Federal Register Vol. 81, No.212,

Members of the public may listen to the discussion by dialing the following Conference Call Toll-Free Number: 1-888-298-3457; Conference ID: 2806935. Please be advised that before being placed into the conference call, the operator will ask callers to provide their names, their organizational affiliations (if any), and an email address (if available) prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free phone number.

Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS) at 1-800-977-8339 and provide the FRS operator with the Conference Call Toll-Free Number: 1-888-298-3457, Conference ID: 2806935. Members of the public are invited to submit written comments; the comments must be received in the regional office by Friday, December 16, 2016. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1050, or emailed to Evelyn Bohor at [email protected]. Persons who desire additional information may contact the Rocky Mountain Regional Office at (303) 866-1040.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=264 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Rocky Mountain Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Rocky Mountain Regional Office at the above phone number, email or street address.

Scope of the Investigation

The product covered by this investigation is ammonium sulfate from the PRC. For a complete description of the scope of this investigation, see Appendix II.

The Department is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.1 For a full description of the methodology underlying our preliminary conclusions, see the Preliminary Decision Memorandum.2 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic version are identical in content.

In making these findings, we relied on facts otherwise available. Additionally, because we find that the mandatory respondents did not act to the best of their ability to respond to the Department's requests for information, and therefore impeded this investigation, we drew an adverse inference where appropriate in selecting from among the facts otherwise available.3 For further information, see “Use of Facts Otherwise Available and Adverse Inferences” in the Preliminary Decision Memorandum.

In accordance with sections 776(a)(1), 776(a)(2), and 776(b) of the Act, we applied facts otherwise available with an adverse inference to assign countervailable subsidy rates for non-cooperative mandatory respondents Wuzhoufeng Agricultural Science & Technology Co. Ltd. (Wuzhoufeng AST) and Yantai Jiahe Agriculture Means of Production Co. Ltd. (Yantai AMP). With respect to the all-others rate, section 705(c)(5)(B) of the Act provides that if the countervailable subsidy rates established for all exporters and producers individually investigated are determined entirely in accordance with section 776 of the Act, the Department may use any reasonable method to establish an all-others rate for exporters and producers not individually investigated. In this case, the rates assigned to Wuzhoufeng AST and Yantai AMP are based entirely on facts otherwise available, with an adverse inference, under section 776 of the Act. There is no other information on the record with which to determine an all-others rate. As a result, in accordance with section 705(c)(5)(B) of the Act, we have established the all-others rate by applying the countervailable subsidy rates for mandatory respondents Wuzhoufeng AST and Yantai AMP. The preliminary estimated countervailable subsidy rates are summarized in the table below.

In accordance with sections 703(d)(1)(B) and (d)(2) of the Act, we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of ammonium sulfate from the PRC as described in the “Scope of the Investigation” entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register, and to require a cash deposit for such entries of merchandise in the amounts indicated above.

In accordance with section 703(f) of the Act, we will notify the International Trade Commission (ITC) of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order, without the written consent of the Assistant Secretary for Enforcement and Compliance.

In accordance with section 705(b)(2) of the Act, if our final determination is affirmative, the ITC will make its final determination within 45 days after the Department makes its final determination.

Interested parties may submit case and rebuttal briefs, as well as request a hearing.4 Case briefs may be submitted no later than 30 days after the publication of this preliminary determination in the Federal Register, and rebuttal briefs, limited to issues raised in the case briefs, may be submitted no later than five days after the deadline for case briefs. Interested parties who wish to request a hearing, or to participate if one is requested, must do so in writing within 30 days after the publication of this preliminary determination in the Federal Register.

This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

The meeting will be open to the public with seating on a first-come, first-served basis. Members of the public may also listen to the meeting by telephone by calling a domestic toll-free telephone or international toll or toll-free number to connect to a live, listen-only audio feed. Call-in participants should be prepared to provide their first name, last name, and affiliation.

Domestic Toll Free: 866-844-9416.

International Toll and Toll Free: Will be posted in the latest press release for the meeting on the MRAC's meetings Web page, http://www.cftc.gov/About/CFTCCommittees/MarketRiskAdvisoryCommittee/mrac_meetings. After opening the latest press release, click on Related Links for the number(s).

Pass Code/Pin Code: CFTC.

Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (“OMB”) for each collection of information they conduct or sponsor. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, the CFTC is publishing notice of the proposed collection of information listed below.

Title: Practice by Former Members and Employees of the Commission (OMB Control No. 3038-0025). This is a request for extension of a currently approved information collection.

Abstract: Commission Rule 140.735-6 governs the practice before the Commission of former members and employees of the Commission and is intended to ensure that the Commission is aware of any existing conflict of interest. The rule generally requires former members and employees who are employed or retained to represent any person before the Commission within two years of the termination of their CFTC employment to file a brief written statement with the Commission's Office of General Counsel. The proposed rule was promulgated pursuant to the Commission's rulemaking authority contained in section 8a(5) of the Commodity Exchange Act, 7 U.S.C. 12a(5) (1994), as amended. With respect to the collection of information, the CFTC invites comments on:

• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;

• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

• Ways to minimize the burden of 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.

Burden Statement: Section 140.735-6 of the Commission's regulations result in information collection requirements within the meaning of the PRA. The respondent burden for this collection is estimated to average 0.10 hours per response to file the brief written statement. This estimate include the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; and transmit or otherwise disclose the information.

Estimated number of responses: 30.

Estimated total annual burden on respondents: 0.10 hours.

Estimated total annual burden on respondents: 3.

Frequency of collection: On occasion.

There are no startup capital costs or operating and maintenance costs associated with this collection.

I. Administration of the Challenge Competition

The Challenge will be conducted by the U.S. Department of Education. Luminary Labs, L.L.C. (Luminary Labs) has been contracted by the Department to assist and support the Department in organizing and managing this competition. Activities conducted by Luminary Labs may also include providing technical assistance to potential entrants, entrants, and finalists.

Simulated digital learning environments, such as virtual and augmented reality experiences, training simulations, and multiplayer video games, represent an emerging class of instructional content delivery in education. Research indicates that simulation-based learning provides students with enriched experiences in information retention, engagement, skills training, and learning outcomes.2 The virtual reality, video game developer, and educational technology communities are invited to design simulations that prepare America's students for the increasingly competitive workforce through next-generation career and technical education.

A call for public feedback, which took place from November 4 to December 9, 2015, helped to shape the Challenge. This public feedback informed the design of several Challenge elements, including the selection criteria, approach to technology, and the content of the submission form. Specifically, the public feedback indicated that the field was interested in the Department allowing maximum flexibility to entrants designing concepts. More information regarding the call for public feedback can be found on the Challenge Web page.

The Challenge will be conducted in four phases:

(1) Challenge launch and the first round submission phase;

(2) Judging of first round submissions and selection of finalists;

(3) Virtual Accelerator Phase (inclusive of finalist mentorship, Innovator's Boot Camp, second round submissions, and Demonstration Day); and

(4) Final judging and selection of winner(s).

The Challenge calls upon potential entrants to submit information concerning concepts that would allow users to gain and demonstrate new academic, technical, and employability skills through engaging simulation experiences. The Department is most interested in immersive and engaging simulations that will help define the next generation of applied learning.

The Department invites potential entrants to submit concepts which may include a prototype for discrete, playable simulations with clearly defined learning goals. The Department seeks concepts that aim to build competency in multiple skills by familiarizing the user with a particular career pathway or providing the user with guided experiences.

The Department seeks concepts with the potential to connect to other simulations and set the stage for a more competitive and robust marketplace for educational simulations. The Department encourages developers to make aspects of their EdSims available through open source licenses and low-cost sharable components in order to increase access to CTE and educational simulations.3

Up to five finalists will be selected from the pool of submissions received during the first round submission phase. From the total prize pool of $680,000, each of the finalists will be awarded $50,000 for their submission based on a review by the judging panel using the criteria in paragraph (a) in the Selection Criteria section of this notice. Finalists will be encouraged to use their winnings to improve upon their submissions. Finalists are required to participate in the Virtual Accelerator Phase, submit a second round submission, and attend the Innovator's Boot Camp and Demonstration Day. After the Virtual Accelerator Phase, Demonstration Day, and final judging using the criteria in paragraph (b) in the Selection Criteria section of this notice, the winner(s) will be selected by the Department and receive the remainder of the prize money.

The Virtual Accelerator Phase begins on the date finalists are announced and concludes on Demonstration Day,4 which is the day when finalists present their second round submissions to the judging panel. During this phase, the finalists will revise and improve upon their submissions in preparation for Demonstration Day. On Demonstration Day, the finalists will be required to present their concept and demonstrate a final prototype.

General Elements of the Virtual Accelerator Phase include the following—

(1) Mentorship: Finalists will have access to subject matter experts (SMEs) who will act throughout the Virtual Accelerator Phase as mentors, helping the finalists to revise and improve their submissions.

(2) Innovator's Boot Camp: 5 Finalists will be required to participate in the Innovator's Boot Camp. The Innovator's Boot Camp will either be a live event in the greater New York City metropolitan area, or a virtual event. Finalists will be required to cover their own expenses to attend the Innovator's Boot Camp and may use their prize money for this purpose. The Innovator's Boot Camp is expected to be conducted over a three-day period. Finalists will receive guidance through teaching modules, which may include hands-on activities, with SMEs and Luminary Labs staff. While the agenda has yet to be finalized, major themes will likely include user testing and interface development along with instructions on how to best revise and improve finalists' submissions, potentially including various design and innovation methodologies that would improve access to CTE programs for everyone, including individuals with disabilities.

(3) Demonstration Day Presentation Support: After the Innovator's Boot Camp and prior to Demonstration Day, all finalists will have the opportunity to practice their presentations and receive feedback from Luminary Labs on how to improve their Demonstration Day presentations.

Following Demonstration Day, a judging panel will provide recommendations to the Department on the selection of one or more winners from the pool of finalists to receive the remainder of the prize money.

Program Authority: The goals, purposes, and activities related to the Challenge are authorized by section 114(c)(1) of Perkins IV, 20 U.S.C. 2324(c)(1). Under this section, the Secretary of the U.S. Department of Education is authorized to carry out research, development, dissemination, evaluation and assessment, capacity building, and technical assistance with regard to CTE programs under Perkins IV. Following the Challenge, the Department plans to post abstracts of the submissions selected as finalists and winners on the Challenge Web page for public viewing. Abstracts will include a concept summary and a selection of multimedia elements from each finalist's and winner's submission. The judge's scores will not be posted. Neither the Department nor Luminary Labs will provide feedback to entrants that are not selected as finalists.

(a) Eligible entrants must be:

(1) Individuals at least 18 years of age and a citizen or permanent resident of the United States; 6

(2) Teams of individuals that:

(i) Are all at least 18 years of age;

(ii) Include at least one citizen or permanent resident of the United States; and

(iii) May also include foreign citizens who affirm at the time of submission of an entry for the Challenge that they are foreign citizens, who are not permanent residents; or

(3) An entity registered or incorporated in accordance with applicable State and local laws, and maintaining a primary place of business in the United States. The entity may include foreign citizens participating as employees of the entity.

(b) Ineligible entrants include—

(1) A foreign citizen unless participating as part of an eligible team or entity;

(2) A Federal entity;

(3) A Federal employee acting within the scope of his or her employment; and

(4) All employees of the Department, Luminary Labs, Challenge sponsors, or any other individual or entity associated with the development or administration of the Challenge, as well as members of such persons' immediate families (spouses, children, siblings, parents), and persons living in the same household as such persons, whether or not related.

(c) Entrants must:

(1) Register on the Challenge Web page (see Additional Terms that are Part of the Official Rules, under the General Terms and Conditions in this notice);

(2) Enter a submission on the Challenge Web page according to the rules, terms, and conditions in this notice;

(3) Comply with all requirements of the Challenge;

(4) Provide affirmation upon submission of an entry for the Challenge that an entrant is eligible under subsection (a) of this section. If selected as a finalist, entrants must provide documentation to demonstrate their eligibility at that time.

(5) Agree to—

(i) Assume any and all risks and waive claims against the Federal government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from their participation in the Challenge, whether the injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arises through negligence or otherwise;

(ii) Indemnify the Federal government against third party claims for damages arising from, or related to, competition activities, patents, copyrights, and trademark infringements; and

(iii) Comply with and abide by the Official Rules, Terms and Conditions in this notice, and the decisions of the Department which shall be final and binding in all respects.

(d) Entrants are not required to obtain liability insurance or demonstrate financial responsibility in order to participate in the Challenge.

The total prize pool for the Challenge is $680,000. From the $680,000 Challenge prize pool funds, up to five finalists will be awarded $50,000 each following the judging of the first round submissions. Finalists will improve upon and revise their submissions during the Virtual Accelerator Phase. At the conclusion of the Virtual Accelerator Phase, finalists must submit a second round submission and present their submissions on Demonstration Day. After Demonstration Day, a judging panel will provide recommendations to the Department on the selection of one or more winners from the pool of finalists to receive the remainder of the prize money.

Prizes awarded under this competition will be paid by electronic funds transfer. Winners are responsible for any applicable local, State, and Federal taxes and reporting that may be required under applicable tax laws.

(a) To participate in the Challenge, an entrant must submit an eligible entry according to the Eligibility section of this notice. Each of the following five selection criteria may be assigned up to five points during the judging of first round submissions in order to select finalists (for a total of up to 25 points). The following criteria will be used to select the finalists:

(1) Learning Outcomes (up to 5 points). The extent to which the submission contains: Clearly defined academic, technical, and employability skill-learning objectives; a comprehensive description of the desired change or improvement in the user's knowledge and skills; and an efficient mechanism to provide feedback to the user and instructor with respect to progress toward achievement of the learning outcomes.

(2) Engagement (up to 5 points). The extent to which the submission describes an engaging user experience that is on par with commercially available entertainment games.

(3) Commitment (up to 5 points). The extent that the submission demonstrates an appropriate level of commitment and ability of the entrant to move from concept to the demonstrative prototype within the timeline of the Challenge.

(4) Implementation Strategy (up to 5 points). The extent to which the submission considers the implementation challenges that schools face, such as cost and potential technological constraints, including how to integrate with existing and future technology.

(5) Scalability and Expansion (up to 5 points). The extent to which the submission demonstrates the scalability of the simulation, including its potential to connect with other simulations, as well as set the stage for a more competitive and robust marketplace for educational simulations.

(b) When judging the finalist submissions, including a prototype, judges will recommend to the Department the winner(s) from the pool of the finalists. From the pool of finalists, the winner(s) will be selected based on the following six criteria. Each of the six selection criteria may be assigned up to five points during the selection of the winner(s) from the pool of finalists (for a total of up to 30 points). The following criteria will be used to select the winner(s):

(1) Learning Outcomes (up to 5 points). The extent to which the simulation prototype contains clearly defined academic, technical, and employability learning objectives; spurs change or improvement in the user's knowledge and skills; and provides data to the user and instructor with respect to progress toward achievement of the learning outcomes.

(2) Engagement—User Experience (up to 5 points). The extent to which the simulation prototype demonstrates an engaging user experience on par with commercially available entertainment games.

(3) Engagement—User Interface (up to 5 points). The extent to which the simulation prototype exhibits a thoughtful user interface design on par with commercially available entertainment games.

(4) Commitment (up to 5 points). The extent to which the submission—

(i) Demonstrates the entrant's evolution and improvement of the concept; and

(ii) Illustrates the entrant's ability and intention to improve upon and scale the simulation beyond the Challenge timeframe.

(5) Implementation Strategy (up to 5 points). The extent to which the submission describes a detailed plan for implementation that takes into account potential barriers such as cost and technological constraints, including integration with existing and future technology, and proposes potential solutions to overcome such barriers.

(6) Long-term Vision (up to 5 points). The extent to which the submission—

(i) Demonstrates a plan for encouraging collaboration among the developer community, including making aspects of the solution available through open source licenses; and

(ii) Provides a vision of how the entrant's plan will stimulate the broader educational simulation market.

1. To participate in the Challenge, an entrant must—

(a) Register on the Challenge Web page.

(b) Enter the required information on the Challenge Web page submission form.

2. Content and Form of Submission:

To submit an entry to the first round of the Challenge, an entrant must complete the submission form on the Challenge Web page. Finalists must submit a second round submission using the second round submission form on the Challenge Web page to be eligible for winner selection.

3. Submission Dates and Times:

The first round submissions phase officially begins November 2, 2016 with this announcement of the Challenge and continues to January 17, 2017 at 4:59:59 p.m., Washington, DC time. Luminary Labs is the official timekeeper for the Challenge.

Submissions must be received during the first round submissions phase of the Challenge to be eligible. To submit an entry to the Challenge, an entrant must go to the Challenge Web page and complete all required fields of the submission form before the close of the first round submissions phase. Each entrant must complete all of the required fields in the submission form in accordance with the Official Rules, Terms, and Conditions section of this notice. All entrants are required to provide consent to those Official Rules, Terms, and Conditions upon submitting an entry. Once submitted, a submission may not be altered during the first round submissions phase. The Department reserves the right to disqualify any submission that the Department deems inappropriate.

Entrants may enter individually or as part of a team, and teams are strongly encouraged. Each team member must be clearly identified on the team's submission form for the team to be eligible. Teams must designate a primary contact to serve as the team lead (Team Lead) and manage the distribution of any awarded prizes. In the event a dispute regarding the identity of the entrant who actually submitted the entry cannot be resolved by the Department, the affected entry will be deemed ineligible.

The first round submissions phase closes at 4:59:59 p.m., Washington, DC time on January 17, 2017. The Department encourages entrants to submit entries as far in advance of the deadline as possible and suggests not later than one hour before the deadline to ensure the completed submission is received. If an entrant is unable to submit an entry before the deadline date because of a technical problem with the Challenge Web page system, the entrant must immediately contact the person listed under For Further Information Contact in this notice, and provide an explanation of the technical problem experienced on the Challenge Web page system. Where possible, this should include a screenshot or photograph of the on-screen problem. The Department will accept the entrant's submission if the Department can confirm that a technical problem occurred with the Challenge Web page system and that the technical problem affected the entrant's ability to submit an entry by 4:59:59 p.m., Washington, DC time, on the entry deadline date. The Department will contact the entrant after a determination is made on whether the entry will be accepted.

Individuals with disabilities who need an accommodation or auxiliary aid in connection with the submission process should contact the person listed under For Further Information Contact in this notice. If the Department provides an accommodation or auxiliary aid to an individual with a disability in connection with the submission process, the entry remains subject to all other requirements and limitations in this notice.

Should the volume of first round submissions exceed the capacity of the independent judges to conduct a thorough evaluation of the submissions, an independent review panel with expertise relevant to the criteria described in the Award Selection Criteria section of this notice will conduct a preliminary review of the first round submissions. In conducting the preliminary review, the independent review panel will assign scores to each first round submission according to the criteria described in the Award Selection Criteria section of this notice. During the preliminary review, each criterion may be assigned up to 5 points for a total of up to 25 points.

The size of the independent review panel will be based on the number of submissions received. Each member of the independent review panel will score a maximum of thirty submissions and all submissions will receive scores from three different independent review panelists.

The submissions with the thirty highest scores assigned by the independent review panel will then be scored by independent judges based on the quality of each entry according to the criteria described in the Award Selection Criteria section of this notice.

Based on their individual expertise, judges will recommend up to five finalists to be selected by the Department. Once the Department has selected a group of finalists based on the recommendations of the judges consistent with the selection criteria, the finalists will then refine their submissions during the Virtual Accelerator Phase. At the conclusion of the Virtual Accelerator Phase, finalists will submit a second round submission and present their submissions on Demonstration Day.

Entries will be scored by the judges based on the quality of each entry according to the criteria described in paragraph (a) of the Selection Criteria section in this notice. When selecting finalists from the first round submission phase, each of the five criteria may be worth up to five points for a total of up to 25 points. When selecting the winner(s) from the finalists, judges will consider the six criteria described in paragraph (b) of the Selection Criteria section in this notice. Each of the six criteria will be assigned up to five points for a total of up to 30 points available.

By participating in the Challenge, each entrant acknowledges and agrees that such recommendations of the judges based on the criteria may differ and agrees to be bound by, and not to challenge, the final decisions of the Department.

The Department reserves the right to suspend, postpone, cease, terminate, or otherwise modify this Challenge or any entrant's participation in the Challenge, at any time at the Department's sole discretion.

All entry information submitted on the Challenge Web page and all materials, including any copy of the submission, becomes property of the Department and will not be acknowledged or returned by Luminary Labs or the Department. However, entrants retain ownership of their concepts, including any software, research, or other intellectual property (IP) that they develop in connection therewith, subject to the license granted to the Department to use submissions as set forth in the Intellectual Property of Solutions section of this notice. Proof of submission is not considered proof of delivery or receipt of such entry. Furthermore, the Department and Luminary Labs shall have no liability for any submission that is lost, intercepted, or not received by the Department or Luminary Labs. The Department and Luminary Labs assume no liability or responsibility for any error, omission, interruption, deletion, theft, destruction, unauthorized access to, or alteration of, submissions.

By participating in the Challenge, each entrant represents, warrants, and covenants as follows:

(a) The entrants are the sole authors, creators, and owners of the submission;

(b) The entrant's submission—

(i) Is not the subject of any actual or threatened litigation or claim;

(ii) Does not, and will not, violate or infringe upon the intellectual property rights, privacy rights, publicity rights, or other legal rights of any third party;

(iii) Does not contain any harmful computer code (sometimes referred to as “malware,” “viruses,” or “worms”); and

(c) The submission, and entrants' use of the submission, does not, and will not, violate any applicable laws or regulations of the United States.

If the submission includes the work of any third party (such as third party content or open source code), the entrant must be able to provide, upon the request of the Department or Luminary Labs, documentation of all appropriate licenses and releases for such third party works. If the entrant cannot provide documentation of all required licenses and releases, the Department reserves the right, in its sole discretion, to disqualify the applicable submission, or direct the entrant to secure the licenses and releases for the Department's benefit within three days of notification of the missing documentation and allow the applicable submission to remain in the Challenge. In addition, the Department reserves all rights to pursue an entrant for claims based on damages incurred by entrant's failure to obtain such licenses and releases.

Entrants will indemnify, defend, and hold harmless the Department and Luminary Labs from and against all third party claims, actions, or proceedings of any kind and from any and all damages, liabilities, costs, and expenses relating to, or arising from, entrant's submission or any breach or alleged breach of any of the representations, warranties, and covenants of entrant hereunder. The Department reserves the right to disqualify any submission that the Department, in its discretion, deems to violate these Official Rules, Terms and Conditions in this notice.

Each entrant retains title to, and full ownership of, its submission. The entrant expressly reserves all intellectual property rights not expressly granted under this agreement. By participating in the Challenge, each entrant hereby irrevocably grants a license to the Department and Luminary Labs to store and access submissions in perpetuity that may be reproduced or distributed in the future. Please refer to the Intellectual Property of Submissions section of this notice for further information regarding rights to submissions.

By participating in the Challenge, each entrant hereby irrevocably grants to the Department and Luminary Labs the right to use such entrant's name, likeness, image, and biographical information in any and all media for advertising and promotional purposes relating to the Challenge in perpetuity and otherwise as stated in the Submission License section of this notice.

The Department reserves the right in its sole discretion to disqualify any entrant who is found to be tampering with the entry process or the operation of the Challenge, Challenge Web page, or other Challenge-related Web pages; to be acting in violation of these Official Rules, Terms and Conditions; to be acting in an unsportsmanlike or disruptive manner, or with the intent to disrupt or undermine the legitimate operation of the Challenge; or to annoy, abuse, threaten, or harass any other person; and, the Department reserves the right to seek damages and other remedies from any such person to the fullest extent permitted by law.

The Challenge Web page may contain links to third-party Web pages that are not owned or controlled by Luminary Labs or the Department. Luminary Labs and the Department do not endorse or assume any responsibility for any such third party sites. If an entrant accesses a third-party Web page from the Challenge Web page, the entrant does so at the entrant's own risk and expressly relieves Luminary Labs or the Department from any and all liability arising from use of any third-party Web page content.

The Challenge Web page contains information and resources from public and private organizations that may be useful to the reader. Inclusion of this information does not constitute an endorsement by the Department or Luminary Labs of any products or services offered or views expressed. Blog articles provide insights on the activities of schools, programs, grantees, and other education stakeholders to promote continuing discussion of educational innovation and reform. Blog articles do not endorse any educational product, service, curriculum, or pedagogy.

The Challenge Web page also contains hyperlinks and URLs created and maintained by outside organizations, which are provided for the reader's convenience. The Department and Luminary Labs are not responsible for the accuracy of the information contained therein.

Attempts to notify finalists and winner(s) will be made using the email address associated with the Team Lead's Luminary LightboxTM account. The Department and Luminary Labs are not responsible for email or other communication problems of any kind.

If, despite reasonable efforts, an entrant does not respond within three days of the first notification attempt regarding selection as a finalist (or a shorter time as exigencies may require) or if the notification is returned as undeliverable to such entrant, that entrant may forfeit the entrant's finalist status and associated prizes, and an alternate finalist may be selected.

If any potential prize winner is found to be ineligible, has not complied with these Official Rules, Terms and Conditions, or declines the applicable prize for any reason prior to award, such potential prize winner will be disqualified. An alternate winner may be selected, or the applicable prize may go unawarded.

To maintain eligibility, finalists are required to participate in Challenge activities organized by the Department and Luminary Labs, which include the Virtual Accelerator Phase, Innovator's Boot Camp, and Demonstration Day. If a finalist is unable to participate in any mandatory activities, the finalist will not be eligible to win the Challenge. Finalists and winner(s) are required to attend these events at their own expense.

Entrants retain ownership of their submission, including any software, research or other IP that they develop in connection therewith, subject to the license granted to the Department to use submissions as set forth herein.

Entrants retain all rights to the submission and any invention or work, including any software, submitted as part of the submission, subject to the following—

If the submission wins, the Department retains an exclusive, nontransferable, irrevocable, paid-up world-wide license to publish and publicly demonstrate any such invention or work of the submission throughout the world, in perpetuity, for Federal purposes.

As specified in Selection Criteria (b)(6) Long-term Vision, finalists will be evaluated, in part, on the aspects of their simulation they plan to make available through open source licenses. Finalists will be asked to provide evidence of their progress towards this goal as part of the second round submission.

The Department reserves the right to modify any dates or deadlines set forth in these Official Rules, Terms and Conditions or otherwise governing the Challenge.

The Department reserves the right to suspend, postpone, cease, terminate or otherwise modify this Challenge, or any entrant's participation in the Challenge, at any time at the Department's discretion.

By participating in the Challenge, each entrant hereby agrees that—

(a) The Department and Luminary Labs shall not be responsible or liable for any losses, damages, or injuries of any kind (including death) resulting from participation in the Challenge or any Challenge-related activity, or from entrants' acceptance, receipt, possession, use, or misuse of any prize; and

(b) The entrant will indemnify, defend, and hold harmless the Department and Luminary Labs from and against all third party claims, actions, or proceedings of any kind and from any and all damages, liabilities, costs, and expenses relating to, or arising from, the entrant's participation in the Challenge.

Without limiting the generality of the foregoing, the Department and Luminary Labs are not responsible for incomplete, illegible, misdirected, misprinted, late, lost, postage-due, damaged, or stolen entries or prize notifications; or for lost, interrupted, inaccessible, or unavailable networks, servers, satellites, Internet Service Providers, Web pages, or other connections; or for miscommunications, failed, jumbled, scrambled, delayed, or misdirected computer, telephone, cable transmissions or other communications; or for any technical malfunctions, failures, difficulties, or other errors of any kind or nature; or for the incorrect or inaccurate capture of information, or the failure to capture any information.

These Official Rules, Terms and Conditions cannot be modified except by the Department in its sole and absolute discretion. The invalidity or unenforceability of any provision of these Official Rules, Terms and Conditions shall not affect the validity or enforceability of any other provision. In the event that any provision is determined to be invalid or otherwise unenforceable or illegal, these Official Rules, Terms and Conditions shall otherwise remain in effect and shall be construed in accordance with their terms as if the invalid or illegal provision were not contained herein.

The failure of the Department to exercise or enforce any right or provision of these Official Rules, Terms and Conditions shall not constitute a waiver of such right or provision.

All issues and questions concerning the construction, validity, interpretation, and enforceability of these Official Rules, Terms and Conditions shall be governed by and construed in accordance with U.S. Federal law as applied in the Federal courts of the District of Columbia if a complaint is filed by any party against the Department, and the laws of the State of New York as applied in the New York state courts in New York City if a complaint is filed by any party against Luminary Labs.

By participating in the Challenge, each entrant hereby agrees that occasionally, the Department and Luminary Labs may also use the entrant's information to contact the entrant about Federal Challenge and innovation related activities, and acknowledges that the entrant has read and accepted the privacy policy at: www.edsimchallenge.com/privacy.

Please review the Luminary LightboxTM Terms of Service at: www.LuminaryLightbox.com/terms for additional rules that apply to participation in the Challenge and more generally to use of the Challenge Web page. Such Terms of Service are incorporated by reference into these Official Rules, Terms and Conditions. If there is a conflict between the Terms of Service and these Official Rules, Terms and Conditions, the latter terms shall control with respect to this Challenge only.

Participation in the Challenge constitutes an entrant's full and unconditional agreement to these Official Rules, Terms and Conditions. By entering, an entrant agrees that all decisions related to the Challenge that are made pursuant to these Official Rules, Terms and Conditions are final and binding, and that all such decisions are at the sole discretion of the Department or Luminary Labs.

Luminary Labs collects personal information from entrants to the Challenge. The information collected is subject to the privacy policy located here: www.LuminaryLightbox.com/privacy.

To obtain a list of finalists and winner(s) (after the conclusion of the Challenge) or a copy of these Official Rules, Terms, and Conditions, send a self-addressed envelope with the proper postage affixed to: Luminary Labs, 30 West 22nd St., Floor 6, New York, NY 10010. Please specify “Winners List” or “Official Rules” and the name of the specific Challenge in this request.

Please contact the person listed under For Further Information Contact in section IX of this notice, should you have any comments or questions about these Official Rules, Terms, and Conditions.

For Further Information Contact: Albert Palacios, U.S. Department of Education, 550 12th Street SW., Room 11-086, Washington, DC 20202 or by email: [email protected].

If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.

Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disk) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT in this notice.

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

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

Background: The Board was established to provide advice and recommendations to the Secretary on the Department's basic and applied research, economic and national security policy, educational issues, operational issues, and other activities as directed by the Secretary.

Purpose of the Meeting: This meeting is the quarterly meeting of the Board.

Tentative Agenda: The meeting will start at 8:30 a.m. on December 13th. The tentative meeting agenda includes: Updates from SEAB's task forces, informational briefings, and an opportunity for comments from the public. The meeting will conclude at 12:30 p.m. Agenda updates will be posted on the SEAB Web site prior to the meeting: www.energy.gov/seab.

Public Participation: The meeting is open to the public. Individuals who would like to attend must RSVP to Karen Gibson no later than 5:00 p.m. on Thursday, December 8, 2016 at [email protected]. Please provide your name, organization, citizenship, and contact information. Anyone attending the meeting will be required to present government issued identification. Please note that the Department of Homeland Security (DHS) has determined that regular driver's licenses (and ID cards) from the following jurisdictions are not acceptable: American Samoa, Missouri, Washington and Wisconsin. Acceptable alternate forms of Photo-ID include:

• U.S. Passport or Passport Card

• An Enhanced Driver's License or Enhanced ID-Card issued by the state of Washington (Enhanced licenses issued by these states are clearly marked Enhanced or Enhanced Driver's License)

• A military ID or other government issued Photo-ID card

Individuals and representatives of organizations who would like to offer comments and suggestions may do so during the meeting. Approximately 30 minutes will be reserved for public comments. Time allotted per speaker will depend on the number who wish to speak but will not exceed 5 minutes. The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Those wishing to speak should register to do so beginning at 8:15 a.m. on December 13th.

Those not able to attend the meeting or who have insufficient time to address the committee are invited to send a written statement to Karen Gibson, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585, email to [email protected].

Minutes: The minutes of the meeting will be available on the SEAB Web site or by contacting Ms. Gibson. She may be reached at the postal address or email address above, or by visiting SEAB's Web site at www.energy.gov/seab.

In the past few years, sales of e-cigarettes have grown rapidly in the United States.1 These devices are available in both disposable and refillable models, in a range of nicotine strengths (including nicotine-free), and in a multitude of flavors. E-cigarettes are manufactured, distributed, and sold by a wide variety of industry members, ranging from large companies, including major U.S. tobacco companies, to small, single-location operators. They can be purchased at conventional retail stores, at “vape shops,” which are retail stores that primarily or exclusively sell e-cigarettes, and online.

For many years, the Commission has published reports on sales and marketing expenditures by the major cigarette and smokeless tobacco manufacturers. These data allow the agency to analyze industry sales and assess how industry members allocate their promotional activities and expenditures. The data also provide information to policymakers and public health researchers that, in many instances, is not available from other sources. Given their increasing prevalence, the Commission believes it is important and necessary for the agency to begin collecting information about e-cigarette sales and marketing activities. The Commission intends to publish a report with the data it obtains,2 and to issue similar information requests regularly in order to track trends over time. The information will be sought using compulsory process under Section 6(b) of the Federal Trade Commission Act, 15 U.S.C. 46(b).

The Commission intends to issue information requests to up to 15 industry members, including larger and smaller entities, and will seek information about the different types of e-cigarette products marketed, certain characteristics of those products, and information about marketing expenditures for broad categories of media. While the data may not represent overall sales and marketing activities for the entire e-cigarette industry, the information provided should provide a valuable snapshot of the current e-cigarette market, including its major players. Because the number of separately incorporated companies affected by the Commission's requests will exceed nine entities, the Commission is seeking OMB clearance under the PRA before requesting any information from the industry members.3 On October 27, 2015, as required by the PRA, the FTC published a Federal Register Notice seeking comments from the public concerning the proposed collection of information from e-cigarette marketers. See 80 FR 65758 (“October 2015 Notice”). As discussed below, 37 comments were received.

Pursuant to the OMB regulations that implement the PRA (5 CFR part 1320), the FTC is providing this second opportunity for public comment while requesting that the OMB grant the clearance for the proposed collection of information. All comments should be filed as prescribed in the Request for Comment part below, and must be received on or before December 2, 2016.

The FTC received 37 comments in response to the October 2015 Notice.4 Of these, 20 comments expressly supported and substantively addressed the proposed data collection. A joint comment favoring the proposal was submitted by the following public health organizations: American Academy of Pediatrics; the American Heart Association; Campaign for Tobacco-Free Kids; Tobacco Control Legal Consortium; and Truth Initiative (“Joint Public Health Comment”). Comments supporting the proposal also were received from three individual public health or public interest organizations.5 Favorable substantive comments were submitted by three government-related entities or individuals: National Association of Attorneys General Tobacco Committee (“NAAG”); the Oregon Public Health Division; and the Comptroller of the City of New York; and from three academic centers involved in public health and tobacco control issues.6 Ten individuals, many involved in local health education or tobacco control activities, filed individual comments supporting the data collection.7

Five comments were received from industry members: R.J. Reynolds Vapor Company and RAI Services Company (“Reynolds”); Altria Client Services Inc. and Nu Mark LLC (“Altria”); Rock River Manufacturing, the tobacco products manufacturing division of Ho-Chunk, Inc. (“Ho-Chunk”); (4) Fontem US, Inc. (“Fontem”), and (5) Logic Technology Development LLC (“Logic”). None of these comments expressly opposed the proposed data collection, although two companies questioned whether the data collection was premature given the then-pending FDA deeming regulation that, among other provisions, asserts regulatory authority over e-cigarettes and other tobacco products.8 Each industry comment made suggestions that it asserted would enhance the quality, utility, and clarity of the information to be collected and reduce the burden on the respondents.

The remaining 12 comments did not substantively address the proposed data collection.

In its October 2015 Notice, the FTC sought comments regarding whether the proposed collection is necessary.9 Many of the comments stated that the data collection would provide important information, especially given the increased use of e-cigarettes by youth,10 and the limited availability of data on e-cigarette advertising and marketing from other sources.11 The Joint Public Health Comment stated that the collected data could provide valuable information and insights into the e-cigarette market and be used as a basis for public policy decisions. The UNC comment stated that the data collection would enable public health professionals to better understand where e-cigarette advertising and marketing dollars are being spent, and to help develop specific interventions to prevent underage use. The UCSF comment stated that the reports would enable retrospective assessment of advocacy activities and policy changes.

A number of comments made favorable comparisons between the proposed collection of information on e-cigarette sales and marketing expenditures and the FTC's existing reports on cigarettes and smokeless tobacco, noting that the existing reports are widely used by public health professionals, researchers, policymakers, and government agencies.12 These comments stated that expansion of data collection to e-cigarettes is needed to inform these same stakeholders about the nature and extent of e-cigarette advertising and marketing practices, and to allow them to monitor trends.13

The FTC believes that these information requests are in the public interest and essential to the agency's performance of its authority to investigate and report publicly on industry practices that affect the economic well-being of consumers. Consistent with the agency's information collection for cigarettes and smokeless tobacco products, the data will also provide important information for researchers and policymakers.

The FTC's October 2015 Notice also sought comment on whether the proposed data collection is necessary for the proper performance of the functions of the FTC, including whether the information will be practically useful.14 The NAAG comment stated that the data collection would greatly facilitate state efforts to better understand and effectively regulate e-cigarettes. The Joint Public Health Comment and the Georgia State comment noted that the FTC's report would facilitate research into e-cigarette marketing because it would provide access to data that are otherwise unavailable from commercial sources, which tend to focus on larger companies and traditional distribution channels such as convenience stores. The UCSF comment states that scholarly research of e-cigarette marketing would be best served by reliable data, such as data collected directly from members of the e-cigarette market. Individual public health educators commented that a report on e-cigarette sales and marketing would facilitate their local and state health education work, which in turn informs evidence-based policymaking and regulatory action.15 One drug prevention specialist stated that a report on e-cigarette sales and marketing expenditures would also inform advocacy work and counter-marketing strategies to discourage youth and other vulnerable populations from using e-cigarettes.16

One industry member, Ho-Chunk, questioned whether the value of the proposed data collection could be outweighed by the risk that a negative public perception of e-cigarettes would damage the growth of the industry. The company expressed concern that the FTC's data collection could send a premature message that the industry is engaged in predatory marketing or that there are as-yet-unknown health and safety risks associated with the use of these products.

The Commission intends to use the data collection to provide useful baseline information (starting with 2015 data) concerning sales of the various e-cigarette products and allow the Commission to analyze how industry members allocate their promotional activities and expenditures across various media. The data also will provide researchers and policymakers with sales and marketing information that will assist their research and regulatory efforts. The Commission does not believe that the data collection itself will create any negative public perception of e-cigarettes or damage the growth of the industry. In particular, the proposal seeks sales and marketing expenditure data only and does not include an inquiry into any hypothetical predatory practices or health or safety information. In addition, the data collection here is very similar in content and methodology to studies that the Commission for many years has undertaken with respect to other markets, including cigarettes and smokeless tobacco products (OMB Control No. 3084-0134); alcoholic beverages (OMB Control No. 3084-0138); and food (OMB Control No. 3084-0139).

In its October 2015 Notice, the FTC invited comments concerning ways to enhance the quality, utility, and clarity of the information to be collected.17 The FTC received substantive comments for enhancing its proposed data collection as follows: (1) Expand the scope of the proposed data collection by collecting data from a broad cross-section of market participants and increasing the number of surveyed entities; (2) collect and report data on a state-by-state basis; (3) collect and report sales data that are segmented by product type, differentiates product characteristics such as flavors and nicotine strength, that include data on refills and cartridges, and that report sales data separately from product give-aways; and (4) collect and report broad categories of marketing expenditure data.

The Commission's October 2015 Notice anticipated collecting and reporting data obtained from as many as 15 entities that would vary in size, in the number of products sold, and in the extent and variety of their advertising and marketing.18 A number of comments recommended that the Commission expand the scope of the data collection by including a broad cross-section of market participants, including distributors and entities whose products are sold in traditional retail stores (e.g., convenience stores), as well as online sellers, and vape shops. To accomplish this goal, some commenters recommended that the Commission increase the number of entities from whom it would collect data.

a. Type of Market Participant. A wide range of commenters, including both industry and public health organizations and researchers, recommended that the Commission expand the scope of the proposed data collection by including a broad cross-section of market participants in the entities surveyed through the data collection. Logic recommended that the FTC seek a broader cross-section of the market. Fontem commented that vape shops comprise a large percentage of the market, and noted that the data collection would not be meaningful if vape shops were not included. Altria also suggested that the FTC send data requests to a selection of vape shops. Reynolds recommended that the Commission differentiate the information requests by type of market participant, reasoning that such segmentation would present less need for highly differentiated sales and marketing data. The Joint Public Health Comment recommended that the FTC survey a selection of large companies, as well as a geographically dispersed selection of e-cigarette manufacturers, distributors, and retailers (including online sellers and vape shops) in order to get a cross-section of market participants. The UNC comment recommended that the proposed data collection differentiate the method of sale (distributors, online, retail) so that subsequent enforcement efforts can be tailored appropriately. Georgia State and one individual also recommended that the Commission differentiate by method of sale. Another individual recommended that the data requests segment market participants into two groups: Those that sell only e-cigarette products and those that sell e-cigarettes and other tobacco products.

The Commission agrees that seeking data from a broad cross-section of the overall market, including distributors to conventional retail sellers, online sellers, and vape shops, would provide a fuller perspective on the overall e-cigarette market. However, the Commission was not able to find sufficient, reliable market data that would permit it to identify and select which smaller online sellers and vape shops should receive data requests. The available data from which the Commission could identify a sample of online sellers or vape shops are so limited and insufficient that any separate samples of these sellers would at best provide anecdotal information.

In contrast, the available market data do permit a reliable sample of the largest e-cigarette marketers and some online sellers. The Commission believes that a sample of these companies will account for at least 80 percent of the conventional retail market and a sizable share of the online market. Thus, the data will provide useful information concerning at least this large subset of the overall market. At the same time, the Commission remains interested in collecting and reporting sales and marketing expenditure data from a broader cross-section of the market. Should more reliable market data become available, the Commission may seek OMB clearance to collect sales and marketing expenditure data for a broader cross-section of companies at such time, and would report on the data received.

b. Number of Entities Submitting Data. To capture data from a broad cross-section of market participants, several commenters recommended that the Commission collect data from more than 15 entities, the number identified in the October 2015 Notice. Altria recommended increasing the number beyond 15 entities given industry fragmentation and the increased market presence of vape shops. Reynolds questioned whether data collection from 15 entities would be sufficient to allow the FTC to characterize overall market sales and marketing activities. Logic stated that the proposed data collection was under-inclusive because too few companies would be required to report data. The Georgia State and Truth In Advertising comments stated that expanding the data collection beyond 15 entities would provide a fuller perspective and more accurate representation of the overall market. The Joint Public Health Comment also recommended that the FTC send data requests to more than 15 entities.

As discussed above, reliable data permitting the Commission to identify a representative sample of a broad cross-section of the market do not appear to be available at this time. As a result, the Commission does not believe it necessary to increase the number of entities from whom it will seek to collect and report data.

The FTC's October 2015 Notice asked whether the agency should seek data on state-by-state sales of e-cigarettes.19 Altria recommended that the Commission consider conducting a state-by-state analysis given the highly fragmented nature of the overall market. Comments from public health organizations and research centers also supported state-by-state data collection for sales and, in some comments, also for marketing expenditures.20 The UNC comment noted that reporting state-by-state data would help tobacco control professionals understand which states and regions have the greatest sales, and help them target their tobacco control efforts accordingly. The Oregon Public Health Division and Georgia State comments noted that state-by-state data would be useful in evaluating the impact of state and local regulatory efforts. Reynolds opposed state-by-state data collection, stating that such data were not readily available for e-cigarettes sold through distributors who sell such products in more than one state. Reynolds further stated that there are no efficient and reliable means to obtain state-by-state data.

Although the Commission agrees that state-by-state data collection could provide useful information, such data collection would significantly increase the complexity and burden of the data requests and might not be readily practical for some e-cigarette sellers. Thus, the Commission has decided against requesting approval for state-by-state data collection at this time. The Commission remains interested in this issue, however, and could request OMB clearance to collect state-by-state data in the future.

a. Type of Product. A number of commenters noted the wide variety of different e-cigarette products currently marketed. Reynolds noted that three general categories of e-cigarette products are currently available: (1) Disposable products, (2) rechargeable and pre-filled cartridge products, and (3) “tank” products that require the user to put e-liquid into an aerosol-generating device. The Joint Public Health Comment recommended that the Commission require responders to report separately by product type.21 The UNC comment also supported separate reporting by product type, noting that separate reporting can be useful to track changes in popularity and use. Similarly, the UCSF comment supported separate reporting as a means to help evaluate how changes in sales of different products correspond to changes in use.

Reynolds recommended against differentiating by product type, noting that the different products generally could be categorized by the retail market where the products are sold, with conventional retail stores selling disposable and rechargeable products, and “vape stores” selling tank products. Reynolds preferred categorizing by type of marketer rather than type of product.

Given the wide variety of products available, the Commission believes that separate reporting by product type will be useful and important in tracking future developments in the e-cigarette market. Thus, the proposed data collection contemplates separate reporting across three categories: (1) Non-refillable (i.e., disposable) products; (2) refillable closed systems (i.e., rechargeable and refillable cartridge products); and (3) refillable open systems (i.e., “tank” systems).

b. Differentiation by Flavors. Comments from public health organizations, research centers, and health educators recommended that the Commission seek sales data that are differentiated by their various characterizing flavors.22 The Joint Public Health Comment stated that flavors appear to be one of the reasons youth and adults try e-cigarettes. The CTFK comment stated that the available data suggest that flavors are a key reason youth try and use e-cigarettes, citing the 2013-2014 Population Assessment of Tobacco and Health (“PATH”) study, which showed that most youth smoked flavored e-cigarettes when they first tried the product and during the past month. The comment also cited data from the PATH study indicating that surveyed youth reported “comes in flavors that I like” as one of the reasons they used e-cigarettes. The Georgia State comment stated that data differentiated by flavors would help regulators and the public health community determine the role flavors play in patterns or reasons for use, perceptions of harm, and social norms.

Reynolds and Fontem opposed the collection of detailed flavor data. Fontem noted that there is no standardized method of reporting flavors across the industry, and both stated that characterizing flavors is subjective. Reynolds stated that the utility of seeking flavor data is not clear.

Given the potential importance of flavors for trial and use of e-cigarettes, especially among youth, the Commission will seek to collect data that differentiate among flavors. However, as discussed infra at section II.D.2, to reduce the burden, the proposed data collection will designate only three flavor categories, rather than requiring companies to report each flavor individually.

c. Differentiation by Nicotine Strength. The comments from public health organizations, research centers, and NAAG supported the collection of data on nicotine content levels. The Georgia State comment indicated that research suggests nicotine levels are related to patterns or reasons for use. The CTFK comment stated that e-cigarettes contain highly variable amounts of nicotine, and there are no reliable data providing information about nicotine strength. The UNC comment indicated that information about nicotine strength could be valuable for determining equivalence to conventional tobacco products and for consideration of potential long-term health risks. The UCSF comment noted that nicotine content data could facilitate the testing of competing hypotheses as to the effect of nicotine regulation on use.

Fontem and Reynolds opposed collection of data concerning nicotine strength. Fontem commented that collection of nicotine content data would not be useful because there is no standardized method of reporting nicotine content across the industry. Reynolds also questioned whether nicotine content data would provide useful information.

The Commission believes that collection of data concerning nicotine strength will provide useful information that is not readily available from other sources. The agency does not believe that the lack of a standardized reporting method invalidates the utility of these data. The FTC will take into account the various comments received in the course of developing its report on the data collection.

d. Cartridges and Refills. Several commenters addressed the Commission's request for comments on the collection of data concerning refills, especially with regard to refillable products sold with more than one refill unit. E-cigarette products, other than disposable products, are often marketed to consumers with the device, battery, atomizer, and one or more refill units sold together in a single package. The Joint Public Health Comment stated that any cartridge or liquid unit above one should be counted as a refill, regardless of whether it is packaged as part of the same stock keeping unit (“SKU”) or sold individually. Fontem stated that there is no consistency among marketers as to blister packs or refills that come in a single package. Thus, Fontem questioned whether gathering information on refills would yield meaningful information. The company recommended that if the Commission opted to track refills, that it simply track the total number of refills. Reynolds recommended that for products sold with more than one cartridge, the FTC should abide by the product configuration as sold to consumers, i.e., allow companies to use the SKUs for reporting. Reynolds stated that relying on existing SKUs would allow responders to use existing records to produce data and, thus, would be simpler and clearer.

On balance, requiring companies to report the total number of refill units will provide a more accurate picture of e-cigarette sales. Thus, if an e-cigarette product is sold with more than one cartridge or e-liquid unit, each cartridge or unit above one should be reported as a refill. Likewise, each cartridge or e-liquid unit sold individually also would count as a refill. In addition, the Commission believes this approach is consistent with the approach it has taken with regard to the collection of sales data for other tobacco products. For example, if three pouches of smokeless tobacco are packaged together as a single unit for sale to consumers, the Commission's compulsory process orders have required a responding company to report each pouch separately, for a total of three units.

e. Sales and Give-Aways. Comments from public health organizations and research centers generally supported the collection of data on both sales and give-aways and the reporting of these data separately.23 CTFK noted that currently only limited data are available concerning market size and that current estimates do not differentiate between sales and give-aways.24 The UNC comment stated that collecting sales and give-away data and reporting those data separately is important for evaluating which products are most frequently purchased, and the Georgia State comment noted that reporting the data separately more accurately reflects market transactions. The UCSF comment stated that give-aways are important to identify separately given their potential to reach youth under the age of 18.

The Commission agrees that data on sales and give-aways should be collected and reported separately given the distinct role each plays in the overall market. In addition, the agency collects and reports data on sales and give-aways separately in its data collection for cigarettes and smokeless tobacco products and, therefore, separate collection and reporting will be consistent with the approach taken for these other tobacco products.

A number of comments supported data collection for the various media specifically identified in the FTC's October 2015 Notice, as well as other marketing channels.25 The NAAG comment stated that collection and reporting of broad categories of marketing expenditure data would be useful not only to the public but also to state officials who are assessing regulatory options and enforcement efforts.

The Joint Public Health Comment and the CTFK comment stated that it is important to collect marketing expenditures for television, radio, and other broadcast media, noting that unlike cigarettes and smokeless tobacco products, no statutory broadcast ban applies to e-cigarettes. Several comments specifically noted the importance of collecting and reporting data for marketing expenditures for media especially attractive to youth, such as point-of-sale advertising,26 sponsorship of concerts and other events as well as sports teams or individual athletes or drivers,27 and celebrity endorsers.28 Several comments specifically identified product placement as a category where marketing expenditures should be collected and reported,29 with the Joint Public Health Comment noting that expenditures for all forms of product placement should be collected, including product placement expenditures for broadcast media, movies, digital, and other media. The Georgia State comment supported detailed data collection for web-based and social media marketing expenditures, noting that availability of these data from commercial data sources is limited. Fontem recommended that the FTC include couponing as a category of marketing expenditures; the UCSF and Georgia State comments likewise identified coupons as well as other forms of price promotion as categories where the Commission should collect marketing expenditure data.

Reynolds recommended that the data collection focus on the marketing expenditure categories already used by the FTC in its data collection for cigarettes and smokeless tobacco products, noting that the Commission has decades of experience collecting those data. One individual commenter also recommended that the Commission seek and report the same categories of marketing expenditure data tracked for cigarettes and smokeless tobacco products in order to facilitate comparisons.30

The Commission agrees that collecting and reporting data for broad categories of marketing expenditures will be useful, including data concerning traditional and newer media, product placement, sponsorship, endorsements, and price promotions. The agency will seek to collect marketing data in categories that generally track those used for cigarettes and smokeless tobacco products, with two primary differences. First, the Commission will seek to collect and report data for marketing expenditures on broadcast media such as television and radio because, unlike cigarettes and smokeless tobacco products, no statute prohibits using these media to advertise and market e-cigarettes. Second, some of the categories have been updated to explicitly recognize newer forms of media now used for advertising and marketing, such as digital and social media.

The Commission's October 2015 Notice invited comments on ways to minimize the burden of the collection of information on entities required to respond to the data requests.31

Reynolds and Fontem suggested that the Commission defer its data collection until after FDA issued its final Deeming Regulation. Reynolds noted that the final regulation would clarify the scope and impact of FDA's regulation of e-cigarettes. As noted above, FDA issued its final regulation on May 10, 2016. There is no overlap between FDA's regulation and the proposed data collection. Accordingly, it is not necessary to defer the data collection.

As discussed above, the Commission plans to collect data concerning e-cigarette flavors and nicotine strength. To reduce the burden of reporting each individual flavor, the Joint Public Health comment and comments from CTFK and the American Lung Association recommended that companies report three categories of flavors: Tobacco, menthol/mint, and other. The Joint Public Health comment stated that these three categories would most easily capture the breadth of flavors available, and make it easier for the industry and the FTC to count all the flavors. CTFK noted that categorizing in this manner would also eliminate the overlap that might result from more limited flavor categories. Comments from UCSF and NAAG, on the other hand, stated that the Commission should collect data on each individual flavor. Given the variety and number of different flavors, the Commission believes that classifying e-cigarettes into three categories of flavors—tobacco, menthol/mint, and other—will provide useful information while significantly reducing the burden on reporting companies, and will use these categories in the data collection, if approved.

The Joint Public Health Comment and the CTFK comment also indicated that reporting nicotine strength by categories might be sufficient and would reduce the reporting burden on responding entities. The UCSF comment, on the other hand, recommended that the Commission require companies to report each different nicotine strength. Categorizing nicotine strengths would require consultation with scientific authorities to determine the appropriate categories for reporting. In addition, reporting in categories could blur trends over time due to inherent imprecision. Thus, the Commission plans to require reporting for each individual nicotine strength sold by the reporting entity, rather than for categories. Once the Commission has these data, it will consider how best to organize and discuss them in the course of developing its report.

Reynolds and Fontem each recommended that the Commission require less detail in the data requests as a means of reducing the burden of responding, and suggested that the collection of certain information might not be useful. Fontem suggested that the Commission not seek information concerning product flavors, nicotine strength, or blister packs and refills. The company suggested that if the Commission did decide to collect flavor data, it require only two categories of information: Tobacco and other. It also suggested that if the agency decided that some information about refills was needed, it simply track total number of refills sold. Reynolds suggested that the Commission model its requests on the information requests for cigarettes and smokeless tobacco products, and not require differentiation by type of product, nicotine concentration, size, method of sale, and flavors. If the Commission opted to seek information about flavors, Reynolds recommended that the agency request data based on brand style names and descriptions the product manufacturers created to describe their products. For the reasons discussed above, the Commission believes that the information collection should include information concerning flavors, nicotine strength, refill units, and other product characteristics. Collection of flavor information by broad categories, rather than individually, will reduce the burden on responding to the information requests.

In its comment, Logic proposed that the Commission limit its information collection to data applicable to: (1) Youth access and (2) illegal, inaccurate, or deceptive advertising claims about e-cigarettes. According to Logic, these two areas address the relevant societal issues for information collection, consistent with the FTC's mandate to prevent unfair or deceptive business practices. Logic stated that collecting substantial data concerning sales and marketing expenditures would represent a substantial burden and, thus, suggested that the Commission confine the information sought to companies' age-screening mechanisms and to production of their advertising campaigns for review to ensure they are not making deceptive claims. The Commission disagrees with limiting the data collection to these two categories of information. Rather, broader information collection about sales and marketing expenditures is in the public interest, because it will allow the Commission to analyze sales and assess how industry members allocate their promotional activities and expenditures. For decades, the Commission has collected and reported information about sales and marketing expenditures for other tobacco products, as well as for other consumer products, and the e-cigarette information requests are consistent with the data collection and reporting for those products. Although the Commission agrees that preventing false and deceptive advertising is an important component of its consumer protection mission, law enforcement action against specific marketers, rather than information collection, is a better means of addressing potentially unfair or deceptive e-cigarette advertising.

In its October 2015 Notice, the Commission anticipated that its data collection requests would include seeking information concerning efforts such as age-screening mechanisms to prevent youth from being exposed to advertising and promotion of e-cigarettes or from obtaining free product samples. One industry member, Logic, supported data collection regarding age-verification methods, stating that many online sellers use no age-verification methods at all while conventional retail stores require rigorous age-verification. The Joint Public Health comment, and comments from CTFK, Georgia State, UCSF, and one individual, also supported data collection for this category, with Georgia State and UCSF also specifying age verification for online purchases. The Georgia State comment noted that data collection and reporting for this category would be useful to determine whether more stringent regulatory action was needed.

The Commission agrees that data concerning age-verification methods would be useful, and plans to collect and report data concerning age-screening mechanisms to prevent youth from being exposed to e-cigarette advertising and promotion or from obtaining free product samples.

The Commission's October 2015 Notice invited comments on 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.32 The Commission estimated a per company average of 200 hours for each recipient of an information request for the first year, and a per company average of 150 hours for the remaining years. Thus, the total hours burden for 15 information requests was estimated to be 3,000 hours for the first year, and 2,250 for each of the subsequent two years, for a total of 7,500 hours. The Commission estimated that the total labor costs for 15 information requests to be $300,000 for the first year, and $225,000 for each of the subsequent two years, for a total of $750,000. This estimate assumed an average $100/hour wage, which is the same estimated wage average used in the Commission's recent request for reauthorization of information requests to cigarette and smokeless tobacco companies.

The comment from Reynolds asserted that the Commission had underestimated the total hours burden. The company stated that it usually takes it twice as long as the FTC's estimated time burden to compile information for similar data collections for cigarette and smokeless tobacco companies. Reynolds also stated that the FTC should include in its estimate the amount of time companies will need to communicate directly with Commission staff when seeking clarification regarding the data collection. Reynolds and Fontem commented that the FTC's labor cost estimate also underestimates the total burden costs, stating that an average wage of $100/hour was too low. Neither company, however, provided an alternative figure or other information indicating what a more accurate hourly labor cost should be.

The Commission believes that its estimate burdens with respect to both average hours and labor costs are reasonable, especially in the absence of more specific information to calculate estimates that are more precise. However, out of an abundance of caution, the Commission has revised its burden estimate from that stated in the October 2015 Notice by increasing its estimated hours burden by 50 percent. As revised, the Commission calculates a per company average of 300 hours for the first year, and 225 hours for each of the two remaining years, resulting in a cumulative total of 11,250 hours for 15 information requests over three years. The Commission has not changed is average hourly cost estimate. The Commission's estimate is based on the assumption that the labor costs will include varying compensation levels among staff, management, and legal review, with most work performed by non-legal staff. In the absence of more precise data, the Commission believes that the same $100/hour wage that it used in its recent application for reauthorization of information requests to cigarette and smokeless tobacco companies is appropriate here as well. As discussed infra, however, the total cost burden will increase due to the increase in the estimated hours burden.

The Joint Public Health Comment and the comments from CTFK and American Lung Association recommended that the Commission coordinate its data collection with FDA. The American Lung Association stated that coordination might be mutually beneficial for both agencies, and CTFK indicated that coordination might help assure consistency in measures. Altria also encouraged the Commission to consider how it would interact with FDA once the Deeming Regulation was issued. The FTC staff and FDA staff already have a long tradition of working together on tobacco issues and the many other areas where the two agencies share jurisdiction. The FTC staff expects that tradition will continue. To the extent that coordination is required for specific issues concerning the proposed information collection, the agencies already have processes and procedures in place to address those issues.

The Georgia State comment recommended that the FTC require detailed brand-specific information, noting that the Commission's reports for cigarettes and smokeless tobacco products report aggregated rather than brand-specific data. The UCSF comment also recommended that the Commission collect and report brand-specific data. The Commission's compulsory process orders to surveyed companies will collect brand-specific data. However, because Section 6(f) of the FTC Act, 15 U.S.C. 46(f), protects confidential commercial information that is submitted to the Commission, the agency cannot publicly identify sales and marketing data for particular brands or companies that is not already public. Thus, the Commission's report on the data collection will provide aggregated rather than brand-specific data.

Commenters also recommended that the Commission seek more detailed differentiation of certain marketing expenditure data. The Joint Public Health Comment recommended that the Commission obtain data concerning the demographic composition of social media networks. The UCSF comment suggested collecting data regarding the amounts spent for different population subgroups, specific information concerning the time when marketing activities occurred, and requiring each responding company to identify its top three outlets and top three marketing programs within each media category. The added detail would significantly increase the complexity and burden of responding to the information requests. In addition, as indicated above, the Commission cannot publicly identify sales and marketing data on particular brands or companies and, thus, would not be able to include the specific data in its report. Thus, the Commission will not seek to include these data in the proposed information requests.

The Georgia State comment recommended that the Commission collect data on e-cigarette device specifications and capabilities. The comment indicated that this information would permit assessment of product differences concerning characteristics such as nicotine delivery, patterns of use, and puff topography. Collection of these data, however, is beyond the scope of the information requests' purpose.

Fontem's comment recommended that the Commission review e-cigarettes as smoking cessation devices and that it expand the information requests in order to collect data on other smoking cessation products, such as nicotine patches. This suggestion is beyond the scope of the proposed information collection, which concerns sales and marketing data for e-cigarette products, not products intended to treat nicotine addiction, which is the intended use for smoking cessation products. Whether any product is approved for use as a smoking cessation product is a question within the jurisdiction of FDA, not the FTC.

As noted earlier, the FTC received twelve comments that did not address the proposed data collection. One individual raised concerns that some e-cigarette marketers were making false claims that the products were effective for smoking cessation, and four individuals indicated that e-cigarettes helped with smoking cessation. Three individuals called for regulation of e-cigarettes, which FDA's recent issuance of its Deeming Regulation accomplishes. One individual stated that e-cigarettes should not be available to persons under the age of 18. FDA's Deeming Regulation prohibits the sale (both in-person and online) of e-cigarettes and other tobacco products to persons under the age of 18.33 One individual commented that e-cigarette advertisements seem to be targeted to youth. One individual commented that the FTC should consider that a substantial portion of the e-cigarette market is for cannabis e-cigarette products rather than tobacco. Finally, one commenter asked the FTC to keep public health at the forefront of its decision-making.

The Commission proposes to send information requests to the ultimate U.S. parent entities of up to 15 e-cigarette marketers in the United States. These companies will vary in size, the number of products sold, and in the extent and variety of their advertising and marketing activities, and will include the largest marketers of e-cigarettes. As noted above, based on available market data, the Commission estimates its sample will account for more than 80 percent of the conventional retail market and a sizable portion of the online market.

The proposed information requests will seek sales data about the types and variety of e-cigarette products sold. The sales information will be reported under three broad categories: (1) Non-refillable (i.e., disposable) products; (2) refillable closed systems (i.e., rechargeable and pre-filled cartridge products); and (3) refillable open systems (i.e., “tank” systems). Within these three categories, companies will report data differentiated by the strength of nicotine content and three categories of flavors: Tobacco, menthol/mint, and other. Data will be reported separately for sales and give-aways. The information requests will collect data for both unit sales as well as by net sales revenues. Data on net sales revenues will be reported by flavor only.

The information requests also will seek information and data concerning advertising and marketing activities and expenditures in a broad variety of media categories, including: (1) Radio, television, and print advertising; (2) Web site, digital, and social media marketing; (3) product placement; (4) endorsements, including celebrity endorsements; (5) sponsorship of concerts and other events and as well as of sports teams or individual athletes such as racing car drivers; (6) distribution of free samples; and (7) price promotions, including couponing programs. These expenditure categories generally track those used by the FTC in its data collections for cigarettes and smokeless tobacco products, with two exceptions. First, the proposed information requests will seek data concerning television and radio expenditures, since e-cigarette advertising is not subject to statutory broadcast media prohibitions. In addition, the media categories have been updated to provide more differentiation among online and digital advertising media.

The proposed information requests also will include information about company policies pertaining to age-screening mechanisms to prevent youth from being exposed to e-cigarette advertising and promotion or from obtaining free samples of e-cigarettes.

FTC staff's estimate of the hours burden is based on the time that would be required to respond to the Commission's information requests. The FTC currently anticipates sending information requests to as many as 15 e-cigarette companies each year. Because the Commission anticipates that these companies will vary in size, in the number of products they sell, and in the extent and variety of their advertising and promotion, and given the currently evolving nature of the e-cigarette industry, FTC staff has not calculated separate burden estimates for large and small companies, as is traditionally the case for the Commission's cigarette and smokeless tobacco information requests. For example, an e-cigarette marketer with a large volume of sales but a relatively small product line could potentially require fewer resources to respond to the Commission's information request than a marketer with lower overall sales but a substantially larger product line that offers consumers a greater range of flavor and nicotine options. Rather than account for each potential permutation of factors, FTC staff has calculated a per company average at the upper limit of this potential range. Some companies likely will require less time to compile their responses.

The Commission anticipates that even if it provides models for the Excel datafiles the companies will be required to submit, recipients of its information requests will need substantial time to prepare a response the first time. Once an e-cigarette marketer has prepared its first response to a Commission information request, however, it will need less time in subsequent years to prepare its reports because it will know what information it will be required to produce, and will already have a template for its submission.

Accordingly, as an approximation, FTC staff assumes a per company average of 300 hours for each recipient of the Commission's information requests the first year they have to comply with the Commission's information request. Staff anticipates that in subsequent years, the per company average will be 225 hours. Thus, the overall estimated burden for 15 recipients of the information requests is 4,500 hours for the first year and 3,375 hours for each of the two subsequent years, or a total of 11,250 hours. Thus, the average yearly burden, over the course of a prospective three-year clearance, is 3,750 hours, or 250 hours per recipient (large and small). These estimates include any time spent by separately incorporated subsidiaries and other entities affiliated with the ultimate parent company that has received the information request.

Commission staff cannot calculate with precision the labor costs associated with these data requests, as they entail varying compensation levels of management and/or support staff among companies of different sizes. FTC staff assumes that computer analysts and other non-legal staff will perform most of the work involved in responding to the information requests, although legal personnel will likely be involved in reviewing the actual submission to the Commission. FTC staff believes that the same $100 per hour wage that it used in its recent request for reauthorization of information requests to the major cigarette and smokeless tobacco manufacturers is appropriate here also for the combined efforts of these individuals. Using this figure, FTC staff's best estimate for the total labor costs for 15 information requests is $450,000 (4,500 hours × $100 per hour) for the first year and $337,000 for the two subsequent years (3,375 hours × $100 per hour × 2), for a total of $1,125,000 over the entire three-year period. The annualized labor cost per respondent will average approximately $25,000.

Staff believes that the capital or other non-labor costs associated with the information requests are minimal. Although the information requests may necessitate that industry members maintain the requested information provided to the Commission, they should already have in place the means to compile and maintain business records.

Section 6(f) of the FTC Act, 15 U.S.C. 46(f), bars the Commission from publicly disclosing trade secrets or confidential commercial or financial information it receives from persons pursuant to, among other methods, special orders authorized by Section 6(b) of the FTC Act. Such information also would be exempt from disclosure under the Freedom of Information Act, 5 U.S.C. 552(b)(4). Moreover, under Section 21(c) of the FTC Act, 15 U.S.C. 57b-2(c), a submitter who designates a submission as confidential is entitled to ten days' advance notice of any anticipated public disclosure by the Commission, assuming that the Commission has determined that the information does not constitute Section 6(f) material. Although materials covered under one or more of these various sections are protected by stringent confidentiality constraints, the FTC Act and the Commission's rules authorize disclosure in limited circumstances (e.g., official requests by Congress, requests from other agencies for law enforcement purposes, and administrative or judicial proceedings). Even in those limited contexts, however, the Commission's rules may afford protections to the submitter, such as advance notice to seek a protective order in litigation. See 15 U.S.C. 57b-2; 16 CFR 4.9-4.11.

Finally, the information presented in the report will not reveal company-specific data, except data that are public. See 15 U.S.C. 57b-2(d)(1)(B). Rather, the Commission anticipates providing information on an anonymous or aggregated basis, in a manner sufficient to protect individual companies' confidential information, to provide a factual summary of e-cigarette industry marketing activities and sales.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before December 2, 2016. Write “Electronic Cigarettes: Paperwork Comment, FTC File No. P114504” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential” as provided in Section 6(f) of the FTC Act 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c).34 Your comment will be kept confidential only if the FTC General Counsel grants your request in accordance with the law and the public interest.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/electroniccigarettespra2, by following the instructions on the web-based form. When this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

If you file your comment on paper, write “Electronic Cigarettes: Paperwork Comment, FTC File No. P114504” on your comment and on the envelope. You can mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024.

The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before December 2, 2016. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see http://www.ftc.gov/ftc/privacy.htm.

Comments on the information collection requirements subject to review under the PRA should additionally be submitted to OMB. If sent by U.S. mail, they should be addressed to Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead should be sent by facsimile to (202) 395-5806.

The information on place of manufacture was formerly used by each Federal agency to prepare a report to Congress required by 41 U.S.C. 8302(b)(1) for FY 2009 through 2011 on acquisitions of articles, materials, or supplies that are manufactured outside the United States. However, the data is still necessary for analysis of the application of the Buy American statue and the trade agreements and for other reports to Congress. Additionally, contracting officers require this data as the basis for entry into the Federal Procurement Data System for further data on the rationale for purchasing foreign manufactured items.

Number of respondents: 482,150.

Responses per respondent: 10.

Total annual responses: 1,483,592.

Hours per response: 0.01.

Total response burden hours: 14,836.

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

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

Please cite OMB Control Number 9000-0161, Reporting Purchases from Sources Outside the United States, in all correspondence.

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

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

1. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Evaluating Coverage to Care (C2C); Use: CMS OMH has contracted with the RAND Corporation to evaluate From Coverage to Care (C2C). From the beginning of the Affordable Care Act's implementation, the Centers for Medicare & Medicaid Services, Office of Minority Health (CMS OMH) recognized that achieving better health and reduced health care costs would require individuals to take an active role in their health care and regularly use primary and preventive care services. To address this need, CMS OMH launched From Coverage to Care (C2C) in June 2014. C2C was designed to help consumers understand what it means to have health insurance coverage, how to find a provider, when and where to seek appropriate health services, and why prevention and partnering with a provider is important for achieving optimal health. It was also designed to equip health care providers and stakeholders in the community who support consumers' connection to care with the tools needed to promote consumer engagement and to promote changes in the health care system that improve access to care. As part of C2C, CMS produced a range of consumer-oriented materials, both web-based and in print. The most in-depth of the print materials is an eight-step booklet titled “A Roadmap to Better Care and a Healthier You.” Based on the need for the information to be communicated in smaller, more digestible packets, booklets were developed to correspond to each of the eight steps. Four of the most popular pages of the Roadmap have been made available as single-page handouts for easier distribution. These materials are currently available in eight languages, including English, Spanish, Arabic, Chinese, Haitian Creole, Korean, Russian, and Vietnamese.

Since the national launch in 2014, CMS has disseminated C2C through speaking engagements, webinars, and meetings sponsored by CMS regional offices. CMS fills product orders and recently completed a redesign of the C2C Web site. C2C has grown to address emerging needs of consumers, as well as stakeholders or organizations that work with and support consumers, across the full continuum of health insurance and care: Plan selection, enrollment, finding a provider, and engaging in care over time.

RAND spent the past year designing and preparing for this evaluation to assess C2C's impact on consumer health insurance literacy and care utilization. This evaluation will also help CMS understand how C2C is spread within a community and disseminated to consumers, and in turn how best to maximize C2C's impact. The next three years will be dedicated to implementing the evaluation described in this submission. We are proposing four data collection activities: (1) A cross-sectional survey of organizations that have ordered and used the materials with consumers; (2) A cross-sectional survey of consumers, drawn from the Knowledge Networks panel, to measure the association between C2C and consumer knowledge and behavior; (3) semi-structured interviews with staff from a limited set of community organizations as part of a case study; and (4) focus groups of consumers as part of a case study. The case study will be conducted in a community where English is not the preferred language, and where C2C materials in another language (e.g., Spanish, Arabic, Chinese, Haitian Creole, Korean, Russian, and Vietnamese) were used with consumers. Form Number: CMS-10632 (OMB control number: 0938-New); Frequency: Occasionally; Affected Public: Individuals or Households; Number of Respondents: 3,460; Total Annual Responses: 3,460; Total Annual Hours: 1,176. (For policy questions regarding this collection contact Ashley Peddicord-Austin at 410-786-0757).

I. Background

FDA is announcing the availability of a draft revised GFI #170 entitled “Animal Drug User Fees and Fee Waivers and Reductions.” This draft revised guidance document describes the types of fees FDA is authorized to collect under ADUFA and how to request waivers and reductions from these fees. It clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures for Small Business waivers, and makes additional clarifying changes.

This level 1 draft revised guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft revised guidance, when finalized, will represent the current thinking of FDA on “Animal Drug User Fees and Fee Waivers and Reductions.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

This draft revised guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information referred to in the guidance entitled “Animal Drug User Fees and Fee Waivers and Reductions” have been approved under OMB control number 0910-0540.

Persons with access to the Internet may obtain the draft revised guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

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

Under section 361 of the Public Health Services Act (42 U.S.C. 264), FDA issued regulations under part 1270 (21 CFR part 1270) to prevent the transmission of human immunodeficiency virus, hepatitis B, and hepatitis C through the use of human tissue for transplantation. The regulations provide for inspection by FDA of persons and tissue establishments engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue. These facilities are required to meet provisions intended to ensure appropriate screening and testing of human tissue donors and to ensure that records are kept documenting that the appropriate screening and testing have been completed.

Section 1270.31(a) through (d) requires written procedures to be prepared and followed for the following steps: (1) All significant steps in the infectious disease testing process under § 1270.21; (2) all significant steps for obtaining, reviewing, and assessing the relevant medical records of the donor as prescribed in § 1270.21; (3) designating and identifying quarantined tissue; and (4) for prevention of infectious disease contamination or cross-contamination by tissue during processing. Section 1270.31(a) and (b) also requires recording and justification of any deviation from the written procedures. Section 1270.33(a) requires records to be maintained concurrently with the performance of each significant step required in the performance of infectious disease screening and testing of human tissue donors. Section 1270.33(f) requires records to be retained regarding the determination of the suitability of the donors and of the records required under § 1270.21. Section 1270.33(h) requires all records to be retained for at least 10 years beyond the date of transplantation if known, distribution, disposition, or expiration of the tissue, whichever is the latest. Section 1270.35(a) through (d) requires specific records to be maintained to document the following: (1) The results and interpretation of all required infectious disease tests; (2) information on the identity and relevant medical records of the donor; (3) the receipt and/or distribution of human tissue, and (4) the destruction or other disposition of human tissue.

Respondents to this collection of information are manufacturers of human tissue intended for transplantation. Based on information from the Center for Biologics Evaluation and Research's (CBER's) database system, FDA estimates that there are approximately 383 tissue establishments, of which 262 are conventional tissue banks and 121 are eye tissue banks. Based on information provided by industry, there are estimated totals of 2,141,960 conventional tissue products and 130,987 eye tissue products distributed per year with an average of 25 percent of the tissue discarded due to unsuitability for transplant. In addition, there are an estimated 29,799 deceased donors of conventional tissue and 70,027 deceased donors of eye tissue each year.

Accredited members of the American Association of Tissue Banks (AATB) and Eye Bank Association of America (EBAA) adhere to standards of those organizations that are comparable to the recordkeeping requirements in part 1270. Based on information provided by CBER's database system, 90 percent of the conventional tissue banks are members of AATB (262 × 90% = 236), and 95 percent of eye tissue banks are members of EBAA (121 × 95% = 115). Therefore, recordkeeping by these 351 establishments (236 + 115 = 351) is excluded from the burden estimates as usual and customary business activities (5 CFR 1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the remaining 32 establishments, which is 8.36 percent of all establishments (383 − 351 = 32, or 32/383 = 8.36%).

FDA assumes that all current tissue establishments have developed written procedures in compliance with part 1270. Therefore, their information collection burden is for the general review and update of written procedures estimated to take an annual average of 24 hours, and for the recording and justifying of any deviations from the written procedures under § 1270.31(a) and (b), estimated to take an annual average of 1 hour. The information collection burden for maintaining records concurrently with the performance of each significant screening and testing step and for retaining records for 10 years under § 1270.33(a), (f), and (h) include documenting the results and interpretation of all required infectious disease tests and results and the identity and relevant medical records of the donor required under § 1270.35(a) and (b). Therefore, the burden under these provisions is calculated together in table 1. The recordkeeping estimates for the number of total annual records and hours per record are based on information provided by industry and FDA experience.

In the Federal Register of June 6, 2016 (81 FR 36310), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received.

FDA estimates the burden of this information collection as follows:

Agenda: The Science Board will hear about: (1) The Center for Biologics Evaluation and Research's strategic goals for regulatory science; (2) a progress update on FDA's Opioid Action Plan and the Bovine Heparin Initiative; (3) a response from the Office of Scientific Professional Development to the Science Board's report on the Commissioner's Fellowship Program; (4) a report from the Scientific Engagements Subcommittee; (5) and a report from the Food Emergency Response Network Cooperative Agreement Program Evaluation Subcommittee.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 8, 2016. Oral presentations from the public will be scheduled between approximately 4 p.m. and 5 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 2, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 4, 2016.

Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Rakesh Raghuwanshi at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

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Information Collection Request Title: Telehealth Outcome Measures OMB No. 0915-0311—Revision.

Abstract: To help carry out its mission, the Office for the Advancement of Telehealth (OAT) created a set of performance measures that grantees use to evaluate the effectiveness of their services programs and monitor their progress through the use of performance reporting data.

Need and Proposed Use of the Information: As required by the Government Performance and Results Act of 1993, all federal agencies must develop strategic plans describing their overall goal and objectives. HRSA's Federal Office of Rural Health Policy (FORHP), OAT, has worked with its grantees to develop performance measures to be used to evaluate and monitor the progress of the grantees. Grantee goals are as follows: To improve access to needed services, reduce rural practitioner isolation, improve health system productivity and efficiency, and improve patient outcomes. In each of these categories, specific indicators were designed and are reported through a performance monitoring Web site. These measures cover the principal topic areas of interest to FORHP. The data are used for program improvement and grantees use the data for performance tracking and improvement. Revisions include minor additions to the OAT Performance Improvement Measurement System (PIMS) to capture minimal data on access to care, population demographics, insurance status, quality improvement and clinical measures.

Likely Respondents: Telehealth Network Grantees.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

When submitting comments or requesting information, please include the information request collection title for reference.

Information Collection Request Title: Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements.

OMB No. 0915-0307—Extension.

Abstract: Title XXVI of the Public Health Service (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White HIV/AIDS Program), Part A section 2604(c), Part B section 2612(b), and Part C section 2651(c), requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs for individuals with HIV, identified and eligible under the legislation. For grantees under Parts A, B, and C to be exempted from the 75 percent core medical services requirement, they must request and receive a waiver from HRSA, as required in the Act.

On October 25, 2013, HRSA published revised standards for core medical services waiver requests in the Federal Register (78 FR 63990). These revised standards allow grant recipients flexibility to adjust resource allocation based on the current situation in their local environment. These standards ensure that grant recipients receiving waivers demonstrate the availability of core medical services, including antiretroviral drugs, for persons with HIV served under Title XXVI of the PHS Act. The core medical services waiver uniform standard and waiver request process will apply to Ryan White HIV/AIDS Program Grant Awards under Parts A, B, and C of Title XXVI of the PHS Act. Core medical services waivers will be effective for a 1-year period that is consistent with the grant recipient award period. Grant recipients may submit a waiver request before the annual grant application, with the application, or up to 4 months after the grant recipient award has been made.

Need and Proposed Use of the Information: HRSA uses the documentation submitted in core medical services waiver requests to determine if the applicant/grant recipient meets the statutory requirements for waiver eligibility including: (1) No waiting lists for AIDS Drug Assistance Program services; and (2) evidence of core medical services availability within the grant recipient's jurisdiction, state, or service area to all individuals with HIV identified and eligible under Title XXVI of the PHS Act. See sections 2604(c)(2), 2612(b)(2), and 2651(c)(2) of the PHS Act.

Likely Respondents: Ryan White HIV/AIDS Program Part A, B, and C grant recipients.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

Total Estimated Annualized burden hours:

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.