Federal Register Vol. 83, No.50,

Public Call Information: Dial: 800-967-7141; Conference ID 1621861.

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

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

This is the fourth in a series of public meetings the Committee will hold on this topic. Please consult the Federal Register or contact the Regional Programs Unit for additional information on these meetings.

Background

This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on November 1, 2017.1 On December 1, 2017, the Department postponed the preliminary determination of this investigation by no later than 130 days after the date on which Commerce initiated this investigation.2

Commerce exercised its discretion to toll all deadlines affected by the closure of the Federal Government from January 20 through 22, 2018. If the new deadline falls on a nonbusiness day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the publication of the preliminary determination of this investigation is now March 7, 2018.3

For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.4 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

The products covered by this investigation are forged steel fittings from China. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the preamble to Commerce's regulations,5 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage, (i.e., scope).6 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice.

For a summary of the product coverage comments and rebuttal responses submitted to the record for this preliminary determination, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.7 The Department is preliminarily modifying the scope language as it appeared in the Initiation Notice. 8 As stated in the Preliminary Scope Decision Memorandum, all interested parties are invited to comment on the proposed modifications no later than March 19, 2018; rebuttal comments are due no later than March 26, 2018. Such comments must be filed via ACCESS on the records of this countervailing duty investigation and the concurrent antidumping duty investigations of forged steel fittings from China, Italy and Taiwan.

Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.9

Commerce notes that, in making these findings, it relied, in part, on facts available and, because it finds that one or more respondents did not act to the best of their ability to respond to Commerce's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available.10 For further information, see “Use of Facts Otherwise Available and Adverse Inferences” in the Preliminary Decision Memorandum.

As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of forged steel fittings from China based on a request made by the petitioners.11 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than July 23, 2018, unless postponed.

Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, the Department shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and de minimis rates and any rates based entirely under section 776 of the Act.

The Department calculated an individual estimated countervailable subsidy rate for Both-Well (Taizhou) Steel Fittings, Co., Ltd. (Both-Well), the only individually examined exporter/producer in this investigation. Because the only individually calculated rate is not zero, de minimis, or based entirely under section 776 of the Act, the estimated weighted-average rate calculated for Both-Well is the rate assigned to all-other producers and exporters, pursuant to section 705(c)(5)(A)(i) of the Act.

The Department preliminarily determines that the following estimated countervailable subsidy rates exist:

In accordance with section 703(d)(1)(B) and (d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the “Scope of the Investigation” section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the rates indicated above.

Commerce intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of its public announcement, or if there is no public announcement, within five days of the date of this notice in accordance with 19 CFR 351.224(b).

As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.12 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its determination. If the final determination is affirmative, the ITC will make its final determination before the later of 120 days after the date of this preliminary determination or 45 days after Commerce's final determination.

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

On May 31, 2017, Commerce published its Amended Initiation Notice.1 According to the Amended Initiation Notice, Commerce stated it was initiating an administrative review only on entries where CS Wind Group was (1) the producer but not the exporter, or (2) the exporter but not the producer of subject merchandise. On November 6, 2017, Commerce published the Preliminary Results.2 The POR is February 1, 2016, through January 31, 2017. We invited interested parties to comment on the Preliminary Results. No party provided comments. Commerce has conducted this administrative review in accordance with section 751(a)(1) of the Tariff Act of 1930, as amended (the Act).

The merchandise covered by this order are certain wind towers, whether or not tapered, and sections thereof. Certain wind towers are designed to support the nacelle and rotor blades in a wind turbine with a minimum rated electrical power generation capacity in excess of 100 kilowatts and with a minimum height of 50 meters measured from the base of the tower to the bottom of the nacelle (i.e., where the top of the tower and nacelle are joined) when fully assembled.

A wind tower section consists of, at a minimum, multiple steel plates rolled into cylindrical or conical shapes and welded together (or otherwise attached) to form a steel shell, regardless of coating, end-finish, painting, treatment, or method of manufacture, and with or without flanges, doors, or internal or external components (e.g., flooring/decking, ladders, lifts, electrical buss boxes, electrical cabling, conduit, cable harness for nacelle generator, interior lighting, tool and storage lockers) attached to the wind tower section. Several wind tower sections are normally required to form a completed wind tower.

Wind towers and sections thereof are included within the scope whether or not they are joined with nonsubject merchandise, such as nacelles or rotor blades, and whether or not they have internal or external components attached to the subject merchandise.

Specifically excluded from the scope are nacelles and rotor blades, regardless of whether they are attached to the wind tower. Also excluded are any internal or external components which are not attached to the wind towers or sections thereof.

Merchandise covered by the order is currently classified in the Harmonized Tariff System of the United States (HTSUS) under subheadings 7308.20.0020 3 or 8502.31.0000.4 Prior to 2011, merchandise covered by the order was classified in the HTSUS under subheading 7308.20.0000 and may continue to be to some degree. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive.

As explained above, in the Preliminary Results, Commerce found that CS Wind Group did not have any shipments of subject merchandise during the POR where CS Wind Group was (1) the producer but not the exporter, or (2) the exporter but not the producer of subject merchandise. Also, in the Preliminary Results, consistent with Commerce's assessment practice in non-market economy cases, Commerce stated it was not rescinding this review but intended to complete the review with respect to CS Wind Group for which it had preliminarily found no shipments and issue appropriate instructions to U.S. Customs and Border Protection (CBP) based on the final results of the review.5

After issuing the Preliminary Results, Commerce received no comments from interested parties, and has not received any information that would cause it to alter our preliminary determination of no shipments. Therefore, for these final results, Commerce continues to find that CS Wind Group did not have any shipments of subject merchandise during the POR where CS Wind Group was (1) the producer but not the exporter, or (2) the exporter but not the producer of subject merchandise. As Commerce received no comments or new information for consideration in these final results, Commerce has not prepared an Issues and Decision Memorandum for this administrative review.

Commerce has determined, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review.6 Commerce intends to issue assessment instructions to CBP 15 days after the date of publication of these final results of review. Additionally, because Commerce determined that CS Wind Group had no shipments of subject merchandise during the POR, any suspended entries that entered under CS Wind Group's antidumping duty case number (i.e., at that exporter's rate) will be liquidated at the Vietnam-wide rate.7

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 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 CS Wind Group, which claimed no shipments, the cash deposit rate will remain unchanged from the rate assigned to CS Wind Group in the most recently issued Notice of Court Decision Not in Harmony with the Final Determination of Less Than Fair Value Determination; 8 (2) for previously investigated Vietnam and non-Vietnam exporters that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (3) for all Vietnam exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the rate previously established for the Vietnam-wide entity (i.e., 58.54 percent); and (4) for all non-Vietnam exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Vietnam exporter that supplied that non-Vietnam exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final 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 Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

In accordance with 19 CFR 351.305(a)(3), 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 APO, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or 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 sanctionable violation.

These final results of this administrative review and notice are published in accordance with sections 751(a)(l) and 777(i)(l) of the Act and 19 CFR 351.213(h).

Background

On July 21, 2016, Commerce published its final determination in the CVD investigation of HWR pipes and tubes from Turkey.2 On September 13, 2016, Commerce published an amended final determination and the CVD order.3

The Court remanded one aspect of Commerce's findings for further consideration.4 Specifically, in its Remand and Opinion Order, the Court held that, if Commerce decided to maintain its Land for Less than Adequate Remuneration (LTAR) benchmark calculation, it must explain the following: (1) Why the high prices for the Istanbul and Yalova Altinova (Yalova) land parcels were not aberrational, and how calculating a simple average of all the land parcel prices used in the land benchmark calculation successfully moderated the price disparities; (2) whether the Istanbul and Yalova land parcels were located in more highly developed areas of Turkey and how that affected Commerce's analysis; and (3) why the future usage of the land parcels is relevant under the applicable provisions of the statute and Commerce's regulations.5

On December 11, 2017, Commerce issued its Remand Redetermination. 6 In its Remand Redetermination, Commerce determined that there was a reasonable basis for treating the Istanbul and Yalova land parcels as outliers because (1) the prices of these parcels deviated substantially from the other prices in the dataset; and (2) the average price of the land parcels in the benchmark would be skewed if the Istanbul and Yalova land parcels were not removed from the dataset.7 Additionally, in its Remand Redetermination, Commerce stated that although it generally avoids selectively removing prices from datasets, it has occasionally done so after finding certain data to be clearly aberrational or unreliable.8 In removing the two parcels at issue from the benchmark, Commerce found that other issues raised by the Court, namely the relative levels of development of the land parcels in the benchmark, the importance of a land parcel's future usage in Commerce's benchmark selection, and other issues involving comparability, were moot.9 Therefore, Commerce did not address these issues in the Remand Redetermination.

On February 1, 2018, the CIT sustained Commerce's Remand Redetermination. 10

In its decision in Timken, 11 as clarified by Diamond Sawblades, 12 the United States Court of Appeals for the Federal Circuit (CAFC) held that, pursuant to section 516A(e) of the Tariff Act of 1930, as amended (the Act), Commerce must publish a notice of a court decision that is not “in harmony” with a Commerce determination and must suspend liquidation of entries pending a “conclusive” court decision. The CIT's February 1, 2018, final judgment affirming the Remand Redetermination constitutes a final decision of that court which is not in harmony with the Amended Final Determination and Order. This notice is published in fulfillment of the publication requirements of Timken. Accordingly, Commerce will continue suspension of liquidation of subject merchandise pending expiration of the period of appeal or, if appealed, pending a final and conclusive court decision.

As there is now a final court decision, Commerce amends its Amended Final Determination and Order. Commerce finds that the following revised net countervailable subsidy rates exist:

Because there has been no subsequent administrative review for MMZ Onur Boru Profit uretirn San Ve Tic. A.S. (MMZ) and Ozdemir, Commerce will instruct U.S. Customs and Border Protection (CBP) to set the cash deposit rates for these companies to the rates listed above, pending a final and conclusive court decision.

Pursuant to section 705(c)(5)(A) of the Act, companies not individually investigated are assigned an “all-others” countervailing duty rate. As a general rule, the all-others rate is equal to the weighted-average of the countervailable subsidy rates established for individually investigated producers, excluding any zero and de minimis countervailable subsidy rates.13 Commerce will instruct CBP that the “all-others” cash deposit rate is to be amended to reflect the revised subsidy rate calculated for Ozdemir, as listed above.

This notice is issued and published in accordance with sections 516A(e)(1), 705(c)(1)(B), and 777(i)(1) of the Act.

Background

In accordance with sections 735(d) and 777(i)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.210(c), on January 16, 2018, Commerce published its affirmative final determinations in the less-than-fair-value (LTFV) investigations of wire rod from South Africa and Ukraine.1 On March 1, 2018, the ITC notified Commerce of its final affirmative determination that an industry in the United States is materially injured within the meaning of section 735(b)(1)(A)(i) of the Act, by reason of the LTFV imports of wire rod from South Africa and Ukraine, and its determination that critical circumstances do not exist with respect to imports of wire rod from South Africa subject to Commerce's affirmative critical circumstances determination.2 The ITC published its final determination on March 7, 2018.3

The merchandise covered by these orders is wire rod from South Africa and Ukraine. For a complete description of the scope of these orders, see the Appendix to this notice.

On March 1, 2018, in accordance with sections 735(b)(1)(A)(i) and 735(d) of the Act, the ITC notified Commerce of its final determinations in these investigations, in which it found that an industry in the United States is materially injured by reasons of imports of wire rod from South Africa and Ukraine.4 The ITC also notified Commerce of its determination that critical circumstances do not exist with respect to imports of wire rod from South Africa subject to Commerce's critical circumstances finding.5 Therefore, in accordance with section 735(c)(2) of the Act, we are issuing these AD orders. Because the ITC determined that imports of wire rod from South Africa and Ukraine are materially injuring a U.S. industry, unliquidated entries of such merchandise from South Africa and Ukraine, entered or withdrawn from warehouse for consumption, are subject to the assessment of antidumping duties.

As a result of the ITC's final affirmative determinations, in accordance with section 736(a)(1) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price (or constructed export price) of the merchandise, for all relevant entries of wire rod from South Africa and Ukraine. Antidumping duties will be assessed on unliquidated entries of wire rod from South Africa and Ukraine entered, or withdrawn from warehouse, for consumption on or after October 31, 2017, the date of publication of the preliminary determinations,6 but will not include entries occurring after the expiration of the provisional measures period and before publication in the Federal Register of the ITC's final injury determination, as further described below.

In accordance with section 735(c)(1)(B) of the Act, we will instruct CBP to reinstitute suspension of liquidation on all relevant entries of wire rod from South Africa and Ukraine. These instructions suspending liquidation will remain in effect until further notice.

Commerce will also instruct CBP to require cash deposits for estimated antidumping duties equal to the estimated weighted-average dumping margins indicated below. Accordingly, effective the date of publication of the ITC's final affirmative injury determination in the Federal Register, CBP will require, at the same time as importers would normally deposit estimated duties on this subject merchandise, a cash deposit equal to the estimated weighted-average dumping margins listed below.7 The relevant “all-others” rates apply to all producers or exporters not specifically listed, as appropriate.

Section 733(d) of the Act states that the suspension of liquidation pursuant to an affirmative preliminary determination may not remain in effect for more than four months, except that Commerce may extend the four-month period to no more than six months at the request of exporters representing a significant proportion of exports of the subject merchandise. In reference to these proceedings, a request to extend the final determination and extend provisional measures pursuant to 19 CFR 351.210(e) was received from exporters of wire rod from South Africa and the Ukraine. Commerce's preliminary determinations were published on October 31, 2017.8 Commerce's final determinations were not extended, and were published on January 16, 2018. As such, the four-month period ended on February 27, 2018. Pursuant to section 737(b) of the Act, the collection of cash deposits at the rates listed below will begin on the date of publication of the ITC's final injury determination.

Therefore, in accordance with section 733(d) of the Act, Commerce will instruct CBP to terminate the suspension of liquidation and to liquidate, without regard to antidumping duties, unliquidated entries of wire rod from South Africa and Ukraine entered, or withdrawn from warehouse, for consumption after February 27, 2018, the date on which provisional measures expired, through the day preceding the date of publication of the ITC's final determination in the Federal Register. Suspension of liquidation will resume on the date of publication of the ITC's final determination in the Federal Register.

With regard to the ITC's negative critical circumstances determination regarding imports of wire rod from South Africa, Commerce will instruct CBP to lift suspension and refund any cash deposits made to secure payment of estimated antidumping duties on subject merchandise entered, or withdrawn from warehouse, for consumption on or after August 2, 2017, (i.e., 90 days prior to the date of publication of the preliminary determinations), but before October 31, 2017, (i.e., the date of publication of the preliminary determinations).

The estimated weighted-average dumping margins for each antidumping order are as follows:

This notice constitutes the antidumping duty orders with respect to wire rod from South Africa and Ukraine pursuant to section 736(a) of the Act. Interested parties can find a list of AD orders currently in effect at http://enforcement.trade.gov/stats/iastats1.html.

These orders are published in accordance with section 736(a) of the Act and 19 CFR 351.211(b).

Commerce published the Preliminary Results of this administrative review in the Federal Register on September 7, 2017.1 We invited interested parties to comment on the Preliminary Results. On October 24, 2017, we received a timely case brief from Yama.2 On October 31, 2017, we received timely rebuttal comments from Berwick Offray LLC (the petitioner).3 On November 28, 2017, Commerce postponed the final results of review until March 6, 2018. Based on an analysis of the comments received, Commerce has made no changes to the subsidy rate determined for the respondent. The final subsidy rate is listed below in the “Final Results of Administrative Review” section.

Commerce exercised its discretion to toll all deadlines affected by the closure of the Federal Government from January 20 through 22, 2018. The revised deadline for the final determination of this investigation is now March 9, 2018.4

The merchandise covered by the order are narrow woven ribbons with woven selvedge from China. A full description of the scope of the order is contained in the Issues and Decision Memorandum, which is hereby adopted by this notice.5

All issues raised in interested parties' briefs are addressed in the Issues and Decision Memorandum accompanying this notice. A list of the issues raised by interested parties and to which we responded in the Issues and Decision Memorandum is provided in the Appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be access directly at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Issues and Decision Memorandum are identical in content.

Based on the comments received from the interested parties, we made no changes to our subsidy rate calculation. For a discussion of these issues, see the Issues and Decision Memorandum.

Commerce conducted this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, we find that there is a subsidy, i.e., a financial contribution from a government or public entity that gives rise to a benefit to the recipient, and that the subsidy is specific.6 For a full description of the methodology underlying all of Commerce's conclusions, including any determination that relied upon the use of adverse facts available pursuant to sections 776(a) and (b) of the Act, see the Issues and Decision Memorandum.

In accordance with section 777A(e) of the Act and 19 CFR 351.221(b)(5), we determine the total net countervailable subsidy rate for the period January 1, 2015 to December 31, 2015 to be:

In accordance with 19 CFR 351.212(b)(2), Commerce intends to issue appropriate instructions to U.S. Customs and Border Protection (CBP) 15 days after the date of publication of the final results of this review. Commerce will instruct CBP to liquidate shipments of subject merchandise produced and/or exported by the company listed above, entered, or withdrawn from warehouse, for consumption, from January 1, 2015, through December 31, 2015, at the ad valorem rate listed above.

Commerce intends also to instruct CBP to collect cash deposits of estimated countervailing duties in the amount shown above for Yama, on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. For all non-reviewed firms, Commerce will instruct CBP to continue to collect cash deposits at the most recent company-specific or all-others rate applicable to the company, as appropriate. Accordingly, the cash deposit requirements that will be applied to companies covered by this order, but not examined in this administrative review, are those established in the most recently completed segment of the proceeding for each company. These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or 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 sanctionable violation.

These final results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

The Board of Overseers of the Malcolm Baldrige National Quality Award (Board) was established in accordance with 15 U.S.C. 3711a(d)(2)(B), pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

1. The Board shall review the work of the private sector contractor(s), which assists the Director of NIST in administering the Malcolm Baldrige National Quality Award (Award). The Board will make such suggestions for the improvement of the Award process as it deems necessary.

2. The Board shall make an annual report on the results of Award activities to the Director of NIST, along with its recommendations for the improvement of the Award process.

3. The Board will function solely as an advisory committee under the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

4. The Board will report to the Director of NIST.

1. The Board will consist of at least five and approximately 12 members selected on a clear, standardized basis, in accordance with applicable Department of Commerce guidance, and for their preeminence in the field of organizational performance excellence. There will be a balanced representation from U.S. service, manufacturing, nonprofit, education, and health care industries. The Board will include members familiar with the quality, performance improvement operations, and competitiveness issues of manufacturing companies, service companies, small businesses, nonprofits, health care providers, and educational institutions.

2. Board members will be appointed by the Secretary of Commerce for three-year terms and will serve at the discretion of the Secretary. All terms will commence on March 1 and end on the last day of February of the appropriate years.

1. Members of the Board shall serve without compensation, but may, upon request, be reimbursed travel expenses, including per diem, as authorized by 5 U.S.C. 5701 et seq.

2. The Board will meet at least annually, but usually two times a year. Additional meetings may be called as deemed necessary by the NIST Director or by the Chairperson. Meetings are usually one day in duration.

3. Board meetings are open to the public. Board members do not have access to classified or proprietary information in connection with their Board duties.

1. Nominations are sought from the private and public sector as described above.

2. Nominees should have established records of distinguished service and shall be familiar with the quality improvement operations and competitiveness issues of manufacturing companies, service companies, small businesses, educational institutions, health care providers, and nonprofit organizations. The category (field of eminence) for which the candidate is qualified should be specified in the nomination letter. Nominations for a particular category should come from organizations or individuals within that category. A summary of the candidate's qualifications should be included with the nomination, including (where applicable) current or former service on Federal advisory boards and Federal employment. In addition, each nomination letter should state that the person agrees to the nomination, acknowledges the responsibilities of serving on the Board, and will actively participate in good faith in the tasks of the Board. Besides participation at meetings, it is desired that members be able to devote the equivalent of seven days between meetings to either developing or researching topics of potential interest, and so forth, in furtherance of their Board duties.

3. The Department of Commerce is committed to equal opportunity in the workplace and seeks a broad-based and diverse Board membership.

The Judges Panel of the Malcolm Baldrige National Quality Award (Panel) was established in accordance with 15 U.S.C. 3711a(d)(1) and the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

1. The Panel will ensure the integrity of the Malcolm Baldrige National Quality Award (Award) selection process. Based on a review of results of examiners' scoring of written applications, Panel members will vote on which applicants' merit site visits by examiners to verify the accuracy of quality improvements claimed by applicants. The Panel will also review results and findings from site visits, and recommend Award recipients.

2. The Panel will ensure that individual judges will not participate in the review of applicants as to which they have any real or perceived conflict of interest.

3. The Panel will function solely as an advisory body, and will comply with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

4. The Panel will report to the Director of NIST.

1. The Panel will consist of no less than 9, and not more than 12, members selected on a clear, standardized basis, in accordance with applicable Department of Commerce guidance. There will be a balanced representation from U.S. service, manufacturing, small business, nonprofit, education, and health care industries. The Panel will include members familiar with the quality improvement operations and competitiveness issues of manufacturing companies, service companies, small businesses, nonprofits, health care providers, and educational institutions.

2. Panel members will be appointed by the Secretary of Commerce for three-year terms and will serve at the discretion of the Secretary. All terms will commence on March 1 and end on the last day of February of the appropriate year.

1. Members of the Panel shall serve without compensation, but may, upon request, be reimbursed travel expenses, including per diem, as authorized by 5 U.S.C. 5701 et seq.

2. The Panel will meet three times per year. Additional meetings may be called as deemed necessary by the NIST Director or by the Chairperson. Meetings are usually one to four days in duration. In addition, each Judge must attend an annual three-day Examiner training course.

3. When approved by the Department of Commerce Chief Financial Officer and Assistant Secretary for Administration, Panel meetings are closed or partially closed to the public.

1. Nominations are sought from all U.S. service and manufacturing industries, small businesses, education, health care, and nonprofits as described above.

2. Nominees should have established records of distinguished service and shall be familiar with the quality improvement operations and competitiveness issues of manufacturing companies, service companies, small businesses, health care providers, educational institutions, and nonprofit organizations. The category (field of eminence) for which the candidate is qualified should be specified in the nomination letter. Nominations for a particular category should come from organizations or individuals within that category. A summary of the candidate's qualifications should be included with the nomination, including (where applicable) current or former service on federal advisory boards and federal employment. In addition, each nomination letter should state that the person agrees to the nomination, acknowledges the responsibilities of serving on the Panel, and will actively participate in good faith in the tasks of the Panel. Besides participation at meetings, it is desired that members be either developing or researching topics of potential interest, reading Baldrige applications, and so forth, in furtherance of their Panel duties.

3. The Department of Commerce is committed to equal opportunity in the workplace and seeks a broad-based and diverse Panel membership.

The ISPAB (Committee or Board) was originally chartered as the Computer System Security and Privacy Advisory Board by the Department of Commerce pursuant to the Computer Security Act of 1987 (Pub. L. 100-235). The E-Government Act of 2002 (Pub. L. 107-347, Title III), amended Section 21 of the National Institute of Standards and Technology Act (15 U.S.C. 278g-4), including changing the Committee's name, and the charter was amended accordingly.

1. The Board will identify emerging managerial, technical, administrative, and physical safeguard issues relative to information security and privacy.

2. The Board will advise NIST, the Secretary of Homeland Security, and the Director of the Office of Management and Budget (OMB) on information security and privacy issues pertaining to Federal Government information systems, including thorough review of proposed standards and guidelines developed by NIST.

3. The Board shall report to the Director of NIST.

4. The Board reports annually to the Secretary of Commerce, the Secretary of Homeland Security, the Director of OMB, the Director of the National Security Agency, and the appropriate committees of the Congress.

5. The Board will function solely as an advisory body, in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

1. The Director of NIST will appoint the Chairperson and the members of the ISPAB, and members serve at the discretion of the NIST Director. Members will be selected on a clear, standardized basis, in accordance with applicable Department of Commerce guidance.

2. The ISPAB will consist of a total of 12 members and a Chairperson.

• The Board will include four members from outside the Federal Government who are eminent in the information technology industry, at least one of whom is representative of small or medium sized companies in such industries.

• The Board will include four members from outside the Federal Government who are eminent in the fields of information technology, or related disciplines, but who are not employed by or representative of a producer of information technology.

• The Board will include four members from the Federal Government who have information system management experience, including experience in information security and privacy, at least one of whom shall be from the National Security Agency.

1. Members of the Board, other than full-time employees of the Federal government, will not be compensated for their services, but will, upon request, be allowed travel expenses pursuant to 5 U.S.C. 5701 et seq., while otherwise performing duties at the request of the Board Chairperson, while away from their homes or a regular place of business.

2. Meetings of the ISPAB are usually two to three days in duration and are usually held quarterly. ISPAB meetings are open to the public, including the press. Members do not have access to classified or proprietary information in connection with their ISPAB duties.

1. Nominations are being accepted in all three categories described above.

2. Nominees should have specific experience related to information security or privacy issues, particularly as they pertain to Federal information technology. Letters of nomination should include the category of membership for which the candidate is applying and a summary of the candidate's qualifications for that specific category. Also include (where applicable) current or former service on Federal advisory boards and any Federal employment. Each nomination letter should state that the person agrees to the nomination, acknowledges the responsibilities of serving on the ISPAB, and that they will actively participate in good faith in the tasks of the ISPAB.

3. Besides participation at meetings, it is desired that members be able to devote a minimum of two days between meetings to developing draft issue papers, researching topics of potential interest, and so forth in furtherance of their ISPAB duties.

4. Selection of ISPAB members will not be limited to individuals who are nominated. Nominations that are received and meet the requirements will be kept on file to be reviewed as ISPAB vacancies occur.

5. The Department of Commerce is committed to equal opportunity in the workplace and seeks a broad-based and diverse ISPAB membership.

The MEP Advisory Board (Board) is authorized under section 501 of the American Innovation and Competitiveness Act (Pub. L. 114-329); codified at 15 U.S.C. 278k(m), as amended, in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

1. The Board will provide advice on MEP activities, plans, and policies.

2. The Board will assess the soundness of MEP plans and strategies.

3. The Board will assess current performance against MEP program plans.

4. The Board will function solely in an advisory capacity, and in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

5. The Board shall transmit through the Director of NIST an annual report to the Secretary of Commerce for transmittal to Congress not later than 30 days after the submission to Congress of the President's annual budget request each year. The report shall address the status of the MEP program.

1. The Board shall consist of not fewer than10 members, appointed by the Director of NIST and broadly representative of stakeholders. At least 2 members shall be employed by or on an advisory board for the MEP Centers, at least 5 members shall be from U.S. small businesses in the manufacturing sector, and at least 1 member shall represent a community college. No member shall be an employee of the Federal Government.

2. The Director of NIST shall appoint the members of the Board. Members shall be selected on a clear, standardized basis, in accordance with applicable Department of Commerce guidance. Board members serve at the discretion of the Director of NIST.

3. The term of office of each member of the Board shall be three years, except that vacancy appointments shall be for the remainder of the unexpired term of the vacancy. Any person who has completed two consecutive full terms of service on the Board shall thereafter be ineligible for appointment during the one-year period following the expiration of the second term.

1. Members of the Board will not be compensated for their services but will, upon request, be allowed travel and per diem expenses as authorized by 5 U.S.C. 5701 et seq., while attending meetings of the Board or subcommittees thereof, or while otherwise performing duties at the request of the Chair, while away from their homes or regular places of business.

2. The Board will meet at least biannually. Additional meetings may be called by the Director of NIST or the Designated Federal Officer (DFO) or his or her designee.

3. Committee meetings are open to the public.

1. Nominations are being accepted in all categories described above.

2. Nominees should have specific experience related to manufacturing and industrial extension services. Letters of nomination should include the category of membership for which the candidate is applying and a summary of the candidate's qualifications for that specific category. Each nomination letter should state that the person agrees to the nomination and acknowledges the responsibilities of serving on the MEP Advisory Board.

3. Selection of MEP Advisory Board members will not be limited to individuals who are nominated. Nominations that are received and meet the requirements will be kept on file to be reviewed as Board vacancies occur.

4. The Department of Commerce is committed to equal opportunity in the workplace and seeks a broad-based and diverse MEP Advisory Board membership.

The NCST Advisory Committee (Committee) was established in accordance with the National Construction Safety Team Act, Public Law 107-231 and the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

1. The Committee shall advise the Director of NIST on carrying out the National Construction Safety Team Act (Act), review the procedures developed under section 2(c)(1) of the Act, and review the reports issued under section 8 of the Act.

2. The Committee functions solely as an advisory body, in accordance with the provisions of the Federal Advisory Committee Act.

3. The Committee shall report to the Director of NIST.

4. On January 1 of each year, the Committee shall transmit to the Committee on Science, Space, and Technology of the House of Representatives and to the Committee on Commerce, Science, and Transportation of the Senate a report that includes: (1) An evaluation of National Construction Safety Team (Team) activities, along with recommendations to improve the operation and effectiveness of Teams, and (2) an assessment of the implementation of the recommendations of Teams and of the Committee.

1. The Committee shall consist of no less than 4 and no more than 12 members. Members shall reflect the wide diversity of technical disciplines and competencies involved in the National Construction Safety Teams investigations. Members shall be selected on the basis of established records of distinguished service in their professional community and their knowledge of issues affecting the National Construction Safety Teams.

2. The Director of the NIST shall appoint the members of the Committee, and they will be selected on a clear, standardized basis, in accordance with applicable Department of Commerce guidance.

1. Members of the Committee shall not be compensated for their services but may, upon request, be allowed travel and per diem expenses in accordance with 5 U.S.C. 5703.

2. Members of the Committee shall serve as Special Government Employees (SGEs), will be subject to the ethics standards applicable to SGEs, and are required to file an annual Executive Branch Confidential Financial Disclosure Report.

3. The Committee shall meet at least once per year. Additional meetings may be called whenever requested by the NIST Director or the Designated Federal Officer (DFO); such meetings may be in the form of telephone conference calls and/or videoconferences.

1. Nominations are sought from industry and other communities having an interest in the National Construction Safety Teams investigations.

2. Nominees should have established records of distinguished service. The field of expertise that the candidate represents should be specified in the nomination letter. Nominations for a particular field should come from organizations or individuals within that field. A summary of the candidate's qualifications should be included with the nomination, including (where applicable) current or former service on federal advisory boards and federal employment. In addition, each nomination letter should state that the nominee agrees to the nomination, acknowledges the responsibilities of serving on the Committee, and will actively participate in good faith in the tasks of the Committee.

3. The Department of Commerce is committed to equal opportunity in the workplace and seeks a broad-based and diverse Committee membership.

The Advisory Committee on Earthquake Hazards Reduction (Committee) was established in accordance with the National Earthquake Hazards Reduction Program Reauthorization Act of 2004, Public Law 108-360 (42 U.S.C. 7704) and the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

1. The Committee will act in the public interest to assess trends and developments in the science and engineering of earthquake hazards reduction; effectiveness of the National Earthquake Hazards Reduction Program (Program) in carrying out the activities under section (a)(2) of the Earthquake Hazards Reduction Act of 1977, as amended, (42 U.S.C. 7704(a)(2)); the need to revise the Program; and the management, coordination, implementation, and activities of the Program.

2. The Committee will function solely as an advisory body, in accordance with the provisions of the Federal Advisory Committee Act.

3. The Committee shall report to the Director of NIST.

4. The Committee shall report to the Director of NIST at least once every two years on its findings of the assessments and its recommendations for ways to improve the Program. In developing recommendations, the Committee shall consider the recommendations of the United States Geological Survey (USGS) Scientific Earthquake Studies Advisory Committee (SESAC).

1. The Committee shall consist of not fewer than 11, nor more than 17 members. Members shall reflect the wide diversity of technical disciplines, competencies, and communities involved in earthquake hazards reduction. Members shall be selected on the basis of established records of distinguished service in their professional community and their knowledge of issues affecting the National Earthquake Hazards Reduction Program.

2. The Director of NIST shall appoint the members of the Committee. Members shall be selected on a clear, standardized basis, in accordance with applicable Department of Commerce guidance.

3. The term of office of each member of the Committee shall be three years, except that vacancy appointments shall be for the remainder of the unexpired term of the vacancy and that members shall have staggered terms such that the Committee will have approximately one-third new or reappointed members each year.

1. Members of the Committee shall not be compensated for their services, but may, upon request, be allowed travel and per diem expenses in accordance with 5 U.S.C. 5701 et seq., while attending meetings of the Committee or subcommittees thereof, or while otherwise performing duties at the request of the Chairperson, while away from their homes or regular places of business.

2. Members of the Committee shall serve as Special Government Employees (SGEs) and will be subject to the ethics standards applicable to SGEs, and are required to file an annual Executive Branch Confidential Financial Disclosure Report.

3. The Committee members shall meet face-to-face at least once per year. Additional meetings may be called whenever requested by the NIST Director or the Chairperson; such meetings may be in the form of telephone conference calls and/or videoconferences.

4. Committee meetings are open to the public.

1. Members will be drawn from industry and other communities having an interest in the National Earthquake Hazards Reduction Program, such as, but not limited to, research and academic institutions, industry standards development organizations, state and local government, and financial communities, who are qualified to provide advice on earthquake hazards reduction and represent all related scientific, architectural, and engineering disciplines.

2. Any person who has completed two consecutive full terms of service on the Committee shall be ineligible for appointment for a third term during the two-year period following the expiration of the second term.

3. Nominees should have established records of distinguished service. The field of expertise that the candidate represents should be specified in the nomination letter. Nominations for a particular field should come from organizations or individuals within that field. A summary of the candidate's qualifications should be included with the nomination, including (where applicable) current or former service on federal advisory boards and federal employment. In addition, each nomination letter should state that the nominee agrees to the nomination, acknowledges the responsibilities of serving on the Committee, and will actively participate in good faith in the tasks of the Committee.

4. The Department of Commerce is committed to equal opportunity in the workplace and seeks a broad based and diverse Committee membership.

The NIST Smart Grid Advisory Committee (Committee) was established in accordance with the Federal Advisory Committee Act, as amended, 5 U.S.C. App and with the concurrence of the General Services Administration.

1. The Committee shall advise the Director of NIST in carrying out duties authorized by section 1305 of the Energy Independence and Security Act of 2007 (Pub. L. 110-140).

2. The Committee duties are solely advisory in nature in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

3. The Committee shall report to the Director of NIST.

4. The Committee shall provide input to NIST on the Smart Grid Standards, Priorities, and Gaps, on the overall direction, status and health of the Smart Grid implementation by the Smart Grid industry including identification of issues and needs, and on the direction of smart grid research and standards activities.

5. Upon request of the Director of NIST, the Committee will prepare reports on issues affecting Smart Grid activities.

1. The Committee shall consist of no less than 9 and no more than 15 members. Members shall be selected on the basis of established records of distinguished service in their professional community and their knowledge of issues affecting Smart Grid deployment and operations. Members shall reflect the wide diversity of technical disciplines and competencies involved in the Smart Grid deployment and operations and will come from a cross section of organizations.

2. The Director of NIST shall appoint the members of the Committee, and they will be selected on a clear, standardized basis, in accordance with applicable Department of Commerce guidance.

1. Members of the Committee shall not be compensated for their service, but will, upon request, be allowed travel and per diem expenses, in accordance with 5 U.S.C. 5701 et seq., while attending meetings of the Committee or subcommittees thereof, while away from their homes or regular places of business.

2. The Committee shall meet approximately two times per year at the call of the Designated Federal Officer (DFO). Additional meetings may be called by the DFO whenever one-third or more of the members so request it in writing or whenever the Director of NIST requests a meeting.

1. Nominations are sought from all fields involved in issues affecting the Smart Grid.

2. Nominees should have established records of distinguished service. The field of expertise that the candidate represents should be specified in the nomination letter. Nominations for a particular field should come from organizations or individuals within that field. A summary of the candidate's qualifications should be included with the nomination, including (where applicable) current or former service on Federal advisory boards and Federal employment. In addition, each nomination letter should state that the person agrees to the nomination, acknowledges the responsibilities of serving on the Committee, and will actively participate in good faith in the tasks of the Committee. The Department of Commerce is committed to equal opportunity in the workplace and seeks a broad-based and diverse Committee membership.

The VCAT (Committee) was established in accordance with 15 U.S.C. 278 and the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

1. The Committee shall review and make recommendations regarding general policy for NIST, its organization, its budget, and its programs, within the framework of applicable national policies as set forth by the President and the Congress. 15 U.S.C. 278(a).

2. The Committee will function solely as an advisory body, in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

3. The Committee shall report to the Director of NIST.

4. The Committee shall provide an annual report, through the Director of NIST, to the Secretary of Commerce for submission to the Congress not later than 30 days after the submittal to Congress of the President's annual budget request in each year. Such report shall deal essentially, though not necessarily exclusively, with policy issues or matters which affect NIST, or with which the Committee in its official role as the private sector policy adviser of NIST is concerned. Each such report shall identify areas of research and research techniques of the Institute of potential importance to the long-term competitiveness of United States industry, in which the Institute possesses special competence, which could be used to assist United States enterprises and Untied States industrial joint research and development ventures. 15 U.S.C. 278(h)(1). The Committee shall submit, through the Director of NIST, to the Secretary and the Congress such additional reports on specific policy matters as it deems appropriate. 15 U.S.C. 278(h)(2).

1. The Committee shall consist of not fewer than nine members appointed by the Director of NIST, a majority of whom shall be from United States industry. 15 U.S.C. 278(a). Members shall be selected solely on the basis of established records of distinguished service; shall provide representation of a cross-section of traditional and emerging United States industries; and shall be eminent in fields such as business, research, new product development, engineering, labor, education, management consulting, environment, and international relations. No employee of the Federal Government shall serve as a member of the Committee. 15 U.S.C. 278(b).

2. The Director of NIST shall appoint the members of the Committee. Members shall be selected on a clear, standardized basis, in accordance with applicable Department of Commerce guidance. 15 U.S.C. 278(a).

3. The term of office of each member of the Committee shall be three years, except that vacancy appointments shall be for the remainder of the unexpired term of the vacancy. 15 U.S.C. 278(c)(1).

1. Members of the Committee will not be compensated for their services, but will, upon request, be allowed travel expenses in accordance with 5 U.S.C. 5701 et seq., while attending meetings of the Committee or of its subcommittees, or while otherwise performing duties at the request of the chairperson, while away from their homes or a regular place of business.

2. Members of the Committee shall serve as Special Government Employees (SGEs) and will be subject to the ethics standards applicable to SGEs.

3. Meetings of the VCAT usually take place at the NIST headquarters in Gaithersburg, Maryland. The Committee will meet at least twice each year at the call of the chairperson or whenever one-third of the members so request in writing. The Committee shall not act in the absence of a quorum, which shall consist of a majority of the members of the Committee not having a conflict of interest in the matter being considered by the Committee. 15 U.S.C. 278(d).

4. Generally, Committee meetings are open to the public.

1. Nominations are sought from all fields described above.

2. Nominees should have established records of distinguished service and shall be eminent in fields such as business, research, new product development, engineering, labor, education, management consulting, environment and international relations. The category (field of eminence) for which the candidate is qualified should be specified in the nomination letter. Nominations for a particular category should come from organizations or individuals within that category. A summary of the candidate's qualifications should be included with the nomination, including (where applicable) current or former service on Federal advisory boards and Federal employment. In addition, each nomination letter should state that the candidate agrees to the nomination, acknowledges the responsibilities of serving on the VCAT, and will actively participate in good faith in the tasks of the VCAT.

3. The Department of Commerce is committed to equal opportunity in the workplace and seeks a broad-based and diverse VCAT membership.

The WPSAR steering committee consists of the Council's Executive Director, the Director of the NMFS Pacific Islands Fisheries Science Center, and the Regional Administrator of the NMFS Pacific Islands Regional Office. You may read more about WPSAR at https://www.pifsc.noaa.gov/peer_reviews/wpsar/index.php.

The public will have an opportunity to comment during the meeting. The agenda order may change. The meeting will run as late as necessary to complete scheduled business.

1. Introductions.

2. Discuss and update the 5-year stock assessment review schedule, including any changes to the scheduling of reviews for stock assessments already on the calendar, and any new additions to the schedule.

3. Discuss and update review levels, that is, whether the stock assessments on the calendar will be benchmark assessments (new assessments) or assessment updates (updates of existing models with recent data).

4. Review the upcoming schedule and nominate additional products for review by the Center for Independent Experts, if necessary.

5. Discuss the Stock Assessment Prioritization process.

6. Discuss any changes related to the proposed action to reclassify certain management unit species as ecosystem component species.

7. Discuss process and timing for efficient release of information, that is, from WPSAR to the Council's Scientific and Statistical Committee, to the Council, and to NMFS for rulemaking.

8. Public Comment.

The meeting is physically accessible to people with disabilities. Make direct requests for sign language interpretation or other auxiliary aids to Marlowe Sabater at (808) 522-8143 or [email protected], at least 5 days prior to the meeting date.

Title, Associated Form, and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS) part 236, Construction and Architect-Engineer Contracts, and related clauses at DFARS 252.236; OMB Control Number 0704-0255.

Needs and Uses: DoD contracting officers need this information to evaluate contractor proposals for contract modifications; to determine that a contractor has removed obstructions to navigation; to review contractor requests for payment for mobilization and preparatory work; to determine reasonableness of costs allocated to mobilization and demobilization; and to determine eligibility for the 20 percent evaluation preference for United States firms in the award of some overseas construction contracts.

Affected Public: Businesses and other for-profit entities.

Respondent's Obligation: Required to obtain or retain benefits.

Type of Request: Revision of a currently approved collection.

Reporting Frequency: On occasion.

Number of Respondents: 1,735.

Responses per Respondent: 5.

Annual Responses: 8,675.

Average Burden per Response: 12.

Annual Response Burden Hours: 104,100.

DFARS 236.570(a) prescribes use of the clause at DFARS 252.236-7000, Modification Proposals—Price Breakdown, in all fixed-price construction solicitations and contracts. The clause requires the contractor to submit a price breakdown with any proposal for a contract modification.

DFARS 236.570(b) prescribes use of the following clauses in fixed-price construction contracts and solicitations as applicable:

(1) The clause at DFARS 252.236-7002, Obstruction of Navigable Waterways, requires the contractor to notify the contracting officer of obstructions in navigable waterways.

(2) The clause at DFARS 252.236-7003, Payment for Mobilization and Preparatory Work, requires the contractor to provide supporting documentation when submitting requests for payment for mobilization and preparatory work.

(3) The clause at DFARS 252.236-7004, Payment for Mobilization and Demobilization, permits the contracting officer to require the contractor to furnish cost data justifying the percentage of the cost split between mobilization and demobilization, if the contracting officer believes that the proposed percentages do not bear a reasonable relation to the cost of the work.

DFARS 236.570(c) prescribes use of the following provisions in solicitations for military construction contracts that are funded with military construction appropriations and are estimated to exceed $1,000,000:

(1) The provision at DFARS 252.236-7010, Overseas Military Construction—Preference for United States Firms, when contract performance will be in a United States outlying area in the Pacific or in a country bordering the Arabian Gulf, requires an offeror to specify whether or not it is a United States firm.

(2) The provision at DFARS 252.236-7012, Military Construction on Kwajalein Atoll—Evaluation Preference, when contract performance will be on Kwajalein Atoll, requires an offeror to specify whether it is a United States firm, a Marshallese firm, or other firm.

Title, Associated Form, and OMB Number: Information Collection in Support of the DoD Acquisition Process (Various Miscellaneous Requirements); OMB Control Number 0704-0187.

Needs and Uses: This information collection requirement pertains to information required in DFARS parts 208, 209, 235, and associated clauses in part 252 that an offeror must submit to DoD in response to a request for proposals or an invitation for bids or a contract requirement. DoD uses this information to—

• Determine whether to provide precious metals as Government-furnished material;

• Determine whether a foreign government owns or controls the offeror to prevent access to proscribed information;

• Determine whether there is a compelling reason for a contractor to enter into a subcontract in excess of $30,000 with a firm, or subsidiary of a firm, that is identified in the “List of Parties Excluded from Federal Procurement and Nonprocurement” as being ineligible for award of Defense subcontracts because it is owned or controlled by the government of a country that is a state sponsor of terrorism;

• Evaluate claims of indemnification for losses or damages occurring under a research and development contract; and

• Keep track of radio frequencies on electronic equipment under research and development contracts so that the user does not override or interfere with the use of that frequency by another user.

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

Respondent's Obligation: Required to obtain or retain benefits.

Type of Request: Revision of a currently approved collection.

Number of Respondents: 308.

Responses per Respondent: 1.

Annual Responses: 308.

Average Burden per Response: 2 hours.

Annual Burden Hours: 616.

Frequency: On occasion.

This information collection pertains to information, as required in DFARS Parts 208, 209, 235, and associated clauses in Part 252 that an offeror must submit to DoD in response to a request for proposals or an invitation for bids or a contract requirement. The information collection covers the following DFARS requirements:

• 252.208-7000, Intent to Furnish Precious Metals as Government-Furnished Material. Paragraph (b) of this clause requires an offeror to cite the type and quantity of precious metals required in the performance of the contract. Paragraph (c) requires the offeror to submit two prices for each deliverable item that contains precious metals: one based on the Government furnishing the precious metals, and the other based on the contractor furnishing the precious metals.

• 252.209-7002, Disclosure of Ownership or Control by a Foreign Government. Paragraph (d) requires the offeror to provide a disclosure with its offer of any interest a foreign government has in the offeror when that interest constitutes control of the offeror by a foreign government.

• 252.209-7004, Subcontracting with Firms that are Owned or Controlled by the Government of a Country that is a State Sponsor of Terrorism. Paragraph (b) requires the Contractor to notify the contracting officer in writing before entering into a subcontract in excess of $30,000 with a party that is identified in the List of Parties Excluded from Federal Procurement and Nonprocurement Programs as being ineligible for award of Defense subcontracts because it is owned or controlled by the government of a country that is a state sponsor of terrorism. The contractor must provide the name of the proposed subcontractor and the compelling reasons for doing business with the subcontractor.

• 252.235-7000, Indemnification under 10 U.S.C. 2534—Fixed Price; 252.235-7001, and Indemnification under 10 U.S.C. 2534—Cost-Reimbursement. Paragraphs (f) and (e), respectively, of these clauses require contractors to notify the contracting officer of any claim and provide (i) proof or evidence of a claim and (ii) copies of all pertinent papers when the contractor is to be indemnified.

• DFARS 252.235-7003, Frequency Authorization. Paragraph (b) requires that the contractor or subcontractor provide to the contracting officer the technical operating characteristics for any experimental, developmental, or operational equipment for which the appropriate frequency allocation has not been made.

Title, Associated Form, and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS), U.S.-International Atomic Energy Agency Additional Protocol; OMB Control Number 0704-0454.

Needs and Uses: This requirement is necessary to provide for protection of information or activities with national security significance. As such, this information collection requires contractors to comply with the notification process at DFARS 252.204-7010, Requirement for Contractor to Notify DoD if the Contractor's Activities are Subject to Reporting Under the U.S.-International Atomic Energy Agency Additional Protocol.

Affected Public: Businesses and other for-profit entities and not-for-profit institutions.

Respondent's Obligation: Required to obtain or retain benefits.

Type of Request: Renewal of a currently approved collection.

Reporting Frequency: On occasion.

Number of Respondents: 300.

Responses Per Respondent: 1.

Annual Responses: 300.

Average Burden Per Response: 1 hour.

Annual Response Burden Hours: 300.

Under the U.S.-International Atomic Energy Agency (IAEA) Additional Protocol, the United States is required to declare a wide range of public and private nuclear-related activities to the IAEA and potentially provide access to IAEA inspectors for verification purposes. The U.S.-IAEA Additional Protocol permits the United States unilaterally to declare exclusions from inspection requirements for activities with direct national security significance.

The DFARS clause at 252.204-7010, as prescribed at DFARS 204.470-3, is included in contracts for research and development or major defense acquisition programs involving fissionable materials (e.g., uranium, plutonium, neptunium, thorium, americium); other radiological source materials; or technologies directly related to nuclear power production, including nuclear or radiological waste materials.

The clause requires a contractor to provide written notification to the applicable DoD program manager and a copy of the notification to the contracting officer if the contractor is required to report its activities under the U.S.-IAEA Additional Protocol. Upon such notification, DoD will determine if access may be granted to IAEA inspectors, or if a national security exclusion should be applied.

Title; Associated Form; and OMB Number: Screening and Monitoring of DoD Personnel Deployed to Ebola Outbreak Areas; DD Form 2990 and DD Form 2991; OMB Control Number 0720-0056.

Needs and Uses: The information collection requirement is necessary to ensure DoD personnel deployed in support of Operation UNITED ASSISTANCE are promptly evaluated for possible exposure(s) to the Ebola virus during deployment to, and within 12 hours prior to departing from, an Ebola outbreak country or region. Ebola is a Quarantinable Communicable Disease as named in Executive Order 13295 and supported by several DoD regulations and Federal laws. This information will be used by DoD medical and public health officials to (1) ensure Ebola exposure risk is evaluated, (2) proper prevention and quarantine efforts are implemented, (3) appropriate medical care is provided, (4) medical surveillance programs are robust and (5) the spread of Ebola beyond area of concern is minimized. The DoD has consulted with the Centers for Disease Control and Prevention, the Department of State, the Agency for International Development, and several Defense Agencies regarding disease control efforts and health surveillance in response to the public health emergency in West Africa and worldwide. DoD has also specifically discussed these new information collections with representatives of the various Military Services, representing deploying military members who have participated in the development of the content of these forms.

Affected Public: Individuals or Households.

Annual Burden Hours: 480.

Number of Respondents: 1,200.

Responses per Respondent: 2.

Annual Responses: 2400.

Average Burden per Response: 12 minutes.

Frequency: On occasion.

Respondents are DoD personnel (active duty service members, federal civilian employees and contractors). Using the DD2990 and DD2991, information will be collected from respondents during deployment and just prior to redeployment (return from deployment). This information will provide for health surveillance while deployed, removal from duty if representing a health risk to self or others, apprehension and detention, or conditional release of individuals to prevent the introduction, transmission, or spread of suspected communicable diseases, pursuant to section 361(b) of the Public Health Service Act (42 U.S.C. 264), UCMJ, DoD Directive 6490.02E, DoD Instruction 6490.03, 5 CFR 339.301. The information will also be collected in order to identify any health concerns and to refer individuals for additional assessment and/or care. The overall intent is to protect the health of the individual and public from EBV. This information will also be included in deployer's medical records.

Title; Associated Form; and OMB Number: Joint Personnel Adjudication System (JPAS); OMB Control Number 0704-0496.

Needs and Uses: This information collection is necessary as the JPAS system requires personal data collection to facilitate the initiation, investigation and adjudication of information relevant to DoD security clearances and employment suitability determinations for active duty military, civilian employees and contractors requiring such credentials. As a Personnel Security System it is the authoritative source for clearance information resulting in accesses determinations to sensitive/classified information and facilities.

Affected Public: Individuals or Households.

Annual Burden Hours: 333,375.

Number of Respondents: 22,225.

Responses per Respondent: 45.

Annual Responses: 1,000,125.

Average Burden per Response: 20 minutes.

Frequency: On occasion.

The Joint Personnel Adjudication System (JPAS) is a DoD personnel security system and is the authoritative source for clearance information resulting in access determinations to sensitive/classified information and facilities. Collection and maintenance of personal data in JPAS is required to facilitate the initiation, investigation and adjudication of information relevant to DoD security clearances and employment suitability determinations for active duty military, civilian employees, and contractors requiring such credentials. Facility Security Officers (FSOs) working in private companies that contract with DoD and who need access to the JPAS system to update security-related information about their company's employees must complete DD Form 2962. Specific uses include: Facilitation for DoD Adjudicators and Security Managers to obtain accurate up-to-date eligibility and access information on all personnel (military, civilian and contractor personnel) adjudicated by the DoD. The DoD Adjudicators and Security Managers are also able to update eligibility and access levels of military, civilian and contractor personnel nominated for access to sensitive DoD information. Once granted access, the FSOs maintain employee personal information, submit requests for investigations, and submit other relevant personnel security information into JPAS on over 1,000,000 contract employees annually.

Introduction: The information contained in the records maintained in this system will be used to conduct a rigorous study of the effectiveness of feedback for teachers based on classroom videos to inform effective teacher preparation and professional development.

The study will address the following central research questions: What is the impact on teaching practices and student achievement of providing novice teachers with feedback on their teaching using multiple videos of their classroom practices? What is the impact on teaching practices and student achievement of providing early career teachers (those in their second, third, or fourth year of teaching) with feedback on their teaching using multiple videos of their classroom practices? Secondary research questions for the study are: Is intensive feedback more effective for certain types of teachers or students? On which teaching practices should feedback interventions focus?

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the person listed under FOR FURTHER INFORMATION CONTACT.

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

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

Title: FERC-725Y, Mandatory Reliability Standard (Personnel Performance, Training, and Qualifications).

OMB Control No.: 1902-0279.

Type of Request: Three-year extension of the FERC-725Y information collection requirements with no changes to the reporting requirements.

Abstract: The FERC-725Y information collection is intended to help ensure the safe and reliable operation of the interconnected grid through the retention of suitably trained and qualified personnel in positions that can impact the reliable operation of the Bulk-Power System. The Commission uses the FERC-725Y to implement the Congressional mandate of the Energy Policy Act of 2005 to develop mandatory and enforceable Reliability Standards to better ensure the reliability of the nation's Bulk-Power System. FERC-725Y will ensure that personnel performing or supporting real-time operations on the Bulk Electric System (BES) are trained using a systematic approach. The Reliability Standard requires entities to maintain records subject to review by the Commission and NERC to ensure compliance with the Reliability Standard.

The Reliability Standard requires entities to maintain records subject to review by the Commission and NERC to ensure compliance with the Reliability Standard. This Reliability Standard contains of five Requirements:

• R1 requires reliability coordinators, balancing authorities, and transmission operators to develop and implement a training program for system operators.

• R2 requires transmission owners to develop and implement a training program for system operators.

• R3 requires reliability coordinators, balancing authorities, transmission operators and transmission owners to verify the capabilities of their identified personnel.

• R4 requires reliability coordinators, balancing authorities, transmission operators and transmission owners to provide those personnel with emergency operations training using simulation technology.

• R6 requires applicable generator operators to develop and implement training for certain of their dispatch personnel at a centrally located dispatch center.

Type of Respondents: Transmission owners and generator owners.

Estimate of Annual Burden: 1 Our estimate below regarding the number of respondents is based on the NERC compliance registry as of September 29, 2017. According to the NERC compliance registry, NERC has registered 176 transmission operators, 331 transmission owners and 890 generator operators.

The Commission estimates the additional annual reporting burden and cost as follows:

Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

On December 28, 2017, the FDIC requested comment for 60 days on a proposal to renew the information collection described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.

1. Title: Account Based Disclosures in Connection with Consumer Financial Protection Bureau Regulations E and DD and Federal Reserve Regulation CC.

OMB Number: 3064-0084.

Form Number: None.

Affected Public: FDIC-Supervised Institutions.

Burden Estimate

General Description of Collection: Regulations E & DD (Consumer Financial Protection Bureau's Regulations) and Regulation CC (the Federal Reserve's Regulation) ensure adequate disclosures regarding accounts, including electronic fund transfer services, availability of funds, and fees and annual percentage yield for deposit accounts. Generally, the Regulation E disclosures are designed to ensure consumers receive adequate disclosure of basic terms, costs, and rights relating to electronic fund transfer (EFT) services provided to them so that they can make informed decisions. Institutions offering EFT services must disclose to consumers certain information, including: Initial and updated EFT terms, transaction information, the consumer's potential liability for unauthorized transfers, and error resolution rights and procedures.

Like Regulation E, Regulation CC has consumer protection disclosure requirements. Specifically, Regulation CC requires depository institutions to make funds deposited in transaction accounts available within specified time periods, disclose their availability policies to customers, and begin accruing interest on such deposits promptly. The disclosures are intended to alert customers that their ability to use deposited funds may be delayed, prevent unintentional (and costly) overdrafts, and allow customers to compare the policies of different institutions before deciding at which institution to deposit funds. Depository institutions must also provide an awareness disclosure regarding substitute checks. The regulation also requires notice to the depositary bank and to a customer of nonpayment of a check.

Regulation DD also has similar consumer protection disclosure requirements that are intended to assist consumers in comparing deposit accounts offered by institutions, principally through the disclosure of fees, the annual percentage yield, and other account terms. Regulation DD requires depository institutions to disclose yields, fees, and other terms concerning deposit accounts to consumers at account opening, upon request, and when changes in terms occur. Depository institutions that provide periodic statements are required to include information about fees imposed, interest earned, and the annual percentage yield (APY) earned during those statement periods. It also contains rules about advertising deposit accounts.

There is no change in the method or substance of the collection. The overall reduction in burden hours is the result of economic fluctuation and the reduced number of FDIC-supervised institutions since the last submission in 2014. In particular, the number of respondents has decreased while the hours per response and frequency of responses have remained the same.

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

Under Federal contracts requiring that equipment (e.g., pumps, fans, generators, chillers, etc.) be installed in a project, the Government must determine that the equipment meets the contract requirements. Therefore, the contractor must submit sufficient data on the particular equipment to allow the Government to analyze the item.

The Government uses the submitted data to determine whether or not the equipment meets the contract requirements in the categories of performance, construction, and durability. This data is placed in the contract file and used during the inspection of the equipment when it arrives on the project and when it is made operable.

The information collection requirement at FAR clause 52.236-5 has decreased based on information from the FY 2017 FPDS database which shows a lower number of estimated respondents that are subject to the clause.

Respondents: 1,377.

Responses per Respondent: 2.0.

Annual Responses: 2,754.

Hours per Response: .25.

Total Burden Hours: 689.

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

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0062, Material and Workmanship, in all correspondence.

A. Purpose

Federal Acquisition Regulation (FAR) 19.301 and the FAR clause at 52.219-28, Post-Award Small Business Program Re-representation, implement the Small Business Administration's (SBA's) regulation at 13 CFR 121.404(g), requiring that a concern that initially represented itself as small at the time of its initial offer must recertify its status as a small business under the following circumstances:

• Within thirty days of an approved contract novation;

• Within thirty days in the case of a merger or acquisition, where contract novation is not required; or

• Within 120 days prior to the end of the fifth year of a contract, and no more than 120 days prior to the exercise of any option thereafter.

The implementation of SBA's regulation in FAR 19.301 and the FAR clause at 52.219-28 require that contractors re-represent size status by updating their representations at the prime contract level in the Representations and Certifications section of the System for Award Management (SAM) and notifying the contracting officer that it has made the required update.

The purpose of implementing small business re-representations in the FAR is to ensure that small business size status is accurately represented and reported over the life of long-term contracts. The FAR also provides for provisions designed to ensure more accurate reporting of size status for contracts that are novated, or performed by small businesses that have merged with or been acquired by another business. This information is used by the SBA, Congress, Federal agencies and the general public for various reasons such as determining if agencies are meeting statutory goals, set-aside determinations, and market research.

An upward adjustment is being made to the estimated annual reporting burden since the last notice regarding an extension for this clearance published on May 4, 2015 in the Federal Register at 80 FR 25293. Based on fiscal year 2017 re-representation modification data from the Federal Procurement Data System (FPDS), the number of annual respondents has increased from 1,700 to 2,200.

Respondents: 2,200.

Responses per Respondent: 1.

Total Number of Responses: 2,200.

Hours per Response: 0.5.

Total Burden Hours: 1,100.

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

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

Please cite OMB Control No. 9000-0163, Small Business Size Re-representation, in all correspondence.

Proposed Project Ambulatory Surgery Center Survey on Patient Safety Culture Database

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, the Agency for Healthcare Research and Quality (AHRQ) invites the public to comment on this proposed information collection. Ambulatory surgery centers (ASCs) are a fast-growing health care setting, demonstrating tremendous growth both in the volume and complexity of procedures being performed. ASCs provide surgical services to patients who are not expected to need an inpatient stay following surgery. The Centers for Medicare and Medicaid Services (CMS) defines ASCs as distinct entities that operate exclusively to provide surgical services to patients who do not require hospitalization and are not expected to need to stay in a surgical facility longer than 24 hours.

How AHRQ's Mission and Directives Relate to ASCs. As described in its 1999 reauthorizing legislation, Congress directed AHRQ to enhance the quality, appropriateness, and effectiveness of health services, as well as access to such services, by establishing a broad base of scientific research and promoting clinical and health systems practice improvements. The legislation also directed AHRQ to “conduct and support research, evaluations, and training, support demonstration projects, research networks, and multidisciplinary centers, provide technical assistance, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to health statistics, surveys, database development, and epidemiology.” 42 U.S.C. 299a(a)(8).

Shortly after Congress enacted this legislation, the Institute of Medicine (IOM) published “To Err is Human,” a seminal report on medical errors that connected the dots between errors and workplace culture. In it, the IOM called for health care organizations to develop a “culture of safety” such that staffing and system processes are aligned to improve the reliability and safety of patient care. This appeal for safety culture improvements directly relates to AHRQ's legislative directive and mission (i.e., “to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used”). Given its legislatively mandated role, AHRQ is uniquely positioned to support data collection and analyses that will help fuel ASC patient safety culture improvements.

The expanding volume and scope of ASC services, the growing attention of federal regulators on patient safety within ASCs, and the resultant implications for public health has prompted AHRQ to present this application to the Office of Management and Budget (OMB). In this request, AHRQ seeks OMB approval to expand its Surveys on Patient Safety CultureTM (SOPSTM) program by creating an ASC SOPS Database to capture and report on ASC SOPS data voluntarily submitted by ASCs that have administered the ASC SOPS. This is the newest database for the SOPS program and would be modeled after four other SOPS databases developed by AHRQ: Hospital SOPS [OMB NO. 0935-0162; last approved 10/18/2016]; Medical Office SOPS [OMB NO. 0935-0196; last approved 08/25/15]; Nursing Home SOPS [OMB NO. 0935-0195; last approved 09/30/15]; and Community Pharmacy SOPS [OMB NO. 0935-0218; last approved 06/26/17].

Background on ASC SOPS. This section provides context for this request to the OMB regarding the need for AHRQ's requested database. Factors include the continued ASC growth trajectory and increasing public attention on the quality of ASC care—particularly as it relates to patient safety culture.

Rapid ASC Growth. Medicare-certified ASCs have experienced impressive growth in the last 35 years—up from 239 facilities in 1983 to 5,316 in 2010. In recent years, Medicare ASCs have seen continued growth in both their number and scope, as illustrated by the annual average growth rate of 1.1 percent between 2010 to 2014. In 2015, CMS spent $4.1 billion for 3.4 million fee-for service Medicare beneficiaries to receive care across 5,500 Medicare-certified ASCs. Research suggests that transitioning eligible surgical procedures from inpatient to ASC settings may yield significant and sustained Medicare cost savings.

Federal Attention on ASC Care Quality and Safety Culture. Concern about the quality of ASC care is not new. Following a 2008 Hepatitis C outbreak in Nevada blamed on poor ASC infection control practices, HHS's Office of the Secretary oversaw a $10 million program for state survey agencies to improve healthcare-associated infection reduction in ASCs. The Centers for Disease Control's National Healthcare Safety Network subsequently expanded its surgical site infection (SSI) surveillance efforts to enable ASC data submission to accommodate state SSI reporting mandates. Through the Affordable Care Act of 2010, Congress also pursued ASC performance improvement by directing the HHS Secretary to implement an ASC-focused Medicare value-based purchasing program.

The relationship between patient safety culture and the quality of ASC care has attracted more recent attention from policymakers and regulators. On the national level, the Joint Commission in early 2017 within its ASC accreditation manual established a new chapter on patient safety systems improvement, which includes strategies for “motivating staff to uphold a fair and just safety culture.” CMS, meanwhile, published in November 2017 its Final Rule outlining the ASC Quality Reporting Program, which ties quality and patient safety performance to reimbursement.

ASC SOPS Pilot. AHRQ developed and pilot tested the ASC SOPS with OMB approval (OMB No. 0935-0216; approved 10/31/2013). The survey is designed to enable any ASC, regardless of type of procedures it performs, to assess its staff's perceptions about patient safety and quality assurance issues, including what safety-related attitudes and behaviors are supported, rewarded, and expected. It includes 27 items that measure 8 composites of patient safety culture, as well as five individual items on near-miss documentation, overall rating on patient safety and communication in the procedure/surgery room. The pilot test was conducted in early 2014 in ASC facilities: (1) Where patients have surgeries, procedures, and treatments and are not expected to need an inpatient stay, and (2) that have been certified and approved to participate in the CMS ASC program. Twenty-five percent of the pilot sites were affiliated with a hospital and 75% were not hospital-affiliated. Participants included 1,800 staff members from 59 ASCs—or approximately one percent of the total number of ASCs at that time.

AHRQ made the survey publicly available along with a Survey User's Guide, the pilot study results, and related toolkit materials on the AHRQ Ambulatory Surgery Center Survey on Patient Safety Culture Web page in April 2015. The AHRQ ASC SOPS Database will consist of data from the AHRQ ASC patient safety culture survey. ASCs in the U.S. will be asked to voluntarily submit data from the survey to AHRQ.

Rationale for the information collection. AHRQ sponsored the development of the ASC SOPS as a new survey in the suite of AHRQ Surveys on Patient Safety Culture. The database will support AHRQ's goals of promoting improvements in the quality and safety of health care in ASC settings. Like the survey and other toolkit materials, the database results will be made publicly available on AHRQ's website. Technical assistance is provided by AHRQ through its contractor at no charge to ASCs to facilitate the use of these materials for ASC patient safety and quality improvement. Technical assistance will also be provided to support ASC data submission.

The goal of this project is to create the ASC SOPS Database. This database will:

This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to health statistics, surveys, and database development. 42 U.S.C. 299a(a)(1) and (8).

To achieve the goal of this project the following activities and data collections will be implemented:

(1) Eligibility and Registration Form—The pointofcontact (POC), often the manager of the ASC, completes a number of data submission steps and forms, beginning with completion of an online Eligibility and Registration Form. The purpose of this form is to collect basic demographic information about the ASC and initiate the registration process.

(2) ASC Site Information—The purpose of the site level specifications, completed by the ASC manager, is to collect background characteristics of the ASC. This information will be used to analyze data collected with the ASC SOPS survey.

(3) Data Use Agreement—The purpose of the data use agreement, completed by the ASC manager, is to state how data submitted by ASCs will be used and provides privacy assurances.

(4) Data Files Submission—POCs upload their data file(s), using ASC survey data file specifications, to ensure that users submit standardized and consistent data in the way variables are named, coded, and formatted. The number of submissions to the database is likely to vary each year because ASCs do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either an ASC administrative manager or a survey vendor who contracts with an ASC to collect and submit its data.

With the approval and addition of the ASC SOPS Database, data from the database will be used to produce three types of products:

ASCs will be invited to voluntarily submit their ASC SOPS survey data into the database. AHRQ's contractor, Westat, will then clean and aggregate the data to produce a PDF-formatted Database Report displaying averages, standard deviations, and percentile scores on the survey's 33 items and 8 patient safety culture dimensions. In addition, the report will also display results by respondent characteristics (e.g., staff position, tenure, and hours worked per week).

The Database Report will include a section on data limitations, emphasizing that the report does not reflect a representative sampling of the U.S. ASC population. Because participating ASCs will choose to submit their data voluntarily into the database and therefore are not a random or national sample of ASCs, estimates based on this self-selected group might be biased estimates. These limitations will be noted in the database report. We will recommend that users review the database results with these caveats in mind.

Each ASC that submits its data will receive a customized survey feedback report that presents their results alongside the aggregated results from other participating ASCs. If an ASC submits data more than once, its survey feedback report will also present trend data.

ASC users of the ASCs SOPS Survey, Database Reports, and Individual ASC Survey Feedback Reports can use these documents to:

• Raise staff awareness about patient safety;

• Diagnose and assess the current status of patient safety culture in their own ASC;

• Identify strengths and areas for patient safety culture improvement;

• Examine trends in patient safety culture change over time; and

• Evaluate the cultural impact of patient safety initiatives and intervention.

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. Given that this will be the first call for voluntary data submission, participation is initially expected to be modest. An estimated 100 ASC managers (i.e., POCs from ASCs) will complete the database submission steps and forms. Each POC will submit the following:

• Eligibility and registration form (completion is estimated to take about 5 minutes).

• Data use agreement (completion is estimated to take about 3 minutes).

• ASC Site Information Form (completion is estimated to take about 5 minutes).

• Survey data submission will take an average of one hour.

The total burden is estimated to be 121 hours.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $5,472.83.

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) 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 upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

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: Extension of a currently approved collection; Title of Information Collection: Appointment of Representative; Use: The Appointment of Representative form is completed by beneficiaries, providers and suppliers, and any party seeking to appoint a representative to assist them with their initial determinations and filing appeals. Form Number: CMS-1696 (OMB control number: 0938-0950); Frequency: Once; Affected Public: Individuals and Households, and the Private sector (Business or other for-profits); Number of Respondents: 3,472,840; Total Annual Responses: 347,284; Total Annual Hours: 86,821. (For policy questions regarding this collection contact Katherine Hosna at 410-786-4993.)

The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 13, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on April 13, 2018 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.

I. Background

This meeting will provide FDA the opportunity to better understand the patient perspective on the impacts of OUD and on treatment approaches for OUD. OUD is the diagnostic term used for a chronic neurobiological disease characterized by a problematic pattern of opioid use leading to significant impairment or distress. OUD includes signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances for no legitimate medical purpose, or, if another medical condition is present that required opioid treatment, the opioid is used in doses far greater than the amount needed for treatment of that medical condition. FDA is interested in learning patients' perspectives on OUD, including the effects on their health and well-being that have the greatest negative effect on daily life, their experience using prescription medical treatments and other treatments or therapies for OUD, and challenges or barriers to accessing or using medical treatments for OUD.

There are three drugs approved by FDA for the treatment of OUD: Buprenorphine, methadone, and naltrexone. FDA is taking steps to facilitate the development of new medications for the treatment of OUD and new formulations of existing drugs that could better suit patient needs. Promoting wider appropriate use of these safe and effective medications is also the focus of FDA's ongoing work to reduce the scope and magnitude of the opioid crisis.

At the meeting, patients and patient representatives will provide patient perspectives on the symptoms and daily impacts of OUD and on treatment approaches for OUD. The questions that will be asked of patients and patient representatives at the meeting are listed in the following section and organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other patient and patient representative participants. In addition to input generated through this public meeting, FDA is interested in receiving patient and patient representative input addressing these questions through written comments, which can be submitted to the public docket (see ADDRESSES). When submitting comments, if you are commenting on behalf of a patient, please indicate that you are doing so and answer the following questions as much as possible from the patient's perspective.

FDA will post the agenda and other meeting materials approximately 5 days before the meeting at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm591290.htm.

1. Of all the ways that OUD negatively affects your health and well-being, which effects have the most significant impact on your daily life? Examples of negative effects may include:

• Effects of using opioids, such as confusion, constipation, or other symptoms;

• Effects of opioid withdrawal, such as nausea, diarrhea, or other symptoms;

• Effects of opioid “cravings;”

• Impacts on ability to function in personal or professional life;

• Emotional or social effects; and

• Other potential effects.

2. How does OUD affect daily life on your best days? On your worst days?

3. How has your OUD changed over time?

4. What worries you most about your condition?

1. Are you currently using, or have you used in the past, any prescription medical treatments to treat your OUD? Such treatments may include buprenorphine, methadone, naltrexone, and others that your health care provider has prescribed. If so, please describe your experiences with these treatments.

• How well have these treatments worked for you? How well have they helped address the effects of OUD that are most bothersome to you?

• What are the biggest problems you have faced in using these treatments? Examples may include bothersome side effects, challenges getting the medicines, concern about stigma, and other possible problems.

2. Besides prescription medical treatments, are there other treatments or therapies that you currently use to address your OUD? If so, please describe. How well do these treatments or therapies help address the effects of OUD that are most bothersome to you?

3. Of all treatments, therapies, or other steps that you have taken to address your OUD, what have you found to be most effective in helping you manage your OUD?

4. What are the biggest factors that you take into account when making decisions about seeking out or using treatments for OUD?

5. What specific things would you look for in an ideal treatment for OUD?

6. If you had the opportunity to consider participating in a clinical trial studying experimental treatments for OUD, what factors would you consider when deciding whether or not to participate?

Registration: To register for the public meeting, visit https://www.eventbrite.com/e/public-meeting-for-patient-focused-drug-development-on-opioid-use-disorder-oud-registration-42531194949. Please register by April 11, 2018. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Persons without access to the internet can call 240-402-6525 to register. If you are unable to attend the meeting in person, you can register to view a live webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the webcast.

Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by April 11, 2018. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 9 a.m.

If you need special accommodations because of a disability, please contact Meghana Chalasani (see FOR FURTHER INFORMATION CONTACT) no later than April 11, 2018.

Panelist Selection: Patients or patient representatives who are interested in presenting comments as part of the initial panel discussions will be asked to indicate in their registration which topic(s) they wish to address. These patients or patient representatives also will be asked to send [email protected] a brief summary of responses to the topic questions by April 2, 2018. Panelists will be notified of their selection approximately 7 days before the public meeting. We will try to accommodate all patients and patient stakeholders who wish to speak, either through the panel discussion or audience participation; however, the duration of comments may be limited by time constraints.

Open Public Comment: There will be time allotted during the meeting for open public comment. Sign-up for this session will be on a first-come, first-serve basis on the day of the workshop. Individuals and organizations with common interests are urged to consolidate or coordinate and request time for a joint presentation. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

Streaming Webcast of the Public Meeting: This public meeting will also be webcast. Please register for the webcast by visiting https://www.eventbrite.com/e/public-meeting-for-patient-focused-drug-development-on-opioid-use-disorder-oud-registration-42531194949.

If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm591290.htm.

In recent years, regulatory authorities and industry associations from around the world have participated in many important initiatives to promote international harmonization of regulatory requirements under the ICH. FDA has participated in several ICH meetings designed to enhance harmonization and FDA is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

ICH was established to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; the FDA; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association.

The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. The Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidance.

In the Federal Register of September 28, 2015 (80 FR 58261), FDA published a notice announcing the availability of a draft guidance entitled “M7(R1) Addendum to ICH M7; Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk,” available at https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. The notice gave interested persons an opportunity to submit comments by November 27, 2015.

After consideration of the comments received and revisions to the guideline, a final draft of the guideline was submitted to the ICH Assembly and endorsed by the regulatory Agencies in June 2017.

This final guidance provides guidance on acceptable intake limits derived for some chemicals that are considered to be mutagenic carcinogens and are also commonly used in the synthesis of pharmaceuticals or are useful examples to illustrate the principles for deriving compound-specific intakes described in the ICH M7 guidance. This guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing. The default method from ICH M7 of linear extrapolation from the cancer potency estimate, TD50 is used as the primary method to derive the acceptable intakes for carcinogens with likely mutagenic mode of action. After consideration of the comments received, hydroxylamine monograph was deleted from the final guidance. Relevant editorial changes were also made to improve clarity and to incorporate the ICH M7(R1) Addendum guidance.

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 “M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.” 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 with access to the internet may obtain the guidance at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

The GPE Program was established in 2002 to assist American Psychological Association (APA) accredited doctoral programs and internships in meeting the costs to plan, develop, operate, or maintain graduate psychology education programs to train health service psychologists to work with vulnerable populations. The purpose of the current program (Funding Opportunity Announcement HRSA-16-059) is to prepare doctoral-level psychologists to provide behavioral health care, including mental health and substance use disorder prevention and treatment services, in settings that provide integrated primary and behavioral health services to underserved and/or rural populations. The program is designed to foster an integrated and interprofessional approach to address access to behavioral health care for underserved and/or rural populations.

Given the value of feedback from stakeholders, HRSA is seeking comments from interested parties including current and former grant recipients, former applicants to the program, doctoral psychology schools and programs, and health care delivery sites that provide behavioral health experiential training to students. The purpose is to identify doctoral-level health service psychologist training needs, salient issues and challenges in the delivery of behavioral health services, including substance use, and to provide individual recommendations to maximize the reach, capacity and success of the GPE Program in addressing Opioid Use Disorder and other behavioral health concerns. This information may be used by HRSA will consider the input as it develops future technical assistance and funding opportunities, and strategic planning to meet the training demands of the behavioral health workforce.

HRSA seeks comments on how the GPE program (and the students it supports) can help address the opioid epidemic. In your comments, please address one or more of the following:

1. What do you see as the most prevalent behavioral health and public health trends or concerns that should be addressed in developing the psychologist workforce?

2. What do you see as the role for doctoral-level health psychologists in addressing the opioid epidemic?

3. What are the didactic and experiential training needs in preparing doctoral-level health psychologists to effectively address substance use disorder (SUD) including opioid use?

4. If your institution has received in the past, is currently receiving, or applied for but did not receive GPE funding, what features or requirements of the GPE Program were easy to incorporate and/or beneficial in the development and implementation of your program, and which ones posed challenges? Please provide specific examples. If your institution did not apply for GPE funding, what features or requirements of the GPE Program posed challenges to the development of your program or dissuaded your institution from applying to the program?

5. What health workforce training strategies within the experiential training sites could the GPE Program address to increase access to integrated behavioral health/primary care services in underserved and/or rural populations? Please provide a description of practice.

6. Type and site including geographic locations (e.g., large health system, private practices, group practices, Federally Qualified Health Center, etc.).

This department-wide system of records was established April 2015 (see 80 FR 17447) and has not been previously revised. It covers records about individuals within and outside HHS who request restricted datasets and software products from HHS, when HHS maintains the requester records in a system from which they are retrieved directly by an individual requester's name or other personal identifier. It currently includes records maintained by three HHS Operating Divisions. It is being revised to add records maintained by a fourth Operating Division, the National Institutes of Health (NIH), which NIH plans to begin retrieving directly by personal identifier, and to include three revised and five new routine uses, some of which will apply to all records in the system and some of which will apply to only NIH's records.

The alterations made to add NIH's records affect the System Location, Legal Authorities, Purposes, Retention, System Manager, and Routine Uses sections of the System of Records Notice (SORN). One new purpose was added to the “Purposes” section, which will apply to all records, not just NIH records, stating that records may be used to evaluate accomplishment of HHS functions related to the purposes of this system of records and to evaluate performance of contractors utilized by HHS to accomplish those functions. Minor wording and formatting changes have been made throughout the SORN to conform to the SORN template prescribed in OMB Circular A-108. The new and revised routine uses are as follows:

• Routine use 1 has been revised to add “including ancillary functions, such as compiling reports and evaluating program effectiveness and contractor performance.”

• Routine use 2 has been revised to add “including ancillary functions” and to add a last sentence stating: “For example, disclosure may be made to qualified experts not within the definition of HHS employees as prescribed in HHS regulations, for opinions as a part of the controlled data access process.”

• Routine use 10 has been revised to use wording prescribed in OMB Memorandum M-17-12 issued January 3, 2017.

• Routine uses 11 through 15 are new. Routine use 11 is a new routine use prescribed by OMB Memorandum M-17-12.

“Restricted” datasets and software products are those that HHS makes affirmatively available to qualified members of the public but provides subject to restrictions, because they contain identifiable data and/or anonymized data that has the potential, when combined with other data, to identify the particular individuals, such as patients or providers, whose information is represented in the data. The datasets and products are made available through an on-line or paper-based ordering and delivery system that provides them to qualified requesters electronically or by mail.

The restrictions are necessary to protect the privacy of individuals whose information is represented in the datasets or software products. The restrictions typically limit the data requester to using the data for research, analysis, study, and aggregate statistical reporting; prohibit any attempt to identify any individual or establishment represented in the data; and require specific security measures to safeguard the data from unauthorized access. HHS is required by law to impose, monitor, and enforce the restrictions (see, for example, provisions in the Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA), 44 U.S.C. 3501 at note). To impose and enforce the restrictions, it is necessary to collect information about the data requesters.

The altered system of records will cover requester records retrieved by requesters' personal identifiers in the following four systems or any successor systems, but only to the extent that the records pertain to requesters seeking restricted datasets:

• Agency for Healthcare Research and Quality (AHRQ) “Online Application Ordering for Products from the Healthcare Cost and Utilization Project (HCUP).” HCUP is an online system established in 2013; it makes restricted databases and software available for qualified applicants to purchase for scientific research and public health use. Applicants may be researchers, patients, consumers, practitioners, providers, policy makers, or educators. The HCUP databases are annual files containing anonymous information from hospital discharge records for inpatient care and certain components of outpatient care. The HCUP software tools enhance the use of the data. The online system supports AHRQ's mission of promoting improvements in health care quality.

• Centers for Medicare & Medicaid Services (CMS) DUA tracking system. A new data use agreement (DUA) tracking system went into production in 2015 and replaced the previous system, “Data Agreement & Data Shipping Tracking System (DADSS).” The DUA system tracks authorization, payment status, shipping status, and ownership of restricted and unrestricted data extracts between CMS, its contractors, and other authorized entities.

• National Institutes of Health (NIH) “Controlled Data Access Systems.” NIH supports “NIH-designated data repositories,” which archive and distribute controlled-access de-identified human data and results from scientific studies under the NIH Genomic Data Sharing Policy. Controlled-access data in NIH-designated data repositories are made available for secondary research only after investigators have obtained approval from NIH to use the requested data for a particular project. The National Center for Biotechnology Information database of Genotypes and Phenotypes (dbGaP) serves as a central portal to submit, locate, and request access to controlled-access human genomic (e.g., GWAS, sequencing, expression, epigenomic) data. The dbGaP's capacity and functionality are extended by repositories managed by public or private organizations through structured partnerships (“trusted partnerships”) established by NIH through a contract mechanism. Information about investigators, Institutional Signing Officials, and other users of NIH-designated controlled access repositories may be located and viewed by approved staff using the dbGaP or trusted partner-managed systems. Sharing research data supports the mission of the NIH and is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health.

• Substance Abuse and Mental Health Services Administration (SAMHSA) “Online Application for the Data Portal (SAMHDA).” This online data portal was established in 2013 to more efficiently make restricted datasets from SAMHSA available to designated, approved researchers. The Data Portal and all applications are maintained through the Substance Abuse and Mental Health Data Archive (SAMHDA). Currently, data from the Drug Abuse Warning Network (DAWN), DAWN Medical Examiner/Coroner component, National Survey on Drug Use and Health (NSDUH), and NSDUH Adult Clinical Interview data are available through the portal. Data recipients must complete a web-based application process and receive project approval from SAMHSA's Center for Behavioral Health and Statistics and Quality (CBHSQ), and can use the datasets for statistical purposes only. No fees are charged for the datasets. The online portal supports SAMHSA' s mission to make substance use and mental disorder information and research more accessible.

Note that this system of records does not include:

• Records about requesters who seek unrestricted datasets, publications, or other information products from an HHS on-line or paper-based ordering and delivery system. Unrestricted materials are also proactively made available to the public by HHS, but are released without restrictions (though some may be subject to terms or conditions of use and require registration for an account and payment of a fee). Because the requests or order forms collect minimal information about the requester (i.e., the requester's name, mailing address or email address, telephone number, or other contact or delivery information, and payment information if a fee is imposed) they would be adequately covered by other SORNs (for example, “Correspondence Tracking Management System (CTMS)” SORN #09-70-3005; “Consumer Mailing List” SORN #09-90-0041; and “HHS Financial Management System Records” SORN #09-90-0024 if a fee is involved), if a SORN is required (i.e., if the records are retrieved directly by an individual requester's name or other personal identifier). Examples include records about requesters who order materials online from AHRQ's Publications Online Store & Clearinghouse or by mail from AHRQ's Publications Clearinghouse, which provide only unrestricted publications and other information products; and records about requesters ordering unrestricted datasets from CMS's DUA tracking system, which processes orders for both restricted and unrestricted datasets.

• Records about data requesters that are not retrieved directly by an individual requester's name or other personal identifier. These records are not subject to the Privacy Act and are not required to be covered in a SORN, even when they are associated with a restricted dataset and include additional information about the requester (such as, the requester's intended research purpose, qualifications, signed Data Use Agreement, and confidentiality training certificate). An example would be requester records that are retrieved first by a dataset identifier and/or a requesting entity's name, and then by an individual researcher's or record custodian's name.

A report on the altered system of records has been sent to OMB and Congress in accordance with 5 U.S.C. 552a(r).

Pursuant to the Government Performance and Results Act (GPRA) of 1993 and the GPRA Modernization Act of 2010, BHW requires all recipients of Health Professions awards to report annual performance data to BHW to enable BHW to determine the success of its programs. The performance data must include information about health professionals who directly or indirectly benefit from a BHW award.

Currently, HRSA awardees submit performance data into the Electronic Handbooks (EHBs), an enterprise grants management system at HRSA. To reduce the reporting burden on awardees, BHW is developing a data collection portal that will allow awardees to collect individual-level trainee data (consisting of the trainee's name, training program, demographic information, aspects of their training, and employment information upon completion of training) directly from trainees via online surveys. For awardees that decide to communicate with trainees for this data collection, trainee email addresses may also be included. The survey responses will be collected, monitored, and managed in the portal, and awardees will be able to transmit and submit the data electronically into EHBs. Awardees will be able to send reminders or notifications to the trainees for initial surveys or any follow-up reminders. Awardees will also have the ability to directly upload bulk individual-level data rather than key in every required data field.

Data elements collected in the portal about individual trainees will be the same as those already being collected in the EHBs; only the source and retrieval method are changing. Enabling awardees to collect individual level trainee data directly from trainees may result in more accurate annual reports to BHW. Retrieving information about individual trainees directly by trainee name or other personal identifier will improve BHW's ability to follow the trainees even after the completion of their training to find out if they are employed in health care and/or work in underserved areas, as required to evaluate the effectiveness and success of BHW health professions programs.

This proposed information collection was previously published in the Federal Register on December 22, 2017, page 60754 (82 FR 60754) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Proposed Collection: Generic Clearance for the collection of Qualitative Feedback on Agency Service Delivery—0925-0648 EXTENSION—National Institutes of Health (NIH).

Need and Use of Information Collection: There are no changes being requested for this submission. The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. This generic will provide information about the NIH Institutes and Centers 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. 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.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 49,333.

This request for information is a coordinated effort of the Director of the National Institutes of Health in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.

Section 2034(d) of the 21st Century Cures Act (Pub. L. 114-255) was enacted December 13, 2016 and requires that the NIH in collaboration with the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions to reduce administrative burden on investigators. In carrying out this effort, the law requests that NIH seek put to identify ways to ensure regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative.

In carrying out the review, NIH OLAW, USDA, and FDA are currently reviewing the following reports and surveys:

• Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden, 2017, Report of an April 17, 2017 workshop organized by Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges, and the Council on Governmental Relations, with support from the National Association for Biomedical Research, http://www.faseb.org/Portals/2/PDFs/opa/2017/FASEB-Animal-Regulatory-Report-October2017.pdf.

• Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century, 2016, National Academies, https://www.nap.edu/catalog/21824/optimizing-the-nations-investment-in-academic-research-a-new-regulatory.

• Reducing Investigators' Administrative Workload for Federally Funded Research, 2014, National Science Board, National Science Foundation, https://www.nsf.gov/pubs/2014/nsb1418/nsb1418.pdf.

• 2012 Faculty Workload Survey Research Report, 2014, Federal Demonstration Partnership (FDP), https://sites.nationalacademies.org/cs/groups/pgasite/documents/webpage/pga_087667.pdf.

• Findings of the FASEB Survey on Administrative Burden, 2013, FASEB, http://www.faseb.org/portals/2/pdfs/opa/6.7.13%20FASEB%20NSB%20Survey%20findings.pdf.

We are seeking the input of interested stakeholders concerning proposed actions that the agencies have identified to improve coordination and harmonization of regulations and policies. The responses received will provide critical information for final recommendations and implementation.

Input is sought on each of the following proposed actions that the agencies are considering:

1. Allow investigators to submit protocols for continuing review using a risk-based methodology.

2. Allow annual reporting to OLAW and USDA on the same reporting schedule and as a single report through a shared portal.

3. Harmonize the guidance from NIH and USDA to reduce duplicative considerations of alternatives to painful and distressful procedures.

4. Provide a minimum 60-day comment period for new OLAW policy guidance.

5. Other approaches not previously mentioned.

Feedback is sought on whether the following tools and resources are or would be helpful for reducing burden on investigators:

1. Encourage the use of sections of the AAALAC International program description in applicable parts of the OLAW Animal Welfare Assurance, for institutions accredited by AAALAC International.

2. Encourage the use of the FDP Compliance Unit Standard Procedures as a repository of best practices for standard procedures used for research with animals.

3. Encourage the use of the IACUC Administrators Association repository of best practices by IACUCs.

4. Encourage the use of new or existing tools to streamline protocol review through use of designated member review (DMR), DMR subsequent to full committee review, and/or Veterinary Verification and Consultation.

5. Expanded IACUC training activities that focus on reducing burden on investigators.

This collection is in accordance with Executive Orders 12862 and 13571 requiring all Federal agencies to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. The Government Performance and Results Act (GPRA) requires Federal agencies to set missions and goals and to measure agency performance against them. The GPRA Modernization Act of 2010 requires quarterly performance assessments of government programs for the purposes of assessing agency performance and improvement. The Federal Emergency Management Agency is collecting information through focus groups to improve its public service advertising campaign on disaster preparedness.

Title: Ready PSA Campaign Creative Testing Research.

Type of Information Collection: Revision of a currently approved information collection.

OMB Number: 1660-0139.

FEMA Forms: FEMA Form 008-0-21, Recruitment Screener; FEMA Form 008-0-22, Focus Group Discussion Guide.

Abstract: FEMA proposes conducting qualitative research in the form of focus groups in order to test creative concepts developed for FEMA's national Ready public service advertising campaign, which aims to educate and empower Americans to prepare for and respond to emergencies. The research will help determine the clarity, relevance, and motivating appeal of the concepts prior to final production of the advertising.

Affected Public: Individuals or households.

Estimated Number of Respondents: 90.

Estimated Number of Responses: 90.

Estimated Total Annual Burden Hours: 58.

Estimated Total Annual Respondent Cost: $2,060.16.

Estimated Respondents' Operation and Maintenance Costs: There are no annual costs to respondents' operations and maintenance costs for technical services.

Estimated Respondents' Capital and Start-Up Costs: There are no annual start-up or capital costs.

Estimated Total Annual Cost to the Federal Government: $52,834.81.

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.

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.

This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at https://msc.fema.gov.

The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.