FACI is to present advice and recommendations to the Federal Insurance Office (FIO) in performing its duties and authorities. The advice and recommendations may cover specific or general insurance topics, processes, studies, and/or reports. The duties of the FACI shall be solely advisory and shall extend only to the submission of advice and recommendations, which shall be non-binding, to FIO. The FACI meets on a periodic basis, and its membership is balanced to include a cross-section of representative views of state and non-government persons having an interest in the duties and authorities of FIO.