Federal Register Vol. 83, No.171,

If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at [email protected] at the Eastern Regional Office at least ten (10) working days before the scheduled date of the meeting.

Time will be set aside at the end of the meeting so that members of the public may address the Committee after the planning meeting. Persons interested in the issue are also invited to submit written comments; the comments must be received in the regional office by Thursday, October 18, 2018. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected]. Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://facadatabase.gov/committee/meetings.aspx?cid=278 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at [email protected] at the Eastern Regional Office at least ten (10) working days before the scheduled date of the meeting.

Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected]. Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

Records and documents discussed during the meeting will be available for public viewing as they become available at http://facadatabase.gov/committee/meetings.aspx?cid=262, and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

Public Call-In Information: Conference call-in number: 1-888-417-8465 and conference ID# 5308701.

Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-888-417-8465 and conference ID# 5308701. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-888-417-8465 and conference ID# 5308701.

Members of the public are invited to make statements during the open comment period of the meetings or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Midwest Regional Office, U.S. Commission on Civil Rights, 230 S. Dearborn Street, Suite 2120, Chicago, IL 60604, faxed to (312) 353-8324, or emailed to David Barreras at [email protected]. Persons who desire additional information may contact the Midwest Regional Office at (312) 353-8311.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=265; click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Midwest Regional Office at the above phone numbers, email or street address.

If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at [email protected] at the Eastern Regional Office at least ten (10) working days before the scheduled date of the meeting.

Time will be set aside at the end of the meeting so that members of the public may address the Committee after the planning meeting. Persons interested in the issue are also invited to submit written comments; the comments must be received in the regional office by Monday, October 15, 2018. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected]. Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://facadatabase.gov/committee/meetings.aspx?cid=254 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

Background

This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on April 25, 2018.1 On June 7, 2018, in accordance with section 703(c)(1)(A) of the Act, Commerce postponed the preliminary determination of this investigation to August 27, 2018.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

The product covered by this investigation is glycine from India. For a complete description of the scope of the investigation, see Appendix I.

In accordance with the preamble to Commerce's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice.

For a summary of the product coverage comments and rebuttal responses submitted to the record for this preliminary determination and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.6 Commerce is not preliminarily modifying the scope language as it appeared in the Initiation Notice. See scope in Appendix I.

Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.7 For a full description of the methodology underlying our preliminary conclusions, see the Preliminary Decision Memorandum.

In accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of glycine from India based on a request made by GEO Specialty Chemicals, Inc. and Chattem Chemicals, Inc. (the petitioners).8 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than January 7, 2019, unless postponed.

Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and de minimis rates, and any rates based entirely under section 776 of the Act. In this investigation, we calculated individual estimated countervailable subsidy rates for Kumar Industries, India and Paras Intermediates Private Limited that are not zero, de minimis, or based entirely on facts available. Notwithstanding the language of section 705(c)(5)(A)(i) of the Act, we have not calculated the “all-others” rate by weight-averaging the rates of the two individually investigated respondents, because doing so risks disclosure of proprietary information. Therefore, for the “all-others” rate, we calculated a simple average of the two responding companies' rates.9

We preliminarily determine that the following estimated countervailable subsidy rates exist:

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

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

As provided in section 782(i)(1) of the Act, we intend to verify the information submitted by the respondents prior to making our final determination.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.10 Pursuant to 19 CFR 351.203(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

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

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

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

Background

This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on April 25, 2018.1 On June 7, 2018, in accordance with section 703(c)(1)(A) of the Act, Commerce postponed the preliminary determination of this investigation to August 27, 2018.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

The product covered by this investigation is glycine from Thailand. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the preamble to Commerce's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice.

For a summary of the product coverage comments and rebuttal responses submitted to the record for this preliminary determination and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.6 Commerce is not preliminarily modifying the scope language as it appeared in the Initiation Notice. See scope in Appendix I.

Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs at issue in this investigation, Commerce examined whether there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and whether the subsidy is specific.7

In accordance with section 703(e)(1) of the Act, we preliminary determine that critical circumstances do not exist with respect to imports of glycine from Thailand. For a full description of the methodology and results of Commerce's analysis, see the Preliminary Decision Memorandum.

In accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of glycine from Thailand based on a request made by GEO Specialty Chemicals, Inc. and Chattem Chemicals, Inc. (the petitioners).8 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than January 7, 2019, unless postponed.

We preliminarily determine that the following estimated countervailable subsidy rates exist:

Consistent with section 703(d) of the Act, Commerce has not calculated an estimated weighted-average subsidy rate for all other producers/exporters because it has not made an affirmative preliminary determination.

Because Commerce preliminarily determines that no countervailable subsidies are being provided to the production or exportation of subject merchandise, Commerce will not direct U.S. Customs and Border Protection to suspend liquidation of any such entries.

Normally, Commerce discloses to interested parties the calculations performed in connection with a preliminary determination within five days of the public announcement of, or, where there is no public announcement, within five days of the date of publication of, the notice of preliminary determination in the Federal Register, in accordance with 19 CFR 351.224(b). However, because Commerce's negative preliminary determination is based on non-use and/or the finding that certain programs are not countervailable, there are no calculations to disclose with regard to the individually examined company in this investigation.9

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

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.10 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

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

In accordance with section 703(f) of the Act, we will notify the International Trade Commission (ITC) of its determination. If the final determination is affirmative, the ITC will make its final injury determination 75 days after the final determination.

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

Background

This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on April 25, 2018.1 On June 7, 2018, in accordance with section 703(c)(1)(A) of the Act, Commerce postponed the preliminary determination of this investigation to August 27, 2018.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

The product covered by this investigation is glycine from China. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the preamble to Commerce's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage, (i.e., scope).5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice.

For a summary of the product coverage comments and rebuttal responses submitted to the record for this preliminary determination and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.6 Commerce is not preliminarily modifying the scope language as it appeared in the Initiation Notice. See scope at Appendix I.

Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.7 Commerce notes that, in making these findings, we relied in total on facts available and, because we find that the mandatory respondents did not act to the best of their ability to respond to Commerce's requests for information, we drew an adverse inference in selecting from among the facts otherwise available.8 For further information, see “Use of Facts Otherwise Available and Adverse Inferences” in the Preliminary Decision Memorandum.

Sections 703(d)(1)(A) and 705(c)(5)(A) of the Act provide that, in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and de minimis rates and any rates based entirely under section 776 of the Act. Pursuant to section 705(c)(5)(A)(ii) of the Act, if the individual estimated countervailable subsidy rates established for all exporters and producers individually examined are zero, de minimis, or determined based entirely on facts otherwise available, Commerce may use any reasonable method to establish the estimated subsidy rate for all-other producers or exporters. In this investigation, we preliminarily determined the individually estimated subsidy rate for each of the individually examined respondents based entirely on facts available under section 776 of the Act. There is no other information on the record with which to determine an all-others rate. Consequently, pursuant to section 705(c)(5)(A)(ii) of the Act, we have established the all-others rate by applying the countervailable subsidy rate assigned to the mandatory respondents. For a full description of the methodology underlying Commerce's analysis, see the Preliminary Decision Memorandum.

We preliminarily determine that the following estimated countervailable subsidy rates exist:

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

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

Because the examined respondents in this investigation did not provide information requested by Commerce and we preliminarily determine each of the examined respondents to have been uncooperative, we will not conduct verification.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 25 days after the date of publication of the preliminary determination. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.9 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

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

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

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

The National Institute of Standards and Technology (NIST) and the National Center for Disaster Medicine and Public Health (NCDMPH) will hold an open meeting on Thursday, September 6, 2018 from 8:30 a.m. to 5:00 p.m. Eastern Time and on Friday, September 7, 2018 from 8:30 a.m. to 12:00 p.m. Eastern Time. The primary purpose of this meeting is to discuss the state-of-the-practice in post-disaster field data collection methods including sampling methodologies across multiple disciplines. The agenda will be posted on the NIST website at https://www.nist.gov/topics/disaster-failure-studies/national-construction-safety-team-ncst/hurricane-maria-ncst.

To participate in the meeting, please submit your first and last name, email address, and phone number to Melissa Banner at [email protected] or (301) 975-8912. After pre-registering, participants will be provided with detailed instructions on how to join the meeting in person or remotely. Physical space at this meeting will be limited; 20 members of the public are anticipated to be able to attend in person and will be selected on a first-come, first-served basis. Others may attend via teleconference. Anyone wishing to attend this meeting in person or via teleconference must register by 5:00 p.m. Eastern Time, Tuesday, September 4, 2018, to attend. Please submit your full name, email address, and phone number to Melissa Banner at [email protected]; her phone number is (301) 975-8912.

I. Abstract

This request is for extension of this information collection.

NOAA Fisheries, Southeast Fisheries Science Center, annually collects socioeconomic data from commercial fishermen in the Gulf of Mexico and South Atlantic shrimp fisheries who hold one or more permits for harvesting shrimp from federal waters (U.S. Exclusive Economic Zone). Information about revenues, variable and fixed costs, capital investment and other socioeconomic information is collected from a random sample of permit holders. These data are needed to conduct socioeconomic analyses in support of management of the shrimp fishery and to satisfy legal requirements. The data will be used to assess how fishermen will be impacted by and respond to federal regulation likely to be considered by fishery managers.

The information will be collected on paper using a mail survey.

OMB Control Number: 0648-0591.

Form Number(s): None.

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

Affected Public: Business or other for-profit organizations; individuals or households.

Estimated Number of Respondents: 650 permit holders.

Estimated Time per Response: 45 minutes.

Estimated Total Annual Burden Hours: 488 hours.

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

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

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

I. Abstract

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

The Magnuson-Stevens Fishery Conservation and Management Act authorizes the Gulf of Mexico Fishery Management Council (Gulf Council) and South Atlantic Fishery Management Council (South Atlantic Council) to prepare and amend fishery management plans for any fishery in Federal waters under their respective jurisdictions. NMFS and the Gulf Council manage the reef fish fishery in the Gulf of Mexico (Gulf) under the Fishery Management Plan (FMP) for Reef Fish Resources of the Gulf of Mexico. NMFS and the South Atlantic Council manage the fishery for rock shrimp in the South Atlantic under the FMP for the Shrimp Fishery in the South Atlantic Region. The vessel monitoring system (VMS) regulations for the Gulf reef fish fishery and the South Atlantic rock shrimp fishery may be found at 50 CFR 622.28 and 622.205, respectively.

The FMPs and the implementing regulations contain several specific management areas where fishing is restricted or prohibited to protect habitat or spawning aggregations, or to control fishing pressure. Unlike size, bag, and trip limits, where the catch can be monitored on shore when a vessel returns to port, area restrictions require at-sea enforcement. However, at-sea enforcement of offshore areas is difficult due to the distance from shore and the limited number of patrol vessels, resulting in a need to improve enforceability of area fishing restrictions through remote sensing methods. In addition, all fishing gears are subject to some area fishing restrictions. Because of the sizes of these areas and the distances from shore, the effectiveness of enforcement through over flights and at-sea interception is limited. An electronic VMS allows a more effective means to monitor vessels for intrusions into restricted areas.

The VMS provides effort data and significantly aids in enforcement of areas closed to fishing. All position reports are treated in accordance with NMFS existing guidelines for confidential data. As a condition of authorized fishing for or possession of Gulf reef fish or South Atlantic rock shrimp in or from Federal waters, vessel owners or operators subject to VMS requirements must allow NMFS, the United States Coast Guard, and their authorized officers and designees, access to the vessel's position data obtained from the VMS.

Respondents have a choice of either electronic or paper forms. Methods of submittal include email of electronic forms, and mail and facsimile transmission of paper forms.

OMB Control Number: 0648-0544.

Form Number(s): None.

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

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 927.

Estimated Time per Response: Installation, 5 hours; installation and activation checklist, 20 minutes; power-down exemption requests, 5 minutes; transmission of fishing activity reports, 1 minute; and annual maintenance, 2 hours.

Estimated Total Annual Burden Hours: 2,557.

Estimated Total Annual Cost to Public: $1,466,255 in start-up, transfer, operations, and maintenance costs.

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

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

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

Purpose of Meeting: The Panel will review and comment on recommendations made to the Director of the Defense Health Agency, by the Pharmacy and Therapeutics Committee, regarding the Uniform Formulary.

The Department of Defense is publishing this notice to announce a Federal Advisory Committee meeting of the Uniform Formulary Beneficiary Advisory Panel (hereafter referred to as the Panel) will take place.

Meeting Accessibility: Pursuant to 5 U.S.C. 552b, as amended, and 41 Code of Federal Regulations (CFR) 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is limited and will be provided only to the first 220 people signing-in. All persons must sign-in legibly.

Written Statements: Pursuant to 41 CFR 102-3.140, the public or interested organizations may submit written statements to the membership of the Panel about its mission and/or the agenda to be addressed in this public meeting. Written statements should be submitted to the Panel's Designated Federal Officer (DFO). The DFO's contact information can be obtained previously in this announcement. Written comments or statements must be received by the committee DFO at least five (5) business days prior to the meeting so that they may be made available to the Panel for its consideration prior to the meeting. The DFO will review all submitted written statements and provide copies to all the committee members.

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

Purpose of the Meeting: The Committee examines the effectiveness with which the Naval Postgraduate School and the Naval War College are accomplishing its missions.

Agenda: Board of Advisors to the Presidents of the Naval Postgraduate School and the Naval War College Committee (the Committee) and its two subcommittees will be held. This meeting will be open to the public. For more information about the Committee, please visit http://my.nps.edu/web/board-of-advisors. 1. October 17, 2018, 9:00 a.m.-1:00 p.m.: The Naval Postgraduate School Board of Advisors subcommittee will meet to inquire into programs and curricula; instruction; administration; state of morale of the student body, faculty, and staff; fiscal affairs of Naval Postgraduate School and any other matters relating to the operations of the Naval Postgraduate School as the subcommittee considers pertinent. 2. October 17, 2018, 1:00 p.m.-5:00 p.m.: General deliberations and inquiry by the Naval War College Board of Advisors subcommittee into Naval War College programs and mission priorities; re-accreditation review; administration; military construction; leader development continuum; defense planning guidance efforts; and any other matters relating to the operations of the Naval War College as the subcommittee considers pertinent. 3. October 18, 2018, 8:30 a.m.-4:00 p.m.: The Naval Postgraduate School and Naval War College subcommittees will provide out briefs from their meetings to the Committee after which the Committee will discuss topics raised during the subcommittee sessions. The most up-to-date changes to the meeting agenda may be found on the website, https://my.nps.edu/web/board-of-advisors/home.

Meeting Accessibility: Meeting room is fully accessible to persons with disabilities in compliance with applicable disability rights laws.

Written Statements: For access or information, or to send written statements for consideration at the meeting, contact Ms. Jaye Panza, Designated Federal Official, Naval Postgraduate School, at 1 University Circle, Monterey, CA 93943-5001 or by fax at 831-656-3238 by October 8, 2018.

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

Title of Collection: High School Equivalency Program (HEP) Annual Performance Report.

OMB Control Number: 1810-0684.

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

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

Total Estimated Number of Annual Responses: 51.

Total Estimated Number of Annual Burden Hours: 1,173.

Abstract: The High School Equivalency Program (HEP) office staff collects information for the HEP Annual Performance Report (APR) in compliance with Higher Education Act of 1965, as amended, Title IV, Sec. 418A; 20 U.S.C. 1070d-2 (special programs for students whose families are engaged in migrant and seasonal farmwork), and the Code of Federal Regulations (CFR), 2 CFR 200.238. CFR states that recipients of multi-year discretionary grants must submit an APR demonstrating that that substantial progress has been made towards meeting the approved objectives. The HEP office staff requests to continue a customized APR that goes beyond the generic 524B APR to facilitate the collection of more standardized and comprehensive data to inform GPRA, to improve the overall quality of data collected, and to increase the quality of data that can be used to inform policy decisions.

This solicitation of third-party comments concerning the performance of accrediting agencies under review by the Secretary of Education is required by § 496(n)(1)(A) of the Higher Education Act (HEA) of 1965, as amended. These accrediting agencies will be on the agenda for the Winter 2019 National Advisory Committee on Institutional Quality and Integrity meeting. The meeting date has not been determined, but will be announced in a separate Federal Register notice.

Agencies Under Review and Evaluation: Below is a list of agencies currently undergoing review and evaluation by the Accreditation Group, including their current and requested scopes of recognition:

1. Accrediting Council for Continuing Education and Training. Scope of Recognition: The accreditation throughout the United States of institutions of higher education that offer continuing education and vocational programs that confer certificates or occupational associate degrees, including those programs offered via distance education.

2. American Veterinary Medical Association, Council on Education. Scope of Recognition: The accreditation and preaccreditation (“Provisional Accreditation”) in the United States of programs leading to professional degrees (D.V.M. or D.M.D.) in veterinary medicine.

3. Council on Education for Public Health. Scope of Recognition: The accreditation within the United States of schools of public health and public health programs outside schools of public health, at the baccalaureate and graduate degree levels, including those offered via distance education.

4. Western Association of Schools and Colleges, Accrediting Commission for Community and Junior Colleges. Scope of Recognition: The accreditation and preaccreditation (“Candidate for Accreditation”) of community and other colleges with a primarily pre-baccalaureate mission located in California, Hawaii, the United States territories of Guam and American Samoa, the Republic of Palau, the Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, and the Republic of the Marshall Islands, which offer certificates, associate degrees, and the first baccalaureate degree by means of a substantive change review offered by institutions that are already accredited by the agency, and such programs offered via distance education and correspondence education at these colleges. This recognition also extends to the Committee on Substantive Change of the Commission, for decisions on substantive changes, and the Appeals Panel.

1. The Council on Chiropractic Education compliance report includes the following: finding identified in the May 25, 2017 letter from the senior Department official following the February 22, 2017 NACIQI meeting available at: https://opeweb.ed.gov/aslweb/finalstaffreports.cfm, with respect to recognition requirements found at 34 CFR 602.20(a). Scope of Recognition: The accreditation of programs leading to the Doctor of Chiropractic degree and single-purpose institutions offering the Doctor of Chiropractic program.

2. Commission on English Language Program Accreditation Compliance report includes the following: Finding identified in the May 25, 2017 letter from the senior Department official following the February 22, 2017 NACIQI meeting available at: https://opeweb.ed.gov/aslweb/finalstaffreports.cfm, with respect to recognition requirements found at 34 CFR 602.20(b). Scope of Recognition: The accreditation of postsecondary, non-degree-granting English language programs and institutions in the United States.

1. Western Association of Schools and Colleges, Accrediting Commission for Community and Junior Colleges. Scope of Recognition: The accreditation and preaccreditation (“Candidate for Accreditation”) of community and other colleges with a primarily pre-baccalaureate mission located in California, Hawaii, the United States territories of Guam and American Samoa, the Republic of Palau, the Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, and the Republic of the Marshall Islands, which offer certificates, associate degrees, and the first baccalaureate degree by means of a substantive change review offered by institutions that are already accredited by the agency, and such programs offered via distance education and correspondence education at these colleges. This recognition also extends to the Committee on Substantive Change of the Commission, for decisions on substantive changes, and the Appeals Panel.

The accreditation and preaccreditation (“Candidate for Accreditation”) of community and other colleges in California, Hawaii, the United States territories of Guam and American Samoa, the Republic of Palau, the Federated States of Micronesia, the Commonwealth of the Northern Marianas, and the Republic of the Marshall Islands, which have as a primary mission the granting of associate degrees, but which may also award certificates and other credentials, including bachelor's degrees, where the provision of such credentials is within the institution's mission and, if applicable, is authorized by their governmental authorities, and the accreditation of such programs offered via distance education and correspondence education at these colleges. This recognition also extends to the Committee on Substantive Change of the Commission, for decisions on substantive changes.

Written comments about the recognition of a specific accrediting or State agency must be received by September 30, 2018, in the [email protected] mailbox and include the subject line “Written Comments: (Agency name).” The email must include the name(s), title, organization/affiliation, mailing address, email address, and telephone number of the person(s) making the comment. Comments should be submitted as a Microsoft Word document or in a medium compatible with Microsoft Word (not a PDF file) that is attached to an electronic mail message (email) or provided in the body of an email message. Comments about an agency that has submitted a compliance report scheduled for review by the Department must relate to the criteria for recognition cited in the senior Department official's letter that requested the report, or in the Secretary's appeal decision, if any. Comments about an agency that has submitted a petition for renewal of recognition must relate to the agency's compliance with the Criteria for the Recognition of Accrediting Agencies, or the Criteria and Procedures for Recognition of State Agencies for Approval of Nurse Education as appropriate, which are available at http://www.ed.gov/admins/finaid/accred/index.html.

Only written material submitted by the deadline to the email address listed in this notice, and in accordance with these instructions, become part of the official record concerning agencies scheduled for review and are considered by the Department and NACIQI in their deliberations.

A later Federal Register notice will describe how to register to provide oral comments at the meeting regarding the recognition of a specific accrediting agency or State approval agency.

Electronic Access to this Document: The official version of this document is the document published in the Federal Register. Free internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

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

Title of Collection: The College Assistance Migrant Program (CAMP) Annual Performance Report (APR).

OMB Control Number: 1810-0727.

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

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

Total Estimated Number of Annual Responses: 50.

Total Estimated Number of Annual Burden Hours: 1,150.

Abstract: The College Assistance Migrant Program (CAMP) office staff collects information for the CAMP Annual Performance Report (APR) in compliance with Higher Education Act of 1965, as amended, Title IV, Sec. 418A; 20 U.S.C. 1070d-2 (special programs for students whose families are engaged in migrant and seasonal farm-work), and the Code of Federal Regulations (CFR), 2 CFR 200.238. CFR states that recipients of multi-year discretionary grants must submit an APR demonstrating that that substantial progress has been made towards meeting the approved objectives. The CAMP office staff requests to continue a customized APR that goes beyond the generic 524B APR to facilitate the collection of more standardized and comprehensive data to inform GPRA, to improve the overall quality of data collected, and to increase the quality of data that can be used to inform policy decisions.

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

Title of Collection: Student Assistance General Provisions—Subpart K—Cash Management.

OMB Control Number: 1845-0106.

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

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

Total Estimated Number of Annual Responses: 3,037,182.

Total Estimated Number of Annual Burden Hours: 916,358.

Abstract: The Department of Education (the Department) is requesting an extension of the information collection for the requirements that are contained in the regulations § 668.164—Disbursing funds. The regulations require that an institution that makes direct payments to a student or parent by electronic funds transfer (EFT) and that chooses to enter into an arrangement described in 668.164(e) or (f), including an institution that uses a third-party servicer to make those payments, must establish a selection process under which the student chooses one of several options for receiving those Title IV, HEA fund payments. The Department amended the Student Assistance General Provisions regulations issued under the Higher Education Act of 1965, as amended (HEA), to implement the changes made to the Student Assistance General Provisions regulations—Subpart K—Cash Management § 668.164—Disbursing funds. These regulations are intended to ensure students and parents have convenient access to their Title IV, HEA program funds, do not incur unreasonable and uncommon financial account fees on these title IV funds and are not led to believe that they must open a particular financial account to receive their Federal student aid.

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

Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, the EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: On May 18, 2016, the EPA proposed the National Pollutant Discharge Elimination System (NPDES): Applications and Program Updates rule (81 FR 31343). The Spring 2018 Regulatory Agenda explained that the EPA would be finalizing the proposed rule in two separate but related actions. This first final rule will address a subset of the revisions proposed in 2016 to modernize the NPDES regulations, clarify regulatory requirements, and promote submission of complete permit applications. This ICR identifies the types of activities regulated and calculates the burden and associated costs of the revisions to be included in the first final rule, the National Pollutant Discharge Elimination System (NPDES): Specific Provisions Affecting Applications and Program Updates (RIN 2040-AF25), and corresponding updated NPDES permit application forms.

Form numbers: OMB. No. 2040-0004; OMB. No. 2040-0086; OMB. No. 2040-0188; OMB. No. 2040-0211; OMB. No. 2040-0250; OMB. No. 2040-0284; OMB. No. 1004-0189; OMB. No. 0596-0082.

Respondents/affected entities: The respondents affected by this collection activity include: The EPA; authorized state, territorial, and tribal programs; and the regulated community.

Respondent's obligation to respond: The collection is required pursuant to CWA section 402, as implemented by the revisions to 40 CFR parts 122, 124, and 125. Compliance with the updated application requirements and corresponding updated application forms is mandatory. The opportunity for NPDES permitting authorities to provide public notice of NPDES permit actions using the internet in lieu of the newspaper is voluntary.

Estimated number of respondents: 20,663 applicants/permittees; 20,019 state, territory, and tribal governments; 644 by the EPA (total: 41,326).

Frequency of response: The burden would be realized once within a five-year period, with the assumption that each permit would be reapplied for and renewed once every five years.

Total estimated burden: A reduction of 19,305 hours (per year). Burden is defined at 5 CFR 1320.03(b)

Total estimated cost: A savings of $2,524,064 (per year), includes a savings of $1,419,673 annualized capital or operation and maintenance costs.

Changes in estimates: There is an overall decrease of 19,305 hours in the total estimated respondent burden. This decrease is due to: Estimated burden reduction to both permittees and permitting authorities resulting from revised application forms that are easier to follow and redesigned to reduce confusion and support completion; permitting authorities exercising the option to publicly notice permitting decisions through public websites rather than through publication in newspapers, and; additional minor reductions in burden associated with permitting authority review of applications submitted by POTWs with pretreatment programs and applications submitted by permittees indicating the use of cooling water. These changes are due to changes in program requirements, as well as updated and improved NPDES permit application forms.

Awards Project Notice, Pursuant to 42 U.S.C. 7403(a)(1) and (2) and sections 103(a)(1) and (2) of the Clean Air Act (CAA), notice is hereby given that the EPA's Office of Air and Radiation (OAR) announces the opening of competition for the 2019 Clean Air Excellence Awards Program (CAEAP). The intent of the program is to recognize and honor outstanding, innovative efforts that help to make progress in achieving cleaner air. The CAEAP is open to both public and private entities. Entries are limited to efforts related to air quality in the United States. There are five general award categories: (1) Clean Air Technology; (2) Community Action; (3) Education/Outreach; (4) State/Tribal/Local Air Quality Policy Innovations; and (5) Transportation Efficiency Innovations. There are also two special awards categories: (1) Thomas W. Zosel Outstanding Individual Achievement Award; and (2) Gregg Cooke Visionary Program Award. Awards are given periodically and are for recognition only.

Entry Requirements: All applicants are asked to submit their entry on a CAEAP entry form, contained in the CAEAP Entry Package, which may be obtained from the CAAAC website at http://epa.gov/air/cleanairawards/entry.html. Applicants can also contact Ms. Catrice Jefferson, Office of Air and Radiation, U.S. EPA by telephone at (202) 564-1668 or by email at [email protected]. The entry form is a simple, four-part form asking for general information on the applicant; a narrative description of the project; three (3) independent references for the proposed entry; and your knowledge of EPA awards programs and resources. Applicants should also submit additional support documentation as necessary. Specific directions and information on filing an entry form are included in the Entry Package.

Judging and Award Criteria: EPA staff will use a screening process, with input from outside subject experts, as needed. Members of the CAAAC will provide advice to EPA on the entries. The EPA Assistant Administrator for Air and Radiation will make the final award decisions. Entries will be judged using both general criteria and criteria specific to each individual category. These criteria are listed in the 2019 Entry Package.

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

Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: This ICR renewal is related to EPA's diesel fuel regulations under 40 CFR part 80, Subpart I, applicable to highway (motor vehicle) diesel fuel and non-road, locomotive and marine diesel fuel (NRLM), Emission Control Area (ECA) marine fuel, and heating oil. Most of the information collected under this ICR is used to evaluate compliance with the requirements of the regulations. Motor vehicle diesel fuel and just about all NRLM diesel fuel now meet a 15 part per million sulfur standard. The activities associated with this ICR include: registration (new refiners and importers, updates to existing registrations); submission of corrections to prior compliance reports; granting of research and development exemptions; generation and retention of quality assurance records; general recordkeeping; batch testing for sulfur content; and the production of product transfer documents and pump labels.

Form numbers: Only ECA0300 and DLQ001 are active. There may be resubmissions of the others.

Respondents/affected entities: Parties involved with diesel fuels.

Respondent's obligation to respond: Mandatory.

Estimated number of respondents: 7,900 (total).

Frequency of response: On occasion.

Total estimated burden: 28,450 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $3,300,200 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in estimates: There is an increase of 17,372 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is due to burdens that were not addressed in the current ICR, such as product transfer documents, the testing of each batch of diesel fuel for sulfur content, and labels on pumps that dispense hearing oil and certain offroad diesel fuels.

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

Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology (e.g., permitting electronic submission of responses). The EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, the EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: This ICR includes ambient air monitoring data and other supporting measurements reporting and recordkeeping activities associated with the 40 CFR 58, Ambient Air Quality Surveillance rule. These data and information are collected by various state and local air quality management agencies and reported to the EPA's Office of Air Quality Planning and Standards within the Office of Air and Radiation.

This ICR reflects revisions of the previous ICR update of 2013, and covers the period of 2019-2021. The number of monitoring stations, sampling parameters, and frequency of data collection and submittal is expected to remain relatively stable for 2019-2021, with minor increases and decreases expected for several ambient air monitoring networks as air monitoring agencies review their monitoring networks.

The data collected through this information collection consist of ambient air concentration measurements for the seven air pollutants with national ambient air quality standards (i.e., ozone, sulfur dioxide, nitrogen dioxide, lead, carbon monoxide, PM2.5 and PM10), ozone precursors, meteorological variables at a select number of sites and other supporting measurements. Accompanying the pollutant concentration data are quality assurance/quality control data and air monitoring network design information.

The EPA and others (e.g., state and local air quality management agencies, tribal entities, environmental groups, academic institutions, industrial groups) use the ambient air quality data for many purposes. Some of the more prominent uses include informing the public and other interested parties of an area's air quality, judging an area's (e.g., county, city, neighborhood) air quality in comparison with the established health or welfare standards (including both national and local standards), evaluating an air quality management agency's progress in achieving or maintaining air pollutant levels below the national and local standards, developing and revising State Implementation Plans (SIPs) in accordance with 40 CFR 51, evaluating air pollutant control strategies, developing or revising national control policies, providing data for air quality model development and validation, supporting enforcement actions, documenting episodes and initiating episode controls, air quality trends assessment, and air pollution research.

The state and local agencies and tribal entities with responsibility for reporting ambient air quality data and information as requested in this ICR submit these data electronically to the EPA's Air Quality System (AQS) database. Quality assurance/quality control records and monitoring network documentation are also maintained by each state and local agency, in AQS electronic format where possible.

Although the state and local air pollution control agencies and tribal entities are responsible for the operation of the air monitoring networks, the EPA funds a portion of the total costs through federal grants. These grants generally require an appropriate level of contribution, or “match,” from the state/local agencies or tribal entities. The costs shown in this renewal are the total costs incurred for the monitoring program regardless of the source of the funding. This practice of using the total cost is consistent with prior ICR submittals and renewals.

Form numbers: None.

Respondents/affected entities: State, local and Tribal Air Pollution Control Agencies.

Respondent's obligation to respond: Mandatory per 40 CFR 58.

Estimated number of respondents: 168 (total).

Frequency of response: Quarterly.

Total estimated burden: 1,756,355 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $212,581,038 (per year), includes $15,066,248 annualized capital or operation & maintenance costs.

Changes in estimates: There is a decrease of 33,666 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is due to a change in program requirements as well as adjustments to the estimates (e.g., to account for inflation, network growth/shrinkage, etc.).

For more information about the study, see EPA's website at https://www.epa.gov/eg/study-oil-and-gas-extraction-wastewater-management.

Participating in the meeting: The public is invited to speak during the October 9 public meeting. Those wishing to attend and/or speak can register at [email protected]. Please provide your name, organization, email address and indicate whether you plan to speak. Each speaker will be limited to three minutes. Registration is recommended but not required for this meeting. For security reasons, we request that you bring photo identification with you to the meeting. Seating will be provided on a first-come, first-served basis. Please note that parking is very limited in downtown Washington, and use of public transit is recommended. The EPA Headquarters complex is located near the Federal Triangle Metro station. Upon exiting the Metro station, walk east to 12th Street. On 12th Street, walk south to Constitution Avenue. At the corner, turn right onto Constitution Avenue and proceed to the EPA East Building entrance.

If you are unable to attend, you can submit a written statement at: http://www.regulations.gov: Enter Docket ID No. EPA-HQ-OW-2018-0618. Follow the online instructions for submitting a written statement. Once submitted, written statements cannot be edited or withdrawn. EPA may publish any written statement received to its public docket.

Do not submit electronically any information you consider to be Confidential Business Information (CBI). For additional submission methods, information about CBI, and general guidance on effective written submissions, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

Proposed Project Medical Expenditure Panel Survey (MEPS) Household Component (HC)

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public the comment on this proposed information collection. For over thirty years, results from the MEPS and its predecessor surveys (the 1977 National Medical Care Expenditure Survey, the 1980 National Medical Care Utilization and Expenditure Survey and the 1987 National Medical Expenditure Survey) have been used by OMB, DHHS, Congress and a wide number of health services researchers to analyze health care use, expenses and health policy.

Major changes continue to take place in the health care delivery system. The MEPS is needed to provide information about the current state of the health care system as well as to track changes over time. The MEPS permits annual estimates of use of health care and expenditures and sources of payment for that health care. It also permits tracking individual change in employment, income, health insurance and health status over two years. The use of the NHIS as a sampling frame expands the MEPS analytic capacity by providing another data point for comparisons over time.

Households selected for participation in the MEPS-HC are interviewed five times in person. These rounds of interviewing are spaced about 5 months apart. The interview will take place with a family respondent who will report for him/herself and for other family members.

The MEPS-HC has the following goal:

To provide nationally representative estimates for the U.S. civilian noninstitutionalized population for:

The MEPS-MPC will contact medical providers (hospitals, physicians, home health agencies and institutions) identified by household respondents in the MEPS-HC as sources of medical care for the time period covered by the interview, and all pharmacies providing prescription drugs to household members during the covered time period. The MEPS-MPC is not designed to yield national estimates as a stand-alone survey. The sample is designed to target the types of individuals and providers for whom household reported expenditure data was expected to be insufficient. For example, Medicaid enrollees are targeted for inclusion in the MEPS-MPC because this group is expected to have limited information about payments for their medical care.

The MEPS-MPC collects event level data about medical care received by sampled persons during the relevant time period. The data collected from medical providers include:

Data collected from pharmacies include:

The MEPS-MPC has the following goal:

• To serve as an imputation source for and to supplement/replace household reported expenditure and source of payment information. This data will supplement, replace and verify information provided by household respondents about the charges, payments, and sources of payment associated with specific health care encounters.

This study is being conducted by AHRQ through its contractors, Westat and RTI International, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the cost and use of health care services and with respect to health statistics and surveys. 42 U.S.C. 299a(a)(3) and (8); 42 U.S.C. 299b-2.

To achieve the goals of the MEPS-HC the following data collections are implemented:

1. Household Component Core Instrument. The core instrument collects data about persons in sample households. Topical areas asked in each round of interviewing include priority condition enumeration, health status, health care utilization including prescribed medicines, expenses and payments, employment, and health insurance. Other topical areas that are asked only once a year include access to care, income, assets, satisfaction with providers, and children's health. While many of the questions are asked about the entire reporting unit (RU), which is typically a family, only one person normally provides this information. All sections of the current core instrument are available on the AHRQ website at http://meps.ahrq.gov/mepsweb/survey_comp/survey_questionnaires.jsp.

2. Adult Self-Administered Questionnaire. A brief self-administered questionnaire (SAQ) will be used to collect self-reported (rather than through household proxy) on health opinions and satisfaction with health care, and information on health status, preventive care and health care quality measures for adults 18 and. The satisfaction with health care items are a subset of items from the Consumer Assessment of Healthcare Providers and Systems (CAHPS®). The health status items are from the Veterans Rand 12 item health survey (VR-12), a generic instrument developed with the support of the Department of Veterans Affairs and the Centers for Medicare and Medicaid Services. Additionally, there are questions addressing adult preventive care for both males and females. This questionnaire is revised from the previous OMB clearance.

3. Veteran SAQ. MEPS includes a new self-administered questionnaire for spring of 2019 data collection targeting the veteran population. The questionnaire asks questions in the following domains of interest: If a veteran is eligible for VA health care; if a Veteran is enrolled in VA health care; coordination of care in and out of the VA health care system, services provided to Veterans in and out of the VA health care system, and VA eligibility priority groups, for Veterans enrolled in VA health care and for Veterans eligible for VA health care. To assist in the correct identification of priority groups, the questionnaire may also include items assessing the following: Presence of service-connected disability; service-connected disability rating; presence of presumptive-conditions; timing and era of active duty; and VA receipt of disability compensation benefits. AHRQ worked with the Veteran Health Administration to develop the questionnaire content.

4. Diabetes Care SAQ. A brief self-administered paper-and-pencil questionnaire on the quality of diabetes care is administered once a year (during rounds 3 and 5) to persons identified as having diabetes. Included are questions about the number of times the respondent reported having a hemoglobin A1c blood test, whether the respondent reported having his or her feet checked for sores or irritations, whether the respondent reported having an eye exam in which the pupils were dilated, the last time the respondent had his or her blood cholesterol checked and whether the diabetes has caused kidney or eye problems. Respondents are also asked if their diabetes is being treated with diet, oral medications or insulin. This questionnaire is unchanged from the previous OMB clearance.

5. Authorization forms for the MEPS-MPC Provider and Pharmacy Survey. As in previous panels of the MEPS, we will ask respondents for authorization to obtain supplemental information from their medical providers (hospitals, physicians, home health agencies and institutions) and pharmacies.

6. MEPS Validation Interview. Each interviewer is required to have at least 15 percent of his/her caseload validated to insure that the computer assisted personal interview (CAPI) questionnaire content was asked appropriately and procedures followed, for example the use of show cards. Validation flags are set programmatically for cases pre-selected by data processing staff before each round of interviewing. Home office and field management may also request that other cases be validated throughout the field period. When an interviewer fails a validation their work is subject to 100 percent validation. Additionally, any case completed in less than 30 minutes is validated. A validation abstract form containing selected data collected in the CAPI interview is generated and used by the validator to guide the validation interview.

To achieve the goal of the MEPS-MPC the following data collections are implemented:

1. MPC Contact Guide/Screening Call. An initial screening call is placed to determine the type of facility, whether the practice or facility is in scope for the MEPS-MPC, the appropriate MEPS-MPC respondent and some details about the organization and availability of medical records and billing at the practice/facility. All hospitals, physician offices, home health agencies, institutions and pharmacies are screened by telephone. A unique screening instrument is used for each of these seven provider types in the MEPS-MPC, except for the two home care provider types which use the same screening form.

2. Home Care Provider Questionnaire for Health Care Providers. This questionnaire is used to collect data from home health care agencies which provide medical care services to household respondents. Information collected includes type of personnel providing care, hours or visits provided per month, and the charges and payments for services received. Some HMOs may be included in this provider type.

3. Home Care Provider Questionnaire for Non-Health Care Providers. This questionnaire is used to collect information about services provided in the home by non-health care workers to household respondents because of a medical condition; for example, cleaning or yard work, transportation, shopping, or child care.

4. Medical Event Questionnaire for Office-Based Providers. This questionnaire is for office-based physicians, including doctors of medicine (MDs) and osteopathy (DOs), as well as providers practicing under the direction or supervision of an MD or DO (e.g., physician assistants and nurse practitioners working in clinics). Providers of care in private offices as well as staff model HMOs are included.

5. Medical Event Questionnaire for Separately Billing Doctors. This questionnaire collects information from physicians identified by hospitals (during the Hospital Event data collection) as providing care to sampled persons during the course of inpatient, outpatient department or emergency room care, but who bill separately from the hospital.

6. Hospital Event Questionnaire. This questionnaire is used to collect information about hospital events, including inpatient stays, outpatient department, and emergency room visits. Hospital data are collected not only from the billing department, but from medical records and administrative records departments as well. Medical records departments are contacted to determine the names of all the doctors who treated the patient during a stay or visit. In many cases, the hospital administrative office also has to be contacted to determine whether the doctors identified by medical records billed separately from the hospital; doctors that do bill separately from the hospital will be contacted as part of the Medical Event Questionnaire for Separately Billing Doctors. HMOs are included in this provider type.

7. Institutions Event Questionnaire. This questionnaire is used to collect information about institution events, including nursing homes, rehabilitation facilities and skilled nursing facilities. Institution data are collected not only from the billing department, but from medical records and administrative records departments as well. Medical records departments are contacted to determine the names of all the doctors who treated the patient during a stay. In many cases, the institution's administrative office also has to be contacted to determine whether the doctors identified by medical records billed separately from the institution itself. Some HMOs may be included in this provider type.

8. Pharmacy Data Collection Questionnaire. This questionnaire requests the NDC and when that is not available the prescription name, strength and form as well as the date prescription was filled, payments by source, the quantity, and person for whom the prescription was filled. When the NDC is available, we do not ask for prescription name, strength or form because that information is embedded in the NDC; this reduces burden on the respondent. Most pharmacies have the requested information available in electronic format and respond by providing a computer generated printout of the patient's prescription information. If the computerized form is unavailable, the pharmacy can report their data to a telephone interviewer. Pharmacies are also able to provide a CD-ROM with the requested information if that is preferred. HMOs are included in this provider type.

Dentists, optometrists, psychologists, podiatrists, chiropractors, and others not providing care under the supervision of a MD or DO are considered out of scope for the MEPS-MPC.

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the MEPS-HC and the MEPS-MPC.

The MEPS-HC Core Interview will be completed by 13,338* (see note below Exhibit 1) “family level” respondents, also referred to as RU respondents. Since the MEPS-HC consists of 5 rounds of interviewing covering a full two years of data, the annual average number of responses per respondent is 2.5 responses per year. The MEPS-HC core requires an average response time of 92 minutes to administer. The Adult Female SAQ will be completed once a year by each female person in the RU that is 18 years old and older, an estimated 12,984 persons. The Adult Male SAQ will be completed once a year by each male person in the RU that is 18 years old and older, an estimated 11,985 persons. The Adult SAQs each require an average of 7 minutes to complete. The Diabetes care SAQ will be completed once a year by each person in the RU identified as having diabetes, an estimated 2,072 persons, and takes about 3 minutes to complete. The Veteran SAQ will be completed once by each in-scope person who is a veteran of the U.S. military identified in the Round 1, Panel 23 interview, an estimated 1,350 persons. The Veteran SAQ requires an average of 15 minutes to complete. The authorization form for the MEPS-MPC Provider Survey will be completed once for each medical provider seen by any RU member. The 12,804 RUs in the MEPS-HC will complete an average of 5.4 forms, which require about 3 minutes each to complete. The authorization form for the MEPS-MPC Pharmacy Survey will be completed once for each pharmacy for any RU member who has obtained a prescription medication. RUs will complete an average of 3.1 forms, which take about 3 minutes to complete. About one third of all interviewed RUs will complete a validation interview as part of the MEPS-HC quality control, which takes an average of 5 minutes to complete. The total annual burden hours for the MEPS-HC are estimated to be 60,278 hours.

All medical providers and pharmacies included in the MEPS-MPC will receive a screening call and the MEPS-MPC uses 7 different questionnaires; 6 for medical providers and 1 for pharmacies. Each questionnaire is relatively short and requires 2 to 19 minutes to complete. The total annual burden hours for the MEPS-MPC are estimated to be 17,388 hours. The total annual burden for the MEPS-HC and MPC is estimated to be 77,666 hours.

Exhibit 2 shows the estimated annual cost burden associated with the respondents' time to participate in this information collection. The annual cost burden for the MEPS-HC is estimated to be $1,467,167; the annual cost burden for the MEPS-MPC is estimated to be $298,580. The total annual cost burden for the MEPS-HC and MPC is estimated to be $1,765,746.

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

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

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public the comment on this proposed information collection. In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in health care, AHRQ developed and pilot tested the Nursing Home Survey on Patient Safety Culture with OMB approval (OMB NO. 0935-0132; Approved July 5, 2007).

The survey is designed to enable nursing homes to assess provider and staff perspectives about patient safety issues, medical error, and error reporting and includes 42 items that measure 12 composites of patient safety culture. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in November 2008 on the AHRQ website.

The AHRQ Nursing Home SOPS Database consists of data from the AHRQ Nursing Home Survey on Patient Safety Culture. Nursing homes in the U.S. can voluntarily submit data from the survey to AHRQ through its contractor, Westat. The Nursing Home SOPS Database (OMB NO. 0935-0195, last approved on September 30, 2015) was developed by AHRQ in 2011 in response to requests from nursing homes interested in viewing their organizations' patient safety culture survey results. Those organizations submitting data receive a feedback report, as well as a report on the aggregated de-identified findings of the other nursing homes submitting data. These reports are used to assist nursing home staff in their efforts to improve patient safety culture in their organizations.

Rationale for the information collection. The Nursing Home SOPS and Nursing Home SOPS Database support AHRQ's goals of promoting improvements in the quality and safety of health care in nursing home settings. The survey, toolkit materials, and database results are all made publicly available on AHRQ's website. Technical assistance is provided by AHRQ through its contractor at no charge to nursing homes, to facilitate the use of these materials for nursing home patient safety and quality improvement.

This database will:

(1) Present results from nursing homes that voluntarily submit their data,

(2) Provide data to nursing homes to facilitate internal assessment and learning in the patient safety improvement process, and

(3) Provide supplemental information to help nursing homes identify their strengths and areas with potential for improvement in patient safety culture.

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

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

(1) Eligibility and Registration Form—The nursing home (or parent organization) point-of-contact (POC) completes a number of data submission steps and forms, beginning with the completion of an online Eligibility and Registration Form. The purpose of this form is to collect basic demographic information about the nursing home and initiate the registration process.

(2) Data Use Agreement—The purpose of the data use agreement, completed by the nursing home POC, is to state how data submitted by nursing homes will be used and provides privacy assurances.

(3) Nursing Home Site Information Form—The purpose of the site information form, completed by the nursing home POC, is to collect background characteristics of the nursing home. This information will be used to analyze data collected with the Nursing Home SOPS survey.

(4) Data File(s) Submission—POCs upload their data file(s) using the data file specifications, to ensure that users submit standardized and consistent data in the way variables are named, coded and formatted. The number of submissions to the database is likely to vary each year because nursing homes do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either a corporate level health care manager for a Quality Improvement Organization (QIO), a survey vendor who contracts with a nursing home to collect their data, or a nursing home Director of Nursing or nurse manager. POCs submit data on behalf of 5 nursing homes, on average, because many nursing homes are part of a QIO or larger nursing home or health system that includes many nursing home sites, or the POC is a vendor that is submitting data for multiple nursing homes.

Survey data from the AHRQ Nursing Home Survey on Patient Safety Culture are used to produce three types of products:

(1) A Nursing Home SOPS User Database Report that is made publicly available on the AHRQ website;

(2) Individual Nursing Home Survey Feedback Reports are individualized reports produced for each nursing home that submits data to the database; and

(3) Research data sets of individual-level and nursing home-level de-identified data to enable researchers to conduct analyses. All data released in a data set are de-identified at the individual-level and the nursing home-level.

Nursing homes will be invited to voluntarily submit their Nursing Home SOPS survey data to the database. The data are then cleaned and aggregated and used to produce a Database Report in PDF format that displays averages, standard deviations, and percentile scores on the survey's 42 items and 12 patient safety culture composites, as well as displaying these results by nursing home characteristics (bed size, urbanicity, ownership, and region) and respondent characteristics (work area/unit, staff position, interaction with residents, shift worked most often, and tenure in nursing home).

Each nursing home that submits data receives an individualized survey feedback report that presents their results alongside the aggregate results from other participating nursing homes.

Nursing homes use the Nursing Home SOPS Database Reports and Individual Nursing Home Survey Feedback Reports for a number of purposes, to:

• Raise staff awareness about patient safety.

• Elucidate and assess the current status of patient safety culture in their nursing home.

• Identify strengths and areas for patient safety culture improvement.

• Evaluate trends in patient safety culture change over time.

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

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 60 POCs, each representing an average of 5 individual nursing homes, will complete the database submission steps and forms. Each POC will submit the following:

• Eligibility and registration form (completion is estimated to take about 3 minutes).

• Data Use Agreement (completion is estimated to take about 3 minutes).

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

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

The total annual burden hours are estimated to be 91 hours.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $4,085 annually.

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

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

FDA is announcing the availability of a final guidance for industry entitled “Physiologically Based Pharmacokinetic Analyses—Format and Content.” A PBPK analysis uses models and simulations that combine physiology, population, and drug characteristics to mechanistically describe the pharmacokinetic behaviors of a drug or drug product. Throughout a drug's life cycle, PBPK model predictions can be used to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, and to support dosing recommendations in product labeling. Because of the lack of regulatory guidance, the format and content of PBPK analysis reports that are submitted to FDA vary significantly. The goal of this guidance is to standardize the content and format of these reports to facilitate FDA's efficient assessment, consistent application, and timely decision making during regulatory review.

This guidance outlines the recommended format and content for a sponsor or applicant to submit PBPK analyses to FDA to support applications including, but not limited to, INDs, NDAs, BLAs, and ANDAs. This guidance does not address methodological considerations and best practices for the conduct of PBPK modeling and simulation or the appropriateness of PBPK analyses for a particular drug or a drug product.

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

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in 21 CFR 314.50(d) has been approved under OMB control number 0910-0001.

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

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

Section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), among other things, establishes requirements for the label or labeling of a medical device so that it is not misbranded and subject to a regulatory action. Certain provisions under section 502 of the FD&C Act require manufacturers, importers, and distributors of medical devices to disclose information about themselves or the devices on the labels or labeling for the devices.

Section 502(b) of the FD&C Act requires that for packaged devices, the label must bear the name and place of business of the manufacturer, packer, or distributor; and an accurate statement of the quantity of the contents. Section 502(f) of the FD&C Act requires that the labeling for a device must contain adequate directions for use. FDA may, however, grant an exemption if the Agency determines that the adequate directions for use labeling requirements are not necessary for the particular case as it relates to protection of the public health.

FDA regulations under parts 800, 801, and 809 (21 CFR parts 800, 801, and 809) require disclosure of specific information by manufacturers, importers, and distributors of medical devices about themselves or the devices, on the label or labeling for the devices, to health professionals and consumers. Most of the regulations under parts 800, 801, and 809 are derived from requirements of section 502 of the FD&C Act. Section 502 provides, in part, that a device shall be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the device, is false or misleading in any particular way, or fails to contain adequate directions for use.

Section 801.150(a)(2) establishes recordkeeping requirements for manufacturers of devices to retain a copy of the agreement containing the specifications for the processing, labeling, or repacking of the device for 2 years after the final shipment or delivery of the device. Section 801.150(a)(2) also requires that the subject respondents make copies of this agreement available for inspection at any reasonable hour to any officer or employee of the Department of Health and Human Services (HHS) who requests them.

Section 801.410(e) requires copies of invoices, shipping documents, and records of sale or distribution of all impact resistant lenses, including finished eyeglasses and sunglasses, be maintained for 3 years by the retailer and made available upon request by any officer or employee of FDA or by any other officer or employee acting on behalf of the Secretary of HHS.

Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years.

Section 801.421(d) establishes requirements for hearing aid dispensers to retain copies of all physician statements or any waivers of medical evaluation for 3 years after dispensing the hearing aid.

Section 801.430(f) requires manufacturers of menstrual tampons to devise and follow an ongoing sampling plan for measuring the absorbency of menstrual tampons. In addition, manufacturers must use the method and testing parameters described in § 801.430(f).

Section 801.435(g) requires latex condom manufacturers to document and provide, upon request, an appropriate justification for the application of the testing data from one product on any variation of that product to support expiration dating in the user labeling.

Sections 800.10(a)(3) and 800.12(c) require that the label for contact lens cleaning solutions bear a prominent statement alerting consumers of the tamper-resistant feature. Further, § 800.12 requires that packaged contact lens cleaning solutions contain a tamper-resistant feature to prevent malicious adulteration.

Section 800.10(b)(2) requires that the labeling for liquid ophthalmic preparations packed in multiple-dose containers provide information on the duration of use and the necessary warning information to afford adequate protection from contamination during use.

Section 801.1 requires that the label for a device in package form contain the name and place of business of the manufacturer, packer, or distributor.

Section 801.5 requires that labeling for a device include information on intended use as defined under § 801.4 and provide adequate directions to assure safe use by the lay consumers.

Section 801.61 requires that the principal display panel of an over-the-counter (OTC) device in package form must bear a statement of the identity of the device. The statement of identity of the device must include the common name of the device followed by an accurate statement of the principal intended actions of the device. Section 801.62 requires that the label for an OTC device in package form shall bear a declaration of the net quantity of contents. The label must express the net quantity in terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size.

Section 801.109 establishes labeling requirements for prescription devices, in which the label for the device must describe the application or use of the device and contain a cautionary statement restricting the device for sale by, or on the order of, an appropriate professional.

Section 801.110 establishes labeling requirements for a prescription device delivered to the ultimate purchaser or user, by a licensed practitioner. The device must be accompanied by labeling bearing the name and address of the licensed practitioner, directions for use, and cautionary statements, if any, provided by the order.

Section 801.150(e) requires a written agreement between firms involved in the assembling or packaging of a nonsterile device containing labeling that identifies the final finished device as sterile and then shipping such device in interstate commerce prior to sterilization. In addition, § 801.150(e) requires that each pallet, carton, or other designated unit be conspicuously marked to show its nonsterile nature when introduced into interstate commerce and while being held prior to sterilization. When both requirements are met, FDA will take no regulatory action against the device as being misbranded or adulterated.

Section 801.405(b)(1) provides for labeling requirements for articles, including repair kits, re-liners, pads, and cushions, intended for use in temporary repairs and refitting of dentures for lay persons. Section 801.405(b)(1) also requires that the labeling contain the word “emergency” preceding and modifying each indication-for-use statement for denture repair kits, and the word “temporary” preceding and modifying each indication-for-use statement for re-liners, pads, and cushions.

Section 801.405(c) provides for labeling requirements that contain essentially the same information described under § 801.405(b)(1). The information is intended to enable a lay person to understand the limitations of using OTC denture repair kits and denture re-liners, pads, and cushions.

Section 801.420(c)(1) requires that manufacturers or distributors of hearing aids develop a user instructional brochure to be provided by the dispenser of the hearing aid to prospective users. The brochure must contain detailed information on the use and maintenance of the hearing aid.

Section 801.420(c)(4) establishes requirements that the user instructional brochure or separate labeling provide for technical data elements useful for selecting, fitting, and checking the performance of a hearing aid. In addition, § 801.420(c)(4) provides for testing requirements to determine that the required data elements must be conducted in accordance with the American National Standards Institute (ANSI) “Specification of Hearing Aid Characteristics,” ANSI S3.22-2003 (Revision of ANSI S3.22-1996), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

Section 801.421(b) establishes requirements for the hearing aid dispenser to provide prospective users with a copy of the user instructional brochure along with an opportunity to review content, either orally or by the predominant method of communication used during the sale.

Section 801.421(c) establishes requirements for the hearing aid dispenser to provide a copy of the user instructional brochure to the prospective purchaser of any hearing aid upon request, or, if the brochure is unavailable, provide the name and address of the manufacturer or distributor from which it may be obtained.

Section 801.430(d) establishes labeling requirements for menstrual tampons to provide information on signs, risk factors, and ways to reduce the risk of Toxic Shock Syndrome (TSS).

Section 801.430(e)(2) requires menstrual tampon package labels to provide information on the ranges of absorbency and absorbency term based on testing required under § 801.430(f) and an explanation of selecting absorbencies that reduce the risk of contracting TSS.

Section 801.435(b), (c), and (h) establishes requirements for condom labeling to bear an expiration date that is supported by testing that demonstrates the integrity of three random lots of the product.

Section 809.10(a) and (b) establishes requirements that a label for an in vitro diagnostic (IVD) device and the accompanying labeling (package insert) must contain information identifying its intended use, instructions for use, lot or control number, and source.

Section 809.10(d) provides that the labeling requirements for general purpose laboratory reagents may be exempt from the requirements of § 809.10(a) and (b) if the labeling contains information to include, identifying its intended use, instructions for use, lot or control number, and source.

Section 809.10(e) provides that the labeling for analyte specific reagents (ASRs) shall provide information to include, identifying the quantity, proportion, or concentration of each reagent ingredient, instructions for use, lot or control number, and source.

Section 809.10(f) provides that the labeling for OTC test sample collection systems for drugs of abuse shall include, among other things, information on the intended use, specimen collection instructions, identification system, and information about use of the test results.

Section 809.30(d) requires that advertising and promotional materials for ASRs include the identity and purity of the ASR and the identity of the analyte.

Section 1040.20(d) (21 CFR 1040.20) provides that manufacturers of sunlamp products and ultraviolet lamps are subject to the labeling regulations under part 801.

The burden estimates are based on FDA's current registration and listing data and shipment information.

In the Federal Register of February 22, 2018 (83 FR 7728), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment regarding environmental concerns. We believe this issue is beyond the scope of this information request.

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

The number of recordkeepers/respondents and records/disclosures has been adjusted to reflect updated Agency data. These adjustments result in an increase of 1,598,48 hours since the last OMB approval.

Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner.

The Cardiovascular and Renal Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.

The committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cardiovascular and renal disorders and makes appropriate recommendations to the Commissioner.

The committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the committee may include one non-voting member who is identified with industry interests.

Further information regarding the most recent charter and other information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/;Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm094743.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner.

The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.

The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders, and makes appropriate recommendations to the Commissioner.

The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.

Further information regarding the most recent charter and other information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm100261.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

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

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

This notice announces the FDA information collection request from OMB for a generic clearance that will allow FDA to use quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test consumers' reactions to FDA communications or educational messaging about FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed. To ensure that communications activities and educational campaigns have the highest potential to be received, understood, and accepted by those for whom they are intended, it is important to assess communications while they are under development. Understanding consumers' attitudes, motivations, and behaviors in response to potential communications and education messaging plays an important role in improving FDA's communications.

If the following conditions are not met, FDA will submit an information collection request to OMB for approval through the normal PRA process:

• The collections are voluntary;

• The collections are low burden for participants (based on considerations of total burden hours, total number of participants, or burden hours per participant) and are low cost for both the participants and the Federal Government;

• The collections are noncontroversial;

• Personally identifiable information (PII) is collected only to the extent necessary 1 and is not retained;

In April 1996, the “FDA Export Reform and Enhancement Act of 1996” (Pub. L. 104-134, amended by Pub. L. 104-180) amended sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381 and 382). As a result of the 1996 amendments, section 801(e)(4) of the FD&C Act provides that persons exporting a drug, animal drug, or device may request FDA to certify that the product meets the requirements of section 801(e)(1), section 802, or other applicable requirements of the FD&C Act. Upon a showing that the product meets the applicable requirements, the law provides that FDA shall issue export certification within 20 days of the receipt of a request for such certification. The law also authorizes us to charge up to $175 for each certification issued within the 20-day period.

In January 2011, section 801(e)(4) of the FD&C Act was further amended by FSMA (Pub. L. 111-353) to authorize FDA to issue, and charge fees for, export certificates for food. Under section 801(e)(4)(C) of the FD&C Act, an export certification can be made in such form (including a publicly available listing) as FDA determines appropriate.

This notice focuses on the fees to be assessed with respect to export certificates issued by the Center for Food Safety and Applied Nutrition (CFSAN) for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. This notice applies to foods such as produce, grains, processed foods, food additives, color additives, food contact substances, generally regarded as safe ingredients, infant formula, and all other foods not specifically excluded. Dietary supplements, medical foods, and foods for special dietary use are excluded from this notice.

CFSAN estimates the annual costs of the export certification program for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use, to be approximately $975,000 per year for preparing and issuing export certificates. The costs are due to payroll and operating expenses. Specifically, there are four cost categories for preparing and issuing export certificates in general: (1) Direct personnel for research, review, tracking, writing, and assembly; (2) an information technology system used for tracking and processing certificates; (3) billing and collection of fees; and (4) overhead and administrative support. In fiscal year (FY) 2017 CFSAN issued approximately 4,072 export certificates for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. Because CFSAN has not been charging fees for issuing these export certificates, the program has been covered by appropriated funds.

As mentioned previously, FDA may charge up to $175 for each certificate. Certificates for some of the foods that are the subject of this notice cost us more than $175 to prepare. Subsequent certificates issued for the same product(s) in response to the same request generally cost FDA less than $175 to prepare. The fee for all subsequent certificates for the same product(s) issued in response to the same request reflects reduced FDA costs for preparing those certificates.

The following fees will be assessed starting October 1, 2018, for export certificates for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use:

The fee for issuing the first export certificate for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use, will be at the maximum allowable amount and consistent with the export certification fees assessed since FY 1997 by other FDA Centers that provide export certification for drugs and devices. It is also consistent with the export certification fees assessed by the Center for Veterinary Medicine (CVM) for certificates for animal food, which CVM began assessing in FY 2016 because the FSMA amendments to section 801(e)(4) of the FD&C Act also apply to animal food. The fees for issuing subsequent certificates continue to differ among the Centers, based on varying costs.

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Title of the Collections: Federal Financial Report (SF-425) and Federal Financial Report Attachment (SF-425A).

Type of Collection: Extension.

OMB No.: 4040-0014.

Abstract: Federal Financial Report (SF-425) and Federal Financial Report Attachment (SF-425A) are OMB-approved collections (4040-0014). These information collections are used by grant awardees. The ICs expire on January 31, 2019. We are requesting a three-year clearance of these collections.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); April 30, 2010 (75 FR 22809); and on January 23, 2017 (82 FR 7920).

The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100-71. The “Mandatory Guidelines for Federal Workplace Drug Testing Programs,” as amended in the revisions listed above, requires strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on urine specimens for federal agencies.

To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections.

Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that it has met minimum standards.

In accordance with the Mandatory Guidelines dated January 23, 2017 (82 FR 7920), the following HHS-certified laboratories and IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens:

* The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS' NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do.

Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (Federal Register, July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the Federal Register on January 23, 2017 (82 FR 7920). After receiving DOT certification, the laboratory will be included in the monthly list of HHS-certified laboratories and participate in the NLCP certification maintenance program.