Federal Register Vol. 83, No.32,

Title: 2018 Census of Aquaculture.

OMB Control Number: 0535-0237.

Type of Request: Statement to Seek Reinstatement of an Information Collection.

Abstract: The population for the 2018 Census of Aquaculture will include all operations in each State that produced and sold or had the potential to sell $1,000 or more of aquaculture or aquaculture products during 2018. The aquaculture census will provide data on the number of farms, acreage, method of production, production and sales by aquaculture species, and sales outlets. Census data are used by the farmers, their representatives, the government, and many other groups of people concerned with the aquaculture industry. The census will provide a comprehensive inventory of aquaculture farms and their production. Results from the census will be used to evaluate new programs, disburse Federal funds, analyze market trends, and help determine the economic impact aquaculture has on the economy. The aquaculture census will provide the only source of dependable, comparable data by State.

Authority: The census of agriculture and subsequent follow-on censuses are required by law under the “Census of Agriculture Act of 1997,” Public Law 105-113, 7 U.S.C. 2204(g). Individually identifiable data collected under this authority are governed by Section 1770 of the Food Security Act of 1985 as amended, 7 U.S.C. 2276, which requires USDA to afford strict confidentiality to non-aggregated data provided by respondents. This Notice is submitted in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3501, et seq.) and Office of Management and Budget regulations at 5 CFR part 1320.

NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),” Federal Register, Vol. 72, No. 115, June 15, 2007, p. 33362. The law guarantees farm operators that their individual information will be kept confidential. NASS uses the information only for statistical purposes and publishes only tabulated total data.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 30 minutes per positive response, 2 minutes per screen-out, and 2 minutes per refusal. The sample will equal the number of respondents who reported positive aquaculture data in the 2017 Census of Agriculture.

Respondents: Farmers and Farm Managers.

Estimated Number of Respondents: 6,000.

Estimated Total Annual Burden on Respondents: 3,000 hours.

Comments: 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 will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) 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 those who are to respond, including through the use of appropriate automated, electronic, mechanical, technological or other forms of information technology collection methods.

All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.

Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-800-210-9006 and conference call ID: 4124362. Please be advised that before placing them into the conference call, the conference call operator may 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 telephone number herein.

Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call number: 1-800-210-9006 and conference call ID: 4124362.

Members of the public are invited to 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, 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=240; 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 Eastern Regional Office at the above phone number, email or street address.

Agenda: Monday, March 19, 2018 at 10:00 a.m.

Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-888-695-0608 and conference call 9211407. 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 1-800-877-8339 and providing the operator with the toll-free conference call-in number: 1-888-695-0608 and conference call 9211407.

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 Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1040, or emailed to Evelyn Bohor at [email protected]. Persons who desire additional information may contact the Rocky Mountain Regional Office at (303) 866-1040.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://www.facadatabase.gov/committee/meetings.aspx?cid=238; click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Rocky Mountain 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 Rocky Mountain Regional Office at the above phone numbers, email or street address.

Agenda: Friday, March 2, 2018, 5:00 (MST).

Persons with accessibility needs should contact the Eastern Regional Office no later than 10 working days before the scheduled meeting by sending an email to the following email address at [email protected].

Members of the public are entitled to submit written comments. The comments must be received in the regional office by April 13, 2018. Comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425 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=241; 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 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 numbers, email or street address.

Agenda: Tuesday, March 13, 2018

Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-888-778-9069 and conference call ID: 6970676. Please be advised that before placing them into the conference call, the conference call operator may 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 telephone number herein.

Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-888-364-3109 and providing the operator with the toll-free conference call number: 1-888-778-9069 and conference call ID: 6970676.

Members of the public are invited to 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, 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=240; 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 Eastern Regional Office at the above phone number, email or street address.

Agenda: Friday, March 16, 2018 at 11:30 a.m. (EDT).

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

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

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

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

The Council was first chartered on November 10, 2009, to advise the Secretary of Commerce on matters related to innovation and entrepreneurship in the United States. NACIE's overarching focus is recommending transformational policies to the Secretary that will help U.S. communities, businesses, and the workforce become more globally competitive. The Council operates as an independent entity within the Office of Innovation and Entrepreneurship (OIE), which is housed within the U.S. Commerce Department's Economic Development Administration. NACIE members are a diverse and dynamic group of successful entrepreneurs, innovators, and investors, as well as leaders from nonprofit organizations and academia.

The purpose of this meeting is to discuss and consider an innovation and entrepreneurship policy framework and related principles. The final agenda will be posted on the NACIE website at http://www.eda.gov/oie/nacie/ prior to the meeting. Any member of the public may submit pertinent questions and comments concerning the Council's affairs at any time before or after the meeting. Comments may be submitted to the Office of Innovation and Entrepreneurship at the contact information below. Copies of the meeting minutes will be available by request within 90 days of the meeting date.

Background

On September 1, 2016, Commerce published in the Federal Register a notice of opportunity to request an administrative review of the antidumping duty order on certain magnesia carbon bricks from Mexico for the POR.1 Commerce received a timely request from the Magnesia Carbon Bricks Fair Trade Committee (the petitioner), in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b), to conduct an administrative review of this antidumping duty order.2

On November 13, 2017, Commerce published in the Federal Register a notice of initiation with respect to RHI-Refmex SA de C.V. and Vesuvius Mexico S.A. de C.V.3 On January 29, 2018, the petitioner timely withdrew its request for an administrative review for both companies.4

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation of the requested review. The petitioner withdrew its request for review by the 90-day deadline, and no other party requested an administrative review of this order. Therefore, we are rescinding the administrative review of the antidumping duty order on certain magnesia carbon bricks from Mexico covering the period September 1, 2016, through August 31, 2017.

Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. Because Commerce is rescinding this administrative review in its entirety, the entries to which this administrative review pertained shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions directly to CBP 41 days after the date of publication of this notice in the Federal Register.

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

This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

This notice is published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(d)(4).

The “Survey of International Air Travelers” (Survey) program, administered by the National Travel and Tourism Office (NTTO) of the International Trade Administration provides source data required to (1) estimate international travel and passenger fare exports, imports and the trade balance for the United States, (2) comply with the U.S. Travel Promotion Act of 2009 (Pub. L. 111-145), collect a one percent sample of inbound travelers, analyze and report information to government and industry stakeholders, and support the increase of U.S. exports, (3) to comply with the 1961, 1981, and 1996 travel and tourism related acts to collect and publish comprehensive international travel and tourism, statistics and other marketing information, and (4) support the continuation of the Travel & Tourism Satellite Accounts for the United States, which provide the only spending and employment figures for the industry, and (5) to support the goals of objectives of the National Travel & Tourism Strategy.

The Survey program contains the core data that is collected, analyzed and communicated by NTTO with other government agencies, associations and businesses that share the same objective of increasing U.S. international travel exports. The Survey assists NTTO in assessing the economic impact of international travel on state and local economies, providing visitation estimates, key market intelligence, and identifying traveler and trip characteristics. The U.S. Department of Commerce assists travel industry enterprises to increase international travel and passenger fare exports for the country as well as outbound travel on U.S. carriers. The Survey program provides the only available estimates of nonresident visitation to the states and cities within the United States, as well as U.S. resident travel abroad.

A revised survey instrument (questionnaire) (English version plus its translations into eleven foreign languages) was implemented in 2012. It reflects input from over 70 respondents, including: Travel Industry (airlines, travel associations, destinations, lodging); Consultants; Financial Firms; Educational Institutions; and other U.S. Government Agencies. A minor (`non-substantive') change was implemented in 2016 to better reflect the visitor's entry experience into the U.S. This was requested by the U.S. Department of Commerce Travel and Tourism Advisory Board to measure compliance with U.S. National Goals.

The revised Survey questionnaire reflects changes in various questions relating to: Trip purpose; Payment methods; Booking/Information sources; additional package components, health care/vaccinations, travel insurance information, additional transportation utilized, Assessment of the visitor's entry and overall experience; and intentions for further travel to the United States; Ethnicity/race. Several questions from the pre-existing 1996 questionnaire were eliminated to further streamline the survey.

The survey instrument/questionnaire (`Survey of International Air Travelers', a/k/a SIAT) continues to be in paper format and is self-administered by the passenger who volunteers to take the survey, either while in the departure gate area or on-board the flight. The flights are selected randomly and this approach is described as `cluster sampling.' The majority (90%) of the passenger surveys are collected in U.S. airport departure gate areas. About 10% of all the passenger surveys are collected during flight (on-board) post departure (Canada is not part of the program). U.S. and foreign flag airlines that volunteer to participate in the Survey program enable the collection either in U.S. departure gate areas or on-board flights.

NTTO is planning to change the format to electronic or to an equally statistically valid process once compelling results have been attained. To date there have been four `e-Survey' tests: The first test in partnership with Global Distribution Systems (GDS), the second and third tests with major airlines in their respective boarding areas to leverage passenger's personal electronic devices (PED) and Wi-Fi capabilities in the airports and on-board certain flights, and the fourth test used `tablet' devices to capture passenger responses in the airport gate areas. Other tests are planned in the foreseeable future based on the results of NTTO's recent request for information as preparation for the next contract cycle.

OMB Control Number: 0625-0227.

Form Number(s): None.

Type of Review: Regular submission [extension of a current information collection].

Affected Public: Individuals or households.

Estimated Number of Respondents: 300,000 due to mandate of the Travel Promotion Act of 2009 which requires a `one percent' sample of overseas arrivals.

Estimated Time per Response: 15 minutes.

Estimated Total Annual Burden Hours: 75,000.

Estimated Total Annual Cost to Public: $0.

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

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

On November 7, 2017, Commerce published the Preliminary Results.1 In the Preliminary Results, we determined that Ambica and Bhansali had no shipments of subject merchandise during the POR. Commerce gave interested parties an opportunity to comment on the Preliminary Results. We received no comments. Commerce conducted this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). Commerce has exercised its discretion to toll deadlines for the duration of the closure of the Federal Government from January 20 through 22, 2018. If the new deadline falls on a non-business day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the final results of this review is now March 12, 2018.2

The merchandise subject to the order is SSB. SSB means articles of stainless steel in straight lengths that have been either hot-rolled, forged, turned, cold-drawn, cold-rolled or otherwise cold-finished, or ground, having a uniform solid cross section along their whole length in the shape of circles, segments of circles, ovals, rectangles (including squares), triangles, hexagons, octagons, or other convex polygons. SSB includes cold-finished SSBs that are turned or ground in straight lengths, whether produced from hot-rolled bar or from straightened and cut rod or wire, and reinforcing bars that have indentations, ribs, grooves, or other deformations produced during the rolling process.

Except as specified above, the term does not include stainless steel semi-finished products, cut-to-length flat-rolled products (i.e., cut-to-length rolled products which if less than 4.75 mm in thickness have a width measuring at least 10 times the thickness, or if 4.75 mm or more in thickness having a width which exceeds 150 mm and measures at least twice the thickness), wire (i.e., cold-formed products in coils, of any uniform solid cross section along their whole length, which do not conform to the definition of flat-rolled products), and angles, shapes, and sections.

Imports of these products are currently classifiable under subheadings 7222.10.00, 7222.11.00, 7222.19.00, 7222.20.00, 7222.30.00 of the Harmonized Tariff Schedule (HTS). Although the HTS subheadings are provided for convenience and customs purposes, our written description of the scope of the order is dispositive.

As noted in the Preliminary Results, Commerce received a claim of no shipments from Ambica and Bhansali. In the Preliminary Results, Commerce preliminarily found that Ambica and Bhansali did not have reviewable entries during the POR.

After issuing the Preliminary Results, Commerce received no comments from interested parties, and has not received any information that would cause it to alter its preliminary determination. Therefore, for these final results, Commerce continues to find that both Ambica and Bhansali had no shipments during the POR.

In accordance with Commerce's practice, for entries of subject merchandise during the POR for which Ambica or Bhansali did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate such entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. Commerce intends to issue assessment instructions to CBP 15 days after the date of publication of these final results of review.

The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Ambica and Bhansali will remain unchanged from the rate assigned to each company in the completed segment for the most recent period for each company; (2) for other producers and exporters covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the completed segment for the most recent period of this proceeding in which that producer or exporter participated; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the producer is, then the cash deposit rate will be the rate established for the completed segment for the most recent period of this proceeding for the producer of subject merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 12.45 percent, the all-others rate established in the investigation.3 These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

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

We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).

The Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801 et seq., as amended by the Sustainable Fisheries Act, Public Law 104-297, provided for the establishment of an AP to assist in the collection and evaluation of information relevant to the development of any FMP or FMP amendment for Atlantic HMS. NMFS consults with and considers the comments and views of AP members when preparing and implementing FMPs or FMP amendments for Atlantic tunas, swordfish, billfish, and sharks.

The AP has previously consulted with NMFS on: Amendment 1 to the Billfish FMP (April 1999); the HMS FMP (April 1999); Amendment 1 to the HMS FMP (December 2003); the Consolidated HMS FMP (October 2006); and Amendments 1, 2, 3, 4, 5a, 5b, 6, 7, 8, 9, and 10 to the 2006 Consolidated HMS FMP (April and October 2008, February and September 2009, May and September 2010, April and September 2011, March and September 2012, January and September 2013, April and September 2014, March and September 2015, and March, September, and December 2016, and May and September 2017), among other things.

The intent of this meeting is to consider alternatives for the conservation and management of all Atlantic tunas, swordfish, billfish, and shark fisheries. We anticipate discussing:

• Domestic implementation of recommendations from the 2017 meeting of the International Commission for the Conservation of Atlantic Tunas to include an emergency rule for shortfin mako sharks, Draft Amendment 11 on shortfin mako sharks, bluefin tuna and northern albacore tuna quotas, and issues for 2018;

• Three-year review of Amendment 7 on bluefin tuna management;

• Progress updates on various other rulemakings, including shark fishery closure criteria, evaluation of existing bluefin tuna management-related gear restricted areas, and evaluation of existing fishing gear modification;

• Recreational fishery issues;

• Closed area data collection and an update regarding the exempted fishing permit request to conduct research in pelagic longline closed areas; and

• Updates on shark stock assessments.

We also anticipate inviting other NMFS offices to provide updates, if available, on their activities relevant to HMS fisheries such as listings under the Endangered Species Act and Pelagic Longline Take Reduction Team rulemaking. Finally, we intend to invite other NMFS offices and the United States Coast Guard to provide updates on their activities relevant to HMS fisheries.

Additional information on the meeting and a copy of the draft agenda will be posted prior to the meeting at: https://www.fisheries.noaa.gov/event/march-2018-hms-advisory-panel-meeting.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Peter Cooper at (301) 427-8503 at least 7 days prior to the meeting.

An electronic copy of the IHA and supporting documents, as well as a list of the references cited in this document, may be obtained online at: www.nmfs.noaa.gov/pr/permits/incidental/research.htm. In case of problems accessing these documents, please call the contact listed above (see FOR FURTHER INFORMATION CONTACT).

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed IHA is provided to the public for review.

An IHA for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

On August 31 2017, NMFS received a request from the NPS for an IHA to take marine mammals incidental to glaucous-winged gull and climate monitoring research activities in GLBA NP, Alaska. The application was considered adequate and complete on November 1, 2017. NPS's request is for take of harbor seals by Level B harassment. NMFS previously issued four IHAs to the NPS for similar work (82 FR 24681, May 20, 2017; 81 FR 34994, June 1, 2016; 80 FR 28229, March 24, 2015; 79 FR 56065, September 18, 2014). Neither NPS nor NMFS expect mortality to result from the research and, therefore, an IHA is appropriate.

A detailed description of the planned GLBA NP project is provided in the Federal Register notice for the proposed IHA (82 FR 56953; December 1, 2017). Since that time, no changes have been made to the planned activities. Therefore, we provide only a summary here. Please refer to that Federal Register notice for the full description of the specific activity.

NPS plans to conduct two research projects within GLBA NP, southeast Alaska: (1) Glaucous-winged gull monitoring and (2) the installation and maintenance of a weather station operation for long-term climate monitoring. NPS will conduct ground and vessel surveys at four study sites within GLBA NP for gull monitoring: Boulder Island, Lone Island, Geikie Rock, and Flapjack Island. These sites will be accessed up to five times per year. In addition, NPS will access Lone Island an additional four times per year for weather station installation, maintenance, and operation bringing the total number of site visits to Lone Island to nine. This includes adding one additional trip for any emergency repairs that may be needed. Researchers accessing the islands for gull monitoring and weather station operation may occasionally cause behavioral disturbance (or Level B harassment) of harbor seals. NPS expects that the disturbance to harbor seals from both projects will be minimal and only limited to Level B harassment.

The purposes for the above-mentioned research activities are as follows. Gull monitoring studies are mandated by a Record of Decision of a Legislative Environmental Impact Statement (LEIS) (NPS 2010) which states that NPS must initiate a monitoring program for glaucous-winged gulls (Larus glaucescens) to inform future native egg harvest by the Hoonah Tlingit in Glacier Bay, Alaska. Installation of a new weather station on Lone Island is being planned as one of several installations intended to fill coverage gaps among existing weather stations in GLBA NP (NPS 2015a). These new stations will be operated as the foundation of a new long-term climate-monitoring program for GLBA NP.

A notice of NMFS's proposal to issue an IHA to the NPS was published in the Federal Register on December 1, 2017 (82 FR 56953). That notice described, in detail, GLBA NP's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. During the 30-day public comment period, NMFS received one comment letter from the Marine Mammal Commission (Commission).

Comment 1: The Commission recommended that NMFS enumerate the number of harbor seals that could be taken during the planned activities by applying standard rounding rules before summing the numbers of estimated takes across survey sites and survey days.

Response: Calculating predicted take is not an exact science and there are arguments for taking different mathematical approaches in different situations, and for making qualitative adjustments in other situations. NMFS is currently engaged in developing a protocol to guide more consistent take calculation given certain circumstances. We believe, however, that the methodology for this action remains appropriate.

A detailed description of the species likely to be affected by the NPS project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, are provided in NPS's application and the Federal Register notice for the proposed IHA (82 FR 56953; December 1, 2017). We are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please refer to additional species information available in the NMFS SARs for Alaska at http://www.nmfs.noaa.gov/pr/sars/region.htm.

Both species in Table 1 are protected under the MMPA and the Steller sea lion is listed as endangered (Western Distinct Population Segment) under the Endangered Species Act (ESA). It was determined that take will not occur for Steller sea lions based on available survey data and for the fact that NPS will maintain a distance of 100 meters from all Steller sea lions in the action area. Therefore, Steller sea lions are not discussed further in this IHA.

The Federal Register notice for the proposed IHA (82 FR 56953; December 1, 2017) included a discussion of the effects of disturbance on marine mammals and their habitat, therefore that information is not repeated here; please refer to the Federal Register notice (82 FR 56953; December 1, 2017) for that information. We provide only a summary here.

The project will not result in permanent impacts to habitats used directly by marine mammals, such as haul out sites, nor impacts to food sources. Based on the available data, previous monitoring reports from GLBA NP, and studies described in the proposed IHA, we anticipate that any pinnipeds found in the vicinity of the project could have short-term behavioral reactions (i.e., may result in marine mammals avoiding certain areas) due to noise and visual disturbance generated by: (1) Motorboat approaches and departures and (2) human presence during gull research activities. We expect pinnipeds to return to a haul out site within minutes to hours of the stimulus based on previous research (Johnson and Acevedo-Gutierrez, 2007; Allen et al., 1985). Pinnipeds may be temporarily displaced from their haul out sites, but we do not expect that the pinnipeds will permanently abandon a haul out site during site monitoring as activities are short in duration (30 minutes to up to 2 hours), and previous surveys have demonstrated that seals have returned to their haul out sites and have not permanently abandoned the sites.

This section provides the amount of take authorized in the IHA, which informs both NMFS's consideration of whether the number of takes is “small” and the negligible impact determination.

Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

Authorized takes will be by Level B harassment only, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to motorboats and the presence of NPS personnel. Based on the nature of the activity, Level A harassment is neither anticipated nor authorized. As described previously, no mortality is anticipated or authorized for this activity. Below we describe how the take is estimated.

Harbor seals may be disturbed when vessels approach or researchers go ashore for the purpose of monitoring gull colonies and for the installation and maintenance of the Lone Island weather tower. Harbor seals tend to haul out in small numbers at study sites. Using monitoring report data from 2015 to 2017 (see raw data from Tables 1 of the 2017, 2016 and 2015 Monitoring Reports), the average number of harbor seals per survey visit was calculated to estimate the approximate number of seals observers will find on any given survey day. As a result, the following averages were determined for each island: Boulder Island—average 3.45 seals, Flapjack Island—average 10.10 seals, Geikie Rock—average 9.58 seals, and Lone Island average of 18.63 seals (See Table 5). Estimated take for gull and climate monitoring was calculated by multiplying the average number of seals observed during past gull monitoring surveys (2015-2017) by the number of total site visits. This includes five visits to Boulder Island, Flapjack Island, and Geikie Rock and nine visits to Lone Island (to include four site visits for climate monitoring activities). Therefore, the total incidents of harassment equals 283 (See Table 5).

During climate monitoring, which is expected to take place between March 2018 to April 2018, and October 2018 to February 2019, seal numbers are expected to dramatically decline within the action area. Although harbor seal survey data within GLBA NP is lacking during the months of October through February, results from satellite telemetry studies suggest that harbor seals travel extensively beyond the boundaries of GLBA NP during the post-breeding season (September-April) (Womble and Gende, 2013b). Therefore, using observation data from past gull monitoring activities (that occurred from May to September) is applicable when estimating take for climate monitoring activities, as it will provide the most conservative estimates.

In order to issue an IHA under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, “and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking” for certain subsistence uses. NMFS regulations require applicants for IHAs to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).

In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:

(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat, as well as subsistence uses. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned) and;

(2) the practicability of the measures for applicant implementation, which may consider such things as cost and impact on operations.

To reduce the potential for disturbance from acoustic and visual stimuli associated with gull and climate monitoring activities within GBLA NP, several mitigation measures for marine mammals were selected for the NPS to conduct. The following is a summation of those mitigation measures presented in the final IHA:

Prior to deciding to land onshore to conduct gull and climate monitoring, NPS researchers will use high-powered image stabilizing binoculars from their watercraft to document the number, species, and location of hauled-out marine mammals at each island. The vessels will maintain a distance of 328 to 1,640 ft (100 to 500 m) from the shoreline to allow the researchers to conduct pre-survey monitoring. If offshore predators, harbor seal pups of less than one week of age, or Steller sea lions are observed, researchers will follow the protocols for site avoidance discussed below. If neither of these instances occur, researchers will then perform a controlled landing on the survey site.

If a harbor seal pup less than one week old is observed near or within the action area, researchers will not go ashore to conduct the gull or climate monitoring activities. Also, if Steller sea lions are observed within or near the study site, researchers will maintain a distance of at least 100 m from the animals at all times.

The researchers will determine whether to approach the island based on type of animals present. Researchers will approach the island by motorboat at a speed of approximately 2 to 3 knots (2.3 to 3.4 mph). This will provide enough time for any marine mammals present to slowly enter the water without panic (flushing). The researchers will also select a pathway of approach farthest from the hauled-out harbor seals to minimize disturbance.

If the researchers visually observe marine predators (i.e., killer whales) present in the vicinity of hauled-out marine mammals, the researchers will not approach the study site.

While onshore at study sites, the researchers will remain vigilant for hauled-out marine mammals. If marine mammals are present, the researchers will move slowly and use quiet voices to minimize disturbance to the animals present.

Based on our evaluation of the applicant's measures, as well as other measures considered by NMFS, NMFS has determined that the mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, areas of similar significance, and on the availability of such species or stock for subsistence uses.

In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth, requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.

GLBANP submitted a marine mammal monitoring plan in section 13 of their application. Monitoring requirement NMFS prescribes shall improve our understanding of one or more of the following:

• Occurrence of marine mammal species or stocks in the area in which take is anticipated (e.g., presence, abundance, distribution, density);

• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (e.g., source characterization, propagation, ambient noise); (2) affected species (e.g., life history, dive patterns); (3) co-occurrence of marine mammal species with the action; or (4) biological or behavioral context of exposure (e.g., age, calving or feeding areas);

• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;

• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;

• Effects on marine mammal habitat (e.g., marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat); and

• Mitigation and monitoring effectiveness.

NPS will conduct marine mammal monitoring during the project, in order to implement the mitigation measures that require real-time monitoring and to gain a better understanding of marine mammals and their impacts to the project's activities. The researchers will monitor the area for pinnipeds during all research activities. Monitoring activities will consist of conducting and recording observations of pinnipeds within the vicinity of the proposed research areas. The monitoring notes will provide dates, location, species, the researcher's activity, behavioral state, numbers of animals that were alert or moved greater than one meter, and numbers of pinnipeds that flushed into the water.

The method for recording disturbances is based on those developed by Mortenson (1996). NPS will record disturbances on a three-point scale that represents an increasing seal response to the disturbance (Table 3). NPS will record the time, source, and duration of the disturbance, as well as an estimated distance between the source and haul out. NMFS considers only responses falling into Levels 2 and 3 as harassment under the MMPA.

As described in the notice of proposed IHA, NPS has complied with the monitoring requirements under the previous authorizations. NMFS posted the 2017 report on our website at www.nmfs.noaa.gov/pr/permits/incidental/research.htm and the results from the previous NPS monitoring reports. These reports support our findings that the mitigation measures required under the 2014-2017 IHAs provide the means of effecting the least practicable impact on the species or stock.

NPS will add to the knowledge of pinnipeds in the proposed action area by noting observations of: (1) Unusual behaviors, numbers, or distributions of pinnipeds, such that any potential follow-up research can be conducted by the appropriate personnel; (2) tag-bearing carcasses of pinnipeds, allowing transmittal of the information to appropriate agencies and personnel; and (3) rare or unusual species of marine mammals for agency follow-up. NPS actively monitors harbor seals at breeding and molting haul out locations to assess trends over time (e.g., Mathews & Pendleton, 2006; Womble et al. 2010, Womble and Gende, 2013b). This monitoring program involves collaborations with biologists from the Alaska Department of Fish and Game, and NMFS' Alaska Fisheries Science Center. NPS will continue these collaborations and encourage continued or renewed monitoring of marine mammal species. NPS will coordinate with state and Federal marine mammal biologists to determine what additional data or observations may be useful for monitoring marine mammals and haul outs in GLBA NP. Additionally, NPS will report vessel-based counts of marine mammals, branded, or injured animals, and all observed disturbances to the appropriate state and Federal agencies.

NPS is required to submit a draft monitoring report to NMFS no later than 90 days after the expiration of the Incidental Harassment Authorization or sixty days prior to the issuance of any subsequent IHA for this project, whichever comes first. The report will include a summary of the information gathered pursuant to the monitoring requirements set forth in the Authorization. NPS will submit a final report to NMFS within 30 days after receiving comments on the draft report. If NPS receives no comments from NMFS on the report, NMFS will consider the draft report to be the final report.

The report will describe the operations conducted and sightings of marine mammals near the proposed project. The report will provide full documentation of methods, results, and interpretation pertaining to all monitoring. The report will provide:

1. A summary and table of the dates, times, and weather during all research activities;

2. Species, number, location, and behavior of any marine mammals observed throughout all monitoring activities;

3. An estimate of the number (by species) of marine mammals exposed to acoustic or visual stimuli associated with the research activities; and

4. A description of the implementation and effectiveness of the monitoring and mitigation measures of the Authorization and full documentation of methods, results, and interpretation pertaining to all monitoring.

In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by the authorization, such as an injury (Level A harassment), serious injury, or mortality (e.g., vessel-strike, stampede, etc.), NPS shall immediately cease the specified activities and immediately report the incident to the Office of Protected Resources, NMFS and the Alaska Regional Stranding Coordinator. The report must include the following information:

• Time, date, and location (latitude/longitude) of the incident;

• Description and location of the incident (including tide level if applicable);

• Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

• Description of all marine mammal observations in the 24 hours preceding the incident;

• Species identification or description of the animal(s) involved;

• Fate of the animal(s); and

• Photographs or video footage of the animal(s) (if equipment is available).

NPS shall not resume its activities until NMFS is able to review the circumstances of the prohibited take. NMFS will work with NPS to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. NPS may not resume their activities until notified by us via letter, email, or telephone.

In the event that NPS discovers an injured or dead marine mammal, and the lead researcher determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition as we describe in the next paragraph), NPS will immediately report the incident to the Office of Protected Resources, NMFS and the Alaska Regional Stranding Coordinator. The report must include the same information identified in the paragraph above this section. Activities may continue while we review the circumstances of the incident. We will work with NPS to determine whether modifications in the activities are appropriate.

In the event that NPS discovers an injured or dead marine mammal, and the lead visual observer determines that the injury or death is not associated with or related to the authorized activities (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), NPS will report the incident to the incident to the Office of Protected Resources, NMFS and the Alaska Regional Stranding Coordinator within 24 hours of the discovery. NPS researchers will provide photographs or video footage (if available) or other documentation of the stranded animal sighting to us. NPS can continue their research activities.

NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers other factors, such as the likely nature of any responses (e.g., intensity, duration), the context of any responses (e.g., critical reproductive time or location, migration), as well as effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS's implementing regulations (54 FR 40338; September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the environmental baseline (e.g., as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels).

Due to the project's minimal levels of visual and acoustic disturbance, NMFS does not expect NPS's specified activities to cause long-term behavioral disturbance, abandonment of the haul out area, injury, serious injury, or mortality. Additional factors for our negligible impact determination are listed below:

• The takes from Level B harassment will be due to potential behavioral disturbance. The effects of the research activities will be limited to short-term startle responses and localized behavioral changes due to the short and sporadic duration of the research activities;

• The proposed activities will not take place in areas of significance for marine mammal feeding, resting, breeding, or pupping and will not adversely impact marine mammal habitat;

• The proposed activities will affect a small portion of harbor seal habitat within GLBA NP for only a short amount of time. This, combined with a large availability of alternate areas for pinnipeds to haul out enables the seals to effectively avoid disturbances from research operations;

• Anecdotal observations and results from previous monitoring reports show that the pinnipeds returned to the various sites and did not permanently abandon haul out sites after NPS conducted their research activities; and

• Harbor seals may flush in the water despite researchers' best efforts to keep calm and quiet around seals; however, injury or mortality has never been documented nor is anticipated from flushing events. Researchers will approach study sites slowly to provide enough time for any marine mammals present to slowly enter the water without panic.

As stated, NMFS does not anticipate any injuries, serious injuries, or mortalities to result from NPS's proposed activities and we do not propose to authorize injury, serious injury, or mortality. Harbor seals may exhibit behavioral modifications, including temporarily vacating the area during the proposed gull and climate research activities to avoid human disturbance. Further, these proposed activities will not take place in areas of significance for marine mammal feeding, resting, breeding, or pupping and will not adversely impact marine mammal habitat. Due to the nature, degree, and context of the behavioral harassment anticipated, we do not expect the activities to impact annual rates of recruitment or survival.

NMFS does not expect pinnipeds to permanently abandon any area surveyed by researchers, as is evidenced by continued presence of pinnipeds at the sites during annual gull monitoring. In summary, NMFS anticipates that impacts to hauled-out harbor seals during NPS' research activities will be behavioral harassment of limited duration (i.e., up to two hours per visit) and limited intensity (i.e., temporary flushing at most).

Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS finds that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.

As noted above, only small numbers of incidental take may be authorized under Section 101(a)(5)(D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.

As mentioned previously, NMFS estimates that NPS' activities could potentially affect, by Level B harassment only, one species of marine mammal under our jurisdiction. For harbor seals, this estimate is small (3.93 percent, see Table 4) relative to the Glacier Bay/Icy Strait stock of harbor seals (7,210 seals, see Table 1). In addition to this, there is a high probability that repetitive takes of the same animals may occur which reduces the percentage of population even further.

Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.

There are no subsistence uses of the affected marine mammal stocks or species implicated by this action. NPS prohibits subsistence harvest of harbor seals within the GLBA NP (Catton, 1995). Therefore, NMFS has determined that the total taking of affected species or stocks will not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

Issuance of an MMPA 101(a)(5)(D) authorization requires compliance with the National Environmental Policy Act.

NMFS determined the issuance of the proposed IHA is consistent with categories of activities identified in CE B4 (issuance of incidental harassment authorizations under section 101(a)(5)(A) and (D) of the MMPA for which no serious injury or mortality is anticipated) of the Companion Manual for NAO 216-6A and we have not identified any extraordinary circumstances listed in Chapter 4 of the Companion Manual for NAO 216-6A that would preclude this categorical exclusion.

No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.

NMFS has issued an IHA to the NPS at Glacier Bay NP for the harassment of small numbers of harbor seals incidental to conducting monitoring and research studies on glaucous-winged gulls within GLBA NP, Alaska provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.

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: Survey of Postgraduate Outcomes for the Fulbright-Hays Doctoral Dissertation Research Abroad (DDRA) Program (Tracking Survey).

OMB Control Number: 1840-NEW.

Type of Review: A new information collection.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 90.

Total Estimated Number of Annual Burden Hours: 23.

Abstract: This survey will be used by the Postgraduate Outcomes for the Fulbright-Hays Doctoral Dissertation Research Abroad (DDRA) grantee institutions and fellows to provide information used by the Department in responding to DDRA GPRA performance and efficiency measures. Fellows will complete the survey online, and the Department will access and report on the collected data regarding fellows' postgraduate employment. The survey is necessary in order to respond to GPRA.

The following applicants filed AM or FM proposals to change the community of license: CENTRAL FLORIDA EDUCATIONAL FOUNDATION, INC, WMYZ, Fac. ID No. 27291, Channel 204C2, From CLERMONT, FL, To THE VILLAGES, FL, BPED-20180117ACL; CEDAR COVE BROADCASTING, INC., KAZK, Fac. ID No. 176305, Channel 209C2, From WILLCOX, AZ, To CATALINA, AZ, BPED-20180111AAA; UNITED STATES CP, LLC, KRYE, Fac. ID No. 164276, Channel 285C3, From OLNEY SPRINGS, CO, To RYE, CO, BPH-20180202AAX; ENTRAVISION HOLDINGS, LLC, KVVA-FM, Fac. ID No. 1331, Channel 296C3, From APACHE JUNCTION, AZ, To SUN LAKES, AZ, BPH-20171227AAK; and SEBAGO BROADCASTING COMPANY, WCTG, Fac. ID No. 88405, Channel 243A, From CHINCOTEAGUE, VA, To WEST POCOMOKE, MD, BPH-20170707AAP.

The full text of these applications is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street SW, Washington, DC 20554 or electronically via the Media Bureau's Consolidated Data Base System, http://licensing.fcc.gov/prod/cdbs/pubacc/prod/cdbs_pa.htm.

On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Final approval under OMB delegated authority of the extension for three years, without revision, of the following report:

Report title: Recordkeeping and Disclosure Requirements Associated with Securities Transactions Pursuant to Regulation H.

Agency form number: Reg H-3.

OMB control number: 7100-0196.

Frequency: Event-generated.

Respondents: State member banks.

Estimated number of respondents: State member banks (de novo): 1; state member banks with trust departments: 228; state member banks without trust departments: 601.

Estimated average hours per response: State member banks (de novo): Recordkeeping, 40 hours. State member banks with trust departments: Recordkeeping, 2 hours; disclosure, 16 hours. State member banks without trust departments: Recordkeeping, 15 minutes; disclosure, 5 hours.

Estimated annual burden hours: State member banks (de novo): Recordkeeping, 40 hours. State member banks with trust departments: Recordkeeping, 12,768 hours; disclosure, 43,776 hours. State member banks without trust departments: Recordkeeping, 4,207 hours; disclosure, 36,060 hours.

General description of report: These recordkeeping and disclosure requirements are pursuant to Sections 208.34(c), (d), and (g) of the Board's Regulation H, which require that state member banks effecting securities transactions for customers establish and maintain a system of records of these transactions, furnish confirmations of transactions to customers that disclose certain information, and establish written policies and procedures relating to securities trading. State member banks are required to maintain records created per these requirements for three years following a securities transaction. These requirements are necessary to protect the customer, to avoid or settle customer disputes, and to protect the institution against potential liability arising under the anti-fraud and insider trading provisions of the Securities Exchange Act of 1934 (“Securities Exchange Act”).

Legal authorization and confidentiality: The Board has determined that the Regulation H requirements are authorized by Section 23 of the Securities Exchange Act, 15 U.S.C. 78w, which empowers the Board to make rules and regulations implementing those portions of the Securities Exchange Act for which it is responsible. The requirements of 12 CFR 208.34(c), (d), and (g) also are impliedly authorized by Section 9 of the Federal Reserve Act (12 U.S.C. 321-328a), which establishes the Board's supervisory authority with respect to the safety and soundness of state member banks. Accordingly, the Board is authorized to impose these recordkeeping, disclosure, and policy establishment requirements. The obligation of a state member bank to comply with the Regulation H requirements is mandatory, save for the limited exceptions set forth in 12 CFR 208.34(a).

Inasmuch as the Board does not collect or receive any information concerning securities transactions pursuant to these requirements, no issues of confidentiality normally will arise. If, however, these records were to come into the possession of the Board, they may be protected from disclosure pursuant to exemption 4 of the Freedom of Information Act (“FOIA”), 5 U.S.C. 552(b)(4), under the standards set forth in National Parks & Conservation Ass'n v. Morton, 498 F.2d 765 (DC Cir. 1974), to the extent an institution can establish the potential for substantial competitive harm. They also may be subject to withholding under FOIA exemption 6, 5 U.S.C. 552(b)(6), should disclosure constitute an unwarranted invasion of personal privacy. Additionally, if such information were included in the work papers of System examiners or abstracted in System reports of examination, the information also may be protected under exemption 8 of FOIA, 5 U.S.C. 552(b)(8). Any withholding determination would be made on a case-by-case basis in response to a specific request for disclosure of the information.

Current actions: On November 27, 2017, the Board published a notice in the Federal Register (82 FR 56022) requesting public comment for 60 days on the extension, without revision, of the Recordkeeping and Disclosure Requirements Associated with Securities Transactions Pursuant to Regulation H (Reg H-3). The comment period for this notice expired on January 26, 2018. The Board did not receive any comments.

Agenda: The committee will discuss supplemental biologic license application (sBLA) 125557/S-013, for BLINCYTO (blinatumomab) injection for intravenous use, application submitted by Amgen, Inc. The proposed indication (use) for this product is for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia.

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

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before February 26, 2018. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11:30 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 21, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 22, 2018.

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

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

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

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

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

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

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product ADDYI (flibanserin). ADDYI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder as characterized by low sexual desire that causes a marked distress or interpersonal difficulty and is NOT due to: (1) A co-existing medical or psychiatric condition, (2) problems within the relationship, or (3) the effects of a medication or other drug substance. Subsequent to this approval, the USPTO received patent term restoration applications for ADDYI (U.S. Patent Nos. 7,151,103 and 7,420,057) from Sprout Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 23, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ADDYI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for ADDYI is 6,852 days. Of this time, 4,730 days occurred during the testing phase and 2,122 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: November 15, 1996. FDA has verified Sprout Pharmaceuticals, Inc. claims that November 15, 1996, is the date the investigational new drug application became effective.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: October 27, 2009. FDA has verified the applicant's claims that the new drug application (NDA) for ADDYI (NDA 22-526) was initially submitted on October 27, 2009.

3. The date the application was approved: August 18, 2015. FDA has verified the applicant's claims that NDA 22-526 was approved on August 18, 2015.

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

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product BRIDION (sugammadex sodium). BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. Subsequent to this approval, the USPTO received a patent term restoration application for BRIDION (U.S. Patent No. RE44733) from Merck Sharp & Dohme, B.V., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 23, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BRIDION represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for BRIDION is 4,265 days. Of this time, 1,297 days occurred during the testing phase of the regulatory review period, while 2,968 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: April 13, 2004. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on April 13, 2004.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: October 31, 2007. FDA has verified the applicant's claim that the new drug application (NDA) for BRIDION (NDA 022225) was initially submitted on October 31, 2007.

3. The date the application was approved: December 15, 2015. FDA has verified the applicant's claim that NDA 022225 was approved on December 15, 2015.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,826 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product FETZIMA (levomilnacipran hydrochloride). FETZIMA is indicated for treatment of Major Depressive Disorder. Subsequent to this approval, the USPTO received a patent term restoration application for FETZIMA (U.S. Patent No. RE43879) from Pierre Fabre Medicament, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated November 3, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of FETZIMA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for FETZIMA is 1,602 days. Of this time, 1,298 days occurred during the testing phase of the regulatory review period, while 304 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: March 8, 2009. FDA has verified the Pierre Fabre Medicament claim that March 8, 2009, is the date the investigational new drug application (IND) became effective.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: September 25, 2012. The applicant claims September 24, 2012, as the date the NDA for FETZIMA was initially submitted. However, FDA records indicate that new drug application (NDA) 204168 was submitted on September 25, 2012.

3. The date the application was approved: July 25, 2013. FDA has verified the applicant's claim that NDA 204168 was approved on July 25, 2013.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 954 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product ZYDELIG (idelalisib). As approved in both NDA 206545 and NDA 205858, ZYDELIG is indicated for treatment of patients with:

• Relapsed chronic lymphocytic leukemia in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

• Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies.

• Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies.

Accelerated approval was granted for FL and SLL based on overall response rate. Improvement in patient survival or disease related symptoms has not been established. Continued approval for these indications may be contingent upon verification of clinical benefit in confirmatory trials.

Subsequent to the approvals, the USPTO received patent term restoration applications for ZYDELIG (U.S. Patent Nos. RE44599 and RE44638) from ICOS Corporation, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated November 4, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approvals of ZYDELIG under NDA 206545 and NDA 205858 represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for ZYDELIG based on NDA 205858 is 2,247 days. Of this time, 1,931 days occurred during the testing phase of the regulatory review period, while 316 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: May 30, 2008. FDA has verified the applicant's claim that the date the investigational new drug application (IND) became effective was on May 30, 2008. This is the same IND and the same date FDA determined as the beginning of the regulatory review period for ZYDELIG approved under NDA 206545. The regulatory review period for ZYDELIG approved under NDA 206545 is publishing in this issue of the Federal Register.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: September 11, 2013. FDA has verified the applicant's claim that NDA 205858 for ZYDELIG was initially submitted on September 11, 2013.

3. The date the application was approved: July 23, 2014. FDA has verified the applicant's claim that NDA 205858 was approved on July 23, 2014.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 537 days or 751 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FDA is announcing the availability of a guidance for industry entitled “Regulatory Classification of Pharmaceutical Co-Crystals.” This guidance provides applicants planning to submit new drug applications and abbreviated new drug applications with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification.

The recommendations in this guidance apply to materials that the Agency has not previously evaluated and determined to be pharmaceutical co-crystals. The recommendations do not apply to materials that the Agency has previously designated as salts, complexes, or other non-co-crystalline forms.

Co-crystals are crystalline materials composed of two or more different molecules, typically active pharmaceutical ingredient (API) and co-crystal formers (“coformers”), in the same crystal lattice. Pharmaceutical co-crystals have provided opportunities for engineering solid-state forms beyond conventional solid-state forms of an API, such as salts and polymorphs. Co-crystals can be tailored to enhance drug product bioavailability and stability and to enhance the processability of APIs during drug product manufacture. Another advantage of co-crystals is that they generate a diverse array of solid-state forms for APIs that lack ionizable functional groups, which is a prerequisite for salt formation.

This guidance addresses the public comments received in response to the draft guidance for industry “Regulatory Classification of Pharmaceutical Co-Crystals” issued in August 2016. In response to this and other feedback from stakeholders, FDA has clarified the appropriate classification of co-crystals and addresses the concern by further clarifying that co-crystals can be viewed as a special case of solvates and hydrates, wherein the second component, the coformer, is not a solvent (including water), and is typically nonvolatile.

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 “Regulatory Classification of Pharmaceutical Co-Crystals.” 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. This guidance refers to information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 314.50(d)(1) and 314.94(a)(5) and (a)(9) have 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.

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

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product ZONTIVITY (vorapaxar sulfate). ZONTIVITY is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. Subsequent to this approval, the USPTO received a patent term restoration application for ZONTIVITY (U.S. Patent No. 7,304,078) from Merck Sharp & Dohme Corp., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated November 4, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ZONTIVITY represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for ZONTIVITY is 3,401 days. Of this time, 3,037 days occurred during the testing phase of the regulatory review period, while 364 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: January 16, 2005. FDA has verified the Merck Sharp & Dohme Corp. claim that January 16, 2005, is the date the investigational new drug application became effective.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: May 10, 2013. FDA has verified the applicant's claim that the new drug application (NDA) for ZONTIVITY (NDA 204886) was initially submitted on May 10, 2013.

3. The date the application was approved: May 8, 2014. FDA has verified the applicant's claim that NDA 204886 was approved on May 8, 2014.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,357 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

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

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the human biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the human biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human biological product SYLVANT (siltuximab). SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease who are human immunodeficiency virus negative and human herpesvirus-8 negative. Subsequent to this approval, the USPTO received patent term restoration applications for SYLVANT (U.S. Patent Nos. 7,612,182 and 7,291,721) from Janssen Biotech, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated October 30, 2015, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of SYLVANT represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for SYLVANT is 3,747 days. Of this time, 3,510 days occurred during the testing phase of the regulatory review period, while 237 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: January 21, 2004. The applicant claims January 8, 2004, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was January 21, 2004, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human biologic product under section 351 of the Public Health Service Act (42 U.S.C. 262): August 30, 2013. FDA has verified the applicant's claim that the biologic license application (BLA) for SYLVANT (BLA 125496/0) was initially submitted on August 30, 2013.

3. The date the application was approved: April 23, 2014. FDA has verified the applicant's claim that BLA 125496/0 was approved on April 23, 2014.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 936 or 1,300 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product ORKAMBI (lumacaftor and ivacaftor). ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the CFTR gene. Subsequent to this approval, the USPTO received patent term restoration applications for ORKAMBI (U.S. Patent Nos. 8,653,103; 8,741,933; and 8,846,718) from Vertex Pharmaceuticals Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ORKAMBI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for ORKAMBI is 2,785 days. Of this time, 2,545 days occurred during the testing phase of the regulatory review period, while 240 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: November 18, 2007. FDA has verified the applicant's claim that November 18, 2007, is the date the investigational new drug application (IND) became effective.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: November 5, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for ORKAMBI (NDA 206038) was initially submitted on November 5, 2014.

3. The date the application was approved: July 2, 2015. FDA has verified the applicant's claim that NDA 206038 was approved on July 2, 2015.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 210 or 317 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2008-0018 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1) 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;

(2) 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;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) 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.

(1) Type of Information Collection: Extension, Without Change, of a Currently Approved Collection.

(2) Title of the Form/Collection: Alien Change of Address Card.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: AR-11; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. The Form AR-11SR, Alien's Change of Address Card, has been used to report changes of address of aliens subject to “special registration” requirements contained in INA 263 and 8 CFR 264.1(f).

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection AR-11 (paper) is 170,306 and the estimated hour burden per response is .20 hours; the estimated total number of respondents for the information collect AR-11 (electronic) is 1,075,917 and the estimated hour burden per response is .17 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 216,967 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $638,648.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2016-0004 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1) 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;

(2) 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;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) 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.

(1) Type of Information Collection: Revision of a Currently Approved Collection.

(2) Title of the Form/Collection: Application for Employment Authorization for Abused Nonimmigrant Spouse.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-765V; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. U.S. Citizenship and Immigration Services (USCIS) will use Form I-765V, Application for Employment Authorization for Abused Nonimmigrant Spouse, to collect the information that is necessary to determine if the applicant is eligible for an initial EAD or renewal EAD as a qualifying abused nonimmigrant spouse. Aliens are required to possess an EAD as evidence of work authorization. To be authorized for employment, an alien must be lawfully admitted for permanent residence or authorized to be so employed by the INA or under regulations issued by DHS. Pursuant to statutory or regulatory authorization, certain classes of aliens are authorized to be employed in the United States without restrictions as to location or type of employment as a condition of their admission or subsequent change to one of the indicated classes. USCIS may determine the validity period assigned to any document issued evidencing an alien's authorization to work in the United States.

USCIS also collects biometric information from EAD applicants to verify the applicant's identity, check or update their background information, and produce the EAD card.

USCIS is submitting this request in order for qualifying abused nonimmigrant spouses to seek safety and financial stability from their abuser.

The Form I-765V, Application for Employment Authorization for Abused Nonimmigrant Spouse, permits battered spouses of nonimmigrants admitted under subparagraph (A), (E)(iii), (G), or (H) of section 101(a)(15) of the Act to apply for employment authorization based on section 106 of the INA.

To be eligible for employment authorization issued under INA section 106, credible evidence must be submitted demonstrating that the applicant:

1. Is married to a qualifying principal nonimmigrant spouse, or was married to a qualifying principal nonimmigrant spouse and

a. The spouse died within two years of filing the EAD application,

b. The spouse lost qualifying nonimmigrant status due to an incident of domestic violence, or

c. The marriage to the principal spouse was terminated within the two years prior to filing for the INA section 106 employment authorization, and there is a connection between the termination of the marriage and the battery or extreme cruelty;

2. Was last admitted as a nonimmigrant under INA section 101(a)(15)(A), (E)(iii), (G), or (H);

3. Was battered or has been subjected to extreme cruelty, or whose child was battered or subjected to extreme cruelty, perpetrated by the principal nonimmigrant spouse during the marriage and after admission as a nonimmigrant under INA section 101(a)(15)(A), (E)(iii), (G), or (H); and

4. Currently resides in the United States.

Form I-765V will provide the information needed to determine eligibility for employment authorization based on INA section 106. If the applicant remarries prior to adjudication of the application, he or she is ineligible for initial issuance or renewal of employment authorization under INA section 106.

In addition, if an applicant for employment authorization is filing based on a claim that his or her child was battered or subjected to extreme cruelty, USCIS requires submission of evidence establishing the applicant's parental relationship with the abused child.

Confidentiality provisions of Title 8, United States Code, section 1367 extend to applicants for employment authorization under INA section 106.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection I-765V is 500 and the estimated hour burden per response is 3.75 hours; the estimated total number of respondents for the information collection Biometric Processing is 500 and the estimated hour burden per response is 1.17 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 2,460 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $125,000.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2007-0037 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1) 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;

(2) 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;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) 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.

(1) Type of Information Collection: Extension, Without Change, of a Currently Approved Collection.

(2) Title of the Form/Collection: Petition for Alien Relative.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-130; I-130A; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract:

Primary: Individuals or households. Form I-130 allows U.S. citizens or lawful permanent residents of the United States to petition on behalf of certain alien relatives who wish to immigrate to the United States. Form I-130A allows for the collection of additional information for spouses of the petitioners necessary to facilitate a decision.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection I-130 is 978,500 and the estimated hour burden per response is 2 hours. The estimated total number of respondents for the information collection I-130A is 45,614 and the estimated hour burden per response is .883 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 1,994,996 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $391,400,000.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2007-0038 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1) 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;

(2) 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;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) 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.

(1) Type of Information Collection: Revision of a Currently Approved Collection.

(2) Title of the Form/Collection: Application to Extend/Change Nonimmigrant Status.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-539; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. This form will be used for nonimmigrants to apply for an extension of stay, for a change to another nonimmigrant classification, or for obtaining V nonimmigrant classification.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection Form I-539 is 251,500 and the estimated hour burden per response is 2.03 hours; biometrics processing is 377,250 total respondents requiring an estimated 1.17 hours per response.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 951,082 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $48,896,120.

The new System of Records will encompass data collected by PD&R to implement the HUD Supportive Services Demonstration (SSD)/Integrated Wellness in Supportive Housing (IWISH). HUD's Office of Policy Development and Research and Office of Multifamily Housing, are launching the Supportive Services Demonstration (SSD), which was authorized under the Fiscal Year 2014 Consolidated Appropriations Act.

The demonstration will test a model of housing and supportive services with the potential to delay or avoid nursing home care for low-income elderly residents in HUD-assisted Multifamily housing. The 3-year demonstration will be implemented in 40 HUD-assisted multifamily properties in California, Illinois, Maryland, Massachusetts, Michigan, New Jersey, and South Carolina. Each property will enter into a cooperative agreement with HUD's Office of Multifamily Housing and receive funds to employ a Resident Wellness Director and Wellness Nurse to assess elderly residents' social service and healthcare needs, connect residents with services, and liaise with providers.

The Resident Wellness Director and Wellness Nurse teams will conduct a Resident Assessment and use a standardized, web-based platform to capture and store self-reported demographic and health and social status information from demonstration participants, including personally identifying information (PII) and protected health information (PHI). The web-based platform, Population Health Logistics (PHL), is provided by Preferred Population Health Management, LLC (PPHM). HUD has a contract with The Lewin Group to support the implementation of the Supportive Services Demonstration; The Lewin Group has a subcontract with PPHM to use PHL for the demonstration.

The new notice states the name and location of the record system, the authority for and manner of its operations, the categories of individuals that it covers, the type of records that it contains, the sources of the information for the records, the routine uses made of the records, and the types of exemptions in place for the records. The notice also includes the business address of the HUD officials who will inform interested persons of how they may gain access to and/or request amendments to records pertaining to themselves.

Publication of this notice allows the Department to provide new information about its system of records notices in a clear and cohesive format. The new system of records will incorporate Federal privacy requirements and Department's policy requirements. The Privacy Act places on Federal agencies principal responsibility for compliance with its provisions, by requiring Federal agencies to safeguard an individual's records against an invasion of personal privacy; protect the records contained in an agency system of records from unauthorized disclosure; ensure that the records collected are relevant, necessary, current, and collected only for their intended use; and adequately safeguard the records to prevent misuse of such information. In addition, this notice demonstrates the Department's focus on industry best practices to protect the personal privacy of the individuals covered by this SORN.

Pursuant to the Privacy Act and the Office of Management and Budget (OMB) guidelines, a report of the system of records was submitted to OMB, the Senate Committee on Homeland Security and Governmental Affairs, and the House Committee on Oversight and Government Reform, as instructed by paragraph 7a of OMB Circular No. A-108, “Federal Agencies Responsibilities for Review, Reporting, and Publication under the Privacy Act,” December 23, 2016.

In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on November 3, 2017 (82 FR 51289). No comments were received.

We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the IACB; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the IACB enhance the quality, utility, and clarity of the information to be collected; and (5) how might the IACB minimize the burden of this collection on the respondents, including through the use of information technology.

Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Abstract: The Source Directory of American Indian and Alaska Native owned and operated arts and crafts enterprises is a program of the Indian Arts and Crafts Board that promotes American Indian and Alaska Native arts and crafts. The Source Directory is a listing of American Indian and Alaska Native owned and operated arts and crafts businesses that may be accessed by the public on the Indian Arts and Crafts Board's website http://www.doi.gov/iacb.

The service of being listed in this directory is provided free-of-charge to members of federally recognized tribes. Businesses listed in the Source Directory include American Indian and Alaska Native artists and craftspeople, cooperatives, tribal arts and crafts enterprises, businesses privately-owned-and-operated by American Indian and Alaska Native artists, designers, and craftspeople, and businesses privately owned-and-operated by American Indian and Alaska Native merchants who retail and/or wholesale authentic Indian and Alaska Native arts and crafts. Business listings in the Source Directory are arranged alphabetically by State.

The Director of the Board uses this information to determine whether an individual or business applying to be listed in the Source Directory meets the requirements for listing. The approved application will be printed in the Source Directory. The Source Directory is updated as needed to include new businesses and to update existing information. There is one type of application form, with a box to check what type of listing they are applying for: (1) New businesses—group; (2) new businesses—individual; (3) businesses already listed—group; and (4) businesses already listed—individual.

Title of Collection: Source Directory of American Indian and Alaska Native Owned and Operated Arts and Crafts Businesses.

OMB Control Number: 1085-0001.

Form Numbers: FWS Forms 3-2354 through 3-2362.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Individuals/households.

Total Estimated Number of Annual Responses: 100.

Total Estimated Number of Annual Burden Hours: 25.

Respondent's Obligation: Required to Obtain or Retain a Benefit.

Frequency of Collection: As needed.

Total Estimated Annual Non-hour Burden Cost: None.

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

The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq).

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

1. Type of Information Collection (check justification or form 83): Extension, without change, of a currently approved collection.

2. The Title of the Form/Collection: Employee Possessor Questionnaire.

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection:

Form number (if applicable): ATF F 5400.28.

Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

4. Affected public who will be asked or required to respond, as well as a brief abstract:

Primary: Individuals or households.

Other (if applicable): Business or other for-profit.

Abstract: Persons employed in the explosives business or operations, who have to ship, transport, receive, or possess explosive materials, are required to complete and submit an Employee Possessor Questionnaire and to ATF, in order to determine if they are qualified to be an employee possessor in an explosive business or operation.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 10,000 respondents will utilize the form, and it will take each respondent approximately 20 minutes to complete the form.

6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 3,334 hours which is equal to 10,000 (# of respondents) * .3333 (20 minutes).

If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

The National Council on the Humanities is meeting pursuant to the National Foundation on the Arts and Humanities Act of 1965 (20 U.S.C. 951-960, as amended). The Committee meetings of the National Council on the Humanities will be held on March 8, 2018, as follows: the policy discussion session (open to the public) will convene at 10:30 a.m. until approximately 11:00 a.m., followed by the discussion of specific grant applications and programs before the Council (closed to the public) from 11:00 a.m. until 12:30 p.m.

All Committee meetings will take place at Constitution Center. For specific room numbers, contact Caitlin Cater at (202) 606-8322 or [email protected].

The plenary session of the National Council on the Humanities will convene on March 9, 2018, at 9:00 a.m. in the Conference Center at Constitution Center. The agenda for the morning session (open to the public) will be as follows:

The remainder of the plenary session will be for consideration of specific applications and therefore will be closed to the public.

As identified above, portions of the meeting of the National Council on the Humanities will be closed to the public pursuant to sections 552b(c)(4), 552b(c)(6), and 552b(c)(9)(B) of Title 5 U.S.C., as amended. The closed sessions will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, and discussion of certain information, the premature disclosure of which could significantly frustrate implementation of proposed agency action. I have made this determination pursuant to the authority granted me by the Chairman's Delegation of Authority to Close Advisory Committee Meetings dated April 15, 2016.

Please note that individuals planning to attend the public sessions of the meeting are subject to security screening procedures. If you wish to attend any of the public sessions, please inform NEH as soon as possible by contacting Caitlin Cater at (202) 606-8322 or [email protected]. Please also provide advance notice of any special needs or accommodations, including for a sign language interpreter.

Title: Hispanic-Serving Institutions (HSI) Certification Form.

OMB Control Number: 3145—NEW.

Abstract: To enhance the quality of undergraduate STEM education at Hispanic-serving institutions (HSIs), the National Science Foundation (NSF) established the Improving Undergraduate STEM Education: Hispanic-Serving Institutions (HSI Program), in response to the Consolidated Appropriations Act, 2017 (Pub. L. 115-31) and the American Innovation and Competitiveness Act (Pub. L. 114-329). The lead institution submitting a proposal to the HSI Program must be an HSI as defined by law in section 502 of the Higher Education Act of 1965 (20 U.S.C. 1101a) (http://legcounsel.house.gov/Comps/HEA65_CMD.pdf). Hence there is a need for institutions to self-certify via an HSI Certification Form (NSF Form Number 1715).

Expected respondents: Hispanic-Serving Institutions.

Estimate of burden: We anticipate 175 proposals for 2 minutes which is approximately 6 hours.

Routine use 1 is changed to allow OIG to disclose records that may not indicate wrongdoing on their face, but in conjunction with other records may constitute evidence that wrongdoing occurred. It is also changed to clarify that disclosure recipients can include tribal governments. Other nonsubstantive changes are made to remove excess or redundant wording.

Routine use 2 is changed to advance oversight and accountability by permitting disclosure when deemed necessary to further OIG's investigative, audit, and inspection activities; and, following such activities, to facilitate institutional actions to address or prevent misconduct. Regarding the latter, we note that disclosure of information about administrative cases—including those cases that result in research misconduct findings—can be useful for NSF-funded entities affected by the investigation and/or outcome. For example, institutions employing involved individuals may need the information to effectively manage their personnel and to administer their research programs.

Routine use 3 is changed to clarify that disclosure recipients can include tribal governments and to remove excess or redundant wording.

Routine use 4 is changed to clarify that disclosure recipients can include tribal governments and to remove excess or redundant wording.

Routine use 6 is changed to refer to “research misconduct” rather than “misconduct in science”, to reflect the change in terminology in NSF's regulation at 45 CFR part 689 effective April 17, 2002. It is also changed to clarify that disclosure recipients can include tribal governments.

Routine use 11 is removed as an unnecessary routine use, given that the described disclosure is already permissible under the Privacy Act, 5 U.S.C. 552a(b).

Routine use 13 is added to enable OIG to release information to the public when: (a) The matter under investigation has become public knowledge because information about it is publicly available (as is the case with suspensions, debarments, convictions, or civil judgments), (b) the Inspector General or designee determines that such disclosure is necessary to preserve confidence in the integrity of the OIG investigative process, or (c) to demonstrate the accountability of NSF employees or other individuals covered by this system. We note that routine use 13 is consistent with uses published by other federal OIGs and represents a balance between privacy interests and the public's interest in transparency. Disclosure of names pursuant to subpart (c) will help deter misconduct involving the Foundation and/or its funded activities. Public disclosure under this use would only be permissible after the Inspector General or designee initially determines that it would not result in an unwarranted invasion of personal privacy.

Routine use 14 addresses limited disclosures—to complainants, victims, and witnesses—in situations not covered by routine use 13, and is consistent with uses promulgated by other federal OIGs. This use not only advances overall transparency, but, by keeping complainants and victims informed about cases in which they are involved, it will encourage individuals to come forward and to cooperate in future investigations. Providing witnesses with records they initially produced, or which contain their own statements or testimony, will, for example, assist the federal government in ongoing legal proceedings concerning the matter investigated.

The new system of records, NSF-76 Account Registration and Management, will contain records from a new centralized and streamlined account registration process that NSF is transitioning towards to provide each user a single profile with a unique identifier to be used across NSF systems. The new account management functionality allows users to maintain their own account profiles, including personal information, and request roles to access NSF systems. It will also provide administrators the ability to manage roles for their organizations through a dashboard with functions to approve, disapprove, and assign roles for their organizations.

Consistent with the American Innovation and Competitiveness Act, Public Law 114-329, NSF is proposing to modify the system by adding a new routine use that will allow NSF to notify other Federal science agencies of findings of research misconduct. In addition, the American Innovation and Competitiveness Act is being added to the “authority for maintenance of the system” section of the system of records notice.

The NRC is granting exemptions from paragraph B of section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the Code of Federal Regulations (10 CFR) and issuing License Amendment Nos. 100 and 99 to COLs, NPF-91 and NPF-92, respectively, to the licensee. The exemptions are required by paragraph A.4 of section VIII, “Processes for Changes and Departures,” appendix D, to 10 CFR part 52 to allow the licensee to depart from Tier 1 information. With the requested amendment, the licensee proposes changes to the Updated Final Safety Analysis Report in the form of departures from the Plant-Specific Design Control Document (PS-DCD) Tier 2 information and involves changes to plant-specific Tier 1 information (and corresponding changes to COL Appendix C). Specifically, the amendment proposes changes to the protection and safety monitoring system including the reactor trip system and the engineered safety feature actuation system, the passive core cooling system, the steam generator blowdown system, and the spent fuel pool cooling system. In addition, revisions are proposed to COL Appendix A, Technical Specifications.

Part of the justification for granting the exemptions was provided by the review of the amendments. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemptions and issued the amendments concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemptions met all applicable regulatory criteria set forth in 10 CFR 50.12, 10 CFR 52.7, and Section VIII.A.4 of appendix D to 10 CFR part 52. The license amendments were found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML17284A075.

Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML17284A068 and ML17284A069, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML17284A070 and ML17284A073, respectively. A summary of the amendment documents is provided in Section III of this document.

Reproduced below is the exemption document issued to VEGP Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:

1. In a letter dated February 17, 2017, and supplemented by letters dated July 21, 2017, and October 3, 2017, the licensee requested from the Commission an exemption from the provisions of 10 CFR part 52, appendix D, section III.B, as part of license amendment request 16-032, “Addition of In-containment Refueling Water Storage Tank (IRWST) Lower Narrow Range Level Instrumentation (LAR-16-032).”

For the reasons set forth in Section 3.1, “Evaluation of Exemption,” of the NRC staff's Safety Evaluation, which can be found in ADAMS under Accession No. ML17284A075, the Commission finds that:

A. The exemption is authorized by law;

B. the exemption presents no undue risk to public health and safety;

C. the exemption is consistent with the common defense and security;

D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;

E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and

F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.

2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendices A and C of the Facility Combined Licenses as described in the licensee's request dated February 17, 2017, and supplemented by letters dated July 21, 2017, and October 3, 2017. This exemption is related to, and necessary for, the granting of License Amendment Nos. 100 and 99, which is being issued concurrently with this exemption.

3. As explained in Section 5.0, “Environmental Consideration,” of the NRC staff's Safety Evaluation (ADAMS Accession No. ML17284A075), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.

4. These exemptions are effective as of the date of its issuance.

By letter dated February 17, 2017, and supplemented by letters dated July 21, 2017, and October 3, 2017, the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this Federal Register notice.

The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.

A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the Federal Register on March 22, 2017 (82 FR 14760). No comments were received during the 30-day comment period.

The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.

Using the reasons set forth in the combined safety evaluation, the staff granted the exemption and issued the amendment that the licensee requested on February 17, 2017, and supplemented July 21, 2017 and October 3, 2017.

The exemptions and amendments were issued on November 22, 2017, as part of a combined package to the licensee (ADAMS Accession No. ML17284A066).

The NRC is granting exemptions from paragraph B of section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the Code of Federal Regulations (10 CFR) and issuing License Amendment Nos. 95 and 94 to COLs, NPF-91 and NPF-92, respectively, to the licensee. The exemptions are required by paragraph A.4 of section VIII, “Processes for Changes and Departures,” appendix D, to 10 CFR part 52 to allow the licensee to depart from Tier 1 information. With the requested amendment, the licensee proposes to depart from plant-specific (PS) Tier 1 emergency planning (EP) inspections, tests, analyses, and acceptance criteria (ITAAC) information and associated COL Appendix C information. The requested amendment also proposes to revise plant-specific EP ITAAC in Appendix C of the VEGP Units 3 and 4 COLs. The proposed changes do not involve changes to the approved emergency plan or the PS Tier 2 DCD. Also, the proposed changes to COL Appendix C information also include changes to the list of acronyms and abbreviations.

Part of the justification for granting the exemptions was provided by the review of the amendments. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemptions met all applicable regulatory criteria set forth in 10 CFR 50.12, 10 CFR 52.7, and section VIII.A.4 of appendix D to 10 CFR part 52. The license amendments were found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML17256A034.

Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML17256A030 and ML17256A031, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML17256A032 and ML17256A033, respectively. A summary of the amendment documents is provided in Section III of this document.

Reproduced below is the exemption document issued to VEGP Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:

1. In a letter dated May 5, 2017, and supplemented by letter dated August 3, 2017, the licensee requested from the Commission an exemption from the provisions of 10 CFR part 52, appendix D, section III.B, as part of license amendment request 17-014, “Emergency Planning ITAAC Revisions.”

For the reasons set forth in Section 3.1, “Evaluation of Exemption,” of the NRC staff's Safety Evaluation, which can be found in ADAMS under Accession No. ML17256A034, the Commission finds that:

A. The exemption is authorized by law;

B. the exemption presents no undue risk to public health and safety;

C. the exemption is consistent with the common defense and security;

D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;

E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and

F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.

2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendix C of the Facility Combined Licenses as described in the licensee's request dated May 5, 2017, and supplemented by letter dated August 3, 2017. This exemption is related to, and necessary for, the granting of License Amendment Nos. 95 or 94, which is being issued concurrently with this exemption.

3. As explained in Section 5.0, “Environmental Consideration,” of the NRC staff's Safety Evaluation (ADAMS Accession No. ML17256A034), these exemptions meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.

4. These exemptions are effective as of the date of its issuance.

By letter dated May 5, 2017, and supplemented by letter dated August 3, 2017, the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this Federal Register notice.

The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.

A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the Federal Register on July 5, 2017 (82 FR 31089). No comments were received during the 30-day comment period.

The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.

Using the reasons set forth in the combined safety evaluation, the staff granted the exemptions and issued the amendments that the licensee requested on May 5, 2017, and supplemented by letter dated August 3, 2017.

The exemptions and amendments were issued on November 3, 2017, as part of a combined package to the licensee (ADAMS Accession No. ML17256A028).

The NRC is granting exemptions from paragraph B of section III, “Scope and Contents,” of Appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the Code of Federal Regulations (10 CFR) and issuing License Amendment Nos. 99 and 98 to COLs, NPF-91 and NPF-92, respectively, to the licensee. The exemptions are required by paragraph A.4 of section VIII, “Processes for Changes and Departures,” appendix D, to 10 CFR part 52 to allow the licensee to depart from Tier 1 information. With the requested amendment, the licensee proposes changes to plant-specific Tier 1 information and corresponding changes to Appendix C. Specifically, the licensee proposes changes to plant-specific Tier 1, Table 2.2.4-1 and Figure 2.2.4-1 (Sheets 1 and 2) and corresponding changes to Appendix C of the COL to install two main feedwater thermal relief valves and two start-up feedwater thermal relief valves. The main feedwater thermal relief valves will be added to the main feedwater line between the main feedwater isolation valves and main feedwater control valves. The startup feedwater thermal relief valves will be added between the startup feedwater isolation valves and startup feedwater control valves. The proposed plant-specific DCD Tier 1 information and corresponding changes to Appendix C of the COL require additional changes to corresponding Tier 2 information in the Updated Final Safety Analysis Report, Chapter 3, “Design of Structures, Components, Equipment, and Systems,” and Chapter 10, “Steam and Power Conversion.”

Part of the justification for granting the exemptions was provided by the review of the amendments. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemptions and issued the amendments concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemptions met all applicable regulatory criteria set forth in 10 CFR 50.12, 10 CFR 52.7, and section VIII.A.4 of appendix D to 10 CFR part 52. The license amendments were found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML17263A074.

Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML17263A079 and ML17263A078, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML17263A077 and ML17263A075, respectively. A summary of the amendment documents is provided in Section III of this document.

Reproduced below is the exemption document issued to VEGP Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:

1. In a letter dated April 21, 2017, revised on August 15, 2017, and supplemented by letter dated September 18, 2017, the licensee requested from the Commission an exemption from the provisions of 10 CFR part 52, appendix D, section III.B, as part of license amendment request 17-012, “Addition of Steam Generator System (SGS) Thermal Relief Valves.”

For the reasons set forth in Section 3.1, “Evaluation of Exemption,” of the NRC staff's Safety Evaluation, which can be found in ADAMS under Accession No. ML17263A074, the Commission finds that:

A. The exemption is authorized by law;

B. the exemption presents no undue risk to public health and safety;

C. the exemption is consistent with the common defense and security;

D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;

E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and

F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.

2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendix C of the Facility Combined Licenses as described in the licensee's request dated April 21, 2017, revised on August 15, 2017 and supplemented by letter dated September 18, 2017. This exemption is related to, and necessary for, the granting of License Amendment Nos. 99 and 98, which is being issued concurrently with this exemption.

3. As explained in Section 5.0, “Environmental Consideration,” of the NRC staff's Safety Evaluation (ADAMS Accession No. ML17263A074), these exemptions meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.

4. These exemptions are effective as of the date of its issuance.

By letter dated April 21, 2017, revised on August 15, 2017 and supplemented by letter dated September 18, 2017, the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this Federal Register notice.

The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.

A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the Federal Register on September 12, 2017 (82 FR 42844). No comments were received during the 30-day comment period.

The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.

Using the reasons set forth in the combined safety evaluation, the staff granted the exemption and issued the amendment that the licensee requested on April 21, 2017, revised on August 15, 2017, and supplemented by letter on September 18, 2017.

The exemptions and amendments were issued on November 17, 2017, as part of a combined package to the licensee (ADAMS Accession No. ML17263A070).