Federal Register Vol. 81, No.34,

The purpose of the meeting is:

1. Discuss current or completed projects and present new projects for review.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by March 10, 2016 to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Randy Jero, Committee Coordinator, USDA, Mendocino National Forest, Grindstone Ranger District, 825 N. Humboldt Ave, Willows, CA 95988; or by email to [email protected], or via facsimile to (530) 934-1212.

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

The purpose of the meeting is:

1. Discuss current or completed projects and present new projects for review.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by March 14, 2016 to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Zach Rich, Committee Coordinator, USDA, Mendocino National Forest, Grindstone Ranger District, 825 N. Humboldt Ave., Willows, CA 95988; or by email to [email protected], or via facsimile to (530) 934-1212.

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

On September 25, 2015, the Department published in the Federal Register the preliminary determination in the LTFV investigation of silicomanganese from Australia.1 In the Preliminary Determination, we postponed the final determination until no later than 135 days after the date of publication of the Preliminary Determination in accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii) and invited parties to comment on our Preliminary Determination. Moreover, as explained in the memorandum from the Acting Assistant Secretary for Enforcement & Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. The revised deadline for the final determination of this investigation is now February 12, 2016.2

The following events have occurred since the Preliminary Determination. Between September 28, 2015, and November 11, 2015, the Department conducted sales and cost verifications of the respondent in this investigation, Tasmanian Electro Metallurgical Company Pty Ltd. (“TEMCO”) and its U.S. affiliate BHP Billiton Marketing Inc. On October 26, 2015, Felman Production, LLC (“Petitioners”) requested a hearing. On December 16, 2015, TEMCO and the Petitioners submitted case briefs. On December 21, 2015, TEMCO and the Petitioners submitted rebuttal case briefs. On January 11, 2016, the Department held a hearing in this investigation.

The period of investigation (“POI”) is January 1, 2014, through December 31, 2014.

The product covered by this investigation is silicomanganese from Australia. For a full description of the scope of the investigation, see Appendix I to this notice.

As provided in section 782(i) of the Act and 19 CFR 351.307(b)(1)(i), from September 28, 2015 through November 11, 2015, we verified the sales and cost information submitted by TEMCO for use in our final determination. We used standard verification procedures including an examination of relevant accounting and production records, and original source documents provided by TEMCO.3

All issues raised in the case and rebuttal briefs by parties in this investigation are addressed in the Issues and Decision Memorandum accompanying this notice, and which is hereby adopted by this notice.4 A list of the issues raised to which the Department responded is attached to this notice as Appendix II. The Issues and 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. The memorandum is available to all parties in the Central Records Unit, located at Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Issues and Decision Memorandum are identical in content.

Based on a review of the record and comments received from interested parties regarding our Preliminary Determination, we made the following changes to TEMCO's margin calculation:

• We recalculated TEMCO's indirect selling expenses (“ISE”) incurred in the United States based on verification findings;

• We recalculated indirect selling expenses incurred in the country of manufacture to reflect minor corrections and verification findings in the calculation of the indirect selling expense ratio;

• We eliminated from the U.S. and home market sales databases the loading charges reported under the fields DLOADU and LOADH, because these charges were double counted in that they were also reported under the fields PACK2H and PACKU;

• We corrected the CEP profit ratio due to a programing error in the Department's margin calculation program from the Preliminary Determination.

• We adjusted the by-product offset for silicomanganese fines generated during production to reflect the POI per-unit sales value.

• We adjusted the reported financial expense ratio to exclude interest income from long-term sources.

The Department determines that the following weighted-average dumping margins exist for the period January 1, 2014, through December 31, 2014:

Section 735(c)(5)(A) of the Act provides that the estimated all-others rate shall be an amount equal to the weighted-average of the estimated weighted-average dumping margins established for exporters and producers individually investigated excluding any zero or de minimis margins, and margins determined entirely under section 776 of the Act. In this investigation, we calculated a weighted-average dumping margin for TEMCO, the only respondent in this investigation, that is above de minimis and which is not based on section 776 of the Act. Therefore, the Department assigned a margin to the all-others rate companies based on TEMCO's weighted-average dumping margin.

We will disclose the calculations performed within five days of the date of any public announcement of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).

Pursuant to section 735(c)(1)(B) of the Act, the Department will instruct U.S. Customs and Border Protection (“CBP”) to continue to suspend liquidation of all of entries of silicomanganese from Australia, which were entered, or withdrawn from warehouse, for consumption on or after September 25, 2015, the date of publication of the Preliminary Determination. Further, pursuant to CFR 351.210(d), the Department will instruct CBP to require a cash deposit equal to the amount by which normal value exceeds U.S. price as follows: (1) For TEMCO, the mandatory respondent listed above, the cash deposit rate will be equal to the dumping margin which the Department determined in this final determination; (2) if the exporter is not a mandatory respondent identified in this investigation, but the producer is, the cash deposit rate will be the rate established for the producer of the subject merchandise; and (3) the cash deposit rates for all other producers or exporters will be 12.03 percent. The suspension of liquidation instructions will remain in effect until further notice.

In accordance with section 735(d) of the Act, we notified the U.S. International Trade Commission (“ITC”) of our final determination. As our final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will determine within 45 days whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports or sales (or the likelihood of sales) for importation of the subject merchandise. If the ITC determines that such injury exists, the Department will issue an antidumping duty order directing CBP to assess, upon further instruction by the Department, antidumping duties on appropriate imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation.

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

We are issuing and publishing this determination and notice in accordance with sections 735(d) and 777(i)(1) of the Act.

The purpose of this meeting is for the Monitoring Committee to review, and if necessary, revise the current management measures designed to achieve the recommended Golden Tilefish catch and landings limits for 2017.

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

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

Coho salmon (O. kisutch): threatened, naturally produced and specified artificially produced stocks in the Southern Oregon/Northern California Coast and Oregon Coast Evolutionarily Significant Units (ESUs).

The ODFW has submitted HGMPs for all hatchery programs along the Oregon Coast to NMFS, pursuant to Limit 5 of the 4(d) Rule for salmon and salmon promulgated under the ESA (65 FR 42422, July 10, 2000). NMFS' action of evaluating ODFW's HGMPs under Limit 5 of the 4(d) Rule is a major Federal action subject to environmental review under NEPA. Therefore, NMFS is seeking public input on the scope of the required NEPA analysis, including the range of reasonable alternatives, recommendations for relevant analysis methods, and information associated with impacts of the alternatives to the resources listed below or other relevant resources. Further, Limit 5 of the 4(d) Rule also specifies the HGMPs be made available for public review and comment prior to NMFS making a decision on the HGMPs.

For more information on the scope of the proposed hatchery programs, and NMFS' review of those programs, and a description of input being sought from the public, see the January 15, 2016, Federal Register notice (81 FR 2197). A list of the hatchery facilities being considered and links to the HGMPs for their associated hatchery programs are available on the Internet (see ADDRESSES).

NMFS provides this notice to: (1) Advise other agencies and the public of its plans to analyze effects related to the action, and (2) obtain suggestions and information that may be useful to the scope of issues and the full range of alternatives to include in the EIS. Comments should be as specific as possible.

The environmental review of the Oregon Coast HGMPs will be conducted in accordance with requirements of the NEPA of 1969 as amended (42 U.S.C. 4321 et seq.), NEPA Regulations (40 CFR parts 1500-1508), other appropriate Federal laws and regulations, and policies and procedures of NMFS for compliance with those regulations. This notice is being furnished in accordance with 40 CFR 1501.7 to obtain suggestions and information from other agencies and the public on the scope of issues and alternatives to be addressed in the EIS.

Under section 4 of the ESA, the Secretary of Commerce is required to adopt such regulations as he deems necessary and advisable for the conservation of species listed as threatened. The ESA salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005) specifies categories of activities that contribute to the conservation of listed salmonids and sets out the criteria for such activities. Limit 5 of the updated 4(d) rule (50 CFR 223.203(b)(5)) further provides that the prohibitions of paragraph (a) of the updated 4(d) rule (50 CFR 223.203(a)) do not apply to activities associated with artificial propagation programs provided that an HGMP has been approved by NMFS to be in accordance with the salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005).

In specifying the purposes, objectives, and functions of the Bureau in section 1021 of the Dodd-Frank Act, Congress authorized the Bureau to exercise its authorities for the purpose of ensuring that markets for consumer financial products and services operate transparently and efficiently to facilitate access and innovation.1 Pursuant to its authority, the Bureau is finalizing the Policy that is set forth in section VI below. Under the Policy, Bureau staff would, in its discretion, issue no-action letters (NALs) to specific applicants in instances involving innovative financial products or services that promise substantial consumer benefit where there is substantial uncertainty whether or how specific provisions of statutes implemented or regulations issued by the Bureau would be applied (for example if, because of intervening technological developments, the application of statutes and regulations to a new product is novel and complicated). The Policy is also designed to enhance compliance with applicable federal consumer financial laws. A NAL would advise the recipient that, subject to its stated limitations, the staff has no present intention to recommend initiation of an enforcement or supervisory action against the requester with respect to a specified matter. NALs would be subject to modification or revocation at any time at the discretion of the staff, and may be conditioned on particular undertakings by the applicant with respect to product or service usage and data-sharing with the Bureau. Issued NALs generally would be publicly disclosed. NALs would be non-binding on the Bureau, and would not bind courts or other actors who might challenge a NAL-recipient's product or service, such as other regulators or parties in litigation. The Bureau believes that there may be significant opportunities to facilitate innovation and access, and otherwise substantially enhance consumer benefits, through the Policy.

On October 16, 2014, the Bureau published in the Federal Register a notice inviting the general public and other Federal agencies to comment on any aspect of its proposed Policy on No-Action Letters (Proposed Policy).2 The Bureau received 28 formal comments on the Proposed Policy. Industry trade associations and other industry-oriented groups submitted 16 comment letters. Financial services providers submitted 3 comment letters. There were 3 comment letters from consumer-oriented groups. Individuals submitted a further 6 comments.

Virtually all commenters supported the stated goals of the Proposed Policy, to reduce regulatory uncertainty and facilitate innovation. No commenter disputed the Bureau's legal authority to adopt the Proposed Policy. Most comments asked for clarification or further detailing around specific parts of the Proposed Policy. Some urged changes to the Proposed Policy, for example, to make NALs more available to providers of consumer financial products and services with less burden or fewer restrictions or, in the case of some consumer-oriented commenters, to provide for additional consumer protections. Many commenters also urged the Bureau to make modifications to address concerns about the disclosure of proprietary business information and trade secrets. One industry trade association urged the Bureau to abandon the Proposed Policy because the organization considered that, as proposed, it would not facilitate and improve compliance in a meaningful way.

This section provides a summary of the principal comments received by subject matter. It also summarizes the Bureau's assessment of the comments by subject matter and, where applicable, describes the resulting changes that the Bureau is making in the final Policy. The Bureau has made some changes in response to comments received and to provide additional clarity, but in substantial part follows the Proposal.

While addressing discrete issues, commenters also expressed more general concerns that the criteria in the Proposed Policy were unworkable or that entities were unlikely to receive NALs. The Bureau believes the Policy will facilitate innovation and otherwise substantially enhance consumer benefits. However, the Bureau plans to monitor the effectiveness of the Policy and to assess periodically whether changes to the Policy would better effectuate these purposes.

Several industry trade groups urged the Bureau to adopt a policy for providing definitive regulatory interpretations to industry participants, such as in the form of Bureau interpretive rules and letters and advisory opinions, in addition to adopting a policy for issuing NALs. These commenters generally argued that guidance of this character would be useful to provide needed clarity regarding matters of potential regulatory uncertainty, and to facilitate compliance, and could address broader topics than may be presented in the context of a particular NAL. Some of these commenters anticipated that industry members would seek Bureau interpretive letters in circumstances in which applying for a NAL would be especially burdensome, or in circumstances that did not involve a product that would meet the parameters of the proposed NAL policy (such as a product already well-established in the marketplace). Various commenters stated that it is important for industry that the Bureau issue types of guidance that are legally binding, on the Bureau as well as (subject to judicial review) on other regulators and on consumer challengers, in addition to NALs, which provide only non-binding staff guidance.

The Bureau is committed to devoting substantial efforts to improving regulatory clarity and transparency to consumers, industry, and other stakeholders. The Bureau provides extensive interpretive guidance regarding regulations it has issued to govern the provision of consumer financial products and services, in a variety of ways. Many of the Bureau's regulations are accompanied by official Bureau interpretations, specifically keyed to the regulations by section number and published in the Code of Federal Regulations, that provide detail regarding interpretation and application of the regulations. Prior to promulgation of rules, Bureau staff has undertaken broad industry outreach to identify areas of potential uncertainty and to ascertain key matters of concern to industry regarding implementation and compliance. In many cases, such official interpretations are promulgated through notice and comment, simultaneously with issuance of the regulations. The Bureau actively monitors these official interpretations, and it has issued revisions of these official interpretations, in light of industry needs and other developments, on multiple occasions. In other instances, apart from official Bureau interpretations published in the Code of Federal Regulations, the Bureau has issued official interpretations or regulatory guidance on a stand-alone basis.

The Bureau has taken a number of steps to support industry implementation of its regulations and provide guidance to help financial institutions and other stakeholders understand, operationalize, and comply with new consumer protections. The Bureau has engaged directly and intensively with financial institutions, vendors, and others through a regulatory implementation project. As part of this effort, the Bureau has published plain-language guides and other resources, such as compliance guides, sample forms, fact sheets, rule summaries, charts, and toolkits. The Bureau has also published readiness guides that include check-lists of things for industry to do prior to a rule's effective date, such as updating policies and procedures and providing training for staff. In addition, the Bureau has conducted free webinars, available for public viewing through the Bureau's Web site, that provide guidance on how to interpret and apply its rules. These resources are available on the Bureau's Web site at www.consumerfinance.gov/regulatory-implementation.

The Bureau also provides unofficial oral staff guidance in response to regulatory interpretive questions that financial institutions and others subject to the Bureau's regulations can submit on an ongoing basis through a dedicated email address. The Bureau has provided unofficial oral guidance in response to thousands of such requests. In addition, Bureau regulatory staff has undertaken extensive post-issuance outreach to identify problem areas and provide further oral and written guidance about its regulations, on a timely basis. 3 Bureau staff regularly meets with industry representatives and other stakeholders regarding all areas within its regulatory jurisdiction to identify areas of regulatory uncertainty or compliance challenges, and to formulate an appropriate response when necessary. For example, the Bureau has published additional official commentary in response to feedback from stakeholders, including industry. Bureau staff has also provided remarks and addressed questions about Bureau rules and related implementation matters at numerous formal events and informal stakeholder meetings.

Moreover, the Bureau has published an array of bulletins to further clarify regulatory obligations and enhance compliance where industry has advised the Bureau of interpretive or other concerns or the Bureau's market awareness has led it to believe there are uncertainties requiring attention.

A substantial portion of the Bureau's personnel and other resources are devoted to these efforts. The Bureau intends to continue engaging closely and working with industry and other stakeholders to answer questions, provide regulatory support and guidance, and evaluate any issues industry and consumers experience as rules are issued and implemented. The Bureau also will continue its coordination with other federal government regulators to promote a consistent regulatory experience for industry. The Bureau is aware that many regulated entities have access to resources, counsel, advice, and processes of their own beyond the tools provided by the Bureau that they may use to assist in the interpretation of regulatory requirements and achieve regulatory compliance. The Bureau does not have the capacity to replace these private resources and tools, and does not believe that it would be desirable as a policy matter for the Bureau to try to do so. The Bureau will continue to engage in broad efforts to obtain industry feedback and attempt to employ its resources to provide broad industry and consumer support and guidance through the most efficient and appropriate means. The Bureau believes that experience with the NAL process will assist the Bureau in evaluating other potential steps.

The Policy being finalized today is intended to be one additional tool in the Bureau's kit to facilitate compliance and innovation, to supplement the foregoing means in instances where no-action treatment appears to offer advantages. Most of the Bureau's guidance resources will continue to be devoted to efforts other than NALs, as discussed above. The NAL Policy is intended to make efficient use of Bureau resources by focusing on matters of significant uncertainty, e.g., where technological developments have given rise to novel products not envisioned at the time existing statutes and regulations were issued, and substantial regulatory uncertainty poses a barrier to marketplace innovation. The Policy calls on applicants to identify the relevant facts, and specific regulatory issues needing attention, because applicants are well-positioned to do so effectively and insightfully. As contrasted with amendment of a regulation or an official interpretation, no-action treatment may often be a more useful tool for such cases because, among other things, the novel aspects of the product in question may be subject to evolution, the policy and legal implications are likely not yet sufficiently well understood to justify a definitive regulatory treatment of the relevant issues, and the time required to mature such a definitive treatment may be inconsistent with product-innovation needs of industry.

Two commenters requested clarification about coordination between Bureau staff and federal prudential regulators, stating that a NAL may be of little benefit to an institution whose prudential regulator considers a proposed product to violate applicable requirements. Other commenters urged the Bureau to make NALs binding on other regulators, to shield a NAL-covered product from the prospect of adverse treatment by another regulator.

The Bureau has not modified the Policy in response to these comments. Bureau staff regularly consults with other governmental agencies, Federal and State, with respect to financial industry matters, including product innovations. Applicants should be aware that Bureau staff may consult with other governmental agencies that may have enforcement, supervisory or licensing authority over the applicant, or other interest in matters relating to a NAL, in appropriate cases. The NAL Policy requires that NAL applicants provide information regarding relevant governmental investigations, licensing discipline, supervisory reviews, and enforcement actions, and this information may be a subject of discussions by Bureau staff with other governmental agencies. If an applicant is a depository institution, it should anticipate that Bureau staff may communicate with the applicant's primary federal prudential regulator and appropriate state regulators in evaluating issuance of a NAL.

While the Bureau may, in some circumstances, have the authority to issue waivers of otherwise-applicable legal requirements, or to establish definitive interpretations of legal requirements, or take similar actions, NALs issued under today's Policy are limited to a statement by Bureau staff that it does not intend to recommend enforcement or supervisory action by the Bureau. As such, they are not intended to bind other agencies. Other agencies will remain free to make independent determinations concerning their respective authorities and concerns. As discussed above, the Bureau will continue to evaluate its existing guidance tools and other guidance tools available to it, and nothing in today's Policy rules out or otherwise addresses other actions that the Bureau may take, for example to issue waivers, identify exceptions, provide interpretations, or undertake other regulatory relief, in appropriate circumstances.

The Proposed Policy indicated that Bureau staff would presumptively not issue NALs where the request concerns a legal or product environment that the staff considers to be inappropriate for no-action treatment, and provided the example that, at the present time, the staff does not anticipate no-action treatment of unfair, deceptive, or abusive acts or practices (UDAAP) matters. The Bureau received two types of comments regarding this statement about UDAAP matters in the Proposed Policy. First, two industry commenters made the point that a NAL would have little utility if it did not include some assurance that the Bureau would not pursue a UDAAP claim against the requester for offering the same product addressed in the letter. Second, several industry commenters more generally urged that UDAAP matters should not be categorically ruled out, and that UDAAPs may be particularly important areas of NAL treatment.

The statement in the Proposed Policy was not directed at the “follow on” UDAAP concern raised by the first type of comment. As detailed in Section C of the Policy, in deciding whether to provide a NAL, staff considerations will include, among other things:

• “The extent to which the requester's product structure, terms and conditions, and disclosures to and agreements with consumers enable consumers to meaningfully understand and appreciate the terms, characteristics, costs, benefits, and risks associated with the product, and to act effectively to protect themselves from unnecessary cost and risk”;

• “The extent to which evidence, including the requester's own testing, indicates that the product's aspects in question may provide substantial benefits to consumers”; and

• “The extent to which the requester controls for and effectively addresses and mitigates risks to consumers.”

Given that a NAL will be based, in part, on such factors, it is highly unlikely that staff would first provide a NAL—which would include a statement that staff has no present intention to recommend initiation of an enforcement or supervisory action against the requester in respect to the particular aspects of its product under the specific identified provisions and applications of statutes or regulations that are the subject of the NAL—and then recommend initiation of such action in respect to those same particular aspects of its product under the Bureau's UDAAP authority in the absence of new facts or circumstances. For example, if staff provided a NAL in response to a request stating that there was substantial uncertainty regarding whether particular disclosures comply with TILA and Regulation Z, the requester could expect that staff would not then recommend an enforcement or supervisory action on the basis that those same disclosures were deceptive under Dodd-Frank Act section 1031—except in the absence of new or extraordinary circumstances. At the same time, a grant of NAL treatment respecting a particular aspect of a product should not be understood to excuse potential UDAAP violations that might arise from other aspects of the product, such as marketing or operation that were not addressed in the NAL letter or stem from subsequent changes in the product.

The Bureau also recognizes the perspective behind the second type of comment. The Bureau's statement about UDAAP matters in the Proposed Policy was based primarily on two considerations. First, evaluation of whether an act or practice constitutes a UDAAP is typically an intensively factual question that requires detailed consideration of a wide range of potentially relevant circumstances. Such evaluations can be more complicated, and uncertain, than evaluation of an act or practice with respect to a regulatory or statutory provision that is drawn more narrowly and precisely than the statutory UDAAP prohibitions. This complexity may be especially pertinent in the context of requests for NAL treatment under the Policy, which are limited to instances in which there is substantial uncertainty regarding whether the particular aspects of the product identified in the request are unfair, deceptive, or abusive. Second, as noted in the Proposed Policy, the Bureau has quite limited resources to devote to consideration and issuance of NALs at this time. The Bureau is concerned that devoting attention to UDAAP-focused NAL requests could misallocate its resources away from more narrowly-focused cases that are more likely to be workable NAL candidates. However, the Bureau need not make a categorical determination at this time.

Accordingly, the example in Section B of the Proposed Policy regarding UDAAP matters has been deleted from the Policy. The Bureau cautions, however, that this change should not be interpreted as portending the issuance of a significant volume of such UDAAP-focused NALs. As noted in the Proposed Policy and elsewhere in this Final Policy Statement, the Bureau anticipates that NALs will be provided rarely because they require a thorough and persuasive demonstration of the appropriateness of NAL treatment. The considerations referred to above are likely to mean that UDAAP-focused NALs will be particularly uncommon.

Several industry commenters suggested that the Bureau adopt a specific timetable for approval or denial of a NAL once an application has been submitted. These commenters generally expressed a view that prescriptive timetables on the order of 45, 60, or 90 days are necessary in order to accommodate the rapid development processes of novel products. At the same time, a number of industry commenters, including some of those urging prescribed timetables for action on applications, expressed the view that it is important that prospective applicants have an opportunity to confer informally with Bureau staff before making an application, in order to align expectations and to allow for development and adjustments before making any formal application.

Although Bureau staff will make reasonable efforts to respond to applications in a timely manner, the Bureau has not included any strict timetable in the Policy. If the NAL process does not reach a conclusion that is in keeping with an innovator's timing or other needs, an innovator may withdraw its application and proceed as it considers appropriate with respect to its product without a NAL. Because NAL applications are expected to be individualized events on the part of the applicant and Bureau staff involving novel products, because product changes may continue during the NAL process, and because the Bureau does not yet have concrete experience in processing NAL applications, the Bureau is not prepared to prescribe a prescriptive timetable by which an application must be resolved. As noted in footnote 7 of the Policy, innovators are encouraged to contact staff for informal preliminary discussion in advance of filing an application for a NAL. Such discussions are expected to address the potential applicant's product development plans, information-sharing, any anticipated complications in the NAL process, and anticipated timetables in light of such considerations.

Several industry representatives criticized the Proposed Policy as requiring applicants to provide an unduly burdensome volume of information. Some commenters suggested that information requirements be minimized specifically for smaller organizations that may have relatively fewer resources to devote to the NAL process. A number of commenters requested changes in the Proposed Policy's requirements that applicants identify the particular provisions of statutes or regulations about which NAL treatment is being requested, state why NAL treatment is necessary and appropriate to remove substantial regulatory uncertainty, and provide a candid explanation of potential consumer risks. In addition to asserting that it would be burdensome to provide such information, commenters expressed concern that providing information along these lines could have the effect of requiring applicants to target their products for third-party challenge if a NAL application is made public.

The Bureau has not changed these information requirements in the Policy in response to these comments. Whenever any conscientious firm, large or small, intends to launch a consumer financial product that raises substantial regulatory questions, the Bureau expects that the firm would on its own, as a matter of its compliance obligations wholly apart from a NAL application, undertake carefully to identify and evaluate the consumer risks, regulatory issues, and other matters the Policy requires a NAL application to address. In this respect, the Bureau does not expect the Policy to involve substantial additional information-gathering burdens. While the Bureau understands that some innovators find it burdensome to undertake their own assessment of applicable regulatory and other legal obligations, consumer impacts that their products might create, and other relevant matters, the Bureau is not in a position, through its NAL policy, to perform these compliance obligations for industry members.

The Bureau's intention is to devote its NAL resources at this time to addressing instances in which substantial uncertainty in the statutes and regulations that are within its jurisdiction are creating a barrier to bringing consumer-beneficial products to market. If an applicant cannot identify its product as presenting such a case, or if the applicant does not intend to be candid in its request and related communications, the Bureau's resources can more usefully be focused elsewhere. To be clear, firms are not required to seek NAL treatment before launching a product. Moreover, in identifying areas of regulatory uncertainty an applicant is not required to concede that its product contravenes any requirement. On the contrary, the Policy explicitly calls on the applicant to explain why it believes its product should not be treated as subject to or precluded by pertinent statutes and regulations as properly understood and applied. If a prospective applicant believes that information regarding its product requires confidential protection, informal advance discussion with the staff can explore what particular information and detail is necessary to be included in an application, the timing of NAL issuance, and how best to protect proprietary matter. In addition, section A.15 of the Policy provides that an application may include a request for confidential treatment of certain information. If a NAL is issued, it may be unavoidable that its publication will, to some extent, publicly identify aspects of regulatory uncertainty that are involved, but the Bureau believes that such transparency to industry and consumers is a critical value to be served by the NAL process.

Some commenters in the consumer advocacy community requested that the Bureau modify the Proposed Policy to provide that any NAL will be subject to a 30-day notice-and-comment period, preferably in advance of NAL issuance. These commenters asserted that such a process is advisable to balance an applicant's self-interested submissions by bringing to bear other viewpoints through a public process.

The Bureau declines to adopt the comment period suggestion. Comment periods are not typical of other agencies' no-action letter procedures. The Bureau believes that imposing such a comment period requirement in advance of issuance would unnecessarily discourage NAL applications and delay the NAL process, inhibiting the intended benefits of the Policy. Staff has the ability to conduct outreach to the public as needed to obtain input on a variety of regulatory matters, which includes issues pertaining to NAL requests. Staff also intends to monitor products that are the subject of NALs on an ongoing basis, including comments that may be received from the public following issuance of a NAL. This monitoring will not be confined to a 30-day or other prescribed period.

Several commenters expressed concern that publication of NALs, which would include publication of a version or summary of the application, may compromise entities' proprietary business information or trade secrets. Some commenters raised a concern that, if the Bureau were to deny a NAL application for innocuous reasons and announce the denial, it might cause injury to the applicant if it later introduced the subject product into the marketplace. Other commenters, including industry commenters, specifically encouraged routine publication so that industry members will have insight into the Bureau staff's perspectives.

The Bureau considers that publication of NALs issued by staff is an important aspect of the Bureau's transparency principles. The released version or summary of the application and the terms of the NAL will provide relevant and potentially important information to consumers and industry concerning the new product and Bureau staff's perspective. In general, the consumer-facing characteristics of the product involved will become known to the market at the time of product launch in any event. The Policy does not specify the timing for the Bureau's NAL publication. To the extent that a potential applicant has concerns regarding the public release of particular information, Bureau staff plans to confer with the applicant, in advance of a submission or later, to discuss whether the information is necessary to submit as part of the application or otherwise, redaction from any documents to be released publicly, timing of any release, application of the Bureau's rule concerning Disclosure of Records and Information, 12 CFR part 1070, and other relevant matters.

Denials of a request for a NAL generally would not be published. However, because a circumstance may arise in which publication of a denial would be in the public interest, the Policy does not categorically rule out publication of denials.

The finalized Policy makes one editing change with respect to publication of NALs and applications, to conform section D of the Policy to the wording of section B of the Policy with respect to publication of a “a version or summary of” the request.

Under the Policy, a NAL is subject to subsequent revocation or modification in the discretion of Bureau staff, and may be immediate upon notice. Revocation or modification of a NAL does not itself constitute a determination that a product violates any regulatory requirement or that the firm must withdraw the product from the market. Obviously, however, modification or revocation reflects a change in facts, circumstances, or outlook on the part of Bureau staff. Some industry and consumer commenters urged the Bureau to adopt procedural protections around the revocation/modification process, including suggesting that the Bureau communicate with recipients prior to revocation or modification, and that it provide a grace period to allow recipients to modify or cease relevant policies or practices.

In response, the Bureau has added a statement to section D.6 of the Policy concerning revocations or modifications initiated by staff. Unless there is a reason not to do so in a particular case, before determining to revoke or modify a NAL, Bureau staff plans to communicate with the requesting entity (or entities) regarding the grounds for potential revocation or modification and permit an opportunity to respond. If staff revokes or modifies a NAL, it intends to do so in writing. Staff plans to make revocations and modifications public.

Several commenters suggested that the Bureau not limit NALs to instances of emerging products, or that it not limit NALs to instances of substantial regulatory uncertainty. These commenters advocated that the Bureau provide NALs dealing with products that are already established and/or where there is no substantial regulatory uncertainty. The Bureau does not believe such a change to the Policy is desirable at this time. The Bureau's resources available to devote to NALs are limited, and the Bureau considers it desirable to focus these resources at this time on reducing barriers to innovation. If a product is already established in the marketplace, or if there are no substantial regulatory uncertainties interfering with its development, then Bureau resources for reducing barriers to innovation would be better allocated to other NAL cases, or to other efforts.

Some consumer advocates urged the Bureau to revise the Proposed Policy to specifically limit NALs to products where staff is convinced that the product will clearly not involve any risk to consumers. Reflecting a different perspective, a number of industry commenters urged that the Bureau eliminate the requirement that a proposed NAL product promise substantial benefits to consumers. Some of these commenters considered that application of the “substantial benefits” standard would involve the Bureau in inappropriately choosing winners and losers, and some expressed the view that assessment of substantial benefits was unknowable for new products or unduly subjective.

The finalized Policy has not incorporated the changes advocated by either of these two perspectives. The Bureau believes that its Policy has appropriately articulated requirements with respect to both risks and benefits. The Policy specifically requires an applicant to candidly disclose potential consumer risk information, and establishes that NAL applications would be assessed on the basis of such risks and how they may be effectively addressed and mitigated. In addition, issuance of a NAL may be conditioned on the provision of future data to enable Bureau staff to monitor ongoing risk and respond as necessary. A firm is not required to obtain a NAL in order to launch a product. But issuance of NALs is committed to the discretion of Bureau staff, and the Policy appropriately requires an applicant to identify anticipated consumer benefits so that Bureau staff can evaluate whether the request merits the diversion of the Bureau's limited resources away from other important consumer protection work.

Under the Policy, decisions whether to issue a NAL are committed to the discretion of Bureau staff. Section B of the Policy describes the categories of formal responses that the staff expects normally to use in response to a request (granting, denying, or declining to grant or deny, the request). Section C of the Policy identifies 10 factors that, among others, staff plans to consider in deciding whether to issue a NAL. Several commenters suggested that the Proposed Policy be amended to prescribe that staff elaborate specific reasons when it determines that a particular application for a NAL will not be granted. The principal point advanced in favor of requiring such a statement of reasons is that it would provide substantive guidance to industry regarding Bureau analysis of regulatory issues. Some other commenters suggested that all denials be made public. Relatedly, some commenters interpreted section B of the Proposed Policy to mean that, in some cases, the Bureau would not communicate in any way with the requesting entity.

The Bureau does not agree that it would be advisable to require staff to provide specific reasons for declining to provide NALs, or that denials generally should be made public. Publishing such statements regarding denials is not typical of no-action letter programs of other agencies, and the Bureau does not believe that providing such statements about denials would be a productive method of industry or public guidance, when weighed against the burden on Bureau resources that would be involved. The Bureau has limited resources to devote to NALs, and it believes that those resources are best focused on the work required to grant NALs when appropriate and to monitor those that are granted. As noted elsewhere, individual applicants are advised to contact staff in advance for informal discussion before committing significant effort toward a potential NAL application. In the unusual case in which none of the types of responses described in Part B of the Policy is provided, the staff plans to notify the requester that its response has been received and that staff has decided not to provide a response that corresponds to one of the types described in Part B of the Policy.

As stated in the Proposed Policy, the Bureau anticipates that NALs would be provided only on the basis of exceptional circumstances and a thorough and persuasive demonstration of the appropriateness of such treatment. Several commenters expressed dissatisfaction that NALs are likely to be rarely issued, and urged that the Bureau should make NALs more widely available, recognizing that they may later be withdrawn if necessary.

Bureau staff currently devotes considerable effort to maintaining ongoing communication with financial services product developers and other industry members, including concrete informal discussions about forthcoming innovations and regulatory considerations. Based on this experience, the Bureau estimates that, realistically, it will on average receive one to three actionable applications per year. If the volume of viable applications exceeds this volume, the Bureau will work to accommodate the need. The Policy anticipates that staff would provide no-action treatment only on a thorough-and-persuasive demonstration that the relevant criteria, as specified in the Policy, are met. That NALs may be withdrawn at a later stage is not, in the Bureau's view, a justification to provide no-action treatment based on unrefined product concepts, inadequate information, or incomplete attention by an applicant to regulatory requirements or mitigation of consumer protection risks.

Some commenters urged the Bureau to address no-action protection of third parties that may be associated with an applicant's product, such as firms that provide functions that are integrated with the product's operation or distribution, or provide ancillary products or services. A product developer seeking NAL treatment may not intend itself to be the provider of that product to consumers, or may depend on other firms as service providers or in other ways. These other firms may be reluctant to participate in the commercialization of the product if they lack NAL protection, but for a variety of legitimate commercial reasons they may not be identifiable at the time of the NAL application or issuance. Some commenters also urged the Bureau to allow trade associations to submit requests on behalf of their members.

The Bureau is sympathetic to the complications described. The Policy envisions that a NAL application may be submitted jointly by multiple firms, which may ease some of these complications. The Bureau is not, however, willing to grant NAL treatment to a firm that is not identified in the application process and has not agreed to the affirmations and undertakings specified by the Policy (such as affirmations regarding the accuracy of information presented about the product and the firm, undertakings to provide additional information, and descriptions of safeguards the applicant will employ). The Bureau envisions that, in many cases, a firm that comes to be involved in the provision of a product, though not itself the applicant covered by a NAL, will draw sufficient comfort from a NAL issued to the identified applicant. Where this is not so, Bureau staff will be available to confer with the applicant, and the other firm(s), regarding the reasons why the other firm(s) were not co-applicants, whether an issued NAL may be modified, and other possible approaches to the situation. For similar reasons, the Bureau is not willing to grant NAL treatment to trade associations on behalf of their members.

Some commenters sought clarification regarding the Proposed Policy's anticipation that a NAL may be subject to time limitations or limitations on the quantity of transactions. The Policy, which is slightly revised on this point for clarity, provides that a NAL issued by Bureau staff will generally include a description of any conditions or limitations attending no-action treatment, such as the requester's undertaking to provide additional safeguards to consumers, or to share certain types of data with the Bureau, as well as any limitations as to time period or quantity of transactions. These NAL terms will be informed by commitments identified in the application and by staff's evaluation of consumer risks. The Bureau expects such considerations to be taken into account on a case-by-case basis. If a NAL application is based on uncertainty regarding a particular regulatory safeguard, for example, the applicant may find it appropriate to introduce a different method to safeguard comparable consumer protection concerns. If an applicant intends to test its product in a particular way, and review consumer data arising from the test, the applicant may suggest limiting the NAL to those terms as a factor in demonstrating limitations on consumer risks. If an applicant envisions the iterative development of a product, different limitations or safeguards may apply at successive stages of the development.

This Policy on No-Action Letters constitutes an agency general statement of policy and/or a rule of agency organization, procedure, or practice exempt from the notice and comment rulemaking requirements under the Administrative Procedure Act, pursuant to 5 U.S.C. 553(b). Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.4

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.), Federal agencies are generally required to seek the Office of Management and Budget (OMB) approval for information collection requirements prior to implementation. Further, the Bureau may not conduct or sponsor a collection of information unless OMB approves the collection under the PRA and it displays a currently valid OMB control number. Notwithstanding any other provision of law, no person is required to comply with, or is subject to penalty for failure to comply with, a collection of information if the collection instrument does not display a currently valid OMB control number. OMB has approved the collections of information contained this Policy. The OMB Number is 3170-0059 (Expiration Date: 02/28/2019).

The text of the final Policy is as follows:

Under Title X of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), the Bureau's objectives include “facilitating [consumer] access” to and “innovation” in markets for consumer financial products.5 The Bureau recognizes that, in certain circumstances, some may perceive that the current regulatory framework may hinder the development of innovative financial products that promise substantial consumer benefit because, for example, existing laws and rules did not contemplate specific products. In such circumstances, it may be substantially uncertain whether or how specific provisions of certain statutes and regulations should be applied to such a product—and thus whether the federal agency tasked with administering those portions of a statute or regulation may bring an enforcement or supervisory action against the developer of the product for failure to comply with those laws. Such regulatory uncertainty may discourage innovators from entering a market, or make it difficult for them to develop suitable products or attract sufficient investment or other support.

Federal agencies can reduce such regulatory uncertainty in a variety of ways. For example, an agency may clarify the application of its statutes and regulations to the type of product in question—by rulemaking or by the issuance of less formal guidance. Alternatively, an agency may provide some form of notification that it does not intend to recommend initiation of an enforcement or supervisory action against an entity based on the application of specific identified provisions of statutes or regulations to its offering of a particular product. This Policy is concerned with the latter means of reducing regulatory uncertainty in limited circumstances.

Pursuant to its authorities under the Dodd-Frank Act, the Bureau is today releasing its Policy on No-Action Letters (Policy). Under the Policy, an entity may submit a request for a No-Action Letter from Bureau staff (staff). A No-Action Letter would include a statement that the staff has no present intention to recommend initiation of an enforcement or supervisory action against the requester with respect to particular aspects of its product, under specific identified provisions of statutes or regulations. Such a letter may be limited as to time, volume of transactions, or otherwise, and may be subject to potential renewal. Whether and how to provide a No-Action Letter or otherwise respond to such requests, including any limitations or conditions on acceptance, will be within the sole discretion of the staff.

The Policy is intended to facilitate consumer access to innovative financial products that promise substantial benefit to consumers, taking into account other marketplace offerings, and also to enhance compliance with applicable federal consumer financial laws.6 By furnishing a dedicated mechanism through which substantial regulatory uncertainty can be reduced, the Policy is also intended to discourage the offering of innovative consumer-harmful financial products in such circumstances. In addition, because No-Action Letters often will be conditioned on specified consumer protection conditions designed to satisfy—or even exceed—applicable disclosure requirements and substantive protections, the Bureau expects the Policy to benefit consumers in further ways. The Bureau also expects the Policy to help further its consumer protection functions and objectives, including market monitoring and rulemaking, particularly when a No-Action Letter is conditioned on a commitment by the requester to share data about the product with the Bureau, or to engage in other consultation that may help inform Bureau decisions regarding whether to take further action in connection with the financial product in question.

The Policy has five sections:

• Section A describes information that should be included in requests for a No-Action Letter.

• Section B describes types of responses the staff may provide to requests for a No-Action Letter.

• Section C lists factors the staff may consider in deciding whether to provide a No-Action Letter.

• Section D describes the general content and limitations of No-Action Letters.

• Section E describes disclosure of data received from entities who have requested No-Action Letters.

Requests for a No-Action Letter should be submitted in writing via email to [email protected]. 7 Submitted requests may be withdrawn by the requester at any time.

Requests should include the following:

1. The name(s) of the entity or entities and individual(s) requesting the No-Action Letter.

2. A description of the consumer financial product involved, including:

a. how the product functions, and the terms on which the product will be offered;

b. the roles and relationships of all parties to transactions involving the product; and

c. the manner in which it is offered to and used by consumers, including any consumer disclosures.

3. The timetable on which the product is expected to be offered. No-Action Letters are not intended for either well-established products or purely hypothetical products that are not close to being able to be offered.

4. An explanation of how the product is likely to provide substantial benefit to consumers differently from the present marketplace, and suggested metrics for evaluating whether such benefits are realized.

5. A candid explanation of potential consumer risks posed by the product—particularly as compared to other products available in the marketplace—and undertakings by the requester to address and minimize such risks.

6. A showing of why the requested No-Action Letter is necessary and appropriate to remove substantial regulatory uncertainty hindering the development of the product, including:

a. Identification of each of the specific provisions of the statutes and regulations regarding which a No-Action Letter is being requested, and a showing how each of these specific provisions of the statute(s) and regulation(s) should be applied to the product is substantially uncertain, including analysis of the relevant legal authorities and policy considerations.

b. A showing of why the product's aspects in question should not be treated as subject to or precluded by the specific identified statute(s) and regulation(s), and/or how the proposed compliance of the product's aspects in question with the specific identified statute(s) and regulation(s) is appropriate.

c. A showing of the product's compliance with other relevant federal and state regulatory requirements.

d. A showing of why the substantial regulatory uncertainty that is the subject of the request cannot be effectively addressed through means other than the requested No-Action Letter, such as modification of the product.

7. An affirmation that the facts and representations in the request are true and accurate.

8. A commitment by the requester to provide information requested by the staff in its evaluation of the request.

9. A description of data that the requester possesses, and data it intends to develop, pertaining to the factual bases cited in support of the request and a statement of any undertaking by the requester, if the request is granted, to share appropriate data regarding the product with the Bureau, including data regarding the impact of the product on consumers. This description should also address the requester's intentions regarding consultation with the Bureau in its plans for development of additional data.

10. Commitments that, if the request is granted, the requester will not represent that the Bureau or its staff has: (i) Licensed, authorized or endorsed the product, or its permissibility or appropriateness, in any way; (ii) determined, or provided an interpretation, that the product is or is not in compliance with legal or other requirements, or has been granted an exception, waiver, safe harbor, or comparable treatment; or (iii) granted No-Action Letter treatment with respect to any aspect of the requester's offerings or any provision of law other than those expressly addressed in the No-Action Letter.

11. An affirmation that, to the requester's knowledge (except as specifically disclosed in the request), neither the requester nor any other party with substantial ties to transactions involving the product is the subject of an ongoing, imminent, or threatened governmental investigation, supervisory review, enforcement action, or private civil action respecting the product, or any related or similar product; and an undertaking promptly to notify the Bureau (unless the request for a No-Action Letter has been withdrawn or denied) of any such governmental investigation, supervisory review, enforcement action, or private civil action that is initiated or threatened.

12. An affirmation that (except as specifically disclosed in the request) the principals of the requester have not been subject to license discipline, adverse supervisory action, or enforcement action with respect to any financial product, license, or transaction within the past ten years.

13. A statement specifying whether the request is limited to a particular time period, to a particular volume of transactions, or to other limitations.

14. A description of any particular consumer safeguards the requester will employ, although they may not be required by law, if a No-Action Letter is issued, including any mitigation of potential for or consequences of consumer injury. The description should specify the requester's basis for asserting and considering that such safeguards are effective. The description should also address any future study the requester will undertake to further evaluate the effectiveness of such safeguards.

15. If a request for confidential treatment is made, this request and the basis therefor should be included in a separate letter and submitted with the request for a No-Action Letter. Requesters are advised to specifically identify data that the Requester believes to be confidential supervisory information that should be shielded from public disclosure.

The decision whether to respond to a request for a No-Action Letter, and the nature of any response, is within the staff's sole discretion. Depending on the circumstances, the staff may: (i) Grant the request (which grant may be partial, or may be subject to limitations or conditions); (ii) deny the request; (iii) specifically decline to either grant or deny the request, with an explanation; or (iv) specifically decline to either grant or deny the request, without explanation. The staff may, but is not required to, communicate with the requester before making any decision regarding whether and how to respond to the request to seek clarification or for other purposes. The staff may permit requests to be modified in the course of such communications.

Type (i) responses, and a version or summary of the request, generally would be published on the Bureau's Web site.8 Type (ii) responses generally would be provided to the requester but generally would not be published on the Bureau's Web site.9 Type (iii) and (iv) responses generally would be provided to the requester and may be published on the Bureau's Web site, particularly if the staff believes that the information will be in the public interest.

Non-exclusive examples of circumstances under which the staff presumptively would provide only responses of type (iii) or (iv), or, where appropriate, no response at all, include:

1. The requester or its principals are the subject of ongoing governmental law enforcement investigation, supervisory review, or enforcement action respecting the product or a related or similar product.10

2. The request concerns an area in which the Bureau is engaged in ongoing or anticipated rulemaking, supervisory, enforcement, or other initiatives.

3. The request concerns matter that the staff considers to be inappropriate for no-action treatment.

4. The staff has decided not to invest the Bureau resources that appear likely to be necessary to address the request adequately.

No-Action Letters will not be routinely available. The Bureau anticipates that No-Action Letters will be provided rarely and on the basis of exceptional circumstances and a thorough and persuasive demonstration of the appropriateness of such treatment. Requesters do not have a legal entitlement to no-action treatment of regulatory uncertainties, and Bureau resources available for consideration of No-Action Letter requests are limited in light of other Bureau priorities. Requesters may wish to include in their submissions any particular reasons why their request should be considered by the Bureau to be a matter of special importance.

The staff considerations, in deciding whether to provide a No-Action Letter,11 include:

1. The extent to which the requester's product structure, terms and conditions, and disclosures to and agreements with consumers enable consumers to meaningfully understand and appreciate the terms, characteristics, costs, benefits, and risks associated with the product, and to act effectively to protect themselves from unnecessary cost and risk.

2. The extent to which evidence, including the requester's own testing, indicates that the product's aspects in question may provide substantial benefits to consumers.

3. The extent to which the asserted benefits to consumers are available in the marketplace from other products.

4. The extent to which the requester controls for and effectively addresses and mitigates risks to consumers.12

5. The extent to which granting the request is necessary in order to reduce substantial regulatory uncertainty for the requester with respect to the requester's product.

6. The extent to which the substantial regulatory uncertainty identified by the requester may be better addressed through other regulatory means, such as Bureau rulemaking, other Bureau guidance, or provision of a waiver under the Bureau's Policy to Encourage Trial Disclosure Programs.13

7. Whether the entity is demonstrably in compliance with other relevant federal and state regulatory requirements.

8. The extent to which the request is sufficiently limited in time, volume of transactions, or otherwise, to allow the Bureau to learn about the product and the aspects in question while minimizing any consumer risk.

9. The extent to which any data that the entity has provided and agrees to provide to the Bureau regarding the operation of the product's aspects in question will be expected to further consumer protection.

10. The extent to which public disclosure of relevant data may be permitted.

When the staff decides to provide a No-Action Letter, it plans to publish the letter, along with a version or summary of the request, on the Bureau's Web site. The expected contents of a No-Action Letter include the following:

1. A statement that, subject to the conditions and limitations set forth, the staff has no present intention to recommend initiation of an enforcement or supervisory action against the requester in respect to the particular aspects of its product under the specific identified provisions and applications of statutes or regulations that are the subject of the No-Action Letter. The statement that the staff has no present intention to recommend initiation of an enforcement or supervisory action does not mean that the Bureau will not conduct supervisory activities or engage in enforcement investigation to evaluate the requester's compliance with the terms of the No-Action Letter or to evaluate other matters.

2. A statement that the no-action treatment is limited to the requester's offering of the product's aspects in question in the manner described, and that it does not pertain to (i) the requester for offering the product in a different manner; (ii) the requester for offering different products, or with respect to other provisions or applications of these or other statutes and regulations, or with respect to other aspects of the product; or (iii) any other person.

3. A statement that the No-Action Letter is based on the facts stated and factual representations made in the request, and is contingent on the correctness of such facts and factual representations.

4. A statement (a) disclaiming any intention that the No-Action Letter constitutes a determination by the Bureau or its staff about, or is an interpretation of, or grants any exception, waiver, safe harbor, or similar treatment respecting the statutes and rules identified in the request, or their application to the product's aspects in question, or otherwise constitutes an official expression of the Bureau's views, and that any explanatory discussion should not be interpreted as such an interpretation, waiver, safe harbor, or the like, that is binding on the Bureau, and (b) that the staff is not necessarily in agreement with any legal or policy analysis, any interpretation of data, or any other matter, set forth in the request.

5. A description of any conditions or limitation attending the No-Action Letter, such as the requester's commitment to provide additional safeguards to consumers, or to share certain types of data with the Bureau, as well as any limitations as to time period or quantity of transactions.

6. A statement that the No-Action Letter is subject to modification or revocation at any time at the discretion of the staff for any reason, including that: the facts and representations in the request appear to be materially inaccurate or uncertain; the requester fails to satisfy conditions or violates limitations specified in the No-Action Letter; the product or any of its material features, terms, or conditions, is altered; or the staff determines that such modification or revocation is appropriate to protect consumers or is otherwise in the public interest. Unless there is a reason not to do so in a particular case, staff plans to communicate with the requesting entity (or entities) regarding the grounds for potential revocation or modification in advance of a revocation or modification, and permit an opportunity to respond. When staff revokes or modifies a No-Action Letter, staff intends to do so in writing. Staff plans to make revocations and modifications public.

7. A statement that the No-Action Letter is not issued by or on behalf of any other government agency or any other person, and is not intended to be honored or deferred to in any way by any court or any other government agency or person.

8. A statement of any expiration date, or volume limitation, applicable to the No-Action Letter (and whether or not the requester may seek to renew the No-Action Letter).

9. A statement that the No-Action Letter becomes inapplicable upon failure to adhere to the affirmations or undertakings made in the request or stated as conditions of the issuance of the letter. To the extent that the facts and representations in the request are materially inaccurate, or the requester fails to satisfy conditions or violates limitations specified in the No-Action Letter, and in other similar circumstances, the No-Action Letter is by its own terms inapplicable (even without modification or revocation) and the staff may recommend initiating a retrospective enforcement or supervisory action if appropriate.

The Bureau's disclosure of a version or summary of the request and any data received from the requester in connection with a request for a No-Action Letter is governed by the Bureau's rules regarding Disclosure of Records and Information.14 For example, 12 CFR 1070.14 generally requires the Bureau to make its records available to any person pursuant to a request that conforms to the rules and procedures of that section, subject to the application of the FOIA exemptions and exclusions. To the extent the Bureau affirmatively wishes to disclose such data, the terms of such disclosure will be consistent with applicable law and the Bureau's own rules and may be specified in a separate agreement with the requester. Consistent with applicable law and its own rules, the Bureau will seek to redact data to protect consumers' privacy interests.

CPSC seeks to renew the following currently approved collection of information:

Title: Safety Standard for Cigarette Lighters.

OMB Number: 3041-0116.

Type of Review: Renewal of collection.

Frequency of Response: On occasion.

Affected Public: Manufacturers and importers of cigarette lighters.

Estimated Number of Respondents: In 2015, 42 firms submitted information to the CPSC on 307 lighter models. There were 4 new models and 303 lighters that were comparable to previously tested models (“comparison lighters”).

Estimated Time per Response: Recordkeeping is composed of two separate components: recordkeeping for new models and recordkeeping for comparison lighters. The time burden for recordkeeping for new models is estimated at 20 hours per model. The total time for recordkeeping of new models is estimated to be 80 hours (20 hours × 4 models). For each new model, product testing for each firm would take approximately 90 hours per model, for a total of 360 hours (90 hours × 4 models).

Firms may also submit comparison lighters to demonstrate compliance with the standard. In 2015, 303 comparison lighters were reported to the CPSC. While firms bear no testing costs for comparison lighters, the burden hours for recordkeeping has been estimated at 3 hours per model. Thus, an estimated 909 hours (303 models × 3 hours) is estimated for recordkeeping for comparison lighters.

Reporting requirements for submitting forms to CPSC are estimated at one hour per model, for a total annual reporting burden on 307 hours (307 models × 1 hour).

Total Estimated Annual Burden: The total number of responses is approximately 307 per year (4 new models + 303 comparison lighters). The number of hours estimated for testing and recordkeeping is 1,349 hours per year, including new-product tests (360 hours if done in house), new product recordkeeping (4 new models × 20 hours = 80 hours), and recordkeeping for comparison lighters (303 comparison lighters × 3 hours = 909 hours). In addition, the CPSC estimates that approximately one hour per product will be required for manufacturers to submit forms to CPSC, or 307 total hours for reporting. Accordingly the total burden hours for recordkeeping and reporting are approximately 1656 hours (1349 + 307).

General Description of Collection: In 1993, the Commission issued the Safety Standard for Cigarette Lighters (16 CFR part 1210) under the Consumer Product Safety Act (“CPSA”) (15 U.S.C. 2051 et seq.) to eliminate or reduce risks of death and burn injury from fires accidentally started by children playing with cigarette lighters. The standard requires certain test protocols, as well as recordkeeping and reporting requirements. 16 CFR part 1210, subpart B. In addition, section 14(a) of the CPSA (15 U.S.C. 2063(a)) requires manufacturers, importers, and private labelers of a consumer product subject to a consumer product safety standard to issue a certificate stating that the product complies with all applicable consumer product safety standards. Section 14(a) of the CPSA also requires that the certificate of compliance must be based on a test of each product or upon a reasonable testing program.

The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:

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

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

Proposed Agenda: The Committee will review commemorative monument requests, receive a briefing on the history of burial eligibility at Arlington National Cemetery and review ongoing construction projects.

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

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

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

Purpose of the Meeting: The Advisory Committee on Arlington National Cemetery is an independent Federal advisory committee chartered to provide the Secretary of the Army independent advice and recommendations on Arlington National Cemetery, including, but not limited to, cemetery administration, the erection of memorials at the cemetery, and master planning for the cemetery. The Secretary of the Army may act on the committee's advice and recommendations. The primary purpose of the Remember Subcommittee is to review and provide recommendations on preserving and caring for the marble components of the Tomb of the Unknown Soldier (TUS) and reviewing proposed commemorative monuments requested for placement in the cemetery.

Proposed Agenda: The Subcommittee will review the status of all pending commemorative monument requests.

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

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

Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), and Section 10(a), Public Law 92-463, as amended, notice is hereby given of a forthcoming meeting of the DACOWITS.

The purpose of the meeting is for the Committee to swear-in new members, and to receive briefings and updates relating to their current work. The Committee will start the meeting with the swearing-in of three new members. The Designated Federal Officer (DFO) will then give a status update on the Committee's requests for information. There will be a panel with the Air Force, Army, and Navy Chaplain Corps. The Office of Diversity Management and Equal Opportunity will provide an update on sexual harassment. There will be a public comment period at the end of day one. On the second day the Committee will announce their 2016 installation visit schedule. Additionally, there will be two panel discussions with the Services on the following topics: Gender Integration and Transition Training programs and resources. Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, interested persons may submit a written statement for consideration by the DACOWITS. Individuals submitting a written statement must submit their statement to the point of contact listed at the address in FOR FURTHER INFORMATION CONTACT no later than 5:00 p.m., Monday, February 29, 2016. If a written statement is not received by Monday, February 29, 2016, prior to the meeting, which is the subject of this notice, then it may not be provided to or considered by the DACOWITS until its next open meeting. The DFO will review all timely submissions with the DACOWITS Chair and ensure they are provided to the members of the Committee. If members of the public are interested in making an oral statement, a written statement should be submitted. After reviewing the written comments, the Chair and the DFO will determine who of the requesting persons will be able to make an oral presentation of their issue during an open portion of this meeting or at a future meeting. Pursuant to 41 CFR 102-3.140(d), determination of who will be making an oral presentation is at the sole discretion of the Committee Chair and the DFO, and will depend on time available and if the topics are relevant to the Committee's activities. Five minutes will be allotted to persons desiring to make an oral presentation. Oral presentations by members of the public will be permitted only on Tuesday, March 8, 2016 from 11:40 a.m. to 12:00 p.m. in front of the full Committee. The number of oral presentations to be made will depend on the number of requests received from members of the public.

Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public, subject to the availability of space.

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

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

Agenda: The RFPB will hold a meeting from 8:20 a.m. to 4:30 p.m. The portion of the meeting from 8:20 a.m. to 1:30 p.m. will be closed to the public and will consist of remarks to the RFPB from invited speakers that include the Deputy Secretary of Defense, the Acting Secretary of the U.S. Army, the Institute for Defense Analyses (IDA) Corporation, the Acting Principal Deputy Under Secretary of Defense for Personnel and Readiness, and the Chief of Naval Personnel. The Deputy Secretary of Defense will address key national security challenges facing our Nation and priorities for adapting the force. The Acting Secretary of the U.S. Army will discuss Army posture, views on the Report of the National Commission on the Future of the Army (NCFA), and plans to adapt the Total Army to meet future challenges. IDA will brief the findings of their study on the Reserve Component effectiveness during Operation Iraqi Freedom. The Acting Principal Deputy Under Secretary of Defense for Personnel and Readiness will discuss readiness of the force to address threats to U.S. national interests, views on the NCFA Report, and progress in and challenges with implementing Force of the Future initiatives. The Chief of Naval Personnel will discuss Navy recruiting and retention, fleet personnel readiness, and plans and initiatives to adapt the Navy personnel system to meet future challenges. The portion of the meeting from 1:40 p.m. to 4:30 p.m. will be open to the public and will consist of briefings from representatives of the former NCFA, the RFPB subcommittee chairs, and will conclude with the Chair's discussion on several proposals. Representatives of the former NCFA, will provide their personal observations and opinions on the NCFA's work and its Final Report. The RFPB subcommittee chairs will provide updates on the work of their respective subcommittee. The Supporting & Sustaining Reserve Component Personnel will discuss views on the Department's and Service's personnel system reforms being considered under the Force of the Future initiative and its effects on the Reserve Components. The Ensuring a Ready, Capable, Available and Sustainable Operational Reserve Subcommittee will present its findings on the assumptions, current authorizations and policies, and mobilization predictability being used across the Department of Defense regarding the availability of the forces of the Reserve Components. The Enhancing DoD's Role in the Homeland Subcommittee will provide an update on the Department of Defense support of civil authorities and FEMA requirements. The RFPB meeting will conclude with discussion from the Chairman on the RFPB's DoD New Administration Transition Book and the National Commission on the Future of the Army Report.

Meeting Accessibility: Pursuant to section 10(a)(1) of the FACA and 41 CFR 102-3.140 through 102-3.165, and subject to the availability of space, the meeting is open to the public from 1:40 p.m. to 4:30 p.m. Seating is on a first-come, first-served basis. All members of the public who wish to attend the public meeting must contact Mr. Alex Sabol, the Designated Federal Officer, not later than 12:00 p.m. on Tuesday, March 8, 2016, as listed in the FOR FURTHER INFORMATION CONTACT section to make arrangements for a Pentagon escort, if necessary. Public attendees requiring escort should arrive at the Pentagon Metro Entrance with sufficient time to complete security screening no later than 1:00 p.m. on March 9. To complete the security screening, please be prepared to present two forms of identification. One must be a picture identification card. In accordance with section 10(d) of the FACA, 5 U.S.C. 552b, and 41 CFR 102-3.155, the Department of Defense has determined that the portion of this meeting scheduled to occur from 8:20 a.m. to 1:30 p.m. will be closed to the public. Specifically, the Acting Under Secretary of Defense (Personnel and Readiness), in coordination with the Department of Defense FACA Attorney, has determined in writing that this portion of the meeting will be closed to the public because it is likely to disclose classified matters covered by 5 U.S.C. 552b(c)(1).

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

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

Title of Collection: Health Education Assistance Loan (HEAL).

OMB Control Number: 1845-0126.

Type of Review: An extension of an existing information collection.

Respondents/Affected Public: Private Sector.

Total Estimated Number of Annual Responses: 390.

Total Estimated Number of Annual Burden Hours: 205.

Abstract: Section 525 of the Consolidated Appropriations Act of 2014 transferred the collection of HEAL program loans from the U.S. Department of Health and Human Services (HHS) to the U.S. Department of Education (Department). The pertinent information collections were transferred from HHS to the Department and the forms were updated with new contact information and numbers. This is a request for an extension of the information collection for forms HEAL 502-1 and 502-2, HEAL repayment schedules and form HEAL 512, Holder's Report on HEAL program loans. The forms 502-1 and 502-2 provide the borrowers with any updated repayment schedule including the cost of the loan, number and amount of payments with Truth-in-Lending disclosures. The form 512 is prepared quarterly and provides information on the status of outstanding loans such as the number of borrowers by stage of loan life-cycle, repayment status and the corresponding dollars.

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

Title of Collection: Federal Direct Consolidation Loan Program Application Documents.

OMB Control Number: 1845-0053.

Type of Review: A revision of an existing information collection.

Respondents/Affected Public: Individuals and Households; Private Sector.

Total Estimated Number of Annual Responses: 3,454,476.

Total Estimated Number of Annual Burden Hours: 817,429

Abstract: This is collection of information includes the following documents: (1) Federal Direct Consolidation Loan Application and Promissory Note (Application and Promissory Note); (2) Instructions for Completing the Federal Direct Consolidation Loan Application and Promissory Note (Instructions); (3) Additional Loan Listing Sheet; (4) Request to Add Loans; and (5) Loan Verification Certificate (LVC). The Application and Promissory Note serves as the means by which a borrower applies for a Federal Direct Consolidation Loan and promises to repay the loan. The Instructions explain to the borrower how to complete the Application and Promissory Note. The Additional Loan Listing Sheet provides additional space for a borrower to list loans that he or she wishes to consolidate, if there is insufficient space on the Application and Promissory Note. The Request to Add Loans serves as the means by which a borrower may add other loans to an existing Federal Direct Consolidation Loan within a specified time period. The LVC serves as the means by which the U.S. Department of Education obtains the information needed to pay off the holders of the loans that the borrower wants to consolidate. This revision updates the forms to reflect regulatory changes, and revises language for greater clarity.

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

Title of Collection: William D. Ford Federal Direct Loan (Direct Loan) Program Federal Direct PLUS Loan Master Promissory Note and Endorser Addendum.

OMB Control Number: 1845-0068.

Type of Review: A revision of an existing information collection.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 1,380,923.

Total Estimated Number of Annual Burden Hours: 690,462.

Abstract: The Federal Direct PLUS Loan Master Promissory Note (Direct PLUS Loan MPN) serves as the means by which an individual applies for and agrees to repay a Federal Direct PLUS Loan. The Direct PLUS Loan MPN also informs the borrower of the terms and conditions of Direct PLUS Loan and includes a statement of borrower's rights and responsibilities. A Direct PLUS Loan borrower must not have an adverse credit history. If an applicant for a Direct PLUS Loan is determined to have an adverse credit history, the applicant may qualify for a Direct PLUS Loan by obtaining an endorser who does not have an adverse credit history. The Endorser Addendum serves as the means by which an endorser agrees to repay the Direct PLUS Loan if the borrower does not repay it. This revision incorporates changes to information based on regulatory changes, expands repayment plan information, and clarifies information through updated language.

This subsequent arrangement concerns the alteration in form or content of 1.3 kg of U.S.-origin highly enriched uranium (HEU), 1.21 kg of which is in the isotope of U-235 (93 percent enrichment) and currently located at PT Industri Nuklir (PT INUKI) in Serpong, Indonesia, through down-blending to reduce its enrichment to less than 20 percent U-235. The purpose of the down-blending of the HEU is to achieve permanent threat reduction by eliminating HEU from Indonesia. PT INUKI will down-blend the HEU contained in 514 bottles of irradiated HEU targets in liquid form and 14 containers of un-irradiated liquid HEU used in the plating process for medical isotope production, on-site at the Pusat Penelitian Ilmu Pengetahuan dan Teknologi facility in Serpong. The quantity of uranium will increase from 1.3 kg to 6.72 kg while the U-235 enrichment will decrease from 93 percent to 18 percent. The down-blend operation is scheduled to last for approximately three months.

In accordance with section 131a. of the Atomic Energy Act of 1954, as amended, it has been determined that this subsequent arrangement concerning the alteration in form or content of nuclear material of United States origin will not be inimical to the common defense and security of the United States of America.

On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the Federal Register (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

On January 5, 2016, the South Carolina Department of Health and Environmental Control (SC DHEC) submitted an application titled State and Local Emissions Inventory System for revisions/modifications to two of its EPA-approved air programs under title 40 CFR to allow new electronic reporting. EPA reviewed SC DHEC's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve South Carolina's request to revise/modify its following EPA-authorized air programs to allow electronic reporting under 40 CFR parts 51 and 70, is being published in the Federal Register:

SC DHEC was notified of EPA's determination to approve its application with respect to the authorized programs listed above.

On July 22, 2013, EPA received a State Implementation Plan (SIP) revision from Maryland Department of the Environment (MDE). This revision consisted of 2012 reasonable further progress (RFP) motor vehicle emission budgets (MVEBs) for the Baltimore 1997 8-Hour Ozone Nonattainment Area. This submission established MVEBs for the Baltimore 1997 8-Hour Ozone Nonattainment Area for the year 2012. The MVEBs are the amount of emissions allowed in the SIP for on-road motor vehicles; it establishes an emissions ceiling for the regional transportation network. The MVEBs are provided in Table 1:

On November 23, 2015, EPA posted the availability of the Baltimore 1997 8-Hour Ozone Nonattainment Area MVEBs on EPA's Web site for the purpose of soliciting public comments as part of the adequacy process. The comment period closed on November 23, 2015 and EPA received no comments.

Today's notice is simply an announcement of a finding that EPA has already made. EPA Region III sent a letter to MDE on January 14, 2016, finding that the 2012 RFP MVEBs in the Baltimore 1997 8-Hour Ozone Nonattainment Area SIP, submitted on July 22, 2013 by MDE, are adequate and must be used for transportation conformity determinations in the Baltimore 1997 8-Hour Ozone Nonattainment Area. The finding and associated letter is available at EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm.

Transportation conformity is required by section 176(c) of the Clean Air Act (CAA). EPA's conformity rule requires that transportation plans, transportation improvement programs, and projects conform to SIPs and establishes the criteria and procedures for determining whether or not they do. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the national ambient air quality standards.

The criteria by which EPA determines whether a SIP's MVEBs are adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4). EPA described the process for determining the adequacy of submitted SIP budgets in a July 1, 2004 preamble starting at 69 FR 40038 and used the information in these resources in making this adequacy determination. Please note that an adequacy review is separate from EPA's completeness review, and should not be used to prejudge EPA's ultimate approval action for the SIP. Even if EPA finds the budgets for the Baltimore 1997 8-Hour Ozone Nonattainment Area adequate, the SIP could later be disapproved. The finding and the response to comments are available at EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm.

On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the Federal Register (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

On October 29, 2015, the Arizona Department of Environmental Quality (ADEQ) submitted an application titled State and Local Emissions Inventory System for revisions/modifications to two of its EPA-approved air programs under title 40 CFR to allow new electronic reporting. EPA reviewed ADEQ's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Arizona's request to revise/modify its following EPA-authorized air programs to allow electronic reporting under 40 CFR parts 51 and 70, is being published in the Federal Register:

ADEQ was notified of EPA's determination to approve its application with respect to the authorized programs listed above.

On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the Federal Register (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

On September 8, 2015, the Hawaii Department of Health (HI DOH) submitted an application titled “Electronic Permitting Portal” for revisions/modifications to its EPA-approved programs under title 40 CFR to allow new electronic reporting. EPA reviewed HI DOH's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Hawaii's request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 51-52, 61-63, 65, 70, 122, 144, 146, 240-259, 262, 264-265, 270-271, 279, 280, 403-471, 745, and 763 is being published in the Federal Register:

HI DOH was notified of EPA's determination to approve its application with respect to the authorized programs listed above.

This document extends the public comment period established in the Federal Register document of December 23, 2015 (80 FR 79886) (FRL-9940-13), which requested new available data on certain chlorinated paraffins in different industries and for different uses, to inform the risk assessments for chlorinated paraffins submitted as Toxic Substances Control Act (TSCA) Premanufacture Notices (PMNs). Commenters requested additional time to research and submit more detailed comments concerning this action. In order to give all interested persons the opportunity to comment fully, EPA is hereby extending the comment period, which was set to end on February 22, 2016, to March 23, 2016.

To submit comments, or access the docket, please follow the detailed instructions provided under ADDRESSES in the Federal Register document of December 23, 2015. If you have questions, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

The Draft Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2014 is being made available for a thirty-day public review and comment period. Annual U.S. emissions for the period from 1990 through 2014 are summarized and presented by source category and sector. The inventory contains estimates of carbon dioxide (CO2), methane (CH4), nitrous oxide (N2O), hydrofluorocarbons (HFC), perfluorocarbons (PFC), sulfur hexafluoride (SF6), and nitrogen trifluoride (NF3) emissions. The inventory also includes estimates of carbon fluxes in U.S. agricultural and forest lands. The technical approach used in this report to estimate emissions and sinks for greenhouse gases is consistent with the methodologies recommended by the Intergovernmental Panel on Climate Change (IPCC), and reported in a format consistent with the United Nations Framework Convention on Climate Change (UNFCCC) reporting guidelines. The Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2014 is the latest in a series of annual U.S. submissions to the Secretariat of the UNFCCC. The EPA requests recommendations for improving the overall quality of the inventory report to be finalized in April 2016, as well as subsequent inventory reports.

Titles and Form Number: EIB 15-03 Small Business Exporter Survey on U.S. Content Requirement

OMB Number: 3048-XXXX

Type of Review: Regular

Need and Use: The information requested enables Ex-Im Bank to identify possible service improvements to the benefit of small business exporters.

The number of respondents: 1,000.

Estimated time per respondent: 10 minutes.

The frequency of response: One time.

Annual hour burden: 167 total hours.

Reviewing time per response: 5 minutes.

Responses per year: 1,000.

Reviewing time per year: 83.3 hours.

Average Wages per hour: $42.50.

Average cost per year: (time * wages) $3,541.67.

Benefits and overhead: 20%.

Total Government Cost: $4,250.

OMB Control Number: 3060-0496.

Title: ARMIS Operating Data Report.

Report Number: FCC Report 43-08.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 53 respondents; 53 responses.

Estimated Time per Response: 139 hours for those that have not applied for conditional forbearance; 35 hours for those that have received conditional forbearance.

Frequency of Response: Annual reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 219 and 220 of the Communications Act of 1934, as amended.

Total Annual Burden: 2,271 hours.

Total Annual Cost: No cost.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: Ordinarily questions of a sensitive nature are not involved in the ARMIS Report 43-08. The Commission contends that areas in which detailed information is required are fully subject to regulation and the issue of data being regarded as sensitive will arise in special circumstances only. In such circumstances, respondents may request materials or information submitted to the Commission be withheld from public inspection under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: The information contained in FCC Report 43-08 has helped the Commission fulfill its regulatory responsibilities. Automated reporting of these data greatly enhances the Commission's ability to process and analyze the extensive amounts of data provided in the reports. Automating and organizing data submitted to the Commission facilitate the timely and efficient analysis of revenue requirements, rates of return and price caps, and provide an improved basis for auditing and other oversight functions. Automated reporting also enhances the Commission's ability to quantify the effects of policy proposals. The Commission has granted all carriers forbearance from many of the requirements of ARMIS 43-08 conditioned on approval of a data retention compliance plan and continued submission of certain ARMIS 43-08 data related to access lines in service to customers. Of the nine holding companies/affiliated carrier groups currently subject to ARMIS 43-08, six have requested and received conditional forbearance. Of the remaining three holding companies/affiliated carrier groups, one has requested conditional forbearance, and we anticipate that the other two may do so in the future.

OMB Control Number: 3060-0537.

Title: Sections 13.9(c), 13.13(c), 13.17(b), 13.211(e) and 13.217, Commercial Operator License Examination Managers (COLEM) Records.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 659 respondents; 659 responses.

Estimated Time per Response: .44 hours to 30 hours.

Frequency of Response: Recordkeeping requirement and on occasion reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154 and 303 of the Communications Act of 1934.

Total Annual Burden: 14,796 hours.

Total Annual Cost: No cost.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Needs and Uses: The Commission will submit this expiring information collection after this comment period to obtain the full, three year clearance from the Office of Management and Budget (OMB). The Commission is requesting approval for a three year extension. The rule sections approved under this collections are 47 CFR sections 13.9, 13.13, 13.17 13.211 and 13.217. If the information collection requirements were not kept or fulfilled it is conceivable that examinees could be overcharged and that fraud and deceit could be used for unjust enrichment of the examiners.

OMB Control Number: 3060-0950.

Title: Bidding Credits for Tribal Lands.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local or tribal government.

Number of Respondents: 5 respondents; 5 responses.

Estimated Time per Response: 10 hours.

Frequency of Response: On occasion reporting requirement and recordkeeping requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151, 154(i), 303(r), and 303(j)(3) and (4) of the Communications Act of 1934, as amended.

Total Annual Burden: 100 hours.

Total Annual Cost: $270,000.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Needs and Uses: The Commission will be submitting this expiring information collection after this comment period to the Office of Management and Budget (OMB) for approval of an extension request.

From June 2000 to August 2004, the Commission adopted various rulemakings in which a winning bidder seeking a bidding credit to serve a qualifying tribal land within a particular market must:

• Indicate on the long-form application (FCC Form 601) that it intends to serve a qualifying tribal land within that market;

• Within 180 days after the filing deadline for the long-form application, amend its long-form application to identify the tribal land it intends to serve and attach a certification from the tribal government stating that:

(a) The tribal government authorizes the winning bidder to site facilities and provide service on its tribal land;

(b) The tribal area to be served by the winning bidder constitutes qualifying tribal land;

(c) The tribal government has not and will not enter into an exclusive contract with the applicant precluding entry by other carriers, and will not unreasonably discriminate among wireless carriers seeking to provide service on the qualifying tribal land; and

(d) Provide certification of the telephone penetration rates demonstrating that the tribal land has a penetration level at or below 85 percent.

The rulemakings also require what each winning bidder must do.

In addition, it also requires that a winning bidder seeking a credit in excess of the amount calculated under the Commission's bidding credit must submit certain information; and a final winning bidder receiving a higher credit must provide within 15 days of the third anniversary of the initial grant of its license, file a certification that the credit amount was spent on infrastructure to provide wireless coverage to qualifying tribal lands, which also includes a final report prepared by an independent auditor verifying that the infrastructure costs are reasonable to comply with our build-out requirements.

Proposal to renew the following currently-approved collection of information:

1. Title: Annual Stress Test Reporting; $10-$50 Billion Templates.

OMB Number: 3064-0187.

Affected Public: Insured state nonmember banks.

Frequency of Response: Annually.

Estimated Number of Respondents: 22.

Estimated Number of Responses: 22.

Estimated Time per Response: 469 hours.

Total Annual Burden: 10,318 hours.

General Description: The FDIC DFAST 10-50 reporting form collects data through two primary schedules: (1) The Results Schedule (which includes the quantitative results of the stress tests under the baseline, adverse, and severely adverse scenarios for each quarter of the planning horizon) and (2) the Scenario Variables Schedule. In addition, respondents are required to submit a summary of the qualitative information supporting their quantitative projections. The FDIC proposes to revise the FDIC DFAST 10-50 Summary Schedule by modifying the financial as of date from September 30th to December 31st. This revision is effective for the 2016 stress test cycle (with reporting in July 2016). In addition, the FDIC proposes to clarify the FDIC DFAST 10-50 reporting form instructions to change the submission date from March 31st to July 31st, to change references to the financial “as of” date from September 30th to December 31st, and to update the line items references to the new Call Report Instructions. The FDIC does not expect that the changes to the DFAST 10-50 Summary Schedule and reporting form instructions will result in a change in burden.

Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

GSAR clause 552.211-77, Packing List, requires a contractor to include a packing list or other suitable document that verifies placement of an order and identifies the items shipped. In addition to information contractors would normally include on packing lists, the identification of cardholder name, telephone number and the term “Credit Card” is required.

Respondents: 7,387.

Responses per Respondent: 27.

Total Annual Responses: 199,449.

Hours per Response: .05.

Total Burden Hours: 9,972.

Public comments are particularly invited on: Whether this collection of information is necessary 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.

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, at 202-501-4755. Please cite OMB Control No. 3090-0246, Packing List Clause, in all correspondence.

The FAR requires contracts to be awarded to only those contractors determined to be responsible. Instances where a firm, its principals, or subcontractors, have been indicted, convicted, suspended, proposed for debarment, debarred, or had a contract terminated for default are critical factors to be considered by a Government contracting officer in making a responsibility determination. FAR 52.209-5 and 52.212-3(h), Certification Regarding Responsibility Matters, and FAR 52.209-6, Protecting the Government's Interest when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment, require the disclosure of this and other information relating to responsibility.

The Federal Awardee Performance and Integrity Information System (FAPIIS) was developed to meet the statutory requirement to develop and maintain an information system that contains specific information on the integrity and performance of covered Federal agency contractors and grantees. FAPIIS provides users access to integrity and performance information from the FAPIIS reporting module in the Contractor Performance Assessment Reporting System (CPARS), as well as proceedings information and suspension/debarment information from the Central Contractor Registration (CCR) and the Excluded Parties List System (EPLS) functions in the System for Award Management (SAM).

The prescription at FAR 9.104-7(b) requires contracting officers to insert the provision at 52.209-7, Information Regarding Responsibility Matters, in solicitations where the resultant contract value is expected to exceed $550,000. This provision contains a check box to be completed by the offeror indicating whether or not it has current active Federal contracts and grants with total value greater than $10,000,000. If the offeror indicated that it has current active Federal contracts and grants with total value greater than $10,000,000, then the offeror must enter certain responsibility information into FAPIIS.

FAR 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters, requires each contractor that checked in the provision at 52.209-7 that it has current active Federal contracts and grants with total value greater than $10,000,000, to update responsibility information in FAPIIS on a semiannual basis, throughout the life of the contract.

FAR 52.209-2 and 52.212-3(n), Prohibition on Contracting With Inverted Domestic Corporations—Representation, is prescribed at 9.108-5(a) for use in each solicitation for the acquisition of products and services (including construction). The provision requires each offeror to represent whether it is, or is not, an inverted domestic corporation or a subsidiary of an inverted domestic corporation.

FAR 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations, is prescribed for use at FAR 9.108-5(b) for use in each solicitation and contract for the acquisition of products and services (including construction). This clause requires the contractor to promptly notify the contracting officer in the event the contractor becomes an inverted domestic corporation or a subsidiary of an inverted domestic corporation.

Respondents: 892,330.

Responses per Respondent: 1.35.

Total Annual Responses: 1,200,502.

Hours per Response: 0.34.

Total Burden Hours: 410,736.

Recordkeepers: 5,080.

Hours per Recordkeeper: 100.

Total Annual Recordkeeping hours: 508,000.

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

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0094, Debarment and Suspension and Other Responsibility Matters, in all correspondence.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).

FDA has approved for marketing the medical device SUPERA PERIPHERAL STENT SYSTEM. SUPERA PERIPHERAL STENT SYSTEM is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery and/or popliteal artery with reference vessel diameters of 4.0 to 6.5 millimeters (mm) and lesion lengths up to 140 mm. Subsequent to this approval, the USPTO received a patent term restoration application for SUPERA PERIPHERAL STENT SYSTEM (U.S. Patent No. 8,419,788) from IDEV Technologies Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of SUPERA PERIPHERAL STENT SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for SUPERA PERIPHERAL STENT SYSTEM is 1,894 days. Of this time, 1,396 days occurred during the testing phase of the regulatory review period, while 498 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: January 21, 2009. FDA has verified the applicant's claim that the date the investigational device exemption (IDE) required under section 520(g) of the FD&C act for human tests to begin became effective January 21, 2009.

2. The date an application was initially submitted with respect to the device under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e): November 16, 2012. The applicant claims November 9, 2012, as the date the premarket approval application (PMA) for SUPERA PERIPHERAL STENT SYSTEM (PMA P120020) was initially submitted. However, FDA records indicate that PMA P120020 was submitted on November 16, 2012.

3. The date the application was approved: March 28, 2014. FDA has verified the applicant's claim that PMA P120020 was approved on March 28, 2014.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 158 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

The bottled water regulations in parts 129 and 165 (21 CFR parts 129 and 165) require that if any coliform organisms are detected in weekly total coliform testing of finished bottled water, followup testing must be conducted to determine whether any of the coliform organisms are Escherichia coli. The adulteration provision of the bottled water standard (§ 165.110(d)) provides that a finished product that tests positive for E. coli will be deemed adulterated under section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)). In addition, the current good manufacturing practice (CGMP) regulations for bottled water in part 129 require that source water from other than a public water system (PWS) be tested at least weekly for total coliform. If any coliform organisms are detected in the source water, the bottled water manufacturers are required to determine whether any of the coliform organisms are E. coli. Source water found to contain E. coli is not considered water of a safe, sanitary quality and would be unsuitable for bottled water production. Before a bottler may use source water from a source that has tested positive for E. coli, a bottler must take appropriate measures to rectify or otherwise eliminate the cause of the contamination. A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site are tested and found to be E. coli negative.

Description of Respondents: The respondents to this information collection are domestic and foreign bottled water manufacturers that sell bottled water in the United States.

In the Federal Register of October 19, 2015 (80 FR 63228) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

The current CGMP regulations already reflect the time and associated recordkeeping costs for those bottlers that are required to conduct microbiological testing of their source water, as well as total coliform testing of their finished bottled water products. We therefore conclude that any additional burden and costs in recordkeeping based on followup testing that is required if any coliform organisms detected in the source water test positive for E.coli are negligible. We estimate that the labor burden of keeping records of each test is about 5 minutes per test. We also require followup testing of source water and finished bottled water products for E. coli when total coliform positives occur. We expect that 319 bottlers that use sources other than PWSs may find a total coliform positive sample about three times per year in source testing and about three times in finished product testing, for a total of 153 hours of recordkeeping. In addition to the 319 bottlers, about 95 bottlers that use PWSs may find a total coliform positive sample about three times per year in finished product testing, for a total of 23 hours of recordkeeping. Upon finding a total coliform sample, bottlers will then have to conduct a followup test for E. coli.

We expect that recordkeeping for the followup test for E. coli will also take about 5 minutes per test. As shown in table 1 of this document, we expect that three bottlers per year will have to carry out the additional E. coli testing, with a burden of 1 hour. These bottlers will also have to keep records about rectifying the source contamination, for a burden of 2 hours. For all expected total coliform testing, E. coli testing, and source rectification, we estimate a total burden of 179 hours. We base our estimate on our experience with the current CGMP regulations.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product BREO ELLIPTA (vilanterol trifenate; fluticasone furoate). BREO ELLIPTA is indicated for long-term, once-daily maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. Subsequent to this approval, the USPTO received a patent term restoration application for BREO ELLIPTA (U.S. Patent No. 7,439,393) from Glaxo Group Limited, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BREO ELLIPTA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for BREO ELLIPTA is 1,980 days. Of this time, 1,677 days occurred during the testing phase of the regulatory review period, while 303 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: December 10, 2007. The applicant claims June 26, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was December 10, 2007, which was 30 days after FDA receipt of the first IND.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: July 12, 2012. FDA has verified the applicant's claim that the new drug application (NDA) for BREO ELLIPTA (NDA 204275) was initially submitted on July 12, 2012.

3. The date the application was approved: May 10, 2013. FDA has verified the applicant's claim that NDA 204275 was approved on May 10, 2013.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 981 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction. However, blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem. FDA believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. The intent of the guidance is to provide common labeling for antihypertensive drugs except where differences are clearly supported by clinical data. The guidance encourages applicants to submit labeling supplements containing the new language.

The guidance contains two provisions that are subject to OMB review and approval under the PRA and one provision that would be exempt from OMB review:

1. Section IV.C of the guidance requests that the CLINICAL STUDIES section of the Full Prescribing Information of the labeling should include a summary of placebo or active-controlled trials showing evidence of the specific drug's effectiveness in lowering blood pressure. If trials demonstrating cardiovascular outcome benefits exist, those trials also should be summarized in this section. Table 1 in Section V of the guidance contains the specific drugs for which FDA has concluded that such trials exist. If there are no cardiovascular outcome data to cite, one of the following two paragraphs should appear:

“There are no trials of [DRUGNAME] or members of the [name of pharmacologic class] pharmacologic class demonstrating reductions in cardiovascular risk in patients with hypertension,” or “There are no trials of [DRUGNAME] demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits.”

In the latter case, the applicant's submission generally should refer to table 1 in section V of the guidance. If the applicant believes that table 1 is incomplete, it should submit the clinical evidence for the additional information to Docket No. FDA-2008-D-0150. The labeling submission should reference the submission to the docket. FDA estimates that no more than one submission to the docket will be made annually from one company, and that each submission will take approximately 10 hours to prepare and submit. Concerning the recommendations for the CLINICAL STUDIES section of the Full Prescribing Information of the labeling, FDA regulations at §§ 201.56 and 201.57 (21 CFR 201.56 and 201.57) require such labeling, and the information collection associated with these regulations is approved by OMB under OMB control number 0910-0572.

2. Section VI.B of the guidance requests that the format of cardiovascular outcome claim prior approval supplements submitted to FDA under the guidance should include the following information:

• A statement that the submission is a cardiovascular outcome claim supplement, with reference to the guidance and related Docket No. FDA-2008-D-0150.

• Applicable FDA forms (e.g., 356h, 3397).

• Detailed table of contents.

• Revised labeling to:

○ Include draft revised labeling conforming to the requirements in §§ 201.56 and 201.57 and

○ include marked-up copy of the latest approved labeling, showing all additions and deletions, with annotations of where supporting data (if applicable) are located in the submission.

FDA estimates that approximately 1 cardiovascular outcome claim supplement will be submitted annually from approximately 1 different companies, and that each supplement will take approximately 20 hours to prepare and submit. The guidance also recommends that other labeling changes (e.g., the addition of adverse event data) should be minimized and provided in separate supplements, and that the revision of labeling to conform to §§ 201.56 and 201.57 may require substantial revision to the ADVERSE REACTIONS or other labeling sections.

3. Section VI.C of the guidance states that applicants are encouraged to include the following statement in promotional materials for the drug.

“[DRUGNAME] reduces blood pressure, which reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.”

The inclusion of this statement in the promotional materials for the drug would be exempt from OMB review based on 5 CFR 1320.3(c)(2), which states that the public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public is not included within the definition of collection of information.

FDA requests public comments on the information collection provisions described set forth in the following table:

Respiratory syncytial virus (RSV) is the most important cause of viral acute lower respiratory infection (ALRI) in infants and children worldwide and is responsible for over 30 million new ALRI episodes worldwide and up to 199,000 deaths in children under five (5) years old. In the United States, the virus infects nearly all children at least once by the age of two (2) and is the most common cause of bronchiolitis and infant pneumonia, causing up to 125,000 hospitalizations of children each year. RSV disease burden is less understood in the developing world, but available data indicates that the virus causes a significant proportion of childhood ALRI in these parts of the world, particularly in the first months of life. The drug palivizumab (Synagis) can help prevent RSV disease in high risk infants, but it cannot treat or cure already-serious RSV infection. No vaccine exists today to prevent RSV due to an incomplete understanding of the body's immune response to the virus, which has challenged and delayed RSV vaccine development efforts.

The methods and compositions of this invention provide a means for prevention of RSV and/or parainfluenza virus (PIV) infection by immunization with live attenuated, immunogenic viral vaccines against RSV and/or PIV.

The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless, within fifteen (15) days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

The field of use may be limited to live attenuated vaccines against respiratory syncytial virus (RSV) and/or parainfluenza virus (PIV) infections in humans.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

This proposed information collection was previously published in the Federal Register (80 FR 63239) on October 19, 2015, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10. CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3507). The comments should address: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden, including the use of automated collection techniques or the use of other forms of information technology; and (e) the annual costs to respondents or record keepers from the collection of information (total capital/startup costs and operations and maintenance costs). The comments that are submitted will be summarized and included in the CBP request for OMB approval. All comments will become a matter of public record. In this document, CBP is soliciting comments concerning the following information collection:

Title: Petroleum Refineries in Foreign Trade Sub-Zones.

OMB Number: 1651-0063.

Abstract: The Foreign Trade Zones Act, 19 U.S.C. 81c(d) contains specific provisions for petroleum refinery sub-zones. It permits refiners and CBP to assess the relative value of such products at the end of the manufacturing period during which these products were produced when the actual quantities of these products resulting from the refining process can be measured with certainty.

19 CFR 146.4(d) provides that the operator of the refinery sub-zone is required to retain all records relating to the above mentioned activities for five years after the merchandise is removed from the sub-zone. Further, the records shall be readily available for CBP review at the sub-zone.

Instructions on compliance with these record keeping provisions are available in the Foreign Trade Zone Manual which is accessible at: http://www.cbp.gov/document/guides/foreign-trade-zones-manual.

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

Type of Review: Extension (without change).

Affected Public: Businesses.

Estimated Number of Respondents: 81.

Estimated Number of Total Annual Responses: 81.

Estimated Time per Response: 1000 hours.

Estimated Total Annual Burden Hours: 81,000.

This proposed information collection was previously published in the Federal Register (80 FR 68327) on November 4, 2015, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10. CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3507). The comments should address: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden, including the use of automated collection techniques or the use of other forms of information technology; and (e) the annual costs to respondents or record keepers from the collection of information (total capital/startup costs and operations and maintenance costs). The comments that are submitted will be summarized and included in the CBP request for OMB approval. All comments will become a matter of public record. In this document, CBP is soliciting comments concerning the following information collection:

Title: Declaration of Free Entry of Returned American Products.

OMB Number: 1651-0011.

Form Number: CBP Form 3311.

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