Federal Register Vol. 82, No.221,

The purpose of the meeting is to provide:

(1) Information Topic: FY 2018 Forest Budget Overview;

(2) Pile burning update;

(3) Over snow use;

(4) Recreation Site Analysis (RSA) update;

(5) Black Hills Resilient Landscape Project update; and

(6) Mountain pine beetle brood survey report.

The meeting is open to the public. If time allows, the public may make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing by December 26, 2017, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Board may file written statements with the Board's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Scott Jacobson, Black Hills National Forest Supervisor's Office, 1019 North Fifth Street, Custer, South Dakota 57730; by email to [email protected], or via facsimile to 605-673-9208.

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

The American Community Survey (ACS) collects detailed socioeconomic data from about 3.5 million addresses in the United States and 36,000 in Puerto Rico each year. The ACS also collects detailed socioeconomic data from about 195,000 residents living in Group Quarters (GQ) facilities. Resulting tabulations from this data collection are provided on a yearly basis. The ACS allows the Census Bureau to provide timely and relevant housing and socioeconomic statistics, even for small geographies.

An ongoing data collection effort with an annual sample of this magnitude requires that the ACS continue research, testing, and evaluations aimed at improving data quality, achieving survey cost efficiencies, and improving ACS questionnaire content and related data collection materials. The ACS Methods Panel is a research program designed to address and respond to survey issues and needs. From 2018 to 2021, the ACS Methods Panel may include testing methods for increasing survey efficiencies, reducing survey cost, lessening respondent burden, improving response rates, and improving data quality.

At this time, plans are in place to propose several tests: Self-response mail messaging tests, a respondent burden field test, testing the use of administrative data, GQ testing, and two content tests. Since the ACS Methods Panel is designed to address emerging issues, we may conduct additional testing as needed. Any additional testing would focus on methods for reducing data collection costs, improving data quality, improving the respondent experience, revising content, or testing new questions that have an urgent need to be included on the ACS.

In response to declining response rates and increasing costs, the Census Bureau plans to study methods to increase self-response, the least expensive mode of data collection. The Census Bureau currently sends up to five mailings to a sampled address to inform the occupants that their address has been selected and to encourage them to respond to the ACS. The proposed tests would include changes to messages included in the mailings to motivate the public to respond to the ACS. The proposed tests would also include modifications to the materials, including the mailing type (for example, sending letters versus postcards). Changes to the number of mailings or the timing of the mailings may be explored. The Census Bureau is also considering testing automated phone reminders.

In 2014, the ACS conducted a comprehensive content review to ensure that only the information needed is requested and that the justifications provided by federal agencies for the ACS questions are current and valid (Chappell and Obenski, 2014). The Census Bureau takes very seriously respondent burden and concerns and recognizes that the content review process was only an initial step to addressing them. The Census Bureau has worked hard to identify a range of possibilities for reducing perceived respondent burden while still maintaining the irreplaceable quality and richness of ACS data (Hughes et al., 2015, Griffin and Hughes, 2013, Hughes et al., 2016, Heimel et al., 2016, Oliver et al., 2016). In a workshop held in 2016, the National Academies of Science Committee on National Statistics recommended identifying a way to quantify or measure respondent burden (National Academies of Sciences, Engineering, and Medicine, 2016). The Census Bureau has begun work to understand respondents' experience responding to the ACS through focus groups and cognitive testing. The next step for this work is to conduct a field test, implementing questions to measure respondent burden.

The Census Bureau has made significant progress exploring the use of administrative data in surveys and censuses, potentially as a substitute for questions asked of respondents. Administrative data refer to data collected by government agencies for the purposes of administering programs or providing services. The Census Bureau has evaluated the availability and suitability of several different data sources for use in the ACS on telephone service, the year a residence was built, condominium status, income, residence one year ago, and self-employment income. We are currently exploring administrative data use for property values, property taxes, and acreage. Additionally, we plan to evaluate the quality, coverage, and feasibility of using administrative records in lieu of enumeration for institutional GQs (U.S. Census Bureau, 2017). In addition to replacing questions on the survey, administrative data may be used to reduce burden of existing questions by allowing for modification of the questions. For example, the ACS currently asks respondents to provide their total income for the past 12 months as well as income received from various sources (for example, wages, interest, retirement income). We are currently cognitively testing modifications to the income questions, including changing the reference year from the past 12 months to the previous calendar year, as well as only asking respondents if income was received from various sources rather than the amount. As a continuation of this research, the Census Bureau proposes a field test of revised content, for income as well as other topics both for the housing unit questionnaire as well as the GQ questionnaire. Some questions may be modified while others would be removed.

The ACS samples about 18,000 GQ facilities each year. A GQ is a place where people live or stay, in a group living arrangement, which is owned or managed by an entity or organization providing housing and/or services for the residents. There are two categories of GQs: Institutional and non-institutional. Institutional GQs include places such as correctional facilities and nursing homes. Non-institutional GQs include college housing, military barracks, and residential treatment centers. Most interviews conducted in GQs are interviewer-administered (over 90 percent of interviews in institutional GQs and just under 75 percent in non-institutional GQs), but some GQ respondents self-respond using a paper questionnaire. The Census Scientific Advisory Committee Working Group on Group Quarters in the ACS recommended that the Census Bureau consider making an “internet version of the ACS available to non-institutional GQ residents, especially in college dorms, military barracks, and group homes” (National Academies of Sciences, Engineering, and Medicine, 2016). Additional support was identified for this in a workshop held in 2016 with the National Academies of Science Committee on National Statistics. The Census Bureau proposes a field test of an internet self-response GQ form for residents in non-institutional GQs.

Working through the Office of Management and Budget (OMB) Interagency Committee for the ACS, the Census Bureau will solicit proposals from other Federal agencies to change existing questions or add new questions to the ACS. The Census Bureau proposes testing any new or revised questions in one of two content tests. A content test using all modes of data collection will be conducted in 2021. Conducting a self-response only content test prior to 2021 allows the Census Bureau to be more agile in reacting to changes in society and legislation. The objective of both content tests is to determine the impact of changing question wording and response categories, as well as redefining underlying constructs, on the quality of the data collected. The Census Bureau proposes to evaluate changes to current questions by comparing the revised questions to the current ACS questions. For new questions, the Census Bureau proposes to compare the performance of two versions of any new questions and benchmark results to other well-known sources of such information.

Self-Response Mail Messaging Tests—We will use the same self-response modes we offer in ACS production data collection, that is, internet and a mail-back paper questionnaire. No interviewer-administered interviews are necessary for these tests. Different strategies to encourage self-response may be used, including changes to the number and timing of the mailings, the messages and materials included in each mailing, as well as automated telephone reminders. Testing is usually conducted with split-sample experiments, using current ACS production materials as the control. The Census Bureau expects to conduct up to four self-response mail messaging tests each year.

Respondent Burden Field Test—The Census Bureau proposes adding several optional questions about the respondent's perception of burden at the end of the ACS interview. The questions would allow respondents the opportunity to give feedback after completing the ACS and are intended to measure the burden of the survey, including the contacts we made to reach the respondent, the time it took to complete the survey, and how difficult and sensitive it was for the respondent to answer the questions. The questions would be asked of respondents across all modes of data collection: Internet, paper questionnaires, and interviewer-administered.

Testing the Use of Administrative Data in Housing Units (HUs) and GQs—We will test replacing or substituting all or parts of the ACS with administrative data, which could make it possible to remove or modify the existing questions on the questionnaire. Respondents could be presented with a new version of the questionnaire with some questions not asked and others modified, as compared to production ACS. Evidence suggests that respondents who respond to the ACS using different modes of data collection (internet, paper questionnaire, and interviewer-administered) have different socioeconomic characteristics. Therefore, this test will include all modes of data collection. This test would include respondents in both HUs and GQs.

Group Quarters Test—A sample of GQ respondents will be given the option of completing the survey via self-response using an internet instrument. We would evaluate the quality of the data received from the internet compared to traditional data collection methods for GQs (paper questionnaires and interviewer-administered) as well as assess operational issues with offering the internet option, including feedback from interviewers.

Content Tests—The self-response content test will include internet and paper-questionnaires for data collection. Additionally, assistance over the phone will be offered to respondents, which can result in an interview being conducted. These interviews are considered self-response in the ACS. The test will be a split-sample experiment with some respondents assigned to receive current production ACS content and some respondents assigned to receive new and revised content. Additionally, a follow-up reinterview may be conducted with all households who responded to measure response burden as well as response bias or response variance. Comparisons will be made between the experimental treatments to determine whether the new or revised content produces better data quality and/or reduces respondent burden. The 2021 ACS Content Test will be similar to the self-response content test in that it will be a split-sample experiment with a follow-up reinterview. However, this test will include all modes of data collection (internet, mail, and interviewer-administered).

OMB Control Number: 0607-0936.

Form Number(s): ACS-1, ACS-1(GQ), ACS-1(PR)SP, ACS CAPI(HU) and ACS RI(HU).

Type of Review: Regular submission.

Affected Public: Individuals and households.

Estimated Number of Respondents:

Self-Response Mail Messaging Tests—We estimate that each of the self-response mail messaging tests will include 60,000 respondents. We anticipate there will be up to 14 tests across the 3-year period.

Respondent Burden Field Test—100,000.

Testing the Use of Administrative Data—100,000.

Self-Response Content Test—100,000 respondents plus 63,000 respondents in the follow-up reinterview.

2021 ACS Content Test—100,000 respondents plus 83,000 respondents in the follow-up reinterview.

Estimated Time per Response:

Self-Response Mail Messaging Tests—40 minutes.

Respondent Burden Field Test—50 minutes (10 minutes for the optional follow-up questions).

Testing the Use of Administrative Data in HUs and GQs—40 minutes.

Group Quarters Test—40 minutes (includes both the interview with the facility manager and the interview itself).

Self-Response Content Test—40 minutes for the initial interview plus 20 minutes for the follow-up reinterview.

2021 ACS Content Test—40 minutes for the initial interview plus 20 minutes for the follow-up reinterview.

Estimated Total Annual Burden Hours: 297,445.

Estimated Total Annual Cost to Public: Except for their time, there is no cost to respondents.

Respondent's Obligation: Mandatory.

Legal Authority: Title 13 U.S.C. Sections 141 and 193.

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

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

On July 3, 2017, the Department published in the Federal Register a notice of opportunity to request an administrative review of the CVD order on steel nails from Vietnam for the period January 1, 2016, to December 31, 2016.1 On July 31, 2017, the Department received a timely request, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), from Mid Continent Steel & Wire Inc. (the petitioner) to conduct an administrative review of this CVD order with respect to 14 companies.2 Based upon this request, on September 13, 2017, in accordance with section 751(a) of the Act, the Department published in the Federal Register a notice of initiation of administrative review for this CVD order.3 On September 28, 2017, the petitioner timely withdrew its request for an administrative review for each of the 14 companies.4

Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if a party who requested the review withdraws the request within 90 days of the date of publication of the notice of initiation of the requested review. As noted above, the petitioner withdrew its request for review by the 90-day deadline. No other party requested an administrative review. Accordingly, we are rescinding the administrative review of the CVD order on steel nails from Vietnam covering the period January 1, 2016, to December 31, 2016.

The Department will instruct U.S. Customs and Border Protection (CBP) to assess CVDs on all appropriate entries at a rate equal to the cash deposit of estimated CVDs required at the time of entry, or withdrawal from warehouse, for consumption, during the period January 1, 2016, to December 31, 2016, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice in the Federal Register.

This notice serves as the only reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the presumption that reimbursement of the countervailing duties occurred and the subsequent assessment of doubled countervailing duties.

This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under an APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction. This notice is issued and published in accordance with sections 751 of the Act and 19 CFR 351.213(d)(4).

Background: The International Trade Administration (ITA) is the premier resource for American companies competing in the global marketplace. ITA has more than 2,200 employees assisting U.S. exporters in more than 100 U.S. cities and 75 markets worldwide. For more information on ITA visit www.trade.gov. Additional information about ITA's standards activities is available at http://www.trade.gov/td/standards/index.html.

Request for Input: ITA is currently reviewing its trade-related standards services and programs in support of U.S. stakeholders to ensure that the services and assistance provided best meet the needs of U.S. stakeholders and support the expansion of the U.S. economy and creation of U.S. jobs. Trade-related standards work includes work related to the adoption and recognition of standards; standards dialogues and other bilateral and regional engagements with trading partners; preparation of standards information in ITA publications such as Top Market reports and Country Commercial Guides; and work to address adoption, implementation, and enforcement of technical regulations and conformity assessment procedures inconsistent with World Trade Organization and free trade agreement obligations. ITA is specifically seeking information on trade-related standards trends in foreign markets, the challenges U.S. exporters are encountering in those markets, and the assistance needed from the U.S. Government, and specifically ITA, to address those challenges and take advantage of export opportunities. ITA will use this input in reviewing how to improve ITA standards-related services and programs to best meet the needs of U.S. stakeholders, including during an internal summit of ITA staff working on trade-related standards issues on March 6-7, 2018 in Washington, DC.

Comments submitted may include information about key standards trends affecting the global competitiveness of U.S. industry; stakeholder experiences, if any, with ITA services that aid stakeholders in understanding and acting on standards-related trade and regulatory issues; and suggestions for improving ITA services in the standards area. Respondents do not need to have detailed knowledge of or experience with ITA standards-related services, but those that do may note this in their submissions.

Submitting Comments Using http://www.regulations.gov: To find the correct docket, enter ITA-2017-0007 in the “Enter Keyword or ID” window at the http://www.regulations.gov home page and click “Search.” The site will provide a search-results page listing all documents associated with the docket number. Find a reference to this notice by selecting “Notice” under “Document Type” on the search-results page, and click on the link entitled “Comment now!” The http://www.regulations.gov Web site provides the option of making submissions by filling in a comment field, or by attaching a document. ITA prefers submissions to be provided in an attached document. (For further information on using http://www.regulations.gov, please consult the resources provided on the Web site by clicking on the “Help” tab.)

Do not include any privileged or confidential business information in comments submitted. The file name should begin with the character “P” (signifying that the comments contain no privileged or confidential business information and can be posted publicly), followed by the name of the person or entity submitting the comments. Written submissions should include an original and five (5) copies.

Please do not attach separate cover letters to electronic submissions; rather, include any information that might appear in a cover letter in the comments themselves. Similarly, to the extent possible, please include any exhibits, annexes, or other attachments in the same file as the submission itself, not as separate files.

Opportunity to present during the ITA Internal Summit: The Summit will convene ITA staff from headquarters and the domestic and foreign fields to develop recommendations for improving standards-related services and programs for ITA stakeholders. It will include “open sessions” with private sector stakeholders where they may share their priorities and recommendations for ITA's work on trade-related standards issues. To accommodate as many stakeholders as possible, the time per stakeholder will be limited. Stakeholders interested in presenting during a summit open session must apply by December 18, 2017, identifying the name and address of the proposed speaker and including a brief description of the stakeholder interest and intended remarks. Stakeholders are limited to one presenter per company or organization.

In seeking private sector presenters, ITA will consider factors such as: (1) Frequency and type of standards-related trade barriers experienced with the goal of selecting presenters with significant experience working to overcome standards-related barriers in foreign markets, and whose experience represents the spectrum of such barriers experienced by U.S. exporters (e.g., challenges with standards development, testing and conformity assessment, and meeting standards-related regulatory requirements in foreign markets); and (2) balance of industries and roles with the goal of selecting presenters that represent a mix of industries affected by standards-related trade barriers, and who are conversant on issues affecting U.S. stakeholders/exporters (standards development, conformity assessment, and technical regulations).

Background

On August 5, 2008, the Department published the antidumping duty order on LWRPT from Mexico.1 On July 31, 2017, Perfiles y Herrajes informed the Department that, effective July 11, 2017, it had changed its name to ” Perfiles LM, S.A. de C.V.,” (i.e., Perfiles) and requested that the Department conduct a CCR under 19 CFR 351.216(b) to determine that Perfiles is the successor-in-interest to Perfiles y Herrajes for purposes of determining Perfiles' antidumping duty cash deposits and liabilities.2

On August 17, 2017, the Department declined to initiate the CCR that Perfiles y Herrajes requested, citing the need for additional information pertaining to any changes in management, production facilities, customers, and suppliers.3 Therefore, the Department issued Perfiles y Herrajes a questionnaire. On October 2, 2017, Perfiles y Herrajes filed its response, in which it provided additional information to support its request.4 We have received no comments from any other interested party.

The merchandise subject to this order is certain welded carbon-quality light-walled steel pipe and tube, of rectangular (including square) cross section, having a wall thickness of less than 4 mm.

The term carbon-quality steel includes both carbon steel and alloy steel which contains only small amounts of alloying elements. Specifically, the term carbon-quality includes products in which none of the elements listed below exceeds the quantity by weight respectively indicated: 1.80 percent of manganese, or 2.25 percent of silicon, or 1.00 percent of copper, or 0.50 percent of aluminum, or 1.25 percent of chromium, or 0.30 percent of cobalt, or 0.40 percent of lead, or 1.25 percent of nickel, or 0.30 percent of tungsten, or 0.10 percent of molybdenum, or 0.10 percent of niobium, or 0.15 percent vanadium, or 0.15 percent of zirconium.

The description of carbon-quality is intended to identify carbon-quality products within the scope. The welded carbon-quality rectangular pipe and tube subject to this order is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7306.61.50.00 and 7306.61.70.60. While HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of this order is dispositive.5

Background

On August 9, 2017, the Department published the Preliminary Results and gave interested parties an opportunity to comment.1 The Department received no comments. The Department conducted this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act).

The merchandise subject to the order is steel wire garment hangers, fabricated from carbon steel wire, whether or not galvanized or painted, whether or not coated with latex or epoxy or similar gripping materials, and/or whether or not fashioned with paper covers or capes (with or without printing) and/or nonslip features such as saddles or tubes. These products may also be referred to by a commercial designation, such as shirt, suit, strut, caped, or latex (industrial) hangers. Specifically excluded from the scope of the order are wooden, plastic, and other garment hangers that are not made of steel wire. Also excluded from the scope of the order are chrome-plated steel wire garment hangers with a diameter of 3.4 mm or greater. The products subject to the order are currently classified under HTSUS subheadings 7326.20.0020, 7323.99.9060, and 7323.99.9080.

Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise is dispositive.

In the Preliminary Results, the Department determined the following: (1) Shanghai Wells sold merchandise at prices below normal value; and (2) Yingqing is not eligible for a separate rate and, therefore, is a part of the PRC-wide entity.2 We have not received information contradicting our preliminary finding; thus, the Department finds there is no reason to modify its analysis. Accordingly, no decision memorandum accompanies this Federal Register notice. For further details of the issues addressed in this proceeding, see the Preliminary Results. 3

The Department's policy regarding the conditional review of the PRC-wide entity applies to this administrative review.4 Under this policy, the PRC-wide entity will not be under review unless a party specifically requests, or the Department self-initiates, a review of the entity. Because no party requested a review of the PRC-wide entity in this review, the entity is not under review and the entity's rate is not subject to change (i.e., 187.25 percent).5

The Department conducted this review in accordance with section 751(a)(1)(B) of the Act. In the Preliminary Results, the Department calculated constructed export prices and export prices in accordance with section 772 of the Act. Because the PRC is a nonmarket economy (NME) within the meaning of section 771(18) of the Act, normal value is calculated in accordance with section 773(c) of the Act. We have not received any information since the issuance of the Preliminary Results that provides a basis for reconsidering this determination. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum, available at http://enforcement.trade.gov/frn/.

The Department determines that the following weighted-average dumping margin exists for the POR from October 1, 2015, through September 30, 2016:

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), the Department has determined, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. The Department intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review.

The Department applied the assessment rate calculation method adopted in Final Modification for Reviews, i.e., on the basis of monthly average-to-average comparisons using only the transactions associated with that importer with offsets being provided for non-dumped comparisons.7 Pursuant to the Department's NME practice, for sales that were not reported in the U.S. sales data submitted by companies individually examined during this review, the Department instructs CBP to liquidate entries associated with those sales at the rate for the PRC-wide entity.8

The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) For the company listed above, Shanghai Wells, the cash deposit rate will be that established in the final results of this review (except, if the rate is zero or de minimis, then zero cash deposit will be required); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recently completed segment of this proceeding in which they were reviewed; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be equal to the weighted-average dumping margin for the PRC-wide entity (i.e., 187.25 percent); and (4) for all non-PRC exporters of subject merchandise which have not received their own separate rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) that supplied that non-PRC exporter. These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

This notice of the final results of this administrative review is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5) and 19 CFR 351.213(h).

Background

As stated above, on July 19, 2017, the Department published the Preliminary Results 1 of the AR of the antidumping duty order on narrow woven ribbon with woven selvedge from the PRC covering the period September 1, 2015, through August 31, 2016, and invited parties to comment on these preliminary results. No parties submitted comments on the Preliminary Results.

The products covered by the Order are narrow woven ribbons with woven selvedge. The merchandise subject to the Order is classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 5806.32.1020; 5806.32.1030; 5806.32.1050; and 5806.32.1060. Subject merchandise also may enter under HTSUS subheadings 5806.31.00; 5806.32.20; 5806.39.20;5806.39.30; 5808.90.00; 5810.91.00; 5810.99.90; 5903.90.10; 5903.90.25; 5907.00.60l and 5907.00.80 and under statistical categories 5806.32.1080; 5810.92.9080; 5903.90.3090; and 6307.90.9889. Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description in the Order remains dispositive.2

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.

The meeting is 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.

Public comment: Written comments may be directed to Gregg Waugh, Executive Director, South Atlantic Fishery Management Council (see ADDRESSES) or electronically via the Council's Web site at http://safmc.net/safmc-meetings/council-meetings/. The public comment form is open for use when the briefing book is posted to the Web site on the Friday, two weeks prior to the Council meeting (11/17/17). Comments received by close of business the Monday before the meeting 11/27/17) will be compiled, posted to the Web site as part of the meeting materials, and included in the administrative record; please use the Council's online form available from the Web site. For written comments received after the Monday before the meeting (after 11/27/17), individuals submitting a comment must use the Council's online form available from the Web site. Comments will automatically be posted to the Web site and available for Council consideration. Comments received prior to noon on Thursday, December 7, 2017 will be a part of the meeting administrative record.

The items of discussion in the individual meeting agendas are as follows:

1. The Personnel Committee will meet in Closed Session to discuss personnel issues and provide recommendations for Council consideration.

1. The Committee will receive a report from the Habitat Protection and Ecosystem-Based Management Advisory Panel.

2. The Committee will review and approve the Implementation Plan for the Fishery Ecosystem-Based Management Plan (FEP II), review and approve the Road Map for the FEP II, review the Dashboard and Tools for the FEP II, receive an update on the Conservation Blueprint 2.2, and provide guidance.

3. The Committee will receive updates on other Habitat-related issues and provide recommendations as appropriate.

1. The Council will meet as a Committee of the Whole to discuss the ABC Control Rule Amendment currently under development and provide guidance to staff.

1. The Committee will receive an update on the status of 2016/17 catches versus the annual catch limit (ACLs), and review draft options for Spiny Lobster Amendment 13 addressing bullynets and measures recommended by the Florida Fish and Wildlife Conservation Commission (FWC), and provide recommendations as appropriate.

1. The Committee will address policy on the Citizen Science Advisory Panel Pool and Action Team appointments and approve for recommendation to Council.

2. The Committee will receive reports from the Citizen Science Action Teams, discuss items brought forward by the Action Teams, and provide guidance to staff as appropriate.

3. The Committee will receive an update on the Citizen Science Program partnerships and Pilot Project and provide guidance to staff as needed.

1. The Committee will receive status reports on the For-Hire Electronic Reporting Amendment, and the Council's Data Collection Pilot Project and Outreach Plan relative to For-Hire Electronic Reporting. The Committee will provide guidance to staff as necessary.

1. The Council will receive an update on the red snapper mini-season, and hold a workshop on recreational reporting with presentations on electronic reporting for big game, the iSnapper voluntary reporting program, Tails'n'Scales mandatory reporting program, and state involvement in reporting for the Marine Recreational Informational Reporting Program (MRIP). Discussion of these programs will be held as part of the workshop.

1. The Committee will receive updates from NOAA Fisheries on commercial and recreational catches versus quotas for species under ACLs and the status of amendments under formal Secretarial review.

2. The Committee will receive a Report from the Snapper Grouper Advisory Panel.

3. The Committee will receive an overview of draft Amendment 46 addressing measures for red snapper, review options, and provide guidance to staff.

4. The Committee will receive an overview Vision Blueprint Regulatory Amendment 26 addressing recreational management actions and alternatives as identified in the 2016-2020 Vision Blueprint for the Snapper Grouper Fishery Management Plan. The Committee will review the revised actions and alternatives, updated analyses, and purpose and need. The Committee will modify the document as necessary and provide guidance to staff.

5. The Committee will review Vision Blueprint Regulatory Amendment 27 addressing commercial management actions and alternatives, as identified in the 2016-2020 Vision Blueprint for the Snapper Grouper Fishery. The Committee will review recommendations from the Scientific and Statistical Committee (SSC), review revised actions and alternatives, updated analyses, and the purpose and need, modify the document as necessary, and provide guidance to staff.

6. The Committee will receive presentations from NOAA Fisheries on proposed Exempted Fishing Permits for lionfish and provide recommendations as appropriate.

7. The Committee will receive an overview on options for draft Amendment 38 addressing management measures for blueline tilefish, receive a presentation on the benchmark stock assessment (SEDAR 50), review fishing level recommendations from the SSC, modify the amendment as necessary, and provide guidance to staff.

8. The Committee will receive an overview of options for the draft For-Hire Moratorium Amendment, discuss and provide guidance to staff.

9. The Committee will receive SSC fishing level recommendations for red grouper, review management options, and approve the abbreviated framework document for formal Secretarial Review.

10. The Committee will receive an overview from staff on golden tilefish management, review recommendations from the SSC, and provide guidance to staff.

11. The Committee will receive an update on the Wreckfish Individual Transferable Quota (ITQ) review and provide guidance to staff.

12. The Committee will receive an overview of management issues relative to yellowtail snapper, review a response from the Gulf of Mexico Fishery Management Council on a potential joint amendment to examine jurisdictional annual catch limits, and provide guidance to staff.

Formal Public Comment, Wednesday, December 6, 2017, 4:30 p.m.—Public comment will be accepted on items on the Council agenda. The Council is also accepting public comment on Executive Order 13771 (2 for 1 regulations) to identify regulations that are (1) outdated, (2) unnecessary, or (3) ineffective. The Council Chair, based on the number of individuals wishing to comment, will determine the amount of time provided to each commenter.

(Closed Session)

1. The Committee will make recommendations for appointments to the Cobia Stock Identification Workshop and for appointments to stock assessments for greater amberjack and red porgy.

(Open Session)

2. The Committee will receive a report from the SSC.

3. The Committee will review Terms of Reference and schedules for greater amberjack and red porgy stock assessments and provide recommendations as appropriate.

4. The Committee will review the SEDAR Steering Committee Report, discuss, and provide guidance as appropriate.

1. The Committee will receive an update on commercial and recreational catches versus quotas for species managed under ACLs and an update on the status of amendments currently under Secretarial review.

2. The Committee will receive an update on development of the Interstate Atlantic Cobia Management Plan from the Atlantic States Marine Fisheries Commission (ASMFC).

3. The Committee will receive an update on the status of a request for recalculation of the 2015 and 2016 recreational landings for Atlantic cobia.

4. The Committee will receive an overview of Coastal Migratory Pelagics Framework Amendment 6 addressing Atlantic king mackerel trip limits, discuss, and provide recommendations for approval for public scoping.

5. The Committee will receive an overview Coastal Migratory Pelagics Amendment 31 addressing proposed management measures for Atlantic cobia, discuss, and provide recommendations for approval for public hearings.

1. The Committee will receive a report from the Information and Education Advisory Panel, discuss and provide recommendations to staff as appropriate.

1. The Committee will review policies for inclusion in the SOPPs and/or Council Handbook, discuss and provide direction to staff as appropriate.

1. The Committee will receive an overview of the current Magnuson-Stevens Reauthorization efforts, discuss and provide guidance and approval as needed.

2. The Committee receive an update on the current budget status and outlook, discuss and provide guidance as needed.

3. The Committee will receive an overview on materials available for Council meetings, discuss, and provide guidance to staff.

5. The Committee will receive an overview of the System Management Plan Advisory Panel, discuss and provide additional guidance as needed.

The Full Council will begin with the Call to Order, adoption of the agenda, announcements and introductions, and presentations.

The Council will receive a Legal Briefing on Litigation from NOAA General Counsel (if needed) during Closed Session. The Council will receive the Executive Director's Report and an update on results from the Northeast Regional Coordinating Council meeting in November. Updates will be provided by NOAA Fisheries including a discussion with Dr. Francisco “Cisco” Werner, Chief Science Advisor and Director of Scientific Programs, reports on the status of commercial and recreational catches versus ACLs for species not covered during an earlier committee meeting, status of Recreational and Commercial Quota Monitoring Tables on the NOAA Fisheries' Southeast Regional Office Web site, a turtle release presentation, and discussion of other issues as necessary. The Council will also receive an update on the status of Bycatch Collection Programs and the pending voluntary commercial electronic logbook reporting effort from NOAA Fisheries' Southeast Fisheries Science Center. The Council will review any Exempted Fishing Permits received by NOAA Fisheries as necessary. The Council will receive Committee reports from the Snapper Grouper, Mackerel Cobia, Spiny Lobster, SEDAR, Data Collection, Habitat and Ecosystem-Based Management, Information and Education, Citizen Science, SOPPs, and Executive Finance Committees; a report from the Committee of the Whole (ABC Control Rule); a report from the Recreational Reporting Workshop; review recommendations; and take action as appropriate.

The Council will receive agency and liaison reports; and discuss other business and upcoming meetings.

Documents regarding these issues are available from the Council office (see ADDRESSES).

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 this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

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

Agenda Tuesday, December 5, 2017

After introductions and brief announcements, the meeting will begin with reports from the Council Chairman and Executive Director, NMFS's Regional Administrator for the Greater Atlantic Regional Fisheries Office (GARFO), liaisons from the Northeast Fisheries Science Center (NEFSC) and Mid-Atlantic Fishery Management Council, representatives from NOAA General Counsel and the Office of Law Enforcement, and staff from the Atlantic States Marine Fisheries Commission (ASMFC) and U.S. Coast Guard. Next, the Council will receive a short briefing from the Northeast Regional Ocean Council on upgrades to the Northeast Ocean Data Portal. The Skate Committee will report next with a final item related to Framework Adjustment 5 to the Northeast Skate Complex Fishery Management Plan (FMP). The Council addressed most of the framework components during its September meeting. During this December meeting, the Council will: (1) Consider options to exempt vessels from skate regulations when fishing exclusively within the Northwest Atlantic Fisheries Organization (NAFO) Regulatory Area; and (2) take final action on the entire framework. Then, ASMFC will brief the Council on the Commission's Draft Addendum XXVI to the Interstate Fishery Management Plan for American Lobster and Addendum III to the Jonah Crab plan. The Council will discuss data collection needs for these fisheries. The Habitat Committee then will provide a short progress report on the Council's Coral Amendment and Clam Dredge Framework, which will be followed by a Bureau of Ocean Energy Management overview of proposed and ongoing offshore wind energy projects in the Northeast.

After the lunch break, GARFO will provide a presentation on the North Atlantic Right Whale Five-Year Review and the reinitiation of formal consultation due to new information on the changed status of right whales. Next, the Atlantic Herring Committee will report on Draft Amendment 8 to the Atlantic Herring FMP. The Council will select preferred alternatives for localized depletion and user conflicts for the amendment and then approve the document for public hearing. The Council debated acceptable biological catch (ABC) control rule alternatives—the other major component of Amendment 8—during its September meeting. The Council also will approve 2019-2021 research priorities for the Atlantic Herring Research Set-Aside Program. Following these actions, the Council will adjourn for the day.

The second day of the meeting will begin with a report from the Northeast Fisheries Science Center on the results of the 2017 operational assessments for 19 of the 20 groundfish stocks managed under the Council's Northeast Multispecies FMP. The Scientific and Statistical Committee (SSC) will report next with overfishing limits (OFLs) and ABCs for the following stocks and fishing years (FY): Atlantic sea scallops for FY 2018 with defaults for FY 2019; northern and southern silver hake and red hake for FY 2018-2020; and all groundfish stocks for 2018-2020 except Georges Bank yellowtail flounder and Atlantic halibut. The Council then will begin its Groundfish Committee report, during which it will take final action on Framework Adjustment 57 to the Northeast Multispecies FMP. The framework includes: (1) 2018-2020 fishery specifications and other management measures; (2) 2018 TACs for U.S./Canada stocks of Eastern Georges Bank cod, Eastern Georges Bank haddock, and Georges Bank yellowtail flounder; (3) Atlantic halibut accountability measures (AMs); (4) recreational management measures; (5) common pool trimester TAC adjustments; (6) southern windowpane flounder AMs; and (7) potential consideration of a Georges Bank cod sub-annual catch limit for the recreational fishery. Also under groundfish, the Council may consider requesting emergency action to reduce catches of Georges Bank cod by implementing additional measures for the recreational fishery.

Following a lunch break, members of the public will have the opportunity to speak during an open comment period on issues that relate to Council business but are not included on the published agenda for this meeting. The Council asks the public to limit remarks to 3-5 minutes. Then, the Groundfish Committee report will resume and continue until related business is concluded. The Council next will discuss its plan to provide input to NMFS on regulatory reform as mandated by Executive Orders 13777, 13771, and 13565. At the conclusion of this discussion, the Council will adjourn for the day.

The third day of the meeting will begin with a discussion of and final action on 2018 Council priorities covering tasks and actions for all committees. Next, the Council will hear from its Scallop Committee and take final action on Framework Adjustment 29 to the Atlantic Sea Scallop FMP. This framework contains: (1) Fishery specifications for the 2018 fishing year and default specifications for 2019; (2) scallop fishery AMs for yellowtail flounder and windowpane flounder; (3) Northern Gulf of Maine Management Area modifications; and (4) measures to modify and/or create access area and open area boundaries consistent with potential changes to habitat and groundfish closed areas under the Council's Omnibus Essential Fish Habitat Amendment 2.

Following a lunch break, the Scallop Committee discussion will continue until business is concluded. The Whiting Committee will report next. The Council will take final action on 2018-2020 specifications for small-mesh multispecies, which include red, silver, and offshore hakes, and then will deliberate Amendment 22 to the Northeast Multispecies FMP, which was developed to consider limiting access to the small-mesh multispecies fishery. The Council will: (1) Consider whether to pursue or drop consideration of triggered possession limit adjustments in the amendment; and (2) approve the draft amendment for public hearing. Next, the Council will take up spiny dogfish to review the previously set 2018 specifications for the fishery and discuss whether to recommend modifications. Finally, the Council will close out the meeting with “other business.”

Although non-emergency issues not contained on this agenda may come before the Council for discussion, those issues may not be the subject of formal action during this meeting. 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 Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

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 (see ADDRESSES) at least 5 days prior to the meeting date.

Agenda

The Scallop Committee will review Framework 29 (FW 29) alternatives and analyses, and make final recommendations. FW 29 will set specifications including acceptable biological catch/annual catch limit (ABC/ACLs), Days at Sea (DAS), access area allocations for Limited Access (LA) and Limited Access General Category (LAGC), Total Allowable Catch (TAC) for Northern Gulf of Maine (NGOM) management area, target-TAC for LAGC incidental catch and set-asides for the observer and research programs for fishing year 2018 and default specifications for fishing year 2019. Make final recommendations for potential FW 29 specifications that includes areas that may open through Omnibus Habitat Amendment 2 (OHA2). The committee will also review FW 29 management measures and make final recommendations. These measures may include, but are not limited to: (1) NGOM management measures; (2) Flatfish accountability measures for Northern windowpane flounder, Georges Bank yellowtail flounder, and Southern New England yellowtail flounder; (3) Measures to modify and/or create access area and open area boundaries, consistent with potential changes to habitat and groundfish closed areas; (4) measures to allocate unused CAI carryover pounds under certain scenarios of OHA2 approval. Other business may 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. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

—Call to Order —Adoption of Agenda —Overview Review outcomes from previous meeting —Review Acceptable Biological Catch (ABC) Control Rule Language Review suggestions from General Counsel and Southeast Fisheries Science Center (SEFSC) on text of Tier 4 of the control rule Develop language to define “consensus” as used in determining Tier assignments (or otherwise alter language to remove the term) —Action 2: Finalize establishment of stock/stock complexes for each of the Puerto Rico, St. Croix, St. Thomas/St. John Fishery Management Plans (FMPs) —Determine use of Indicator Species to recommend to the Council —Finalize recommendations on: —Criteria used to select indicator species —How indicator species will be used to determine management reference points for stock complexes —Action 3: Management Reference Points for Stocks/Stock complexes in each of the Puerto Rico, St. Thomas/St. John and St Croix FMPs Tiered ABC Control Rule: —Review and finalize Tier assignments (4a or 4b): Puerto Rico, St. Croix, St. Thomas/St. John —Define process for determining the scalars used in Tiered ABC Control Rule —Define process for determining the buffer from the overfishing limit (OFL) to ABC (scientific uncertainty buffer) used in the Tiered ABC Control Rule. —Choice of scalar and scientific uncertainty buffer for Tiers 4a and 4b for the applicable stocks. Stocks/stock complexes to which the Tiered ABC CR cannot be applied: —Recommendations on time series of landings data (year sequences) to establish reference points for the applicable stocks/stock complexes. —Recommendations on the establishment of the maximum sustainable yield proxy (e.g., mean, median, following the Caribbean Annual Catch Limit Amendments' approach) for the applicable stocks/stock complexes. —Recommendations on the scientific uncertainty buffer to determine the ABC for the applicable stocks/stock complexes. —Recommendations to the Caribbean Fishery Management Council —Other Business

The order of business may be adjusted as necessary to accommodate the completion of agenda items. The meeting will begin on December 4, 2017 at 9 a.m. Other than the start time, interested parties should be aware that discussions may start earlier or later than indicated. In addition, the meeting may be extended from, or completed prior to the date established in this notice.

These meetings are physically accessible to people with disabilities. For more information or request for sign language interpretation and other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone: (787) 766-5926, at least 5 days prior to the meeting date.

The Council will begin its plenary session at 8 a.m. in the Aleutian Room on Wednesday, December 6, continuing through Tuesday, December 12, 2017. The Scientific and Statistical Committee (SSC) will begin at 8 a.m. in the King Salmon/Iliamna Room on Monday, December 4 and continue through Wednesday, December 6, 2017. The Council's Advisory Panel (AP) will begin at 8 a.m. in the Dillingham/Katmai Room on Tuesday, December 5, and continue through Saturday, December 9, 2017. The Halibut Charter Management Committee will meet Monday, December 4, from 9 a.m. to 4 p.m. (Room TBD). The Legislative Committee will meet Tuesday, December 5, 2017, from 1 p.m. to 4 p.m. (Room TBD).

Council Plenary Session: The agenda for the Council's plenary session will include the following issues as well as an executive session. The Council may take appropriate action on any of the issues identified.

The Advisory Panel will address most of the same agenda issues as the Council.

The SSC agenda will include the following issues:

In addition to providing ongoing scientific advice for fishery management decisions, the SSC functions as the Council's primary peer review panel for scientific information as described by the Magnuson-Stevens Act section 302(g)(1)(e), and the National Standard 2 guidelines (78 FR 43066). The peer review process is also deemed to satisfy the requirements of the Information Quality Act, including the OMB Peer Review Bulletin guidelines.

The Agenda is subject to change, and the latest version will be posted at http://www.npfmc.org/.

Although other non-emergency issues not on the agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Actions 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 Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.

Agenda

The Advisory Panel will review Framework Adjustment 57/Specifications and Management Measures, review the draft alternatives under consideration, the Groundfish Plan Development Team's (PDT) impact analysis, and make recommendations on preferred alternatives to the Groundfish Committee. They will also disucss Amendment 23/Groundfish Monitoring and review an updated draft outline prepared by the PDT of the likely range of alternatives and make recommendations to the Committee. The Advisory Panel will also hold a discussion of possible groundfish priorities for 2018 and make recommendations to the Committee. They also plan to discuss several recent Executive Orders that have been issued about streamlining current regulations, and NOAA is seeking public input on the efficiency and effectiveness of current regulations and whether they can be improved. Discuss whether there are any regulations in the Northeast Multispecies fishery management plan that could be eliminated, improved, or streamlined. 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.

The purpose of the meeting is to review and approve the EAFM based risk assessment for the Mid-Atlantic fishery resources which has been under development since early 2017. The Committee will review the final list of elements and the evaluation of risk posed by each element as recommended by Council staff. The Committee will make recommendations to the full Council for consideration at its December meeting in Annapolis, MD.

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

The subject permit is requested under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

File No. 20590: The applicant (Dr. Phillips) is requesting authorization to import tissue samples from 5 species of listed sawfish including the smalltooth sawfish (Pristis pectinata), largetooth sawfish (P. pristis), green sawfish (P. zijsron), dwarf sawfish (P. clavata), and narrow sawfish (Anoxypristis cuspidate) to assess the impact of population decline through genetic diversity. This study will use tissue samples obtained opportunistically from saws with known location data held in museums, educational and private collections to: (1) Assess whether there has been a recent loss of genetic diversity in sawfishes globally, and (2) evaluate the long-term survival outlook for sawfishes. The applicant proposes to import tissue samples from up to a total of 500 sawfish specimens, from all species, annually from at least Mexico, Belize, United Arab Emirates, United Kingdom, and Australia to The University of Southern Mississippi for analysis. The requested duration of the permit is five years.

File No. 20610: The applicant (Dr. Portnoy) is requesting authorization to import scalloped hammerhead (Sphyrna lewini) tissue in the form of fin clips or small muscle biopsies from Belize (Central & SW Atlantic DPS, up to 50 samples), Trinidad (Central & SW Atlantic DPS, up to 50 samples), Mexico (Eastern Pacific DPS, up to 100 samples; NW Atlantic & GOM DPS, up to 50 samples), Cuba (Central & SW Atlantic DPS, up to 50 samples), and Sierra Leone (Eastern Atlantic DPS, up to 50 samples) for genetic analysis at Texas A&M University in Corpus Christi. These samples would be used as part of a larger project to characterize the stock structure of S. lewini populations within the western Atlantic, as well as between the western Pacific and Atlantic, using next generation sequencing techniques. Tissue samples would be from animals that have been previously collected, or will be taken opportunistically as scalloped hammerheads are encountered in fish markets. The requested duration of the permit is five years.

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

The Alaska Commercial Operator's Annual Report (COAR) is a report that collects harvest and production information broken out by specific criteria such as gear type, area, delivery and product type, and pounds and value. The COAR is due by April 1 of the year following any buying or processing activity.

Any person or company who received a Fisheries Business License from the Alaska Department of Revenue and an Intent to Operate Permit by Alaska Department of Fish and Game (ADF&G) is required to annually submit the COAR to the ADF&G, under Alaska Administrative Code (AAC), chapter 5 AAC 39.130. In addition, any person or company who receives an Exclusive Economic Zone (EEZ)-only permit from ADF&G annually must submit a COAR to ADF&G. Any owner of a catcher/processor or mothership with a Federal permit operating in the EEZ off Alaska is required to annually submit a COAR to ADF&G under 50 CFR 679.5(p).

The COAR contains data on seafood purchasing, production, ex-vessel values, and first wholesale values for seafood products. Containing information from shoreside processors, stationary floating processors, motherships, and catcher/processors, this data collection yields equivalent annual product value information for all respective processing sectors and provides a consistent time series according to which groundfish resources may be managed more efficiently. Use of the information generated by the COAR is coordinated between NMFS and the ADF&G.

The COAR is available in pdf and Microsoft Word formats on the ADF&G Web site at http://www.adfg.alaska.gov/index.cfm?adfg=fishlicense.coar. Respondents complete either a paper form or the fillable file available online and submit the form by mail to the ADF&G.

OMB Control Number: 0648-0428.

Form Number(s): None.

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

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 179.

Estimated Time per Response: 8 hr.

Estimated Total Annual Burden Hours: 1,432.

Estimated Total Annual Cost to Public: $716 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 Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Gainful Employment Programs—Subpart Q.

OMB Control Number: 1845-0123.

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

Respondents/Affected Public: Private Sector; Individuals or Households; State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 42,303,576.

Total Estimated Number of Annual Burden Hours: 3,777,952.

Abstract: The Student Assistance General Provisions regulations were amended by adding Subpart Q to Part 668, to establish measures for determining whether certain postsecondary educational programs lead to gainful employment in recognized occupations, and the conditions under which these educational programs remain eligible for student financial assistance programs authorized under Title IV of the Higher Education Act of 1965, as amended (HEA).

On June 16, 2017, the Department of Education (the Department) published a notice in the Federal Register announcing the intention to establish a negotiated rulemaking committee to revise the gainful employment regulations published on October 31, 2014. The Department anticipates scheduling the negotiated rulemaking sessions beginning in November or December 2017. There have been no changes to the regulations since the October 31, 2014 regulatory approval.

This clearance package includes §§ 668.405, 668.410, 668.411, 668.413, and 668.414. The burden related to § 668.412 was removed from this collection and applied to information collection 1845-0107 in February 2017 to more accurately associate the requirements of the regulations with the correct collection package.

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

Title of Collection: Gainful Employment Program—Subpart Q—Appeals for Debt to Earnings Rates.

OMB Control Number: 1845-0122.

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

Respondents/Affected Public: Private Sector; State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 792.

Total Estimated Number of Annual Burden Hours: 23,860.

Abstract: The Student Assistance General Provisions regulation was amended by adding Subpart Q to Part 668. This subpart applies to postsecondary educational programs that lead to gainful employment (GE) in recognized occupations. 1845-0122 pertains to § 668.406—Appeals for Debt to Earnings (D/E) rates. The regulations allow an institution to submit alternate earnings appeals to challenge the Secretary's determination of a GE program that is failing or in the zone based on the D/E rates calculated for a specific GE program.

On June 16, 2017, the Department of Education (the Department) published a notice in the Federal Register announcing the intention to establish a negotiated rulemaking committee to revise the gainful employment regulations published on October 31, 2014. The Department anticipates scheduling the negotiated rulemaking sessions beginning in November or December 2017.

The Department is requesting an extension without change of burden to the currently approved information collection as any new regulations will not be available before the expiration of this current package. There have been no changes to the regulations since the initial approval of the information collection on November 3, 2014.

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

Title of Collection: Gainful Employment Program—Subpart R—Cohort Default Rates.

OMB Control Number: 1845-0121.

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

Respondents/Affected Public: Private Sector; State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 1,559.

Total Estimated Number of Annual Burden Hours: 5,656.

Abstract: The Student Assistance General Provisions regulation was amended by adding Subpart R to 34 CFR part 668. Subpart R—Program Cohort Default Rates mirrors Subpart N—Cohort Default Rates where applicable. Subpart R established a programmatic cohort default rate (pCDR) for gainful employment (GE) programs, whereas Subpart N established an institutional cohort default rate (iCDR).

On June 16, 2017, the Department of Education (the Department) published a notice in the Federal Register announcing the intention to establish a negotiated rulemaking committee to revise the gainful employment regulations published on October 31, 2014. The Department anticipates scheduling the negotiated rulemaking sessions beginning in November or December 2017.

The Department is requesting an extension without change of burden to the currently approved information collection as any new regulations will not be finalized before the expiration of this current package. There have been no changes to the regulations since the initial collection approval.

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

Title of Collection: Freedom of Information Act (FOIA) Third Party Perjury Form.

OMB Control Number: 1880-0545.

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

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 62,000.

Total Estimated Number of Annual Burden Hours: 31,000.

Abstract: This collection is necessary to certify the identity of individuals requesting information under the Freedom of Information Act (FOIA) and Privacy Act (PA). This certification is required under 5 U.S.C. Section 552a(b). The form is used by Privacy Act requesters to obtain personal records via regular mail, fax or email. The department will use the information to help identify first-party or third party requesters with same or similar name when requesting retrieval of their own documents.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

Abstract: SmartWay is a voluntary program that focuses on increasing efficiency and lowering air pollution generated by goods movement that is open to organizations that own, operate, or contract with fleet operations, including truck, rail, barge, air and multi-modal carriers, logistics companies, and shippers. Organizations that do not operate fleets, but that are working to strengthen the freight industry, such as industry trade associations, state and local transportation agencies and environmental groups, also may join as SmartWay affiliates. All organizations that join SmartWay are asked to provide EPA with information as part of their SmartWay registration to annually benchmark their transportation-related operations and improve the environmental performance of their freight activities.

A company joins SmartWay when it completes and submits a SmartWay Excel-based tool (“reporting tool”) to EPA. The data outputs from the submitted tool are used by partners and SmartWay in several ways. First, the data provides confirmation that SmartWay partners are meeting established objectives in their Partnership Agreement. The reporting tool outputs enable EPA to assist SmartWay partners as appropriate, and to update them with environmental performance and technology information that empower them to improve their efficiency. This information also improves EPA's knowledge and understanding of the environmental and energy impacts associated with goods movement, and the effectiveness of both proven and emerging strategies to lessen those impacts.

In addition to requesting annual freight transportation-related data, EPA may ask its SmartWay partners for other kinds of information which could include opinions and test data on the effectiveness of new and emerging technology applications, sales volumes associated with SmartWay-recommended vehicle equipment and technologies, the reach and value of partnering with EPA through the SmartWay Partnership, and awareness of the SmartWay brand. In some instances, EPA might query other freight industry representatives (not just SmartWay partners), including trade and professional associations, nonprofit environmental groups, energy and community organizations, and universities, and a small sampling of the general public.

Form Numbers: None.

Respondents/affected entities: Private and public organizations that join SmartWay Transport Partnership; freight industry representatives who engage in activities related to the SmartWay Partnership; and representative samplings of consumers in the general public.

Respondent's obligation to respond: Voluntary.

Estimated number of respondents: 4,605.

Frequency of response: Once, on occasion and annually.

Total estimated burden: 13,224 hours.

Total estimated cost: $909,828, which includes no capital or operation and maintenance costs.

Changes in the Estimates: There is an increase of 1,720 hours in the total estimated respondent partner burden compared with the ICR currently approved by OMB. This increase reflects the following adjustments and program changes:

(1) Adjustments increase associated with increased interest in SmartWay, and thus, an increase in new annual respondents, as well as robust program retention practices, leading to increased number of existing respondent partners reporting annually, increase in the number of applications for the SmartWay Excellence Awards and the affiliate challenge annually;

(2) Program change increase associated with the new SmartWay Affiliate Program and new requirements under SmartWay Tractor and Trailer program; and,

(3) Adjustment decrease due to EPA's change in policy for submitting Awards materials electronically, rather than by mail.

Throughout this document, whenever “we,” “us,” or “our” is used, we mean the EPA.

Today's notice is simply an announcement of a finding that we have already made. The EPA sent a letter to CARB on October 19, 2017 stating that the motor vehicle emissions budgets in the submitted 2016 San Diego Ozone Plan for the RFP milestone year 2017 are adequate for transportation conformity purposes.1 We announced availability of the plan and related budgets on the EPA's transportation conformity Web site on July 20, 2017, requesting comments by August 21, 2017. We received no comments in response to the adequacy review posting. The finding is available at the EPA's conformity Web site: https://www.epa.gov/state-and-local-transportation/state-implementation-plans-sip-submissions-epa-has-found-adequate-or. The adequate motor vehicle emissions budgets are provided in the following table:

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

The criteria we use to determine whether a SIP's motor vehicle emission budgets are adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4), promulgated on August 15, 1997.2 We have further described our process for determining the adequacy of submitted SIP budgets in our final rule dated July 1, 2004, and we used the information in these resources in making our adequacy determination.3 Please note that an adequacy review is separate from the EPA's completeness review and should not be used to prejudge the EPA's ultimate action on the SIP. Even if we find a budget adequate, the SIP could later be disapproved.

Pursuant to 40 CFR 93.104(e), within 2 years of the effective date of this notice, SANDAG and the U.S. Department of Transportation will need to demonstrate conformity to the new budgets if the demonstration has not already been made.4 For demonstrating conformity to the budgets in this plan, the on-road motor vehicle emissions from implementation of the transportation plan or program should be projected consistently with the budgets in this plan, i.e., by taking the county's emissions results derived from CARB's EMFAC model (short for EMission FACtor) and then rounding the emissions up to the nearest ton.

Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.

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

Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.

No comments were received by the agency in response to the 60-day notice published in the Federal Register of December 22, 2010 (75 FR 80542).

Below we provide EEOC's projected average estimates for the next three years:

Current Actions: New collection of information.

Type of Review: New collection.

Affected Public: Individuals and households, businesses and organizations, State, Local or Tribal Government.

Average Expected Annual Number of Activities: 5.

Respondents: 8,020.

Annual Responses: 11,020.

Frequency of Response: Once per respondent for four activities, twice per respondent for one activity.

Average Minutes per Response: 6.5.

Burden Hours: 1194.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.

Title: FTC Cigarette and Smokeless Tobacco Data Collection.

OMB Control Number: 3084-0134.

Type of Review: Extension of currently approved collection.

On August 10, 2017, the Commission sought comment on the information collection requirements associated with the Cigarette and Smokeless Tobacco Data Collection. 82 FR 37440 (“August 10, 2017 Notice”). Pursuant to the OMB regulations, 5 CFR part 1320, that implement the PRA, 44 U.S.C. 3501 et seq., the FTC is providing a second opportunity for the public to comment while seeking OMB approval to renew the existing clearance for the information the FTC proposes to seek from the largest domestic cigarette manufacturers and smokeless tobacco manufacturers.

In response to the August 10, 2017 Notice, the Commission received comments from the Campaign for Tobacco-Free Kids (“CTFK”) and Altria Client Services (“Altria”).

The CTFK comment specifically noted the utility and importance of the Commission's Cigarette and Smokeless Tobacco Reports, and urged the agency to continue collecting and reporting industry sales and marketing expenditure data, which CTFK stated provide “critical data to researchers, policymakers, advocates and the general public.” CTFK additionally observed:

CTFK, however, suggested certain modifications to the Commission's reports. Specifically, CTFK recommended that the Commission: (1) Report separately price discount expenditures for retailers and wholesalers; (2) clarify the definitions of certain expenditure categories—specifically, in which category coupons that consumers obtain online are to be counted; (3) report data on a company-specific or brand-specific basis, rather than on a fully-aggregated basis; (4) require manufacturers to report expenditures related to corporate sponsorships and advertisements; and (5) provide an option to download the published report data in spreadsheet format. Id. at 2.

The Commission agrees that collecting and reporting separately price discount expenditures for retailers and wholesalers is useful. Beginning with its 6(b) Orders for 2014, the Commission has been separately collecting and reporting information about price discounts paid to retailers and price discounts paid to wholesalers.

The Commission will clarify in future Orders that expenditures on coupons delivered online should be reported together with coupons delivered by other means. The full impact of couponing by the major cigarette and smokeless tobacco manufacturers can only be seen if expenditures for all coupons are reported together, regardless of how those coupons are delivered to consumers.

Regarding CTFK's suggestion that data be reported on other than a fully-aggregated, nationwide basis, the cigarette and smokeless tobacco companies assert that those data are confidential and, as CTFK acknowledges, the Commission cannot publicly release trade secrets or certain commercial or financial information. Id. at 2 n.2.

As for requiring manufacturers to report expenditures related to corporate sponsorships and advertisements, the Commission already requires the recipients of its 6(b) Orders to report certain expenditures made in the name of the company, rather than any of its brands.1 However, the Commission does not include those data in its Cigarette and Smokeless Tobacco Reports. The Commission will consider whether those expenditures should be reported in the future or whether to cease collecting this information.

The Commission agrees that it would be helpful to provide an option to download the published report data in spreadsheet format and will begin doing so with its next published reports.

Altria stated that the Commission should no longer collect any information from cigarette and smokeless tobacco manufacturers “in light of the Food and Drug Administration's . . . extensive, active regulatory authority over tobacco products under the Family Smoking Prevention and Tobacco Control Act,” calling such collections “superfluous” and “unnecessary burdens.” Altria at 1, 3. Altria contends that the FTC's most recent requests seek “not only information that the companies already produce to FDA, but also information unrelated to the advertising and promotion of tobacco products.” Id. at 3-4. It gives the following examples:

The FTC staff and FDA staff have a long tradition of working together on the many areas where the two agencies share jurisdiction. The FDA is not collecting cigarette or smokeless tobacco sales and marketing expenditure data like that required by the Commission's 6(b) Orders, so there is no overlap or duplication with respect to such data. Moreover, to the extent there might be some overlap in the collection of information about whether brand styles of cigarettes are filtered or unfiltered, menthol or non-menthol, and their cigarette length, the Commission needs those data so it can combine them with sales information for each brand style in order to report the percentages of cigarettes sold by the leading manufacturers falling into each product type category (e.g., 26% of the cigarettes sold by these manufacturers in 2015 were menthol). FDA is not collecting cigarette sales information, so it cannot calculate sales percentages by product types. The Commission intends to continue collecting cigarette and smokeless tobacco sales and marketing expenditure data, together with cigarette length, flavor, and filter information. To the extent that in the future the FDA duplicates the FTC's data collection, the FTC can modify or cease its collection.

Until 2000, the Commission collected cigarette tar, nicotine, and carbon monoxide yields and published that information by brand style. Because of concerns that the yield information was misleading consumers, the Commission ceased publishing that information, but it has continued to collect tar, nicotine, and carbon monoxide yields to the extent recipients of the 6(b) Orders possess it, and the Commission releases the data to researchers in response to Freedom of Information Act requests. In recent years, however, there have been very few requests for the data. Given that the Commission no longer publishes tar, nicotine, and carbon monoxide reports and the limited interest in these data, the Commission intends to cease collecting tar, nicotine, and carbon monoxide yield data.

There are other information fields that the Commission no longer needs to collect, including information about cigarette package type, cigarette package size, cigarette styles, and whether a cigarette variety's tar yield and its nicotine yield are disclosed on its package. The Commission intends to continue to collect UPC-Codes in order to distinguish one variety from another, but does not need any other variety descriptors beyond cigarette length, flavor, and filter information. The Commission also no longer needs lists of cigarettes first sold or discontinued in a calendar year.

Contrary to Altria's suggestion, the FTC did not recently expand its requests to seek information from parent companies. More than a decade ago, the Commission began directing its orders to the ultimate domestic parents of the cigarette and smokeless tobacco manufacturers because some parent companies owned more than one subsidiary selling those products and the Commission wanted to ensure that no relevant data from affiliated companies went unreported. Moreover, the 6(b) Orders ask several questions about whether the recipient engages in certain practices, such as paying for cigarette or smokeless tobacco product placement in movies, and the Commission wants to be sure that such practices by any related company are reported, even if that company does not itself sell cigarette or smokeless tobacco products. The Commission intends to continuing directing its 6(b) Orders to the parent companies of the leading cigarette and smokeless tobacco manufacturers.

Burden Statement: 2

Estimated Annual Burden: 1,980 hours.3

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Budget Workload Reports and Supporting Regulations; Use: We will use the collected information to determine the amount of Federal reimbursement for surveys conducted. Use of the information includes program evaluation, audit, budget formulation and budget approval. Form CMS-102 is a multi-purpose form designed to capture and record all budget and expenditure data. Form CMS-105 captures the annual projected CLIA workload that the State survey agency will accomplish. Our regional offices also use the information to approve the annual projected CLIA workload. The information is required as part of the section 1864 agreement with the state. Form Numbers: CMS-102 and CMS-105 (OMB control number: 0938-0599); Frequency: Quarterly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 50; Total Annual Responses: 50; Total Annual Hours: 1,700. (For policy questions regarding this collection contact Jeffrey Pleines at 410-786-0684.)

In the Federal Register of July 31, 2017 (82 FR 35532), FDA published a notice announcing the public workshop entitled “Cardiac Troponin Assays; Public Workshop; Request for Comments” with a 120-day comment period to request comments.

The Agency has received requests for a 30-day extension of the comment period for the public workshop. The request conveyed concern that the current 120-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the public workshop.

FDA has considered the request and is extending the comment period for the public workshop for 30 days, until December 28, 2017. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments.

FDA is announcing the availability of a draft document entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.” The draft guidance, when finalized, will provide device manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as “regenerative medicine advanced therapies” or “RMATs”. Specifically, as required by section 3034 of the 21st Century Cures Act (Pub. L. 114-255) (Cures Act), the draft guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.

The issuance of this draft guidance fulfills the statutory requirement set forth in section 3034(a) of the Cures Act. Furthermore, the Agency intends for this document, when finalized, to serve as a source of information about the Agency's current thinking about a wide range of concepts related to the regulation of devices, as they apply to devices used in the recovery, isolation, and delivery of RMATs. FDA has provided general information in the draft guidance in lieu of specific examples because the Agency does not yet possess a wide body of experience regarding the evaluation of devices used with RMATs, given the recent establishment of the RMAT designation program in the Cures Act.

As we gain more experience with such devices, we intend to incorporate such information into the final guidance. To that end, although you are welcome to comment on any aspect of the guidance, we encourage commenters to support their comments with information related to specific marketed devices or types of devices that are used in the recovery, isolation, and delivery of RMATs.

Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a document entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.” Among other things, that document provides information about the RMAT designation program.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on Evaluation of Devices Used with Regenerative Medicine Advanced Therapies. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807 have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR part 1271 have been approved under OMB control number 0910-0543.

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

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

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

Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational and public information programs.

In conducting studies relating to the regulation and communications related to tobacco products, FDA will need to employ formative qualitative research including focus groups, usability testing, and/or indepth interviews (IDIs) to assess knowledge and perceptions about tobacco-related topics with specific target audiences. The information collected will serve three major purposes. First, formative research will provide critical knowledge about target audiences. FDA must first understand people's knowledge and perceptions about tobacco related topics prior to developing survey/research questions as well as stimuli for experimental studies. Second, by collecting communications usability information, FDA will be able to serve and respond to the ever-changing demands of consumers of tobacco products. Additionally, we will be able to determine the best way to present messages. Third, initial testing will allow FDA to assess consumer understanding of survey/research questions and study stimuli. Focus groups and/or IDIs with a sample of the target audience will allow FDA to refine the survey/research questions and study stimuli while they are still in the developmental stage. FDA will collect, analyze, and interpret information gathered through this generic clearance in order to: (1) Better understand characteristics of the target audience—its perceptions, knowledge, attitudes, beliefs, and behaviors—and use these in the development of appropriate survey/research questions, study stimuli, or communications; (2) more efficiently and effectively design survey/research questions and study stimuli; and (3) more efficiently and effectively design experimental studies.

FDA is requesting approval of this new generic clearance for collecting information through the use of qualitative methods (i.e., individual interviews, small group discussions, and focus groups) for studies involving all tobacco products regulated by FDA. This information will be used as a first step to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the Agency. This information may also be used to help identify and develop communication messages, which may be used in education campaigns. Focus groups play an important role in gathering information because they allow for an indepth understanding of individuals' attitudes, beliefs, motivations, and feelings. Focus group research serves the narrowly defined need for direct and informal public opinion on a specific topic.

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

The number of respondents to be included in each new pretest may vary, depending on the nature of the material or message being tested and the target audience. Table 1 provides examples of the types of studies that may be administered and estimated burden levels during the 3-year period. Time to read, view, or listen to the message being tested is built into the “Hours per Response” figures.

The burden for this collection has decreased by 18,437 hours from 29,059 to 10,622. FDA attributes this decrease to assessing the planned studies for the next 3 years.

On May 5, 2017, President Trump signed the Consolidated Appropriations Act, 2017 (Pub. L. 115-31). Section 756 of the Consolidated Appropriations Act, 2017 requires FDA to issue final regulations revising Federal drug regulations with respect to medical gases. These public workshops are being held as part of FDA's implementation of the requirements of section 756.

Since the 2012 enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), FDA has engaged in multiple activities related to medical gases, including rulemaking. For example, in 2016, FDA issued the final rule “Medical Gas Containers and Closures: Current Good Manufacturing Practice Requirements” (81 FR 81685, November 18, 2016). Other activities include FDA's June 2017 revised draft guidance for industry on current good manufacturing practice for medical gases,1 updated guidance for FDA inspectors regarding medical gases (March 2015),2 an extensive review of Federal drug regulations related to medical gases from 2012 to 2014 (a report on the review was submitted to Congress in 2015),3 and implementation of FDASIA's requirements regarding certification of medical gases (to date, over 70 certifications have been granted).

FDA intends to engage in additional rulemaking in this area in accordance with section 756 of the Consolidated Appropriations Act, 2017. To conduct rulemaking as efficiently as possible, FDA intends to build on the information and stakeholder input received since FDASIA's enactment. As noted in more detail below, FDA invites comments from stakeholders on specific medical gas issues that could or should be addressed in regulation.

We are holding these workshops to provide an opportunity for medical gas manufacturers and any other interested members of the public to provide input on potential areas of Federal drug regulation that should be revised with respect to medical gases.

We are asking stakeholders to comment on existing medical gas issues which, in their view, should be addressed by regulation change (rather than through other means, such as revisions to guidance or inspection practices). Commenters should include concrete and specific reasons that rulemaking is preferable to other options. Commenters' views regarding the prioritization of particular rulemaking proposals would also be helpful. If a stakeholder would like a comment to be discussed at a particular public workshop, it should be submitted with a discussion request by no later than 1 week before the date of the workshop. If a stakeholder would like a comment to be included in FDA's consideration of public comments presented and received for a particular workshop, it should be submitted no later than 90 days after the date of the workshop. As noted above, the https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 10, 2018. Late comments will not be considered.

During Workshop I (December 2017), FDA intends to discuss the anticipated scope of the medical gas rulemaking, as well as three regulations to which stakeholders have previously requested changes: 21 CFR part 201 (labeling generally and labeling for medical air specifically), 21 CFR part 207 (registration and listing), and 21 CFR parts 210 and 211 (current good manufacturing practice). Depending on the number of speakers and time available, we may also consider comments on additional regulations.

During Workshop II (February 2018), FDA intends to discuss 21 CFR part 314 (adverse event reporting) and the intersection of regulations for medical gases and regulations for medical devices and animal drugs. Depending on the number of speakers and time available, we may also consider comments on additional regulations and medical gas issues not currently addressed in regulation. FDA is considering whether to schedule one or more additional public workshops in 2018 to hear from stakeholders regarding any remaining topics.

Registration: The workshops are free and seating will be on a first-come, first-served basis. Attendees who do not wish to make an oral presentation do not need to register.

If you need special accommodations because of a disability, please contact [email protected] (or see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of each workshop.

Requests for Oral Presentations: If you wish to a make an oral presentation, you must register by submitting your name, title, firm name, address, telephone, email address, and Fax number to [email protected] (see FOR FURTHER INFORMATION CONTACT) by December 8, 2017, for Workshop I, or February 2, 2018, for Workshop II. Please also indicate the type of organization you represent (e.g., industry, consumer organization) and a brief summary of your remarks (including the discussion topic(s) that you would like to address).

FDA will try to accommodate all persons who wish to make a presentation; however, the duration of each speaker's presentation may be limited by time constraints. FDA will notify registered presenters of their scheduled presentation times. Persons registered to speak should check in before the workshops and are encouraged to arrive early to ensure their designated order of presentation. Participants who are not present when called may not be permitted to speak at a later time. An agenda will be made available at least 3 days before each workshop at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm. FDA may also post specific questions for consideration at the meeting Web page; these will be made available at least 3 days before each workshop at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm.

Streaming Webcast and Video of the Public Workshops: These public workshops will be webcast; the URL will be posted at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm at least 1 day before each workshop. A video record of the public workshops will be available at the same Web site address for 1 year.

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

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

This information collection supports Agency regulations. Specifically, section 413(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350b(a)) provides that at least 75 days before the introduction or delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary ingredient, the manufacturer or distributor of the dietary supplement or of the new dietary ingredient is to submit to FDA (as delegate for the Secretary of Health and Human Services) information upon which the manufacturer or distributor has based its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. FDA's implementing regulation, § 190.6 (21 CFR 190.6), requires this information to be submitted to the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) in the form of a notification. Under § 190.6(b), the notification must include the following: (1) The name and complete address of the manufacturer or distributor; (2) the name of the new dietary ingredient; (3) a description of the dietary supplement(s) that contain the new dietary ingredient, including the level of the new dietary ingredient in the dietary supplement and the dietary supplement's conditions of use; (4) the history of use or other evidence of safety establishing that the new dietary ingredient will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of the dietary supplement; and (5) the signature of a responsible person designated by the manufacturer or distributor.

These premarket notification requirements are designed to enable us to monitor the introduction into the marketplace of new dietary ingredients and dietary supplements that contain new dietary ingredients in order to protect consumers from ingredients and products whose safety is unknown. FDA uses the information collected in new dietary ingredient notifications to evaluate the safety of new dietary ingredients in dietary supplements and to support regulatory action against ingredients and products that are potentially unsafe.

FDA has developed an electronic portal that respondents may use to electronically submit their notifications to ONLDS via FDA Unified Registration and Listing System (FURLS). Firms that prefer to submit a paper notification in a format of their own choosing still have the option to do so; however, Form FDA 3880 prompts a submitter to input the elements of a new dietary ingredient notification (NDIN) in a standard format and helps the respondent organize its NDIN to focus on the information needed for FDA's safety review. Safety information may be submitted via a supplemental form entitled “New Dietary Ingredient Safety Information.” This form provides a standard format to describe the history of use or other evidence of safety on which the manufacturer or distributor bases its conclusion that the new dietary ingredient is reasonably expected to be safe under the conditions of use recommended or suggested in the labeling of the dietary supplement, as well as related identity information that is necessary to demonstrate safety by showing that the new dietary ingredient and dietary supplement(s) that are the subject of the notification are the same or similar to the ingredients and products for which safety data and information have been provided. We invite comment on Form FDA 3880 and the supplemental safety information form, which may be found on our Web site at https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/default.htm.

Description of Respondents: The respondents to this collection of information are manufacturers and distributors in the dietary supplement industry; specifically, firms that manufacture or distribute new dietary ingredients or dietary supplements that contain a new dietary ingredient.

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

We have made no adjustments to the currently approved burden estimate for the information collection. While we have received previous comments suggesting our burden estimate may be too low, the comments did not discuss the basis for such a conclusion. We therefore specifically invite those commenters offering an alternative burden estimate to include the methodology or reasoning used to do so.

Based on our experience with the information collection over the past 3 years, we estimate that 55 respondents will submit 1 premarket notification each. We estimate that extracting and summarizing the relevant information from what exists in the company's files and presenting it in a format that meets the requirements of § 190.6 will take approximately 20 hours of work per notification. We have carefully considered the burden associated with the premarket notification requirement and believe that estimates greater than 20 hours are likely to include burden associated with researching and generating safety data for a new dietary ingredient. We also believe that the burden of the premarket notification requirement on industry is minimal and reasonable because we are requesting only safety and identity information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in compliance with the FD&C Act. Under section 413(a)(2) of the FD&C Act, a dietary supplement that contains a new dietary ingredient is deemed to be adulterated unless there is a history of use or other evidence of safety establishing that the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling of the dietary supplement. This requirement is separate from and additional to the requirement to submit a premarket notification for the new dietary ingredient. FDA's regulation on new dietary ingredient notifications, § 190.6(a), requires the manufacturer or distributor of the dietary supplement or of the new dietary ingredient to submit to FDA the information that forms the basis for its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. Thus, § 190.6 only requires the manufacturer or distributor to extract and summarize information that should have already been developed to meet the safety requirement in section 413(a)(2) of the FD&C Act.

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

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

This information collection supports Agency guidance regarding staff meetings with the Office of Orphan Products Development. Each year, the Office of Orphan Products Development (OOPD) staff participates in meetings with stakeholders who seek guidance or clarification relating to orphan drug or humanitarian use device (HUD) designation requests, OOPD grant programs, or other rare disease issues. These meetings can be “informal” or “formal” and help build a common understanding on FDA's thoughts on orphan products, which may include drugs, biological products, devices, or medical foods for a rare disease or condition. These meetings may represent critical points in the orphan product development process and may even have an impact on the eventual availability of products for patients with rare diseases and conditions. It is important that these meetings be scheduled within a reasonable time, conducted effectively, and documented where appropriate.

Topics addressed in this guidance include: (1) Clarification of what constitutes an “informal” or “formal” meeting, (2) program areas within OOPD that may be affected by this draft guidance, (3) procedures for requesting and scheduling meetings with OOPD, (4) description of what constitutes a meeting package, and (5) procedures for the conduct and documentation of meetings with OOPD. This guidance provides consistent procedures to promote well-managed meetings between OOPD and stakeholders.

Burden estimate. Table 1 of this document provides an estimate of the annual reporting burden associated with the recommendation found in the guidance.

Request for a meeting. Based upon information collected from OOPD program areas, approximately 2,332 informal and 51 formal meetings were requested with OOPD in fiscal year (FY) 2016 regarding orphan drug designation requests, HUD designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related issues. FDA anticipates that the number of meeting requests and stakeholders will remain the same or will only slightly increase and therefore estimates the total number of meeting requests will be 2,383 annually (2332 informal and 51 formal meetings). The hours per response, which is the estimated number of hours that a stakeholder would spend preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be approximately 3 hours for informal meetings and approximately 10 hours for formal meetings. Based on FDA's experience, the Agency expects that it will take stakeholders this amount of time to gather and copy brief statements about the product and a description of the purpose and details of the meeting. Therefore, the Agency estimates that stakeholders will spend 7,506 hours per year (6,996 hours for informal meetings and 510 hours for formal meetings) preparing meeting requests to OOPD regarding orphan drug designation requests, HUD designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related issues.

Meeting packages. Based upon information collected from OOPD program areas, OOPD held approximately 51 formal meetings in FY 2016 regarding orphan drug designation requests, HUD designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related issues. FDA anticipates that the number of formal meetings, and therefore meeting packages, may increase only slightly as a result of this guidance; thus, the Agency estimates that the total responses will be 51 annually. As stated previously, it is current practice for stakeholders to submit meeting packages to the Agency in advance of any such formal meeting. The hours per response, which is the estimated number of hours that a stakeholder would spend preparing the meeting package in accordance with this guidance, is estimated to be approximately 18 hours. Based on FDA's experience, the Agency expects it will take stakeholders this amount of time to gather and copy brief statements about the product, a description of details for the anticipated meeting, and data and information that generally would already have been compiled for submission to the Agency. Therefore, the Agency estimates that stakeholders will spend 918 hours per year submitting meeting packages to the Agency prior to a formal meeting regarding orphan drug designation requests, HUD designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related issues.

Draft meeting minutes. Based upon information collected from OOPD program areas, OOPD received approximately 51 draft meeting minutes for formal meetings and 23 draft meeting minutes for informal meetings in FY 2016 regarding orphan drug designation requests, HUD designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related issues. FDA anticipates that the number of stakeholders submitting draft meeting minutes may remain the same or increase only slightly; thus, the Agency estimates that the total number of respondents will be 74 annually. As stated previously, it is current practice for stakeholders to submit draft meeting minutes to the Agency after all formal meetings and certain informal meetings. The hours per response, which is the estimated number of hours that a stakeholder would spend preparing draft meeting minutes in accordance with this guidance, is estimated to be approximately 8 hours. Based on FDA's experience, the Agency expects it will take stakeholders this amount of time to summarize the meeting discussion points, agreements, disagreements, and action items. Therefore, the Agency estimates that stakeholders will spend 592 hours per year submitting draft meeting minutes to the Agency documenting the meeting outcomes, agreements, disagreements, and action items as followup to all formal and certain informal meetings.

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

Since the last OMB approval, we have increased our estimate by 832 hours and 229 respondents in parallel to an increase in overall orphan drug designation submissions and to correspond meeting requests to the Office of Orphan Products Development.

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

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

Section 701 of the Federal Food, Drug, and Cosmetic Act charges the Secretary of Health and Human Services, through FDA, with the responsibility of assuring recalls (21 U.S.C. 371, Regulations and hearings, and 21 CFR part 7, Enforcement Policy, Subpart C, Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibilities which pertain to the recall regulations and provide guidance to manufacturers on recall responsibilities). The regulations and guidance apply to all FDA-regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco).

These responsibilities of companies conducting recalls include providing FDA with complete details of the recall including: (1) Reason(s) for the removal or correction, risk evaluation, quantity produced, distribution information, firm's recall strategy, a copy of any recall communication(s), and a contact official (§ 7.46); (2) notifying direct accounts of the recall, providing guidance regarding further distribution, giving instructions as to what to do with the product, providing recipients with a ready means of reporting to the recalling firm (§ 7.49); and (3) submitting periodic status reports so that FDA may assess the progress of the recall. Status report information may be determined by, among other things, evaluation return reply cards, effectiveness checks and product returns (§ 7.53), and providing the opportunity for a firm to request in writing that FDA terminate the recall (§ 7.55(b)).

A search of the FDA database was performed to determine the number of recalls that took place during fiscal years 2014 to 2016. The resulting number of total recalls (8,560) from this database search were then averaged over the 3 years, and the resulting per year average of recalls (2,853) are used in estimating the current annual reporting burden for this report. The resulting number of total terminations (8,560) from this database search were then averaged over the 3 years, and the resulting per year average of terminations (2,853) are used in estimating the current annual reporting burden for this report.

FDA estimates the total annual industry burden to collect and provide the required information to be 470,745 burden hours.

The following is a summary of the estimated annual burden hours for recalling firms (manufacturers, processors, and distributors) to comply with the reporting requirements of FDA's recall regulations, recognizing that there may be a vast difference in the information collection and reporting time involved in different recalls of FDA's regulated products.

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

We request firms that voluntarily remove or correct foods and drugs (human or animal), cosmetics, medical devices, biologics, and tobacco to immediately notify the appropriate FDA District Office of such actions. The firm is to provide complete details of the recall reason, risk evaluation, quantity produced, distribution information, firms' recall strategy, and a contact official as well as requires firms to notify their direct accounts of the recall and to provide recipients with a ready means of reporting to the recalling firm. Under these portions of the collection of information, the Agency estimates it will receive 2,853 responses annually based on the average number of recalls over the last 3 fiscal years. The number of responses multiplied by the number of respondents equals 2,853. The average burden hours, 25, multiplied by total number of annual responses equal 71,325.

We request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. This request only applies to firms with active recalls, and periodic status reports are estimated to be reported every 2 to 4 weeks. This collection of information will generate approximately 2,853 responses annually, based on the average number of recalls over the last 3 fiscal years, 8,560. The number of respondents multiplied by the number of responses per respondents (13) equals a total number of annual responses of 37,089. The total number of responses, 37,089, multiplied by an average burden hours of 10 per response equals a total of 370,890 total hours.

We provide the firms an opportunity to request in writing that FDA end the recall. The Agency estimates it will receive 2,853 responses annually based on the average number of terminations over the past 3 fiscal years. The total annual responses of 2,853 multiplied by the average burden hours of 10 per response equals a total number of hours of 28,530.

Recall Communications. We request that firms notify their consignees of the recall and to provide recipients with a ready means of reporting to the recalling firm. Under this portion of the collection of information, the Agency estimates firms will provide 4,433,562 notifications annually based on the number of respondents/consignees (2,853) multiplied by the number of disclosures per respondent (1,554). The total number of hours is 248,279 (based on 4,433,562 multiplied by 0.056 hours).

FDA regulates many different types of products including, but not limited to, medical products, food and feed, cosmetics, and tobacco products. FDA notes that not all third-party disclosures provided by firms to their consignees are similar in nature and may entail different methods and mediums of communication. FDA estimates the burden for third-party disclosure per recall event to be an average of 25 hours. This burden estimate factored out to the average number of consignees per recall (1,554) results in a burden per disclosure estimate of approximate hours (25 hours per recall/1,554 disclosures/recall = 0.056 hours).

I. Background

Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives.

Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security under section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or the health and security of U.S. citizens living abroad.

Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA 1 concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing (i) such disease or condition; or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; and (4) that such other criteria as may be prescribed by regulation are satisfied.

No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self-executing, regulations or guidance are not required for FDA to implement the EUA authority.

On February 26, 2016, the Secretary of HHS determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on the basis of such determination, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under section 564 of the FD&C Act. Notice of the determination and declaration of the Secretary was published in the Federal Register on March 2, 2016 (81 FR 10878). On September 8, 2017, Siemens Healthcare Diagnostics, Inc. requested, and on September 18, 2017, FDA issued, an EUA for the ADVIA Centaur Zika test, subject to the terms of the Authorization. On September 14, 2017, Chembio Diagnostic Systems, Inc. requested, and on September 27, 2017, FDA issued an EUA for the DPP Zika IgM Assay System, subject to the terms of the Authorization.

An electronic version of this document and the full text of the Authorizations are available on the internet at https://www.regulations.gov/.

Having concluded that the criteria for issuance of the Authorizations under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of two in vitro diagnostic devices for detection of Zika virus subject to the terms of the Authorizations. The Authorizations in their entirety (not including the authorized versions of the fact sheets and other written materials) follow and provide an explanation of the reasons for issuance, as required by section 564(h)(1) of the FD&C Act:

FDA is announcing the availability of a draft document entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.” The draft guidance document describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions (referred to in the draft guidance as serious conditions), including those products designated as RMATs; provides information about the provisions in the 21st Century Cures Act (Cures Act) (Pub. L. 114-225) regarding the use of the accelerated approval pathway for regenerative medicine therapies that have been granted designation as an RMAT; describes how CBER will encourage flexibility in clinical trial design to facilitate the development of data to demonstrate the safety and effectiveness of regenerative medicine therapies that are being developed to address unmet needs in patients with serious conditions; and describes the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff.

The draft guidance document addresses regenerative medicine therapies, which are defined in section 506(g)(8) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Cures Act, as including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) and 21 CFR part 1271. Gene therapies, including genetically modified cells, that lead to a durable modification of cells or tissues can meet the definition of a regenerative medicine therapy. Under section 506(g) of the FD&C Act, RMAT designation is available for a drug (i.e., a human drug, including a drug that is a biological product) that meets the definition of regenerative medicine therapy; is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and with respect to which preliminary clinical evidence indicates the potential to address unmet medical needs for such disease or condition. A combination product (biologic-device, biologic-drug, or biologic-device-drug) can be eligible for RMAT designation when the biological product provides the greatest contribution to the overall intended therapeutic effects of the combination product (i.e., the primary mode of action in the combination product is conveyed by the biological product component).

Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a document entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.”

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information regarding formal meetings in “Guidance for Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” have been approved under OMB control number 0910-0429; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information for expedited programs in “Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics,” have been approved under OMB control number 0910-0765; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001.

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

In the Federal Register of Friday, November 3, 2017 (82 FR 51277), in FR Doc. 2017-23947, the following correction is made:

On page 51277, in the second column, in the header of the document, “[Docket FDA-2014-D-1147]” is corrected to read “[Docket No. FDA-2014-D-1167]”.

Section 801.45 (21 CFR 801.45) requires a device to be directly marked with a UDI when the device is intended to be used more than once and intended to be reprocessed before each use. However, “intended to be used more than once” and “intended to be reprocessed” are not defined in the UDI regulations. This guidance provides FDA's interpretation of these terms, clarifies when direct marking of devices with a UDI is required, provides recommendations for how labelers should comply with the UDI direct marking requirements, and clarifies the criteria for exceptions to the direct marking requirement.

In the Federal Register of June 26, 2015, FDA published the notice of availability of “Draft Guidance for Industry and Food and Drug Administration Staff: Unique Device Identification: Direct Marking of Devices” (80 FR 36821) (the “Draft Guidance”). In the notice of availability, FDA also solicited feedback on two questions related to interpretation of “intended to be reprocessed”: (1) Should the definition of “reprocessing” for purposes of UDI direct marking requirements include cleaning alone without subsequent disinfection and/or sterilization of the device? and (2) what public health benefits would be served by requiring a UDI direct marking to be affixed to devices intended to be reused for which reprocessing instructions include cleaning only and not disinfection and/or sterilization? Interested persons were invited to comment by September 24, 2015. FDA considered the comments received on the draft guidance, including comments responding to the specific questions in the notice of availability, and revised the guidance as appropriate in response to these comments.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Unique Device Identification: Direct Marking of Devices.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of “Unique Device Identification: Direct Marking of Devices” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1400031 to identify the guidance you are requesting.

This guidance refers to previously approved collections of information described in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 830 pertaining to GUDID labeler accounts and data submissions addressed in this draft guidance document have been approved under OMB control number 0910-0720.

The meeting will focus on the Report to Congress that includes information on federal advances related to serious mental illness (SMI) and serious emotional disturbance (SED), including data evaluation, and recommendations for action. Members of the public can attend the meeting via telephone or webcast. The meeting can be accessed via webcast at www.hhs.gov/live. To obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please visit the SAMHSA Advisory Committees Web page at https://www.samhsa.gov/about-us/advisory-councils/smi-committee or contact Pamela Foote, Designated Federal Official (see contact information below).

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written statements should be submitted to the DFO on or before November 30, 2017. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations must notify the DFO on or before November 30, 2017. Two minutes will be allotted for each presentation as time permits. Substantive meeting information and a roster of Committee members is available at the Committee's Web site https://www.samhsa.gov/about-us/advisory-councils/smi-committee or by contacting Pamela Foote, DFO.

Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee

Dates/Time/Type: Thursday, December 14, 2017, 10:30 a.m. 12:00 p.m./OPEN

Place: Webcast and teleconference (see information above).

Contact: Pamela Foote, Designated Federal Official, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Room14E53C, Rockville, MD 20857, Telephone: 240-276-1279, Fax: 301-480-8491, Email: [email protected].

The ISMICC was established on March 15, 2017, in accordance with section 6031 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C. App., as amended, to report to the Secretary, Congress, and any other relevant federal department or agency on advances in serious mental illness (SMI) and serious emotional disturbance (SED), research related to the prevention of, diagnosis of, intervention in, and treatment and recovery of SMIs, SEDs, and advances in access to services and support for adults with SMI or children with SED. In addition, the ISMICC will evaluate the effect federal programs related to serious mental illness have on public health, including public health outcomes such as (A) rates of suicide, suicide attempts, incidence and prevalence of SMIs, SEDs, and substance use disorders, overdose, overdose deaths, emergency hospitalizations, emergency room boarding, preventable emergency room visits, interaction with the criminal justice system, homelessness, and unemployment; (B) increased rates of employment and enrollment in educational and vocational programs; (C) quality of mental and substance use disorders treatment services; or (D) any other criteria as may be determined by the Secretary. Finally, the ISMICC will make specific recommendations for actions that agencies can take to better coordinate the administration of mental health services for adults with SMI or children with SED. Not later than 1(one) year after the date of enactment of the 21st Century Cures Act, and 5 (five) years after such date of enactment, the ISMICC shall submit a report to Congress and any other relevant federal department or agency.

This ISMICC consists of federal members listed below or their designees, and non-federal public members.

A roster of Committee members is available at the Committee's Web site: https://www.samhsa.gov/about-us/advisory-councils/smi-committee

The ISMICC is required to meet twice per year.

Section 106 of the National Historic Preservation Act (“NHPA”) (54 U.S.C. 306108) requires federal agencies to take into account the effects of undertakings they carry out, license, permit, or assist on historic properties and provide the Advisory Council on Historic Preservation (“ACHP”) a reasonable opportunity to comment with regard to such undertakings. Historic properties are those that are listed on the National Register of Historic Places (“National Register”) or eligible for such listing. The definition of historic properties and other terms relevant to the proposed Section 106 program comment for railroad and rail transit rights-of-way (“rail ROW”) are provided in Section VI, Definition of Terms, and are consistent with the NHPA and the Section 106 regulations.

The Section 106 implementing regulations allow federal agencies to tailor the Section 106 process to meet their needs through a variety of program alternatives (36 CFR 800.14). Types of Section 106 program alternatives include program comments and exemptions. The process for establishing an exemption is detailed in 36 CFR 800.14(c). In accordance with 36 CFR 800.14(c)(1), the ACHP may approve an exemption for a program or category of undertakings if: (i) The actions within the program or category would otherwise qualify as “undertakings” as defined in 36 CFR 800.16; (ii) the potential effects of the undertakings within the program or category upon historic properties are foreseeable and likely to be minimal or not adverse; and (iii) exemption of the program or category is consistent with the purposes of the NHPA. The ACHP takes into account the magnitude of the exempted undertaking or program and the likelihood of impairment of historic properties in reviewing a proposed exemption. Further, at 36 CFR 800.14(e), the Section 106 implementing regulations provide a process for the ACHP to issue a program comment. Through a program comment, the ACHP comments on a category of undertakings in lieu of conducting individual reviews under 36 CFR 800.4-800.6.

Section 11504 of the Fixing America's Surface Transportation Act (“FAST Act”) (49 U.S.C. 24202), enacted on December 4, 2015, mandated the development of a Section 106 exemption for “railroad rights-of-way.” The FAST Act requires that “the Secretary [of the United States Department of Transportation (“USDOT”)] shall submit a proposed exemption of railroad rights-of-way from the review under section 306108 of title 54 to the [ACHP] for consideration, consistent with the exemption for interstate highways approved on March 10, 2005 (70 FR 11928).” The FAST Act continues that, “Not later than 180 days after the date on which the Secretary submits the proposed exemption. . .to the Council, the Council shall issue a final exemption of railroad rights-of-way from review under chapter 3061 of title 54 consistent with the exemption for interstate highways approved on March 10, 2005 (70 FR 11928).” While the Section 106 regulations provide the process and criteria for development of program alternatives, the FAST Act modified the timeframe and directed agency actions.

This proposed Section 106 program comment includes an activities-based exemption that would fulfill the FAST Act mandate by exempting certain routine transportation-related undertakings that occur within rail ROW. The list of activities proposed to be exempt from Section 106 review is provided in Appendix A. Based on the past experience of USDOT Operating Administrations (“USDOT OAs”), undertakings limited to the activities specified in Appendix A have typically resulted in effects to historic properties that are either minimal or not adverse. In addition to incorporating exempt activities that meet the criteria specified in the Section 106 regulations at 36 CFR 800.14(c)(1), this program comment includes an optional, Project Sponsor-led property-based approach that ultimately could provide additional streamlining for undertakings that may cause adverse effects.

The railroad industry in the United States has developed for nearly two centuries. Ongoing activities such as maintenance, improvements, and upgrades are necessary to allow rail infrastructure to continue to serve the transportation needs of the nation safely and efficiently. Further, these activities when carried out properly preserve the infrastructure and historic transportation purpose of moving goods and passengers. Most of the nation's railroads are privately-owned and maintained through the continuous investments of private owners. According to the Association of American Railroads (AAR), privately-owned freight railroads spent more than $630 billion on rail equipment and infrastructure, including tracks, bridges, and tunnels, during the 36-year period from 1980 to 2016.1

The federal government also makes substantial investments in and has oversight of the nation's railroads and rail transit systems. This includes maintaining and expanding intercity passenger rail, rail transit, and freight rail services, and regulating and improving the safety and efficiency of rail operations. USDOT serves both an investment (e.g., grants, loans) role and a regulatory and safety oversight role, with activities carried out most frequently by the following USDOT OAs: The Federal Railroad Administration (“FRA”), the Federal Transit Administration (“FTA”), and the Federal Highway Administration (“FHWA”).

For example, FRA provides financial and technical assistance for planning and infrastructure projects that enable the nation's railroads to move passengers and goods across the United States. FRA's investments are principally, but not exclusively, in support of intercity passenger rail operations and often provide financial assistance for maintenance, improvements, and upgrades to railroad infrastructure, equipment, and technologies, including those focused on improving the safety of railroad operations and roadway/railroad grade crossings, as well as for research and development activities and training. FTA provides financial and technical assistance to transit agencies for investment in public transportation systems that include various forms of rail transit that occupy existing or former rail ROW, such as heavy rail, commuter rail, streetcar, and light rail. FHWA supports state, local, and tribal governments and federal agencies in the design, construction, and maintenance of the nation's highway systems. Highways frequently cross over, go under, or are parallel to rail ROW, requiring extensive coordination between the entities responsible for the highway and the railroad or rail transit lines, including safety considerations. FHWA's Railway-Highway Crossings Program 2 provides funds for safety improvements to reduce the number of fatalities, injuries, and crashes at public railway-highway grade crossings.

On June 5, 2008, a congressional hearing before the Subcommittee on Railroads, Pipelines, and Hazardous Materials, within the House Committee on Transportation and Infrastructure, included testimonies by the ACHP, the Alaska Railroad Corporation, the National Conference of State Historic Preservation Officers (“NCSHPO”), the National Trust for Historic Preservation (“NTHP”), the North Carolina Department of Transportation, and the Rails-to-Trails Conservancy.3 The purpose of the hearing was to consider whether federal requirements for the preservation of historic properties created unnecessary delays and administrative burdens for improvements to rail infrastructure. This hearing revealed that while the nation's railroad system is historically important, the existing federal review process in some cases could be carried out more efficiently to expedite project delivery. As a result, Congress mandated a study to explore these issues and to recommend solutions.

Pursuant to Section 407 of the Passenger Rail Investment and Improvement Act of 2008 (“PRIIA”), FRA, in partnership with other USDOT OAs, state departments of transportation (“state DOTs”), and historic preservation organizations and agencies, including the ACHP, NCSHPO, and NTHP, conducted a study assessing the current state of historic preservation for federally funded railroad projects and the potential for expediting compliance with Section 106 and Section 4(f) (23 U.S.C. 138, 49 U.S.C. 303). In 2013, FRA submitted to Congress the resulting study, titled “Streamlining Compliance with Section 4(f) of the Department of Transportation Act and Section 106 of the National Historic Preservation Act for Federally Funded Railroad Infrastructure and Improvement Projects” (“2013 FRA Study”).4

The 2013 FRA Study drew upon the experiences shared by the participating agencies and organizations, SHPOs, and other stakeholders, and on best practices and data extrapolated from case studies. The 2013 FRA Study concluded that there is no consistent approach on how to address the National Register eligibility of railroad corridors or how to avoid, minimize, or mitigate impacts to individual rail properties along a corridor once it is determined to be eligible for the National Register. The lack of consistency was attributed to a multitude of entities conducting National Register evaluations, including SHPOs, Tribal Historic Preservation Officers (“THPOs”), federal agencies, consultants, state DOTs and railroad and rail transit operators. These inconsistency issues raised concerns regarding the lack of specific nationwide guidance for identifying, evaluating, and classifying rail properties and differentiation based on likely importance of particular historic resources on the part of each evaluator. This variety of approaches leads to inconsistent standards for evaluation and procedures to consider and address impacts, an overly burdensome process, delays in project delivery, and some projects failing to advance. The substantial experience of USDOT OAs over the years in funding maintenance, improvements, and upgrades to railroads and rail transit systems, and highway/rail grade crossings, has provided further evidence of this conclusion. Furthermore, the experience of USDOT OAs has been that undertakings involving maintenance, improvements, and upgrades to rail infrastructure often do not result in adverse effects to historic properties under Section 106 when early planning involves diverse stakeholders.

The 2013 FRA Study offered several streamlining recommendations, including the development of a Section 106 administrative exemption and a program comment. In 2015, Congress mandated a proposed administrative exemption in the FAST Act and directed USDOT that the exemption be consistent with the Interstate Highway Exemption. Developed by FHWA and approved by the ACHP in 2005, the Section 106 exemption for the Interstate Highway System acknowledges “the importance of the Interstate System in American history, but also recognizes that ongoing maintenance, improvements and upgrades are necessary to allow the system to continue to serve the transportation needs of the nation.” 5 Further, the concept for the exemption for the Interstate Highway System stated that, “While actions carried out by federal agencies to maintain or improve the Interstate System will, over time, alter various segments of the system, such changes are considered to be `minimal or not adverse' when viewing the system as a whole. Moreover, the exemption does not apply to certain historically important elements of the system.” Therefore, in exempting only certain effects of undertakings to the interstate highway system, the exemption met the requirements of 36 CFR 800.14(c)(1).

In accordance with Section 11504 of the FAST Act, the USDOT, led by FRA and FTA, proposed to the ACHP in July 2017 a Section 106 exemption that would have applied to certain types of undertakings within rail ROW that would result in effects to rail properties that were likely to be minimal or not adverse. FRA's and FTA's proposed exemption drew upon the collective expertise and experience of the USDOT OAs and acknowledged the unique history, construction, and technological improvements of railroads and rail transit systems. The exemption as initially drafted also included an optional Project Sponsor-led property-based approach that could have streamlined the review process for other types of undertakings having the potential to adversely affect historic properties.

To develop the proposed exemption, FRA and FTA held early coordination meetings with the ACHP, NCSHPO, and NTHP. The purpose of these meetings was to discuss the most effective approach to an exemption that would satisfy the FAST Act requirement. It was also identified during these meetings that more information on the history of rail transit development in the country was needed to have comparable information to what was contained in FRA's 2013 Study. Subsequently, in 2017 FTA prepared a broad historic context report entitled, “Historic Context Report for Transit Rail System Development.” 6 Also during the early coordination meetings, the ACHP, NCSHPO, and USDOT acknowledged that opportunities for stakeholder outreach would be provided to obtain input from railroad and rail transit industries, state agencies (e.g., state DOTs), SHPOs and THPOs, Indian tribes and Native Hawaiian organizations, and historic preservation interest groups.

FRA's and FTA's original approach to the proposed exemption was to treat the ROW in which railroads and rail transit systems operate as a resource unto itself that would be exempt from Section 106 review. FRA and FTA conducted outreach to discuss and seek feedback from stakeholders regarding how such a property-based approach might be developed and implemented. The ACHP expressed concern that a property-based approach would exceed the limit of its authority to exempt activities under 54 U.S.C. 304108(c) and 36 CFR 800.14(c)(1) because it did not define the program or category of undertakings that would be subject to its terms and as proposed, it could allow adverse effects to historic properties without requiring Section 106 review. The ACHP recommended that FRA and FTA take an activities-based approach to the Section 106 exemption that focused on routine undertakings involving rail properties located within rail ROW, with effects that would be foreseeable and likely to be minimal or not adverse. This recommendation was echoed in comments submitted to FRA and FTA by numerous stakeholders, particularly from the preservation community. The ACHP also recommended FRA and FTA consider developing a separate program comment to provide for the property-based approach along a parallel track.

Subsequently, in response to the concerns and requests of Project Sponsors, particularly transportation stakeholders, that the program alternative should include the flexibility to address a broader range of undertakings and effects to historic properties, FRA, FTA, and the ACHP decided to incorporate the proposed activities-based exemption within a proposed program comment in order to restore the two-part concept within a single program alternative, including the property-based approach, as originally proposed by FRA and FTA. The proposed program comment recognizes that many properties in the national railroad network and rail transit systems have historic significance and that important historic rail properties (as defined in the draft program comment, Section VI: Definition of Terms) located within rail ROW should remain subject to Section 106 review when proposed undertakings cannot avoid adverse effects on such properties.

The proposed program comment is intended to balance the need for continued safe and efficient transportation with the goals of historic preservation, and takes into account the differences between the Interstate Highway System and railroad and rail transit operations. Each railroad and rail transit system has its own unique history of construction and operation, including private or public ownership; periods of economic success; opening of key markets or geographic areas; and improvements, acquisition, and consolidation or abandonment. Many buildings and structures within rail ROW followed the common standard plans of a specific carrier, but there were exceptions for individual buildings, bridges, and other structures that may have unique qualities or unusual design characteristics. Similarly, many rail corridors follow a simple natural grade and alignment, but there were exceptions made for difficult terrain, climate, and topography that may have involved unique or unusual engineering techniques and structures. Railroads have been adapted to accommodate modern freight, passenger train operations, higher speeds, and much heavier freight loads than those for which the original rail infrastructure was designed and built. Finally, rail ROW is typically privately-owned, making it challenging or impossible to perform the cultural resources surveys usually necessary to develop a comprehensive inventory of rail properties.

The nation's rail ROW and rail properties located therein have a long history, dating to the mid-1800s, and maintenance, improvements, and upgrades are necessary to their preservation and continued safe use. These activities have occurred and continue to occur regularly within rail ROW to maintain the efficient use and safety of the nation's railroads, rail transit systems, and roads; and support the continued function for which surface transportation is historically important.

The continued operation of railroads and rail transit systems is vital to enabling the efficient and safe movement of people and goods throughout America. Various linear segments of rail lines, as well as individual buildings and structures along those rail lines, were determined eligible for and/or listed on the National Register prior to Congress's mandate to develop a Section 106 exemption for rail ROW.

A primary objective of the proposed program comment is to expedite certain types of maintenance, improvements, and upgrades to railroad and rail transit infrastructure located within rail ROW that typically have not resulted in adverse effects to historic properties based on years of experience gained through the Section 106 consultations among USDOT OAs, SHPOs, and consulting parties for individual undertakings. Under such an approach, fewer routine undertakings involving rail properties would be subject to Section 106 review thereby enabling federal agencies to focus their time and resources on undertakings that have the potential to cause adverse effects on historic properties. Federal agency staff, Project Sponsors, SHPOs, THPOs, and other stakeholders would be able to devote more time and resources to developing solutions that avoid, minimize, or resolve adverse effects to important historic rail properties and non-rail historic properties located within an undertaking's Area of Potential Effects (“APE”).

Recognizing the concerns and needs of industry stakeholders and seeking to achieve further efficiencies in project reviews, the ACHP, FRA and FTA incorporated the originally proposed exemption into a different program alternative under 36 CFR 800.14: a program comment. Unlike an exemption, which the ACHP can only approve for undertakings that have effects to historic properties that are foreseeable and likely to be minimal or not adverse, a program comment may provide an optional alternative process for compliance with Section 106 for a category of undertakings, including those that may result in adverse effects. Therefore, the proposed program comment includes both an activities-based exemption and an optional Project Sponsor-led approach to identify important historic rail properties and streamline the review process for other transportation-related activities. It is important to note that this Project Sponsor-led approach would require an investment of time and resources and would not likely result in immediate efficiencies as would the approval of the list of exempted activities under Appendix A. To ensure the requirements of the FAST Act are met, the program comment would incorporate the substance of the exemption for certain activities within rail ROW, as well as add the property-based approach as envisioned by FRA and FTA and discussed during the agencies' outreach to stakeholders in late 2016 and early 2017.

Given the unique history of the rail industry and the challenge of conducting the cultural resources surveys that would be needed to develop a comprehensive nationwide inventory of rail properties (including restrictions regarding access to privately-owned rail ROW, the extensive linear miles of rail ROW nationwide, and the number of qualified professionals and financial resources that would be needed), it is not feasible for USDOT OAs or Project Sponsors to identify all important historic rail properties nationwide concurrently with the development of this program alternative. The program comment would include a modified review process for transportation-related undertakings that would only apply after completion of the optional Project Sponsor-led approach to identify important historic rail properties within a study area.

Under the program comment, Project Sponsors, in coordination with the appropriate USDOT OA(s), the ACHP, NCSHPO, individual SHPOs/THPOs, NTHP, railroad and rail transit operators, state DOTs, and other appropriate stakeholders, would have the option to follow an established process to develop a list of important historic rail properties within a designated study area. The Project Sponsor would ensure that the public would be given an opportunity to provide input on the proposed list of such properties. The appropriate USDOT OA(s), in consultation with Project Sponsors, the ACHP, SHPOs/THPOs, and other stakeholders, would confirm the significance and integrity of these important historic rail properties consistent with National Register criteria.

The intent of this optional Project Sponsor-led identification and evaluation effort would be to (1) revisit those rail properties that have been previously determined eligible for listing or listed on the National Register to confirm that the property meets one or more of the National Register eligibility criteria, retains integrity, and is considered important (as defined in Section VI, Definitions of Terms), and (2) identify previously unevaluated rail properties located within the study area that should be recognized as important historic rail properties. Once the identification process is complete, federal agencies would be able to carry out, license, permit, or assist transportation-related undertakings that meet the terms listed in the Program Comment without further Section 106 review.

Project Sponsors could benefit from this optional property-based approach because it would expedite Section 106 reviews for non-routine undertakings through the early identification of and agreement on important historic rail properties located in rail ROW. The upfront identification of such properties would allow Project Sponsors to plan for and design projects within rail ROW in a manner that could avoid or minimize effects to such important properties. Furthermore, if a Project Sponsor completes the process to identify important historic rail properties, another review efficiency would apply. Future transportation-related activities within the same study area that require a license, permit, or assistance from any federal agency and that would affect rail properties that are not included on a USDOT OA-approved list of important historic rail properties would not be subject to further Section 106 review.

The lead federal agency for a proposed transportation-related undertaking in rail ROW will be responsible for determining if the program comment applies. Approval by the lead federal agency would be required in the form of written approval or through another established review and decision-making process normally used by the lead federal agency (e.g., grant-making processes or permit issuance).

In accordance with 36 CFR 800.14(e)(2), USDOT, in coordination with the ACHP, is arranging for public participation appropriate to the subject matter and scope of the category of undertakings to be included within this program comment. This notice invites the public to comment on the proposed draft program comment.

In addition to this notice, FRA and FTA have previously solicited the views of a diverse group of stakeholders and subject matter experts. While that outreach was conducted with the intent to develop a Section 106 exemption (as defined in 36 CFR 800.14(c)), the substance of FRA's and FTA's original proposal is essentially the same as the content of the draft program comment that is being made available for public review and comment in this notice. This outreach included in-person meetings, webinars followed up with attendees' submittal of written comments and questions, teleconferences, and presentations at national transportation conferences with representatives from the following: USDOT OAs, the ACHP, NCSHPO, the National Association of Tribal Historic Preservation Officers, NTHP, tribal governments, individual SHPOs and their staff, THPOs, and state DOTs; national transportation associations (e.g., AAR, American Public Transportation Association); private railroad companies; intercity passenger rail service providers (e.g., Amtrak) and rail transit agencies; the Surface Transportation Board (STB); 7 and historic preservation organizations (e.g., American Cultural Resources Association). These agencies and organizations shared their unique and varied perspectives and concerns and provided valuable feedback. Prior to transitioning the approach from an exemption to a program comment and when proposing to request an exemption, in response to the ACHP's recommendation to satisfy its consultation responsibilities under 36 CFR 800.14(c)(3), FRA and FTA provided a draft exemption to all SHPOs and THPOs for review and requested their feedback regarding any significant issues. Pursuant to 36 CFR 800.14(c)(4), the ACHP shared a draft of the proposed exemption with Indian tribes and Native Hawaiian organizations and hosted two conference calls to solicit their input and feedback. Comments were received from nine SHPOs and 14 tribes in October 2017. FRA and FTA considered these comments and made further revisions to the draft of the proposed exemption primarily to clarify the scope of the proposed exemption to make it clear that the focus was strictly on rail properties and would not apply to other types of historic properties that could be located within or adjacent to rail ROW. FRA and FTA also refined some of the proposed exempted activities in Appendix A in response to comments from SHPOs and Indian tribes, but did not eliminate any activities from the draft list because the agencies felt that all stakeholders should have the opportunity to review and provide comments. The draft exemption shared with SHPOs, THPOs, Indian tribes, and Native Hawaiian organizations in September and October 2017 focused only on exempted activities and did not include the optional Project Sponsor-led approach for identifying important historic rail properties.

The feedback received over the past year has been helpful in informing the development of the proposed program alternative and generally related to the following topics: (1) The scope, applicability, and implementation of exempt activities; (2) how important historic rail properties could be identified; (3) what types of resources, including archaeological sites, should explicitly not be covered by the program alternative; and (4) developing and clarifying the definitions of terms used in the proposed exemption. FRA and FTA used this feedback to refine the proposed list of exempt activities included in Appendix A and to revise key definitions (such as the definition of rail ROW). As FRA and FTA refined the approach to and scope of the proposed exemption based on stakeholder input, they determined that certain actions, such as those approved by STB (e.g., rail line abandonments, new rail line constructions) as well as conversion of rail ROW to shared use (e.g., bicycle, pedestrian) trails (sometimes referred to as “rails-to-trails” initiatives), have the potential to cause adverse effects or greater than minimal effects on historic properties, and therefore are not appropriate for inclusion in the proposed list of exempt activities included in Appendix A. The fundamental purpose of the proposed exempted activities list is to enable federal agencies to expedite reviews and approvals of proposed transportation-related undertakings for certain types of maintenance, improvements, and upgrades to railroad and rail transit infrastructure; accordingly, FRA and FTA expect that these activities would primarily involve extant buildings, structures, and equipment in existing rail ROW. Therefore, and in consideration of stakeholder comments received to date, FRA and FTA determined that effects to archaeological resources of any nature, including those associated with railroads and rail transit, should not be covered by the proposed exemption. Lastly, in response to feedback from NCSHPO and several individual SHPOs, the draft program comment includes an annual reporting requirement to help assess the effectiveness of Section 106 review streamlining as well as to help ensure that the program comment's terms are being appropriately applied.

In addition to providing substantive comments regarding the scope and content of the proposed exemption, some SHPOs questioned the type of Section 106 program alternative itself. The FAST Act specifically mandates development of an exemption; however, after further consideration and in order to fulfill the intent of that statutory mandate, USDOT and the ACHP have revised the exemption to this draft program comment. The program comment would have a broader scope and include more types of undertakings than would have the exemption.

The following is the draft text of the proposed program comment:

Section 106 of the National Historic Preservation Act (“NHPA”), 54 U.S.C. 306108 (“Section 106”), requires federal agencies to “take into account” the effects of their undertakings on historic properties and to provide the Advisory Council on Historic Preservation (ACHP) a reasonable opportunity to comment with regard to such undertakings. The ACHP has issued regulations that set forth the process through which federal agencies comply with these duties. Those regulations are codified under 36 CFR part 800 (“Section 106 regulations”).

Under section 800.14(e) of those regulations, agencies can request the ACHP to provide a “program comment” on a particular category of undertakings in lieu of conducting separate reviews of each individual undertaking under such category, as set forth in 36 CFR 800.3 through 800.7. Federal agencies can meet their Section 106 responsibilities with regard to the effects of transportation-related undertakings on rail properties located in railroad and rail transit rights-of-way (“rail ROW”) by following this program comment and the steps set forth therein.

This program comment exempts from Section 106 review the activities listed in Appendix A provided the conditions specified therein are met. It also establishes an optional Project Sponsor-led property-based approach. This optional approach could be followed to identify important historic rail properties in rail ROW in advance of specific transportation-related undertakings. Undertakings affecting such important historic rail properties and that involve activities not included in Appendix A would remain subject to Section 106 review, in order to ensure potential adverse effects are avoided, minimized, or mitigated. However, the optional property-based approach, described in Section IV below, if completed by an interested Project Sponsor, would also create efficiencies by (1) allowing transportation-related undertakings proposed to be carried out, licensed, permitted, or assisted by any federal agency to proceed without Section 106 review if the affected rail property(ies) is not on the USDOT OA-approved list of important historic rail properties and (2) providing Project Sponsors with an early awareness of which rail properties are important so that they could design projects in a manner to either avoid adverse effects or to factor sufficient time into project planning and design to resolve any unavoidable adverse effects.

The proposed program alternative has been developed in accordance with section 11504 of the FAST Act (49 U.S.C. 24202). Section 11504 mandated the development of a Section 106 exemption for “railroad rights-of-way.” More specifically, it required the Secretary of Transportation to submit a proposed exemption to the ACHP for consideration, and for the ACHP to issue a final exemption not later than 180 days after the date of receipt of U.S. Department of Transportation's (“USDOT's”) submittal.

Pursuant to 36 CFR 800.14(e), the ACHP can issue a program comment on its own initiative or at the request of another agency. This program comment would provide the ACHP's comment on those transportation-related undertakings that may affect rail properties within rail ROW. If a federal agency responsible for carrying out, licensing, permitting, or assisting such an undertaking with the potential to affect rail-related historic properties meets the terms of this program comment, its Section 106 responsibility to take into accounts those effects would be satisfied.

Under 36 CFR 800.14(c), an exemption from Section 106 for federal undertakings must be consistent with the purposes of the NHPA. Furthermore, in order to be exempted, the potential effects of those undertakings on historic properties must be “foreseeable and likely to be minimal or not adverse.” The substance of USDOT's originally proposed exemption, incorporated within this program comment, meets these criteria. The transportation-related undertakings that federal agencies carry out, license, permit, and assist to maintain, improve, or upgrade rail properties located within rail ROW will alter over time various elements of rail ROW, but such changes are minimal or not adverse when viewing rail ROW as a whole and when limited to the activities specified in Appendix A.

The program comment would apply to (1) those undertakings that are strictly limited to the activities listed in Appendix A and are carried out, licensed, permitted, or assisted by any federal agency and involve rail properties located within existing rail ROW; and (2) any transportation-related undertaking that would be carried out, licensed, permitted, or assisted by any federal agency and meets the terms for the completed optional Project-Sponsor led approach to identify important historic rail properties. The activities listed in Appendix A are for the intended purpose of routine maintenance, improvements, and upgrades to transportation infrastructure. Should the Program Comment be issued by the ACHP, federal agencies would be able to proceed with carrying out, licensing, permitting, or assisting undertakings that are limited to the activities listed in Appendix A and that meet the certain conditions specified therein without further Section 106 review regardless of whether the rail properties involved or affected are eligible for or listed on the National Register. Undertakings involving activities that are not included in Appendix A would not be included within the proposed exemption section of the program comment (e.g., demolition; decommissioning, abandonment and/or conversion of rail infrastructure to a non-transportation use; double-tracking a historically single-tracked rail corridor; major new construction activities such as construction of a new or substantially expanded passenger station; or construction of a new railroad or rail transit line on new right-of-way (commonly referred to as “greenfield construction”)). However, some of these activities may fall within the other section of the program comment regarding the optional Project Sponsor-led property-based approach.

Activities requiring a federal license, permit, or assistance that are not listed in Appendix A but constitute a transportation-related undertaking with the potential to affect rail properties located within rail ROW, as defined in Section VI, Definitions of Terms, would not require Section 106 review provided the optional Project Sponsor-led approach for identifying important historic rail properties has been completed for a defined study area and the affected rail property(ies) within that study area are not included on a USDOT OA-approved list of important historic rail properties.

If the optional Project Sponsor-led approach to identify important historic rail properties has been completed for a defined study area, transportation-related undertakings involving activities that are not included in Appendix A and would affect properties included on a USDOT OA-approved list of important historic rail would require Section 106 review. This would ensure that potential adverse effects to important historic rail properties are appropriately avoided, minimized, or mitigated consistent with the purposes of the NHPA.

Federal agencies remain responsible for determining whether a proposed undertaking, including those activities listed in Appendix A, has the potential to cause effects to non-rail historic properties, such as those of religious and cultural significance to Indian tribes or Native Hawaiian organizations or archaeological sites of any nature, in the undertaking's APE. If a federal agency determines such potential exists, the federal agency must follow the requirements of 36 CFR part 800 or follow an applicable program alternative executed pursuant to 36 CFR 800.14 in order to consider the potential effects to such properties located within that APE.

Under the Surface Transportation Project Delivery Program, codified at 23 U.S.C. 327, a state may assume the Secretary of Transportation's responsibilities to comply with Section 106 for certain projects or classes of projects. In such cases, the state may rely on this program comment to fulfill its Section 106 responsibilities. Where a program alternative developed pursuant to 36 CFR 800.14, such as a statewide programmatic agreement, delegates Section 106 responsibility to another entity, that entity may also utilize the terms of this program comment for relevant transportation-related undertakings.

Undertakings that are carried out by a federal agency or require a federal license, permit, or assistance to maintain, improve, or upgrade rail properties located in railroad and rail transit rights-of-way (“rail ROW”) and are limited to the activities specified in Appendix A: Exempted Activities, are exempt from the requirements of Section 106 of the National Historic Preservation Act, 54 U.S.C. 306108 (“Section 106”) because their effects on rail historic properties are foreseeable and likely to be minimal or not adverse.

If a Project Sponsor wishes to carry out a transportation-related activity that requires a federal license, permit, or assistance and is not included in Appendix A and therefore has the potential to cause adverse effects to historic rail properties, it must either: (1) Notify the lead federal agency, which will then determine whether the standard Section 106 process or an available program alternative applies to the proposed undertaking; or (2) follow the Project-Sponsor led approach outlined in this section to identify important historic rail properties. Important historic rail properties, as defined further in Section VI, are individual rail properties or rail property types that meet the National Register eligibility criteria (36 CFR part 63), illustrate the history of the development of the nation's railroads or rail transit systems, and either possess national significance or are of certain state or local importance.

Given the variety and number of rail properties nationwide, the fact that many systems cross state boundaries, and the challenges of a “one size fits all” nationwide approach, important historic rail properties would be initially identified within defined study areas by Project Sponsors that wish to get additional benefit from this program comment beyond the list of exempted activities included in Appendix A. The process would intentionally provide a great deal of flexibility for Project Sponsors to identify important historic rail properties to meet state and local needs and interests and to take into account state and local historic contexts. Within six months of the ACHP's issuance of the final Program Comment, FRA, FTA, and FHWA, in coordination with the ACHP, and other federal agencies who may have an interest in utilizing the Program Comment (e.g., permitting agencies such as US Army Corps of Engineers or US Coast Guard), will develop supplemental guidance for implementing the optional Project Sponsor-led property-based approach described below to identify important historic rail properties.

1. Individual Project Sponsors or multiple Project Sponsors working collaboratively must clearly identify the study area to be subject to this process: The portion of rail ROW (i.e., by location (state, county); name of rail corridor, railroad, rail transit system or line; mile-post information; etc.). Project Sponsors must propose to the appropriate USDOT OA(s) (i.e., FRA, FTA and/or FHWA), rail properties to be included on a list of important historic rail properties. To develop such a list, Project Sponsors will consult with the appropriate USDOT OA(s), appropriate State Historic Preservation Officers (“SHPOs”), appropriate Tribal Historic Preservation Officers (“THPOs”), and other interested parties, i.e. those parties that would typically be involved in the standard Section 106 process to identify historic properties as specified in 36 CFR 800.4(a)-(c), that have knowledge and expertise regarding rail properties and of the history and operations of the nation's railroads and rail transit systems. The proposed list of important historic rail properties may include particular individual properties (i.e., a building, structure, object, or district) or a property type (e.g., bridges of a certain type (stone arch, metal truss, covered, or moveable); roundhouses). The Project Sponsor's efforts to develop a list of important historic rail properties will be informed by available background research, historic context studies, surveys and evaluations performed by persons meeting the Secretary of the Interior's Professional Qualification Standards for Architectural Historians, and other relevant documentation and professional experience and expertise.

2. Once a Project Sponsor proposes a list of important rail properties located within a study area, the Project Sponsor will coordinate with the appropriate USDOT OA(s) to determine an appropriate method(s) for seeking public input on the proposed list and to determine which entity(ies) will be responsible for implementing the agreed-upon public outreach strategy. The Project Sponsor and/or the USDOT OA(s), as appropriate, will then implement the agreed-upon strategy. The USDOT OA(s) will consider input from interested parties and the public before approving the list of important historic rail properties.

3. The USDOT OAs make the final decision regarding the list of important historic rail properties within each study area, and will publish all finalized lists on their respective agency Web sites (www.fra.dot.gov, www.fta.dot.gov, or www.fhwa.dot.gov). The relevant USDOT OA will update the list anytime a Project Sponsor completes the process described herein to identify important historic rail properties located within another study area.

4. Once approved by the appropriate USDOT OA(s), the list of important historic rail properties will be available for use by any Project Sponsor and any federal agency.

Should any of the exempted activities in Appendix A referred to in Section III be proposed and affect important historic rail properties included on a USDOT OA-approved list, no further Section 106 review would be required for those activities.

For rail properties in a given study area that are not included on a USDOT OA-approved list of important historic rail properties, the effects of transportation-related undertakings to those rail properties would be exempt from Section 106 review.

Section 106 review is still required for transportation-related undertakings within rail ROW in the following situations under both the activities-based exemption and Project Sponsor-led property-based approach:

A. Undertakings that are located within, or would affect historic properties located on tribal lands;

B. Undertakings, within a study area that has completed the optional Project Sponsor-led approach that involve activities that are not included in Appendix A and would affect important historic rail properties

C. Undertakings that could affect historic buildings, structures, sites, objects, or districts that do not have a demonstrable association with the function and operation of a railroad or rail transit system;

D. Undertakings that could affect archaeological sites located within, partially within, or bisected by rail ROW, regardless of whether the sites are associated with railroads or rail transit systems; 8 and

E. Undertakings that could affect historic properties of religious and cultural significance to federally recognized Indian tribes or Native Hawaiian organizations.

In addition, federal agencies remain responsible for determining whether a proposed undertaking has the potential to cause effects to non-rail above-ground historic properties (buildings, structures, objects and districts) and archaeological sites of any nature (regardless of a rail nexus) that are located in the undertaking's area of potential effects (“APE”) but outside of or adjacent to rail ROW under both the activities-based exemption and Project Sponsor-led property-based approach.

Likewise, if an unanticipated discovery of a non-rail historic property, archaeological site, or human remains is made during implementation of an exempt activity listed in Appendix A, the Project Sponsor must cease the activity and consult with the lead federal agency, who must follow the requirements of 36 CFR 800.13(b) and/or applicable state burial law with regard to the discovery; if an undertaking involves multiple exempted activities, those that do not involve or effect the discovery may continue.

A. Area of potential effects, as defined in 36 CFR 800.16(d), means the geographic area or areas within which an undertaking may directly or indirectly cause alterations in the character or use of historic properties, if any such properties exist. The area of potential effects is influenced by the scale and nature of an undertaking and may be different for different kinds of effects caused by the undertaking.

B. Historic properties, as defined in 36 CFR 800.16(l), means any prehistoric or historic district, site, building, structure, or object included in, or eligible for inclusion in, the National Register of Historic Places maintained by the Secretary of the Interior. This term includes artifacts, records and remains that are related to and located within such properties. The term includes properties of religious and cultural importance to a federally recognized Indian tribe or Native Hawaiian organization that meet the National Register criteria.

C. Important historic rail properties means rail properties located in rail ROW that have been identified through the Project-Sponsor led approach established in Section IV. Such properties must meet the National Register eligibility criteria (36 CFR part 63), illustrate the history of the development of the nation's railroads or rail transit systems, and either possess national significance (see the definition below) or be of certain state or local importance. Examples of properties of certain state or local importance may include extant architectural properties, such as passenger depots, roundhouses, bridges, and tunnels that are not included in common standard plans; that met unique engineering challenges; that have exceptional design quality and characteristics; or that are of unusual or noteworthy importance, or are a rare property type.

D. National significance means a historic property that is either, (1) designated as a National Historic Landmark; (2) designated as a Civil Engineering Landmark; (3) listed as nationally significant in its nomination or listing in the National Register; or (4) determined to have significance at the national level.9

E. Project Sponsor means an entity such as a state, tribal or local government, joint venture, or private company that is eligible to receive financial assistance under a federal transportation-related financial assistance program (e.g., grant, loan). A project sponsor may also be an entity that requires a federal permit, license, or approval in order to carry out a proposed activity in rail ROW (e.g., a permit under Section 404 of the Clean Water Act issued by the Army Corps of Engineers or a permit under Section 9 of the Rivers and Harbors Act of 1899 issued by the United States Coast Guard).

F. Rail properties means, for the purpose of this program comment, infrastructure within the rail ROW that has a demonstrable relationship to the past or current function and operation of a railroad or rail transit system, including but not limited to: Rails and tracks, ties, ballast, rail beds, signal and communication systems, switches, overhead catenary systems, signage, traction power substations, passenger stations/depots and associated infrastructure and utilities, freight transfer facilities, boarding areas and platforms, boarding platform shelters and canopies, bridges, culverts, tunnels, retaining walls, ancillary facilities, ventilation structures, equipment maintenance and storage facilities, railyards, parking lots and structures, landscaping, passenger walkways, and security and safety fencing. The definition does not include properties with no demonstrable relationship to the function and operation of a railroad or rail transit system, such as: Adjacent residential, commercial or municipal buildings; archaeological resources underneath rail ROW that are unrelated to the railroad or rail transit line; or property unrelated to existing or former railroads and rail transit lines that is proposed to be used for new rail infrastructure.

G. Railroad and Rail Transit Rights-of-Way (rail ROW) means, for the purpose of this program comment, the land and infrastructure that have been developed for existing or former intercity passenger rail, freight rail, or rail transit operations, or that are maintained for the purpose of such operations. Rail ROW includes current or former railroad or rail transit lines regardless of current ownership and whether there is rail service operating on the railroad or rail transit line. It does not include land that was never developed and lacks visual evidence of historic railroad or rail transit use. Rail ROW includes and may be identifiable by the presence of infrastructure that has a demonstrable relationship to the past or current function and operation of a railroad or rail transit system that commonly includes but is not limited to the rail properties specified in the definition above.

H. Section 106 means Section 106 of the National Historic Preservation Act, 54 U.S.C. 306108, and its implementing regulations, 36 CFR part 800.

I. Undertaking, as defined at 36 CFR 800.16(y), means a project, activity, or program funded in whole or in part under the direct or indirect jurisdiction of a federal agency, including those carried out by or on behalf of a federal agency; those carried out with federal financial assistance; and those requiring a federal permit, license or approval.

This program comment shall go into effect on the date it is issued by the ACHP, at which time federal agencies may immediately utilize the list of exempted activities in Appendix A, including undertakings that have not yet been initiated and undertakings for which the Section 106 review process is underway but not completed.

Any lead federal agency that utilizes this program comment shall report annually to NCSHPO, NATHPO, and the ACHP regarding the application of the exempt activities in Appendix A. The USDOT OAs will also report annually to NCSHPO, NATHPO, and the ACHP regarding any coordination with Project Sponsors to pursue the property-based approach.

The Chairman of the ACHP may amend this program comment after consulting with the USDOT and other relevant federal agencies, NCSHPO, NATHPO, tribal representatives, the National Trust for Historic Preservation, and industry representatives, as appropriate. The ACHP will publish a notice in the Federal Register informing the public of any amendments that are made to the program comment.

This program comment will expire twenty (20) years from the date of its issuance, unless it is amended prior to that date to extend the period in which it is in effect.

The Chairman of the ACHP may withdraw this program comment, pursuant to 36 CFR 800.14(e)(6), by publication of a notice in the Federal Register 30 days before the withdrawal will take effect.

Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. Appendix.

As required by the Biggert-Waters Flood Insurance Reform Act of 2012, the TMAC makes recommendations to the FEMA Administrator on: (1) How to improve, in a cost-effective manner, the (a) accuracy, general quality, ease of use, and distribution and dissemination of flood insurance rate maps and risk data; and (b) performance metrics and milestones required to effectively and efficiently map flood risk areas in the United States; (2) mapping standards and guidelines for (a) flood insurance rate maps, and (b) data accuracy, data quality, data currency, and data eligibility; (3) how to maintain, on an ongoing basis, flood insurance rate maps and flood risk identification; (4) procedures for delegating mapping activities to State and local mapping partners; and (5) (a) methods for improving interagency and intergovernmental coordination on flood mapping and flood risk determination, and (b) a funding strategy to leverage and coordinate budgets and expenditures across Federal agencies. Furthermore, the TMAC is required to submit an Annual Report to the FEMA Administrator that contains: (1) A description of the activities of the Council; (2) an evaluation of the status and performance of flood insurance rate maps and mapping activities to revise and update Flood Insurance Rate Maps; and (3) a summary of recommendations made by the Council to the FEMA Administrator.

Agenda: On December 6, 2017, the TMAC will review the final narrative content for the TMAC 2017 Annual Report and conduct a vote on the final content and, if approved, submit the report including the previously approved 2017 recommendations and implementation actions to the FEMA Administrator. Members of the public will be afforded an opportunity to comment (no more than 2 minutes per individual) prior to any votes taken by the TMAC. A more detailed agenda will be posted by November 30, 2017, at http://www.fema.gov/TMAC.

The National Flood Insurance Program (NFIP) is authorized by the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4001 et seq. The Federal Emergency Management Agency (FEMA) administers the NFIP and maintains the maps that depict flood hazard information. The land area covered by the floodwaters of the base flood is the Special Flood Hazard Area (SFHA) on NFIP maps. The SFHA is the area where the NFIP's floodplain management regulations must be enforced and the area where the mandatory purchase of flood insurance applies. If a SFHA has been determined to exist for property and the owner or lessee of the property believes his/her property has been incorrectly included in a SFHA, information can be provided to support removal of the SFHA designation. NFIP regulations, at 44 CFR parts 65 and 70, outline the data that must be submitted by an owner or lessee of property who believes his/her property has been incorrectly included in a SFHA. In order to remove an area from a SFHA, the owner or lessee of the property must submit scientific or technical data demonstrating that the area is “reasonably safe from flooding” and not in the SFHA.

This information collection expired on September 30, 2017. FEMA is requesting a reinstatement, without change, of a previously approved information collection for which approval has expired.

Title: Revisions to National Flood Insurance Program Maps: Application Forms and Instructions for (C)LOMAs and (C)LOMR-Fs.

Type of information collection: Reinstatement, without change, of a previously approved information collection for which approval has expired.

OMB Number: 1660-0015.

Form Titles and Numbers: FEMA Form 086-0-26, Property Information; FEMA Form 086-0-26A, Elevation Form; FEMA Form 086-0-26B, Community Acknowledgement Form; FEMA Form 086-0-22 and FEMA Form 086-0-22A (Spanish), Application Form for Single Residential Lot or Structure Amendments to National Flood Insurance Program Maps.

Abstract: FEMA collects scientific and technical data submissions to determine whether a specific, single-lot property is located within or outside of a Special Flood Hazard Area (SFHA). If the property is determined not to be within a SFHA, FEMA provides a written determination and the appropriate map is modified by a Letter of Map Amendment (LOMA) or a Letter of Map Revision-Based on Fill (LOMR-F). The owner or lessee of a property uses a LOMA or LOMR-F to show that a property is not located within the SFHA, making it possible for the lending institution to waive the flood insurance requirement. If the policyholder decides to maintain insurance on the property, the new determination should result in lower rates.

Affected Public: Individuals and Households; and Business or Other for-Profit Institutes.

Estimated Number of Respondents: 121,116.

Estimated Number of Responses: 121,116.

Estimated Total Annual Burden Hours: 150,725 hours.

Estimated Total Annual Respondent Cost: $6,501,379.

Estimated Respondents' Operation and Maintenance Costs: $24,099,750.

Estimated Respondents' Capital and Start-Up Costs: $0.

Estimated Total Annual Cost to the Federal Government: $268,401.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Notice is hereby given that the incident period for this emergency is closed effective October 10, 2017.

Notice of this meeting is given in accordance with the Aviation Security Stakeholder Participation Act, codified at 49 U.S.C. 44946. Pursuant to 49 U.S.C. 44946(f), ASAC is exempt from the Federal Advisory Committee Act (5 U.S.C. App.). The committee provides advice and recommendations for improving aviation security measures to the Administrator of TSA.

The meeting will be open to the public and will focus on items listed in the “Meeting Agenda” section below. Members of the public, and all non-ASAC members and non-TSA staff must register in advance with their full name and date of birth to attend. Due to space constraints, the meeting is limited to 75 people, including ASAC members and staff, on a first to register basis. Attendees are required to present government-issued photo identification to verify identity.

In addition, members of the public must make advance arrangements, as stated below, to present oral or written statements specifically addressing issues pertaining to the items listed in the “Meeting Agenda” section below. The public comment period will begin at approximately 11:00 a.m., depending on the meeting progress. Speakers are requested to limit their comments to three minutes. Contact the person listed in the FOR FURTHER INFORMATION CONTACT section no later than November 30, 2017, to register to attend the meeting and/or to present oral or written statements addressing issues pertaining to the items listed in the “Meeting Agenda” section below. Anyone in need of assistance or a reasonable accommodation for the meeting should contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

The Committee will meet to discuss items listed in the agenda below:

The Deputy Secretary of the Department of Housing and Urban Development revokes and rescinds any Orders of Succession for the Office of Deputy Secretary that was signed by a previous Deputy Secretary or Acting Deputy Secretary, including Orders of Succession published in the Federal Register or published by memorandum.

This publication supersedes all prior Orders of Succession for the Office of the Deputy Secretary, including Orders of Succession published by memorandum on January 8, 2017 and August 4, 2017.

The African elephant (Loxodonta africana) is listed as threatened under the Endangered Species Act of 1973, as amended (ESA or Act; 16 U.S.C. 1531 et seq.), on the List of Endangered and Threatened Wildlife in title 50 of the Code of Federal Regulations (50 CFR 17.11(h)). It is also regulated under the provisions of section 4(d) of the Act (known as a “section 4(d) rule”) with a rule found at 50 CFR 17.40(e). The section 4(d) rule includes specific requirements for the import of sport-hunted trophies. Under § 17.40(e)(6)(i)(B), in order for the Service to authorize the import of a sport-hunted elephant trophy, the Service must find that the killing of the trophy animal will enhance the survival of the species in the wild (known as an “enhancement finding”).

The Zimbabwe elephant population, along with elephant populations in Botswana, Namibia, and South Africa, are also included in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) for the exclusive purpose of allowing certain trade subject to annotation, including trade in hunting trophies for noncommercial purposes. All specimens not included in the annotation are deemed Appendix I specimens, and trade in them is regulated accordingly. On August 22, 1997, the U.S. Fish and Wildlife Service (Service) published a proposed rule announcing decisions by the Conference of the Parties to CITES and seeking comment on whether the United States should enter a reservation for any of the species that had been listed on CITES Appendices I and II (62 FR 44627). We discussed how the populations of African elephants in Zimbabwe, Botswana, and Namibia had been down-listed from CITES Appendix I to Appendix II and noted that, because African elephants are listed under the ESA as threatened, the African elephant section 4(d) rule found at 50 CFR 17.40(e) would continue to apply. This rule required that we find that the killing of the animal whose trophy was intended for import would enhance the survival of the species before a sport-hunted trophy could be imported. We also stated that, in making the required enhancement finding for the import of sport-hunted trophies, the Service must review the status of the elephant population and the total management program for the elephant in each country to ensure the program is promoting the conservation of the species.

The preamble to the 1997 proposed rule noted that positive enhancement findings for the countries of Zimbabwe, Botswana, and Namibia had been made and would remain in effect until the Service found that the conditions of the section 4(d) rule are no longer met and published notice of a changed finding in the Federal Register. On May 18, 2001, we published a final rule again announcing decisions made at a meeting of the Conference of the Parties to CITES, including the decision to down-list the South African population of African elephants from CITES Appendix I to Appendix II (66 FR 27601). We again discussed the import requirements for African elephant sport-hunted trophies and stated that the enhancement finding for South African elephants would remain in effect until the Service found that conditions of the rule are no longer met and published notice of a changed finding in the Federal Register. The U.S. District Court for the District of Columbia, in Safari Club International, et al. v. Jewell, et al., 213 F. Supp. 3d 48 (D.D.C. Sept. 30, 2016), has held that the Service created a binding duty on itself when it stated in the preamble of the 1997 proposed rule that it would publish notice in the Federal Register before making a change in its 1997 enhancement finding for Zimbabwe, and that the Service then violated this commitment when it published the Federal Register notice on May 12, 2014, several weeks after making an interim negative enhancement finding for Zimbabwe on April 4, 2014. As remedy, the Court ordered that the effective date of the 2014 enhancement finding is the date of the Federal Register notice, May 12, 2014, meaning that trophies taken on or before May 11, 2014 were allowed to meet the enhancement requirement. We did not intend to create a legal duty to publish changed enhancement findings through these Federal Register preamble statements.

On June 6, 2016, the Service amended the African elephant section 4(d) rule (81 FR 36388). With this amendment, ESA permits are required to import all African elephant sport-hunted trophies, including those from the CITES Appendix II populations of Zimbabwe, Botswana, Namibia, and South Africa. Because all imports will be accompanied by a threatened species permit evaluated through the ESA permit application process found at 50 CFR 17.32(a), we will no longer publish notice of changed enhancement findings for African elephant sport-hunted trophies in the Federal Register. In the future, when there are subsequent changes to the determination, the individual applicant will be notified regarding whether his or her permit application was granted or denied, including a brief statement of the grounds for any denial. We may also post information on the import of African elephant hunting trophies on the Service's Web page (www.fws.gov/international), as appropriate and consistent with applicable laws and regulations.

On April 4, 2014, the Service announced an interim suspension of imports of sport-hunted elephant trophies taken in Zimbabwe during the 2014 season. We revised this finding on April 17, 2014, primarily to clarify that the suspension applied only to elephants hunted on or after April 4, 2014. This determination was announced in the Federal Register on May 12, 2014 (79 FR 26986). Our decision to establish an interim suspension of imports of elephant trophies from Zimbabwe was due to having insufficient information on the status of elephants in Zimbabwe and on Zimbabwe's current elephant management program to make an enhancement finding. On July 17, 2014, the Service found that the import of elephant trophies taken in Zimbabwe in 2014 on or after April 4, 2014, would be suspended. We revised this finding on July 22, 2014, to make non-substantive corrections and announced this determination in the Federal Register on July 31, 2014 (79 FR 44459). The July 17, 2014, decision to uphold the April 4, 2014, suspension was due to the Service being unable to make an enhancement finding even after receiving additional materials from the Zimbabwe Parks and Wildlife Management Authority (ZPWMA) and others. On March 26, 2015, the Service made another determination to continue the suspension (80 FR 42524, July 17, 2015). This decision was again due to the Service being unable to make an enhancement finding even after receiving additional materials from ZPWMA and others. The suspension that resulted from the negative enhancement findings did not prohibit U.S. hunters from traveling to Zimbabwe and participating in an elephant hunt. The Act does not prohibit take (e.g., hunting) within a foreign country; it prohibits import of trophies taken during such hunts without required authorization under the Act.

Following the Service's March 26, 2015, finding, the Service sent a letter on May 12, 2015, to the Honorable Saviour Kasukuwere, (formerly) Zimbabwe's Minister of Environment, Water and Climate, outlining the concerns the Service still had regarding elephant trophy imports from Zimbabwe. The letter identified six areas of concern: the lack of a current management plan; the current population status of elephants in Zimbabwe; poaching levels and prevention; regulations and enforcement concerns; the sustainable utilization of elephants in Zimbabwe; and the utilization of hunting revenues.

On July 20, 2015, ZPWMA responded to each of the questions outlined in the Service's letter and included a draft version of the Action Plan for Elephant Conservation and Management in Zimbabwe (2015-2020). In January 2016, the Service received the final version of the action plan, the Zimbabwe National Elephant Management Plan (2015-2020), that had been approved and signed by the (then) Director-General of ZPWMA Edson Chidziya, on January 20, 2016, and the Honorable Oppah Muchinguri-Kashiri, Minister of Environment, Water and Climate, on January 21, 2016.

In September 2016, during the 17th Meeting of the Conference of the Parties to CITES, the Service met with representatives from Zimbabwe to further discuss the current status of the Service's evaluation of the importation of elephant trophies. As a result of those conversations, the Service received a letter dated November 8, 2016, with supplemental information regarding Zimbabwe's elephant management plan priorities. Further, on January 27, 2017, the Service received a letter from ZPWMA containing a report, “The Role of Trophy Hunting of Elephants in Support of the Zimbabwe's Communal Areas Management Programme for Indigenous Resources (CAMPFIRE) Program: December 2016” that more fully discussed the source and amount of revenue generated between 2010 and 2015 through the CAMPFIRE program, the current role of CAMPFIRE, and how revenue generated by elephant hunting has been utilized within communal areas over this 6-year period and into the future.

Under 50 CFR 17.40(e)(6)(i)(B), the Service evaluates a number of factors to determine whether the killing of the trophy animal taken in a range country will enhance the survival of African elephants as well as taking into consideration the permit issuance criteria outlined in 50 CFR 17.32(a)(2). In evaluating each of these criteria, the Service has considered the information currently available to the Service as of the date of this finding on elephant hunting in Zimbabwe in 2016, 2017, and 2018, including information provided by the Government of Zimbabwe, current applicants for permits to import sport-hunted elephant trophies, interested individuals and organizations, and other information available to the Service.

On January 21, 2016, Zimbabwe adopted the Zimbabwe National Elephant Management Plan (2015-2020) (EMP) that replaced The Policy and Plan for Elephant Management in Zimbabwe (1997) and Elephant Management in Zimbabwe, third edition (July 1996), the former management plans. The EMP incorporates an adaptive management framework with higher level targets, with key components, strategic objectives, and outputs. Each key component has management actions that can be measured and verified through “Key Performance Indicators.” A set deadline for each action was identified. These measurable provisions allow ZPWMA to monitor the success of the new management plan and, through an adaptive management approach, address newly emerging concerns and long-term management needs. The EMP addresses the challenges identified by the 2014 workshop participants and concerns identified by the Service about the previous management plans. The EMP was developed as an outcome of several national and regional workshops that included government officials, nongovernmental organizations (NGOs), rural community leaders, and safari outfitters and landowners.

The 2014 Pan African Elephant Aerial Survey, also known as the Great Elephant Census (GEC), available in 2015, provided ZPWMA with a better elephant baseline population abundance estimate to assess future hunting quotas, management efforts, and anti-poaching activities. Confirmed results from the GEC reported an estimate for elephant abundance in Zimbabwe to be 82,304 individuals (73,715-90,893). The International Union for Conservation of Nature's African Elephant Specialist Group (IUCN AfESG) African Elephant Status Report-2016 estimated Zimbabwe's elephant population at 82,630 ± 8,589 across a range of 81,228 km2. The results of the 2014 GEC, and subsequent survey data reported in the 2016 AfESG report, are more reliable and provide a better basis for establishing management priorities than previous surveys and guesses, and are now utilized in the EMP and quota setting.

As identified in the 2015 finding, the Service explained that, if properly implemented, the ZPWMA regulatory mechanisms for managing elephants appear to be adequate. A key issue in the 2015 finding was whether an adequate mechanism is in place to reliably document the financial benefits that U.S. hunters provide for elephant conservation through participation in a hunting program that addresses management needs of the species and whether the funds were utilized in a meaningful manner. Since the 2015 finding, the Service has received information regarding the Tourism Receipts Accounting System (TRAS) and its web-based system (TRAS2) under which the Reserve Bank of Zimbabwe, in collaboration with relevant stakeholders, can now track all revenue generated through hunting activities. Under this system, all authorized hunts are now being registered, allowing for the capture of hunting data, such as the origin of clients, value of trophies and hunts, and area hunted, so that officials can monitor hunting quota utilization and track hunted trophies. This system will provide data that was not previously easily obtained and greatly improve the ability to track hunting revenue.

One concern expressed by the Service in its previous findings was whether ZPWMA was responding to the apparent poaching crisis facing Zimbabwe. Based on communication from ZPWMA, as well as information received from other sources, ZPWMA has stepped up its anti-poaching efforts nationally by adopting a number of “Urgent Measures.” As shown in their July 2015 response to Service questions, most of ZPWMA's budget (77 percent) is allocated to staff costs and patrol provisions. These expenditures reportedly fund anti-poaching efforts throughout the elephant range. ZPWMA reportedly has a staff of 1,504 active field rangers and has stated that there is intent to increase this number. According to “The Zimbabwe National Elephant Supplementary Management Plan (2015-2020)”, provided to the Service in late 2016, over 80 percent of spending under the new EMP has been on law enforcement (anti-poaching) and training, with law enforcement identified as the top priority going forward.

With the adoption of the EMP on January 21, 2016, it appears that ZPWMA has the means to successfully implement these laws and regulations. Moreover, ZPWMA has a mechanism in place to monitor the effects of the EMP and adapt to changing environmental and social factors that would adversely affect elephant populations within Zimbabwe.

According to the information provided to the Service in late 2014 and 2015, Zimbabwe had established hunting quotas for all areas of the country. However, it was not until late 2015 and early 2016 that the Service received more specific information on how these quotas are established, including how other forms of take, such as poaching and problem animal control, were taken into account. Further, it was not until the EMP was signed into effect on January 21, 2016, that the Service had confidence that ZWPMA had in place effective mechanisms to ensure long-term sustainability of its elephant population.

According to ZPWMA, quotas that were established before the EMP were set to maximize the sustainable production of high-quality trophies without detriment to the population. With the establishment of the EMP, there is a more systematic, scientific approach to establish national quotas. While ZPWMA still currently starts with an annual quota of 500 elephants, the quota is not immediately divided among all of the hunting areas. Instead, ZPWMA takes into consideration the results of the 2014 survey and subsequent surveys, results from research efforts, the size of the hunting area in relation to elephant habitat requirements, illegal harvest and other forms of take, how the hunting areas are managed in relation to land use or fencing, human-wildlife conflicts that have occurred previously, and recommended sustainable harvest levels developed based on ecological assessments of the hunting area. This information is then further evaluated in consideration of other species within the hunting area, past elephant trophy quality, and community benefits of proposed harvests.

Since our findings in 2014 and 2015, CAMPFIRE has provided more information on how their programs support the conservation of elephants and provide benefits to and promote greater tolerance of wildlife in rural communities, including new efforts to improve the effectiveness of CAMPFIRE and new revenue-sharing guidelines. An overarching analysis of CAMPFIRE, supported by a grant of 12 million Euros from the European Union, is currently being conducted and is scheduled to be completed by the end of 2017. Although this review is still under way, more information has been provided to the Service regarding how funds are utilized and the basis for hunting quotas.

Since our 2014 and 2015 findings, there are strong indications that the efforts of private landowners and consortiums to manage elephants within their areas of control have received greater support from ZPWMA and the Zimbabwean Government. ZPWMA has devolved authority to manage and benefit from wildlife on communal and private lands to the landholders. There now appears to be a greater effort on the part of ZPWMA to work with NGOs, landowners, and safari area concessionaires to improve elephant management and anti-poaching efforts. According to their July 2015 response to the Service, and supported by the report on the implementation of the EMP, ZPWMA is engaging private players in co-management in some areas and entering into long-term lease agreements (10-25 years) to manage some protected areas. In certain areas, ZPWMA is reportedly collaborating with safari operators; in others, they collaborate with NGOs, such as the Tashinga Initiative in the Zambezi Valley and World Wildlife Fund in the Hwange-Sanyati Biological Corridor. There is increased support from the Central Government and Rural District Councils to expand and support local conservation efforts, and there is evidence that local conservation efforts are meeting management deficiencies that the Service identified previously.

Therefore, in accordance with the regulatory requirements, the Service is able to make a determination that the killing of trophy animals in Zimbabwe, on or after January 21, 2016, and on or before December 31, 2018, will enhance the survival of the African elephant. With the information currently available, applications to import trophies hunted during this time period will be considered to have met this requirement unless we issue a new finding based on available information. In accordance with the section 4(d) rule for the African elephant at 50 CFR 17.40(e), the Service will review each application received for import of such specimens on a case-by-case basis and each application also needs to meet all other applicable permitting requirements before it may be authorized. On an ongoing basis and as it evaluates each application, the Service will continue to monitor the status of the elephant population, the management program for elephants in the country to ensure that the program is promoting the conservation of the species, and whether the participation of U.S. hunters in the program provides a clear benefit to the species. Accordingly, the Service may modify its determination based on available information consistent with the regulatory requirements. In addition, the Service will reevaluate the status of African elephants in Zimbabwe before the end of 2018 and make a new finding in the beginning of 2019 for, at least, the 2019 hunting season.

Today's enhancement finding has been posted at http://www.fws.gov/international/pdf/enhancement-finding-2017-elephant-Zimbabwe.PDF. In addition, a list of frequently asked questions regarding the importation of sport-hunted elephant trophies from Zimbabwe is available on the Service's web page at https://www.fws.gov/international/permits/by-activity/sport-hunted-trophies-elephants.html.