Federal Register Vol. 80, No.131,

The purpose of the meeting is to:

1. Provide RAC updates, and

2. Review project proposal submittals.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by at least a week in advance to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Beth Martinez, RAC Coordinator, Stanislaus National Forest, 19777 Greenley Road, Sonora, California 95370; by email to [email protected], or via facsimile to ATTN: Beth Martinez at 209-533-1890.

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

The purpose of the meeting is:

1. The RAC will meet to conduct RAC business,

2. Review and discuss project proposals, and

3. Make recommendations for projects to fund from Title II monies for Garfield, Gunnison, Mesa and Montrose counties, Colorado.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by August 6, 2015, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Lee Ann Loupe, RAC Coordinator, 2250 Highway 50, Delta, Colorado 81416; by email to [email protected], or via facsimile to 970-874-6686.

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

At the Board meeting scheduled on Wednesday, July 29, 2015 from 1:30 to 3:00 p.m., the Access Board will consider the following agenda items:

• Approval of the draft March 11, 2015 meeting minutes (vote)

• Ad Hoc Committee Reports: Information and Communications Technologies; Self-Service Transaction Machines; Public Rights-of-Way and Shared Use Paths; Transportation Vehicles; Passenger Vessels; Medical Diagnostic Equipment; Frontier Issues; and Design Guidance

All meetings are accessible to persons with disabilities. An assistive listening system, Communication Access Realtime Translation (CART), and sign language interpreters will be available at the Board meeting and committee meetings. Persons attending Board meetings are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants (see www.access-board.gov/the-board/policies/fragrance-free-environment for more information).

You may view the Wednesday, July 29, 2015 meeting through a live webcast from 1:30 p.m. to 3:00 p.m. at: http://www.access-board.gov/webcast. Call-in information (listen only) and a communication access real-time translation (CART) Web streaming link for the presentation of the Rail Vehicles Access Advisory Committee report will be posted on the Access Board's Rail Vehicles Access Advisory Committee Web site page at www.access-board.gov/rvaac.

On June 29, 2015, the Department of Commerce (the Department) published the preliminary affirmative countervailing duty determination on certain uncoated paper from the People's Republic of China.1 The Preliminary Determination contained inadvertent errors related to certain company names. Specifically, in the Preliminary Determination the Department should have indicated that the mandatory respondent, referred to in the collective as the Asia Symbol Companies, is comprised of the following firms: Asia Symbol (Guangdong) Paper Co., Ltd. (AS Guangdong), Asia Symbol (Shandong) Pulp & Paper Co., Ltd. (AS Shandong), Asia Symbol (Guangdong) Omya Minerals Co., Ltd. (AS Omya), and Greenpoint Global Trading (Macao Commercial Offshore) Limited (Greenpoint). Additionally, in the Preliminary Determination, the Department should have referred to UPM Changshu as UPM (China) Co. Ltd. (UPM).

This correction to the Preliminary Determination is issued and published in accordance with section 703(b)(1) of the Tariff Act of 1930, as amended.

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

On March 2, 2015, notice was published in the Federal Register (80 FR 11177) that a request for a permit to commercial or educational photography on bottlenose dolphins (Tursiops truncatus) in the Florida Bay had been submitted by the above-named applicant. The requested permit has been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.) and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

The permit authorizes filming and photography of the Florida Bay stock of bottlenose dolphins for purposes of a documentary film. The activities fall under the definition of level B harassment via aircraft and from a small 20 ft vessel. Filming would take place for approximately 30 days between May 20, 2015 and September 1, 2015. The permit is valid through September 30, 2015.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

The purpose of this meeting is for the Council's Atlantic Bluefish Monitoring Committee to discuss and recommend multi-year (2016-18) annual catch targets (ACTs) and other associated management measures for the Atlantic bluefish fisheries.

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

The Summer Flounder, Scup, and Black Sea Bass Monitoring Committee will meet from 1 p.m. to 5 p.m. on Thursday, July 23 and from 8 a.m. to 12 p.m. on Friday, July 24 to discuss and recommend 2016 annual catch targets (ACTs) and other associated management measures for the summer flounder, scup, and black sea bass fisheries. Multi-year ACTs and management measures, applicable to fishing years 2016-18, may be considered.

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

The subject amendment to Permit No. 14450-02 is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

Permit No. 14450-02, last amended on December 31, 2014, authorizes the SEFSC to take all cetacean species that occur in U.S. and international waters of the Atlantic Ocean, Gulf of Mexico and Caribbean Sea. Activities include aerial and vessel-based line-transect sampling, acoustic sampling, behavioral observations, vessel-based photo-identification, and biopsy sampling. Satellite tagging of ESA-listed large whales is also authorized. Tissue samples collected in other countries may be imported into the U.S. The permit expires on February 28, 2019.

The SEFSC is requesting the permit be amended to authorize satellite tagging of non-ESA listed cetaceans during authorized vessel surveys to support NMFS stock assessments as follows: 40 Bryde's whales (Balaenoptera edeni), 40 of each species of short-finned (Globicephala macrorhynchus) and long-finned (Globicephala melas) pilot whales, and 20 individuals each of the 21 other authorized non-listed cetacean species, annually. Tags would be either suction cup attachments, fully implantable or minimally invasive dart attachments. A maximum of 2 tags could be placed on an animal at one time. Adults of both sexes without calves would be tagged. In addition, the SEFSC is requesting authorization to import and export marine mammals samples from sources (other than currently authorized biopsy sampling) to support the NMFS research on these species.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activities proposed are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding copies of the amendment requests to the Marine Mammal Commission and its Committee of Scientific Advisors.

On March 20, 2015, notice was published in the Federal Register (80 FR 14907) that requests for amendments to Permit Nos. 17278 and 17557 to import specimens from long-finned pilot whales (Globicephala melas; 17278) and scalloped hammerhead sharks (Sphyrna lewinia; 17557) for scientific research had been submitted by the above-named applicants. The requested permit amendments have been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), as applicable.

Permit No. 17278 authorizes Dr. Shine to import and receive parts from subsistence-collected long-finned pilot whales (Globicephala melas) archived at the Faroese Museum of Natural History, Faroe Islands. The permit, as amended, increases the number of samples authorized to be imported from 15 to 100 animals annually, as well as authorization to conduct analyses of chlorinated and fluorinated organic chemicals using the same samples.

Permit No. 17557 authorizes the NMFS Forensics Office to receive, import, export, transfer, archive, and conduct analyses on marine mammal and ESA-listed species parts under NMFS jurisdiction. The permit has been amended to include scalloped hammerhead sharks (Sphyrna lewinia) recently listed under the ESA.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

As required by the ESA, issuance of the permit amendment (Permit No. 17557-01) was based on a finding that such permit: (1) Was applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

I. Background

The USPTO is continually looking for ways to improve the quality of issued patents and to promote work sharing between other Intellectual Property (IP) Offices throughout the world. The USPTO has launched several work sharing pilot programs in recent years (e.g., numerous Patent Prosecution Highway Pilot Programs). In furtherance of promoting interoffice work sharing, the USPTO and KIPO will cooperate in a study to determine whether work sharing between IP offices, in the form of exchanging the results from independently performed concurrent searches, increases the efficiency and quality of patent examination. This exchange of search reports would occur prior to making determinations regarding patentability. Work sharing benefits applicants by promoting compact prosecution, reducing pendency, and supporting patent quality by reducing the likelihood of inconsistencies in patentability determinations (not predicated upon differences in national patent laws) between IP offices when considering corresponding counterpart applications.

Currently, an application filed in the USPTO with a claim of foreign priority may have a search report and art cited by the foreign office in the priority application provided to applicant during the U.S. application's pendency. After review of the search report and cited art, an applicant may submit an Information Disclosure Statement (IDS) in the U.S. application to provide the information to the USPTO. Often this submission occurs after examination on the merits is already underway in the U.S. application. Upon evaluation of the search report and cited art, the U.S. examiner may determine that the art cited by the foreign office is relevant to patentability and merits further examination before making a final determination on patentability. The delay caused by further examination results in additional costs to an applicant and the USPTO that could have been avoided if the U.S. examiner was in possession of the foreign office's search results before commencing examination of the application. Furthermore, in light of the various expedited examination programs currently in place, the potential exists that a U.S. application may reach final disposition before an applicant is in receipt of a foreign office's search report. Work sharing between intellectual Property (IP) offices in the form of an exchange of search reports may increase efficiency and promote patent examination quality by providing the examiner with both offices' search reports when examination commences. In order to study the benefits of the exchange of search reports between offices, current USPTO examination practice would need to be modified to conduct a search and generate a search report, without issuance of an Office action. The U.S. application also would need to be “made special” pursuant to USPTO procedures to ensure that it could be contemporaneously searched with its corresponding counterpart application.

The USPTO is using the First Action Interview Pilot Program (FAI) in this search report work sharing pilot program because its procedure bifurcates the determination and evaluation of a prior art search from the notice of rejection. See Full First Action Interview Pilot Program, 1367 Off. Gaz. Pat. Office 42 (June 7, 2011). Under the FAI pilot program, participants receive a Pre-Interview Communication providing the results of a prior art search conducted by the examiner. Participants then have three options: (1) File a request not to conduct a first action interview; (2) submit a reply under 37 CFR 1.111 after reviewing the Pre-Interview Communication; or (3) conduct an interview with the examiner. Participants in the FAI pilot program experience many benefits including: (1) The ability to advance prosecution of an application; (2) enhanced interaction between applicant and the examiner; (3) the opportunity to resolve patentability issues one-on-one with the examiner at the beginning of the prosecution process; and (4) the opportunity to facilitate possible early allowance.

The US-KR CSP program differs from the FAI pilot program procedure by requiring a Petition to Make Special for the participating application, and providing for the exchange of information with KIPO at different stages of prosecution as set forth in this notice.

The USPTO also is initiating a joint Work Sharing Pilot Program with the Japan Patent Office (JPO). The KIPO and JPO pilot programs are different in the way that they operate. Thus, while there may be applications that are eligible for both work sharing pilot programs, such applications will not be permitted to participate in both pilot programs due to the differences in work sharing procedures of these two different programs. More information about the US-KR CSP program can be found on the USPTO's Internet Web site at: http://www.uspto.gov/patents-getting-started/international-protection/collaborative-search-pilot-program-csp.

An application must meet all of the requirements set forth in section III of this notice to be accepted into this pilot program. An applicant must file a Petition to Make Special using form PTO/SB/437KR via EFS-web in a U.S. application. Use of the form will assist an applicant in complying with the pilot program's requirements. Form PTO/SB/437KR is available at: http://www.uspto.gov/patents-getting-started/international-protection/collaborative-search-pilot-program-csp. An applicant's use of this form allows the USPTO to quickly identify participating applications, facilitates timely processing in accordance with this notice, and simplifies petition preparation and submission for an applicant. The collection of information involved in this pilot program has been submitted to OMB. The collection will be available at the OMB's Information Collection Review Web site (www.reginfo.gov/public/do/PRAMain).

No fee is required for submission of petitions using Form PTO/SB/437KR. The fee (currently $140.00) for a petition under 37 CFR 1.102 (other than those enumerated in 37 CFR 1.102(c)) is hereby sua sponte waived for petitions to make special based upon the procedure specified in this notice.

Each office may reevaluate the workload and resources needed to administer the pilot program at any time. The USPTO will provide notice of any substantive changes to the program (including early termination of the program) at least thirty (30) days prior to implementation of any changes.

New patent applications are normally taken up for examination in the order of their U.S. filing date. Applications accepted into the US-KR CSP program will receive expedited processing by being granted special status and taken out of turn until issuance of a Pre-Interview Communication, or first action allowance, but will not maintain special status thereafter. While KIPO and USPTO will be sharing search reports, the possibility exists that there may be differences in the listing of references made of record by the USPTO versus those made of record in the corresponding KIPO counterpart application. Participants in the US-KR CSP program should review the references cited in each respective office's search reports. If any KIPO communication to an applicant cites references that are not already of record in the USPTO application and the applicant wants the examiner to consider the references, the applicant should promptly file an Information Disclosure Statement (IDS) that includes a copy of the KIPO communication along with copies of the newly cited references in accordance with 37 CFR 1.98 and MPEP section 609.04(a)-(b). See also MPEP sections 609 and 2001.06(a).

The following requirements must be satisfied for a petition under the US-KR CSP Program to be granted:

(1) The application must be a non-reissue, non-provisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage in compliance with 35 U.S.C. 371(c), with an effective filing date of no earlier than March 16, 2013. The U.S. application and the corresponding KIPO counterpart application must have a common earliest priority date that is no earlier than March 16, 2013.

(2) A completed petition form PTO/SB/437KR must be filed in the application via EFS-Web. Form PTO/SB/437KR is available at: http://www.uspto.gov/patents-getting-started/international-protection/collaborative-search-pilot-program-csp.

(3) The petition submission must include an express written consent under 35 U.S.C. 122(c) for the USPTO to accept and consider prior art references and comments from KIPO, during the examination of the U.S. application participating in the pilot program. The petition also must provide written authorization for the USPTO to provide KIPO access to the participating U.S. application's bibliographic data and search reports in accordance with 35 U.S.C. 122(a) and 37 CFR 1.14(c). Form PTO/SB/437KR includes language compliant with the consent requirements for this pilot program.

(4) The petition must be filed at least one day before a first Office action on the merits of the application appears in the Patent Application Information Retrieval (PAIR) system (i.e., at least one day prior to the date when a first Office action on the merits, notice of allowability or allowance, or action under Ex parte Quayle, 1935 Dec. Comm'r Pat. 11 (1935), appears in the PAIR system). An applicant should check the status of the application using the PAIR system prior to submitting the petition to ensure that this requirement is met.

(5) The petition for participation filed in the corresponding KIPO counterpart application for the US-KR CSP Program must be grant or have granted by KIPO. The KIPO and the USPTO petitions should be filed within fifteen days of each other. Both the KIPO and the USPTO petitions must be granted for the applications to be treated under the US-KR CSP program. As the requirements of each office's pilot program may differ, applicants should review the requirements for both pilot programs when considering participation, ensuring that the respective corresponding counterpart applications can comply with each office's requirements.

(6) The petition submission must include a claims correspondence table that notes which claims between the pending U.S. and KIPO applications have a substantially corresponding scope to each other. Claims are considered to have a “substantially corresponding scope” where, after accounting for differences due to claim format requirements, the scope of the corresponding claims in the corresponding KIPO counterpart application would either anticipate or render obvious the subject matter recited under U.S. law. Additionally, claims in the corresponding U.S. counterpart application that introduce a new/different category of claims than those presented in the corresponding KIPO counterpart application are not considered to substantially correspond. For example, where the corresponding KIPO counterpart application contains only claims relating to a process of manufacturing a product, then any product claims in the corresponding U.S. counterpart application are not considered to substantially correspond, even if the product claims are dependent on process claims which substantially correspond to claims in the corresponding KIPO counterpart application. Applicants may file a preliminary amendment in compliance with 37 CFR 1.121 to amend the claims of the corresponding U.S. counterpart application to satisfy this requirement when attempting to make the U.S. application eligible for the program.

(7) The application must contain three or fewer independent claims and twenty or fewer total claims. The application must not contain any multiple dependent claims. For an application that contains more than three independent claims or twenty total claims, or any multiple dependent claims, applicants may file a preliminary amendment in compliance with 37 CFR 1.121 to cancel the excess claims and/or the multiple dependent claims to make the application eligible for the program.

(8) The claims must be directed to a single invention. If the Office determines that the claims are directed to multiple inventions (e.g., in a restriction requirement), the applicant must make a telephonic election without traverse in accordance with the procedures outlined in section V of this notice. An applicant is responsible for ensuring that the same invention is elected in both the U.S. and KIPO corresponding counterpart applications for concurrent treatment in the US-KR CSP program.

(9) All submissions for the participating application while being treated under the US-KR CSP program's procedure must be filed via EFS-Web.

(10) The petition must include a statement that the applicant agrees not to file a request for a refund of the search fee and any excess claim fees paid in the application after the mailing or notification date of the Pre-Interview Communication. See form PTO/SB/413C. Any petition for express abandonment under 37 CFR 1.138(d) to obtain a refund of the search fee and excess claim fee filed after the mailing or notification date of a Pre-Interview Communication will not be granted.

An applicant must file a Petition to Make Special using Form PTO/SB/437KR in an eligible U.S. application for entry into the US-KR CSP program. Applicant also must file the appropriate petition paper in the corresponding KIPO counterpart application for participation in the US-KR CSP program. Once both petitions are granted, the U.S. application will receive expedited processing by being placed on the examiner's special docket for examination in accordance with sections V-VIII of this notice.

An applicant must file appropriate petition papers in both the USPTO and KIPO corresponding counterpart applications within fifteen days of each other. If the petitions are not filed within fifteen days of each other, an applicant runs the risk of one of the pending applications being acted upon by an examiner before entry into the pilot program, which will result in both applications being denied entry into the pilot program. Both offices must grant the respective petitions in order for the applications to participate in the pilot program. Once the USPTO issues a decision granting the petition, an applicant will no longer have a right to file a preliminary amendment that amends the claims. Any preliminary amendment filed after petition grant and before issuance of a Pre-Interview Communication amending the claims will not be entered unless approved by the examiner. After the petition is granted and before issuance of the Pre-Interview Communication, an applicant may still submit preliminary amendments to the specification that do not affect the claims. If either office determines that the petition must be denied, then the other office will be informed of the denial determination, and both offices will issue decisions denying the petition.

If an applicant files an incomplete Form PTO/SB/437KR, or if an application accompanied by Form PTO/SB/437KR does not comply with the requirements set forth in this notice, the USPTO will notify the applicant of the deficiency by issuing a dismissal decision and the applicant will be given a single opportunity to correct the deficiency. If an applicant still wishes to participate in the pilot program, the applicant must make appropriate corrections within one month or thirty days of the mailing date of the dismissal decision, whichever is longer. The time period for reply is not extendable under 37 CFR 1.136(a). If the applicant fails to correct all of the noted deficiencies within the time period set forth, the USPTO will render a denial decision and notify KIPO in accordance with this notice, and neither application will be eligible for the pilot program. The U.S. application will then be taken up for examination in accordance with standard examination procedures, unless designated special in accordance with another established procedure (e.g., Prioritized Examination, Special Based on Applicant's Age, etc.). If an applicant timely files a response to the dismissal that corrects all the noted deficiencies and does not introduce new instances of non-compliance, the USPTO will issue a decision granting the petition.

An application can be withdrawn from the pilot program only by filing a withdrawal of the petition to participate in the pilot program prior to issuance of a decision granting the petition. Once the petition for participation in the pilot program has been granted (one day before it appears in PAIR), withdrawal from the pilot program is not permitted. The USPTO will treat any request for withdrawal from the pilot program filed after the mailing or notification of acceptance into the pilot program as a request to not conduct an interview, and subsequent to the mailing of the Pre-Interview Communication, the USPTO will issue a First-Action Interview Office Action, in due course. (See section VII.B.1. of this notice.)

If the examiner determines that not all the claims presented are directed to a single invention, the telephone restriction practice set forth in MPEP section 812.01 will be followed. An applicant must make an election without traverse during the telephonic interview. If the applicant refuses to make an election without traverse, or if the examiner cannot reach the applicant after a reasonable effort (i.e., three business days), the examiner will treat the first claimed invention (the group of claim 1) as constructively elected without traverse for examination. When a telephonic election is made, the examiner will provide a complete record of the telephone interview, including the restriction or lack of unity requirement and the applicant's election, as an attachment to the Pre-Interview Communication. Applicants are strongly encouraged to ensure that applications submitted for the pilot program are written such that they claim a single, independent, and distinct invention. An applicant is responsible to ensure the same invention is elected in both the U.S. and KIPO corresponding counterpart applications for concurrent treatment in this joint office work sharing pilot program.

If the application contains only one invention or an applicant has elected one invention without traverse, the examiner will conduct a prior art search for the claimed invention under consideration. The examiner may prepare either a Notice of Allowability or a Pre-Interview Communication.

If the examiner determines that the application is in condition for allowance or the application could be placed in condition for allowance with minor corrections or a possible amendment or submission, a Pre-Interview Communication and all subsequent FAI procedures under this pilot program will not be necessary. The examiner may allow the application, or contact the applicant and conduct an interview in accordance with MPEP section 713 to discuss any possible amendments or submissions to place the application in condition for allowance. If the USPTO has not received the KIPO search report at the time the examiner has decided the claims are allowable, the USPTO will notify KIPO of the examiner's findings and references identified during the search. The USPTO will wait for up to 90 days from the date of notification for receipt of the KIPO search. Upon receipt of the KIPO search report, the examiner will consider the references cited in the KIPO search report before making a final determination whether to issue a Notice of Allowability. If the KIPO search report is not received within 90 days, the examiner will issue a Notice of Allowability without consideration of the KIPO search report. An applicant will be responsible for determining the appropriateness of any future correspondence with the USPTO for information later obtained from KIPO. If the examiner issues a Notice of Allowability with consideration of the KIPO search report, the examiner will cite references from the KIPO search report in a Notice of References Cited (PTO-892). The Notice of Allowability with a completed form PTO-892 also will be forwarded to KIPO for further consideration by the KIPO examiner of record for the corresponding KIPO counterpart application. If a Notice of Allowability will not issue, then the examiner will prepare and issue a Pre-Interview Communication in accordance with Section VI.B of this notice.

If the examiner determines the application is not in condition for allowance, the examiner will prepare a Pre-Interview Communication and a PTO-892 citing the prior art references, identifying any rejections or objections relevant to the claimed invention, and any designation of allowable subject matter. If the USPTO has not received the KIPO search report at the time the examiner has completed the Pre-Interview Communication, the USPTO will notify KIPO of the examiner's findings and references identified during the search. The USPTO will wait for up to 90 days from the date of notification for receipt of the KIPO search. Upon receipt of the KIPO search report, the examiner will issue a Pre-Interview Communication and include a copy of the KIPO search report. Thus, the examiner is not required to cite in the Pre-Interview Communication references cited in the KIPO search report, because the KIPO search report is being sent to the applicant with the Pre-Interview Communication. If the KIPO search report is not received within 90 days, the examiner will issue the Pre-Interview Communication to the applicant, and the application will be removed from the pilot program for evaluation purposes only, but will continue to be treated in accordance with this notice. An applicant is responsible for responding to the USPTO Pre-Interview Communication in accordance with the First Action Interview Program procedures discussed in Section VII of this notice.

The Pre-Interview Communication issued to an applicant will set forth a time period of one month or thirty days, whichever is longer, for the applicant to request or decline an interview. An applicant is responsible for responding to the Pre-Interview Communication in accordance with the First Action Interview Program procedures discussed in Section VII of this notice. The USPTO will permit the applicant to extend this time period for reply pursuant to 37 CFR 1.136(a) for one additional month as set forth in section VII, subsection B (Applicant's Options and Reply to Pre-Interview Communication) and subsection C (Failure to Respond to Pre-Interview Communication) of this notice. The examiner's typical working schedule also will be provided with the Pre-Interview Communication to indicate the examiner's availability for scheduling the interview.

Once a Pre-Interview Communication has been entered in an application, an applicant no longer has a right to amend the application until the first action interview is conducted and the First-Action Interview Office Action is sent. Therefore, any amendments filed after the Pre-Interview Communication, but before the interview and the mailing or notification date of a First-Action Interview Office Action (PTOL-413FA), will not be entered unless approved by the examiner or in accordance with the procedure of the Full First Action Interview Pilot Program in section VII, subsection B(2), or section VIII, subsection B(3), of this notice. This is because the examiner has devoted a significant amount of time to the preparation of the Pre-Interview Communication. See 37 CFR 1.115(b) and MPEP section 714.01(e). The USPTO may enter the amendment if it is clearly limited to: Cancellation of claims; adoption of examiner suggestions; placement of the application in condition for allowance, including an explanation on how the proposed amendments overcome art cited and/or applied in the KIPO search report, if necessary, in accordance with U.S. patent laws; and/or correction of informalities (similar to the treatment of an after-final amendment). Amendments will be entered solely at the examiner's discretion.

Upon receipt of a Pre-Interview Communication, the applicant has three options:

(1) File a “Request to Not Have a First Action Interview”;

(2) File a reply under 37 CFR 1.111 waiving the first action interview and First-Action Interview Office Action—an applicant is accepting that the Pre-Interview Communication is the first Office action on the merits; or

(3) Schedule the first action interview—an applicant must file an Applicant Initiated Interview Request Form (PTOL-413A) electronically via EFS-Web, accompanied by a proposed amendment or arguments, and schedule the interview to be conducted within two months or sixty days, whichever is longer, from the filing of the Applicant Initiated Interview Request.

If an applicant wishes not to have the first action interview, the applicant should electronically file a letter requesting not to have a first action interview within the time period set forth in the Pre-Interview Communication. In this situation, a first action interview will not be conducted, and the examiner will provide the First-Action Interview Office Action setting forth the requirements, objections, and rejections relevant to the claimed invention. However, such a request will not preclude the examiner from contacting the applicant and conducting a regular interview in accordance with MPEP section 713 to discuss any issues or possible amendment to place the application in condition for allowance. To ensure that the request will be processed and recognized timely, an applicant should file the request electronically via EFS-Web, selecting the document description “Request to Not Have a First Action Interview” on the EFS-Web screen.

Once the petition for entry into the pilot program has been granted (one day before it appears in PAIR), withdrawal from the pilot program is not permitted. Therefore, the USPTO will treat a request for withdrawal from the pilot program filed after the mailing or notification of granting an applicant's petition to participate in the pilot program as a request to not conduct an interview, issue a Pre-Interview Communication, and subsequently enter a First-Action Interview-Office Action, in due course.

Applicants may file, preferably in conjunction with a request to not conduct the interview, a reply in compliance with 37 CFR 1.111(b)-(c) to address every rejection, objection, and requirement set forth in the Pre-Interview Communication, including any issues of patentability raised by the art cited and/or applied in the KIPO search report, if necessary, in accordance with U.S. patent laws, thereby waiving the first action interview and First Action Interview Office Action. The reply under 37 CFR 1.111 must be filed within the time period for reply set forth in the Pre-Interview Communication. To ensure that the request will be processed and recognized timely, an applicant should file the request electronically via EFS-Web, selecting the document description “Reply under 1.111 to Pre-Interview Communication” on the EFS-Web screen.

In this situation, a first action interview will not be conducted, and a First Action Interview Office Action will not be provided to the applicant. The Pre-Interview Communication will be deemed the first Office action on the merits. The examiner will consider the reply under 37 CFR 1.111 and provide an Office action in response to the reply, in due course. The Office action will be the second Office action on the merits, and thus it could be a final Office action, a notice of allowability, or other appropriate action.

If an applicant wants a first action interview with the examiner, the applicant must timely file an Applicant Initiated Interview Request Form (PTOL 413A), electronically using EFS-Web, accompanied by a proposed amendment and/or arguments (as an attachment to the request). To ensure that the request will be processed and recognized timely, the applicant should select the document description “First Action Interview—Schedule Interview Request.”

An applicant must designate a proposed date to conduct the interview to facilitate scheduling of the first action interview. The applicant's proposed date to conduct the interview must be within two months or sixty days, whichever is longer, from the filing of the Applicant Initiated Interview Request Form. An applicant should consult the examiner's work schedule provided in the Pre-Interview Communication and discuss with the examiner the best date for conducting the interview.

After filing the Applicant Initiated Interview Request Form, the applicant must contact the examiner to confirm the interview date. The applicant's failure to conduct an interview within two months or sixty days, whichever is longer, from the filing of Applicant Initiated Interview Request Form will be treated as a failure to respond to the Pre-Interview Communication. See section VII; subsection C (Failure to Respond to Pre-Interview Communication) of this notice. The interview may be in person, telephonic, or a video-conference. The applicant must provide written authorization to conduct any Internet email communications with the examiner. See MPEP section 502.03 for more information.

The proposed amendment or arguments must be clearly labeled as “PROPOSED” at the header or footer of each page and filed electronically via EFS-Web as an attachment to the Applicant Initiated Interview Request Form. The proposed amendment or arguments will not be entered as a matter of right. The proposed amendment or arguments must address every proposed rejection, objection, and requirement set forth in the Pre-Interview Communication, including any issues of patentability raised by the art cited and/or applied in the KIPO search report, if necessary, in accordance with U.S. patent laws. The examiner, based upon discussions, feedback, and agreement with an applicant during the interview may at his or her discretion enter the amendment if found sufficient to advance prosecution on the merits. See MPEP sections 713.01 III and 713.04; see also MPEP sections 714 and 1302.04. Even if the examiner denies entry of the proposed amendment, the proposed amendment will be placed in the application file.

Preparation for the Interview: An applicant must be prepared to fully discuss the prior art of record, any relevant interview talking points from the interview talking points posted at http://www.uspto.gov/web/offices/pac/dapp/opla/preognotice/fai_talking_points.pdf, and any rejections or objections with the intent to clarify and resolve all issues with respect to patentability during the interview, including any issues of patentability raised by the art cited and/or applied in the KIPO search report, if necessary, in accordance with U.S. patent laws. An applicant also must be prepared to discuss any proposed amendment or arguments previously submitted and discuss and resolve any relevant issues that arise. The interview talking points posted at http://www.uspto.gov/web/offices/pac/dapp/opla/preognotice/fai_talking_points.pdf represent a non-exhaustive list of potential topics for discussion in a first action interview. The talking points are available to the public and the patent examining corps to assist and facilitate comprehensive and effective first action interviews.

Multiple proposed amendments or sets of arguments are not permitted.

Inventor Participation: Inventor participation in the interview process is encouraged, as it may assist in the resolution of outstanding rejections and/or objections.

If an applicant fails to: (1) Respond to the Pre-Interview Communication within the time period for reply or (2) conduct the interview within two months or sixty days, whichever is longer, from the filing of the Applicant Initiated Interview Request Form, the Office will enter a First-Action Interview Office Action. Therefore, the consequence for failure to respond to the Pre-Interview Communication is issuance of a First-Action Interview Office Action without the benefit of an interview.

The interview will be conducted in accordance with the procedure provided in MPEP section 713 except as otherwise provided in this notice. The interview should focus on and include:

1. A discussion to assist the examiner in developing a better understanding of the invention;

2. A discussion to establish the state of the art as of the effective filing date of the claimed invention, including the prior art references cited by the applicant and the examiner (as only applications subject to the First Inventor to File provisions of the Leahy-Smith America Invents Act (AIA) are eligible for this pilot program); and

3. A discussion of the features of the claimed subject matter which make the invention patentable, including any proposed amendments to the claims.

4. A discussion regarding any issues of patentability raised by the art cited and/or applied in the KIPO search report, if necessary, in accordance with U.S. patent laws.

1. An agreement is reached and all claims are in condition for allowance. If the applicant and the examiner reach agreement that the application is in condition for allowance, the examiner must complete an Interview Summary (PTOL-413), enter and attach any necessary amendments or arguments (e.g., the proposed amendment and/or an examiner's amendment), generate a notice of allowability (PTOL-37), and attach a copy of the completed Applicant Initiated Interview Request Form. If the examiner agrees to enter the proposed amendment, the examiner must annotate the first page of the proposed amendment (e.g., “OK to enter”). In an in-person interview, a courtesy copy of the completed forms will be given to the applicant at the conclusion of the interview. The completed forms will then be promptly made of record with a Notice of Allowability and a Notice of Allowance and Fees Due (PTOL 85). The Notice of Allowability and the Notice of Allowance, interview summary, and all amendments made of record along with a completed Notice of References Cited form PTO-892 listing any newly cited references will also be forwarded to KIPO for consideration by the KIPO examiner of record for the corresponding KIPO counterpart application.

2. An agreement as to allowability is not reached. If the applicant and the examiner do not reach agreement during the interview, the examiner will set forth any unresolved, maintained, or new requirements, objections, and rejections in the First-Action Interview Office Action. The examiner also will complete an Interview Summary, highlighting the basis for any unresolved, maintained, or new requirements, objections, and rejections as well as resolution of any issues that occurred during the interview, attaching a copy of the completed Applicant Initiated Interview Request Form and any proposed amendments or arguments. In a personal interview, a courtesy copy of the completed forms may be given to the applicant at the conclusion of the interview. The completed forms will be promptly made of record.

For this situation, the First-Action Interview Office Action is deemed the first Office action on the merits. Because the requirements, objections, and grounds of rejection are provided in the Pre-Interview Communication and the First-Action Interview Office Action, the applicant has sufficient notice of the requirements, objections, and grounds of rejection. To avoid abandonment of the application, the applicant must, within two months or sixty days, whichever is longer, from the mailing or notification date of the First-Action Interview Office Action, file a reply in compliance with 37 CFR 1.111(b)-(c). This time period for reply is extendable under 37 CFR 1.136(a) for only two additional months. The First-Action Interview Office Action, interview summary and a completed Notice of References Cited form PTO-892 listing any newly cited references also will be forwarded to KIPO for consideration by the KIPO examiner of record for the corresponding KIPO counterpart application.

3. An agreement as to allowability is not reached, and applicant wishes to convert the previously submitted proposed amendment into a reply under 37 CFR 1.111(b) and waive receipt of a First-Action Interview Office Action. Applicants may request the USPTO to enter the previously filed proposed amendment and/or arguments as a reply under 37 CFR 1.111 to address every rejection, objection, and requirement set forth in the Pre-Interview Communication, waiving a First-Action Interview Office Action, if the proposed amendment and/or arguments comply with the requirements of 37 CFR 1.121 and 37 CFR 1.111(b)-(c). If the examiner agrees to enter the proposed amendment as the reply under 37 CFR 1.111 to the Pre-Interview Communication, the examiner must annotate the first page of the proposed amendment (e.g., “OK to enter”), and provide a statement in the Interview Summary (e.g., “Applicant requested to enter the proposed amendment as a reply under 37 CFR 1.111 to the Pre-Interview Communication, waiving the First-Action Interview Office Action”). The applicant cannot file any additional amendment and/or arguments until the mailing or notification of the next Office action.

In this situation, a First-Action Interview Office Action will not be provided to the applicant. The Pre-Interview Communication and the interview will be deemed the first Office action on the merits. The interview summary and a completed Notice of References Cited form PTO-892 listing any newly cited references, if any, also will be forwarded to KIPO for consideration by the KIPO examiner of record for the corresponding KIPO counterpart application. The examiner will enter the proposed amendment and/or arguments, consider it as the reply under 37 CFR 1.111, and provide an Office action in response to the reply. The Office action will be the second Office action on the merits, and thus it could be a final Office action, a notice of allowability, or other appropriate action.

A complete written statement as to the substance of the interview with regard to the merits of the application must be made of record in the application, whether or not an agreement with the examiner was reached at the interview. It is the applicant's responsibility to make of record the substance of an interview, and it is the examiner's responsibility to see that such a record is made and to correct inaccuracies, including those which bear directly on the question of patentability. See MPEP section 713.04.

The Defense Logistics Agency notices for systems of records subject to the Privacy Act of 1974, as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or from the Defense Privacy and Civil Liberties Division Web site at http://dpcld.defense.gov/.

The proposed system report, as required by the Privacy Act of 1974, as amended, was submitted on June 19, 2015, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

Title; Associated Form; and OMB Number: USMC Children, Youth and Teen Programs (CYTP) Registration Packet; NAVMC 11720, NAVMC 1750/4, and NAVMC 1750/5; OMB Control Number 0703-XXXX.

Needs and Uses: The information collected on these forms is used by Marine Corps Family Care Programs (MFP) and Inclusion Action Team (IAT) professionals for purposes of patron registration, to determine the general health status of patrons participating in CYTP activities and if necessary the appropriate accommodations for the patron for full enjoyment of CYTP services, and provides consent for information to be exchanged between MFP personnel and other designated individuals or organizations about a patron participating in MFP. These forms may potentially be completed by a member of the public. Collected information will be filed pursuant to the Privacy Act System of Records Notice NM01754-3.

NAVMC 1750/5 USMC Children, Youth & Teen Programs (CYTP) Registration Form:

Annual Burden Hours: 56,000.

Number of Respondents: 112,000.

Responses per Respondent: 1.

Average Burden per Response: 30 minutes.

Frequency: Annually.

NAVMC 1750/4 USMC Children, Youth & Teen Programs (CYTP) Health Assessment and Health Screening Tool for Inclusion Action Team (IAT):

Annual Burden Hours: 56,000.

Number of Respondents: 112,000.

Responses per Respondent: 1.

Average Burden per Response: 30 minutes.

Frequency: Annually.

NAVMC 11720 USMC Family Care Programs—Consent to Release Information:

Annual Burden Hours: 32,167.

Number of Respondents: 193,000.

Responses per Respondent: 1.

Average Burden per Response: 10 minutes.

Frequency: Annually.

Total:

Affected Public: Individuals or Households.

Annual Burden Hours: 165,000.

Number of Respondents: 198,000.

Responses per Respondent: 2.

Annual Responses: 396,000.

Average Burden per Response: 25 minutes.

Frequency: Annually.

Respondents are MFP patrons who provide information to MFP and IAT personnel in order to allow the child to participate in CYTP activities, determine the general health status of patrons participating in CYTP activities, and if necessary, determine the appropriate accommodations for the patron for full enjoyment of CYTP services, and provide consent for information about the patron from other specified individuals and organizations. These forms provide CYTP personnel with demographic information and emergency contact information. It also allows parents/guardians to provide consent for specific activities that may take place while participating in CYTP. Failure to provide information may limit MFP's ability to properly consider participants' health and special needs, adversely impact individuals from participation in CYTP activities, and will limit MFP's ability to communicate with organizations or individuals outside of DoD which may adversely affect available services. Having these forms is essential in providing the requested child care services and activities to all CYTP participants, and maintaining the continuity of care, safety and health of CYTP participants.

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: EDFacts Data Collection School Years 2016-17, 2017-18, and 2018-19.

OMB Control Number: 1850—NEW (previously 1875-0240).

Type of Review: A revised information collection.

Respondents/Affected Public: State, Local or Tribal Government.

Total Estimated Number of Annual Responses: 61.

Total Estimated Number of Annual Burden Hours: 126,880.

Abstract: EDFacts is a U.S. Department of Education (ED) initiative to collect, analyze, report on and promote the use of high-quality, pre-kindergarten through grade 12 (pre-K-12) performance data for use in education planning, policymaking, and management and budget decision making to improve outcomes for students. EDFacts enables the National Center for Education Statistics (NCES) to report on students, schools, staff, services, and education outcomes at the state, district, and school levels, by centralizing data provided by state education agencies, local education agencies, and schools. This centralized approach provides ED users with the ability to efficiently analyze and report on submitted data and has reduced the reporting burden for state and local data producers through the use of streamlined data collection, analysis, and reporting tools. EDFacts collects information on behalf of ED grant and program offices for approximately 180 data groups for all 50 states, Washington DC, Puerto Rico, and seven outlying areas and freely associated states (American Samoa, Federated States of Micronesia, Guam, Marshall Islands, Commonwealth of the Northern Mariana Islands, Republic of Palau, and the U.S. Virgin Islands), the Department of Defense Education Activity (DoDEA), and the Bureau of Indian Education (BIE). NCES seeks authorization from OMB to continue its EDFacts data collection and is requesting a new clearance for the 2016-17, 2017-18, and 2018-19 school years in order to continue to provide EDFacts data to Department of Education program offices, as well as SEAs, LEAs, and schools. This collection package will be available for public comment during two open periods, a 60 day and a 30 day, and revisions will be made accordingly. This submission includes a few proposed changes to the EDFacts data collection. In addition to reviewing the proposed changes (detailed in Attachment C and the B Attachments), ED requests that SEAs and other stakeholders respond to the directed questions found in Attachment D.

The U.S. electricity sector operates a complex and highly reliable electric power system, upon which the Nation's economy and security depend. The North American Bulk Power System (BPS) is extensive, consisting of various infrastructure components, including transformers, switches, transmission towers and lines, control centers, and computer controls. Of the BPS' physical infrastructure, large power transformers (LPTs) are critical components, because the reliable operation of the BPS depends heavily on the safe and efficient operation of a network of interconnected LPTs.

LPTs have long been a concern for the U.S. electricity sector because the failure of a single unit can interrupt electricity service to a large number of customers and lead to collateral damage, and it could be difficult to quickly replace it. LPTs are large, custom-designed pieces of equipment that entail a significant capital expenditure and a long lead-time to manufacture and ship. LPTs are not usually interchangeable. System owners often own and maintain spare LPTs at a number sufficient to mitigate risks from premature failure. The limited availability of spare LPTs, and the long lead times to procure replacements, could pose a potential threat to the availability and reliability of the Nation's bulk power system in the event of an emergency where a relatively large number of existing LPTs are damaged or destroyed.

Large-scale disruptions to the U.S. BPS are rare; however, it faces a wide variety of evolving threats, including but not limited to: Cyber and physical security intrusions, weather-related incidents; geomagnetic disturbances (GMD); and electromagnetic pulse (EMP) effects. The electricity sector serves one of the four lifeline functions as identified by the Department of Homeland Security, which means that its reliable operation is so critical that a disruption or loss of electricity will directly affect the security and resilience of other critical infrastructure and the Nation.

The recently released “Quadrennial Energy Review, Energy Transmission, Storage and Distribution Infrastructure Report, April 2015,” recommends that “DOE should coordinate with the Department of Homeland Security and other Federal agencies, States, and industry—an initiative to mitigate the risks associated with the loss of transformers (p. 2-42).” This request for comment is an initial step in executing that recommendation. Part of the national strategy to reduce risk from large power transformers, which has been under development by the DOE, includes assessing the need for a reserve of LPTs.

For the reasons stated above, DOE is exploring possible National strategies to mitigate risk to the reliability of the bulk power system arising from the loss of LPTs. This RFI provides the public, and industry stakeholders, the opportunity to provide their view on the development and structure of a National program to establish and maintain large power transformer reserves in the United States. The intent of this RFI is to solicit information pertinent to the need and viability—regulatory, economic, and technical—of such a program. The information obtained is meant to be used by DOE for program design and strategy development purposes. In your comments, please reference the question(s) to which you are responding. Please also provide supporting information if noted, including studies, reports, data, and examples relevant to mitigating the risks associated with the loss of LPTs.

Is there a need for a National Power Transformer Reserve? How would such a reserve affect the reliability and resiliency of the North American bulk power system? Are there alternatives to a power transformer reserve program that can help ensure the reliability, resiliency, and recovery of the bulk power system? Is there a need for a nationally-maintained inventory of large power transformers?

What types and sizes of power transformers should be considered for inclusion in a transformer reserve program versus operational spare capacity? What are the design considerations for replacement transformers to support the bulk power system?

What would be an appropriate structure for procuring and inventorying power transformers? How, and by whom, should a program of this type be administered? How would a transformer reserve be funded?

Is it technically feasible to develop a reserve of large power transformers when most are custom engineered? Is additional research and development (R&D) necessary to develop suitable replacement transformers that can be rapidly deployed from inventory in the event of an emergency?

How should procurement, maintenance and management of the reserve power transformers be conducted? For example, should manufacturers be pre-qualified, and if so, according to what criteria?

What are the critical supply chain components for the manufacture and delivery of large power transformers (e.g., electrical steel, copper, silicone, high voltage bushings, etc.)? Are there shortages or other considerations that could necessitate using the Defense Production Act Priority Ratings to ensure sufficient parts are available in a time of need? Are there related skilled workforce issues?

Is there adequate manufacturing capacity to support a transformer reserve program? What is the lead time for engineering, manufacture, and delivery of large power transformers? Are there approaches that could help to speed manufacture and delivery of large power transformers?

What specialized transport infrastructure would be necessary to ship large power transformers from manufacturing site to storage locations, and from storage locations to field site in the event of an emergency? What should be the number and location of transformer storage sites? What are feasible delivery times for LPTs that reside in a reserve to an affected site?

Are there adequate domestic engineering and installation resources available throughout the United States to install multiple bulk power transformers simultaneously? What additional resources would be necessary?

What criteria should be used for activating and deploying transformers from the reserve? How would deployment be funded?

Are there additional concerns regarding a National Power Transformer Reserve Program that need to be considered?

BETO seeks to collect information from key industry, university, national laboratory, and other stakeholders regarding the challenges associated with the coproduction of biomass-derived chemicals, products, and biofuels. The following topic areas of interest are intended to be covered at the workshop:

1. Identifying and evaluating economic drivers for producing bioproducts.

2. Identifying and prioritizing targets for bioproducts produced from biofuel waste streams, coproduced with biofuels, or produced at standalone facilities.

3. Identifying research and development challenges associated with bioproducts produced from biofuel waste streams, coproduced with biofuels, or produced at standalone facilities.

4. Identifying environmental considerations (i.e., life-cycle analysis), carbon percentage dedicated to fuels vs. products (i.e., split stream), and ideal intermediates for bioproduct production to enable biofuels.

Members of the public are welcome to attend the workshop. Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 4 p.m. MDT, July 15, 2015. Early registration is recommended because facilities are limited and, therefore, DOE may limit the number of participants from each organization. To register for the public workshop, please visit http://www.yesevents.com/MEGABio2015. Registrants will receive confirmation after they have been accepted. If you need special accommodations due to a disability, please contact Andrea Bailey no later than July 15, 2015.

This information collection request contains: (1) OMB No. 1905-0165; (2) Information Collection Request Title: Petroleum Supply Reporting System; (3) Type of Request: Three-year extension; (4) Purpose: The Federal Energy Administration Act of 1974 (15 U.S.C. 761 et seq.) and the DOE Organization Act (42 U.S.C. 7101 et seq.) require the EIA to carry out a centralized, comprehensive, and unified energy information program. This program collects, evaluates, assembles, analyzes, and disseminates information on energy resource reserves, production, demand, technology, and related economic and statistical information. This information is used to assess the adequacy of energy resources to meet near and longer term domestic demands and to promote sound policymaking, efficient markets, and public understanding of energy and its interaction with the economy and the environment.

The EIA, as part of its effort to comply with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.), provides the general public and other Federal agencies with opportunities to comment on collections of energy information conducted by or in conjunction with the EIA. Also, the EIA will later seek approval for this collection by the Office of Management and Budget (OMB) under Section 3507(a) of the Paperwork Reduction Act of 1995.

The weekly petroleum supply surveys (Forms EIA-800, EIA-802, EIA-803, EIA-804, EIA-805 and EIA-809) are designed to provide an early, initial estimate of weekly petroleum refinery and fractionator operations, inventory levels, and imports of selected petroleum products in a timely manner. The information appears in the publications listed below and is also available electronically on EIA's Web site at http://www.eia.doe.gov/.

Publications: Internet only publications are the Weekly Petroleum Status Report (http://www.eia.gov/petroleum/supply/weekly/), Short-Term Energy Outlook (http://www/forecasts/steo/), and This Week in Petroleum (http://www.eia.gov/petroleum/weekly/).

The monthly petroleum supply surveys (Forms EIA-22M, EIA-810, EIA-812, EIA-813, EIA-814, EIA-815, EIA-816, EIA-817, and EIA-819) are designed to provide statistically reliable and comprehensive monthly information to EIA, other Federal agencies, and the private sector for use in forecasting, policy making, planning, and analysis activities. The information appears in the publications listed below and is also available electronically on EIA's Web site at http://www.eia.doe.gov/.

Publications: Internet only publications are the Petroleum Supply Monthly (http://www.eia.gov/petroleum/supply/monthly/), Company-Level Imports (http://www.eia.gov/petroleum/imports/companylevel/), the Petroleum Supply Annual, Volume 1 (http://www.eia.gov/petroleum/supply/annual/volume1/), the Annual Energy Outlook (http://www.eia.gov/forecasts/aeo/index.cfm); and the Monthly Biodiesel Production Report (http://www.eia.gov/biofuels/biodiesel/production/).

The annual refinery survey (Form EIA-820) provides data on refinery capacities, fuels consumed, natural gas consumed as hydrogen feedstock, and crude oil receipts by method of transportation, for operating and idle petroleum refineries (including new refineries under construction), and refineries shutdown during the previous year. The information appears in the Refinery Capacity Report (http://www.eia.gov/petroleum/refinerycapacity/) and the Refinery Outage Report (http://www.eia.gov/petroleum/refinery/outage/).

Please refer to the proposed forms and instructions for more information about the purpose, who must report, when to report, where to submit, the elements to be reported, detailed instructions, provisions for confidentiality, and uses (including possible nonstatistical uses) of the information. For instructions on obtaining materials, see the “For Further Information Contact” section.

(4a) Proposed Changes to Information Collection: The following changes are proposed to the data elements collected on surveys in the Petroleum Supply Reporting System.

We propose the following changes to the geographical detail collected and published on surveys.

Midwest (Petroleum Administration for Defense District 2): EIA proposes two new subregions for the Midwest, PADD 2. as follows: Subregion PADD 2A will include Minnesota, North Dakota, South Dakota, and Wisconsin and Subregion PADD 2B will include Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Missouri, Nebraska, Ohio, Oklahoma, and Tennessee. Given the increased production of crude oil in the proposed new PADD 2A Subregion, there is increasing interest in the flows of crude oil into and out of that area. This change will allow EIA to track movements of crude oil from Subregion PADD 2A to other parts of the Midwest and to also provide more detailed regional data on inventories of propane, a key heating fuel, during winter months. This change applies to Forms EIA-812, EIA-813, and EIA-817.

Puerto Rico and the U.S. Virgin Island (PADD 6): We propose to add PADD 6 because this information is needed to report to the International Energy Agency (IEA). This change applies to Forms EIA-813 and EIA-817.

Texas Gulf Coast Refining District: We propose to collect data on crude oil inventories in tank farms in the Texas Gulf Coast as a subset of total PADD 3 inventories, in a manner comparable to those collected for tank farms in Cushing, Oklahoma. The Texas Gulf Coast is composed of the counties that define the Texas Gulf Coast Refinery District. This area includes the Houston Ship Channel and the Corpus Christi area, both areas where crude oil inventory levels are critical for oil markets. This change applies to Forms EIA-803 and EIA-813.

We propose to revise and rearrange categories for reporting biofuel, distillate fuel oil (by sulfur category), hydrocarbon gas liquids, kerosene-type jet fuel, and motor gasoline on select surveys as indicated below.

Biofuels: We propose to collect data on biofuel products for the following categories (and subcategories): Ethanol (cellulosic and noncellulosic), Butanol, Biodiesel, Biojet and biokerosene (cellulosic and noncellulosic), bionaphtha and biogasoline (cellulosic and noncellulosic), and other (cellulosic and noncellulosic). This change assures continued relevance of the data and improves market coverage by accommodating potential for introduction of new biofuels. This change applies to all the monthly survey forms except Forms EIA-813 and EIA-816.

Distillate Fuel Oil: We propose to reduce from four to three the number of categories of distillate fuel oil, based on sulfur content. We currently collect the following four distillate categories (by sulfur content): (1) Less than 15 parts per million (ppm), (2) 15-500 ppm, (3) 500-2000 ppm, and (4) greater than or equal to 2000 ppm. We plan to merge the latter two categories, 500-2000 ppm, and greater than or equal to 2000 ppm, into a single category—distillates with greater than 500 ppm of sulfur. Federal and State legislation requires more areas to use distillate fuel that contains less than 15 ppm sulfur, also known as Ultra Low Sulfur Diesel (ULSD) Many Northeast states also require that ULSD be used for heating purposes. While there are diminishing volumes of 15-500 ppm distillate fuel produced currently, capturing its production and disposition is important for maintaining data quality control, so we've proposed to continue collecting it even though we intend to publish data for the categories of ULSD and other distillate fuel.

Hydrocarbon Gas Liquids (formerly Natural Gas Plant Liquids (NGPL) and Liquefied Refinery Gases (LRG): We propose to adopt EIA's framework for Hydrocarbon Gas Liquid that was described in the report “Hydrocarbon Gas Liquids (HGL): Recent Market Trends and Issues,” released November, 2014, and available at http://www.eia.gov/analysis/hgl. We have rearranged the existing categories to include the following categories (and sub-categories): Ethane/Ethylene (Ethane by sources (Gas Plant and Refinery) and Ethylene); Propane/Propylene (Propane by source (Gas Plant and Refinery)) and Propylene); Normal Butane/Butylene (Normal Butane by sources (Gas Plant and Refinery (Refinery Grade and excluding Refinery Grade)) and Butylene); Isobutane/Isobutylene (Isobutane by sources (Gas Plant and Refinery) and Isobutylene; Natural Gasoline (previously Pentanes Plus). We also propose to add categories for Plant Condensate and Consumer and Export-Grade Propane. The primary reason for this rearrangement of categories and subcategories is to use the same categories to collect data consistently across all EIA surveys. This change applies to all of the survey forms except for Forms EIA-22M, 803, 809, and 813.

Kerosene-type Jet Fuel: We propose to discontinue breaking out the end use categories of commercial and military and only collect total kerosene jet-fuel as a single category. Military jet fuel represents less than three percent (3%) of all jet fuel produced in 2014. We expect sales for military use to continue to decline further as a result of the military's decision to allow military aircraft to use commercial grade jet fuel. We do not foresee any impact on analytical capabilities as a result of this change. This change applies only to Forms EIA-800 and EIA-810.

Motor Gasoline: We propose to reduce the number of motor gasoline categories from nine to five. We propose to collect the following data on motor gasoline and blending components: Motor gasoline blended with less than 51 volume percent ethanol (<E51), motor gasoline blended with 51 volume percent ethanol or more (≥E51), motor gasoline not blended with ethanol, motor gasoline blending components, and reformulated blendstock for oxygenate blending (RBOB). Currently, the gasoline categories are based upon reformulated and conventional gasoline. The new categories EIA proposes are based on gasoline with ethanol and gasoline without ethanol. We expect this change will support and improve the utility of the information needed for important analytical and policy issues relating to gasoline markets at this time and in the future. This change applies to all of the survey forms except for Forms EIA-22M, 803, 809, and 813.

Pipeline and Tank Farm activities: We propose to collect data separately for pipelines and tank farms. These changes apply to the following Forms: EIA-803 and EIA-813.

Storage Capacity: We propose to discontinue storage capacity on Forms EIA-812 and EIA-819. We currently collect storage capacity twice a year (as of March 31 and September 30). Collecting storage capacity of product pipelines and ethanol plants did not provide useful information for assessing available petroleum supplies. Product pipeline inventories are used for operational purposes, not commercial purposes. Stocks held at fuel ethanol plants also are primarily for operational rather than commercial purposes. EIA will still collect storage capacity data for petroleum products held at terminals and refineries. Discontinuing the collection of storage capacity on Forms EIA-812 and EIA-819 will eliminate confusion in analyzing storage capacity utilization and improve data quality. Storage Capacity in Operation: We propose to discontinue reporting storage capacity by the subcategories for exclusive use and leased to others on Forms EIA-813 and EIA-815. This data is no longer needed for analysis purposes.

Stocks in Transit: We propose to discontinue collecting stocks in transit by tanker, barge and rail on Forms EIA-800, 802, 803, 805, 809, 810, 812, 813, 815, 816, and 819. EIA proposes to collect the stocks in transit data at the corporate level on the EIA-817. Collecting this stock information on one form reduces respondent burden and will improve data quality.

Unit of Measurement: We propose to collect data in actual barrels rather than thousand barrels. For some of our data collection we are missing small volumes from respondents because they are reporting in thousands of barrels. These missing volumes may not add up to a large volume, but data for some small-volume products, such as certain biofuels and fuels blended with biofuels, are important for assessment of important policy decisions. For example, if a respondent produces less than 500 barrels of E85, they would report that production as zero (0) when using current thousand barrels reporting units. Under this proposal, they would report the actual volume they produced. Rather than collecting information by two different units of measurement using barrels, EIA proposes to apply this change consistently across all of the surveys except for the EIA-22M which collects data in gallons.

We propose to make the following survey-specific changes to forms in this program.

We propose to change the scope and title of the EIA-22M, “Monthly Biodiesel Production Report” to the EIA-22M, “Biodiesel, Biojet, Biokerosene and Renewable Diesel Report.” We are expanding the survey to collect data on renewable fuels in addition to biodiesel as growth is anticipated in the renewable fuels industry in the future.

We propose to eliminate parts 3D “Sales of B100 and blended biodiesel” and 3E “End use sales of biodiesel” from the current Form EIA-22M. Data from these sections of the survey form were found not to be useful for analysis of available biodiesel supplies.

We propose to expand part 2A of the existing Form EIA-22M to include capacities of renewable diesel fuel plants in addition to biodiesel producers. We also propose to expand part 3A of the existing Form EIA-22M to account for production and blending of noncellulosic biofuels (biojet, biokerosene, renewable diesel fuel, and other) and cellulosic biofuels (cellulosic distillate fuel, cellulosic biojet and biokerosene, and other). Information on production and blending are relevant to understand activities of the renewable and biofuel industries.

We propose to collect Input and Production of Unfinished Oils instead of Total Input” on Part 3: Refinery and Fractionator Activity on Form EIA-800, “Weekly Refinery and Fractionator Report.” We are trying to collect more relevant data for data users on refinery activities.

We propose to discontinue collecting data on volumes of Ultra-Low Sulfur Diesel Fuel (15 ppm and under) downgraded during the report week on Part 4: Diesel Fuel Downgrade on Form EIA-802, “Weekly Product Pipeline Report.” This data is no longer relevant.

We propose to change the list of countries in Part 4: Total U.S. Crude Oil Imports by Country of Origin and to adopt the U.S. Census Bureau's country codes on Form EIA-804, “Weekly Imports Report.” We propose to allow companies to report imports from 31 countries from which the U.S. imported the most crude oil during 2015, and for Iran. Crude oil imports from any other countries are reported in the “Other” country category. We anticipate this change will enhance information quality.

We propose to collect ethanol and to discontinue collecting denatured and undenatured ethanol separately on Form EIA-809, “Weekly Oxygenate Report.”

We propose to discontinue collecting lease inventories on Form EIA-813, “Monthly Crude Oil Report.” Lease inventories are inventories stored at crude oil production sites. The purpose of stocks held on oil and gas producing leases (lease stocks) is to facilitate oil and gas production operations. Lease stocks are typically held only long enough for oil to be picked up by trucks or otherwise removed from production sites. While the total number of barrels held as lease stocks is significant, the barrels are widely dispersed at producing sites with only small quantities at any given location. For these reasons, we have determined that continued tracking of lease stocks on EIA surveys has limited value for assessment of crude oil supplies available to markets. In addition, our research has shown that some or all of the barrels included as lease stocks are actually outside of the U.S. and regional crude oil balances developed by EIA because barrels may be recorded as crude oil production, which is the first supply component of our balance, only after the barrels are withdrawn from lease stocks. EIA will create and publish historical data series of crude oil stocks excluding lease stocks in order to meet analyst requirements for crude oil inventory data that are consistent over time.

We propose to continue to collect data on API gravity, sulfur content, processing plant name and location of crude oil and to continue to collect data on sulfur categories for distillate fuels. However, we will discontinue collecting data for the processing plants name and location of unfinished oils and motor gasoline blending components on Form EIA-814, “Monthly Imports Report.” We have determined that the data proposed for elimination on Form EIA-814 have limited value and the respondent burden for reporting was not justified.

No additional changes proposed for Form EIA-815, “Monthly Terminal Blenders Report.”

We propose to add plant condensate to Part 2 of Form EIA-816, “Monthly Natural Gas Liquids Report.” In addition, we are asking in Part 2 for the volume blended into crude oil. The quantity of plant condensate blended into crude oil is important as a way to balance crude oil supply and disposition and thereby reduce the crude oil adjustment (unaccounted-for crude oil) quantity.

We propose to change the title of Form EIA-817, “Monthly Tanker and Barge Movements Report” to EIA-817, Monthly Tanker, Barge, and Rail Movements and Stocks in Transit Report.” We intend to collect rail movements and stocks in transit for all Petroleum Administration for Defense Districts (PADDs) and select sub-PADDs on this survey. Rail movements of crude oil and petroleum products have increased in recent years due to changes in the regional distribution of crude oil, petroleum product, and biofuel supplies. Based on cognitive interviews with companies that report on Form EIA-817, respondents indicated that reporting stocks in transit on a company basis reduces respondent burden and improves data quality.

We propose to change the title of Form EIA-819 “Monthly Oxygenate Report” to EIA-819 “Monthly Biofuel and Oxygenate Report”. We also plan to reorganize the Form EIA-819 to clarify reporting requirements. The new Form EIA-819 will have separate sections for reporting biofuel production, non-biofuel oxygenate production, and blending activity involving biofuels, petroleum products, and hydrocarbon gas liquids. In addition, product details will be added to identify products as non-cellulosic biofuels (ethanol, butanol, bionaphtha and biogasoline, and other) and cellulosic biofuels (cellulosic ethanol, cellulosic naphtha and gasoline, and other). Currently EIA collects petroleum refinery fuel consumption data, but not renewable fuel plant consumption data. Collecting this data will allow analysts and modelers to gauge trends in energy efficiency at ethanol and biodiesel plants as they do now with data collected from petroleum refineries.

Gasoline products included in Part 6 “Blending Activity including Addition of Denaturants” will be updated with new gasoline products described earlier. We also propose to add normal butane and isobutane in addition to natural gasoline (formerly pentanes plus) to Part 6. We are also expanding the coverage from the 50 states and the District of Columbia, to the 50 states, the District of Columbia and the Virgin Islands and Puerto Rico.

In addition to clarifying reporting requirements by separating activities into separate sections of the form, the addition of new products will position EIA to provide data on new biofuel products that may become important sources of U.S. fuel supplies.

We propose to redesign the layout of Part 1 and 2 of the forms due to the new electronic modes of data collection. Most of this information will be prepopulated and we will use skip patterns to request respondents provide updates as needed. We are doing this to reduce respondent burden. This change applies to all of the surveys.

Please refer to the proposed forms and instructions for more information about the purpose of the survey, who must submit, when to submit, provision for confidentiality, elements to be reported, and uses (including nonstatistical uses) of the information. These materials are available on EIA's Web site at http://www.eia.gov/survey/.

(5) Annual Estimated Number of Respondents: 4,503.

(6) Annual Estimated Number of Total Responses: 102,656.

(7) Annual Estimated Number of Burden Hours: 198,321.

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: EIA estimates that there are no additional costs to respondents associated with the surveys other than the costs associated with the burden hours. The information is maintained in the normal course of business. The cost of burden hours to the respondents is estimated to be $14,273,162 (198,321 burden hours times $71.97 per hour), which represents a reduction of 15,241 burden hours from the prior renewal of this collection in 2013. Therefore, other than the cost of burden hours, EIA estimates that there are no additional costs for generating, maintaining and providing the information.

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

On January 20, 2010, the Alaska Department of Environmental Conservation (ADEC) submitted an application titled “Water Online Application System (OASys)” for revision/modification of its EPA-authorized authorized Part 123 program under title 40 CFR. EPA reviewed ADEC's request to revise/modify its EPA-authorized Part 123—EPA Administered Permit Programs: The National Pollutant Discharge Elimination System program and, based on this review, EPA determined that the application met the standards for approval of authorized program revision/modification set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Alaska's request to revise/modify its Part 123—EPA Administered Permit Programs: The National Pollutant Discharge Elimination System program to allow electronic reporting under 40 CFR part 122 is being published in the Federal Register.

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

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

Abstract: EPA currently requires an entity to be certified in order to be considered a Minority Business Enterprise (MBE) or Women's Business Enterprise (WBE) under EPA's Disadvantaged Business Enterprise (DBE) Program. To qualify as an MBE or WBE under EPA's programs, an entity must establish that it is owned and/or controlled by socially and economically disadvantaged individuals who are of good character and are citizens of the United States. The EPA DBE Program also includes contract administration requirements designed to prevent unfair practices that adversely affect DBEs.

Form Numbers: 6100-1a, 6100-1b, 6100-1c, 6100-1d, 6100-1e, 6100-1f, 6100-1g, 6100-1h, 6100-1i, 6100-2, 6100-3, and 6100-4.

Respondents/Affected Entities: All recipients of EPA financial assistance agreements, and entities receiving identified loans under a financial assistance agreement capitalizing a revolving loan fund.

Respondent's Obligation to Respond: Required to obtain or retain a benefit per 40 CFR part 33, subpart B and 40 CFR part 33, subpart E.

Estimated Number of Respondents: 1,865 (total).

Frequency of Response: Certification: On occasion.

Total Estimated Burden: 11,614 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total Estimated Cost: $362,712 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in the Estimates: There is no change of hours in the total estimated respondent burden compared with the ICR currently approved by OMB.

The Bureau has suspension and debarment authority pursuant to 47 CFR 54.8 and 0.111(a)(14). Icon's conviction for making a false statement in violation of 18 U.S.C. 1002(a)(2), in connection with fraudulent claims against the Lifeline program, requires the Bureau to suspend the Company from participating in activities associated with the Lifeline program. Attached is the notice of suspension and initiation of debarment proceeding (Notice of Suspension), DA 15-627, which was mailed to Icon and released on May 26, 2015. The complete text of the Notice of Suspension is available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portal II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. In addition, the complete text is available on the FCC's Web site at http://www.fcc.gov.

The Bureau has suspension and debarment authority pursuant to 47 CFR 54.8 and 0.111(a)(14). Mr. Perez-Zumaeta's conviction for money laundering in violation of 18 U.S.C. 1957(a) and 18 U.S.C. 2, in connection with fraudulent claims against the Lifeline program, requires the Bureau to suspend him from participating in activities associated with the Lifeline program. Attached is the notice of suspension and initiation of debarment proceeding (Notice of Suspension), DA 15-669, which was mailed to Mr. Perez-Zumaeta and released on June 8, 2015. The complete text of the Notice of Suspension is available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portal II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. In addition, the complete text is available on the FCC's Web site at http://www.fcc.gov.

Dear Mr. Perez-Zumaeta: The Federal Communications Commission (Commission) has received notice of your conviction for money laundering in violation of 18 U.S.C. 1957(a) and 18 U.S.C. 2, in connection with fraudulent claims against the federal Lifeline universal service support mechanism (Lifeline program).1 Pursuant to its rules, the Enforcement Bureau (Bureau) hereby suspends you from participating in activities associated with the Lifeline program.2 The Bureau is also commencing a proceeding to debar you from future participation in the Lifeline program.3

Any person who has “defrauded the government or engaged in similar acts through activities associated with or related to the [Lifeline program]” may be prohibited from receiving the benefits associated with that program.4 The Lifeline program is a government program that provides support to eligible telecommunications carriers (ETCs) that in turn offer discounts on telephone service for eligible low-income consumers.5 An ETC may receive reimbursement in connection with the Lifeline program only if it certifies as part of its reimbursement request that it is in compliance with the Lifeline rules.6

You owned and managed PSPS Sales LLC (PSPS), a California entity that recruited low-income individuals to apply for Lifeline telephone service through Icon Telecom, Inc. (Icon).7 On June 12, 2014, Icon pled guilty to knowingly making a false statement to the Universal Service Administrative Company in connection with fraudulent claims against the Lifeline program.8 According to court records, you were charged with directing PSPS workers to enroll fictitious customers and falsify Lifeline recertification forms for use in Icon's fraudulent scheme.9 On November 7, 2014, you pled guilty to one count of money laundering for depositing a $52,390.00 check from Icon into a PSPS bank account, despite knowing that more than $10,000.00 of those funds was the result of criminal fraud against the Commission.10

Pursuant to section 54.8(b) of the Commission's rules,11 your conviction requires the Bureau to suspend you from participating in any activities associated with or related to the Lifeline program, including receiving funds or discounted services through the Lifeline program, or consulting with, assisting, or advising applicants or service providers regarding the Lifeline program.12 Your suspension becomes effective upon either your receipt of this letter or its publication in the Federal Register, whichever comes first.13

In accordance with the Commission's suspension and debarment rules, you may contest this suspension or its scope by filing arguments, with any relevant documents, within thirty (30) calendar days of your receipt of this letter or its publication in the Federal Register, whichever comes first.14 Such requests, however, will not ordinarily be granted.15 The Bureau may reverse or limit the scope of a suspension only upon a finding of extraordinary circumstances.16 The Bureau will decide any request to reverse or modify a suspension within ninety (90) calendar days of its receipt of such request.17

In addition to your immediate suspension from the Lifeline program, your conviction is cause for debarment as defined in section 54.8(c) of the Commission's rules.18 Therefore, pursuant to section 54.8(b) of the Commission's rules, your conviction requires the Bureau to commence debarment proceedings against you.19

As with the suspension process, you may contest the proposed debarment or its scope by filing arguments and any relevant documentation within thirty (30) calendar days of receipt of this letter or its publication in the Federal Register, whichever comes first.20 The Bureau, in the absence of extraordinary circumstances, will notify you of its decision to debar within ninety (90) calendar days of receiving any information you may have filed.21 If the Bureau decides to debar you, its decision will become effective upon either your receipt of a debarment notice or publication of the decision in the Federal Register, whichever comes first.22

If and when your debarment becomes effective, you will be prohibited from participating in activities associated with or related to the Lifeline program for three years from the date of debarment.23 The Bureau may set a longer debarment period or extend an existing debarment period if necessary to protect the public interest.24

Please direct any response, if sent by messenger or hand delivery, to Marlene H. Dortch, Secretary, Federal Communications Commission, 445 12th Street SW., Room TW-A325, Washington, DC 20554 and to the attention of Celia Lewis, Paralegal Specialist, Investigations and Hearings Division, Enforcement Bureau, Room 4-A422, Federal Communications Commission, 445 12th Street SW., Washington, DC 20554 with a copy to Kalun Lee, Deputy Chief, Investigations and Hearings Division, Enforcement Bureau, Room 4-C237, Federal Communications Commission, 445 12th Street SW., Washington, DC 20554. All messenger or hand delivery filings must be submitted without envelopes.25 If sent by commercial overnight mail (other than U.S. Postal Service (USPS) Express Mail and Priority Mail), the response must be sent to the Federal Communications Commission, 9300 East Hampton Drive, Capitol Heights, Maryland 20743. If sent by USPS First Class, Express Mail, or Priority Mail, the response should be addressed to Celia Lewis, Paralegal Specialist, Investigations and Hearings Division, Enforcement Bureau, Federal Communications Commission, 445 12th Street SW., Room 4-A422, Washington, DC 20554, with a copy to Kalun Lee, Deputy Chief, Investigations and Hearings Division, Enforcement Bureau, Federal Communications Commission, 445 12th Street SW., Room 4-C237, Washington, DC 20554. You shall also transmit a copy of your response via email to Celia Lewis, [email protected], and Kalun Lee, [email protected].

If you have any questions, please contact Ms. Lewis via U.S. postal mail, email, or by telephone at (202) 418-7456. If Ms. Lewis is unavailable, you may contact Kalun Lee, Deputy Chief, Investigations and Hearings Division, by telephone at (202) 418-0796 or at the email address noted above.

Section 4314(c) of Title 5, U.S.C. requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more PRBs. The PRB shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any response by the senior executive, and make recommendations to the final rating authority relative to the performance of the senior executive.

The persons named below have been selected to serve on the FLRA's PRB.

William R. Tobey, Chief Counsel; H. Joseph Schimansky, Executive Director, Federal Service Impasses Panel; James E. Petrucci, Director, Dallas Regional Office; Peter A. Sutton, Deputy General Counsel; Sarah Whittle Spooner, Executive Director.

Request for Comment on Information Collection Proposal

The following information collection, which is being handled under this delegated authority, has received initial Board approval and is hereby published for comment. At the end of the comment period, the proposed information collection, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under OMB delegated authority. Comments are invited on the following:

a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;

b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

c. Ways to enhance the quality, utility, and clarity of the information to be collected;

d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

e. Estimates of capital or start up costs and costs of operation, maintenance, and purchase of services to provide information.

Proposal to approve under OMB delegated authority the extension for three years, with revision, of the following report:

Report title: The Banking Organization Systemic Risk Report.

Agency form number: FR Y-15.

OMB control number: 7100-0352.

Frequency: Quarterly.

Reporters: U.S. bank holding companies (BHCs) and savings and loan holding companies (SLHCs) with $50 billion or more of total consolidated assets and any U.S.-based organizations designated as global systemically important banks (G-SIBs) that do not otherwise meet the consolidated assets threshold for BHCs.

Estimated annual reporting hours: One-time implementation: Savings and loan holding companies—1,000 hours; ongoing—54,536 hours.

Estimated average hours per response: One-time implementation: Savings and loan holding companies—1,000 hours; ongoing—401 hours.

Number of respondents: 34.

General description of report: This information collection is mandatory and is authorized by the Dodd-Frank Act (sections 163, 165, and 604), the International Banking Act, the Bank Holding Company Act, and the Home Owners' Loan Act (12 U.S.C. 1462, 1467, and 3106).

Abstract: The FR Y-15 report collects systemic risk data from U.S. BHCs and SLHCs with total consolidated assets of $50 billion or more, and any U.S.-based organization identified as a global systemically important bank (G-SIB) 1 based on data from the previous calendar year that does not otherwise meet the consolidated assets threshold for BHCs. The Federal Reserve uses the FR Y-15 data primarily to monitor, on an ongoing basis, the systemic risk profile of the institutions which are subject to enhanced prudential standards under section 165 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (DFA).2

Current Actions: The Federal Reserve proposes the following revisions to the FR Y-15, which would be effective December 31, 2015:

In September 2014, the Federal Reserve, together with the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency, revised the definition of “total leverage exposure” used to calculate a BHC's supplementary leverage ratio.3 To reflect the revised leverage ratio standard and accompanying disclosure table, the Federal Reserve proposes to collect 10 new items: Posted cash collateral used to offset the negative mark-to-fair value of derivative contracts (item 1(c)), cash variation margin included as an on-balance sheet receivable (item 1(e)), exempted central counterparty legs of client-cleared transactions included in on-balance sheet assets (item 1(f)), effective notional amount offsets and potential future exposure (PFE) adjustments for sold credit protection (item 1(g)), total derivative exposures (item 1(h)), securities financing transaction (SFT) indemnification and other agent-related exposures (item 2(c)), gross value of offsetting cash payables (item 2(d)), total SFT exposures (item 2(e)), other on-balance sheet assets (item 3(a)), and the credit exposure equivalent of other off-balance sheet items (item 4(e)). To maintain consistency with the exposures definition used in the international G-SIB methodology, the Federal Reserve proposes to also collect total exposures prior to regulatory deductions (item 5).

The Federal Reserve proposes to remove nine line items that are not used in the calculation. Four of these are provided by respondents [cash collateral netted against the derivative exposures in item 1(c)(1) (item 1(c)(2)); credit derivatives sold net of related credit protection bought, adjusted for maturity (item 2(b)(3)); unconditionally cancellable credit card commitments (item 2(c)(1)); and other unconditionally cancellable commitments (item 2(c)(2))], two are automatically retrieved from the FR Y-9C (FR Y-9C; OMB No. 7100-0128) [total assets (item 1(a)) and net value of SFTs (item 1(b)(1)], and three are automatically calculated on behalf of the respondent [total on-balance sheet items (item 1(d)), total off-balance sheet items (item 2(g)), and total exposures (item 4)].

The Federal Reserve proposes to adjust the position and names of the remaining items to conform to the revised presentation of the data. This includes moving three of the remaining items which are not required for the exposures calculation to a new memoranda section.

Consistent with the supplementary leverage ratio adopted in September 2014, the Federal Reserve proposes to collect average values over the reporting period.4 For on-balance sheet items, the Federal Reserve proposes collecting averages using daily data. For off-balance sheet items, the Federal Reserve proposes collecting averages using monthly data. This would affect the definitions for all items in Schedule A.

The intra-financial system assets (IFSA) indicator captures the amount of funds deposited with and lent to other financial institutions (item 1), while intra-financial system liabilities (IFSL) only captures deposits. In accordance with the international standard that will be adopted starting with the end-2015 collection,5 the Federal Reserve proposes to correct this asymmetry by adding a new item, borrowings obtained from other financial institutions (item 8), to the IFSL total.

Under the current definitions, certificates of deposit are included in both the IFSL and securities outstanding indicators. To eliminate this double counting, the Federal Reserve proposes to remove certificates of deposit from deposits due to depository institutions (item 7(a)) and deposits due to non-depository institutions (item 7(b)). This change is also scheduled to be adopted in the international standard starting with the end-2015 collection.6

To capture a more holistic measure of securities holdings, the Federal Reserve proposes to update the definition of holdings of securities issued by other financial institutions (item 3) to include the historical cost of equity securities without readily determinable fair values (see FR Y-9C, Schedule HC-F, item 4). To mirror the instructions used in the international G-SIB methodology, the Federal Reserve also proposes to update the definitions for net positive current exposure of SFTs with unaffiliated financial institutions (item 4) and net negative current exposure of SFTs with unaffiliated financial institutions (item 10).

IFSA includes the unused portion of committed lines extended to other financial institutions (item 2). The indicator does not, however, include financial and performance standby letters of credit, which may represent an important source of intra-financial connectivity. To capture this value without affecting the IFSA calculation, the Federal Reserve proposes to collect standby letters of credit extended to other financial institutions as a memorandum item (item M1).

Starting with the end-2015 assessment, the international G-SIB methodology will no longer use a fixed set of exchange rates in converting the payments totals to the reporting currency.7 In accordance with this change, the Federal Reserve proposes allowing FR Y-15 respondents to construct their own exchange rates using a consistent series of exchange rate quotations. This is the method already employed for payments data involving currencies that are outside the scope of the international assessment.

Furthermore, the Basel Committee on Banking Supervision (BCBS) has identified three additional currencies that may be important in measuring the overall substitutability of a firm: Mexican pesos, New Zealand dollars, and Russian rubles. The Federal Reserve proposes capturing payments made in these currencies over the last four quarters as memoranda items. For readability, the Federal Reserve also recommends moving all currencies not listed above (from item 1(m) to item M4) and unsecured settlement/clearing lines provided (from Schedule F, item 11 to item M5).

Two of the items in Schedule D rely on the definitions for level 1 and level 2 liquid assets. In finalizing the previous revisions to the FR Y-15, the Federal Reserve stated that, “after the U.S. rule implementing the LCR is finalized, the Federal Reserve will consider aligning the definitions of level 1 and level 2 assets used in the two items of the FR Y-15 with the definitions in the U.S. rule.” 8 Now that the rule implementing the liquidity coverage ratio (LCR) has been finalized, the Federal Reserve proposes adopting the level 1, level 2A, and level 2B liquid asset definitions used in the U.S. rule for the purpose of reporting trading and available-for-sale (AFS) securities that meet the definition of level 1 assets (item 7) and trading and AFS securities that meet the definition of level 2 assets with haircuts (item 8).9 While this revision aligns level 1 and level 2 liquid assets with the definition of high-quality liquid assets in the U.S. LCR rule, this could, in turn, result in a more stringent measure of the trading and AFS securities indicator relative to the international standard.

To enhance readability, the Federal Reserve also proposes to change held-to-maturity securities (item M1) to a memoranda item.

The Federal Reserve proposes no changes to this schedule.

The Federal Reserve proposes adopting a more logical ordering of the revenue-related items (items 3, 4, and 5). As peak equity market capitalization (item 6) is no longer being captured in the international collection, the Federal Reserve proposes removing the item from the FR Y-15. To help prevent potential misinterpretations, the Federal Reserve proposes to revise the instructions for the gross value of cash provided and gross fair value of securities provided in SFTs (renumbered item 6) and the gross value of cash received and gross fair value of securities received in SFTs (renumbered item 7). The Federal Reserve proposes to move unsecured settlement/clearing lines provided (item 11) and held-to-maturity securities (item 12) to other schedules.

As explained in a recent notice of proposed rulemaking regarding implementation of a capital requirement for G-SIBs,10 the financial crisis revealed dangers that can emerge as a result of a firm's reliance on short-term wholesale funding. During periods of stress, this reliance can leave firms vulnerable to runs that undermine financial stability. When short-term creditors lose confidence in a firm or believe other short-term creditors may lose confidence in that firm, those creditors have a strong incentive to withdraw funding quickly before withdrawals by other creditors drain the firm of its liquid assets. To meet its obligations, the borrowing firm may be required to rapidly sell less liquid assets, which it may be able to do only at fire sale prices that deplete the seller's capital and drive down asset prices across the market. In a post-default scenario, fire sale externalities could result if the defaulted firm's creditors seize and rapidly liquidate assets the defaulted firm has posted as collateral. Financial distress can spread among firms as a result of counterparty relationships or because of perceived similarities among firms, forcing firms to rapidly liquidate assets in a manner that places the financial system as a whole under significant strain.

Consistent with the view that short-term wholesale funding is a critical component of a firm's systemic footprint, the Federal Reserve proposes adding a new schedule (Schedule G) that captures a firm's level of short-term wholesale funding. The new schedule would be reported starting with the end-June 2016 as-of date 11 and would capture funding secured by level 1 liquid assets (item 1(a)), funding secured by level 2A liquid assets (item 2(a)), unsecured wholesale funding obtained outside of the financial sector (item 2(b)), retail brokered deposits and sweeps (item 2(c)), covered asset exchanges from level 1 to level 2A liquid assets (item 2(d)), short positions involving a level 1 or level 2A liquid asset (item 2(e)), total second tier short-term wholesale funding (item 2(f)), funding secured by level 2B liquid assets (item 3(a)), other covered asset exchanges and short positions (item 3(b)), total third tier short-term wholesale funding (item 3(c)), unsecured wholesale funding obtained within the financial sector (item 4(a)), all other components of short-term wholesale funding (item 4(b)), total other short-term wholesale funding (item 4(c)), and total short-term wholesale funding, by maturity, after applying the associated weighting (item 5). Each of these items would be divided into four maturity buckets: Funding with a remaining maturity of 30 days or less (along with funding with no maturity date), funding with a remaining maturity of 31 to 90 days, funding with a remaining maturity of 91 to 180 days, and, funding with a remaining maturity of 181 to 365 days. Finally, the new schedule would also capture total short-term wholesale funding (item 6) calculated as the sum of the subcomponents in item 5.

The recent proposal to implement a capital requirement for G-SIBs included short-term wholesale funding as a systemic risk indicator for the purposes of calculating a firm's G-SIB surcharge.12 The Federal Reserve is currently in the process of reviewing public comments that have been received regarding this proposal. Should a short-term wholesale funding metric ultimately be adopted for the purposes of calculating a G-SIB surcharge, the Federal Reserve intends to update the FR Y-15, where needed, to reflect the final rule.

While the original FR Y-15 proposal included SLHCs as respondents, the Federal Reserve decided to provide an exemption and “publish a separate proposal for comment . . . after the regulatory capital rules for SLHCs are finalized.” 13 Now that these capital requirements are in place, the Federal Reserve proposes to add covered SLHCs (i.e., those which are not substantially engaged in insurance or commercial activities) to the FR Y-15 reporting panel.

To improve the Federal Reserve's ability to monitor the systemic risk profile of domestic banking organizations throughout the year, the Federal Reserve proposes to switch from annual to quarterly reporting starting March 31, 2016. Currently, the Federal Reserve assesses the overall systemic importance of a firm using a single yearly observation. This snapshot may not adequately represent the true systemic footprint of the firm throughout the year. Moreover, should a firm's systemic footprint change significantly during the year (e.g., due to a fundamental change in business strategy), this move would not be fully assessed until the next year-end. More frequent reporting would allow the Federal Reserve to better monitor the systemic footprint of individual firms as well as the collective systemic footprint of the largest banking organizations.

The increased frequency would simultaneously provide the market with additional data on the overall systemic footprint of an institution, allowing market participants to better project the potential future capital requirements for U.S. G-SIBs. The current international G-SIB standard involves a relative methodology, where the values of all of the firms are needed in order to calculate the scores. Thus, firms only have complete information about their surcharge once a year. This makes it difficult for firms to see the benefits of incremental improvements in their overall footprint throughout the year. By collecting the required data more frequently, firms would have additional information about their own systemic footprint vis-à-vis other respondents, and would be better positioned to predict individual assessment scores under the BCBS methodology.14

One consequence of moving to quarterly reporting is that the annual flow variables (i.e., payments and underwriting activity) would need to be reported over the previous four quarters. Furthermore, the values captured in Schedule A (Total exposures) would represent quarterly averages.

Many items are unique to the FR Y-15 (e.g., payments and assets under custody). As such, there are certain terms that may have a different meaning in the context of the FR Y-15 or otherwise may not be found in other regulatory reports. To help ensure uniform interpretation of the instructions, the Federal Reserve proposes to introduce a new glossary of terms that would contain definitions relevant to the completion of the FR Y-15 report.

To improve the readability of the report, the Federal Reserve proposes relabeling certain items which are not included in the indicator calculations as memoranda items. This would allow related metrics to be grouped together on the same schedule.

The Federal Reserve proposes to incorporate instructional clarifications in response to feedback and questions received from banking organizations over the last two reporting periods. The Federal Reserve also proposes to integrate relevant definitional adjustments and clarifications that have been incorporated into the instructions for the international G-SIB assessment.15

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

AoA estimates the burden of this collection of information as follows: Annual submission of the Program Performance Reports are due 90 days after the end of the budget period and final project period. The current form and instructions are posted on the AoA Web site at http://www.aoa.gov/AoARoot/Grants/Reporting_Requirements\insex.aspx.

Respondents: Federally Recognized Tribes, Tribal and Native Hawaiian Organizations receiving grants under Title VI, Part A, Grants for Native Americans; Title VI, Part B, Native Hawaiian Program and Title VI, Part C, Native American Caregiver Support Program. Estimated Number of Responses: 266. Total Estimated Burden Hours: 731.5.

FDA is announcing the availability of a guidance for industry, researchers, patient groups, and FDA staff entitled “Meetings with the Office of Orphan Products Development.” Each year, OOPD staff participates in meetings with stakeholders who seek guidance or clarification relating to orphan drug or HUD designation requests, OOPD grant programs, or other rare disease issues. These meetings can be “informal” or “formal” and help build a common understanding on FDA's thoughts on orphan products, which may include drugs, biological products, devices, or medical foods for a rare disease or condition. These meetings may represent critical points in the orphan product development process and may even have an impact on the eventual availability of products for patients with rare diseases and conditions. It is important that these meetings be scheduled within a reasonable time, conducted effectively, and documented where appropriate. This guidance is intended to provide consistent procedures to promote well-managed meetings between OOPD and stakeholders.

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

In the Federal Register of April 9, 2014 (79 FR 19623), FDA issued, for public comment, “Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings with the Office of Orphan Products Development.” The Agency issued this draft guidance to assist stakeholders with requesting, preparing, scheduling, conducting, and documenting meetings with OOPD. In particular, the draft guidance provided clarification on what constitutes an “informal” or “formal” meeting, program areas within OOPD that may be affected by the guidance, procedures for requesting and scheduling meetings with OOPD, description of what constitutes a meeting package, and procedures for the conduct and documentation of meetings.

We received several comments on the draft guidance. Most comments appreciated the clarification and explanation provided by the draft guidance. Some comments made recommendations to improve clarity.

FDA is issuing the draft guidance in final form with minor revisions to improve clarity. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on meetings with OOPD. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

This guidance contains 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 this guidance were approved under OMB control numbers 0910-0167, 0910-0332, and 0910-0787.

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

Persons with access to the Internet may obtain the document at either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm or at http://www.regulations.gov.

I. Background

Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the FD&C Act.

On April 2, 2014, the U.S. District Court for the Eastern District of Virginia entered judgment against Ms. Durr for one count of introducing misbranded drugs into interstate commerce with intent to defraud or mislead, in violation of sections 301(a) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(a) and 333(a)(2)).

FDA's finding that debarment is appropriate is based on the felony conviction referenced herein. The factual basis for this conviction is as follows: Ms. Durr was a sales representative for Gallant Pharma International Inc. (Gallant Pharma) between October 2010 and August 2013, and was responsible for selling injectable cosmetic drugs and devices, and intravenous chemotherapy drugs, to doctors and hospitals in Massachusetts and Connecticut. Some of the drugs Ms. Durr facilitated the sale of were misbranded within the meaning of the FD&C Act.

Ms. Durr admitted that she sold drugs which were not approved by the FDA for use on patients in the United States. She further admitted that the drugs she sold on behalf of Gallant Pharma were misbranded in that they did not bear adequate directions for use and were not subject to an exemption from that requirement, and they were accompanied by non-FDA approved packaging and inserts.

Between August 2012 and August 2013, Ms. Durr admitted to selling more than $699,000 in misbranded drugs and devices to doctors and medical practices in Massachusetts and Connecticut. She further admitted that the loss amount attributable to her personal sales, under U.S. Sentencing Guidelines, was between $400,000 and $1,000,000.

Between October 2010 and August 2013, Ms. Durr personally sold misbranded drugs to 33 distinct doctors and medical practices, and generated more than $2.6 million in illegal proceeds from these sales. She admitted that, as of August 2012, she became willfully blind to the illegality of Gallant Pharma's business. Nonetheless, she continued her sales activity with Gallant Pharma until her arrest in August 2013.

As a result of her conviction, on March 9, 2015, FDA sent Ms. Durr a notice by certified mail proposing to permanently debar her from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on the finding, under section 306(a)(2)(B) of the FD&C Act, that Ms. Durr was convicted of a felony under Federal law for conduct related to the regulation of a drug product. FDA determined that Ms. Durr's felony conviction was related to the regulation of drug products because the conduct underlying her conviction undermined FDA's regulatory oversight over drug products marketed in the United States by intentionally introducing into interstate commerce drug products that did not bear adequate directions for use and were not subject to an exemption from that requirement, and which, among other things, were accompanied by non-FDA approved packaging and inserts. The proposal also offered Ms. Durr an opportunity to request a hearing, providing her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. The proposal was received on March 24, 2015. Ms. Durr failed to respond within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and has waived any contentions concerning her debarment (21 CFR part 12).

Therefore, the Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of the FD&C Act, under authority delegated to the Director (Staff Manual Guide 1410.35), finds that Patricia Durr has been convicted of a felony under federal law for conduct relating to the regulation of a drug product. Section 306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 335a(c)(2)(A)(ii)) requires that Ms. Durr's debarment be permanent.

As a result of the foregoing findings, Patricia Durr is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see section 201(dd), 306(c)(1)(B), and 306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 321(dd), 335a(c)(1)(B), and 335a(c)(2)(A)(ii)). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Patricia Durr, in any capacity during her debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. Durr provides services in any capacity to a person with an approved or pending drug product application during her period of debarment she will be subject to civil money penalties (section 307(a)(7) of the FD&C Act (21 U.S.C. 335b(a)(7))). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Patricia Durr during her period of debarment (section 306(c)(1)(A) of the FD&C Act (21 U.S.C. 335a(c)(1)(A))).

Any application by Ms. Durr for special termination of debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should be identified with Docket No. FDA-2014-N-2100 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20.

Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The USP 1 heparin monographs have recently undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a major contributing factor in these errors. This draft guidance document is intended to address these safety concerns by clarifying new expectations for labeling with regard to the soon-to-be revised heparin USP monographs (USP36-NF31),2 as well as outline safety testing recommendations.

In addition, the outbreak of serious and often fatal events due to heparin contamination with over-sulfated chondroitin sulfate in 2008 led the USP to include in its monograph additional testing of heparin source material to ensure its quality and purity. This draft guidance also outlines use of conformance to the monograph in premarket submissions, specifically testing and documentation requirements and recommendations contained in the current USP monograph, and the guidance document “Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality” (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291390.pdf).3

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on labeling and safety testing requirements for heparin-containing medical devices and combination products. 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 statute and regulations.

Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Device and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1817 to identify the guidance you are requesting.

This draft guidance refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) have been approved under OMB control number 0910-0139. The collections of information in FDA's medical devices regulations in 21 CFR parts 801 (Labeling); 803 (Medical Device Reporting); 807, subpart E (Premarket Notification Procedures); 812 (Investigational Device Exemptions); 814, subparts A through E (Premarket Approval of Medical Devices); 814, subpart H (Humanitarian Use Devices); and 820 (Quality System Regulation) have been approved under OMB control numbers 0910-0485, 0910-0437, 0910-0120, 0910-0078, 0910-0231, 0910-0332, and 0910-0073 respectively.

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

Acute ischemic stroke medical devices are intended to remove blood clots from the cerebral neurovasculature. This may be achieved through a variety of mechanisms, such as mechanical, laser, ultrasound, or a combination of technologies. Acute ischemic stroke medical devices can present both important safety and effectiveness questions as well as study design and data analysis challenges.

The workshop seeks to involve industry and academia in addressing scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices. By bringing together relevant stakeholders, which include scientists, patient advocates, clinicians, researchers, industry representatives, and regulators, to this workshop, we hope to facilitate the improvement of this rapidly evolving product area.

This workshop is aimed to address scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices, including but not limited to, the following topic areas:

• Considerations for clinical study trial designs, patient populations, and patient selection methods, and

• Considerations for clinical study endpoints, e.g., clinically relevant outcome measures and related statistical analyses.

Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by September 25, 2015, at 4 p.m. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 12 p.m.

If you need special accommodations due to a disability, please contact Susan Monahan, email: [email protected] or phone: 301-796-5661 no later than September 25, 2015.

To register for the public workshop, please visit FDA's Medical Devices News & Events—Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this meeting/public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, email, and telephone number. Those without Internet access should contact Susan Monahan to register. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list.

In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is November 3, 2015.

Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific questions as outlined in section II of this document, please identify the question you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may also be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

Information Collection Request Title: Maternal, Infant, and Early Childhood Home Visiting (Home Visiting) Program, Competitive Funding Opportunity Announcement OMB No. 0915-0351—Extension.

Abstract: The Home Visiting Program, administered by the Health Resources and Services Administration (HRSA) in close partnership with the Administration for Children and Families (ACF), supports voluntary, evidence-based home visiting services during pregnancy and to parents with young children up to kindergarten entry. The 50 states, District of Columbia, and 5 territories and eligible nonprofit organizations are eligible for Home Visiting Competitive Funding.

Need and Proposed Use of the Information: The purpose of this announcement is to solicit Fiscal Year 2016 (FY16) applications for the Home Visiting Competitive Grant program. Competitive Grants provide funds to eligible entities that are states and certain territories that continue to make significant progress toward implementing a high-quality home visiting program as part of a comprehensive, high-quality early childhood system and are ready and able to take effective programs to scale to address unmet need. This information collection is needed for eligible entities to apply for competitive funding opportunities under the MIECHV. As noted above, this program is authorized under the Social Security Act, Title V, Section 511 (42 U.S.C. 701), as amended by Section 2951 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148). A portion of funding under this program is awarded to participating states and eligible jurisdictions 1 by formula. However, an additional portion of funds is awarded competitively.

The information collected will be used to collect applicant information regarding proposed project plans sufficient to inform peer review and subsequent grant award and monitoring. Peer reviewers will be selected from among experts in the relevant fields to assess and score applicant proposals. On the basis of reviewer scores, applications will be ranked, and the highest scoring applications will be funded according to availability of funds. Applications approved for funding are entered into HRSA's Electronic Handbook (EHB).

Subsequent to award, the approved plans set forth in the applications in the EHB will be monitored by Federal Project Officers to ensure implementation according to these plans, as submitted in this data collection instrument. Failure to collect this information would result in either a failure to make awards to eligible entities as required by law, or would necessitate award of all funds by formula, which is inconsistent with established program policy and implementation, as competitive awards have been made a part of this program's administration.

Likely Respondents: Applicants to FY16 Home Visiting Competitive Funding Opportunity Announcement.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. Appendix. The Advisory Committee on Commercial Operations to U.S. Customs and Border Protection (COAC) provides advice to the Secretary of Homeland Security, the Secretary of the Treasury, and the Commissioner of U.S. Customs and Border Protection (CBP) on matters pertaining to the commercial operations of CBP and related functions within Department of Homeland Security and the Department of the Treasury.

The Advisory Committee on Commercial Operations to U.S. Customs and Border Protection (COAC) will hear from the following subcommittees on the topics listed below and then will review, deliberate, provide observations, and formulate recommendations on how to proceed on those topics:

1. The One U.S. Government Subcommittee will discuss the Automated Commercial Environment (ACE), Single Window working group recommendations and provide input on Trade Readiness and Partner Government Agencies' readiness for the upcoming November 1, 2015 ACE implementation of Single Window.

2. The Exports Subcommittee will address policy and a strategic approach regarding exports. The Option 4 and Air Manifest working groups will provide recommendations.

3. The Trade Enforcement and Revenue Collection Subcommittee will discuss the establishment of the 14th Term Antidumping and Countervailing Duty and Intellectual Property Rights working groups and provide recommendations.

4. The Trade Modernization Subcommittee will discuss operational uniformity of Centers of Excellence and Expertise (CEE) with a goal of developing recommendations for the creation of service levels for various Center activities. The subcommittee will report plans for engaging CBP on international trade agreements, simplification of CBP processes, the role of various international trade entities and the development of private and public sector trade expertise.

5. The Trusted Trader Subcommittee will start work once the Trusted Trader pilot has advanced to the implementation phase for testing CBP and Partner Government Agency trade benefits. The subcommittee will explore certifying trusted products through the supply chain.

6. The Global Supply Chain Subcommittee will discuss the feasibility, benefits and risks of using Electronic Cargo Security Devices. The subcommittee will report on long term development of recommendations regarding Customs and Border Protection's development of automation and regulations governing the commodities being moved by pipelines. Further discussion will involve the Customs-Trade Partnership Against Terrorism Program as it pertains to the ocean mode of transportation, results of various pre-inspection pilots at land ports of entry and the Air Cargo Advance Screening.

Meeting materials will be available at: http://www.cbp.gov/trade/stakeholder-engagement/coac/coac-public-meetings.

Background

The Smith's blue butterfly was listed as endangered by the Service on June 1, 1976. Section 9 of the Act (16 U.S.C. 1531 et seq.) and its implementing regulations prohibit the “take” of fish or wildlife species listed as endangered or threatened. “Take” is defined under the Act to include the following activities: “[T]o harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct” (16 U.S.C. 1532); however, under section 10(a)(1)(B) of the Act, we may issue permits to authorize incidental take of listed species. “Incidental Take” is defined by the Act as take that is incidental to, and not the purpose of, carrying out of an otherwise lawful activity. Regulations governing incidental take permits for threatened and endangered species are, respectively, in the Code of Federal Regulations at 50 CFR 17.32 and 17.22. Issuance of an incidental take permit also must not jeopardize the existence of federally listed fish, wildlife, or plant species.

However, take of listed plants is not prohibited under the Act unless such take would violate State law. As such, take of plants cannot be authorized under an incidental take permit. Plant species may be included on a permit in recognition of the conservation benefits provided them under a habitat conservation plan. All species included in the incidental take permit would receive assurances under our “No Surprises” regulations (50 CFR 17.22(b)(5) and 17.32(b)(5)). In addition to meeting other criteria, actions undertaken through implementation of the HCP must not jeopardize the continued existence of federally listed plant or animal species.

The Point Sur Lighthouse and Light Station are located on the Big Sur Coast in Monterey County, California at the Point Sur State Historic Park (PSSHP), located approximately 135 miles south of San Francisco and 23 miles south of the City of Monterey via California State Highway 1. This lighthouse has been in continuous operation since 1889 and is accessible by a paved service road that leads to the top of Moro Rock at Point Sur and crosses five timber bridges in need of maintenance and repair. The PSSHP consists of four parcels managed by the CDPR. Collectively, these four parcels measure approximately 72 acres.

Surveys for both the larval and adult life stages of the Smith blue butterfly have been performed at PSSHP. Despite an intensive search effort, no life stages were observed; however, weather conditions may have hindered the surveys. Smith's blue butterfly life stages have been observed within dispersal distance of PSSHP and habitat at PSSHP is present; therefore, the Smith's blue butterfly is assumed present at the site.

The proposed HCP and associated incidental take permit would authorize take of the Smith's blue butterfly. This take would be incidental to the CDPR's proposed replacement and repair of the five bridges, installation of permanent erosion control mats, and storm drain improvements, as well as future routine maintenance activities for the access road and its associated ditches. It would also cover revegetation activities that would occur at the bridge repair sites and other locations adjacent to the service road as well as at the dunes mitigation site located east and northeast of the base of Moro Rock. Impacts to Smith's blue butterfly from project-related activities will be primarily limited to small work areas associated with repairs to the five bridges and erosion control measures. Additional impacts would occur due to storm water improvements and periodic routine road and ditch maintenance. The total area of impact on Smith's blue butterfly habitat would be approximately 10,196 square feet (0.2341 acre).

The CDPR proposes to implement general and specific conservation measures designed to avoid or minimize take of Smith's blue butterfly. To mitigate for unavoidable impacts, the CDPR proposes to restore 3.6 acres of northern foredunes at the dunes mitigation site near the base of Moro Rock. Management goals include removal and control of invasive vegetation, erosion control; restoration of the northern foredune habitat including revegetation of Smith's blue butterfly seacliff buckwheat (Eriogonum parvifolium) habitat at a 3:1 ratio; and revegetation of other dune plants endemic to the dunes at PSSHP.

Two alternatives to the proposed action are considered in the HCP. Under the No Action Alternative, the proposed project would not occur and an incidental take permit would not be issued by the Service. Two of the access bridges to the Point Sur Lighthouse would remain closed to all vehicular traffic. The conditions of the remaining bridges would continue to deteriorate, and existing erosion and storm water issues would not be corrected. Conservation measures described in the HCP would not be implemented and the restoration of the 3.6-acre dune mitigation site would not occur; therefore, the No Action Alternative is considered to have less conservation value to the covered species than the proposed project and accompanying HCP. Under the Redesigned Project Alternative, the areas of impact would be reduced at the five impact areas located along the access roads, which would likely result in reduced take of Smith's blue butterfly; however, smaller work areas would not allow the CDPR to properly repair the five timber bridges and correct the erosion and storm water issues.

We are requesting comments on our preliminary determination that the CDPR's proposed project will have minor or negligible effects on the Smith's blue butterfly and that the plan qualifies as a low-effect HCP as defined by our Habitat Conservation Planning Handbook (Service 1996). We base our determinations on three criteria: (1) Implementation of the proposed project as described in the HCP would result in minor or negligible effects on federally listed, proposed, and/or candidate species and their habitats; (2) implementation of the HCP would result in minor negligible effects on other environmental values or resources; and (3) HCP impacts, considered together with those of other past, present, and reasonably foreseeable future projects, would not result in cumulatively significant effects. In our analysis of these criteria, we have made a preliminary determination that the approval of the HCP and issuance of an incidental take permit qualify for categorical exclusions under the NEPA (42 U.S.C. 4321 et seq.), as provided by the Department of Interior Manual (516 DM 2 Appendix 2 and 516 DM 8); however, based upon our review of public comments that we receive in response to this notice, this preliminary determination may be revised.

We will evaluate the permit application, including the plan and comments we receive, to determine whether the application meets the requirements of section 10(a) of the Act. We will also evaluate whether issuance of the section 10(a)(1)(B) permit would comply with section 7 of the Act by conducting intra-Service section 7 consultation for the plan. We will use the result of this consultation, in combination with the above findings, in our final analysis to determine whether or not to issue the permit. If the requirements are met, we will issue a permit to the applicant for the incidental take of the Smith's blue butterfly. We will make the final permit decision no sooner than 30 days after the date of this notice.

We provide this notice under section 10(c) of the Act and the NEPA public involvement regulations (40 CFR 1500.1(b), 1500.2(d), and 1506.6). We are requesting comments on our determination that the applicant's proposal will have a minor or negligible effect on the Smith's blue butterfly and that the plan qualifies as a “low-effect” HCP as defined by our 1996 Habitat Conservation Planning Handbook.

If you wish to comment on the permit applications, plans, and associated documents, you may submit comments by any one of the methods in ADDRESSES.

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 view, we cannot guarantee that we will be able to do so.

We provide this notice under section 10 of the Act (16 U.S.C. 1531 et seq.) and NEPA regulations (40 CFR 1506.6).

With this notice, we finalize the CCP process for James River NWR. We started this process through a notice in the Federal Register on January 11, 2012 (77 FR 1716). We released a draft CCP and environmental assessment (EA) to the public and requested comments in a notice in the Federal Register on October 22, 2014 (79 FR 63161).

We have selected alternative B for implementation, as it is described in the final CCP for James River NWR. We announce our decision and the availability of the FONSI for the final CCP in accordance with National Environmental Policy Act (40 CFR 1506.6(b)) requirements. We completed an analysis of impacts on the human environment in the draft CCP and EA. We made minor changes and clarifications to the final CCP, where appropriate, to address public comments we received on the draft CCP and EA. A summary of the public comments, and our responses to them, is included as Appendix F in the final CCP.

The 4,324-acre James River NWR lies in the Chesapeake Bay watershed and is located along the James River in Prince George County, Virginia, approximately 8 miles southeast of the city of Hopewell, and 30 miles southeast of Richmond. The refuge was established in 1991 under the authority of the Endangered Species Act of 1973 (16 U.S.C. 1534) to protect nationally significant nesting and roosting habitat for the bald eagle (Haliaeetus leucocephalus).

The National Wildlife Refuge System Administration Act of 1966 (16 U.S.C. 668dd-668ee) (Refuge Administration Act), as amended by the National Wildlife Refuge System Improvement Act of 1997, requires us to develop a CCP for each refuge. The purpose for developing a CCP is to provide refuge managers with a 15-year plan for achieving refuge purposes and contributing to the mission of the National Wildlife Refuge System, consistent with sound principles of fish and wildlife management, conservation, legal mandates, and our policies. In addition to outlining broad management direction on conserving wildlife and their habitats, CCPs identify wildlife-dependent recreational opportunities available to the public, including opportunities for hunting, fishing, wildlife observation and photography, and environmental education and interpretation. We will review and update the CCP at least every 15 years in accordance with the Refuge Administration Act.

Alternative B combines the actions we believe would best achieve the refuge's purposes, vision, and goals, and respond to public issues. The basis of our decision is detailed in the FONSI (Appendix G in the final CCP). Under alternative B, we would emphasize the management of specific refuge habitats to support priority species whose habitat needs would benefit other species of conservation concern that are found in the area. We would promote the transition of 2,651 acres of former pine plantation toward mature pine savanna for resident and breeding cavity-dwelling and ground-nesting species, including the brown-headed nuthatch, Chuck-will's-widow, red-headed woodpecker, and yellow-billed cuckoo. We would also emphasize protecting and promoting bald eagle nesting habitat, and protecting the integrity of the refuge's other habitats for native species, including migrating waterfowl, waterbirds, the federally endangered Atlantic sturgeon, and federally threatened sensitive joint-vetch. We would also expand our conservation, research, monitoring, and management partnerships to help restore and conserve the refuge.

We would enhance our cultural resource protection to increase knowledge and appreciation for the refuge's rich cultural history and heritage, as well as expand our visitor services programs to improve opportunities for wildlife-dependent recreation. Visitor service improvements would include expanding the on-refuge opportunities for wildlife observation, photography, environmental education, and interpretation of natural and cultural resources in partnership with others. We would also pursue Service administrative requirements to expand public deer hunting, open the refuge to spring and fall turkey hunting, open the refuge to limited waterfowl hunting by youth, promote youth involvement in all hunting opportunities, and open the refuge to fishing at two designated locations. Further details on our selected alternative and management actions can be found in the CCP.

In addition to sources listed under ADDRESSES, you can view the final CCP at the Prince George Library, 6605 Courts Drive, Prince George, VA 23875.

A person or party who wishes to protest against this survey must file a written notice with the Oregon State Director, Bureau of Land Management, stating that they wish to protest. A statement of reasons for a protest may be filed with the notice of protest and must be filed with the Oregon State Director within thirty days after the protest is filed. If a protest against the survey is received prior to the date of official filing, the filing will be stayed pending consideration of the protest. A plat will not be officially filed until the day after all protests have been dismissed or otherwise resolved. 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.

I. Background

Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:

1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or

2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.

In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.

Docket Number: M-2015-002-M.

Petitioner: Solvay Chemicals, Inc., P.O. Box 1167, 400 County Road 85, Green River, Wyoming 82935.

Mine: Solvay Chemicals, Inc., MSHA I.D. No. 48-01295, located in Sweetwater County, Wyoming.

Regulation Affected: 30 CFR 57.4760(a) (Shaft mines).

Modification Request: The petitioner requests a modification of the existing standard due to the potential negative impact that would adversely affect the safety of persons in the mine as a result of changes to the mine ventilation system. The petitioner states that:

1. The proposed modification would allow relief from providing at least one of the following means in the event of fire, smoke or toxic gases as stated in 30 CFR 57.4760(a):

(a) Solvay Chemicals, Inc. is categorized as a Category III mine in which non-combustible ore is extracted.

(b) The mine liberates a concentration of methane that is explosive, or is capable of forming explosive mixtures with air, or has the potential to do so, based on the history of the mine or the geological area in which the mine is located.

2. A Category III mine is subjected to 30 CFR 57.22214(a), which requires that any changes in ventilation which affect the main air current or any split thereof and which adversely affect the safety of persons in the mine must be made when the mine is idle.

3. The installation of control doors or the reversal of mechanical ventilation would affect the main air currents and splits thus adversely impacting the ventilation system's ability to render and dilute concentrations of toxic gases or methane gas. Additionally, the installation of control doors or the reversal of mechanical ventilation can only be achieved by shutting down the mines main exhaust fans. Due to the expanse of the mine, evacuation of all personnel underground to the surface in ten minutes or less is not an alternative means of compliance with the standard.

4. The best solution is to remove the miners in a safe manner prior to making any ventilation changes, that include closure or opening of control doors or mechanical ventilation reversal.

5. When a fire is detected the protocol within the Emergency Response Plan will be followed to include evacuating the mine in a safe and effective manner prior to making any ventilation changes.

6. The mine maintains two designated separate escapeways which provides miners with means of evacuating the mine; reducing the likelihood of miners having to travel through smoke or toxic gasses.

The petitioner asserts that compliance with the existing standard would result in a diminution of safety to the miners at the Solvay Chemicals Mine.

Docket Number: M-2015-003-M.

Petitioner: Tata Chemicals (Soda Ash) Partners, P.O. Box 551, Green River, Wyoming 82935.

Mine: Tata Chemicals Mine, MSHA I.D. No. 48-00155, located in Sweetwater County, Wyoming.

Regulation Affected: 30 CFR 57.4760(a) (Shaft mines).

Modification Request: The petitioner requests a modification of the existing standard because compliance with the 30 CFR 57.4760(a) via installation and use of control doors at mine intake shafts will likely result in a dangerous and impermissible change in underground ventilation, thereby diminishing the safety of miners working underground. Additionally, compliance with 30 CFR 57.4760(a) via installation and use of control doors would conflict with petitioner's ability to comply with another mandatory safety standard for Category III mines, 30 CFR 57.22214.

Petitioner is requesting relief from compliance with 30 CFR 57.4760(a) due to the potential diminution of safety to miners from the changes to the mine ventilation system that would likely result from installing and using control doors in the event of an underground fire. The petitioner states that:

1. On March 18 and 19, 2015, MSHA issued Citation Numbers 8830553, 8830554, and 8830555 at Tata Chemicals intake shafts #6, #2, and #3 alleging that Tata failed to provide control doors in compliance with 30 CFR 57.4760(a). 30 CFR 57.4760(a) provides three alternative methods that shaft mines must follow to control the spread of fire, smoke, and toxic gases underground in the event of a fire: (1) Installation of control doors, (2) reversal of mechanical ventilation, or (3) implementation of effective evacuation procedures. MSHA concedes in all three citations that reversal of the mine's mechanical ventilation system is not a feasible means of compliance with 30 CFR 57.4760(a), as fan reversal would push methane over nonpermissible equipment.

2. Although petitioner has an emergency evacuation plan, there is no feasible means of ensuring evacuation of miners working underground within ten minutes, as the regulation requires, due to the vast size of the petitioner's mine. Thus, MSHA concluded, that the petitioner must install control doors at its intake shafts in order to comply with 30 CFR 57.4760(a).

3. For the following reasons, petitioner disagrees with MSHA's conclusion, contends that there is no safe way of complying with the cited standard, and requests a variance from its application at the mine.

4. Petitioner conducted an independent analysis of the impacts that installation and use of a single or multiple intake air shaft ventilation control doors would have on the integrity of the mine's ventilation infrastructure and on the health and safety of miners working underground. The analysis concluded that:

(a) Using doors to isolate #2, #3, or #6 intake shafts constitutes a major air change. Changes of this magnitude will detrimentally influence the mine ventilation airflow balance. It would result in several likely scenarios that could quickly introduce return air and methane into the intake airways where numerous ignition sources exist.

(b) The fans are set to operate at the intersection of the fan and mine pressure-volume curves.

(c) A major air change modifies the mine curve and a new operating point of the fan is established.

(d) If the fans are not shut off before the air change, the operating point is likely to move toward or into this stall zone which will lead to damage and possible destruction of the fan and/or ventilation structures.

(e) The closure of control doors at intake shafts in the event of a fire would affect the main air currents and splits, thereby adversely impacting the ability of the ventilation system to dilute and render harmless concentrations of toxic gases or methane gas and in turn, endangering the health and safety of miners working underground.

5. The Tata mine is a Category III mine, a classification that applies to mines “in which noncombustible ore is extracted and which liberate a concentration of methane that is explosive, or is capable of forming explosive mixtures with air, or have the potential to do so based on the history of the mine or the geological area in which the mine is located. The concentration of methane in such mines is explosive or is capable of forming explosive mixtures if mixed with air,” 30 CFR 57.22003(a)(3). Tata must comply with the regulations applicable to Category III mines, including 30 CFR 57.22214(a), which mandates that changes in ventilation which affect the main air current or any split thereof and which adversely affect the safety of persons in the mine will only be made when the mine is idle. Petitioner states that it is not possible to comply with both 30 CFR 57.4760(a) and 57.22214(a) at the Tata mine because the closure of one or more control doors in the event of a fire would certainly affect the main air currents and splits in such a way as to endanger the safety of persons working underground. Under 30 CFR 57.22214(a), such a ventilation change can only be carried out when the mine is idled with no miners underground. Compliance with 30 CFR 57.4760(a) via closure of a control door would not only endanger miners but would also be in violation of 30 CFR 57.22214(a).

6. 30 CFR 57.4760(a) does not take into account the complexities involved with suddenly restricting airflow in mines that have multiple shafts, multiple fan installations, and methane liberation. Petitioner noted that Part 75, which regulates underground coal mines, does not have any requirements that are equivalent to 30 CFR 57.4760 requirements for air control doors or alternative ventilation measures for the bottom, or near the bottom of coal mine intake shafts. The ventilation requirements applicable to Class III mines were specifically tailored to suit the conditions in a gassy trona mine like the Tata mine. Petitioner strongly contends that miners are already afforded adequate and equivalent protection via compliance with the fire prevention and control, and the ventilation requirements applicable to Class III mines. Mine rescue rules and basic ventilation flow principles dictate what changes in ventilation should be made in emergency situations, including a fire. Petitioner has a refuge and evacuation procedure set forth in the Mine's Emergency Response Plan. When a fire is detected underground, the mine's Emergency Response Plan is immediately implemented, and miners are trained on how to evacuate in a safe and swift manner depending on the location of the ignition. The mine maintains three designated separate escapeways which reduces the likelihood of miners having to travel through or past smoke or toxic gasses.

The petitioner asserts that compliance with the existing standard results in a diminution of safety to the miners at the Tata Mine.

Please refer to Docket ID NRC-2008-0441 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2008-0441.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. The revised application for amendment, dated June 29, 2015, is available in ADAMS under Accession No. ML15181A079.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2008-0441 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at http://www.regulations.gov as well as entering the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

The NRC is considering issuance of an amendment to Facility Operating License Nos. NPF-93 and NPF-94, issued to SCE&G and Santee Cooper for operation of the Virgil C. Summer Nuclear Station, Units 2 and 3, located in Fairfield County, South Carolina.

The proposed amendment would revise the plant-specific Design Control Document (DCD) Tier 2 and involved Tier 2* material incorporated into the Updated Final Safety Analysis Report (UFSAR), by revising the requirement to utilize American Welding Society (AWS) D1.1-1992, Structural Welding Code—Steel, when meeting the American Institute of Steel Construction (AISC) N690-1994 requirements. The changes involve the replacement of AWS D1.1-1992 with AWS D1.1-2000 and additional supplemental provisions consistent with provisions in AWS D1.1-2010 to provide criteria for AISC N690 activities related to the design, qualification, fabrication, and inspection of welds for nuclear island structures and the seismic Category II portions of the annex building and turbine building.

Before any issuance of the proposed license amendment, the NRC will need to make the findings required by the Atomic Energy Act of 1954, as amended (the Act), and NRC's regulations.

The NRC has made a proposed determination that the license amendment request involves no significant hazards consideration. Under the NRC's regulations in § 50.92 of Title 10 of the Code of Federal Regulations (10 CFR), this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the license amendment request involves a No Significant Hazards Consideration.

The NRC is seeking public comments on this proposed determination that the license amendment request involves no significant hazards consideration. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.

Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day notice period if the Commission concludes the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the Federal Register a notice of issuance. Should the Commission make a final No Significant Hazards Consideration Determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently.

Within 60 days after the date of publication of this Federal Register notice, any person whose interest may be affected by this proceeding and who desires to participate as a party in the proceeding must file a written request for hearing or a petition for leave to intervene specifying the contentions which the person seeks to have litigated in the hearing with respect to the license amendment request. Requests for hearing and petitions for leave to intervene shall be filed in accordance with the NRC's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at http://www.nrc.gov/reading-rm/doc-collections/cfr/.

As required by 10 CFR 2.309, a request for hearing or petition for leave to intervene must set forth with particularity the interest of the petitioner in the proceeding and how that interest may be affected by the results of the proceeding. The hearing request or petition must specifically explain the reasons why intervention should be permitted, with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The hearing request or petition must also include the specific contentions that the requestor/petitioner seeks to have litigated at the proceeding.

For each contention, the requestor/petitioner must provide a specific statement of the issue of law or fact to be raised or controverted, as well as a brief explanation of the basis for the contention. Additionally, the requestor/petitioner must demonstrate that the issue raised by each contention is within the scope of the proceeding and is material to the findings that the NRC must make to support the granting of a license amendment in response to the application. The hearing request or petition must also include a concise statement of the alleged facts or expert opinion that support the contention and on which the requestor/petitioner intends to rely at the hearing, together with references to those specific sources and documents. The hearing request or petition must provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact, including references to specific portions of the application for amendment that the petitioner disputes and the supporting reasons for each dispute. If the requestor/petitioner believes that the application for amendment fails to contain information on a relevant matter as required by law, the requestor/petitioner must identify each failure and the supporting reasons for the requestor's/petitioner's belief. Each contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who does not satisfy these requirements for at least one contention will not be permitted to participate as a party.

Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and to submit a cross-examination plan for cross-examination of witnesses, consistent with NRC regulations, policies, and procedures. The Atomic Safety and Licensing Board will set the time and place for any prehearing conferences and evidentiary hearings, and the appropriate notices will be provided.

Hearing requests or petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii).

If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.

To comply with the procedural requirements of E-Filing, at least ten 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at [email protected], or by telephone at 301-415-1677, to request (1) a digital identification (ID) certificate, which allows the participant (or its counsel or representative) to digitally sign documents and access the E-Submittal server for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a request or petition for hearing (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the hearing in this proceeding if the Secretary has not already established an electronic docket.

Information about applying for a digital ID certificate is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/getting-started.html. System requirements for accessing the E-Submittal server are detailed in the NRC's “Guidance for Electronic Submission,” which is available on the agency's public Web site at http://www.nrc.gov/site-help/e-submittals.html. Participants may attempt to use other software not listed on the Web site, but should note that the NRC's E-Filing system does not support unlisted software, and the NRC Meta System Help Desk will not be able to offer assistance in using unlisted software.

If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html.

Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html. A filing is considered complete at the time the documents are submitted through the NRC's E-Filing system. To be timely, an electronic filing must be submitted to the E-Filing system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an email notice confirming receipt of the document. The E-Filing system also distributes an email notice that provides access to the document to the NRC's Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the documents on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before a hearing request/petition to intervene is filed so that they can obtain access to the document via the E-Filing system.

A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html, by email to [email protected], or by a toll-free call at 1-866-672-7640. The NRC Meta System Help Desk is available between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday, excluding government holidays.

Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.

Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at http://ehd1.nrc.gov/ehd/, unless excluded pursuant to an order of the Commission, or the presiding officer. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or home phone numbers in their filings, unless an NRC regulation or other law requires submission of such information. However, in some instances, a request to intervene will require including information on local residence in order to demonstrate a proximity assertion of interest in the proceeding. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their submission.

For further details with respect to this action, see the application for license amendment dated May 26, 2015.

Attorney for licensee: Ms. Kathryn M. Sutton, Morgan, Lewis & Bockius LLC, 1111 Pennsylvania Avenue NW., Washington, DC 20004-2514.

NRC Branch Chief: Paul Kallan.

In the FR on June 30, 2015, in FR Doc. 2015-16034, on page 37314, Section 14.3.8, “Radiation Protection—Inspections, Tests, Analyses, and Acceptance Criteria,” ADAMS Accession No. ML15127A385, is added to the table listing the NuScale-specific DSRS sections that the NRC is soliciting comment on.

Please refer to Docket ID NRC-2008-0252 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2008-0252.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. The application for amendment, dated June 29, 2015, is available in ADAMS under Accession No. ML15181A078.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2008-0252 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at http://www.regulations.gov as well as entering the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

The NRC is considering issuance of an amendment to Facility Operating License Nos. NPF-91 and NPF-92, issued to Southern Nuclear Operating Company, Inc. (SNC), Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC., MEAG POWER SPVP, LLC., and the City of Dalton, Georgia for operation of the Vogtle Electric Generating Plant Units 3 and 4, located in Burke County, Georgia.

The proposed amendment departs from Tier 2* and associated Tier 2 information in the VEGP Units 3 and 4 UFSAR (which includes the plant specific Design Control Document Tier 2 information) to revise the application of American Institute for Steel Construction (AISC) N690-1994, Specification for the Design, Fabrication and Erection of Steel Safety Related Structures for Nuclear Facilities, to allow use of American Welding Society (AWS) D1.1-2000, Structural Welding Code—Steel, in lieu of the AWS D1.1-1992 edition identified in AISC N690-1994.

Before any issuance of the proposed license amendment, the NRC will need to make the findings required by the Atomic Energy Act of 1954, as amended (the Act), and NRC's regulations.

The NRC has made a proposed determination that the license amendment request involves no significant hazards consideration. Under the NRC's regulations in § 50.92 of Title 10 of the Code of Federal Regulations (10 CFR), this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the license amendment request involves a No Significant Hazards Consideration.

The NRC is seeking public comments on this proposed determination that the license amendment request involves no significant hazards consideration. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.

Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day notice period if the Commission concludes the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the Federal Register a notice of issuance. Should the Commission make a final No Significant Hazards Consideration Determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently.

Within 60 days after the date of publication of this Federal Register notice, any person whose interest may be affected by this proceeding and who desires to participate as a party in the proceeding must file a written request for hearing or a petition for leave to intervene specifying the contentions which the person seeks to have litigated in the hearing with respect to the license amendment request. Requests for hearing and petitions for leave to intervene shall be filed in accordance with the NRC's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at http://www.nrc.gov/reading-rm/doc-collections/cfr/.

As required by 10 CFR 2.309, a request for hearing or petition for leave to intervene must set forth with particularity the interest of the petitioner in the proceeding and how that interest may be affected by the results of the proceeding. The hearing request or petition must specifically explain the reasons why intervention should be permitted, with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The hearing request or petition must also include the specific contentions that the requestor/petitioner seeks to have litigated at the proceeding.

For each contention, the requestor/petitioner must provide a specific statement of the issue of law or fact to be raised or controverted, as well as a brief explanation of the basis for the contention. Additionally, the requestor/petitioner must demonstrate that the issue raised by each contention is within the scope of the proceeding and is material to the findings that the NRC must make to support the granting of a license amendment in response to the application. The hearing request or petition must also include a concise statement of the alleged facts or expert opinion that support the contention and on which the requestor/petitioner intends to rely at the hearing, together with references to those specific sources and documents. The hearing request or petition must provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact, including references to specific portions of the application for amendment that the petitioner disputes and the supporting reasons for each dispute. If the requestor/petitioner believes that the application for amendment fails to contain information on a relevant matter as required by law, the requestor/petitioner must identify each failure and the supporting reasons for the requestor's/petitioner's belief. Each contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who does not satisfy these requirements for at least one contention will not be permitted to participate as a party.

Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and to submit a cross-examination plan for cross-examination of witnesses, consistent with NRC's regulations, policies, and procedures. The Atomic Safety and Licensing Board will set the time and place for any prehearing conferences and evidentiary hearings, and the appropriate notices will be provided.

Hearing requests or petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii).

If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.

To comply with the procedural requirements of E-Filing, at least ten 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at [email protected], or by telephone at 301-415-1677, to request (1) a digital identification (ID) certificate, which allows the participant (or its counsel or representative) to digitally sign documents and access the E-Submittal server for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a request or petition for hearing (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the hearing in this proceeding if the Secretary has not already established an electronic docket.

Information about applying for a digital ID certificate is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/getting-started.html. System requirements for accessing the E-Submittal server are detailed in the NRC's “Guidance for Electronic Submission,” which is available on the agency's public Web site at http://www.nrc.gov/site-help/e-submittals.html. Participants may attempt to use other software not listed on the Web site, but should note that the NRC's E-Filing system does not support unlisted software, and the NRC Meta System Help Desk will not be able to offer assistance in using unlisted software.

If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html.

Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html. A filing is considered complete at the time the documents are submitted through the NRC's E-Filing system. To be timely, an electronic filing must be submitted to the E-Filing system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an email notice confirming receipt of the document. The E-Filing system also distributes an email notice that provides access to the document to the NRC's Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the documents on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before a hearing request/petition to intervene is filed so that they can obtain access to the document via the E-Filing system.

A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html, by email to [email protected], or by a toll-free call at 1-866-672-7640. The NRC Meta System Help Desk is available between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday, excluding government holidays.

Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.

Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at http://ehd1.nrc.gov/ehd/, unless excluded pursuant to an order of the Commission, or the presiding officer. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or home phone numbers in their filings, unless an NRC regulation or other law requires submission of such information. However, in some instances, a request to intervene will require including information on local residence in order to demonstrate a proximity assertion of interest in the proceeding. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their submission.

For further details with respect to this action, see the application for license amendment dated May 26, 2015.

Attorney for licensee: Ms. Kathryn M. Sutton, Morgan, Lewis & Bockius LLC, 1111 Pennsylvania Avenue NW., Washington, DC 20004-2514.

NRC Branch Chief: Paul Kallan.

On June 26, 2015, the Postal Service filed notice that it has agreed to an Amendment to the existing Parcel Select & Parcel Return Service Contract 3 negotiated service agreement approved in this docket.1 In support of its Notice, the Postal Service includes a redacted copy of the Amendment.

On June 30, 2015, Chairman's Information Request No. 1 was issued.2 The Postal Service responded to CHIR No. 1 on July 1, 2015, and filed the unredacted amendment under seal.3 The Postal Service seeks to incorporate by reference the Application for Non-Public Treatment originally filed in this docket for the protection of information that it has filed under seal. Notice at 1.

The Amendment describes the assignment and delegation rights under the contract and the package label indicia that will be valid in the event of the assignment, delegation, or transfer of the contract.

The Postal Service intends for the Amendment to become effective one business day after the date that the Commission completes its review of the Notice. Id. The Postal Service asserts that the Amendment will not impair the ability of the contract to comply with 39 U.S.C. 3633. Id.

The Commission invites comments on whether the changes presented in the Postal Service's Notice are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR 3015.5, and 39 CFR part 3020, subpart B. Comments are due no later than July 10, 2015. The public portions of these filings can be accessed via the Commission's Web site (http://www.prc.gov).

The Commission appoints Lyudmila Bzhilyanskaya to represent the interests of the general public (Public Representative) in this docket.

It is ordered:

1. The Commission reopens Docket No. CP2012-22 for consideration of matters raised by the Postal Service's Notice.

2. Pursuant to 39 U.S.C. 505, the Commission appoints Lyudmila Bzhilyanskaya to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.

3. Comments are due no later than July 10, 2015.

4. The Secretary shall arrange for publication of this order in the Federal Register.

The following is a temporary order and a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or an applicant using the Company name box, at http://www.sec.gov/search/search.htm, or by calling (202) 551-8090.

1. Macquarie Capital, a Delaware corporation, is an indirect, wholly-owned subsidiary of Macquarie Group Limited (“MGL”) and a broker-dealer registered under the Securities Exchange Act of 1934 (the “Exchange Act”). MCIM, a Delaware limited liability company, is an indirect, wholly-owned subsidiary of MGL and an investment adviser registered under the Investment Advisers Act of 1940 (the “Advisers Act”). DMC and DIFA are series of DMBT, which is a Delaware statutory trust and an indirect, wholly-owned subsidiary of MGL. DMBT is an investment adviser registered under the Advisers Act. FCCM, a Delaware limited liability company, is a wholly-owned subsidiary of a series of DMBT and an investment adviser registered under the Advisers Act. Delaware Distributors, a Delaware limited partnership, is an indirect, wholly-owned subsidiary of MGL and a broker-dealer registered under the Exchange Act. MFMHK is an indirect, wholly-owned subsidiary of MGL and an investment adviser registered under the Advisers Act. DMC and DIFA, as series of DMBT, MCIM, FCCM, and MFMHK (collectively, the “Adviser Applicants”) each serve as investment adviser or investment sub-adviser to investment companies registered under the Act, or series of such companies (each, a “Fund”) 1 and Delaware Distributors provides principal underwriting services to certain Funds. The Adviser Applicants and Delaware Distributers are collectively referred to as the “Fund Servicing Applicants.”

2. While no existing company of which Macquarie Capital is an affiliated person within the meaning of section 2(a)(3) of the Act (“Affiliated Person”), other than the Fund Servicing Applicants, currently serves as an investment adviser or depositor of any Fund or principal underwriter (as defined in section 2(a)(29) of the Act) for any open-end registered investment company (“Open-End Fund”), registered UIT, or registered FACC (such activities, “Fund Services Activities”), Applicants request that any relief granted also apply to any existing company of which Macquarie Capital is an Affiliated Person and to any other company of which Macquarie Capital may become an Affiliated Person in the future (together with the Fund Servicing Applicants, the “Covered Persons”) 2 with respect to any activity contemplated by section 9(a) of the Act.

3. On March 27, 2015, the Commission filed a complaint (the “Complaint”) in the District Court. According to the Complaint, Macquarie Capital was the lead underwriter on a 2010 secondary public stock offering by Puda Coal, Inc. (“Puda Coal”), which traded on the New York Stock Exchange at the time and purportedly owned a coal company in the People's Republic of China. According to the Complaint, in the offering documents, Puda Coal falsely claimed that it held a 90-percent ownership interest in the Chinese coal company. According to the Complaint, Macquarie Capital repeated those statements in its marketing materials for the offering despite obtaining a report showing that Puda Coal did not possess an ownership interest in the coal company. The Complaint alleges that two former Macquarie Capital employees were negligent by failing to act on due diligence information about the true ownership interest in the Chinese coal company and instead moving forward with the offering.3 The Complaint alleges that Macquarie Capital was negligent as an organization by underwriting and marketing the offering while in possession of this information.

4. On April 1, 2015, the District Court entered an order (the “Court Order”) enjoining Macquarie Capital from violating sections 17(a)(2) and 17(a)(3) of the Securities Act of 1933 (the “Injunction”).4 The Court Order also requires Macquarie Capital to pay $12 million in disgorgement and prejudgment interest and a civil monetary penalty in the amount of $3 million. Macquarie Capital consented to the entry of the Court Order without admitting or denying the allegations in the Complaint (other than those relating to the jurisdiction of the District Court and the jurisdiction of the Commission over the Conduct 5 ).

5. Applicants represent that escrow accounts have been established into which have been or will be deposited amounts equal to the advisory fees paid by the Funds to the Adviser Applicants for the period from April 1, 2015 through May 15, 2015.

1. Section 9(a)(2) of the Act, in relevant part, prohibits a person who has been enjoined from engaging in or continuing any conduct or practice in connection with the purchase or sale of a security, or in connection with activities as an underwriter, broker or dealer, from acting, among other things, as an investment adviser or depositor of any registered investment company or a principal underwriter for any Open-End Fund, UIT or FACC. Section 9(a)(3) of the Act makes the prohibition in section 9(a)(2) applicable to a company, any affiliated person of which has been disqualified under the provisions of section 9(a)(2). Section 2(a)(3) of the Act defines “affiliated person” to include, among others, any person directly or indirectly controlling, controlled by, or under common control with, the other person. Applicants state that, taken together, sections 9(a)(2) and 9(a)(3) have the effect of precluding the Fund Servicing Applicants and Covered Persons from engaging in Fund Services Activities as a result of the Injunction entered against Macquarie Capital because Macquarie Capital is an Affiliated Person of each Fund Servicing Applicant and Covered Person.

2. Section 9(c) of the Act provides that, upon application, the Commission shall by order grant an exemption from the disqualification provisions of section 9(a) of the Act, either unconditionally or on an appropriate temporary or other conditional basis, to any person if that person establishes that: (a) The prohibitions of section 9(a), as applied to the person, are unduly or disproportionately severe or (b) the conduct of the person has been such as not to make it against the public interest or the protection of investors to grant the exemption. Applicants have filed an application pursuant to section 9(c) seeking a Temporary Order and a Permanent Order exempting the Fund Servicing Applicants and other Covered Persons from the disqualification provisions of section 9(a) of the Act. The Fund Servicing Applicants and other Covered Persons may, if the relief is granted, in the future act in any of the capacities contemplated by section 9(a) of the Act subject to the applicable terms and conditions of the Orders. On May 15, 2015, Applicants received a temporary conditional order from the Commission exempting the Covered Persons from section 9(a) of the Act with respect to the Injunction from May 15, 2015 until the Commission takes final action on an application for a Permanent Order or, if earlier, July 14, 2015.

3. Applicants believe they meet the standards for exemption specified in section 9(c). Applicants state that the prohibitions of section 9(a) as applied to them would be unduly and disproportionately severe and that the conduct of Applicants has not been such as to make it against the public interest or the protection of investors to grant the exemption from section 9(a).

4. Applicants state that the alleged Conduct giving rise to the Injunction did not in any way involve any of the Fund Servicing Applicants acting in their capacity as investment adviser, sub-adviser or principal underwriter for the Funds. Applicants also state that the Conduct did not involve any Fund or Fund assets with respect to which Fund Servicing Applicants engaged in Fund Services Activities. In addition, Applicants state that none of the Funds to which Fund Servicing Applicants provide Fund Services Activities purchased, held, or hold securities issued in the 2010 Puda Coal stock offering.

5. Applicants state that: (i) None of the current or former directors, officers or employees of the Fund Servicing Applicants had any involvement in the Conduct and (ii) the personnel who were involved in the Conduct have had no, and will not have any, involvement in providing Fund Services Activities and will not serve as an officer, director, or employee of any Covered Person providing Fund Services Activities. Applicants assert that because the personnel of the Fund Servicing Applicants did not have any involvement in the Conduct, shareholders of Funds that received investment advisory, depository and principal underwriting services from the Fund Servicing Applicants were not affected any differently than if those Funds had received services from any other non-affiliated investment adviser, depositor or principal underwriter.

6. Applicants submit that section 9(a) should not operate to bar them from serving the Funds and their shareholders in the absence of improper practices relating to their Fund Services Activities. Applicants state that the section 9(a) disqualification could result in substantial costs to the Funds to which the Fund Servicing Applicants provide investment advisory services, and such Funds' operations would be disrupted, as they sought to engage new advisers or sub-advisers. Applicants assert that these effects would be unduly severe given the Fund Servicing Applicants' lack of involvement in the Conduct. Moreover, Applicants state that Macquarie Capital has taken remedial actions to address the Conduct, including reviewing its due diligence policies and procedures with the assistance of a number of different outside law firms, as outlined in the application. Thus, Applicants believe that granting the exemption from section 9(a), as requested, would be consistent with the public interest and the protection of investors.

7. Applicants state that the inability of the Fund Servicing Applicants to continue to provide investment advisory services to Funds would result in those Funds and their shareholders facing unduly and disproportionately severe hardships. Applicants assert that imposing the section 9(a) disqualifications upon the Adviser Applicants would deprive the shareholders of certain Funds of the advisory or sub-advisory services that they expected to receive when they decided to invest in the Funds. Applicants state that many shareholders have long-standing investments and relationships with the Funds. Applicants represent that each Adviser Applicant has developed a familiarity and expertise with a particular Fund's operations, and that replacing the Adviser Applicants with another adviser would result in inefficiencies and potential investment losses during a transition period. Applicants assert that disqualification from providing these services would disrupt investment strategies and could potentially result in large net redemptions of shares of the Funds, which in turn could both frustrate efforts to effectively manage the Funds' assets and increase the Funds' expense ratios to the detriment of non-redeeming shareholders. Applicants also note that any effort to find suitable replacement investment advisers and/or sub-advisers would necessarily take time, during which the Funds would lack advisory services, and that the cost to the Funds of obtaining shareholder approval for the new investment advisory or sub-advisory services would be substantial. Applicants further assert that the disqualification of Delaware Distributors would cause the Funds to expend time and resources to find and engage substitute principal underwriters, and that the substitute underwriters would not be able to replicate the selling network established by Delaware Distributors.

8. Applicants also represent that the boards of directors or trustees (the “Boards”) of those Funds for which a Fund Servicing Applicant serves as the primary adviser or principal underwriter have been apprised of the consequences to the relevant Fund Servicing Applicants as a result of the issuance of the Injunction, and that such Boards have requested that the relevant Fund Servicing Applicants continue to provide services to their Funds. Applicants further state that for those Funds for which a Fund Servicing Applicant serves as a sub-adviser, Applicants have provided the primary investment advisers with written materials describing the Conduct, the Injunction, the disqualification under section 9(a) of the Act, and the process for obtaining exemptive relief under section 9(c) of the Act, and that none of the sub-advised Funds or their primary advisers has requested that the Fund Servicing Applicants cease providing sub-advisory services.

9. Applicants state that, once a Permanent Order is issued, the Fund Servicing Applicants will, as soon as reasonably practicable, distribute additional written materials with updated information to the Boards of the Funds. The written materials will include an offer to meet in person with the Boards, including the directors who are not “interested persons” of such Funds as defined in section 2(a)(19) of the Act and their independent legal counsel as defined in rule 0-1(a)(6) under the Act.

10. Applicants represent that they have undertaken to develop procedures reasonably designed to prevent violations of section 9(a) by Fund Servicing Applicants and their affiliated persons. Applicants state that as part of this process their legal and compliance groups have issued a firm-wide communication establishing a procedure whereby the legal and compliance personnel in each of MGL's business groups globally must identify and escalate potential cross-divisional and cross-jurisdictional impacts from a regulatory enforcement matter or litigation, including disqualifying events under applicable securities laws and regulations, to central legal and compliance management, which will further assess the event to determine, among other things, whether there exists any disqualification events under federal securities laws.

11. Applicants represent that they will engage an independent consultant (“Independent Consultant”) to review and test the existing procedures relating to compliance with section 9(a) and to recommend appropriate enhancements to ensure that the procedures are reasonably designed to prevent violations of section 9(a) by Covered Persons. Applicants state that, as part of this process, the Independent Consultant specifically will consider enhancements to the procedures to provide for the escalation of information regarding potential disqualifying events under section 9(a) so that the information may be appropriately analyzed in a timely manner. Applicants further represent that, based on the recommendations of the Independent Consultant, Applicants will implement, within 60 days of the date of the Permanent Order, enhancements to the procedures that are reasonably designed to prevent violations of section 9(a) by Covered Persons. Applicants state that, in the case of Covered Persons that are registered investment advisers, such procedures will be part of their written policies and procedures adopted and implemented pursuant to rule 206(4)-7 under the Advisers Act. In addition, Applicants state that, in the case of Delaware Distributors or any other Covered Person that serves as a principal underwriter to a registered investment company in the future, such procedures will be part of their Written Supervisory Procedures. Applicants represent that the Board of each Fund that has a Covered Person as its primary investment adviser and/or principal underwriter also will review the adequacy of these procedures and the effectiveness of their implementation at or before the next annual review of the policies and procedures of the relevant primary investment adviser and/or principal underwriter in accordance with rule 38a-1 under the Act. Applicants further represent that, for each sub-advised Fund, the Fund Servicing Applicants will transmit such procedures to each Fund's primary investment adviser for consideration by the relevant Board in accordance with rule 38a-1 under the Act.

12. Applicants state that if the Fund Servicing Applicants were barred under section 9(a) of the Act from providing investment advisory services to the Funds, and were unable to obtain the requested exemption, the effect on their businesses and employees would be unduly and disproportionately severe because they have committed substantial capital and other resources to establishing an expertise in advising Funds. Applicants further state that prohibiting the Fund Servicing Applicants from engaging in Fund Services Activities would not only adversely affect their businesses, but would also adversely affect their employees who are involved in those activities. Applicants state that many of these employees working for the Fund Servicing Applicants could experience significant difficulties and/or delays in finding alternative fund-related employment.

13. Applicants state that none of the Applicants has previously applied for an exemptive order under section 9(c) of the Act.

Applicants agree that any order granted by the Commission pursuant to the application will be subject to the following conditions:

1. As a condition to the Temporary Order, Applicants will continue to hold in escrow amounts equal to all advisory fees paid by the Funds to the Adviser Applicants for the period from April 1, 2015 through May 15, 2015. Amounts paid into the escrow accounts will be disbursed to the relevant Funds and/or Adviser Applicants after the Commission has acted on the application for a Permanent Order and discussions with the relevant Funds.

2. Any temporary exemption granted pursuant to the application shall be without prejudice to, and shall not limit the Commission's rights in any manner with respect to, any Commission investigation of, or administrative proceedings involving or against, Covered Persons, including without limitation, the consideration by the Commission of a permanent exemption from section 9(a) of the Act requested pursuant to the application or the revocation or removal of any temporary exemptions granted under the Act in connection with the application.

3. Each Applicant and Covered Person will adopt and implement policies and procedures reasonably designed to ensure that it will comply with any terms and conditions of the Orders within 60 days of the date of the Permanent Order.

4. Macquarie Capital will comply with the Court Order.

5. Applicants will provide written notification to the Chief Counsel of the Commission's Division of Investment Management with a copy to the Chief Counsel of the Commission's Division of Enforcement of a material violation of the terms and conditions of the Orders or Court Order within 30 days of discovery of the material violation.

The Commission has considered the matter and finds that Applicants have made the necessary showing to justify granting a temporary exemption.

Accordingly,

It is hereby ordered, pursuant to section 9(c) of the Act, that the Fund Servicing Applicants and any other Covered Persons are granted a temporary exemption from the provisions of section 9(a) effective forthwith, solely with respect to the Injunction, subject to the representations and conditions in the application, until the date the Commission takes final action on their application for a Permanent Order.

The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of TEXAS, dated 05/29/2015, is hereby amended to include the following areas as adversely affected by the disaster.

All other information in the original declaration remains unchanged.

The notice of the Presidential disaster declaration for the State of TEXAS, dated 05/29/2015 is hereby amended to include the following areas as adversely affected by the disaster:

All other information in the original declaration remains unchanged.

Notice is hereby given that as a result of the President's major disaster declaration on 06/26/2015, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.

The following areas have been determined to be adversely affected by the disaster:

The Interest Rates are:

The number assigned to this disaster for physical damage is 14363B and for economic injury is 14364B.

Boots to Business is an entrepreneurial education initiative offered by the U.S. Small Business Administration (SBA) as a career track within the Department of Defense's revised Training Assistance Program called Transition Goals, Plans, Success (Transition GPS). The curriculum provides valuable assistance to transitioning service members exploring self-employment opportunities by leading them through the key steps for evaluating business concepts and the foundational knowledge required for developing a business plan. Participants are also introduced to SBA resources available to help access startup capital and additional technical assistance.

The Boots to Business Post Course surveys will be online, voluntary surveys that enable the Boots to Business program office to capture data related but not limited to the effectiveness of all Boots to Business courses, quality of the instructors and materials, and number of small businesses created as a result of participating in Boots to Business. Boots to Business will send an initial survey via email to all course participants immediately following course completion to gain insight on the quality of the program. Every 6 months following course completion, a follow up survey will be sent to all participants to measure participant outcomes as we link course effectiveness to the creation of veteran owned small businesses. Participants will be surveyed twice a year for 5 years following course completion to allow time for business creation.

Solicitation of Public Comments:

SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.

Summary of Information Collection:

Title: Boots to Business Post Course Surveys.

Description of Respondents: Service members, veterans and spouses.

Form Number: N/A.

Total Estimated Annual Responses: 26,000.

Total Estimated Annual Hour Burden: 3,474 hours.