Federal Register Vol. 80, No.88,

Brazos is proposing to construct a new gas-fired combustion turbine generation facility and is evaluating a potential site located in Hill County, Texas. The 40 acre site is located in the northeast corner of Hill County approximately 8 miles east of Itasca, Texas on FM 66 just west of the Hill County line. Associated facilities include a 4.5 mile gas pipeline and new switching facilities to connect the generation plant to existing transmission lines crossing the site.

Comments regarding the proposed project may be submitted in writing at the public scoping workshop or in writing no later than June 21, 2015, to RUS at the address provided above.

An Environmental Assessment (EA) will be prepared for the proposed project. Based on a review of the EA and other relevant information, RUS will determine if the preparation of an Environmental Impact Statement is necessary. Should RUS determine that the preparation of an Environmental Impact Statement is not necessary, it will prepare a Finding of No Significant Impact.

Any final action by RUS related to the proposed project will be subject to, and contingent upon, compliance with all relevant Federal, State, and local environmental laws and regulations and completion of the environmental review procedures as prescribed by RUS' Environmental Policies and Procedures.

The Inspector General Act of 1978, as amended, 5 U.S.C. App. 3, authorizes DOC OIG to conduct investigations to detect and prevent fraud, waste, mismanagement and abuse, and to promote economy and efficiency, in the DOC's programs and operations. OIG uses records in this system in the course of investigating individuals and entities suspected of criminal, civil, or administrative misconduct, and in supporting related judicial and administrative proceedings. OIG's Office of Investigations (OI) maintains and manages OIG's investigative records. DOC OIG proposes to amend the system of records entitled “OIG Investigative Records—COMMERCE/DEPT-12,” published in the Federal Register on March 14, 2012 (77 FR 15038) and January 19, 2012 (77 FR 2692) to reflect a new investigative case management system and an electronic discovery tool; update OIG routine uses; update OIG's practices for storing, retrieving, and safeguarding records in the system; and generally update the system's notice. Specifically, the following sections of the system of records are proposed to be amended: Categories of Individuals Covered by the System; Categories of Records in the System; Routine Uses; Storage; Retrievability; Safeguards; and System Manager.

The updates to the system will not involve the collection of additional categories of information, but will provide methods for data tracking, organization, and retrieval previously unavailable. OIG's changes will generally improve the organization, security, ability to search, and reporting capability of investigative records. For the public's convenience, DOC OIG restates below in its entirety the system of records, including the proposed amendments.

On May 29, 2014, the Department initiated an administrative review of the antidumping duty order on certain steel threaded rod from the PRC for the period, April 1, 2013, through March 31, 2014, for 92 companies.4 On June 18, 2014, Vulcan Threaded Products, Inc. (“Petitioner”) timely withdrew its request for an administrative review of 83 companies.5 On September 23, 2014, the Department rescinded this administrative review with respect to 83 companies named in the Initiation Notice based on the timely withdrawal of requests for review,6 in accordance with 19 CFR 351.213(d)(1).7 Accordingly, nine companies remain under review for these preliminary results.

The merchandise covered by the order includes steel threaded rod. The subject merchandise is currently classifiable under subheading 7318.15.5051, 7318.15.5056, 7318.15.5090, and 7318.15.2095 of the United States Harmonized Tariff Schedule (“HTSUS”). Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the merchandise is dispositive.8

As noted above, a review was requested, but not rescinded, for nine companies. Aside from the mandatory respondents, Gem-Year and RMB/IFI Group, the remaining seven companies are not eligible for separate rate status or rescission because none submitted a completed separate rate application or certification.9 Accordingly, these seven companies are part of the PRC-wide entity. Additionally, the Department preliminarily determines that Gem-Year and the RMB/IFI Group, the mandatory respondents, failed to cooperate by not acting to the best of their abilities to comply with requests for information, and therefore, neither is eligible for a separate rate. Accordingly, the Department preliminarily finds, based on AFA, that the PRC-wide entity also includes these two companies.10

The Department's change in policy regarding conditional review of the PRC-wide entity applies to this administrative review.11 Under this policy, the PRC-wide entity will not be under review unless a party specifically requests, or the Department self-initiates, a review of the entity. Because no party requested a review of the PRC-wide entity in this review, the entity is not under review and the entity's rate is not subject to change, (i.e., 206 percent).12

The Department conducted this review in accordance with section 751(a)(1)(B) of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.13 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 7046 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the internet at http://www.trade.gov/enforcement/. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

The Department preliminarily determines that, for the period April 1, 2013, through March 31, 2014, the companies identified in Appendix I to this notice are part of the PRC-wide entity.

Interested parties may submit case briefs within 30 days after the date of publication of these preliminary results of review.14 Rebuttals to case briefs, which must be limited to issues raised in the case briefs, must be filed within five days after the time limit for filing case briefs.15 Parties who submit arguments are requested to submit with the argument (a) a statement of the issue, (b) a brief summary of the argument, and (c) a table of authorities.16 Parties submitting briefs should do so pursuant to the Department's electronic filing system, ACCESS.

Any interested party may request a hearing within 30 days of publication of this notice.17 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations will be limited to issues raised in the briefs.18 If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.19

The Department intends to issue the final results of this administrative review, which will include the results of our analysis of all issues raised in the case briefs, within 120 days of publication of these preliminary results in the Federal Register, unless extended, pursuant to section 751(a)(3)(A) of the Act.

Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.20 The Department intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review.

For any individually examined respondent whose weighted average dumping margin is above de minimis (i.e., 0.50 percent) in the final results, the Department will calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of sales, in accordance with 19 CFR 351.212(b)(1). Where an importer- (or customer-) specific ad valorem rate is greater than de minimis, the Department will instruct CBP to collect the appropriate duties at the time of liquidation.21 Where either a respondent's weighted average dumping margin is zero or de minimis, or an importer- (or customer-) specific ad valorem rate is zero or de minimis, the Department will instruct CBP to liquidate appropriate entries without regard to antidumping duties.22 We intend to instruct CBP to liquidate entries containing subject merchandise exported by the PRC-wide entity at the PRC-wide rate.

The Department announced a refinement to its assessment practice in non-market economy (“NME”) cases.23 Pursuant to this refinement in practice, for entries that were not reported in the U.S. sales databases submitted by companies individually examined during the administrative review, the Department will instruct CBP to liquidate such entries at the PRC-wide rate. Additionally, if the Department determines that an exporter had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (i.e., at that exporter's rate) will be liquidated at the PRC-wide rate.24

In accordance with section 751(a)(2)(C) of the Act, the final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable.

The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) For any companies listed that have a separate rate, the cash deposit rate will be that established in the final results of this review (except, if the rate is zero or de minimis, then zero cash deposit will be required); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed 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 PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be that for the PRC-wide entity; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter that supplied that non-PRC exporter.

These deposit requirements, when imposed, shall remain in effect until further notice.

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

These preliminary results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).

The merchandise subject to the antidumping duty order is polyethylene retail carrier bags, which are currently classified under subheading 3923.21.0085 of the Harmonized Tariff Schedule of the United States (HTSUS). The HTSUS number is provided for convenience and customs purposes. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.2 The written description is dispositive.

The products covered by the order include drawn stainless steel sinks. Imports of subject merchandise are currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7324.10.0000 and 7324.10.0010. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive.1

The Department conducted this review in accordance with section 751(a)(2)(B) of the Tariff Act of 1930, as amended (the Act). Export prices have been calculated in accordance with section 772 of the Act. Because the PRC is a non-market economy (NME) within the meaning of section 771(18) of the Act, NV has been calculated in accordance with section 773(c) of the Act.

For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. 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; the Preliminary Decision Memorandum is also available to all parties in the Central Records Unit, room 7046 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the Enforcement and Compliance's Web site at http://www.trade.gov/enforcement/. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content. A list of the topics discussed in the Preliminary Decision Memorandum is attached as the Appendix to this notice.

Because Feidong Import & Export Co., Ltd., Shunde Native Produce Import & Export Co, Ltd. of Guangdong, and Zhongshan Silk Import & Export Group Co., Ltd. of Guangdong did not demonstrate they were entitled to a separate rate, the Department preliminarily finds these companies to be part of the PRC-wide entity.2 The rate previously established for the PRC-wide entity is 76.53 percent.3

The Department preliminarily determines that the following weighted-average dumping margins exist for the period October 4, 2012, through March 31, 2014:

The Department intends to disclose to the parties the calculations performed for these preliminary results within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs no later than 30 days after the date of publication of these preliminary results of review.4 Rebuttals to case briefs may be filed no later than five days after the written comments are filed and all rebuttal comments must be limited to comments raised in the case briefs.5

Any interested party may request a hearing within 30 days of publication of this notice.6 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.7

Unless otherwise extended, the Department intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in the case briefs, within 120 days of publication of these preliminary results, pursuant to section 751(a)(3)(A) of the Act.

Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.8 The Department intends to issue appropriate assessment instructions to CBP 15 days after the publication of the final results of this review.

For each individually-examined respondent in this review (i.e., Dongyuan and Yingao) which has a weighted-average dumping margin which is not zero or de minimis (i.e., less than 0.5 percent), we will calculate importer- (or customer-) specific per-unit duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's (or customer's) examined sales to the total sales quantity associated with those sales, in accordance with 19 CFR 351.212(b)(1).9 Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer- (or customer-) specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

For the respondents which were not selected for individual examination in this administrative review and which qualified for a separate rate, the assessment rate will be equal to the average of the weighted-average dumping margins assigned to Dongyuan and Yingao in the final results of this review.

For the final results, if we continue to treat the three companies identified above as part of the PRC-wide entity, we will instruct CBP to apply an ad valorem assessment rate of 76.45 percent to all entries of subject merchandise during the POR which were produced and/or exported by those companies.

The Department announced a refinement to its assessment practice in NME cases. Pursuant to this refinement in practice, for entries that were not reported in the U.S. sales databases submitted by companies individually examined during this review, the Department will instruct CBP to liquidate such entries at the PRC-wide rate. In addition, if the Department determines that an exporter under review had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (i.e., at that exporter's rate) will be liquidated at the PRC-wide rate.10

The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For the companies listed above that have a separate rate, the cash deposit rate will be that rate established in the final results of this review (except, if the rate is zero or de minimis, then a cash deposit rate of zero will be established for that company); (2) for previously investigated or reviewed PRC and non-PRC 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 PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the rate for the PRC-wide entity, which is 76.45 percent; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

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

We are issuing and publishing these results of reviews in accordance with sections 751(a)(l) and 777(i)(l) of the Act.

The products covered by the order are all gauges of raw, pre-treated, or primed polyethylene terephthalate film, whether extruded or co-extruded. Excluded are metallized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer more than 0.00001 inches thick. Also excluded is roller transport cleaning film which has at least one of its surfaces modified by application of 0.5 micrometers of SBR latex. Tracing and drafting film is also excluded. Polyethylene terephthalate film is classifiable under subheading 3920.62.00.90 of the Harmonized Tariff Schedule of the United States (HTSUS). While HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the order is dispositive.2

This anti-circumvention inquiry covers PET Film produced in Bahrain by JBF Bahrain from inputs (PET chips and silica chips) manufactured in the UAE, and that is subsequently exported from Bahrain to the United States.

The Department has conducted this preliminary determination of circumvention in accordance with section 781(b) of the Act and 19 CFR 351.225(h). For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.3 The Preliminary Decision Memorandum 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 it is available to all parties in the Central Records Unit in room 7046 of the main Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and electronic versions of the Preliminary Decision Memorandum are identical in content.

As detailed in the Preliminary Decision Memorandum, the Department has preliminarily determined that the process of completion or assembly of PET Film produced by JBF Bahrain is not minor or insignificant, pursuant to section 781(b)(2) of the Act, nor is the value of the merchandise produced in the UAE a significant portion of the value of PET film exported from Bahrain to the United States, pursuant to section 781(b)(1)(D) of the Act. Therefore, the Department preliminarily determines that PET Film produced by JBF Bahrain in Bahrain using inputs from the UAE, and exported from Bahrain to the United States, is not circumventing the Order.

The Department intends to disclose the analysis used in these preliminary findings within five days of publication of this notice. Interested parties are invited to comment on the preliminary results of this review. Pursuant to 19 CFR 351.309(b)(2), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may not be filed later than five days after the time limit for filing case briefs.4 Case and rebuttal briefs, when submitted, must comport with the requirements contained in 19 CPR 351.309(c)(2) and (d)(2).

Any interested party who wishes to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days after the day of publication of this notice pursuant to 19 CFR 351.310(c). A request should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed.5 Issues raised in the hearing will be limited to those raised in case briefs.

According to 19 CFR 351.225(f)(5), the Department will normally issue a final scope ruling in a circumvention inquiry within 300 days of the date of the initiation inquiry. Because of the extensive cost, investment, and research and development information required for this analysis from JBF, the Department is extending the deadline for the final ruling in this inquiry. The final determination with respect to this anti-circumvention inquiry, including results of the Department's analysis of any written comments, will be issued no later than July 31, 2015.

This preliminary negative circumvention determination is published in accordance with section 781(b) of the Act and 19 CFR 351.225.

On April 10, 2015, the Department disclosed to interested parties its calculations for the Final Results. 2 On April 15, 2015, we received a ministerial error allegation from Petitioners 3 regarding the Department's margin calculation for Guizhou Tyre Co., Ltd./Guizhou Tyre Import and Export Co., Ltd. (collectively, “GTC”).4

The merchandise covered by this order includes new pneumatic tires designed for off-the-road and off-highway use, subject to certain exceptions. The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (“HTSUS”) subheadings: 4011.20.10.25, 4011.20.10.35, 4011.20.50.30, 4011.20.50.50, 4011.61.00.00, 4011.62.00.00, 4011.63.00.00, 4011.69.00.00, 4011.92.00.00, 4011.93.40.00, 4011.93.80.00, 4011.94.40.00, and 4011.94.80.00. The HTSUS subheadings are provided for convenience and customs purposes only; the written product description of the scope of the order is dispositive.5

Section 751(h) of the Tariff Act of 1930, as amended (“the Act”), and 19 CFR 351.224(f) define a “ministerial error” as an error “in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any similar type of unintentional error which the Secretary considers ministerial.” We analyzed Petitioners' ministerial error comments and determined, in accordance with section 751(h) of the Act and 19 CFR 351.224(e), that we made a ministerial error in our calculation of GTC's margin for the Final Results by inadvertently neglecting to include two of GTC's inputs in the total material cost buildup for normal value.6

In accordance with section 751(h) of the Act and 19 CFR 351.224(e), we are amending the Final Results. 7 The revised weighted-average dumping margins are detailed below.

As a result of correcting this ministerial error, we determine that the following weighted-average dumping margins exist for the POR:

The Department shall determine, and the U.S. Customs and Border Protection (“CBP”) shall assess, antidumping duties on all appropriate entries covered by this review pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b).9 The Department intends to issue assessment instructions to CBP 15 days after the date of publication of these amended final results of review.

For customers or importers of GTC for which we do not have entered value, we calculated importer- (or customer-) specific antidumping duty assessment amounts based on the ratio of the total amount of dumping duties calculated for the examined sales of subject merchandise to the total sales quantity of those same sales.10 For customers or importers of GTC for which we received entered-value information, we have calculated importer- (or customer-) specific antidumping duty assessment rates based on importer- (or customer-) specific ad valorem rates.11 For the non-examined separate rate companies, we will instruct CBP to liquidate all appropriate entries at 11.41 percent. For the PRC-wide entity, including Double Coin, we will instruct CBP to liquidate all appropriate entries at 105.31 percent.

Consistent with the Department's assessment practice in non-market economy cases,12 for entries that were not reported in the U.S. sales databases submitted by companies individually examined during this review, the Department will instruct CBP to liquidate such entries at the PRC-wide rate. In addition, if the Department determines that an exporter under review had no shipments of subject merchandise, any suspended entries that entered under that exporter's case number (i.e., at that exporter's rate) will be liquidated at the PRC-wide rate.

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the amended final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be equal to the weighted-average dumping margin identified in the “Amended Final Results” section; (2) for previously investigated or reviewed PRC and non-PRC exporters that are not under review in this segment of the proceeding but that received a separate rate in a previous segment, the cash deposit rate will continue to be the exporter-specific rate (or exporter-producer chain rate) published for the most recently completed segment of this proceeding; (3) for all PRC exporters of subject merchandise which have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate of 105.31 percent; 13 and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) that supplied that non-PRC exporter. The cash 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 and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.

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

We will disclose the calculations performed for these amended final results to interested parties within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

These amended final results of review are issued and published in accordance with section 751(h) of the Tariff Act of 1930 Act and 19 CFR 351.224(f).

The Committee was established under the discretionary authority of the Secretary of Commerce and in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2). It provides advice to the Secretary of Commerce on the necessary elements of a comprehensive policy approach to supply chain competitiveness designed to support U.S. export growth and national economic competitiveness, encourage innovation, facilitate the movement of goods, and improve the competitiveness of U.S. supply chains for goods and services in the domestic and global economy; and provides advice to the Secretary on regulatory policies and programs and investment priorities that affect the competitiveness of U.S. supply chains. For more information about the Committee visit: http://trade.gov/td/services/oscpb/supplychain/acscc/.

Committee members are expected to deliberate and vote on the Trade and Competitiveness subcommittee's recommendation to Secretary Pritzker, which generally urges the Administration to expand market access for U.S. firms to international markets, implement the WTO Trade Facilitation Agreement (TFA), support customs trade transformation initiatives, and ensure our trading partners' compliance with our trade agreements. This recommendation, available at: http://trade.gov/td/services/oscpb/supplychain/acscc/documents/May%2021%202015%20Conf%20Call/ACSCC%20trade%20ltr%20to%20SPP%20TC%20Subcomm.pdf, has been reviewed and discussed over the last several open meetings of the ACSCC, most recently at the April 16 meeting. The Office of Supply Chain, Professional & Business Services will post the final agenda and the recommendation on its Web site at least one week prior to the meeting. The conference call will be open to the public and press on a first-come, first-served basis. Access lines are limited. The minutes of the meetings will be posted on the Committee Web site within 60 days of the meeting.

The Council's Mackerel-Squid-Butterfish (MSB) Monitoring Committee will meet to develop recommendations for future MSB specifications. There will be time for public questions and comments. The Council utilizes the Monitoring Committee recommendations at each June Council meeting when setting the subsequent years' MSB specifications.

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

Title of Collection: Gramm-Leach-Bliley Act (Regulation P) 12 CFR 1016.

OMB Control Number: 3170-0010.

Type of Review: Extension without change of a currently approved collection.

Affected Public: Businesses and other for-profit institutions.

Estimated Number of Respondents: 29,544.

Estimated Total Annual Burden Hours: 366,134

Abstract: Section 502 of the Gramm-Leach-Bliley Act (GLBA) (Pub. L. 106-102) generally prohibits a financial institution from sharing nonpublic personal information about a consumer with nonaffiliated third parties unless the institution satisfies various disclosure requirements (including provision of initial privacy notices, annual notices, notices of revisions to the institution's privacy policy, and opt-out notices) and the consumer has not elected to opt out of the information sharing. The CFPB promulgated Regulation P (12 CFR 1016) to implement the GLBA's notice requirements and restrictions on a financial institution's ability to disclose nonpublic personal information about consumers to nonaffiliated third parties.

Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the 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. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record.

Title and OMB Number: Information Collection in Support of the 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 or other for-profit and not-for-profit institutions.

Annual Burden Hours: 342,315.

Number of Respondents: 3,353.

Responses per Respondent: Approximately 1.

Annual Responses: 3,369.

Average Burden per Response: Approximately 101 hours.

Frequency: On occasion.

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.

CARB first adopted its CHE regulation on December 31, 2006. The regulation applied to newly purchased, leased, or rented on- and off-road vehicles and equipment, as well as to in-use on- and off-road vehicles and equipment with compression-ignition (CI) engines that operate at ports and intermodal rail yards.1 On February 21, 2012, EPA granted California a full waiver for those parts of the CHE regulation establishing emission standards for new on-road motor vehicles and full authorization for standards and other requirements related to the control of emissions affecting new and in-use nonroad engines.2 CARB formally adopted the CHE amendments on October 14, 2012,3 and they are codified at title 13, California Code of Regulations (CCR), section 2479. The CHE amendments modify certain retrofit, operational, and compliance requirements; strengthen certain emission standards; and address definitions and provide other clarifying language. By letter dated May 16, 2013, CARB submitted a request to EPA pursuant to section 209(e) of the Act, seeking EPA's confirmation that certain CHE amendments fall within the scope of EPA's February 2012 authorization and a full authorization for other CHE amendments. Those CHE amendments for which CARB sought within-the-scope confirmation are related to compliance flexibility and reduced compliance costs and include: Modification to retrofit requirements and operational practices; demonstration of emissions equivalency for alternative technology; and modification of certain compliance requirements. CARB sought a full authorization for the CHE amendments related to new, more stringent requirements and include: A new opacity based monitoring program for in-use nonroad vehicles and equipment; and, a new retrofit requirement for engines meeting the Tier 4 Family Emissions Limit standards.

Section 209(e)(1) of the Act permanently preempts any state, or political subdivision thereof, from adopting or attempting to enforce any standard or other requirement relating to the control of emissions for certain new nonroad engines or vehicles.4 For all other nonroad engines (including “non-new” engines), states generally are preempted from adopting and enforcing standards and other requirements relating to the control of emissions, except that section 209(e)(2)(A) of the Act requires EPA, after notice and opportunity for public hearing, to authorize California to adopt and enforce such regulations unless EPA makes one of three enumerated findings. Specifically, EPA must deny authorization if the Administrator finds that (1) California's protectiveness determination (i.e., that California standards will be, in the aggregate, as protective of public health and welfare as applicable federal standards) is arbitrary and capricious, (2) California does not need such standards to meet compelling and extraordinary conditions, or (3) the California standards and accompanying enforcement procedures are not consistent with section 209 of the Act.

On July 20, 1994, EPA promulgated a rule interpreting the three criteria set forth in section 209(e)(2)(A) that EPA must consider before granting any California authorization request for nonroad engine or vehicle emission standards.5 EPA revised these regulations in 1997.6 As stated in the preamble to the 1994 rule, EPA historically has interpreted the consistency inquiry under the third criterion, outlined above and set forth in section 209(e)(2)(A)(iii), to require, at minimum, that California standards and enforcement procedures be consistent with section 209(a), section 209(e)(1), and section 209(b)(1)(C) of the Act.7

In order to be consistent with section 209(a), California's nonroad standards and enforcement procedures must not apply to new motor vehicles or new motor vehicle engines. To be consistent with section 209(e)(1), California's nonroad standards and enforcement procedures must not attempt to regulate engine categories that are permanently preempted from state regulation. To determine consistency with section 209(b)(1)(C), EPA typically reviews nonroad authorization requests under the same “consistency” criteria that are applied to motor vehicle waiver requests under section 209(b)(1)(C). That provision provides that the Administrator shall not grant California a motor vehicle waiver if she finds that California “standards and accompanying enforcement procedures are not consistent with section 202(a)” of the Act. Previous decisions granting waivers and authorizations have noted that state standards and enforcement procedures will be found to be inconsistent with section 202(a) if (1) there is inadequate lead time to permit the development of the necessary technology, giving appropriate consideration to the cost of compliance within that time, or (2) the federal and state testing procedures impose inconsistent certification requirements.

In light of the similar language of sections 209(b) and 209(e)(2)(A), EPA has reviewed California's requests for authorization of nonroad vehicle or engine standards under section 209(e)(2)(A) using the same principles that it has historically applied in reviewing requests for waivers of preemption for new motor vehicle or new motor vehicle engine standards under section 209(b).8 These principles include, among other things, that EPA should limit its inquiry to the three specific authorization criteria identified in section 209(e)(2)(A),9 and that EPA should give substantial deference to the policy judgments California has made in adopting its regulations. In previous waiver decisions, EPA has stated that Congress intended EPA's review of California's decision-making be narrow. EPA has rejected arguments that are not specified in the statute as grounds for denying a waiver:

If California amends regulations that were previously authorized by EPA, California may ask EPA to determine that the amendments are within the scope of the earlier authorization. A within-the-scope determination for such amendments is permissible without a full authorization review if three conditions are met. First, the amended regulations must not undermine California's previous determination that its standards, in the aggregate, are as protective of public health and welfare as applicable federal standards. Second, the amended regulations must not affect consistency with section 209 of the Act, following the same criteria discussed above in the context of full authorizations. Third, the amended regulations must not raise any “new issues” affecting EPA's prior authorizations.12

In previous waiver decisions, EPA has recognized that the intent of Congress in creating a limited review based on the section 209(b)(1) criteria was to ensure that the federal government did not second-guess state policy choices. As the agency explained in one prior waiver decision:

Similarly, EPA has stated that the text, structure, and history of the California waiver provision clearly indicate both a congressional intent and appropriate EPA practice of leaving the decision on “ambiguous and controversial matters of public policy” to California's judgment.14 This interpretation is supported by relevant discussion in the House Committee Report for the 1977 amendments to the Clean Air Act.15 Congress had the opportunity through the 1977 amendments to restrict the preexisting waiver provision, but elected instead to expand California's flexibility to adopt a complete program of motor vehicle emission controls. The report explains that the amendment is intended to ratify and strengthen the preexisting California waiver provision and to affirm the underlying intent of that provision, that is, to afford California the broadest possible discretion in selecting the best means to protect the health of its citizens and the public welfare.16

As the U.S. Court of Appeals for the D.C. Circuit has made clear in MEMA I, opponents of a waiver request by California bear the burden of showing that the statutory criteria for a denial of the request have been met:

With regard to the standard of proof, the court in MEMA I explained that the Administrator's role in a section 209 proceeding is to:

With regard to the protectiveness finding, the court upheld the Administrator's position that, to deny a waiver, there must be “clear and compelling evidence” to show that proposed enforcement procedures undermine the protectiveness of California's standards.22 The court noted that this standard of proof also accords with the congressional intent to provide California with the broadest possible discretion in setting regulations it finds protective of the public health and welfare.23

With respect to the consistency finding, the court did not articulate a standard of proof applicable to all proceedings, but found that the opponents of the waiver were unable to meet their burden of proof even if the standard were a mere preponderance of the evidence. Although MEMA I did not explicitly consider the standards of proof under section 209 concerning a waiver request for “standards,” as compared to a waiver request for accompanying enforcement procedures, there is nothing in the opinion to suggest that the court's analysis would not apply with equal force to such determinations. EPA's past waiver decisions have consistently made clear that: “[E]ven in the two areas concededly reserved for Federal judgment by this legislation—the existence of `compelling and extraordinary' conditions and whether the standards are technologically feasible—Congress intended that the standards of EPA review of the State decision to be a narrow one.” 24

On May 28, 2014, EPA published a Federal Register notice announcing its receipt of California's authorization request. In that notice, EPA invited public comment on each of the CHE amendments and an opportunity to request a public hearing.25

First, EPA requested comment on the CHE amendments, as follows: (1) Should California's CHE amendments be considered under the within-the-scope analysis, or should they be considered under the full authorization criteria?; (2) If those amendments should be considered as a within-the-scope request, do they meet the criteria for EPA to grant a within-the-scope confirmation?; and (3) If the amendments should not be considered under the within-the-scope analysis, or in the event that EPA determines they are not within the scope of the previous authorization, do they meet the criteria for full authorization?

EPA received one anonymous written comment that opposed “any new Regulation or Rule promulgated by EPA on California State Non Road Engine Pollution Control Standards: Mobile Cargo Handling Equipment at Ports and Intermodal Rail Yards Regulations.” 26 EPA is not promulgating any regulations or rules regarding California's CHE regulations, but rather is adjudicating whether or not the amendments that CARB made to its own CHE regulations are within the scope of previous authorizations granted by EPA or fulfill the criteria for a full authorization under the Clean Air Act. EPA received no requests for a public hearing. Consequently, EPA did not hold a public hearing.

The CHE amendment package contains six categories of amendments. CARB seeks within-the-scope confirmation for the following amendments: (1) Modification to retrofit requirements; (2) modification of operation practices; (3) allowance of demonstration of emissions equivalency for alternative technology; and (4) modification of compliance requirements. CARB seeks a full authorization to enforce amendments that establish: (1) A new opacity based monitoring program; and (2) new retrofit requirements for engines meeting the Tier 4 Family Emission Limits standards.

California maintains that many of the CHE amendments were enacted to address a variety of implementation issues associated with the initial CHE regulations. CARB asserts that the amendments provide additional compliance flexibilities without sacrificing significant emission reductions.

CARB's amendments to the retrofit requirements allow additional time for fleet owners/operators (fleets) to retrofit equipment for which no verified diesel emission control strategies (VDECS) are available. The retrofit amendments also add safety as a criterion for assessing VDECS availability, allow additional time to request a compliance date extension, and allow an extension of the time for the use of experimental diesel particulate matter emissions control strategies for the purpose of gathering verification data on such strategies.

According to CARB, the amendments that modify the operational practice requirements involve four minor adjustments to the CHE regulations. These include a low-use compliance extension (a two-year extension for equipment that operates less than 200 hours per year), an allowance for cargo handling equipment other than yard trucks (“non-truck CHE”), owned or leased by one party to be transferred to another location under certain limitations, an allowance for fleets to replace engines still under the original equipment manufacturer's warranty with replacement engines that meet the emission standards of the original engine, even when newer engine emission standards are in place for newly produced engines, and a new provision allowing fleets to rent non-compliant equipment in the event that compliant equipment is unavailable due to manufacturer delivery delays.

The third set of amendments that CARB maintains are within the scope of the prior authorization establishes a compliance option that allows fleets to demonstrate emissions equivalency for alternative technology. CARB states that these amendments are designed to encourage introduction of new technologies such as hybrid and electric equipment.

Finally, the fourth set of amendments modifies compliance requirements by establishing a compliance schedule that allows fleets to bring older engines into compliance first if owners and operators choose to do so, and by exempting equipment at rural low-throughput ports.27

CARB maintains that the amendments noted above meet all three within-the-scope criteria, i.e. that the amendments: (1) Do not undermine the original protectiveness determination underlying California's CHE regulations; (2) do not affect the consistency of the CHE regulations with section 209, and (3) do not raise any new issues affecting the prior authorizations.28 We received no adverse comments or evidence suggesting a within-the-scope analysis is inappropriate, or that these CHE amendments fail to meet any of the three criteria for within-the-scope confirmation.

With regard to the first within-the-scope prong, CARB maintains that the stringency of its emission standards is, in the aggregate, at least as protective of public health and welfare as applicable federal standards.29 CARB also notes that its amendments will not create any expected adverse environmental impacts.30 Finally, CARB notes that there can be no question that the CHE regulations are at least as protective of public health and welfare as applicable federal standards given that EPA is unable to regulate emissions from in-use nonroad engines and equipment and that no federally applicable regulations exist. EPA agrees that there are no federally applicable standards for in-use nonroad engines and that no evidence exists in the record to demonstrate that CARB's CHE regulations, in the aggregate, are less protective than applicable federal standards. Therefore, we cannot find that the CHE amendments, as noted, undermine the protectiveness determination made with regard to the original CHE authorization.

With regard to the second within-the-scope prong (consistency with section 209), CARB maintains that the CHE amendments do not regulate new motor vehicles or motor vehicles engines and so are consistent with section 209(a). Likewise the CHE amendments do not regulate any of the permanently preempted categories of engines or vehicles, and so are consistent with section 209(e)(1). Finally, CARB maintains that the CHE amendments do not cause any technological feasibility issues or cause inconsistency between state and federal test procedures, per section 209(b)(1)(C). CARB maintains that the CHE amendments, as noted, provide additional compliance flexibilities beyond the CHE regulations already found to be technologically feasible. Because there is no evidence in the record to indicate that CARB's CHE amendments are inconsistent with section 209 we cannot find that the CHE amendments, as noted, are inconsistent with section 209.

Third, California states that no new issues exist, and EPA has received no evidence to the contrary.31 We therefore do not find any new issues raised by the CHE amendments as noted.

Having received no contrary evidence regarding these amendments, we find that California has met the three criteria for a within-the-scope authorization approval, and these amendments are thus confirmed as within the scope of previous EPA authorizations of California's CHE regulations.

As noted above, CARB seeks a full authorization to enforce amendments that establish a new opacity based monitoring program and new retrofit requirements for engines meeting the Tier 4 Family Emission Limits standards.

CARB's CHE amendments establish new in-use opacity standards and require owners/operators to conduct annual opacity monitoring of all CHE more than four years old from the date of its original manufacture to ensure proper operation and maintenance so that engines continue to perform as designed and certified. Retrofitted engines are similarly monitored to ensure that the engines continue to be in compliance with the VDECS executive order issued by CARB. Equipment found to be in excess of opacity standards would be required to receive maintenance and repair before being returned to service.

Under the CHE regulation that EPA previously authorized, engine manufacturers are allowed some flexibility during periods in which emission standards are transitioning from one emission level (tier) to another emission level (tier). This flexibility allows engine manufacturers to certify a certain percentage of engines manufactured, and identified as being part of the more stringent tier, to emission levels that do not meet that more stringent tier. CARB established a family emission limit (FEL) alternate particulate matter (PM) emission standard (Tier 4 Alternate PM standard) that is essentially equivalent to the less stringent Tier 3 PM emission standard. The Tier 4 Alternate PM standard is about ten times higher than the otherwise applicable Tier 4 PM standard. Through inadvertent error by CARB, the CHE regulations allowed for in-use nonroad non-truck CHE to meet the applicable upgrade requirements by meeting the Tier 4 Alternate PM standard rather than the Tier 4 PM standard. CARB's CHE amendments correct this error by requiring fleets that used the FEL-certified engines to retrofit these engines with the highest available (best—Tier 4) VDECS within one year.

With regard to the first full authorization prong at section 209(e)(2)(i) of the Act, CARB maintains that the stringency of its emission standards is, in the aggregate, at least as protective of public health and welfare as applicable federal standards.32 CARB also notes that its amendments will not create any expected adverse environmental impacts.33 Finally, CARB notes that there can be no question that its CHE regulation is at least as protective of public health and welfare as applicable federal standards given that EPA is unable to regulate emissions from in-use nonroad engines and equipment and that no federally applicable regulations exist. EPA agrees that there are no federally applicable standards for in-use nonroad engines and that no evidence exists in the record to demonstrate that CARB's CHE regulation is less protective, in the aggregate, than applicable federal standards. Accordingly, we cannot find that CARB's protectiveness finding is arbitrary and capricious.

With regard to the second authorization criterion, section 209(e)(2)(A)(ii) instructs that EPA cannot grant an authorization if the Agency finds that California “does not need such California standards to meet compelling and extraordinary conditions.” EPA's inquiry under this second criterion (found both in paragraphs 209(b)(1)(B) and 209(e)(2)(A)(ii)) has been to determine whether California needs its own mobile source pollution program (i.e. set of standards) for the relevant class or category of vehicles or engines to meet compelling and extraordinary conditions, and not whether the specific standards that are the subject of the authorization or waiver request are necessary to meet such conditions.34 CARB notes that in adopting its CHE amendments the CARB Board confirmed its longstanding position that California continues to need its own nonroad engine emission program to meet serious air pollution problems.35 Based on the lack of evidence in the record or any suggestion that CARB no longer has a need for its standards to meet compelling and extraordinary conditions, we have no reason to deny CARB's authorization request based on this second authorization criterion.

Section 209(e)(2)(A)(iii) of the Act instructs that EPA cannot grant an authorization if California's standards and enforcement procedures are not consistent with “this section.” As described above, EPA's section 209(e) rule states that the Administrator shall not grant authorization to California if she finds (among other tests) that the “California standards and accompanying enforcement procedures are not consistent with section 209.” EPA has interpreted the requirement to mean that California standards and accompanying enforcement procedures must be consistent with at least section 209(a), section 209(e)(1), and section 209(b)(1)(C), as EPA has interpreted this last subsection in the context of motor vehicle waivers.36 Thus, this can be viewed as a three-pronged test.

Section 209(a) of the Clean Air Act prohibits states or any political subdivisions of states from setting emission standards for new motor vehicles or new motor vehicle engines. Section 209(a) is modified in turn by section 209(b) which allows California to set such standards if other statutory requirements are met. To find a standard to be inconsistent with section 209(a) for purposes of section 209(e)(2)(A)(iii), EPA must find that the standard in question actually regulates new motor vehicles or new motor vehicle engines. In its authorization request, CARB stated that by definition, the CHE amendments do not regulate new motor vehicles or new motor vehicle engines. EPA received no comments to suggest the contrary. Therefore, EPA cannot deny California's request based on the CHE amendments being inconsistent with section 209(a) of the Act.

To be consistent with section 209(e)(1), California's standards or other requirements relating to the control of emissions must not relate to new engines which are used in farm or construction equipment or vehicles and which are smaller than 175 horsepower (hp), and new locomotives or new engines used in locomotives.

CARB maintains that its CHE amendments do not regulate new engines which are used in construction or farm equipment or vehicles below 175 hp, nor do the CHE amendments regulate new locomotives or new engines used in locomotives.

In light of the lack of contrary information in the record, EPA cannot make a finding that CARB's CHE amendments are inconsistent with section 209(e)(1). Therefore, EPA cannot deny CARB's authorization request on this basis.

The requirement that California's standards be consistent with section 209(b)(1)(C) of the Clean Air Act effectively requires consistency with section 202(a) of the Act. To determine this consistency, EPA has applied to California nonroad standards the same test it has used previously for California motor vehicle standards; namely, state standards are inconsistent with section 202(a) of the Act if there is inadequate lead-time to permit the development of technology necessary to meet those requirements, giving appropriate consideration to the cost of compliance within that timeframe. California's accompanying enforcement procedures would also be inconsistent with section 202(a) if federal and California test procedures conflicted. The scope of EPA's review of whether California's action is consistent with section 202(a) is narrow. The determination is limited to whether those opposed to the authorization or waiver have met their burden of establishing that California's standards are technologically infeasible, or that California's test procedures impose requirements inconsistent with the federal test procedures.37

CARB states that the smoke opacity test is a quick and inexpensive way to detect if an engine is emitting excessive emissions. CARB maintains that the smoke opacity test is technologically feasible and that compliance with the standards does not require the incorporation of any new technology not already required by existing regulations that have previously received an EPA authorization. CARB also states that the clarification of the Tier 4 FEL emission standards provisions are technologically feasible and were designed to correct an unintentional error and to clarify the original intent of the previously authorized CHE regulations. The CHE amendments only require retrofit to the Tier 4 emission level if appropriate technology is available and require the retrofit be performed within one year. EPA did not receive any comment or evidence to suggest that either of the two amendments for which CARB requested authorization is technologically infeasible.

Consequently, based on the record, EPA is unable to make the finding that the CHE amendments are not technologically feasible with the available lead time giving consideration to the cost of compliance.

EPA received no comments suggesting that CARB's CHE amendments pose any test procedure consistency problem. Therefore, based on the record, EPA cannot find that CARB's testing procedures are inconsistent with section 202(a) and cannot deny CARB's request based on this criterion.

The Administrator has delegated the authority to grant California section 209(e) authorizations to the Assistant Administrator for Air and Radiation. After evaluating CARB's amendments to its CHE regulations described above and CARB's submissions for EPA review, EPA is taking the following actions.

First, EPA is granting a within-the-scope authorization for the CHE amendments that modify the retrofit requirements, modify operational practices, allow demonstration of emissions equivalency for alternative technology, and modify compliance requirements.

Second, EPA is granting a full authorization for the CHE amendments that establish a new opacity based monitoring program and new retrofit requirements for engines meeting the Tier 4 FEL standards.

This decision will affect persons in California and those manufacturers and/or owners/operators nationwide who must comply with California's requirements. In addition, because other states may adopt California's standards for which a section 209(e)(2)(A) authorization has been granted if certain criteria are met, this decision would also affect those states and those persons in such states. See CAA section 209(e)(2)(B). For these reasons, EPA determines and finds that this is a final action of national applicability, and also a final action of nationwide scope or effect for purposes of section 307(b)(1) of the Act. Pursuant to section 307(b)(1) of the Act, judicial review of this final action may be sought only in the United States Court of Appeals for the District of Columbia Circuit. Petitions for review must be filed by July 6, 2015. Judicial review of this final action may not be obtained in subsequent enforcement proceedings, pursuant to section 307(b)(2) of the Act.

As with past authorization and waiver decisions, this action is not a rule as defined by Executive Order 12866. Therefore, it is exempt from review by the Office of Management and Budget as required for rules and regulations by Executive Order 12866.

In addition, this action is not a rule as defined in the Regulatory Flexibility Act, 5 U.S.C. 601(2). Therefore, EPA has not prepared a supporting regulatory flexibility analysis addressing the impact of this action on small business entities.

Further, the Congressional Review Act, 5 U.S.C. 801, et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule for purposes of 5 U.S.C. 804(3).

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

On February 25, 2015, the Florida Department of Environmental Protection (FDEP) submitted an application titled “National Pollutant Discharge Elimination System e-Reporting Tool (NeT)” for revisions/modifications of its EPA-authorized programs under title 40 CFR. EPA reviewed FDEP's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Florida's request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 122, 403, and 503 is being published in the Federal Register:

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

The Commission is requesting that OMB approve this revised information collection under the emergency processing provisions of the PRA, 5 CFR 1320.5, 1320.8(d), and 1320.13 by July 1, 2015.

OMB Control Number: 3060-0806.

Title: Universal Service—Schools and Libraries Universal Service Program, FCC Forms 470 and 471.

Form Number: FCC Forms 470 and 471.

Type of Review: Revision to a currently approved collection.

Respondents: State, local or tribal government public institutions, and other not-for-profit institutions.

Number of Respondents and Responses: 82,000 respondents; 82,000 responses.

Estimated Time per Response: 3.5 hours for FCC Form 470 (3 hours for response; 0.5 hours for recordkeeping); 4.5 hours for FCC Form 471 (4 hours for response; 0.5 hours for recordkeeping).

Frequency of Response: On occasion and annual reporting requirements, and recordkeeping requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151-154, 201-205, 218-220, 254, 303(r), 403, and 405.

Total Annual Burden: 334,000 hours.

Total Annual Cost: N/A.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no assurance of confidentiality provided to respondents concerning this information collection. However, respondents may request materials or information submitted to the Commission or to the Administrator be withheld from public inspection under 47 CFR 0.459 of the FCC's rules.

Needs and Uses: The Commission seeks to revise OMB 3060-0806 to conform this information collection to changes implemented in the Second E-Rate Modernization Order (WC Docket No. 13-184, FCC 14-189; 80 FR 5961, February 4, 2015). Collection of the information on FCC Forms 470 and 471 is necessary so that the Commission and the Universal Service Administrative Company (USAC) have sufficient information to determine if entities are eligible for funding pursuant to the schools and libraries support mechanism, to determine if entities are complying with the Commission's rules, and to prevent waste, fraud, and abuse. In addition, the information is necessary for the Commission to evaluate the extent to which the E-rate program is meeting the statutory objectives specified in section 254(h) of the 1996 Act, and the Commission's own performance goals established in the E-rate Modernization Order and Second E-rate Modernization Order. This information collection, as described in more detail below, is being revised to modify FCC Form 470 pursuant to program and rule changes in the Second E-rate Modernization Order and to accommodate USAC's new online portal as well as the requirement that all FCC Forms 470 be electronically filed. The FCC Form 470, which is used to seek competitive bids on eligible services from service providers, must be available to applicants on July 1 (or very soon thereafter) to ensure schools and libraries can take full advantage of the Commission's reforms in funding year 2016. This revision does not propose changes to the FCC Form 471.

The supporting documents for this submission, including revised forms and instructions, may be accessed via this Web site by searching under “OMB 3060-0806”: http://www.reginfo.gov/public/do/PRASearch.

OMB Control Number: 3060-1053.

OMB Approval Date: March 31, 2015.

OMB Expiration Date: March 31, 2018.

Title: Two-Line Captioned Telephone Order, IP Captioned Telephone Service Declaratory Ruling; and Internet Protocol Captioned Telephone Service Reform Order, CG Docket Nos. 13-24 and 03-123.

Form Number: N/A.

Respondents: Business or other for-profit entities.

Estimated Number of Respondents and Responses: 148,006 respondents; 556,010 responses.

Estimated Time per Response: 0.25 hours (15 minutes) to 8 hours.

Frequency of Response: Annual, every five years, on-going, and one-time reporting requirement; Recordkeeping requirement; Third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for the information collection requirements is found at sec. 225 [47 U.S.C. 225] Telecommunications Services for Hearing-Impaired Individuals; The Americans with Disabilities Act of 1990, (ADA), Public Law 101-336, 104 Stat. 327, 366-69, was enacted on July 26, 1990.

Estimated Total Annual Burden: 399,072 hours.

Total Annual Costs: $1,680,000.

Nature and Extent of Confidentiality: An assurance of confidentiality is not offered because this information collection does not require the collection of personally identifiable information by the FCC from individuals.

Privacy Act Impact Assessment: No impact(s).

Needs and Uses: On August 1, 2003, the Commission released Telecommunication Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities, CC Docket No. 98-67, Declaratory Ruling, 68 FR 55898, September 28, 2003, clarifying that one-line captioned telephone voice carry over (VCO) service is a type of telecommunications relay service (TRS) and that eligible providers of such services are eligible to recover their costs from the Interstate TRS Fund (Fund) in accordance with section 225 of the Communications Act. The Commission also clarified that certain TRS mandatory minimum standards do not apply to one-line captioned telephone VCO service and waived 47 CFR 64.604(a)(1) and (a)(3) for all current and future captioned telephone VCO service providers, for the same period of time beginning August 1, 2003. The waivers were contingent on the filing of annual reports.

On July 19, 2005, the Commission released Telecommunication Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities, CC Docket No. 98-67 and CG Docket No. 03-123, Order, 70 FR 54294, September 14, 2005, clarifying that two-line captioned telephone VCO service, like one-line captioned telephone VCO service, is a type of TRS eligible for compensation from the Fund.

On January 11, 2007, the Commission released Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities, CG Docket No. 03-123, Declaratory Ruling, 72 FR 6960, February 14, 2007, granting a request for clarification that Internet Protocol (IP) captioned telephone relay service (IP CTS) is a type of TRS eligible for compensation from the Fund. The Commission also waived certain TRS mandatory minimum standards that do not apply to IP CTS, contingent on the filing of annual reports.

On August 26, 2013, the Commission issued Misuse of Internet Protocol (IP) Captioned Telephone Service; Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities, CG Docket Nos. 13-24 and 03-123, Report and Order, 78 FR 53684, August 30, 2013, to regulate practices relating to the marketing of IP CTS, impose certain requirements for the provision of this service, and mandate registration and certification of IP CTS users.

On June 20, 2014, the D.C. Circuit vacated the rule prohibiting compensation to providers for minutes of use generated by equipment consumers received from providers for free or for less than $75 ($75 equipment charge rule) and the rule requiring providers to maintain captions off as the default setting for IP CTS equipment. Sorenson Communications, Inc. and CaptionCall, LLC v. FCC, 755 F.3d 702 (D.C. Cir. 2014) (D.C. Circuit IP CTS Order).

On August 22, 2014, the Commission issued Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities; Waivers of iTRS Mandatory Minimum Standards, CG Docket No. 03-123, Report and Order, 79 FR 62875, October 21, 2014 (iTRS Waiver Order), to make permanent waivers of certain TRS mandatory minimum standards and eliminate waivers of other TRS mandatory minimum standards for IP CTS and CTS. The Commission also eliminated the requirement that IP CTS and CTS providers file annual reports regarding the TRS mandatory minimum standards.

This notice pertains to OMB approval of revisions to the information collection requirements as a result of the iTRS Waiver Order eliminating the requirement that IP CTS and CTS providers file annual reports regarding the TRS mandatory minimum standards and as a result of the D.C. Circuit IP CTS Order vacating the $75 equipment charge rule and the rule requiring providers to maintain captions off as the default setting for IP CTS equipment.

Federal Acquisition Regulation 42.1203 and 42.1204 provide requirements for contractors to request novation/change of name agreements and supporting documents when a firm performing under Government contracts wishes the Government to recognize (1) a successor in interest to these contracts, or (2) a name change, it must submit certain documentation to the Government.

Respondents: 1,178.

Responses per Respondent: 1.

Annual Responses: 1,178.

Hours per Response: 2.0.

Total Burden Hours: 2,356.

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

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0076, Novation/Change of Name Requirements, in all correspondence.

Under 5 U.S.C. 5707(c), as implemented in the Federal Travel Regulation, Part 300-70, Subpart A—Requirement To Report Agency Payments for Employee Travel and Relocation, and Part 302-1, Subpart B—Requirement to Report Agency Data for Employee Relocation, the Administrator of General Services is required to collect data on total agency payments for travel, transportation, and relocation expenses every year. This bulletin provides guidance to agencies that spent more than $5 million on travel and transportation payments, including relocation costs, and the requirement procedures to report the data to GSA. Federal Travel Regulation Bulletin 15-04 and all other FTR Bulletins can be found at www.gsa.gov/ftrbulletin.

In 2004, AHRQ developed and published a measurement tool to assess the culture of patient safety in hospitals (OMB control no. 0935-0115). The Hospital Survey on Patient Safety Culture (HSOPS) is a survey of providers and staff that can be implemented by hospitals to identify strengths and areas for patient safety culture improvement as well as raise awareness about patient safety. When conducted routinely, the survey can be used to examine trends in patient safety culture over time and evaluate the cultural impact of patient safety initiatives and interventions. The data can also be used to make comparisons across hospital units. AHRQ also produced a survey user's guide to assist hospitals in conducting the survey successfully. The guide addresses issues such as which providers and staff should complete the survey, how to select a sample of hospital providers and staff, how to administer the questionnaire, and how to analyze and report on the resulting data.

Since 2004, thousands of hospitals within the U.S. and internationally have implemented the survey. In response to requests for comparative data from other hospitals, AHRQ funded the development of a comparative database on the survey in 2006 (OMB control no. 0935-0162). The database is currently compiled every two years, using the latest data provided by participating hospitals (and retaining submitted data for no more than 2 years). Reports describing the findings from analysis of the database are made available on the AHRQ Web site to assist hospitals in comparing their results. The 2014 database contains data from 405,281 hospital provider and staff respondents within 653 participating hospitals. The 2014 User Comparative Database Report presents results by hospital characteristics (e.g., number of beds, teaching status, geographic location) and respondent characteristics (e.g., position type, work area/unit).

The survey constructed in 2004 remains in use today, more than 10 years after its initial launch. Since the launch of HSOPS, AHRQ has funded development of patient safety culture surveys for other settings. In 2008, surveys were published for outpatient medical offices (OMB control no. 0935-0131) and nursing homes (OMB control no. 0935-0132). In 2012, a survey for community pharmacies (OMB control no. 0935-0183) was released. Surveys for each setting built upon the strengths of HSOPS but improved and updated items where appropriate.

Users of HSOPS have provided feedback over the years suggesting that changes to the instrument would be valuable and welcomed. The comparative database registrants provided feedback about potential changes in 2013, and telephone interviews were conducted with 8 current survey users and vendors to gain an in-depth understanding of their thoughts on the current survey and possible changes. As a result of this feedback, the Hospital Survey on Patient Safety Culture Version 2.0 (HSOPS 2.0) is being constructed with the following 8 objectives in mind.

(1) Shift to a Just Culture framework for understanding responses to errors. In the original HSOPS, questions around responses to errors were negatively worded to detect a “culture of blame” in organizations. For example, respondents evaluated the extent to which errors were held against them and whether it felt as though the person was being written up rather than the problem. In contrast, a Just Culture framework emphasizes learning from mistakes, providing a safe environment for reporting errors, and utilizing a balanced approach to errors that considers both system and individual behavioral reasons as causes for errors. New items will be constructed in HSOPS 2.0 to capture the extent to which positive responses to error consistent with a Just Culture framework are present in an organization. For example, respondents will be asked to evaluate the extent to which the organization tries to understand the factors that lead to patient safety errors.

(2) Reduce the number of negatively worded items. The original HSOPS has negatively worded items. For example, respondents are asked whether there are “patient safety problems in this unit” (negatively worded). Using some negatively worded items was intended to reduce social desirability and acquiescence biases and identify individuals not giving the survey their full attention (e.g., “straight-lining,” or providing the same answer for every item, regardless of positive or negative wording). However, many users have indicated that respondents sometimes had difficultly correctly interpreting and responding to the negatively worded items. Therefore, many survey users recommended that the number of negatively worded items should be reduced, but they did not recommend removing all of these items as they felt a mixture of items helps keep respondents engaged.

(3) Add a “Does not apply/Don't know” response option. Analysis of the Comparative Database data found that a percentage of respondents selects “neither agree nor disagree” on many items when they really should have answered “Does not apply/Don't know”. While some portion of respondents will always have neutral feelings about a statement, in some cases a respondent will select a neutral response to an item because they do not have experience in that area or the item does not apply to their position. Addition of a “does not apply/don't know” response option should reduce neutral responses to an item in cases where the item is not relevant for a respondent, providing more statistical variability in responses. Recognizing these issues, the other AHRQ Surveys on Patient Safety Culture all have a 5th “Does not apply/Don't know” response option.

(4) Reword unclear or difficult-to-translate items. HSOPS was originally designed for use in U.S. hospitals, but it has since been translated into languages other than English. Some HSOPS items use idiomatic expressions that do not translate well, such as “things fall between the cracks” and “the person is being written up.” Other items have words that are complex or may mean different things to different people, such as “sacrifice” and “overlook.” HSOPS 2.0 uses more universal phrases which can be accurately translated and have more consistent meaning across respondents, some of whom are non-clinical staff. A related change across many items is use of the word “we” rather than “staff.” It may be unclear to respondents whether providers such as physicians, residents, and interns qualify as “staff,” while “we” invites a more inclusive view of those in the hospital or unit.

(5) Reword items to be more applicable to physicians and non-clinical staff. Users have indicated that the wording of some of the items makes it awkward for physicians to answer. For example, the section that asks about “Your Supervisor/Manager” does not apply well to physicians who report to a clinical leader but not to a manager per se. In addition, some items were difficult for non-clinical staff to answer. For example, the item “We have patient safety problems in this unit” may not be relevant for staff who do not have direct interaction with patients (e.g., IT staff).

(6) Align the HSOPS survey with AHRQ patient safety culture surveys for other settings. The development of patient safety culture surveys for other settings provided opportunities to test new items and refinements of original HSOPS items. Many of these items have performed well for other settings and are relevant to the hospital setting. In addition, standardizing items across the patient safety culture surveys would allow cross-setting comparisons that are not currently possible.

(7) Reduce survey length. To increase response rates and reduce the survey administration burden for hospitals, the revised survey is intended to be shorter than the original instrument. Some of the original items have relatively low variability and therefore contribute little to discrimination between positive and negative assessment of patient safety culture. However, the need for careful testing of alternative questions means that the initial draft of the revised or 2.0 survey is slightly longer than the original. Through cognitive interviewing, pilot testing, and expert review, we will identify items that can be deleted, resulting in a shorter final instrument.

(8) Investigate supplemental items/composites. Develop a set of supplemental items for the HSOPS 2.0 survey pertaining to Health Information Technology (Health IT).

Further details about the specific changes by composite and at the item level can be found on the AHRQ Web site at: http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/hospital/update/index.html.

The draft 2.0 version of the instrument has undergone preliminary cognitive testing with 9 hospital physicians and staff members as well as review by a Technical Expert Panel (TEP).

This research has the following goals:

(1) Cognitively test with individual respondents the items in a) the draft HSOPS 2.0 survey and b) HSOPS 2.0 supplemental item set assessing Health IT Patient Safety. Cognitive testing will be conducted in English and Spanish.

(2) Conduct data collection as follows:

a. A combined pilot test and bridge study for the draft HSOPS 2.0 in 40 hospitals and modify the questionnaire as necessary. The pilot test component will entail administering the draft 2.0 version to determine which items to retain. The bridge study component will entail administering the original HSOPS in addition to the draft HSOPS 2.0 version to provide guidance to hospitals in understanding changes in their scores resulting from the new instrument versus changes resulting from true changes in culture.

b. The pilot testing of the supplemental item set will be conducted with the same hospitals and respondents as the pilot test for the draft HSOPS 2.0. These supplemental items will be added to the draft HSOPS 2.0 survey for pilot testing.

(3) Engage a TEP in review of pilot results and finalize the questionnaire and supplemental item set.

(4) Make the final HSOPS 2.0 survey and the supplemental items publicly available.

This work is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).

Cognitive interviews—The purpose of these interviews is to understand the cognitive processes respondents engage in when answering each item on the survey, which will aid in refining the survey instrument. These interviews will be conducted with a mix of hospital personnel, including physicians, nurses, and other types of staff (from dietitians to housekeepers).

Draft HSOPS 2.0—Cognitive interviews have already been conducted with 9 respondents to inform development of the current draft HSOPS 2.0. Up to three additional rounds of interviews will be conducted by telephone with a total of 27 respondents (nine respondents each round). The instrument will be translated into Spanish and another round of cognitive interviews will be conducted with nine Spanish-speaking respondents for a total of up to 36 respondents across all four rounds. A cognitive interview guide will be used for all rounds.

Supplemental Items—Up to three rounds of interviews will be conducted by telephone for a total of 27 respondents (nine respondents each round). The supplemental items will be translated into Spanish and another round of cognitive interviews will be conducted with nine Spanish-speaking respondents for a total of up to 36 respondents across all four rounds. A cognitive interview guide will be used for all rounds.

Feedback obtained from the first round of interviews for the draft HSOPS 2.0 and the supplemental items will be used to refine the items. The results of Round 1 testing, along with the proposed revisions, will be reviewed with a TEP prior to commencing with Rounds 2 and/or 3 testing. In total, up to 72 cognitive interviews will be conducted to refine the draft HSOPS 2.0 and supplemental items for pilot testing.

(2) Pilot test and bridge study—There will be one data collection effort which will provide data for the pilot test and the bridge study. The pilot test of the draft HSOPS 2.0 and supplemental items will allow the assessment of the psychometric properties of the items and composites. We will assess the variability, reliability, factor structure and construct validity of the draft HSOPS 2.0 and supplemental items and composites, allowing for their further refinement. The draft HSOPS 2.0 survey and supplemental items will be pilot tested with hospital personnel in approximately 40 hospitals to facilitate multilevel analysis of the data. Approximately 500 providers and staff will be sampled from each hospital, with 250 receiving HSOPS 2.0 with supplemental items for the pilot test and 250 receiving the original HSOPS for the bridge study comparisons. A hospital point of contact will be recruited in each hospital to publicize the survey and assemble a list of sampled providers and staff. Providers and staff will receive notification of the survey and reminders via email and the web-based survey will be fielded entirely online.

The goal of the bridge study will be to provide users with guidance on how their new results will compare with results from the original HSOPS survey. Although users have requested that the HSOPS survey be revised, they are also concerned about their ability to trend results with data from prior years. A similar bridge study was conducted during the 1994 redesign of the Census Bureau's Current Population Survey (CPS). In the CPS bridge study, an additional 12,000 households were added to the survey's monthly rotation schedule between July 1992 and December 1993. The added households received the redesigned version of the instrument. Thus, the CPS fielded both the revised and the original versions of the instrument simultaneously. One of the most important results of the CPS bridge study was the development of metrics that allowed estimates of change that were due to the changes in the instrument. These metrics were used to adjust the estimates produced by the revised CPS instrument. As a result of the study, key labor force metrics such as the unemployment rate could be trended accurately after the instrument's redesign.

We propose to conduct a similarly constructed bridge study in which sampled providers and staff take either the draft HSOPS 2.0 or original versions of HSOPS. As noted above, a split ballot design will be used in which half of sampled providers and staff in each hospital receive the original HSOPS (N=250) and the other half receive the draft HSOPS 2.0 (N=250). This bridge study is designed to produce metrics of change that are attributable to the changed survey instrument. The number of hospitals and sampled providers and staff for this data collection effort was calculated to ensure the statistical power needed to detect relatively small differences in scores (3 percentage points).

(3) TEP feedback—A TEP has been assembled to provide input to guide patient safety culture survey product development and has been convened to discuss the proposed changes to the HSOPS survey and supplemental items. Upon completion of the pilot test, results will be reviewed with the TEP and the survey will be finalized. This TEP activity does not impose a burden on the public and is therefore not included in the burden estimates in Exhibits 1 and 2.

(4) Dissemination activities—The final HSOPS 2.0 instrument and supplemental items will be made publicly available through the AHRQ Web site. A report from the bridge study will also be made public as a resource to hospitals making the transition to the new survey. This dissemination activity does not impose a burden on the public and is therefore not included in the burden estimates in Exhibits 1 and 2.

Exhibit 1 shows the estimated annualized burden hours for the participants' time to take part in this research. Cognitive interviews for the draft HSOPS 2.0 will be conducted with 36 individuals and will take about one hour and 30 minutes to complete. Cognitive interviews for the supplemental items will be conducted with 36 individuals and take about one hour to complete. We will recruit 40 hospitals for the pilot test and bridge study, sampling approximately 500 staff members in each (250 taking the original survey and 250 taking the HSOPS 2.0 and supplemental item set). Because we require such a large sample within each hospital, we will target only hospitals with 49 or more beds. For hospitals with fewer than 500 providers and staff, we will conduct a census in the hospital (assuming on average 375 providers and staff in these hospitals this will yield a total of 18,375 sample members assuming all 40 hospitals participate. Assuming a response rate of 50 percent, this will yield a total of 9,188 completed questionnaires. The total annualized burden is estimated to be 2,387 hours.

Exhibit 2 shows the estimated annualized cost burden associated with the participants' time to take part in this research. The total cost burden is estimated to be $83,533.26.

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 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.

42 U.S.C. 299c provides that the Secretary shall appoint to the National Advisory Council for Healthcare Research and Quality twenty one appropriately qualified individuals. At least seventeen members shall be representatives of the public and at least one member shall be a specialist in the rural aspects of one or more of the professions or fields listed in the above summary. In addition, the Secretary designates, as ex officio members, representatives from other Federal agencies, principally agencies that conduct or support health care research, as well as Federal officials the Secretary may consider appropriate. 42 U.S.C. 299c(c)(3). The Council meets in the Washington, DC, metropolitan area, generally in Rockville, Maryland, approximately three times a year to provide broad guidance to the Secretary and AHRQ's Director on the direction of and programs undertaken by AHRQ.

Seven individuals will be selected by the Secretary to serve on the Council beginning with the meeting in the spring of 2016. Members generally serve 3-year terms. Appointments are staggered to permit an orderly rotation of membership.

Interested persons may nominate one or more qualified persons for membership on the Council. Self-nominations are accepted. Nominations shall include: (1) A copy of the nominee's resume or curriculum vitae; and (2) a statement that the nominee is willing to serve as a member of the Council. Selected candidates will be asked to provide detailed information concerning their financial interests, consultant positions and research grants and contracts, to permit evaluation of possible sources of conflict of interest. Please note that once a candidate is nominated, AHRQ may consider that nomination for future positions on the Council. Federally registered lobbyists are not permitted to serve on this advisory board pursuant to the Presidential Memorandum entitled “Lobbyists on Agency Boards and Commissions” dated June 10, 2010, and the Office of Management and Budget's “Final Guidance on Appointment of Lobbyists to Federal Boards and Commissions,” 76 FR 61756 (October 5, 2011).

The Department seeks a broad geographic representation. In addition, AHRQ conducts and supports research concerning priority populations, which include: low-income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. See 42 U.S.C. 299(c). Nominations of persons with expertise in health care for these priority populations are encouraged.

Employer-sponsored health insurance is the source of coverage for 78 million current and former workers, plus many of their family members, and is a cornerstone of the U.S. health care system. The Medical Expenditure Panel Survey—Insurance Component (MEPS-IC) measures on an annual basis the extent, cost, and coverage of employer-sponsored health insurance. These statistics are produced at the National, State, and sub-State (metropolitan area) level for private industry. Statistics are also produced for State and local governments. The MEPS-IC was last approved by OMB on November 21, 2013 and will expire on November 30, 2016. The OMB control number for the MEPS-IC is 0935-0110. All of the supporting documents for the current MEPS-IC can be downloaded from OMB's Web site at http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201310-0935-001.

In order to ensure that the MEPS-IC is able to capture important changes in the employer-sponsored health insurance market due to the implementation of the Patient Protection and Affordable Care Act (ACA), AHRQ will field a longitudinal survey in 2015 to include a sample of 5,000 small private sector employers that responded to the 2014 MEPS-IC. The OMB clearance that was approved on November 21, 2013 included the 2014 longitudinal survey, a survey of 3,000 respondents to the 2013 MEPS-IC, but did not include the 2015 longitudinal survey. This submission is for the 2015 longitudinal survey only; there are no other changes.

This research has the following goals:

(1) Provide data for Federal policymakers evaluating the effects of National and State health care reforms.

(2) Provide descriptive data on the current employer-sponsored health insurance system and data for modeling the differential impacts of proposed health policy initiatives.

(3) Supply critical State and National estimates of health insurance spending for the National Health Accounts and Gross Domestic Product.

(4) Support evaluation of the impact on health insurance offered by small employers due to the implementation of Small Business Health Options Program (SHOP) exchanges under the ACA, through the addition of a longitudinal component to the sample.

The MEPS-IC is conducted pursuant to AHRQ's statutory authority to conduct surveys to collect data on the cost, use and quality of health care, including the types and costs of private insurance. 42 U.S.C. 299b-2(a).

To achieve the goals of this project for both private sector and state and local government employers, the following data collections will be implemented:

(1) Prescreener Questionnaire—The purpose of the Prescreener Questionnaire, which is collected via telephone, varies depending on the insurance status of the establishment contacted. (Establishment is defined as a single, physical location in the private sector and a governmental unit in state and local governments.) For establishments that do not offer health insurance to their employees, the prescreener is used to collect basic information such as number of employees via a phone call. For establishments that do offer health insurance, the prescreener is used to collect contact names and address information is that are used to mail a written establishment and plan questionnaires. Obtaining this contact information helps ensure that the questionnaires are directed to the person best equipped to complete them.

(2) Establishment Questionnaire—The purpose of the mailed Establishment Questionnaire is to obtain general information from employers who provide health insurance to their employees. The Questionnaire collects such information as total active enrollment in health insurance, other employee benefits offered, demographic characteristics of employees, and retiree health insurance.

(3) Plan Questionnaire—The purpose of the mailed Plan Questionnaire is to collect plan-specific information on each plan (up to four) offered by establishments that provide health insurance to their employees. This questionnaire asks about total premiums, employer and employee contributions to the premium, and plan enrollment for each type of coverage offered—single, employee-plus-one, and family—within a plan. It also asks for information on deductibles, copays, and other plan characteristics.

(4) Longitudinal Sample (LS)—For 2015, an additional sample of small employers (those with 100 or fewer employees) will be included in the collection. The LS will consist of 5,000 small, private-sector employers who responded to the 2014 MEPS-IC regular survey. These employers will be surveyed again in 2015—using the same collection methods as the regular survey—in order to track changes in their health insurance offerings, characteristics, and costs.

The primary objective of the MEPS-IC is to collect information on employer-sponsored health insurance. Such information is needed in order to provide the tools for Federal, State, and academic researchers to evaluate current and proposed health policies and to support the production of important statistical measures for other Federal agencies.

Exhibit 1 shows the estimated annualized burden hours for the respondent's time to provide the requested data for the 2015 longitudinal survey. The Prescreener questionnaire will be completed by 4,300 respondents and takes about 51/2 minutes to complete. The Establishment questionnaire will be completed by 2,054 respondents and takes about 23 minutes to complete. The Plan questionnaire will be completed by 2,054 respondents and will require an average of 1.4 responses per respondent. Each Plan questionnaire takes about 11 minutes to complete. The total burden hours are estimated to be 1,686 hours.

Exhibit 2 shows the estimated annualized cost burden associated with the respondents' time to participate in this data collection. The annualized cost burden is estimated to be $52,709.

Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) requires the Secretary of the Department of Health and Human Services (the Secretary) to establish procedures for coding and payment determinations for new clinical diagnostic laboratory tests under Part B of title XVIII of the Social Security Act (the Act) that permit public consultation in a manner consistent with the procedures established for implementing coding modifications for International Classification of Diseases (ICD-9-CM). The procedures and public meeting announced in this notice for new tests are in accordance with the procedures published on November 23, 2001 in the Federal Register (66 FR 58743) to implement section 531(b) of BIPA.

Section 942(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added section 1833(h)(8) of the Act. Section 1833(h)(8)(A) of the Act requires the Secretary to establish by regulation procedures for determining the basis for, and amount of, payment for any clinical diagnostic laboratory test with respect to which a new or substantially revised Healthcare Common Procedure Coding System (HCPCS) code is assigned on or after January 1, 2005 (hereinafter referred to as “new tests”). A code is considered to be substantially revised if there is a substantive change to the definition of the test or procedure to which the code applies (such as, a new analyte or a new methodology for measuring an existing analyte-specific test). (See section 1833(h)(8)(E)(ii) of the Act).

Section 1833(h)(8)(B) of the Act sets forth the process for determining the basis for, and the amount of, payment for new tests. Pertinent to this notice, section 1833(h)(8)(B)(i) and (ii) of the Act requires the Secretary to make available to the public a list that includes any such test for which establishment of a payment amount is being considered for a year and, on the same day that the list is made available, cause to have published in the Federal Register notice of a meeting to receive comments and recommendations (including accompanying data, on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for the tests on such list. This list of codes for which the establishment of a payment amount under the clinical laboratory fee schedule (CLFS) is being considered for calendar year (CY) 2016 is posted on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html. Section 1833(h)(8)(B)(iii) of the Act requires that we convene the public meeting not less than 30 days after publication of the notice in the Federal Register. These requirements are codified at 42 CFR part 414, subpart G.

Two bases of payment are used to establish payment amounts for new tests. The first basis called “crosswalking,” is used when a new test is determined to be comparable to an existing test code, multiple existing test codes, or a portion of an existing test code. The new test code is assigned the local fee schedule amounts and the national limitation amount of the existing test. Payment for the new test is made at the lesser of the local fee schedule amount or the national limitation amount. (See 42 CFR 414.508(a).)

The second basis called “gapfilling,” is used when no comparable existing test is available. When using this method, instructions are provided to each Part A and Part B Medicare Administrative Contractor (MAC) to determine a payment amount for its Part B geographic areas for use in the first year. The contractor-specific amounts are established for the new test code using the following sources of information, if available: Charges for the test and routine discounts to charges; resources required to perform the test; payment amounts determined by other payers; and charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant. (See 42 CFR 414.508(b) and § 414.509 for more information regarding the gapfilling process.)

Under section 1833(h)(8)(B)(iv) of the Act, the Secretary, taking into account the comments and recommendations (and accompanying data) received at the public meeting, develops and makes available to the public a list of proposed determinations with respect to the appropriate basis for establishing a payment amount for each code, an explanation of the reasons for each determination, the data on which the determinations are based, and a request for public written comments on the proposed determinations. Under section 1833(h)(8)(B)(v) of the Act, taking into account the comments received during the public comment period, the Secretary develops and makes available to the public a list of final determinations of final payment amounts for new test codes along with the rationale for each determination, the data on which the determinations are based, and responses to comments and suggestions received from the public.

After the final determinations have been posted on our Web site, the public may request reconsideration of the basis and amount of payment for a new test as set forth in § 414.509. Pertinent to this notice, those requesting that CMS reconsider the basis for payment or, for crosswalking, reconsider the payment amount as set forth in § 414.509(a) and (b)(1) may present their reconsideration requests at the following year's public meeting provided that the requestor made the request to present at the public meeting in the written reconsideration request. For purposes of this notice, we refer to these codes as the “reconsidered codes.” The public may comment on the reconsideration requests. (See the November 27, 2007 CY 2008 Physician Fee Schedule final rule with comment period (72 FR 66275 through 66280) for more information on these procedures.)

We are following our usual process, including an annual public meeting to determine the appropriate basis and payment amount for new and reconsidered test codes under the CLFS for CY 2016.

This meeting is open to the public. The on-site check-in for visitors will be held from 8:30 a.m. to 9:00 a.m., followed by opening remarks. Registered persons from the public may discuss and make recommendations for specific new and reconsidered test codes for the CY 2016 CLFS.

Because of time constraints, presentations must be brief, lasting no longer than 10 minutes, and must be accompanied by three written copies. In addition, CMS recommends that presenters make copies available for approximately 50 meeting participants, since CMS will not be providing additional copies. Written presentations must be electronically submitted to CMS on or before July 2, 2015. Presentation slots will be assigned on a first-come, first-served basis. In the event that there is not enough time for presentations by everyone who is interested in presenting, CMS will gladly accept written presentations from those who were unable to present due to time constraints. Presentations should be sent via email to Glenn McGuirk, at [email protected]. For reconsidered and new test codes, presenters should address all of the following items:

• Reconsidered or new test code(s) and descriptor.

• Test purpose and method.

• Costs.

• Charges.

• A recommendation with rationale for one of the two bases (crosswalking or gapfilling) for determining payment for new tests, or a recommendation with rationale for changing the basis or payment amount, as applicable, for reconsidered tests.

Additionally, the presenters should provide the data on which their recommendations are based. Written presentations from the public meeting will be available upon request, via email, to Glenn McGuirk at [email protected]. Presentations regarding reconsidered and new test codes that do not address the above five items may be considered incomplete and may not be considered by CMS when making a determination.

Taking into account the comments and recommendations (and accompanying data) received at the public meeting, we intend to post our proposed determinations with respect to the appropriate basis for establishing a payment amount for each new test code and our preliminary determinations with respect to the reconsidered codes along with an explanation of the reasons for each determination, the data on which the determinations are based, and a request for public written comments on these determinations on the CMS Web site by early September 2015. This Web site can be accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html. We also will include a summary of all comments received by August 6, 2015 (15 business days after the meeting). Interested parties may submit written comments on the proposed determinations for new test codes or the preliminary determinations for reconsidered codes by early October, 2015, to the address specified in the ADDRESSES section of this notice or electronically to Glenn McGuirk at [email protected] (the specific date for the publication of the determinations on the CMS Web site, as well as the deadline for submitting comments regarding the determinations will be published on the CMS Web site). Final determinations for new test codes to be included for payment on the CLFS for CY 2016 and reconsidered codes will be posted on our Web site in November 2015, along with the rationale for each determination, the data which the determinations are based, and responses to comments and suggestions received from the public. The final determinations with respect to reconsidered codes are not subject to further reconsideration. With respect to the final determinations for new test codes, the public may request reconsideration of the basis and amount of payment as set forth in § 414.509.

The Division of Ambulatory Services in the CMS Center for Medicare is coordinating the public meeting registration. Beginning June 8, 2015, registration may be completed on-line at the following Web address: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. All the following information must be submitted when registering:

• Name.

• Company name.

• Address.

• Telephone numbers.

• Email addresses.

When registering, individuals who want to make a presentation must also specify for which new test codes they will be presenting comments. A confirmation will be sent upon receipt of the registration. Individuals must register by the date specified in the DATES section of this notice.

The meeting will be held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. It is suggested that you arrive at the CMS facility between 8:15 a.m. and 8:30 a.m., so that you will be able to arrive promptly at the meeting by 9:00 a.m. Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 8:15 a.m. (45 minutes before the convening of the meeting).

Security measures include the following:

• Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. Persons without proper identification may be denied access to the building.

• Interior and exterior inspection of vehicles (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection.

• Passing through a metal detector and inspection of items brought into the building. We note that all items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration.

Individuals attending the meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance, should provide that information upon registering for the meeting. The deadline for registration is listed in the DATES section of this notice.

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

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

FDA has approved for marketing the medical device ISTENT TRABECULAR MICRO-BYPASS STENT. ISTENT TRABECULAR MICRO-BYPASS STENT is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. Subsequent to this approval, the USPTO received a patent term restoration application for the ISTENT TRABECULAR MICRO-BYPASS STENT (U.S. Patent No. 6,626,858) from Glaukos Corporation, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 30, 2014, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of the ISTENT TRABECULAR MICRO-BYPASS STENT represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for the ISTENT TRABECULAR MICRO-BYPASS STENT is 2,820 days. Of this time, 1,535 days occurred during the testing phase of the regulatory review period, while 1,285 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: October 7, 2004. FDA has verified the applicant's claim that the date the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective October 7, 2004.

2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): December 19, 2008. FDA has verified the applicant's claim that the premarket approval application (PMA) for the ISTENT TRABECULAR MICRO-BYPASS STENT (PMA P080030) was initially submitted December 19, 2008.

3. The date the application was approved: June 25, 2012. FDA has verified the applicant's claim that PMA P080030 was approved on June 25, 2012.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 5 years of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by July 6, 2015. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 3, 2015. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written or electronic petitions. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. If you submit a written petition, two copies are required. A petition submitted electronically must be submitted to http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

FDA's mandatory food recall authority went into effect when FSMA was enacted on January 4, 2011. Section 423 of the Federal Food, Drug and Cosmetic Act (FD&C Act), as added by section 206 of FSMA, gives FDA the authority to order a responsible party to recall an article of food where FDA determines that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the FD&C Act [21 U.S.C. 342] or misbranded under section 403(w) of the FD&C Act [21 U.S.C. 343(w)] and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (SAHCODHA).

FDA is announcing the availability of a draft guidance for industry entitled “Questions and Answers Regarding Mandatory Food Recalls; Draft Guidance for Industry.” The draft guidance provides answers to common questions that might arise about the mandatory recall provisions and FDA's plans for their implementation.

This guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

This guidance does not refer to any information collection provisions found in FDA regulations. Collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). We conclude that the Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls is not subject to Paperwork Reduction Act of 1995.

Interested persons may submit either written comments regarding the guidance to the Division of Dockets Management (see ADDRESSES) or electronic comments regarding the guidance to http://www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Persons with access to the Internet may obtain the guidance at eitherhttp://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

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

The Administrative Procedures Act (5 U.S.C. 553(e)) provides that every Agency shall give an interested person the right to petition for issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) sets forth the format and procedures by which an interested person may submit to FDA, in accordance with § 10.20 (21 CFR 10.20) (Submission of documents to Division of Dockets Management), a citizen petition requesting the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action.

The Commissioner may grant or deny such a petition, in whole or in part, and may grant such other relief or take other action as the petition warrants. Respondents are individuals or households, State or local governments, and not-for-profit institutions or groups.

Section 10.33 (21 CFR 10.33), issued under section 701(a) of the Federal, Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 371(a)), sets forth the format and procedures by which an interested person may request reconsideration of part or all of a decision of the Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of administrative proceedings). A petition for reconsideration must contain a full statement in a well-organized format of the factual and legal grounds upon which the petition relies. The grounds must demonstrate that relevant information and views contained in the administrative record were not previously or not adequately considered by the Commissioner. The respondent must submit a petition no later than 30 days after the decision involved. However, the Commissioner may, for good cause, permit a petition to be filed after 30 days. An interested person who wishes to rely on information or views not included in the administrative record shall submit them with a new petition to modify the decision. FDA uses the information provided in the request to determine whether to grant the petition for reconsideration. Respondents to this collection of information are individuals of households, State or local governments, not-for-profit institutions, and businesses or other for-profit institutions who are requesting from the Commissioner of FDA a reconsideration of a matter.

Section 10.35 (21 CFR 10.35), issued under section 701(a) of the FD&C Act, sets forth the format and procedures by which an interested person may request, in accordance with § 10.20 (Submission of documents to Division of Dockets Management), the Commissioner to stay the effective date of any administrative action.

Such a petition must do the following: (1) Identify the decision involved; (2) state the action requested, including the length of time for which a stay is requested; and (3) include a statement of the factual and legal grounds on which the interested person relies in seeking the stay. FDA uses the information provided in the request to determine whether to grant the petition for stay of action.

Respondents to this information collection are interested persons who choose to file a petition for an administrative stay of action.