Federal Register Vol. 83, No.8,

Members of the public can listen to the discussion. This meeting is available to the public through the above listed toll free number. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

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

Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Indiana Advisory Committee link (http://www.facadatabase.gov/committee/meetings.aspx?cid=247). Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Unit Office at the above email or street address.

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstance of this Committee doing work on the FY 2018 statutory enforcement report.

Commerce has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping and countervailing duty orders and findings with November anniversary dates.

All deadlines for the submission of various types of information, certifications, or comments or actions by Commerce discussed below refer to the number of calendar days from the applicable starting time.

If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (POR), it must notify Commerce within 30 days of publication of this notice in the Federal Register. All submissions must be filed electronically at http://access.trade.gov in accordance with 19 CFR 351.303.1 Such submissions are subject to verification in accordance with section 782(i) of the Tariff Act of 1930, as amended (the Act). Further, in accordance with 19 CFR 351.303(f)(1)(i), a copy must be served on every party on Commerce's service list.

In the event Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review. We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 30 days of publication of the initiation Federal Register notice. Comments regarding the CBP data and respondent selection should be submitted seven days after the placement of the CBP data on the record of this review. Parties wishing to submit rebuttal comments should submit those comments five days after the deadline for the initial comments.

In the event Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:

In general, Commerce has found that determinations concerning whether particular companies should be “collapsed” (e.g., treated as a single entity for purposes of calculating antidumping duty rates) require a substantial amount of detailed information and analysis, which often require follow-up questions and analysis. Accordingly, Commerce will not conduct collapsing analyses at the respondent selection phase of this review and will not collapse companies at the respondent selection phase unless there has been a determination to collapse certain companies in a previous segment of this antidumping proceeding (e.g., investigation, administrative review, new shipper review or changed circumstances review). For any company subject to this review, if Commerce determined, or continued to treat, that company as collapsed with others, Commerce will assume that such companies continue to operate in the same manner and will collapse them for respondent selection purposes. Otherwise, Commerce will not collapse companies for purposes of respondent selection. Parties are requested to (a) identify which companies subject to review previously were collapsed, and (b) provide a citation to the proceeding in which they were collapsed. Further, if companies are requested to complete the Quantity and Value (Q&V) Questionnaire for purposes of respondent selection, in general each company must report volume and value data separately for itself. Parties should not include data for any other party, even if they believe they should be treated as a single entity with that other party. If a company was collapsed with another company or companies in the most recently completed segment of this proceeding where Commerce considered collapsing that entity, complete Q&V data for that collapsed entity must be submitted.

Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. In order to provide parties additional certainty with respect to when Commerce will exercise its discretion to extend this 90-day deadline, interested parties are advised that Commerce does not intend to extend the 90-day deadline unless the requestor demonstrates that an extraordinary circumstance has prevented it from submitting a timely withdrawal request. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.

In proceedings involving non-market economy (NME) countries, Commerce begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is Commerce's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.

To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, Commerce analyzes each entity exporting the subject merchandise. In accordance with the separate rates criteria, Commerce assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both de jure and de facto government control over export activities.

All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification, as described below. For these administrative reviews, in order to demonstrate separate rate eligibility, Commerce requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on Commerce's website at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the certification, please follow the “Instructions for Filing the Certification” in the Separate Rate Certification. Separate Rate Certifications are due to Commerce no later than 30 calendar days after publication of this Federal Register notice. The deadline and requirement for submitting a Certification applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers who purchase and export subject merchandise to the United States.

Entities that currently do not have a separate rate from a completed segment of the proceeding 2 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. In addition, companies that received a separate rate in a completed segment of the proceeding that have subsequently made changes, including, but not limited to, changes to corporate structure, acquisitions of new companies or facilities, or changes to their official company name,3 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. The Separate Rate Status Application will be available on Commerce's website at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the Separate Rate Status Application, refer to the instructions contained in the application. Separate Rate Status Applications are due to Commerce no later than 30 calendar days of publication of this Federal Register notice. The deadline and requirement for submitting a Separate Rate Status Application applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers that purchase and export subject merchandise to the United States.

For exporters and producers who submit a separate-rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.

In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than November 30, 2018.

During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.

For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period, of the order, if such a gap period is applicable to the POR.

Interested parties must submit applications for disclosure under administrative protective orders in accordance with the procedures outlined in Commerce's regulations at 19 CFR 351.305. Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures (e.g., the filing of separate letters of appearance as discussed at 19 CFR 351.103(d)).

Commerce's regulations identify five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). These regulations require any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. The regulations, at 19 CFR 351.301, also provide specific time limits for such factual submissions based on the type of factual information being submitted. Please review the final rule, available at http://enforcement.trade.gov/frn/2013/1304frn/2013-08227.txt, prior to submitting factual information in this segment.

Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness of that information.8 Parties are hereby reminded that revised certification requirements are in effect for company/government officials as well as their representatives. All segments of any antidumping duty or countervailing duty proceedings initiated on or after August 16, 2013, should use the formats for the revised certifications provided at the end of the Final Rule. 9 Commerce intends to reject factual submissions in any proceeding segments if the submitting party does not comply with applicable revised certification requirements.

Parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by the Secretary. See 19 CFR 351.302. In general, an extension request will be considered untimely if it is filed after the time limit established under Part 351 expires. For submissions which are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Examples include, but are not limited to: (1) Case and rebuttal briefs, filed pursuant to 19 CFR 351.309; (2) factual information to value factors under 19 CFR 351.408(c), or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2), filed pursuant to 19 CFR 351.301(c)(3) and rebuttal, clarification and correction filed pursuant to 19 CFR 351.301(c)(3)(iv); (3) comments concerning the selection of a surrogate country and surrogate values and rebuttal; (4) comments concerning U.S. Customs and Border Protection data; and (5) quantity and value questionnaires. Under certain circumstances, Commerce may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, Commerce will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. This modification also requires that an extension request must be made in a separate, stand-alone submission, and clarifies the circumstances under which Commerce will grant untimely-filed requests for the extension of time limits. These modifications are effective for all segments initiated on or after October 21, 2013. Please review the final rule, available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in these segments.

These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).

Targeted Genome Editing is a technology space where there is a great need for reliable measurement methods for assuring the results of editing. Modalities for targeted genome editing include but are not limited to Zinc Finger Proteins (ZFPs), Homing Endonucleases, Transcription Activator-Like Nucleases (TALENs) and Clustered, Regularly Interspaced Palindromic Repeats (CRISPR). These technologies are being actively pursued by industry, academic, government and non-profit sectors to advance medicine and bioscience in areas such as: Regenerative medicine, synthetic biology, novel antimicrobials and antivirals, protein therapeutic biomanufacturing, agriculture and global food production. Utilizing these technologies for production and medicine will first require robust quantitative assays and measurements to enable high confidence characterization of DNA alterations resulting from genome editing.

NIST has reached out to companies to assess their measurement needs, and has co-led workshops that have brought together experts across the genome editing field including stakeholders in industry, academia and government. These discussions have identified common pre-competitive measurement needs that if resolved can push forward the field as it relates to understanding the reliability of data from assays being used to measuring aspects of genome edited cells.

This Consortium's purpose is to develop measurement solutions and standards to advance confidence in measurements supporting the genome editing technology space.

The Consortium will have three working groups with the following responsibilities:

(1) Specificity Measurements:

a. Design, generate, and evaluate a set of purified DNA samples and mixtures that can be used to mimic both of on-target and off-target genome editing induced variants at known frequencies in a background of human genomic DNA which can be used to benchmark validation of sequencing pipelines intended to identify genome editing induced variants.

b. Design and conduct controlled evaluations of assays intended to identify where genome editing enzymes have been active in a genome, with an experimental design that allows for enough power to assess the sources of variability, repeatability, and reproducibility within an assay.

(2) Data and Meta Data:

a. Identify community norms for data formats and tools for benchmarking data analysis including in silico data sets and an experimental data set.

b. Determine the type of meta data that would be needed to be shared, housed, and interrogated from genome editing experiments.

(3) Lexicon: Identify terms and related definitions to form a common genome editing community lexicon.

No proprietary information will be shared as part of the Consortium.

Process: Interested parties with relevant genome editing associated capabilities (see below), products, and/or technical expertise to support this Consortium should contact NIST using the information provided in the ADDRESSES section of this notice. NIST will then provide each interested party with a letter of interest template, which the party must complete, and submit to NIST. NIST will contact interested parties if there are questions regarding the responsiveness of the letters. NIST will select participants who have submitted complete letters of interest based on the capabilities listed below. Eligibility will be determined solely by NIST based on information provided by interested organizations and upon the availability of necessary resources to NIST.

To participate, the eligible applicant will be required to sign a CRADA with NIST.

Requirements: Each letter of interest should provide the following information:

(1) A description of the experience in genome editing or genome engineering, bioinformatics, next-generation sequencing, detection or quantitation of DNA variants or related expertise to contribute to the Consortium.

(2) Subgroups or topic areas of interest for participation. There is no limit on the number of areas of participation.

(3) List of interested party's anticipated participants.

Letters of interest may not include business proprietary information. NIST will not treat any information provided in response to this Notice as proprietary information. NIST will notify each organization of its eligibility. In order to participate in this Consortium, each eligible organization must sign a CRADA for this Consortium. All participants to this Consortium will be bound by the same terms and conditions. Participants will be required to contribute financial or equivalent in-kind resources, as determined by NIST, of at least $20,000. NIST does not guarantee participation in the Consortium or in any other collaboration to any organization submitting a Letter of Interest.

The Council created a Citizen Science Advisory Panel Pool in June 2017. The Council appointed members of the Citizen Science Advisory Panel Pool to five Action Teams in the areas of Volunteers, Data Management, Projects/Topics Management, Finance, and Communication/Outreach/Education to develop program policies and operations for the Council's Citizen Science Program.

Each Action Team has been meeting since August 2017 to work on developing recommendations on program policies and operations to be reviewed by the Council's Citizen Science Committee. The January 31, 2018 meeting will bring all members of all five Action Teams together to review and discuss draft recommendations from each Action Team. Public comment will be accepted at the beginning of the meeting.

Items to be addressed during these meetings:

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

This request is for a new collection of information.

The Northwest Fisheries Science Center and Southwest Fisheries Science Center are undertaking an economics research project to assess the preferences of recreational steelhead anglers for trip attributes including opportunities for catching wild and hatchery steelhead. The Economic Survey of Recreational Steelhead Fishermen (ESRSF) will yield information on angling preferences that will inform management of recreational steelhead resources and steelhead hatchery operations in The Pacific Northwest. More specifically, the ESRSF will collect data needed to (1) assess the socioeconomic characteristics of recreational anglers; (2) assess the economic value of steelhead recreational fishing trips through statistical estimation of models; and (3) assess the change in these values associated with possible changes in recreational steelhead angling opportunities, including catch rates of wild and hatchery fish, site attributes, and travel costs.

A sample of Washington State fishing license holders who intended to fish for steelhead will be screened with an email survey (screener), followed by an internet survey. Sampled anglers who do not have an email address in the license database used for sampling will be sent an invitation by mail to the web-based screener and subsequent survey. Respondents to the internet survey will submit data online.

OMB Control Number: 0648-xxxx.

Form Number(s): None.

Type of Review: Regular submission (new information collection).

Affected Public: Individuals or households.

Estimated Number of Respondents: 629.

Estimated Time per Response: Five minutes for the screening survey; 25 minutes for the full survey.

Estimated Total Annual Burden Hours: 102.

Estimated Total Annual Cost to Public: $0 in recordkeeping/reporting costs.

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

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

The purpose of the meeting is to conduct a methodology review of the NOAA acoustic-trawl survey methodology (ATM), conducted regularly to collect fisheries and oceanographic information in U.S. West Coast waters. The ATM survey has been approved for use in stock assessments for Pacific sardine, but has not yet been approved for use in stock assessments for northern anchovy, Pacific mackerel, or jack mackerel. At its April 2018 meeting, the Pacific Council will consider the results of this review, and will consider whether to approve the ATM for use in stock assessments for stocks other than Pacific sardine. An agenda and other meeting materials will be available by January 15, 2018, on the Pacific Council's ftp site: ftp://ftp.pcouncil.org/pub/2018%20ATM%20Methodology%20Review/.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

This public listening station is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Dale Sweetnam (858) 546-7170 at least 10 days prior to the meeting date.

The committee will provide recommendations to the Council on FY2018 recreational measures for Gulf of Maine cod and haddock, and possibly Georges Bank cod. The committee will also consider providing a recommendation to the Council for a new control date for the party/charter fishery. They will also receive an overview of the Council's priorities for 2018. The committee plans discuss the progress on Amendment 23/Groundfish Monitoring. Other business will be discussed as necessary.

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

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

This request is for an extension of a current information collection.

The National Oceanic and Atmospheric Administration's (NOAA) National Marine Fisheries Service (NMFS) established programs to reduce excess fishing capacity by paying fishermen to surrender their vessels/permits. These fishing capacity reduction programs, or buybacks, are conducted pursuant to the Magnuson-Stevens Fishery Conservation and Management Act, and the Magnuson-Stevens Reauthorization Act (Pub. L. 109-479). The buybacks can be funded by a Federal loan to the industry or by direct Federal or other funding. Buyback regulations are at 50 CFR part 600.

The information collected by NMFS involves the submission of buyback requests by industry, submission of bids, referenda of fishery participants and reporting of collection of fees to repay buyback loans. For buybacks involving State-managed fisheries, the State may be involved in developing the buyback plan and complying with other information requirements. NMFS requests information from participating buyback participants to track repayments of the loans as well as ensure accurate management and monitoring of the loans. The recordkeeping and reporting requirements at 50 CFR parts 600.1013 through 600.1017 form the basis for the collection of information.

Paper reports or electronic reports are required from buyback participants. Methods of submittal include mailing of paper reports, electronic submission via the internet, and/or facsimile transmission.

OMB Control Number: 0648-0376.

Form Number(s): None.

Type of Review: Regular submission (extension of a current information collection).

Affected Public: Business or other for-profit organizations; individuals or households; and state, local, or tribal government.

Estimated Number of Respondents: 1,000.

Estimated Time per Response: Implementation plan, 6,634 hours; referenda votes, bids, seller/buyer reports and annual fee collection reports, 4 hours each; completion of fish ticket, 10 minutes; monthly fee collection report, 2 hours; advising holder/owner of conflict with accepted bidders' representations, 1 hour; potentially 270 hours-state approval/review of plans.

Estimated Total Annual Burden Hours: 15,838.

Estimated Total Annual Cost to Public: $1,596 in recordkeeping/reporting costs.

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

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

This request is for extension of a currently approved information collection.

The Coral Reef Conservation Act of 2000 (Act) was enacted to provide a framework for conserving coral reefs. The Coral Reef Conservation Grant Program, under the Act, provides funds to broad-based applicants with experience in coral reef conservation to conduct activities to protect and conserve coral reef ecosystems. The information submitted by applicants is used to determine if a proposed project is consistent with the NOAA coral reef conservation priorities and the priorities of authorities with jurisdiction over the area where the project will be carried out. As part of the application, NOAA requires a Data and Information Sharing Plan in addition to the standard required application materials.

The information will be collected by the secure web based tool grants.gov or by mail when the internet is not available.

OMB Control Number: 0648-0448.

Form Number(s): None.

Type of Review: Regular submission (extension of a currently approved information collection).

Affected Public: Business or other for-profit organizations; not-for-profit institutions; state, local, or tribal government.

Estimated Number of Respondents: 40.

Estimated Time per Response: 2 hours.

Estimated Total Annual Burden Hours: 80 hours.

Estimated Total Annual Cost to Public: $35 in recording/reporting costs.

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

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

The Recreational Advisory Panel will provide recommendations to the Groundfish Committee on FY2018 recreational measures for Gulf of Maine cod and haddock, and possibly Georges Bank cod. The advisory panel will also consider providing a recommendation to the Groundfish Committee for a new control date for the party/charter fishery. They will also receive an overview of the Council's priorities for 2018. Other business will be discussed as necessary.

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

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

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

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

The meeting will begin in FULL COUNCIL SESSION to review and discuss the appointments for the 2018 Committee Roster. The Spiny Lobster Management Committee will review the 2016/2017 Spiny Lobster Landings and draft options paper for Joint Spiny Lobster Amendment 13. The Administrative/Budget Committee will meet to review the Ad Hoc Advisory Panels and discuss the Scientific and Statistical Committees' (SSC) Organization. After lunch, the Sustainable Fisheries Management Committee will convene to review the Mackerel Landings and Bag Limit Analysis; options paper for Carryover of Unharvested Quota; and the public hearing draft for Amendment 49—Modifications to the Sea Turtle Release Gear and Framework Procedure for the Reef Fish Fishery. The Committee will also review a draft policy for descending devices and venting tools; the Ecosystem Approach to Fisheries Management (EAFM) by Gulf Council and other regional approaches; and a presentation on Reef Fish Charter For-Hire Permit Transfers and Potential Management Actions. The Committee will receive the Environmental Assessment and Exempted Fishery Permits for Lionfish Trap Testing in the Gulf and South Atlantic, and hold a discussion on Dead Zone regarding RESTORE Act Activities. Approximately 4:30 p.m., the Council will reconvene in a CLOSED SESSION of the Full Council to select members to the Ad Hoc Red Snapper and Grouper-Tilefish IFQ Advisory Panel and discuss hiring of the new Executive Director.

The Reef Fish Management Committee will convene to review and discuss Reef Fish Landings and State Management of Recreational Red Snapper. After lunch, the Committee will receive an update on the implementation of the Generic For-Hire Reporting Amendment; and discuss the analysis of Red Grouper Indices of Abundance. The Committee will review Amendment 41—Allocation-based Management for Federally Permitted Charter Vessels and Amendment 42—Reef Fish Management of Headboat Survey Vessels. The Committee will receive a response from NMFS regarding referendum requirements for auctions and receive a report from the Scientific and Statistical Committee (SSC). The Committee will also receive a summary from the Ad Hoc Private Angler Red Snapper Advisory Panel and a presentation on Modifications to the Greater Amberjack Commercial Fishing Year, and Trip Limits and Recreational Vessel Limits and Split Quotas.

The Full Council will convene in the morning with a Call to Order, Announcements, and Introductions; Adoption of Agenda and Approval of Minutes; receive a presentation from the Louisiana Law Enforcement and an overview presentation of the Aquaculture Fishery Management Plan (FMP). At mid-morning the Council will review Exempted Fishing Permit (EFPs) Applications. After lunch, the Council will continue reviewing and discussing EFPs as well as receive a summary of any public comments on the EFPs. The Council will receive open public testimony from 3 p.m. until 6 p.m. on Fishery Issues or Concerns. Anyone wishing to speak during public comment should sign in at the registration station located at the entrance to the meeting room.

Full Council will receive committee reports from Reef Fish, Spiny Lobster, Administrative/Budget and Sustainable Fisheries Management Committees, and, a report on the members selected to serve on the Ad Hoc Red Snapper and Grouper -Tilefish IFQ Advisory Panel; and, vote on any Exempted Fishing Permit (EFP) applications. The Council will receive updates from the following supporting agencies: South Atlantic Fishery Management Council; Gulf States Marine Fisheries Commission; U.S. Coast Guard; U.S. Fish and Wildlife Service; and, the Department of State.

Lastly, the Council will discuss any Other Business items.

The timing and order in which agenda items are addressed may change as required to effectively address the issue. The latest version will be posted on the Council's file server, which can be accessed by going to the Council's website at http://www.gulfcouncil.org and clicking on FTP Server under Quick Links. For meeting materials, go to the Gulf Council website or Gulf Council file server and select the “Briefing Books/Briefing Book 2018-01” folder. The username and password are both “gulfguest”. The meetings will be webcast over the internet. A link to the webcast is available here, https://attendee.gotowebinar.com/register/9086970310199522563.

Although other non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subjects of formal action during these meetings. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided that 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 aids should be directed to Kathy Pereira (see ADDRESSES) at least 5 days prior to the meeting date.

At its September 2018 meeting, the Pacific Council decided to embark on the Climate and Communities Initiative pursuant to its Fishery Ecosystem Plan. The purpose of this initiative is to help the Pacific Council, its advisory bodies, and the public to better understand the effects of near-term climate shift and long-term climate change on our fish, fisheries, and fishing communities and identify ways in which the Council could incorporate such understanding into its decision-making. As a first step, the Council's Ad Hoc Ecosystem Workgroup is working with scientists at NMFS Northwest and Southwest Fisheries Science Centers to present a series of webinars to educate the Pacific Council, advisory bodies, and the interested public about current research and forecasts related to the effects of climate variability/change on the California Current Ecosystem.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (503) 820-2411 at least 10 business days prior to the meeting date.

Background: Executive Order 13800 on Strengthening the Cybersecurity of Federal Networks and Critical Infrastructure called for “resilience against botnets and other automated, distributed threats.” 1 The Order directed the Secretary of Commerce, together with the Secretary of Homeland Security, to “lead an open and transparent process to identify and promote action by appropriate stakeholders” with the goal of “dramatically reducing threats perpetrated by automated and distributed attacks (e.g., botnets).” 2

The Departments of Commerce and Homeland Security worked jointly on this effort through three approaches—hosting a workshop, publishing a request for comment, and initiating an inquiry through the President's National Security Telecommunications Advisory Committee (NSTAC)—all aimed at gathering a broad range of input from experts and stakeholders, including private industry, academia, and civil society. The Departments worked in consultation with the Departments of Defense, Justice, and State, the Federal Bureau of Investigation, the sector-specific agencies, the Federal Communications Commission, and Federal Trade Commission, as well as other interested agencies. These activities all contributed to the information gathering process for developing a draft Report.

The draft Report, published on January 5, 2018, and available at https://www.ntia.doc.gov/report/2018/report-president-enhancing-resilience-internet-and-communications-ecosystem-against, characterizes the status of the internet and communications ecosystem, and offers a positive vision of the future. The Departments determined that the opportunities and challenges in working toward dramatically reducing threats from automated, distributed attacks can be summarized in six principal themes.

1. Automated, distributed attacks are a global problem. The majority of the compromised devices in recent botnets have been geographically located outside the United States. Increasing the resilience of the internet and communications ecosystem against these threats will require coordinated action with international partners.

2. Effective tools exist, but are not widely used. The tools, processes, and practices required to significantly enhance the resilience of the internet and communications ecosystem are widely available, if imperfect, and are routinely applied in selected market sectors. However, they are not part of common practices for product development and deployment in many other sectors for a variety of reasons, including (but not limited to) lack of awareness, cost avoidance, insufficient technical expertise, and lack of market incentives.

3. Products should be secured during all stages of the lifecycle. Devices that are vulnerable at time of deployment, lack facilities to patch vulnerabilities after discovery, or remain in service after vendor support ends make assembling automated, distributed threats far too easy.

4. Education and awareness is needed. Knowledge gaps in home and enterprise customers, product developers, manufacturers, and infrastructure operators impede the deployment of the tools, processes, and practices that would make the ecosystem more resilient.

5. Market incentives are misaligned. Perceived market incentives do not align with the goal of “dramatically reducing threats perpetrated by automated and distributed attacks.” Market incentives motivate product developers, manufacturers, and vendors to minimize cost and time to market, rather than to build in security or offer efficient security updates. There has to be a better balance between security and convenience when developing products.

6. Automated, distributed attacks are an ecosystem-wide challenge. No single stakeholder community can address the problem in isolation.

The Report lays out five complementary and mutually supportive goals that would dramatically reduce the threat of automated, distributed attacks and improve the resilience of the ecosystem. They are:

1. Identify a clear pathway toward an adaptable, sustainable, and secure technology marketplace;

2. Promote innovation in the infrastructure for dynamic adaptation to evolving threats;

3. Promote innovation at the edge of the network to prevent, detect, and mitigate bad behavior;

4. Build coalitions between the security, infrastructure, and operational technology communities domestically and around the world; and

5. Increase awareness and education across the ecosystem.

For each goal, the report suggests supporting activities to be taken by both government and private sector actors. With this Request for Comment, the Department is asking for a response to the issues and goals raised by the draft Report, as well as the proposed approach, current initiatives, and next steps. Following the completion of the comment period, the Department will host a workshop to discuss substantive comments and the way forward for the Report. The workshop will be held February 28-March 1, 2018 at the National Cybersecurity Center of Excellence (NCCoE). Additional information regarding the workshop, including logistics and registration information, is available at https://csrc.nist.gov/Events/2018/second-botnet-workshop.

Information obtained through this Request for Comment, the NCCoE-hosted workshop, and other stakeholder interactions will be considered for incorporation into the final version of the Report. The final Report is due to the President on May 11, 2018.

The goal of this Request for Comment is to solicit feedback on the draft Report, its characterization of the challenges, and proposed actions. The Department invites comment on the full range of issues that may be presented by this inquiry, including issues that are not specifically raised in the following questions. Respondents are invited to respond to some or all of the questions below:

1. The Ecosystem: Is the Report's characterization of risks and the state of the current internet and communications ecosystem accurate and/or complete? Are there technical details, innovations, policy approaches, or implementation barriers that warrant new or further consideration?

2. Goals: Are the Report's stated goals appropriate for achieving a more resilient ecosystem? Do the actions support the relevant goals? In aggregate, are the actions sufficient to significantly advance the goals?

3. Stakeholder Roles: How can specific actions be refined for efficacy and achievability? What actors, inside the Federal government, in the private sector, and across the global community, can be instrumental in the successful accomplishment of these activities? Who should play a leadership role; and where and how? What stakeholders are key to particular successes?

4. Road map: What information can help the government and stakeholders delineate a road map for achieving these goals? How should implementation be phased to optimize resources and commitments? Which actions are of highest priority, or offer opportunities for near term progress? Which actions depend on the completion of other actions? Are there known barriers that may inhibit progress on specific actions?

5. Incentives: What policies, innovations, standards, best practices, governance approaches, or other activities can promote market-based solutions to the challenges and goals discussed in the report? Are there specific incentive ideas beyond the market-based approaches discussed in the report (e.g., procurement, multistakeholder policy development, R&D, best practices, and adoption & awareness efforts) that demand new consideration or exploration?

6. Further Activities: What additional specific actions can improve the resilience of the internet and communications ecosystem? What partners can drive success for these activities?

7. Metrics: How should we evaluate progress against the stated goals?

Instructions for Commenters: The Department invites comment on the full range of issues that may be presented by this inquiry, including issues that are not specifically raised in the above questions. Commenters are encouraged to address any or all of the above questions. Comments that contain references to studies, research, and other empirical data that are not widely available should include copies of the referenced materials with the submitted comments.

Comments submitted by email should be machine-readable and should not be copy-protected. Responders should include the name of the person or organization filing the comment, which will facilitate agency follow up for clarity as necessary, as well as a page number on each page of their submissions. All comments received are a part of the public record and will generally be posted on the NTIA website, http://www.ntia.doc.gov/, without change. All personal identifying information (for example, name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information. The Department will also accept anonymous comments.

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

Purpose of the Meeting: The purpose of the meeting is to provide advice and recommendations to the Secretary of Defense, through the Under Secretary of Defense for Personnel and Readiness, on academic and administrative matters critical to the full accreditation and successful operation of USU. These actions are necessary for USU to pursue its mission, which is to educate, train and comprehensively prepare uniformed services health professionals, officers, scientists and leaders to support the Military and Public Health Systems, the National Security and National Defense Strategies of the United States, and the readiness of our Uniformed Services.

Agenda: The actions scheduled to occur include the review of the minutes from the Board meeting held on November 3, 2017; recommendations regarding the awarding of associate, baccalaureate and post-baccalaureate degrees; recommendations regarding the approval of faculty appointments and promotions; and recommendations regarding award nominations. The USU President will provide a report on recent actions affecting academic and operational aspects of USU. Member reports will include an Academics Summary consisting of reports from the Dean of the F. Edward Hébert School of Medicine, Dean of the Daniel K. Inouye Graduate School of Nursing, Executive Dean of the Postgraduate Dental College, Dean of the College of Allied Health Sciences, Director of the Armed Forces Radiobiology Research Institute and the President of the USU Faculty Senate. Member Reports will also include a Finance and Administration Summary consisting of reports from the Senior Vice President, Southern Region; Senior Vice President, Western Region; Commander, USU Brigade; and the President and CEO of the Henry M. Jackson Foundation for the Advancement of Military Medicine. There will be reports from the USU Vice President for Research and the USU Vice President for Finance and Administration. A closed session will be held, after the open session, to discuss active investigations and personnel actions.

Meeting Accessibility: Pursuant to Federal statutes and regulations (5 U.S.C., Appendix, 5 U.S.C. 552b, and 41 CFR 102-3.140 through 102-3.165) and the availability of space, the meeting is open to the public from 8:00 a.m. to 10:05 a.m. Seating is on a first-come basis. Members of the public wishing to attend the meeting should contact Jennifer Nuetzi James no later than five business days prior to the meeting, at the address and phone number noted in the FOR FURTHER INFORMATION CONTACT section. Pursuant to 5 U.S.C. 552b(c)(2, 5-7), the Department of Defense has determined that the portion of the meeting from 10:10 a.m. to 10:40 a.m. shall be closed to the public. The Under Secretary of Defense (Personnel and Readiness), in consultation with the Office of the Department of Defense General Counsel, has determined in writing that this portion of the Board's meeting will be closed as the discussion will disclose sensitive personnel information, will include matters that relate solely to the internal personnel rules and practices of the agency, will involve allegations of a person having committed a crime or censuring an individual, and may disclose investigatory records compiled for law enforcement purposes.

Written Statements: Pursuant to section 10(a)(3) of the Federal Advisory Committee Act of 1972 and 41 CFR 102-3.140, the public or interested organizations may submit written comments to the Board about its approved agenda pertaining to this meeting or at any time regarding the Board's mission. Individuals submitting a written statement must submit their statement to the Designated Federal Officer at the address listed in the FOR FURTHER INFORMATION CONTACT section. Written statements that do not pertain to a scheduled meeting of the Board may be submitted at any time. However, if individual comments pertain to a specific topic being discussed at the planned meeting, then these statements must be received at least 5 calendar days prior to the meeting, otherwise, the comments may not be provided to or considered by the Board until a later date. The Designated Federal Officer will compile all timely submissions with the Board's Chair and ensure such submissions are provided to Board Members before the meeting.

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

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

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

This information collection request contains:

(1) OMB No.: 1910;

(2) Information Collection Request Title: Department of Energy Superior Energy Performance® Certification Program Information Collection Request;

(3) Type of Request: Renewal;

(4) Purpose: This Information Collection Request applies to the Department of Energy (DOE) voluntary ISO 50001 programs for industrial facilities: Superior Energy Performance® (SEP®) and 50001 ReadyTM recognition. The information being collected is needed so as to include participants in the DOE's SEP. SEP is an energy efficiency certification and recognition program for industrial facilities demonstrating energy management excellence and sustained energy savings. 50001 Ready recognition is a self-attestation of the implementation of an ISO 50001 energy management system without the need for external audits.

SEP builds on the ISO 50001 energy management system standard and provides a rigorous, internationally-recognized business process for companies to continually improve their energy performance. The SEP third-party verification of energy performance improvement is unique in the marketplace, and assists to differentiate certified companies from their competitors. This request for information consists of a voluntary data collection process for SEP participation: To enroll industrial facilities, manage and track certification cycles, and relay the costs and benefits of SEP certification to industry. 50001 Ready collects a minimal amount of self-attested information to manage and track recognition cycles and to recognize the achievements of its participants.

There are four types of information to be collected from primary participants: (1) Background data, including contact information and basic information about the facility's experience with energy management—collected in the SEP Enrollment Form; (2) Basic facility information about its energy use, energy consumption, and energy performance indicators—collected in the SEP Application Form; (3) Information on energy performance improvement in SEP-certified facilities—collected in the SEP Energy Performance Improvement Report; (4) Information on the costs and benefits of participating in SEP (optional; not required for SEP certification)—collected in the SEP Voluntary Costs/Benefits Form. 50001 Ready collects only a subset of the same types of information in categories (1), (2), and (3), and without the need for external audit.

Background data will primarily be used to track basic information about SEP and 50001 Ready participants and identify opportunities to provide participants with technical assistance. Basic information about a facility's energy use, energy consumption, and energy performance indicators will be used to administer SEP and 50001 Ready. Information on energy performance improvement will be used by DOE to manage and track participation cycles, and to track the results of participation in SEP and 50001 Ready. For SEP, optional information on costs and benefits of SEP participation will be used to conduct and refine analysis on the costs and benefits of SEP participation. Responses to the DOE's Information Collection Request will be voluntary.

(5) Annual Estimated Number of Respondents: 575;

(6) Annual Estimated Number of Total Responses: 475;

(7) Annual Estimated Number of Burden Hours: 650;

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: $31,295.

This meeting of the Board will be open to the public (limited space available). Please send an email to [email protected] at least 24 hours before the meeting. In your email include: Name, postal address, entity you are representing (if applicable), and telephone number. You will receive an email confirmation from us. Please be prepared to show a photo identification when you arrive. If you need assistance for accessibility reasons, or if you have any questions, contact Dale L. Aultman, Secretary to the Farm Credit System Insurance Corporation Board, at (703) 883-4009. The matters to be considered at the meeting are:

The Board invites comment on proposed guidance setting forth core principles of effective senior management, the management of business lines, and independent risk management (“IRM”) and controls for large financial institutions (“LFIs”). This proposal is part of a broader initiative by the Federal Reserve to develop a supervisory rating system and related supervisory guidance that would align with its consolidated supervisory framework for LFIs. Drawing on lessons from the 2007-2009 financial crisis, the Federal Reserve reevaluated its approach to supervision of LFIs, including systemically important firms. In 2010, the Federal Reserve established the Large Institution Supervision Coordinating Committee (“LISCC”) to coordinate its supervisory oversight for the systemically important firms that pose the greatest risk to U.S. financial stability.1 In 2012, the Federal Reserve implemented a new consolidated supervisory program for LFIs (“LFI supervision framework”) described in SR letter 12-17.2 The LFI supervision framework is focused on four core areas—capital planning and positions, liquidity risk management and positions, governance and controls, and resolution planning.3

In August 2017, the Board invited comment on two proposals that relate to this guidance, a new rating system for LFIs (“proposed LFI rating system”) 4 and proposed guidance addressing supervisory expectations for boards of directors (“BE proposal”).5 On November 17, 2017, the Board extended the public comment period for the proposed LFI rating system and BE proposal until February 15, 2018, to give the public an opportunity to understand and comment on the proposed LFI rating system, the BE proposal, and this proposed guidance together.

The proposed LFI rating system would provide a supervisory evaluation of whether a firm possesses sufficient financial and operational strength and resilience to maintain safe and sound operations through a range of conditions. Consistent with the LFI supervision framework, the proposed LFI rating system would include assessments of a firm's capital, liquidity, and governance and controls. As discussed further below, the BE proposal and this proposal set forth supervisory expectations relevant to the assessment of a firm's governance and controls.

The governance and controls component would consist of three elements: (i) Effectiveness of a firm's board of directors, (ii) management of business lines and independent risk management and controls, and (iii) recovery planning (for domestic LISCC firms only).

To facilitate comment on the proposed LFI rating system, the preamble to the proposed LFI rating system included a summary which previewed the proposed expectations included in this proposal. This proposal is generally consistent with that summary, with two exceptions. First, this proposal expands the scope of the guidance to foreign banking organizations.6 Second, this proposal adopts slightly different terminology than is used in the proposed LFI rating system to describe expectations for the management of business lines. However, the change does not change the substance of those expectations described in the proposed LFI rating system.7 The Board would expect to apply the terminology used in this guidance in any final LFI rating system; however, this change would not impact the supervisory assessment of a firm's management of business lines for purposes of the governance and controls component rating.

The BE proposal sets forth attributes of an effective board of directors. It is intended to better distinguish the supervisory expectations for boards from those of senior management and encourage boards to focus time and attention on their core responsibilities.8 The expectations in the BE proposal would inform the Board's evaluation of the effectiveness of a firm's board of directors under the governance and control component of the proposed LFI rating system.

The proposed LFI rating system would provide a supervisory evaluation of whether a firm possesses sufficient financial and operational strength and resilience to maintain safe and sound operations through a range of conditions. This proposed guidance builds upon the proposed LFI rating system framework by providing additional detail regarding supervisory expectations for a firm's management of business lines and independent risk management and controls. For firms that would be subject to the proposed LFI rating system, these expectations would help inform the Federal Reserve's overall supervisory evaluation, for purposes of the proposed LFI rating system, of each firm's governance and controls to support the firm's financial and operational strength and resilience, which would be reflected by the governance and controls component rating under the proposed LFI rating system.9

The Federal Reserve would not expect to examine all of a firm's business lines which are subject to this proposed guidance during a single year. Instead, consistent with its current supervisory practice, the Federal Reserve would use a risk-based approach to determine which business lines of a firm to examine or review during the year. In conducting its supervisory planning for an upcoming exam cycle, the Federal Reserve would consider factors related to the potential for weaknesses in a firm's governance and controls.10 Such factors would include the size and complexity of the business line, recent supervisory experience, the relative growth and maturity of the business line, and significant changes to strategy, structure, or management since the last exam cycle. In order to minimize unnecessary duplication for firms subject to this guidance, the Federal Reserve would, to the extent possible, evaluate a firm's governance and controls in coordination with other relevant Federal and state agencies, particularly the primary regulators of the firm's insured depository institution subsidiaries.

The proposed guidance is intended to consolidate and clarify the Federal Reserve's existing supervisory expectations regarding risk management.11 In addition, the proposed guidance is designed to delineate the roles and responsibilities for individuals and functions related to risk management. It would complement the BE proposal by aligning the attributes of senior management with those of an effective board of directors. For instance, the BE proposal provides that an effective board of directors sets the firm's strategy and risk tolerance, and this proposal contemplates that the firm's senior management implements the strategy and risk tolerance approved by the board. In this way, the proposed guidance would better distinguish the supervisory expectations for boards from those of senior management. The proposal also defines the roles and responsibilities for various individuals and functions within an organization that are accountable for risk management, including a firm's senior management, business line management, and independent risk management and audit functions. Delineating roles and responsibilities for risk management should enable the Federal Reserve to provide firms with more specific and consistent supervisory feedback.

The proposed guidance would apply to domestic bank holding companies with total consolidated assets of $50 billion or more; savings and loan holding companies with total consolidated assets of $50 billion or more; the combined U.S. operations of foreign banking organizations (“FBOs”) with combined U.S. assets of $50 billion or more; any state member bank subsidiaries of the foregoing; and systemically important nonbank financial companies designated by FSOC for supervision by the Board.12

For FBOs, the proposed guidance would apply to an FBO's combined U.S. operations, including branch and subsidiary operations. This scope would be consistent with certain requirements of the Board's Regulation YY, which requires, among other things, FBOs to establish a risk management framework that covers both the U.S. branch and U.S. non-branch subsidiary operations, establish a U.S. risk committee to oversee the risks of the combined U.S. operations, and employ a chief risk officer (“CRO”) based in the United States.13

Given that an FBO's combined U.S. operations are part of a larger global organization, the proposed guidance notes that certain elements of an FBO's governance framework may be located outside of the United States. In this event, the proposed guidance provides that these elements should enable effective governance and risk management by the U.S. senior management, the U.S. risk committee, and the intermediate holding company (“IHC”) board (as applicable), and should facilitate U.S. supervisors' ability to assess the adequacy of governance and controls in the combined U.S. operations.

The proposed guidance also applies to nonbank financial companies supervised by the Board and insurance or commercial savings and loan holding companies with total consolidated assets of $50 billion or more. The concepts set forth in the proposed guidance relate to fundamental risk management practices that are applicable to all LFIs.

The proposed guidance is organized in three parts: (1) Core principles of effective senior management; (2) core principles of the management of business lines; and (3) core principles of IRM and controls.

The proposed guidance sets forth core principles of effective senior management. Senior management is defined as the core group of individuals directly accountable to the board of directors for the sound and prudent day-to-day management of the firm. Under the board's oversight, a firm's senior management is responsible for managing the day-to-day operations of the firm and ensuring safety and soundness and compliance with laws and regulations, including those related to consumer protection, and internal policies and procedures. Two key responsibilities of senior management are overseeing the activities of the firm's business lines (individually and collectively) and the firm's IRM and system of internal control. In addition to the general expectations regarding senior management, the IRM and controls section of the proposed guidance sets forth specific expectations for the CRO and chief audit executive (“CAE”), as these individuals have specific responsibilities related to IRM and internal audit, respectively.

The proposed guidance tailors the application of these expectations for an FBO, given that the combined U.S. operations are part of a larger global organization. For instance, the proposed guidance notes that the risk tolerance for the combined U.S. operations may be developed separately for the IHC and branch operations, respectively, and notes that the strategy for the combined U.S. operations may mean the manner in which the U.S. operations support the global strategy. The proposal also notes that for an FBO, “senior management” can refer to individuals located inside or outside the United States who are accountable to the IHC board, U.S. risk committee, or global board of directors with respect to the U.S. operations.14

The proposed guidance sets forth core principles of the management of business lines. Business line management is defined as the core group of individuals responsible for the prudent day-to-day management of the business line and who report directly to senior management.15 Business line management is expected to execute business line activities consistent with the firm's strategy and risk tolerance, identify and manage risk within the business line, provide sufficient resources and infrastructure to the business line, ensure the business line has the appropriate system of internal control, and ensure accountability for operating within established policies and guidelines and in accordance with laws and regulations, including those related to consumer protection.

For a LISCC firm, due to its size, risk profile, and systemic importance of operations, the core principles of the management of business lines would apply to all of the firm's business lines. For an LFI that is not a LISCC firm, the core principles of the management of business lines would apply to any business line where a significant control disruption, failure, or loss event could result in a material loss of revenue, profit, or franchise value, or result in significant consumer harm.16 The proposed guidance uses slightly different terminology than the proposed LFI rating system to describe the core principles of the management of business lines. The proposed LFI rating system referred to these principles as relating to the “management of core business lines.” For a LISCC firm, “core” business lines were defined to include all business lines, whereas for other LFIs, “core” business lines were defined to include any business line where a significant control disruption, failure, or loss event could result in a material loss of revenue, profit, or franchise value, or result in significant consumer harm. Although this proposal uses the term “management of business lines,” the principles would apply to the same business lines that were identified as “core” in the proposed LFI rating system. The revised terminology is intended to simplify the guidance.

The proposed guidance does not include specific expectations regarding organizational structure at firms and states that business line management may also serve as senior management. If business line management is not part of senior management, business line management is responsible for fully engaging senior management, so that senior management can effectively carry out their responsibilities.

For an FBO, the proposed guidance acknowledges that a business line in the United States may be part of a larger global business line and clarifies that the guidance applies only to that portion of the business conducted in the United States. The proposed guidance notes that business line management should ensure that business line risks are comprehensively captured, with consideration given to risks outside of the United States that may impact the FBO's U.S. operations.17

The proposed guidance describes core principles of a firm's IRM and controls, which refers to a firm's independent risk management function, system of internal control, and internal audit function.18 The proposal sets forth responsibilities of the CRO and CAE, the members of senior management responsible for IRM and internal audit, respectively. As described in the proposed guidance, both the CRO and CAE should have clear roles and responsibilities to establish and maintain an IRM and internal audit function, respectively, that are appropriate for the size, complexity, and risk profile of the firm.

The proposed guidance describes expectations for a firm's IRM, which include evaluating the firm's risk tolerance; establishing enterprise-wide risk limits and monitoring adherence to those limits; identifying, measuring, and aggregating risks; providing an independent assessment of the firm's risk profile; and providing risk reports to the board and senior management. The proposed guidance builds upon the framework set forth in Regulation YY, which requires a firm to have an independent risk management function.19

While IRM would be expected to evaluate the firm's risk tolerance, the proposed guidance would not set the expectation that IRM would have sole responsibility for the risk tolerance. Depending on a firm's organizational structure, it may be appropriate for business line management to provide input into the risk tolerance or drive its development. The proposed guidance would assign responsibility for enterprise-wide risk limits to IRM, but acknowledge that business line management may develop its own limits for internal business line use and may provide input to the risk limit-setting process defined by IRM. However, the internal limits of a business line should not be less stringent than the limits set by IRM because the IRM limits should be the operative, formal, and binding limits across the firm.

For internal controls, the proposed guidance expands upon the expectation for internal controls described in SR letter 12-17. As described in the proposed guidance, a firm should identify its system of internal control and demonstrate that that system is commensurate with the firm's size, scope of operations, activities, risk profile, strategy, and risk tolerance; demonstrate that it is consistent with all applicable laws and regulations; regularly evaluate and test the effectiveness of internal controls; and monitor the functioning of controls so that deficiencies are identified and communicated in a timely manner. The proposed guidance provides that developing and maintaining effective internal controls is the responsibility of several parties, including business line management.

The strength of a firm's internal audit practices are an important consideration in the Federal Reserve's supervisory assessment of the effectiveness of the firm's governance and controls. This proposed guidance would not expand upon the Federal Reserve's expectations for internal audit; instead the proposed guidance references existing guidance.20

The Board invites comments on all aspects of the proposed guidance, including responses to the following questions:

(1) What considerations beyond those outlined in this proposal should be considered in the Federal Reserve's assessment of whether an LFI has sound governance and controls such that the firm has sufficient financial and operational strength and resilience to maintain safe and sound operations?

(2) How could the roles and responsibilities between the board of directors set forth in the proposed board effectiveness guidance, and between the senior management, business line management, and IRM be clarified?

(3) What, if any, aspects of the structure and coverage of IRM and controls should be addressed more specifically by the guidance?

(4) The proposal tailors expectations for FBOs, recognizing that the U.S. operations are part of a larger organization. How could this tailoring be improved?

(5) In what ways, if any, does the guidance diverge from industry practice? How could the guidance better reflect industry practice while facilitating effective risk management and controls? Are there any existing standards for internal control frameworks to which the guidance should follow more closely?

(6) Other supervisory communications have used the term “risk appetite” instead of risk tolerance. Are the terms “risk appetite” and “risk tolerance” used interchangeably within the industry, and what confusion, if any, is created by the terminology used in this guidance?

(7) The proposal would adopt different terminology than is used in the proposed LFI rating system, and the Board expects to align the terminology so the element in the governance and controls component would change from “management of core business lines” to “management of business lines.” Does this proposal clearly explain this expected change? Do commenters anticipate any impact from this change?

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) (“PRA”), the Board may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (“OMB”) control number. The Board reviewed the proposed supervisory guidance under the authority delegated to the Board by OMB.

The proposed supervisory guidance contains a collection of information subject to the PRA. Recordkeeping requirements are found in the proposed guidance. Among expectations for business line management, the proposed guidance states that business line management should establish specific business and risk objectives for business lines, and establish policies and guidelines that delineate accountability within the business line. In addition, the proposed guidance sets expectations for a firm's IRM function, including related to the scope of a firm's risk limits and an expectation for written risk assessment that would be provided to the senior management and, as appropriate, the board. The proposed guidance also sets expectations for internal audit, including an expectation for an internal audit risk assessment and audit reports.

Comments are invited on:

a. Whether the collections of information are necessary for the proper performance of the Board's functions, including whether the information has practical utility;

b. The accuracy or the estimate of the burden of the information collections, including the validity of the methodology and assumptions used;

c. Ways to enhance the quality, utility, and clarity of the information to be collected;

d. Ways to minimize the burden of the information collections on respondents, including through the use of automated collection techniques or other forms of information technology; and

e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

All comments will become a matter of public record. Comments on aspects of this notice that may affect reporting, recordkeeping, or disclosure requirements and burden estimates should be sent to: Secretary, Board of Governors of the Federal Reserve System, 20th and C Streets NW, Washington, DC 20551. A copy of the comments may also be submitted to the OMB desk officer by mail to U.S. Office of Management and Budget, 725 17th Street NW, #10235, Washington, DC 20503; facsimile to (202) 395-6974; or email to [email protected], Attention, Federal Banking Agency Desk Officer.

Report title: Governance and Controls Guidance.

Agency form number: FR 4204.

OMB control number: 7100-NEW.

Frequency: Annual.

Respondents: Domestic bank and savings and loan holding companies with total consolidated assets of $50 billion or more, systemically important nonbank financial companies designated by FSOC for supervision by the Board, the U.S. operations of FBOs with combined U.S. assets of $50 billion or more, and state member bank subsidiaries of the foregoing.

Legal authorization and confidentiality: This information collection is voluntary. The Board has determined that the collection of information is authorized by section 5(c) of the Bank Holding Company Act (12 U.S.C. 1844(c)), section 10(b) of the Homeowners' Loan Act (12 U.S.C. 1467a(b)(4), section 113 of the Dodd-Frank Act (12 U.S.C. 5323). The information contained would be considered confidential pursuant to exemption 8 of the Freedom of Information Act (5 U.S.C. 552(b)(8)).

Estimated number of respondents: 56.

Estimated average hours per response: 3,872 hours initial setup, 560 hours for ongoing.

Estimated annual burden hours: 216,832 hours initial setup, 31,360 hours for ongoing.

The Federal Reserve is providing an initial regulatory flexibility analysis with respect to this proposal. While the proposed guidance is not being adopted as a rule, the Federal Reserve has considered the potential impact of the proposal on small banking organizations using considerations that would apply if the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (“RFA”) were applicable. Based on the Board's analysis and for the reasons stated below, the Board believes that the proposed guidance will not have a significant economic impact on a substantial number of small entities.

Under regulations issued by the Small Business Administration, a small entity includes a depository institution, bank holding company, or savings and loan holding company with assets of $550 million or less (“small banking organizations”). As of June 1, 2017, there were approximately 3,539 small banking organizations. As described above, the proposed guidance would apply only to all bank holding companies with total consolidated assets of $50 billion or more; state member banks of such bank holding companies; all savings and loan holding companies with total consolidated assets of $50 billion or more; systemically important nonbank financial companies designated by FSOC for supervision by the Federal Reserve; and the U.S. operations of FBOs with combined U.S. assets of $50 billion or more. Small banking organizations would therefore not be subject to the proposed guidance. As a result, the proposed guidance should have any impact on small banking organizations. In light of the foregoing, the Board believes that the proposed guidance will not have a significant economic impact on small banking organizations supervised by the Board.

Governance and controls involves (i) the oversight of a firm by its board of directors, (ii) management of business lines and independent risk management (IRM) and controls, and (iii) for domestic Large Institution Supervision Coordinating Committee (LISCC) firms only, recovery planning. This guidance sets forth the second part of the Federal Reserve's expectations for large financial institutions (LFIs or firms)—core principles of the management of business lines and IRM and controls. This guidance also builds upon supervisory guidance previously issued by the Federal Reserve.21

Guidance related to the first part of governance and controls, the oversight of a firm by its board of directors (BE Guidance), was released earlier.22 It describes attributes of an effective board of directors and distinguishes a board's responsibilities from those of a firm's senior management.

Like the BE Guidance, the supervisory expectations described in this guidance regarding the management of business lines and IRM and controls would help inform the Federal Reserve's overall supervisory evaluation of a firm's governance and controls to support the firm's financial and operational strength and resilience. Among other factors, this evaluation would be an input to the governance and controls component rating under the proposed LFI rating system.23

The guidance applies to domestic bank holding companies (BHCs) and domestic savings and loan holding companies with total consolidated assets of $50 billion or more, the combined U.S. operations of foreign banking organizations (FBOs) with combined U.S. assets of $50 billion or more, and any state member bank subsidiaries of the foregoing. The guidance also applies to systemically important nonbank financial companies designated by the Financial Stability Oversight Council (FSOC) for supervision by the Board.

Regulation YY requires FBOs with combined U.S. assets of $50 billion or more to maintain a U.S. risk committee to oversee the risk management framework of the combined U.S. operations.24 Regulation YY also requires FBOs with U.S. non-branch assets of $50 billion or more to establish an intermediate holding company (IHC), which is governed by a board of directors or managers with equivalent rights, powers, privileges, duties, and responsibilities to those of a board of directors of a domestic corporation.25 The Federal Reserve's expectations for governance of the combined U.S. operations of an FBO are generally consistent with its expectations for governance of large domestic firms and, in this guidance, a reference to “firm” should be taken also as a reference to the combined U.S. operations of an FBO, unless the context requires otherwise. Given that an FBO's combined U.S. operations are part of a larger global organization, the Federal Reserve anticipates that certain elements of an FBO's governance framework may be located outside of the United States. In this event, these elements should enable effective governance and risk management by the U.S. senior management, the U.S. risk committee, and the IHC board (as applicable), and should facilitate U.S. supervisors' ability to assess the adequacy of governance and controls in the combined U.S. operations.

This guidance sets forth core principles of effective senior management, the management of a firm's business lines 26 and IRM and controls.27

Under the board's oversight, a firm's senior management is responsible for managing the day-to-day operations of the firm, and for ensuring safety and soundness and compliance with internal policies and procedures, laws, and regulations, including those related to consumer protection.28 Two key responsibilities of senior management are overseeing the activities of the firm's business lines (individually and collectively) and the firm's IRM and controls.

Senior management is responsible for implementing the firm's strategy and risk tolerance approved by the board.29 Senior management should implement the strategic and risk objectives across the firm to support the firm's long-term resiliency and safety and soundness, including the firm's ability to withstand the impact of a range of stressed conditions.30 Senior management should ensure the firm's infrastructure, staffing, and resources are sufficient to carry out the firm's strategy and manage the firm's activities in a safe and sound manner, and in compliance with applicable laws and regulations, including those related to consumer protection, as well as policies, procedures, and limits. Senior management should also identify when there is a risk that the firm's activities collectively may deviate from the firm's strategy and risk tolerance and escalate such instances to the board of directors.

Senior management is responsible for maintaining and implementing an effective risk management framework and ensuring the firm appropriately manages risk consistent with its strategy and risk tolerance.31 This includes establishing clear responsibilities and accountability for the identification, measurement, management, and control of risk. Senior management is responsible for promoting and enforcing prudent risk-taking behaviors and business practices, including through the firm's compensation and performance management programs. Senior management is responsible for developing and maintaining the firm's policies and procedures and system of internal control, commensurate with the firm's size, scope of operations, activities, and risk profile, to ensure compliance with laws and regulations, including those related to consumer protection, and consistency with supervisory expectations.32 Senior management should also periodically assess the risk management framework as a whole to ensure that the framework remains comprehensive and appropriate and has kept pace with changes in the business line's products, services, and activities as well as changes in economic conditions and the broader market environment.

Senior management should ensure effective communication and information sharing across the entire firm. Senior management should also address any impediments to the effective flow of information, including those that could result in decisions being made or actions being taken in isolation.

In overseeing the firm's day-to-day operations, senior management should base its decisions and actions, as well as its communications with the board, on a full understanding of the firm's risks and activities. Therefore, senior management should have in place robust mechanisms for:

• Keeping apprised of drivers and trends related to current and emerging risks, material limit breaches, and other material issues;

• Maintaining and assessing the firm's system of internal control;

• Staying informed about material deficiencies and limitations in risk management and control practices, and ensuring that such deficiencies are remediated in a timely fashion;

• Assessing the potential impact of the firm's activities and risk positions on the firm's capital,33 liquidity, and overall risk profile;

• Assessing the firm's financial and nonfinancial performance relative to the firm's strategy and risk objectives;

• Maintaining robust management information systems to support oversight of the firm's activities and risk positions, and to provide information to the board; and

• Maintaining current succession and contingency staffing plans for key positions.

Senior management is responsible for providing timely, useful, and accurate information to the board. Senior management should also be responsive to direction from the board and to the board's informational needs. Further, senior management is responsible for ensuring resolution of risk management issues (including those identified by the firm and outstanding supervisory matters), escalating issues to the board, and communicating issues internally when appropriate. Senior management should regularly report to the board on responses to, and remediation of, material audit and supervisory findings, risk management and control deficiencies, material compliance issues (including those related to consumer protection), and the outcomes of risk reviews which may result in remedial actions.

This section sets forth core principles of the management of business lines, including critical operations.34 As used in this guidance, business line management refers to the core group of individuals responsible for prudent day-to-day management of a business line and accountable to senior management for that responsibility.35

For a LISCC firm, due to its size, risk profile, and systemic importance, these principles apply to all of the firm's business lines. For an LFI that is not a LISCC firm, these principles apply to any business line in which a significant control disruption, failure, or loss event could result in a material loss of revenue, profit, or franchise value, or result in significant consumer harm.

A business line may cross legal entities or geographic jurisdictions. In instances where a business line of an FBO is part of a larger business conducted outside of the United States, expectations apply only to the portion of that business conducted in the United States.36

This section is organized as follows:

Business line management should establish specific business and risk objectives for each business line that align with the firmwide strategy and risk tolerance. Business line management should inform senior management when the business line's risk management capabilities are insufficient to achieve those business and risk objectives. In addition, during the strategic planning process with senior management, business line management should clearly present the risks emanating from the business line's activities. Business line management should explain how those risks are managed and align with the firm's risk tolerance.

Business line management should provide information to senior management regarding the business line's current and potential risk profile and its alignment with the firm's risk tolerance. Information reported should enable senior management to make critical decisions about the business line's strategic direction and risks.

Business line management should identify, measure, and manage current and emerging risks that stem from the business line's activities and changes to external conditions.38 Where it is difficult to assess risks quantitatively, business line management should still assess the impact of those risks, such as through qualitative means. These risks should include significant exposures and activities, both on-balance and off-balance sheet, and any other potential sources of risk related to the business line's activities. Business line management should incorporate appropriate feedback from IRM on business line risk positions, implementation of the risk tolerance, and risk management practices, including risk mitigation.

In measuring risks, business line management should consider the size and risk characteristics of the business line's exposures and business activities. Business line management should aggregate risks, including by business activities or products. For instance, management of a large commercial lending business line should understand risks affecting the business line as a whole, and also within segments of the business line, such as large corporate exposures, commercial real estate loans, and small business lending.

The activities of a business line should remain within risk limits established by IRM.39 Business line management should consult with senior management before allowing any exceptions to risk limits.40 This consultation should culminate in a well-supported decision by management to accept the risk or reduce its risk exposure. Business line management should subject any exceptions to risk limits to the firm's formal approval process. A business line may need to employ risk mitigation strategies to remain aligned with the firmwide strategy and risk tolerance.

A firm should have policies and procedures for vetting new business products and initiatives. Risks from new businesses should be identified and captured in risk management governance, infrastructure, compliance, and processes before commencing the new business. Business line management should escalate to senior management any required changes or modifications to risk management systems or internal control policies and procedures arising from the adoption of a new business or initiative. Additionally, growth in the new business should be consistent with the firm's risk management capabilities.

Business line management should provide a business line with sufficient resources and infrastructure to meet strategic objectives while maintaining financial and operational strength and resilience over a range of operating conditions, including stressful ones.41 Sufficient resources and infrastructure include personnel with appropriate training and expertise and management information systems. Business line management should inform senior management if the business line's resources and infrastructure are insufficient to meet its business objectives.

Business line management should ensure that the business line's infrastructure is sound and appropriate for the intended specific business activities and that management information systems are sufficiently flexible to produce ad hoc and more frequent reporting when necessary. Business line management should address any gaps or weaknesses identified in the existing infrastructure and escalate to senior management if appropriate.

Business line management should ensure that the business line has:

• Clearly defined staff roles and responsibilities for key positions, as well as management reporting lines;

• Appropriate separation of duties and internal controls for effectively managing risk associated with its business strategy;

• Staff with skills and experience commensurate with the business line's activities and risks; and

• Succession and contingency plans for key positions.

Business line management should provide training and development to its staff to ensure sufficient knowledge of business line activities; compliance, operations and risk management processes; controls; and business continuity. Business line management should reinforce balanced risk-taking and provide incentives for appropriate behaviors through talent management processes, compensation arrangements, and other performance management processes.

Business line management should develop and maintain an effective system of internal control for its business line that helps to ensure compliance with laws and regulations, including those related to consumer protection, and supports effective risk management.42 For example, a business line's system of internal control should include access controls, change controls, and data integrity controls, including data reconciliations, variance analysis, and data quality logic checks. The system of internal control for a business line should be commensurate with the business line's size, scope of operations, activities, and risk profile. A comprehensive system of internal control includes policies, procedures, systems, and processes specific to the business line.

Business line management should regularly test to ensure the controls within its business line are functioning as expected and are effective in managing risks. More frequent testing is appropriate for key controls, or controls that have undergone a material change. Business line management should ensure that deficiencies in control design and operating effectiveness are remediated. Business line management should provide periodic reports on the operation of controls to senior management and escalate to senior management material internal control deficiencies and any systematic control violations. Finally, business line management should reassess all key controls periodically to ensure relevancy and alignment with current approved policies.

Business line management should establish policies and guidelines that specify accountability, set forth clear lines of management authority within the business line, and clearly align desired behavior with the firm's performance management incentives. Business line management should hold their staff accountable to the extent behavior that is inconsistent with the board and senior management directives and inform senior management as appropriate. Business line management should ensure that training for new and existing employees explicitly addresses and emphasizes the importance of professional conduct and compliance with laws and regulations, including those related to consumer protection.

Business line management should have ongoing and effective means to prevent, detect, and remediate risk management and compliance failures of business line policies and procedures, as well as policies and limits established by the firm's senior management. Business line management should develop processes with indicators and early warning mechanisms to facilitate timely detection of existent and potential issues. Business line management should actively supervise employees in light of the firm's policies and guidelines.

There are three key areas covered in this section: (1) IRM, which provides an objective, critical assessment of risks and evaluates whether a firm remains aligned with its stated risk tolerance; (2) a system of internal control to guide practices, provide appropriate checks and balances, and confirm quality of operations; and (3) internal audit, which provides independent assessments of the effectiveness of the risk management framework and the system of internal control.

This section is organized as follows:

Except for the roles of the CRO and the CAE, this guidance does not purport to prescribe in detail the governance structure for a firm's IRM and controls. Senior management should establish and maintain clear lines of responsibility and accountability so that activities are conducted in a manner that satisfies supervisory expectations.

Supervisory expectations related to independent risk management apply to the U.S. CRO and the U.S. risk committee of an FBO for the combined U.S. operations in the same manner as these expectations apply to the CRO and risk committee of a domestic holding company. For an FBO, the internal audit function for the combined U.S. operations should have appropriate independent oversight of those.

The Board's Regulation YY requires certain firms to have a CRO with sufficient capability and experience in identifying, assessing, and managing risk exposures of large, complex financial institutions.44 To promote the stature and independence of IRM, the CRO must report directly to the board's risk committee as well as to the CEO.45 The CRO also must provide reports to the board's risk committee at least quarterly.46

As part of overseeing IRM, the CRO should guide IRM to establish and monitor compliance with enterprise-wide risk limits, identify and aggregate the firm's risks, assess the firm's risk positions relative to the parameters of the firm's risk tolerance, and provide relevant risk information to senior management and the board. The CRO should also oversee communication of the firm's risk limits to the board and relevant firm management and staff.

The CRO should inform the board if his or her stature, independence, or authority is not sufficient to provide objective and independent assessments of the firm's risks, risk management activities, and system of internal control.47 Further, the CRO should be included in discussions with other senior management and the board related to key decisions such as strategic planning and capital and liquidity planning. The CRO should also provide input to the board on incentive compensation plan design and effectiveness.

The CRO should escalate issues to senior management and the board when activities or practices at the firmwide, risk-specific, and business-line level do not align with the firm's overall risk tolerance. For example, the CRO should report concerns to the board's risk committee if the firm does not have sufficient risk management capacity to enter into a proposed merger or new product line and promote the taking of appropriate actions, as warranted. The CRO should recommend constraints on risk-taking and enhancements to risk management practices to senior management and the board. The CRO or IRM should be involved in any proposal to waive or make exceptions to established risk limits, including on a temporary basis, should provide an assessment of any such proposal, and should escalate the proposal to the board of directors as appropriate. The necessary level of approval within IRM and escalation should be clearly articulated in policies and procedures and commensurate with the nature of the risk limit.

The CRO should support the independence of IRM from the business lines by establishing clearly defined roles and responsibilities, and reporting lines. The CRO should periodically assess whether IRM has appropriate staffing and systems; sufficient understanding of the risks and business activities being evaluated; and sufficient authority to identify and escalate material or persistent risk management and control deficiencies and to challenge senior management and business line management when warranted.

A firm should have a CAE, appointed by the board, with sufficient capability, experience, independence and stature to manage the internal audit function's responsibilities appropriate to the size and complexity of the firm.48 The CAE should effectively manage all aspects of internal audit work on an ongoing basis, including any internal audit work that is outsourced. The CAE should have the authority to oversee all internal audit activities and to hire internal audit staff with sufficient capability and stature. Under the direction of the CAE, the internal audit function performs independent assessments of the effectiveness of the firm's system of internal control and the risk management framework. The CAE should report findings, issues, and concerns to the board's audit committee and senior management.

IRM should provide input into and evaluate the firm's risk tolerance to ensure that it appropriately captures the firm's material risks and aligns with the firm's strategy and the corresponding business activities.50 In addition, IRM should evaluate whether the risk tolerance:

• Addresses risks under normal and stressed conditions and considers changes in the risk environment;

• Includes risks associated with the firm's revenue generating activities, as well as other aspects of risks inherent to the business, such as compliance, information technology, and cybersecurity;

• Incorporates realistic risk and reward assumptions that, for example, do not overestimate expected returns from business activities or underestimate risks associated with business activities; and

• Guides the firm's risk-taking and risk mitigation activities.

IRM should determine whether the firm's risk profile is consistent with the firm's risk tolerance and assess whether the firm's risk management framework has the capacity to manage the risks outlined in the risk tolerance. Specifically, IRM should determine whether there are sufficient resources and infrastructure in the relevant areas of the firm to properly identify, manage, and report the risks associated with the business strategies outlined in the risk tolerance, including during stressful or unanticipated conditions.

Under direction of the CRO, IRM should establish enterprise-wide risk limits that are consistent with the firm's risk tolerance for the firm's full set of risks, including risks associated with revenue generating activities and those inherent to the business. Risk limits should be assigned to specific risk types, business lines, legal entities, jurisdictions, geographic areas, concentrations, products or activities, commensurate with the firm's risk profile. For example, risk limits can cover single counterparty credit exposures, funding concentrations, country exposures, or subprime lending activities. Risk limits should be clear, relevant, and current. IRM should create lower-level risk limits, such as for an individual business line, based on the enterprise-wide risk limits.

Risk limits should be quantitative and qualitative. For instance, quantitative limits can be set relative to earnings, assets, liabilities, capital, liquidity, or other relevant benchmarks. IRM should set qualitative limits—such as an expert assessment to constrain business in a given country—as a proxy for risks or aspects of risks that are more difficult to quantify. Risk limits should include explicit thresholds that, if crossed, strictly prohibit the activity generating the risk.

To the extent possible, risk limits should:

• Consider the range of possible external conditions facing the firm over a period of time;

• Consider the aggregation and interaction of risks across the firm;

• Be consistent with the firm's financial resources, such as available capital and liquidity, as well as with non-financial aspects, such as managerial, technological, and operational resources; and

• Reinforce compliance with laws and regulations, including those related to consumer protection, and consistency with supervisory expectations.

IRM should monitor and update risk limits as appropriate, especially as the firm's risk tolerance is updated, the firm's risk profile changes, or external conditions change. IRM should also identify significant trends in risk levels to evaluate whether risk-taking and risk management practices are consistent with the firm's strategic objectives. IRM should escalate to senior management any material breaches of the firm's enterprise-wide risk limits and risk tolerance, as well as instances where IRM's conclusions differ from the conclusions of a business line.

IRM's activities are conducted in addition to business line risk management activities described above and should provide an objective, critical perspective of a firm's risks. IRM should identify and measure current and emerging risks within and across business lines and risk types, as well as any other relevant perspectives, such as by legal entity or jurisdiction. Where it is difficult to assess risks quantitatively, IRM should still assess the impact of those risks, such as through qualitative means. IRM should conduct its risk identification and measurement work on an ongoing basis to reflect any changes in exposures, business activities, and the broader operating environment, including changes in law and supervisory expectations.

IRM should identify risk types, including credit, market, operational, liquidity, interest rate, legal, compliance and related risks (such as consumer protection and Bank Secrecy Act/anti-money laundering). IRM should establish minimum internal standards for all of its risk identification and measurement practices to ensure consistent quality across different risks. IRM's standards should include both quantitative and qualitative elements, with the latter especially important for risks or aspects of risks that are more difficult to quantify. The standards at a firm should be dynamic, inclusive, and comprehensive.

To conduct effective risk identification and measurement, IRM should have access to timely, reliable, and comprehensive information about all risk-related exposures and activities in the firm. This should include emerging or potential sources of risk. IRM should seek input across the firm in identifying risks. IRM may utilize information collected or used from business lines; however, IRM should not rely on business line information exclusively. IRM staff should also draw upon external information, such as peer data or market information, to supplement their assessments.

IRM should regularly measure identified risks under both normal and stressful operating conditions. In measuring risks, IRM should consider the size and risk characteristics of the firm's exposures and business activities. Within each risk type, IRM should rely on a range of metrics and use measures appropriate to different risk types.

IRM should aggregate risks across the entire firm and assess those risks relative to the firm's risk tolerance.51 IRM should identify material or critical concentrations of risks and assess the likelihood and potential impact of those risks on the firm. Further, IRM should identify activities or exposures that have related risk factors and assess the combined impact of those risk factors on the firm. IRM should assess risk information along different meaningful dimensions at a more granular level than firmwide, such as by business line, geographic regions, obligors, counterparties, and products, to determine how those impact the firm's risk profile.

IRM should conduct risk assessments using information from risk identification, measurement, and aggregation to determine the impact of risks on the firm and to inform senior management and the board about the suitability of risk positions relative to risk limits and the risk tolerance. IRM should assess risks and risk drivers within and across business lines and risk types, as well as any other material perspectives, such as by legal entity or jurisdiction. Further, IRM should analyze any assumptions related to risk diversification. IRM also should assess risk mitigation strategies, including the effectiveness of such mitigation in a range of circumstances, and recommend alternatives if concerns arise.

IRM should identify information gaps, uncertainties, and limitations in risk assessments for senior management, and as appropriate, for the board. For instance, in analyzing a new product area or business line, IRM should acknowledge areas of insufficient information that limit a complete assessment of the risks and provide a measured implementation plan to obtain the necessary information.

Risk reporting should be comprehensive, useful, accurate, and timely. Risk reporting should cover current and emerging risk and adherence to risk limits and risk concentrations as well as the firm's ongoing strategic, capital, and liquidity planning processes. Risk reporting should enable prompt escalation and remediation of material problems; enhance appropriate and timely responses to identified problems; provide current and forward-looking perspectives; and support or influence strategic decision-making. Risk reporting should provide information on aggregate risks within and across business lines and risk types, as well as by legal entity or jurisdiction and significant concentrations.

Risk reporting should be tailored to meet the differing information needs of the board, senior management, and others within the firm. The frequency of reporting should depend on needs of the firm and the materiality of the issues. Risk reporting should adapt to market downturns or stress events.

Internal controls cover a wide range of activities and processes, and could include the following: 52

• Policies and procedures that set expectations for and govern the firm's business activities and support functions; establish appropriate levels of authority, responsibility, and accountability for overseeing and executing the firm's activities; and establish standards for prudent risk-taking behaviors.

• Clear assignment of roles and responsibilities and appropriate separation of duties.

• Physical controls for restricting access to tangible assets.

• Approvals and appropriate dual authorizations for key decisions, transactions, and execution of processes.

• Verifications of transaction details and periodic reconciliations, such as those comparing cash flows to account records and statements.

• Access controls, change management controls, data entry and related controls.

• Escalation procedures with a system of checks and balances in situations that allow for managerial or employee discretion.

Internal controls instill confidence in financial reporting and are important to ensure the integrity of the process and information relied upon by the firm to manage itself. Developing and maintaining an effective system of internal control is the responsibility of several parties, including business line management.53 Accordingly, a firm should assign management responsibilities for the establishment and maintenance of internal controls. To foster an appropriate control culture within the firm, adequate control activities should be integrated into the daily functions of all relevant personnel. All personnel should fully understand and adhere to policies and procedures affecting their duties and responsibilities.

A firm should have mechanisms to test its system of internal control and to identify and escalate issues that appear to compromise its effectiveness. A firm should regularly evaluate and test the quality, reliability and effectiveness of internal controls, and monitor any potential deterioration. Generally, testing activities are conducted at specific points in time, whereas monitoring activities are continuous processes. The scope, frequency, and depth of testing should consider the complexity of the firm, the results of the firm's risk assessments, and the number and significance of the deficiencies identified during prior testing. A firm should test and monitor internal controls using a risk-based approach, prioritizing efforts on controls in areas of highest risk and less effective controls.

A firm should evaluate and communicate internal control deficiencies in a timely manner to those parties responsible for taking corrective action, including senior management. Firms should establish management information systems that track internal control weaknesses and escalate serious matters to the board, senior management, and responsible business line management, as appropriate.

An effective internal audit function provides independent assurance to the board and senior management concerning the effectiveness of risk management and internal control systems. The Federal Reserve issued guidance outlining the key components of an effective internal audit function in SR letter 03-5, and followed that with supplemental guidance in SR letter 13-1/CA letter 13-1, “Supplemental Policy Statement on the Internal Audit Function and Its Outsourcing.” The supplemental guidance builds upon the 2003 interagency guidance of SR letter 03-5 and further addresses the characteristics, governance, and operational effectiveness of a firm's internal audit function. That existing audit guidance remains in place and is not superseded by this guidance.

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

The information required under section 402(j)(5)(B) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) is submitted in the form of a certification, Form FDA 3674, which accompanies applications and submissions currently submitted to FDA and already approved by OMB. The OMB control numbers and expiration dates for those applications and submissions are: 21 CFR parts 312 and 314 (human drugs), OMB control number 0910-0014, expiring February 28, 2019, and OMB control number 0910-0001, expiring December 31, 2017; 21 CFR parts 312 and 601 (biological products), OMB control number 0910-0014, expiring February 28, 2019, and OMB control number 0910-0338, expiring March 31, 2020; and 21 CFR parts 807 and 814 (devices), OMB control number 0910-0120, expiring June 30, 2020, and OMB control number 0910-0231, expiring March 31, 2020.

Title VIII of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) amended the PHS Act by adding section 402(j). The provisions broadened the scope of clinical trials subject to submitting information and required additional information to be submitted to the clinical trials databank (https://clinicaltrials.gov) (FDA has verified the website address, but FDA is not responsible for any subsequent changes to the website after this document publishes in the Federal Register) previously established by the National Institutes of Health (NIH)/National Library of Medicine. This includes expanded information on applicable clinical trials and summary information on the results of certain clinical trials. The provisions include responsibilities for FDA as well as several amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

One provision, section 402(j)(5)(B) of the PHS Act, requires that a certification accompany human drug, biological, and device product submissions made to FDA. Specifically, at the time of submission of an application under sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification, Form FDA 3674, that all applicable requirements of section 402(j) of the PHS Act have been met. Where available, such certification must include the appropriate National Clinical Trial (NCT) numbers that are assigned upon submission of required information to the NIH databank at https://clinicaltrials.gov.

The proposed extension of the collection of information is necessary to satisfy the previously mentioned statutory requirement. The importance of obtaining these data relates to adherence to the legal requirements for submissions to the clinical trials registry and results databank, and ensuring that individuals and organizations submitting applications or reports to FDA under the listed provisions of the FD&C Act or the PHS Act adhere to the appropriate legal and regulatory requirements for certifying to having complied with those requirements. The failure to submit the certification required by section 402(j)(5)(B) of the PHS Act, and the knowing submission of a false certification, are both prohibited acts under section 301 of the FD&C Act (21 U.S.C. 331). Violations are subject to civil money penalties. The Form FDA 3674 provides a convenient mechanism for sponsors/applicants/submitters to satisfy the certification requirements of the statutory provision.

To assist sponsors/applicants/submitters in understanding the statutory requirements associated with Form FDA 3674, we have provided a guidance available at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm. This guidance recommends the applications and submissions FDA considers should be accompanied by the certification form, Form FDA 3674. The applications and submissions identified in the guidance are reflected in the burden analysis. In 2017, we updated the guidance to include references to the NIH Final Rule implementing 402(j) of the PHS Act (42 U.S.C. 282(j)). The final rule, published on September 21, 2016 (81 FR 64982) (42 CFR part 11), clarifies the requirements for submission of clinical trial information to https://clinicaltrials.gov.

Investigational New Drug Applications. FDA's Center for Drug Evaluation and Research (CDER) received 1,669 investigational new drug applications (INDs) and 15,285 clinical protocol IND amendments in calendar year (CY) 2016. CDER anticipates that IND and clinical protocol amendment submission rates will remain at or near this level in the near future.

FDA's Center for Biologics Evaluation and Research (CBER) received 381 new INDs and 456 clinical protocol IND amendments in CY 2016. CBER anticipates that IND and clinical protocol amendment submission rates will remain at or near this level in the near future. The estimated total number of submissions (new INDs and new protocol submissions) subject to mandatory certification requirements under section 402(j)(5)(B) of the PHS Act is 16,954 for CDER plus 837 for CBER, or 17,791 submissions per year. The minutes per response is the estimated number of minutes that a respondent would spend preparing the information to be submitted to FDA under section 402(j)(5)(B) of the PHS Act, including the time it takes to enter the necessary information on the form.

Based on its experience with current submissions, FDA estimates that approximately 15 minutes on average would be needed per response for certifications that accompany IND applications and clinical protocol amendment submissions. It is assumed that most submissions to investigational applications will reference only a few protocols for which the sponsor/applicant/submitter has obtained an NCT number from https://clinicaltrials.gov prior to making the submission to FDA. It is also assumed that the sponsor/applicant/submitter has electronic capabilities allowing them to retrieve the information necessary to complete the form in an efficient manner.

Marketing Applications/Submissions. In CY 2016, CDER and CBER received 252 new drug applications (NDA)/biologics license applications (BLA)/resubmissions and 1,067 NDA/BLA amendments for which certifications are needed. CDER and CBER received 253 efficacy supplements/resubmissions to previously approved NDAs/BLAs in CY 2016. CDER and CBER anticipate that new drug/biologic applications/resubmissions and efficacy supplement submission rates will remain at or near this level in the near future.

FDA's Center for Devices and Radiological Health (CDRH) received a total of 330 new applications for premarket approvals (PMA), 510(k) submissions containing clinical information, PMA supplements, applications for humanitarian device exemptions (HDE) and amendments in CY 2016. CDRH anticipates that application, amendment, supplement, and annual report submission rates will remain at or near this level in the near future.

FDA's Office of Generic Drugs (OGD) received 1,036 abbreviated new drug applications (ANDAs) in 2016. OGD received 698 bioequivalence amendments/supplements in 2016. OGD anticipates that application, amendment, and supplement submission rates will remain at or near this level in the near future.

Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s, and ANDAs and experience with current submissions of Form FDA 3674, FDA estimates that approximately 45 minutes on average would be needed per response for certifications that accompany NDA, BLA, PMA, HDE, 510(k), and ANDA marketing applications and submissions. It is assumed that the sponsor/applicant/submitter has electronic capabilities allowing them to retrieve the information necessary to complete the form in an efficient manner.

In the Federal Register of September 22, 2017 (82 FR 44417), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

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 animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal 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 an animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B).

FDA has approved for marketing the animal drug product ENTYCE (capromorelin). ENTYCE is indicated for appetite stimulation in dogs. Subsequent to this approval, the USPTO received patent term restoration applications for ENTYCE (U.S. Patent Nos. 6,107,306 and 6,673,929) from RaQualia Pharma Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated December 1, 2016, FDA advised the USPTO that this animal drug product had undergone a regulatory review period and that the approval of ENTYCE 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 ENTYCE is 1,645 days. Of this time, 1,589 days occurred during the testing phase of the regulatory review period, while 56 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 FD&C Act (21 U.S.C. 355(i)) became effective: November 16, 2011. The applicant claims December 5, 2002, as the date the investigational new animal drug application (INAD) became effective. However, FDA records indicate that the INAD effective date was November 16, 2011, which was the date a major health or environmental effects test is begun or the date on which the Agency acknowledges the filing of a notice of claimed investigational exemption for a new animal drug, whichever is earlier.

2. The date the application was initially submitted with respect to the animal drug product under section 512 of the FD&C Act (21 U.S.C. 360b): March 22, 2016. The applicant claims March 21, 2016, as the date the new animal drug application (NADA) for ENTYCE (NADA 141-457) was initially submitted. However, FDA records indicate that NADA 141-457 was submitted on March 22, 2016.

3. The date the application was approved: May 16, 2016. FDA has verified the applicant's claim that NADA 141-457 was approved on May 16, 2016.

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 applications for patent extension, this applicant seeks 1,826 and 1,827 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, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), 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 comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (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 https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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 EPANOVA (omega-3-carboxylic acids). EPANOVA is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Subsequent to this approval, the USPTO received patent term restoration applications for EPANOVA (U.S. Patent Nos. 5,948,818; 7,960,370; 7,792,795; and 8,383,678) from AstraZeneca Pharmaceuticals LP, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated December 1, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of EPANOVA 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 EPANOVA is 4,269 days. Of this time, 3,964 days occurred during the testing phase of the regulatory review period, while 305 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: August 29, 2002. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on August 29, 2002.

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 5, 2013. The applicant claims July 3, 2013, as the date the NDA for EPANOVA was initially submitted. However, FDA records indicate that NDA 205060 was submitted on July 5, 2013, which is considered to be the NDA initially submitted date.

3. The date the application was approved: May 5, 2014. FDA has verified the applicant's claim that NDA 205060 was approved on May 5, 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 applications for patent extension, this applicant seeks 682 days, 371 days, and 5 years of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), 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 comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (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 https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Agenda: On March 5 and 6, 2018, the committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The Pregnancy and Lactation Labeling Rule (PLLR) was implemented in June 2015, and required changes to labeling of information in prescription drug and biological products to better communicate clinically relevant information to health care providers on risks associated with medication exposure during pregnancy and lactation. The Agency seeks input and recommendations on: (1) How information in PLLR labeling is being perceived and used by health care providers and other stakeholders, (2) factors that are critical to health care providers' interpretation of the data and counseling of pregnant women on the risks and benefits of a medication, and (3) how to convey risk information to health care providers to accurately and adequately inform risk-benefit considerations for medication use during pregnancy.

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

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 26, 2018. Oral presentations from the public will be scheduled between approximately 12:45 p.m. and 1:45 p.m. on March 5, 2018, and between 9:10 a.m. and 9:30 a.m. on March 6, 2018. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 16, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 20, 2018.

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

For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

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

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

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

I. Background

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 MICRA TRANSCATHETER PACING SYSTEM. MICRA TRANSCATHETER PACING SYSTEM is indicated for use in patients who have experienced one or more of the following conditions: (1) Symptomatic paroxysmal or permanent high-grade atrioventricular (AV) block in the presence of atrial fibrillation (AF); (2) symptomatic paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy; (3) symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy. Subsequent to this approval, the USPTO received patent term restoration applications for MICRA TRANSCATHETER PACING SYSTEM (U.S. Patent Nos. 7,824,805 and 8,129,622) from Medtronic, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated March 13, 2017, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of MICRA TRANSCATHETER PACING 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 MICRA TRANSCATHETER PACING SYSTEM is 788 days. Of this time, 585 days occurred during the testing phase of the regulatory review period, while 203 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 (FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: February 10, 2014. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective on April 3, 2014. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on February 10, 2014, which represents the IDE effective date.

2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): September 17, 2015. FDA has verified the applicant's claim that the premarket approval application (PMA) for MICRA TRANSCATHETER PACING SYSTEM (PMA P150033) was initially submitted September 17, 2015.

3. The date the application was approved: April 6, 2016. FDA has verified the applicant's claim that PMA P150033 was approved on April 6, 2016.

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 applications for patent extension, this applicant seeks 457 days and 494 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, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), 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 comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (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 https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Agenda: The committee will discuss supplemental new drug application (sNDA) 022496/S-009, for EXPAREL (bupivacaine liposomal injectable suspension), submitted by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia.

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

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 31, 2018. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on February 15, 2018. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 23, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 24, 2018.

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

For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Moon Hee V. Choi at least 7 days in advance of the meeting (See FOR FURTHER INFORMATION CONTACT).

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

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).